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Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study.


ABSTRACT: Interleukin-6 (IL-6) is implicated in rheumatoid arthritis (RA) pathophysiology. Unlike IL-6 receptor inhibitors, sirukumab is a human monoclonal antibody that selectively binds to the IL-6 cytokine. The phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group SIRROUND-D study (ClinicalTrials.gov identifier NCT01604343) evaluated the efficacy and safety of sirukumab in patients with active RA refractory to disease-modifying antirheumatic drugs.Patients were randomised 1:1:1 to treatment with sirukumab 100?mg every 2?weeks, 50?mg every 4?weeks or placebo every 2 weeks subcutaneously. Results through week 52 are reported.Of 1670 randomised patients, significantly more patients achieved American College of Rheumatology 20% (ACR20) response at week 16 (coprimary endpoint) with sirukumab 100?mg every 2 weeks (53.5%) or 50?mg every 4 weeks (54.8%) versus placebo (26.4%; both p<0.001). Mean (SD) change from baseline in modified Sharp/van der Heijde score at week 52 (coprimary endpoint) was significantly lower with sirukumab (100?mg every 2 weeks: 0.46 (3.26); 50?mg every 4 weeks: 0.50 (2.96)) versus placebo (3.69 (9.25); both p<0.001). All major secondary endpoints (week 24 Health Assessment Questionnaire-Disability Index change from baseline, ACR50 response, 28-joint Disease Activity Score based on C reactive protein and major clinical response (ACR70 for six continuous months by week 52)) were met. The most common adverse events with sirukumab were elevated liver enzymes, upper respiratory tract infection, injection site erythema and nasopharyngitis.Sirukumab 100?mg every 2 weeks and 50?mg every 4 weeks led to significant reductions in RA symptoms, inhibition of structural damage progression and physical function and quality of life improvements, with an expected safety profile.NCT01604343; Results.

SUBMITTER: Takeuchi T 

PROVIDER: S-EPMC5705845 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study.

Takeuchi Tsutomu T   Thorne Carter C   Karpouzas George G   Sheng Shihong S   Xu Weichun W   Rao Ravi R   Fei Kaiyin K   Hsu Benjamin B   Tak Paul P PP  

Annals of the rheumatic diseases 20170830 12


<h4>Objectives</h4>Interleukin-6 (IL-6) is implicated in rheumatoid arthritis (RA) pathophysiology. Unlike IL-6 receptor inhibitors, sirukumab is a human monoclonal antibody that selectively binds to the IL-6 cytokine. The phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group SIRROUND-D study (ClinicalTrials.gov identifier NCT01604343) evaluated the efficacy and safety of sirukumab in patients with active RA refractory to disease-modifying antirheumatic drugs.<h4>M  ...[more]

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