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FRI0251 SIRUKUMAB, an ANTI-IL-6 cytokine monoclonal antibody, leads to improvements in work productivity and general health status in patients with active rheumatoid arthritis refractory to ANTI-TNF therapy: results from the phase 3 SIRROUND-T study
  1. Y Tanaka1,
  2. D Aletaha2,
  3. S Peterson3,
  4. R Ganguly4,
  5. R Kurrasch4,
  6. S Popik3,
  7. P Agarwal3,
  8. N Li3
  1. 1University of Occupational & Environmental Health, Kitakyushu, Japan
  2. 2Division of Rheumatology, Medical University of Vienna, Vienna, Austria
  3. 3Janssen Research & Development, LLC, Spring House, PA
  4. 4GlaxoSmithKline, Collegeville, PA, United States

Abstract

Background Sirukumab is an anti–interleukin-6 (IL-6) monoclonal antibody that selectively binds to the cytokine with high affinity and is in development for rheumatoid arthritis (RA) and other diseases.

Objectives This study evaluated the effects of sirukumab on work productivity/interference and health status in patients with active RA despite treatment with anti-tumor necrosis factor (TNF) therapy.

Methods In this randomized, double-blind, phase 3 trial, 878 eligible patients with active RA who were intolerant/refractory to anti-TNFs were randomized 1:1:1 to sirukumab subcutaneous (SC) 50mg every 4 weeks (q4w; n=292), sirukumab SC 100mg every 2 weeks (q2w; n=292), or placebo SC q2w (n=294). At Week 18, placebo patients were re-randomized to 1 of the sirukumab doses if insufficient (<20%) improvement; at Week 24, all patients remaining on placebo crossed over to sirukumab. The Work Limitations Questionnaire (WLQ) evaluated health-related job limitations and productivity loss in 4 domains (mental-interpersonal, output, physical demands, time management); the 3-level EuroQol-5 Dimension (EQ-5D) questionnaire measured 5 dimensions of health status (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).

Results At Week 24, mean total WLQ scores improved significantly from baseline for sirukumab 50mg q4w and 100mg q2w versus placebo (mean change, –2.2 and –2.3 vs 0.2, respectively; both p<0.001), as did all 4 mean WLQ domain scores (all p≤0.01). Improvements from baseline in mean total WLQ and all 4 domain scores were maintained through Week 52 for both sirukumab doses. Mean EQ-5D index and health state visual analog scale (VAS) scores improved significantly from baseline at Week 24 for sirukumab 50mg q4w and 100mg q2w versus placebo (mean index change, 0.2 and 0.2 vs 0.0, respectively; mean VAS change, 13.9 and 15.4 vs 4.8, respectively; all p<0.001); improvements from baseline were maintained through Week 52 with both sirukumab doses.

Conclusions Sirukumab treatment led to significant improvements in work-related productivity and general health status in patients with active RA despite anti-TNF therapy, consistent with demonstrated effects of sirukumab on RA disease improvement.

Disclosure of Interest Y. Tanaka Grant/research support from: Abbvie, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, MSD, Takeda, Speakers bureau: Abbvie, Asahi Kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eli Lilly, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe, Pfizer, Sanofi, Takeda, Teijin, YL Biologics, D. Aletaha Grant/research support from: AbbVie, Pfizer, Grünenthal, Merck, Medac, UCB, Mitsubishi/Tanabe, Janssen, and Roche, Consultant for: AbbVie, Pfizer, Grünenthal, Merck, Medac, UCB, Mitsubishi/Tanabe, Janssen, and Roche, S. Peterson Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, R. Ganguly Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, R. Kurrasch Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, S. Popik Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, P. Agarwal Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, N. Li Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC

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