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AB0513 Safety and efficacy of golimumab, a human anti-tnf monoclonal antibody injected subcutaneously every 4 weeks, in chinese patients with active ankylosing spondylitis: one-year results of a phase 3, randomized, placebo-controlled study
  1. C. Bao1,
  2. F. Huang2,
  3. M. A. Khan3,
  4. K. Fei4,
  5. Z. Wu4,
  6. Y. Zhuang4,
  7. T. Gathany5,
  8. C. Han5,
  9. E. C. Hsia6
  1. 1Shanghai Renji Hospital, Shanghai
  2. 2Chinese PLA General Hospital, Beijing, China
  3. 3Case Western Reserve Univ, Cleveland
  4. 4Janssen R&D, LLC, Spring House
  5. 5Janssen Global Services, LLC, Malvern
  6. 6Janssen R&D, LLC/U of Penn, Spring House/Philadelphia, United States

Abstract

Background A multicenter, randomized, placebo (PBO)-controlled study of golimumab (GLM) was performed in Chinese pts with ankylosing spondylitis (AS).

Objectives To assess efficacy and safety of golimumab (GLM) through wk56 in Chinese pts with active AS.

Methods Chinese pts aged≥18yrs with a diagnosis of active AS (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]≥4, and a visual analogue scale [VAS] for total back pain≥4, each on a scale of 0-10cm) for ≥3 months prior to screening were eligible. Pts with prior exposure to anti-TNF agents and those with complete ankylosis of the spine were excluded.213 pts were randomized to q4wk SC injections of PBO from wks 0 to 20, followed by GLM 50mg from wks 24 to 48 (Group1, n=105) or GLM 50mg from wks 0 to 48 (Group2, n=108). Group1 pts with <20% improvement from baseline in both total back pain and morning stiffness at wk16 were switched to SC GLM 50mg SC q4wks in a blinded fashion (early escape). At wk24, all remaining PBO pts in Group1 crossed over to SC GLM 50mg q4wks. The primary endpoint for efficacy was the proportion of patients who achieved ASAS20 response (≥ 20% improvement in the ASsessment in AS [ASAS] criteria) at wk14. Major secondary endpoints included ASAS20 response at wk24, changes from baseline at wk14 in Bath AS Functional Index (BASFI) and Bath AS Metrology Index (BASMI). Other efficacy assessments included health-related quality of life (SF-36 PCS and MCS scores), and sleep (Jenkins Sleep Evaluation Questionnaire, JSEQ) measures. Antibodies to GLM were evaluated at wk52. The last GLM injection was at wk48; final efficacy assessments were at wk52. Safety was monitored through wk56.

Results Baseline demographics were comparable in the 2 groups; median age was 29yrs, median weight of 62.0kg, and 83.1% were males. ASAS20 at wk14 was achieved by 49.1% of pts in Group2 vs. 24.8% in Group1 (p<0.001). GLM treatment also elicited a significantly better response than PBO in other efficacy parameters assessed, including ASAS20 response at wk24 (50.0% vs. 22.9%; p<0.001) and mean improvements in BASFI (-1.26 vs. 0.113; p<0.001) and BASMI (-0.42 vs. -0.19; p=0.021) scores at wk14 and SF-36 PCS and MCS and JSEQ at wk14 and wk24. These improvements in clinical symptoms, physical function, range of motion, as well as significant improvements in SF-36 MCS and PCS were further enhanced through the final efficacy assessment at wk52. Through wk16, 31.4% and 30.6% of pts had adverse events (AEs) in Groups1 and 2, respectively. Through wk56, 41.2% of GLM-treated patients reported AEs, and 2.8% reported serious AEs. Through wk56, infections were reported in 20.9% of all GLM-treated pts. One SAE of tuberculosis pleurisy was reported, and the pt recovered. No opportunistic infections or deaths were reported. Antibodies to GLM were not detected in GLM-treated patients through wk52.

Conclusions GLM significantly reduced AS symptoms/signs and functional limitations and improved health-related quality of life in Chinese pts with active AS. Treatment with GLM was well tolerated and without unexpected safety concerns.

Disclosure of Interest C. Bao Grant/research support from: Janssen R&D, LLC, F. Huang Grant/research support from: Janssen R&D, LLC, M. Khan Grant/research support from: Janssen R&D, LLC, K. Fei Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, Z. Wu Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, Y. Zhuang Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, T. Gathany Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, C. Han Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, E. Hsia Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC

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