AB0468

IMPROVED PHYSICAL FUNCTION, PAIN, AND HEALTH RELATED QUALITY OF LIFE WITH CERTOLIZUMAB PEGOL IN JAPANESE RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO METHOTREXATE: RESULTS FROM THE JRAPID STUDY

H. Yamanaka ^1,*K. Yamamoto ²T. Takeuchi ³N. Ishiguro ⁴Y. Tanaka ⁵K. Eguchi ⁶A. Watanabe ⁷H. Origasa ⁸T. Shoji ⁹Y. Sakamaki ¹⁰N. Miyasaka ¹¹T. Koike ¹²

¹Tokyo Women's Medical University, ²The University of Tokyo, ³Keio University, Tokyo, ⁴Nagoya University, Aichi, ⁵University of Occupational and Environmental Health, Fukuoka, ⁶Sasebo City General Hospital, Nagasaki, ⁷Tohoku University, Miyagi, ⁸University of Toyama, Toyama, ⁹Otsuka Pharmaceutical Co., ¹⁰UCB Pharma, ¹¹Tokyo Medical and Dental University, Tokyo, ¹²Hokkaido University, Hokkaido, Japan

Background: This study examined the efficacy of certolizumab pegol (CZP) + MTX in Japanese patients (pts) with active RA and an inadequate response to MTX.¹

Objectives: To assess the impact of CZP on physical function, pain and HRQoL in patients with concomitant MTX.

Methods: In this 24-week (Wk), Phase II/III, multicenter, double-blind, randomised, placebo (PBO)-controlled, study, Japanese pts with active RA and an inadequate response to MTX were randomized (1:1:1:1) to CZP 100, 200, or 400mg +MTX, or PBO +MTX every 2 Wks. CZP pts received induction dosing with 200mg (100mg group) or 400mg (200 and 400mg groups) at Wks 0, 2, and 4. Pts who did not achieve an ACR20 response at Wks 12 and 14 were withdrawn from the study at Wk 16 and were eligible to enter an OLE study, as were pts completing the study. Primary efficacy end point was ACR20 response at Wk 12. Physical function was assessed with HAQ-DI and pain with VAS at each visit, and HRQoL with SF36 at Wks 12 and 24. ACR responses were assessed using NRI, and HAQ-DI, pain (VAS) and SF36 using LOCF.

Results: A total of 316 pts were randomized. Demographic and baseline (BL) characteristics were similar between treatment groups: average values for RA disease duration ranged from 5.6 to 6.0 years, DAS28(ESR) from 6.19 to 6.46, HAQ-DI from 1.12 to 1.19, and MTX dose from 7.4 to 7.6mg/Wk across groups. ACR20 response at Wk 12 in CZP 100, 200, 400mg and PBO groups was 62.5%, 76.8%, 77.6%, and 28.6%, respectively (p<0.001 each CZP group vs PBO). As early as Wk 1, HAQ-DI was significantly improved in the CZP group vs PBO. HAQ-DI change from BL at Wk 1 was -0.24, -0.28, and -0.22 in the CZP groups vs -0.01 in the PBO group (p<0.001 each CZP group vs PBO), and at Wk 24 was -0.43, -0.55, and -0.57 in the CZP groups vs -0.18 in the PBO group (p<0.01 each CZP group vs PBO). Pain (VAS) was also significantly improved; change from BL at Wk 1 was -17.3, -16.6 and -14.8 in CZP groups vs -3.9 in PBO group (p<0.001 each CZP group vs PBO), and at Wk 24 was -26.9, -27.9 and -31.9 in CZP groups vs -10.6 in PBO group (p<0.001 each CZP group vs PBO). CZP 200mg and 400mg showed significantly greater improvements in the SF36 physical and mental components vs PBO at Wks 12 and 24. Changes in physical and mental components summary scores from BL at Wk 24 were 8.87, 10.17 and 11.36 in 100mg, 200mg and 400mg CZP groups vs 4.27 in PBO group (P<0.01 each CZP group vs PBO), and 3.19, 5.58 and 5.84 in CZP groups vs 1.24 in PBO group (P<0.01 for 200mg and 400mg CZP group vs PBO).

Conclusions: Treatment with CZP + MTX resulted in a rapid and sustained reduction in RA signs and symptoms, and improved physical function, pain and HRQoL in Japanese RA patients with an inadequate response to MTX.

References: 1. Yamamoto H. et al. Arthritis Rheum;63(Suppl10);S474

Disclosure of Interest: H. Yamanaka Grant / Research support from: Otsuka Pharmaceutical Co., Ltd, UCB Pharma Consultant for: Otsuka Pharmaceutical Co., Ltd, UCB PharmaK. Yamamoto Consultant for: Otsuka Pharmaceutical Co., Ltd, UCB PharmaT. Takeuchi Consultant for: Otsuka Pharmaceutical Co., Ltd, UCB PharmaN. Ishiguro Consultant for: Otsuka Pharmaceutical Co., LtdY. Tanaka Consultant for: Otsuka Pharmaceutical Co., LtdK. Eguchi Consultant for: Otsuka Pharmaceutical Co., LtdA. Watanabe Consultant for: Otsuka Pharmaceutical Co., LtdH. Origasa Consultant for: Otsuka Pharmaceutical Co., Ltd, UCB PharmaT. Shoji Employee of: Otsuka Pharmaceutical Co., LtdY. Sakamaki Employee of: UCB PharmaN. Miyasaka Consultant for: Otsuka Pharmaceutical Co., LtdT. Koike Consultant for: Otsuka Pharmaceutical Co., Ltd