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SAT0167 Health-Related Physical and Emotional Well-Being and Fatigue Improve Significantly with Sirukumab Treatment: Results of A Phase 3 Study in Patients with Active Rheumatoid Arthritis Refractory To Conventional Disease-Modifying Anti-Rheumatic Drugs
  1. G. Karpouzas1,
  2. C. Thorne2,
  3. T. Takeuchi3,
  4. K. McQuarrie4,
  5. S. Sheng4,
  6. W. Xu4,
  7. S. Peterson4,
  8. R. Ganguly5,
  9. C. Han4,
  10. K. Fei4,
  11. B. Hsu4
  1. 1Division of Rheumatology, Harbor-UCLA Medical Center, Torrance, CA, United States
  2. 2University of Toronto and Southlake Regional Health Centre, Newmarket, ON, Canada
  3. 3Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan
  4. 4Janssen Research & Development, LLC, Spring House, PA
  5. 5GlaxoSmithKline, King of Prussia, PA, United States

Abstract

Background Rheumatoid arthritis (RA) may have a substantial negative impact on physical and emotional well-being and fatigue. Sirukumab, a selective, high-affinity human anti-IL6 monoclonal antibody, is being evaluated for RA treatment.

Objectives To evaluate the effects of sirukumab on health-related physical and emotional well-being (based on Short Form-36 [SF-36] health survey) and fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scale) in patients (pts) with RA refractory to Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

Methods This Phase 3 study evaluated 2 sirukumab doses in pts with active RA and inadequate response to DMARDs. Pts were randomized (1:1:1) to double-blind treatment with sirukumab subcutaneous (SC) 50 mg q4w, sirukumab SC 100 mg q2w, or placebo SC q2w. In the placebo group, pts with <20% improvement at Wks 18 or 40 or still on placebo at Wk 52 were re-randomized to treatment with 1 of the 2 sirukumab doses. Pts completed the SF-36 and FACIT-Fatigue at baseline (BL) and Wks 8, 16, 24, 36, and 52. Clinically meaningful improvements from BL were defined as ≥5-point increase for the SF-36 physical and mental component summary (PCS and MCS) scores and ≥4-point increase for the FACIT-Fatigue score.

Results Significantly greater mean increases (improvements) from BL in mean SF-36 PCS and MCS, all 8 SF-36 domain scores, and the FACIT-Fatigue score were observed for sirukumab 50mg q4w and 100mg q2w vs placebo at Wks 8, 16, 24, 36, and 52 (all P<0.02; Table). Also, significantly more pts achieved clinically meaningful improvements from BL in the SF-36 PCS and MCS scores (≥5-point increase) and the FACIT-Fatigue score (≥4-point increase) on sirukumab (both doses) vs placebo at Wks 8, 16, 24, 36, and 52 (all P<0.05).

Table 1.

SF-36 and FACIT-Fatigue Outcomes at Wk 52a

Conclusions Sirukumab treatment yielded early, durable, statistically significant and clinically meaningful improvements in health-related physical and emotional well-being and fatigue in patients with DMARD-refractory RA compared to placebo throughout Wk 52.

Disclosure of Interest G. Karpouzas Consultant for: Janssen, Speakers bureau: Janssen, 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, T. Takeuchi Grant/research support from: Astellas Pharma, Bristol–Myers K.K., Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahikasei Pharma Corp., and Taisho Toyama Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Ltd, Consultant for: Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., and Asahi Kasei Medical K.K.,abbivie GK, Daiichi Sankyo Co.,Ltd., Bristol–Myers K.K., Nipponkayaku Co.Ltd., Speakers bureau: AbbVie GK., Bristol–Myers K.K., Chugai Pharmaceutical Co,. Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., and Takeda Pharmaceutical Co., Ltd., Astellas Pharma, and Diaichi Sankyo Co., Ltd., Celtrion, Nipponkayaku Co. Ltd, K. McQuarrie Employee of: Janssen Research & Development, LLC, S. Sheng Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, W. Xu Employee of: Janssen Research & Development, LLC, S. Peterson Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, R. Ganguly Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, C. Han Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, K. Fei Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, B. Hsu Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC

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