Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn's Disease.

Antibodies, Monoclonal; 90ZX3Q3FR7 (risankizumab); FU77B4U5Z0 (Ustekinumab); Adult; Female; Humans; Male; Middle Aged; Young Adult; Antibodies, Monoclonal/therapeutic use/adverse effects; Crohn Disease/diagnosis/drug therapy; Intention to Treat Analysis; Remission Induction; Severity of Illness Index; Ustekinumab/therapeutic use/adverse effects; Endoscopy, Gastrointestinal

Abstract :

[en] BACKGROUND: The efficacy and safety of risankizumab as compared with ustekinumab in patients with Crohn's disease are unknown. METHODS: In this phase 3b, multicenter, open-label, randomized, controlled trial with blinded assessment of end points, patients with moderate-to-severe Crohn's disease who had had an inadequate response to anti-tumor necrosis factor (TNF) therapy or unacceptable side effects with such therapy were randomly assigned to receive risankizumab or ustekinumab at standard doses for 48 weeks. The two primary end points, which were tested sequentially, were clinical remission at week 24 (defined as a Crohn's Disease Activity Index score of <150 [range, 0 to 600, with higher scores indicating more severe disease activity]), which was analyzed in the first 50% of patients to complete the week 24 visit, with a noninferiority margin of 10 percentage points; and endoscopic remission at week 48 (defined as a score of ≤4, a decrease of ≥2 points from baseline, and no subscore >1 in any individual variable on the Simple Endoscopic Score for Crohn's Disease [range, 0 to 56, with higher scores indicating more severe disease]), which was analyzed for superiority in 100% of the patients. Safety was assessed in all patients who received at least one dose of risankizumab or ustekinumab. RESULTS: In the full intention-to-treat population for the efficacy analysis, 230 of 255 patients (90.2%) who received risankizumab and 193 of 265 patients (72.8%) who received ustekinumab completed all the assigned treatments. Both primary end points were met; risankizumab was noninferior to ustekinumab with respect to clinical remission at week 24 (58.6% vs. 39.5%; adjusted difference, 18.4 percentage points; 95% confidence interval [CI], 6.6 to 30.3) and superior to ustekinumab with respect to endoscopic remission at week 48 (31.8% vs. 16.2%; adjusted difference, 15.6 percentage points; 95% CI, 8.4 to 22.9; P<0.001). The incidence of adverse events appeared to be similar in the two groups. CONCLUSIONS: In this head-to-head clinical trial of risankizumab and ustekinumab involving patients with moderate-to-severe Crohn's disease who had had unacceptable side effects with anti-TNF therapy or an inadequate response to such therapy, risankizumab was noninferior to ustekinumab with respect to clinical remission at week 24 and superior with respect to endoscopic remission at week 48. (Funded by AbbVie; ClinicalTrials.gov number, NCT04524611.).

Disciplines :

Gastroenterology & hepatology

Author, co-author :

Peyrin-Biroulet, Laurent; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Chapman, J Casey; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Colombel, Jean-Frederic; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Caprioli, Flavio; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

D'Haens, Geert; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Ferrante, Marc; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Schreiber, Stefan; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Atreya, Raja; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Danese, Silvio; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Lindsay, James O; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Bossuyt, Peter; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Siegmund, Britta; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Irving, Peter M; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Panaccione, Remo; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Cao, Qian; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Neimark, Ezequiel; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Wallace, Kori; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Anschutz, Toni; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Kligys, Kristina; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Duan, W Rachel; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Pivorunas, Valerie; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Huang, Xiu; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Berg, Sofie; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Shu, Lei; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

Dubinsky, Marla; From the Department of Gastroenterology, INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France (L.P.-B.), the Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal (L.P.-B.), and the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB (R.P.) - both in Canada, the Crohn's and Colitis Center at the Baton Rouge General and the GI Alliance, Baton Rouge, LA (J.C.C.), the Henry D. Janowitz Division of Gastroenterology, Department of Medicine (J.-F.C.), and the Susan and Leonard Feinstein IBD Center (M.D.), Icahn School of Medicine at Mount Sinai, New York, the Department of Pathophysiology and Transplantation, Università degli Studi di Milano and the Unit of Gastroenterology and Endoscopy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano (F.C.), and Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele (S.D.) - both in Milan, the Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam (G.D.), the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven (M.F.), and the Imelda GI Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden (P.B.) - both in Belgium, the Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel (S.S.), the Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (R.A.), and the Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin (B.S.) - all in Germany, the Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (J.O.L.), the Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust (P.M.I.), and the School of Immunology and Microbial Sciences, King's College London (P.M.I.) - all in London, the Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (Q.C.), and AbbVie, North Chicago, IL (E.N., K.W., T.A., K.K., W.R.D., V.P., X.H., S.B., L.S.).

More authors (16 more)

Other collaborator :

Louis, Edouard ; Université de Liège - ULiège > Département des sciences cliniques > Hépato-gastroentérologie

Balderramo, Domingo

De Paula, Juan

Goncalves, Silvina

Gonzalez, Raquel Analia

Lasa, Juan

Novillo, Abel

Zubiaurre, Ignacio

Begun, Jakob

Moore, Gregory

More authors (290 more)

Language :

English

Title :

Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn's Disease.

Publication date :

18 July 2024

Journal title :

New England Journal of Medicine

ISSN :

0028-4793

eISSN :

1533-4406

Publisher :

Massachusetts Medical Society, Us ma

Volume :

391

Issue :

Pages :

213-223

Peer reviewed :

Peer Reviewed verified by ORBi

Additional URL :

https://www.nejm.org/doi/10.1056/NEJMoa2314585

Funders :

AbbVie

Commentary :

Available on ORBi :

since 05 February 2025

Statistics

Number of views

7 (0 by ULiège)

Number of downloads

0 (0 by ULiège)

More statistics

Scopus citations^®

Scopus citations^®
without self-citations

OpenCitations

OpenAlex citations

Bibliography

Roda G, Chien Ng S, Kotze PG, et al. Crohn’s disease. Nat Rev Dis Primers 2020; 6:22.
Pouillon L, Travis S, Bossuyt P, Danese S, Peyrin-Biroulet L. Head-to-head trials in inflammatory bowel disease: past, present and future. Nat Rev Gastroenterol Hepatol 2020;17:365-76.
Atreya R, Neurath MF, Siegmund B. Personalizing treatment in IBD: hype or reality in 2020? Can we predict response to Anti-TNF? Front Med (Lausanne) 2020; 7:517.
Eder P, Michalak M, Katulska K, et al. Magnetic resonance enterographic predictors of one-year outcome in ileal and ileocolonic Crohn’s disease treated with anti-tumor necrosis factor antibodies. Sci Rep 2015;5:10223.
Sochal M, Krzywdzińska M, Gabryelska A, Talar-Wojnarowska R, Białasiewicz P, Małecka-Panas E. A simple index to predict the efficiency of adalimumab treatment in Crohn disease with a limited duration of therapy. Pol Arch Intern Med 2020;130:910-2 (https://www.mp.pl/paim/issue/article/15507).
Stidham RW, Lee TCH, Higgins PDR, et al. Systematic review with network meta-analysis: the efficacy of anti-TNF agents for the treatment of Crohn’s disease. Aliment Pharmacol Ther 2014;39: 1349-62.
Gisbert JP, Chaparro M. Primary failure to an anti-TNF agent in inflammatory bowel disease: switch (to a second anti-TNF agent) or swap (for another mechanism of action)? J Clin Med 2021;10:5318.
Singh S, Fumery M, Sandborn WJ, Murad MH. Systematic review and network meta-analysis: first- and second-line biologic therapies for moderate-severe Crohn’s disease. Aliment Pharmacol Ther 2018;48:394-409.
Dubinsky M, Ma C, Griffith J, et al. Matching-adjusted indirect comparison between risankizumab and ustekinumab for induction and maintenance treatment of moderately to severely active Crohn’s disease. Adv Ther 2023;40:3896-911.
Barberio B, Gracie DJ, Black CJ, Ford AC. Efficacy of biological therapies and small molecules in induction and maintenance of remission in luminal Crohn’s disease: systematic review and network meta-analysis. Gut 2023;72:264-74.
Han B, Tang D, Lv X, et al. Comparative efficacy and safety of combination therapy with infliximab for Crohn’s disease: a systematic review and network meta-analysis. Int J Colorectal Dis 2023;38:82.
Wu G, Yang Y, Liu M, Wang Y, Guo Q. Systematic review and network meta-analysis: comparative efficacy and safety of biosimilars, biologics and JAK1 inhibitors for active Crohn Disease. Front Pharmacol 2021;12:655865.
Pugliese D, Onali S, Privitera G, Armuzzi A, Papi C. Comparative effectiveness research: a roadmap to sail the seas of IBD therapies. J Clin Med 2022;11:6717.
Ahuja D, Singh S. Comparative efficacy trials in inflammatory bowel disease: current and future implications for practice. Curr Opin Gastroenterol 2022; 38:337-46.
Sands BE, Irving PM, Hoops T, et al. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn’s disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet 2022;399: 2200-11.
Chyuan I-T, Lai J-H. New insights into the IL-12 and IL-23: from a molecular basis to clinical application in immune-mediated inflammation and cancers. Biochem Pharmacol 2020;175:113928.
Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet 2008;371:1665-74.
Langley RG, Lebwohl M, Krueger GG, et al. Long-term efficacy and safety of ustekinumab, with and without dosing adjustment, in patients with moderate-to-severe psoriasis: results from the PHOENIX 2 study through 5 years of follow-up. Br J Dermatol 2015;172:1371-83.
Krueger JG, Ferris LK, Menter A, et al. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2015;136(1):116-124.e7.
Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis 2022;81:225-31.
D’Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet 2022;399:2015-30.
Ferrante M, Panaccione R, Baert F, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet 2022;399:2031-46.
Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis 2022;81:351-8.
Papp KA, Blauvelt A, Bukhalo M, et al. Risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis. N Engl J Med 2017;376:1551-60.
Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet 2018;392:650-61.
Papp KA, de Vente S, Zeng J, Flack M, Padilla B, Tyring SK. Long-term safety and efficacy of risankizumab in patients with moderate-to-severe chronic plaque psoriasis: results from a phase 2 open-label extension trial. Dermatol Ther (Heidelb) 2021;11:487-97.
Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med 2016;375:1946-60.
Louis E, Panaccione R, Parkes G, et al. OP06 risankizumab maintenance therapy in patients with moderately to severely active ulcerative colitis: efficacy and safety in the randomised phase 3 COMMAND study. Crohn’s Colitis 2024;18:Suppl 1: i10-i12 (https://academic.oup.com/ecco-jcc/article/18/Supplement_1/i10/7586101).
Louis E, Panaccione R, Parkes G, et al. S845 Risankizumab induction therapy in patients with moderately to severely active ulcerative colitis: efficacy and safety in the randomized phase 3 INSPIRE study. Am J Gastroenterol 2023;118:(10S):S624-S625 (https://journals.lww.com/ajg/fulltext/2023/10001/s845_risankizumab_induction_therapy_in_patients.1384.aspx).
Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2019;381:1201-14.
Sandborn WJ, Feagan BG, Hanauer SB, et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn’s disease. Gastroenterology 2002;122:512-30.
Daperno M, D’Haens G, Van Assche G, et al. Development and validation of a new, simplified endoscopic activity score for Crohn’s disease: the SES-CD. Gastrointest Endosc 2004;60:505-12.
Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn’s disease activity index: National Cooperative Crohn’s Disease Study. Gastroenterology 1976;70:439-44.
Olivera P, Sandborn WJ, Panés J, et al. Physicians’ perspective on the clinical meaningfulness of inflammatory bowel disease trial results: an International Organization for the Study of Inflammatory Bowel Disease (IOIBD) survey. Aliment Pharmacol Ther 2018;47:773-83.
Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology 2021;160:1570-83.
Zhou L, Wang Y, Wan Q, et al. A nonclinical comparative study of IL-23 antibodies in psoriasis. MAbs 2021;13:1964420.
Meyaard L, Hovenkamp E, Otto SA, Miedema F. IL-12-induced IL-10 production by human T cells as a negative feedback for IL-12-induced immune responses. J Immunol 1996;156:2776-82.
Rutgeerts P, Gasink C, Chan D, et al. Efficacy of ustekinumab for inducing endoscopic healing in patients with Crohn’s disease. Gastroenterology 2018;155:1045-58.