Article Text

PDF
SAT0194 Sirukumab integrated safety in rheumatoid arthritis patients: analysis of the sirround phase 3 data
  1. D Aletaha1,
  2. C Thorne2,
  3. M Schiff3,
  4. M Harigai4,
  5. R Rao5,
  6. N Goldstein6,
  7. B Cheng6,
  8. C Cohen7,
  9. B Hsu6,
  10. K Brown7
  1. 1Medical University of Vienna, Vienna, Austria
  2. 2University of Toronto and Southlake Regional Health Centre, Newmarket, ON, Canada
  3. 3University of Colorado School of Medicine, Denver, CO, United States
  4. 4Tokyo Women's Medical University, Tokyo, Japan
  5. 5GSK Medicines Research Centre, Hertfordshire, United Kingdom
  6. 6Janssen Research & Development, LLC, Spring House, PA
  7. 7GlaxoSmithKline, Collegeville, PA, United States

Abstract

Background Sirukumab (SIR), a human monoclonal antibody that selectively binds the IL-6 cytokine, is in development for the treatment of rheumatoid arthritis (RA). Efficacy of SIR was shown in several phase 3 trials in RA patients (pts; SIRROUND program).

Objectives To analyze safety data from completed/ongoing studies in the SIRROUND program.

Methods Safety comparisons included SIR 50mg q4w and 100mg q2w doses vs placebo (pbo) in the pbo-controlled period (Wk 0–18) of 2 phase 3 studies. A long-term comparison of the safety of SIR 50mg q4w and 100mg q2w for the entire program was also performed.

Results In phase 3 studies, 2926 pts received SIR for up to 3.4y (median duration, 1.46y). During Wk 0–18, there were more adverse events (AEs), AEs leading to discontinuation, and serious AEs (SAEs) with SIR vs pbo, with cumulative rates of SAEs remaining constant over time (Table). In general, no dose effect with SIR was observed in the 18-wk or long-term analysis. Mortality rates were similar across treatment groups through 18 wks and remained stable in long-term analysis. Serious infections were more frequent in SIR-treated pts vs pbo during Wk 0–18, with similar rates through long-term analysis. Rates of gastrointestinal (GI) perforations and malignancies were low and similar across groups during the 18-wk and long-term analysis; major adverse cardiovascular event (MACE) rates were similar through 18 wks and numerically higher with SIR 50mg q4w vs 100mg q2w in long-term analysis.

Table 1.

Treatment-emergent AEs in Phase 3 Studies

Conclusions SIR is well tolerated in pts with moderately to severely active RA. Overall, no dose relationship was observed between SIR 50mg q4w and 100mg q2w for types or frequencies of AEs.

Disclosure of Interest 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, C. Thorne Grant/research support from: AbbVie, Amgen, Celgene, Lilly, Novartis, Pfizer, Sanofi, and UCB, Consultant for: AbbVie, Amgen, Celgene, Centocor, Genzyme, Hospira, Janssen, Lilly, Medexus/Medac, Merck, Novartis, Pfizer, Sanofi, and UCB, Speakers bureau: Medexus/Medac, M. Schiff Consultant for: AbbVie, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, UCB, Speakers bureau: AbbVie, M. Harigai Grant/research support from: AbbVie Japan, Astellas Pharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Ono Pharmaceuticals, Santen Pharmaceutical, Takeda Pharmaceutical, UCB Japan, Teijin Pharma, Consultant for: AbbVie Japan, Janssen Pharma, Chugai Pharmaceutical, Teijin Pharma, Eli Lilly Japan, and Zenyaku Kogyo, R. Rao Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, N. Goldstein Employee of: Janssen Research & Development, LLC, B. Cheng Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, C. Cohen Employee of: GlaxoSmithKline, B. Hsu Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, K. Brown Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.