Investigating sirukumab for rheumatoid arthritis: 2-year results from the phase III SIRROUND-D study

Carter Thorne, Tsutomu Takeuchi, George Athanasios Karpouzas, Shihong Sheng, Regina Kurrasch, Kaiyin Fei, Benjamin Hsu

Research output: Contribution to journalArticle

Abstract

Objectives The phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group SIRROUND-D study evaluated long-term efficacy and safety of the interleukin (IL)-6 inhibitor, sirukumab, in patients with active rheumatoid arthritis (RA) refractory to disease-modifying antirheumatic drugs (DMARDs). Methods Patients were randomised 1:1:1 to sirukumab 100mg every 2 weeks (q2w), 50mg every 4 weeks or placebo q2w subcutaneously. Patients initially randomised to placebo were rerandomised at Weeks 18, 40 or 52 to one of the sirukumab groups until Week 104. Results Of 1670 randomised patients, 1402 were included in the full analysis set and 1269 in the radiographic analysis set at Week 104. American College of Rheumatology scores, Disease Activity Score based on C-reactive protein, Clinical Disease Activity Index and clinically meaningful improvements in patient-reported outcomes were sustained at Week 104 among patients initially randomised to sirukumab. Placebo patients subsequently rerandomised to sirukumab showed clinical improvements at Week 104 that were comparable to results among patients initially randomised to sirukumab. Radiographic progression from Week 52 to Week 104 was comparable between all groups whether initially randomised to sirukumab or subsequently rerandomised to sirukumab from placebo. No new safety signals were identified in the extended exposure period compared with the initial 52 weeks of treatment. Conclusions Sirukumab treatment resulted in sustained reductions in clinical signs and symptoms and minimal progression in radiographic damage over 2 years among patients with RA refractory to DMARDs. The safety profile of sirukumab was as expected for an anti-IL-6 agent, with no new signals reported.

Original languageEnglish
Article numbere000731
JournalRMD Open
Volume4
Issue number2
DOIs
Publication statusPublished - 2018 Nov 1
Externally publishedYes

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Rheumatoid Arthritis
Placebos
Antirheumatic Agents
Safety
Interleukin-6
sirukumab
C-Reactive Protein
Signs and Symptoms
Therapeutics

Keywords

  • cytokines
  • DMARDs (biologic)
  • DMARDs (synthetic)
  • rheumatoid arthritis
  • treatment

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Investigating sirukumab for rheumatoid arthritis : 2-year results from the phase III SIRROUND-D study. / Thorne, Carter; Takeuchi, Tsutomu; Karpouzas, George Athanasios; Sheng, Shihong; Kurrasch, Regina; Fei, Kaiyin; Hsu, Benjamin.

In: RMD Open, Vol. 4, No. 2, e000731, 01.11.2018.

Research output: Contribution to journalArticle

Thorne, Carter ; Takeuchi, Tsutomu ; Karpouzas, George Athanasios ; Sheng, Shihong ; Kurrasch, Regina ; Fei, Kaiyin ; Hsu, Benjamin. / Investigating sirukumab for rheumatoid arthritis : 2-year results from the phase III SIRROUND-D study. In: RMD Open. 2018 ; Vol. 4, No. 2.
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