Improvements In Patient-Reported Outcomes In Ankylosing Spondylitis Patients Treated With Golimumab: Sub-Analysis Of Asian Patients Enrolled In Phase-3 Clinical Trials

Background:Clinical efficacy and safety of golimumab (GLM) for patients with ankylosing spondylitis (AS) who have not received prior biologic therapy were studied in two phase-3 clinical trials (NCT00265083 - GO RAISE and NCT01248793). In both studies, a greater proportion of patients treated with GLM 50 mg every 4 weeks achieved improvement in clinical signs and symptoms measured by ASAS20 and in patient-reported outcomes, such as Health Related Quality of Life (HRQoL) and sleep disturbance when compared with placebo (PBO) at Weeks 14 and 24.Objectives:To assess the effect of GLM on HRQoL, back pain, and sleep disturbances in phase-3 studies in Asian patients with AS.Methods:Post-hoc sub-analysis to examine HRQoL, measured with the Short Form 36 (SF-36) Physical and Mental Component Summary (PCS and MCS), total back pain (VAS) and sleep disturbance, assessed with the Jenkins Sleep Evaluation Questionnaire (JSEQ) in active AS patients enrolled from Asian countries (China, including Taiwan region and South Korea). Improvement from baseline to Week 24 was expressed as mean and standard deviation (SD) for SF-36 PCS and MCS and total back pain. Reduction of sleep disturbance was expressed as the proportion of patients with improvement from baseline ≥2 points in the JSEQ, defined as baseline value minus post-baseline value with lower scores indicating the better sleep evaluation.Results:At Week 24, active AS patients treated with GLM 50 mg had greater mean improvements in SF-36 and total back pain than PBO. The pooled results were comparable with patients enrolled from other regions (Table 1). A higher proportion of Asian patients who received GLM had reduced sleep disturbance (JSEQ ≥2) after 24 weeks than PBO (59.7% [83/139] vs 38.5% [47/122]; Δ21.2) and the results were similar with AS patients on GLM (67.4% [64/95] vs 45.6% [26/57]; Δ21.8) pooled from other regions.Conclusion:Asian patients with AS treated with GLM demonstrated improved HRQoL, total back pain, and reduced sleep disturbance. The pooled results were comparable with other regions.Table 1.Mean Improvement from Baseline in HRQoL and total back pain at Week 24: Randomized Patients in AS Studies Pooled for Asia and all other regionsPooled AS in APACPooled AS in All Other RegionsParameterPlaceboGLM 50 mgPlaceboGLM 50 mgNMean (SD)NMean (SD)NMean (SD)NMean (SD)SF-36 PCS1222.51 (6.372)1397.10 (8.434)581.91 (8.268)9910.12 (11.096)SF-36 MCS1220.22 (9.609)1393.32 (9.280)581.20 (9.705)991.98 (8.032)Total Back Pain1201.86 (2.469)1352.73 (2.607)580.79 (2.688)993.39 (3.210)APAC, Asia-Pacific; AS, ankylosing spondylitis; GLM, golimumab; HRQoL, Health Related Quality of Life; MCS, mental component summary; PCS, physical component summary; SD, standard deviation; SF-36, Short Form 36Disclosure of Interests:Wen-Chan Tsai Consultant of: Pfizer, AbbVie, Roche, and Eli Lilly, Chunde Bao: None declared., Daniel Furtner Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson Pte. Ltd., Singapore, Kim Hung Lo Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Yiying Zhou Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Elizabeth C Hsia Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC.