[en] [en] BACKGROUND: Glucocorticoids (GCs) are standard treatment for giant cell arteritis (GCA). Many patients experience relapses or GC-related toxicity. Secukinumab, a fully human monoclonal antibody that selectively inhibits interleukin-17A, is being studied as additional therapy for GCA.
METHODS: GCAptAIN was a randomized, parallel-group, double-blind, placebo-controlled, multicenter phase 3 trial. Patients with new-onset or relapsing GCA were initially randomly assigned (2:1) to either 300 mg of secukinumab (SEC-300) or placebo for 52 weeks. After a protocol amendment, patients were randomly assigned (1:1:1) to either SEC-300, 150 mg of secukinumab (SEC-150), or placebo. Patients in the SEC-300 and SEC-150 groups received a 26-week GC taper. Patients in the placebo group received a 52-week GC taper. The primary outcome was the proportion of patients experiencing sustained remission in the SEC-300 versus placebo groups at week 52. Sustained remission in patients in the SEC-150 group versus patients in the placebo group enrolled after the protocol amendment was a secondary outcome. Adverse events (AEs) and serious AEs (SAEs) were assessed.
RESULTS: A total of 140 patients in the SEC-300 group, 98 in the SEC-150 group, and 115 in the placebo group (19 patients were enrolled in the placebo group before and 96 after the protocol amendment) were analyzed for efficacy and safety. The proportion of patients achieving sustained remission at week 52 was 25.6% for SEC-300 versus 16.9% for placebo (marginal difference: 8.7 percentage points; 95% confidence interval [CI], -1.3 to 18.8; P=0.09) and 19.4% for SEC-150 versus 17.7% for placebo (marginal difference, 1.6 percentage points; 95% CI, -9.2 to 12.4). AEs occurred in 92.9%, 95.9%, and 97.4% of patients in the SEC-300, SEC-150, and placebo groups, respectively. SAEs occurred in 20.0%, 27.6%, and 32.2% of patients in the SEC-300, SEC-150, and placebo groups, respectively. Serious infections occurred in 5.0%, 9.2%, and 6.1% of patients in the SEC-300, SEC-150, and placebo groups, respectively.
CONCLUSIONS: Sustained remission at week 52 did not differ significantly between patients with GCA randomly assigned to receive SEC-300 with a 26-week GC taper versus placebo with a 52-week GC taper. (Funded by Novartis Pharma; EudraCT number, 2020-004809-31; ClinicalTrials.gov number, NCT04930094.).
Disciplines :
Rheumatology
Author, co-author :
Stone, John H; Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
Venhoff, Nils; Department of Rheumatology and Clinical Immunology, Medical Center, University of Freiburg, Freiburg, Germany
Buttgereit, Frank; Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany ; Deutsches Rheumaforschungszentrum, ein Institut der Leibniz Gemeinschaft, Berlin, Germany
Dejaco, Christian; Department of Rheumatology, Hospital of Brunico, Südtiroler Sanitätsbetrieb - Azienda Sanitaria dell'Alto Adige (SABES-ASAA), Teaching Hospital of the Paracelsus University, Brunico, Italy ; Department of Rheumatology and Immunology, Medical University of Graz, Graz, Austria
Schmidt, Wolfgang A; Immanuel Krankenhaus Berlin, Medical Center for Rheumatology Berlin-Buch, Berlin, Germany ; Rheumatology, Waldfriede Hospital, Berlin, Germany
Spiera, Robert; Department of Medicine, Hospital for Special Surgery, New York, NY, USA
Blanco, Ricardo; Servicio de Reumatología, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Medicine and Psychiatry Department, University of Cantabria, Santander, Spain
Rubbert-Roth, Andrea; Department of Rheumatology, University of Zurich, Zurich, Switzerland
Von Frenckell, Christian ; Université de Liège - ULiège > Département des sciences cliniques ; Centre Hospitalier Universitaire de Liège - CHU > > Service de rhumatologie
Blockmans, Daniel; Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium ; Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium
Terrier, Benjamin; Department of Internal Medicine, National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France ; Université Paris Cité, Paris, France
Tracey, Gerald; Paradise Arthritis and Rheumatology, Gold Coast, QLD, Australia ; Griffith University, Brisbane, QLD, Australia
Hauge, Ellen Margrethe; Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark ; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
Keyport, Monica Pastoral; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
Ng, Jennifer; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
Hiremath, Renuka; Novartis Healthcare Pvt Ltd, Hyderabad, India
Fu, Rong; China Novartis Institutes for Biomedical Research, Shanghai, China
Cho, GaEun; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
Thiel, Jens; Department of Rheumatology and Clinical Immunology, Medical Center, University of Freiburg, Freiburg, Germany ; Department of Rheumatology and Immunology, Medical University of Graz, Graz, Austria
Mendelson, Meryl H; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
