Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naïve patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study

Annals of the Rheumatic Diseases
Peter C TaylorBenjamin Hsu

Abstract

This randomised, double-blind, parallel-group, phase 3 study compared monotherapy with sirukumab, an anti-interleukin-6 cytokine monoclonal antibody, with adalimumab monotherapy in patients with rheumatoid arthritis (RA). Biologic-naïve patients with active RA who were inadequate responders or were intolerant to, or inappropriate for, methotrexate were randomised to subcutaneous sirukumab 100 mg every 2 weeks (n=187), sirukumab 50 mg every 4 weeks (n=186) or adalimumab 40 mg every 2 weeks (n=186). Primary endpoints at week 24 were change from baseline in Disease Activity Score in 28 joints (DAS28) using erythrocyte sedimentation rate (ESR) and proportion of patients achieving an American College of Rheumatology (ACR) 50 response; these endpoints were tested in sequential order. This study is registered at EudraCT (number: 2013-001417-32) and ClinicalTrials.gov (number: NCT02019472). Significantly greater improvements from baseline in mean (SD) DAS28 (ESR) were observed at week 24 with sirukumab 100 mg every 2 weeks (-2.96 (1.580)) versus adalimumab 40 mg every 2 weeks (-2.19 (1.437); P<0.001). Sirukumab 50 mg every 4 weeks also showed significantly greater improvement from baseline at week 24 in DAS28 (ESR) (-2.58 (1.524)) comp...Continue Reading

References

Sep 11, 2002·Cytokine & Growth Factor Reviews·Katsuhiko Ishihara, Toshio Hirano
Aug 11, 2006·Arthritis Research & Therapy·Cem Gabay
Apr 14, 2011·JAMA : the Journal of the American Medical Association·Geertje M BarteldsGerrit Jan Wolbink
Sep 2, 2011·The Journal of Clinical Investigation·Simon A JonesStefan Rose-John
Jul 31, 2014·Annals of the Rheumatic Diseases·Peter C TaylorMichael Weinblatt
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Nov 8, 2015·Arthritis & Rheumatology·Jasvinder A SinghTimothy McAlindon
Sep 1, 2017·Annals of the Rheumatic Diseases·Tsutomu TakeuchiPaul P Tak

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Citations

Mar 5, 2018·Rheumatology and Therapy·Andrea Rubbert-RothErhan Berber
Sep 25, 2020·International Journal of Rheumatic Diseases·Wee Fang Yap, Hwee Cheng Chong
Apr 25, 2020·Nature Reviews. Rheumatology·Ernest H ChoyTadamitsu Kishimoto
Jul 3, 2020·Therapeutic Advances in Musculoskeletal Disease·Gerasimos EvangelatosGeorge E Fragoulis
Nov 30, 2018·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Ali Berkant AvciGerd Rüdiger Burmester
Nov 13, 2019·Seminars in Cancer Biology·Pathum S ThilakasiriAshwini L Chand
Feb 18, 2021·Journal of Neuroinflammation·Elnaz RoohiFarshad Hashemian
Apr 21, 2021·Expert Review of Clinical Immunology·Nicola PotereAldo Bonaventura
Dec 18, 2021·Experimental & Molecular Medicine·Soon Sang ParkTae Jun Park

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