Golimumab Administered Subcutaneously Every 4 Weeks in Chinese Patients with Active Ankylosing Spondylitis: Week 24 Safety and Efficacy Results From a Randomized, Placebo-Controlled Study

Background/Purpose: This multicenter, randomized, placebo (PBO)-controlled study was conducted to evaluate the efficacy and safety of golimumab (GLM) in Chinese patients with active ankylosing spondylitis (AS). 

Methods:   Patients ≥18yrs of age with a diagnosis of active AS for ≥3 months prior to screening and symptoms of active disease (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 to 10cm) were eligible to be enrolled for study screening. Patients with prior exposure to biologic anti-tumor necrosis factor alpha (TNF) agents and patients with complete ankylosis of the spine were not permitted to be included in the study. Patients who passed study screening were randomized in 1:1 ratio to receive sub-cutaneous (SC) injections of GLM 50mg or PBO q4wks through wk20. At wk16, all patients randomized to PBO that met early escape criteria (<20% improvement from baseline in both total back pain and morning stiffness measures) began receiving GLM 50mg SC injections in a blinded fashion at wk16 and q4wks thereafter through wk48; all other patients still receiving placebo injections began receiving GLM 50 mg SC injection at wk24 and q4wks thereafter through wk48; all patients randomized to GLM continued receiving GLM 50 mg SC at wk24 and q4wk through wk48 regardless of the status of early escape.The primary efficacy endpoint was the proportion of patients with ³ 20% improvement in the ASsessment in AS (ASAS) criteria at wk14.

Results:  213 patients were randomized to treatment; baseline demographics were comparable between groups with median age of 29yrs, median weight of 62.0kg, and 83.1% male. The primary endpoint and major secondary endpoints were achieved (Table). Adverse events through 24 wks were reported in 38.9% of GLM-treated and 34.3% of PBO-treated patients.  Serious adverse events were reported in 0.9% (1 ovarian epithelial cancer) and 0.0% of GLM and PBO-treated patients, respectively. Infections were reported in 22.2% and 19.0% of GLM and PBO-treated patients, respectively (primarily upper respiratory tract infections). No serious infections, TB or opportunistic infections, or deaths were reported. Antibodies to GLM were not detected in GLM-treated patients through wk24.

Conclusion:   GLM significantly improved, as compared to the placebo group, signs and symptoms and physical function in Chinese patients with active AS. GLM was well tolerated through 24wks of treatment. 

Table: