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.

Autor:	Taylor PC; NDORMS, Botnar Research Centre, University of Oxford, Oxford, UK., Schiff MH; School of Medicine, University of Colorado, Greenwood Village, Colorado, USA., Wang Q; Janssen Research & Development, Spring House, Pennsylvania, USA., Jiang Y; Janssen Research & Development, Spring House, Pennsylvania, USA., Zhuang Y; Janssen Research & Development, Spring House, Pennsylvania, USA., Kurrasch R; GlaxoSmithKline, Collegeville, Pennsylvania, USA., Daga S; GlaxoSmithKline, Uxbridge, UK., Rao R; GlaxoSmithKline, Stevenage, UK., Tak PP; GlaxoSmithKline, Stevenage, UK., Hsu B; Janssen Research & Development, Spring House, Pennsylvania, USA.
Jazyk:	angličtina
Zdroj:	Annals of the rheumatic diseases [Ann Rheum Dis] 2018 May; Vol. 77 (5), pp. 658-666. Date of Electronic Publication: 2018 Feb 26.
DOI:	10.1136/annrheumdis-2017-212496
Abstrakt:	Objective: 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). Methods: 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). Results: 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)) compared with adalimumab (P=0.013). The ACR50 response rates with the 100 mg (35.3%) and 50 mg (26.9%) doses of sirukumab were comparable to that with adalimumab (31.7%) at week 24. The safety profile of sirukumab was consistent with that observed with anti-interleukin-6 receptor antibodies. A dose-related effect on the incidence of injection-site reactions was observed with sirukumab. Conclusion: Sirukumab monotherapy showed greater improvements in DAS28 (ESR), but similar ACR50 response rates, versus adalimumab monotherapy. Competing Interests: Competing interests: PCT has served as a consultant to AbbVie, Biogen, Bristol-Myers Squibb, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche, Sandoz and UCB Pharma, and has received research grant funding from Celgene, GlaxoSmithKline, Janssen and UCB Pharma. MHS has served as a consultant to AbbVie, Bristol-Myers Squibb, Johnson & Johnson, Eli Lilly and UCB Pharma, and as a speaker for AbbVie and Bristol-Myers Squibb. QW, YZ and BH are employees and shareholders of Janssen Research & Development. YJ is a contractor of Janssen Research & Development. RK, SD, RR and PPT are employees and shareholders of GlaxoSmithKline. (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
Databáze:	MEDLINE
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