[en] Background: Treatment choices for patients with inflammatory bowel disease (IBD) are based on the balance between risks and benefits. Our AI was to compare the perspectives of patients and physicians in evaluating the risks and benefits before initiating therapy for IBD. Methods: An anonymous survey was conducted between March and August 2022. All patients with confirmed IBD and all physicians who attended an IBDscope webinar were invited to participate. Results: In total, 367 patients and 146 physicians participated. For most patients (71.4%) and physicians (89.0%), efficacy and safety were equally important. Clinical improvement and clinical remission were the most relevant outcomes for patients (90.9 and 88.4), while clinical remission and endoscopic remission were for physicians (90.0 and 87.6). The main factors in the benefit-risk assessment were quality of life (95.1%), disease activity (87.5%), and presence of comorbidities (84.5%) for patients, and presence of comorbidities (99.3%), disease activity (97.9%), and prior failure to biologics/small molecules (96.6%) for physicians. Based on patients’ and physicians’ opinions, the risk of serious infections, malignancies, cardiovascular events, death, relapse, all infections, surgery, and hospitalization should be included in the benefit-risk assessment. Conclusion: Physicians and patients have different priorities in evaluating the benefit-risk balance of a new therapy.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
D’Amico, Ferdinando; Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, 20132 Milan, Italy ; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20090 Milan, Italy
Vieujean, Sophie ; Centre Hospitalier Universitaire de Liège - CHU > > Service de gastroentérologie, hépatologie, onco. digestive
Caron, Benedicte; INSERM, NGERE, University of Lorraine, F-54000 Nancy, France ; Department of Gastroenterology, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France
Peyrin-Biroulet, Laurent; INSERM, NGERE, University of Lorraine, F-54000 Nancy, France ; Department of Gastroenterology, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France
Danese, Silvio ; Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, 20132 Milan, Italy
Language :
English
Title :
Risk-Benefit of IBD Drugs: A Physicians and Patients Survey
Ungaro R. Mehandru S. Allen P.B. Peyrin-Biroulet L. Colombel J.-F. Ulcerative colitis Lancet 2017 389 1756 1770 10.1016/S0140-6736(16)32126-2 27914657
Roda G. Chien Ng S. Kotze P.G. Argollo M. Panaccione R. Spinelli A. Kaser A. Peyrin-Biroulet L. Danese S. Crohn’s disease Nat. Rev. Dis. Prim. 2020 6 22 10.1038/s41572-020-0156-2 32242028
Raine T. Bonovas S. Burisch J. Kucharzik T. Adamina M. Annese V. Bachmann O. Bettenworth D. Chaparro-Sanchez M. Czuber-Dochan W. et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment J. Crohn’s Colitis 2021 jjab178 10.1093/ecco-jcc/jjab178 34635919
Torres J. Bonovas S. Doherty G. Kucharzik T. Gisbert J.P. Raine T. Adamina M. Armuzzi A. Bachmann O. Bager P. et al. ECCO Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment J. Crohn’s Colitis 2020 14 4 22 10.1093/ecco-jcc/jjz180 31711158
Turner D. Ricciuto A. Lewis A. D’Amico F. Dhaliwal J. Griffiths A.M. Bettenworth D. Sandborn W.J. Sands B.E. Reinisch W. 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 1583 10.1053/j.gastro.2020.12.031
Raine T. Danese S. Breaking Through the Therapeutic Ceiling: What Will It Take? Gastroenterology 2022 162 1507 1511 10.1053/j.gastro.2021.09.078
Caron B. D’Amico F. Jairath V. Netter P. Danese S. Peyrin-Biroulet L. Available methods for benefit-risk assessment: Lessons for inflammatory bowel disease drugs J. Crohn’s Colitis 2022 jjac113 10.1093/ecco-jcc/jjac113
Palomba S. Sereni G. Falbo A. Beltrami M. Lombardini S. Boni M.C. Fornaciari G. Sassatelli R. La Sala G.B. Inflammatory bowel diseases and human reproduction: A comprehensive evidence-based review World J. Gastroenterol. 2014 20 7123 7136 10.3748/wjg.v20.i23.7123
Boeri M. Myers K. Ervin C. Marren A. DiBonaventura M. Cappelleri J.C. Hauber B. Rubin D.T. Patient and physician preferences for ulcerative colitis treatments in the United States Clin. Exp. Gastroenterol. 2019 12 263 278 10.2147/CEG.S206970
Barello S. Guida E. Leone S. Previtali E. Graffigna G. Does patient engagement affect IBD patients’ health-related quality of life? Findings from a cross-sectional study among people with inflammatory bowel diseases Health Qual. Life Outcomes 2021 19 77 10.1186/s12955-021-01724-w
Barnes E.L. Long M.D. Kappelman M.D. Martin C.F. Sandler R.S. High Patient Activation Is Associated with Remission in Patients with Inflammatory Bowel Disease Inflamm. Bowel Dis. 2019 25 1248 1254 10.1093/ibd/izy378 30590700
Jairath V. Zou G.Y. Parker C.E. MacDonald J.K. AlAmeel T. Al Beshir M. Almadi M.A. Al-Taweel T. Atkinson N.S. Biswas S. et al. Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis Cochrane Database Syst. Rev. 2017 9 CD011572 10.1002/14651858.CD011572.pub2 28886205
Loftus E.V. Colombel J.-F. Takeuchi K. Gao X. Panaccione R. Danese S. Dubinsky M. Schreiber S. Ilo D. Finney-Hayward T. et al. Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1 of Induction Treatment Clin. Gastroenterol. Hepatol. 2022 10.1016/j.cgh.2022.11.029 36464141
D’Amico F. Magro F. Peyrin-Biroulet L. Danese S. Positioning Filgotinib in the Treatment Algorithm of Moderate to Severe Ulcerative Colitis J. Crohn’s Colitis 2022 16 835 844 10.1093/ecco-jcc/jjab206 34791103
Long M.D. Afzali A. Fischer M. Hudesman D. Abdalla M. McCabe R. Cohen B.L. Ungaro R.C. Harlan W. Hanson J. et al. Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting Inflamm. Bowel Dis. 2022 29 570 578 10.1093/ibd/izac121
Siegmund B. Axelrad J. Pondel M. Osterman M.T. Ahmad H.A. Memaj A. Regueiro M. Armuzzi A. Afzali A. DOP43 Rapidity of ozanimod-induced symptomatic response and remission in patients with moderately to severely active Ulcerative Colitis: Results from the induction period of True North J. Crohn’s Colitis 2022 16 i092 i093 10.1093/ecco-jcc/jjab232.082
Zhao M. Gönczi L. Lakatos P.L. Burisch J. The Burden of Inflammatory Bowel Disease in Europe in 2020 J. Crohn’s Colitis 2021 15 1573 1587 10.1093/ecco-jcc/jjab029
Singh S. Murad M.H. Fumery M. Sedano R. Jairath V. Panaccione R. Sandborn W.J. Ma C. Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn’s disease: A systematic review and network meta-analysis Lancet Gastroenterol. Hepatol. 2021 10.1016/S2468-1253(21)00312-5
Piovani D. Danese S. Peyrin-Biroulet L. Nikolopoulos G.K. Bonovas S. Systematic review with meta-analysis: Biologics and risk of infection or cancer in elderly patients with inflammatory bowel disease Aliment. Pharmacol. Ther. 2020 51 820 830 10.1111/apt.15692
Solitano V. Facciorusso A. Jess T. Ma C. Hassan C. Repici A. Jairath V. Armuzzi A. Singh S. Comparative Risk of Serious Infections with Biologic Agents and Oral Small Molecules in Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis Clin. Gastroenterol. Hepatol. 2022 10.1016/j.cgh.2022.07.032
Burr N.E. Gracie D.J. Black C.J. Ford A.C. Efficacy of biological therapies and small molecules in moderate to severe ulcerative colitis: Systematic review and network meta-analysis Gut 2021 71 1976 1987 10.1136/gutjnl-2021-326390 34937767
Lasa J.S. Olivera P.A. Danese S. Peyrin-Biroulet L. Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: A systematic review and network meta-analysis Lancet Gastroenterol. Hepatol. 2022 7 161 170 10.1016/S2468-1253(21)00377-0 34856198
Singh S. George J. Boland B.S. Vande Casteele N. Sandborn W.J. Primary Non-Response to Tumor Necrosis Factor Antagonists is Associated with Inferior Response to Second-line Biologics in Patients with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis J. Crohn’s Colitis 2018 12 635 643 10.1093/ecco-jcc/jjy004 29370397
Gisbert J.P. Panés J. Loss of response and requirement of infliximab dose intensification in Crohn’s disease: A review Am. J. Gastroenterol. 2009 104 760 767 10.1038/ajg.2008.88
Billioud V. Sandborn W.J. Peyrin-Biroulet L. Loss of response and need for adalimumab dose intensification in Crohn’s disease: A systematic review Am. J. Gastroenterol. 2011 106 674 684 10.1038/ajg.2011.60 21407178
Peyrin-Biroulet L. Danese S. Argollo M. Pouillon L. Peppas S. Gonzalez-Lorenzo M. Lytras T. Bonovas S. Loss of Response to Vedolizumab and Ability of Dose Intensification to Restore Response in Patients With Crohn’s Disease or Ulcerative Colitis: A Systematic Review and Meta-analysis Clin. Gastroenterol. Hepatol. 2019 17 838 846.e2 10.1016/j.cgh.2018.06.026 29935327
Alayo Q.A. Fenster M. Altayar O. Glassner K.L. Llano E. Clark-Snustad K. Patel A. Kwapisz L. Yarur A.J. Cohen B.L. et al. Systematic Review with Meta-analysis: Safety and Effectiveness of Combining Biologics and Small Molecules in Inflammatory Bowel Disease Crohn’s Colitis 360 2022 4 otac002 10.1093/crocol/otac002
Ahmed W. Galati J. Kumar A. Christos P.J. Longman R. Lukin D.J. Scherl E. Battat R. Dual Biologic or Small Molecule Therapy for Treatment of Inflammatory Bowel Disease: A Systematic Review and Meta-analysis Clin. Gastroenterol. Hepatol. 2022 20 e361 e379 10.1016/j.cgh.2021.03.034
Yang E. Panaccione N. Whitmire N. Dulai P.S. Vande Casteele N. Singh S. Boland B.S. Collins A. Sandborn W.J. Panaccione R. et al. Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn’s disease Aliment. Pharmacol. Ther. 2020 51 1031 1038 10.1111/apt.15719
Danese S. Parigi T.L. Peyrin-Biroulet L. Ghosh S. Defining difficult-to-treat inflammatory bowel disease: Why and how Lancet Gastroenterol. Hepatol. 2021 6 520 522 10.1016/S2468-1253(21)00141-2
Parigi T.L. D’Amico F. Abreu M.T. Rubin D.T. Dignass A. Dotan I. Jairath V. Magro F. Peyrin-Biroulet L. Ghosh S. et al. Difficult-to-treat inflammatory bowel disease: Results from a global IOIBD survey Lancet Gastroenterol. Hepatol. 2022 7 390 391 10.1016/S2468-1253(22)00085-1 35397241