POS0437 IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH GOLIMUMAB: SUB-ANALYSIS OF ASIAN PATIENTS ENROLLED IN PHASE-3 CLINICAL TRIALS

Abstract

Background:Clinical efficacy and safety of Tumour Necrosis Factor-alpha inhibitor golimumab (GLM) for patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX) were studied in phase-3 clinical trials. A greater proportion of patients treated with GLM 50 mg every 4 weeks (q4w) achieved improvement in clinical signs and symptoms, measured by American College of Rheumatology 20% improvement (ACR20) response and patient-reported outcomes (PROs) when compared with placebo (PBO) at Weeks 14 and 24.Objectives:To assess PROs in RA patients from Asia treated with GLM in phase-3 trials.Methods:Post-hoc PRO (Health Assessment Questionnaire [HAQ], Short-Form 36 [SF-36] physical component score [PCS] and mental component score [MCS], pain, and work productivity) sub-analysis of RA patients from China (including Taiwan region) and South Korea with inadequate response to MTX randomized to subcutaneous GLM 50 mg + MTX or PBO + MTX from 2 clinical trials (GO-FORWARD, NCT01248780).Clinically meaningful improvement was defined as improvement of ≥0.25 point in HAQ or ≥5 points in SF-36 PCS and MCS. Nominal p-values were used for descriptive and exploratory purposes.Results:At Week 24, MTX-experienced patients from Asia treated with GLM + MTX demonstrated improvements versus PBO + MTX in all PROs analyzed. Pooled patients from Asia on GLM + MTX had greater improvements at Week 24 in all measures of PROs than patients with PBO + MTX, and the improvements are comparable to all other regions (Table 1). Greater proportions of RA patients from Asia in GLM group than PBO achieved clinically meaningful improvement in HAQ, SF-36 PCS, and SF-36 MCS (Figure 1).Conclusion:MTX-experienced RA patients from Asia treated with GLM demonstrated improved PROs after 24 weeks. The pooled results were comparable with patients enrolled from all other regions and demonstrated clinical meaningful improvements in HAQ, SF-36 PCS, and SF-36 MCS.Table 1.Summary of Improvement from Baseline in HAQ-DI, HRQoL, Pain, and Work Productivity at Week 24: Randomized Patients in RA Studies Pooled for Regions Outside Asia and Randomized Patients from AsiaMTX experienced from AsiaPooled RA in All Other RegionsPlacebo + MTX(N=152)GLM50 mg + MTX(N=146)DifferencePlacebo + MTX(N=107)GLM50 mg + MTX(N=74)DifferenceMean (SD)Mean (SD)Mean (SE)Nominal p-valueMean (SD)Mean (SD)Mean (SE)Nominalp-valueHAQ-DI-0.13 (0.670)0.28 (0.575)0.41 (0.072)<.0010.18 (0.596)0.48 (0.540)0.30 (0.087)<.001SF-36 PCS-0.57 (7.011)4.73 (7.034)5.30 (0.814)<.0014.77 (8.343)*8.67 (8.862)3.90 (1.299)0.003SF-36 MCS-1.89 (11.866)1.87 (10.833)3.76 (1.318)0.0051.31 (9.440)*3.80 (10.969)2.50 (1.533)0.105Pain VAS-0.00 (2.437)1.46 (2.940)1.46 (0.312)<.0010.76 (2.776)2.72 (2.586)1.96 (0.408)<.001Productivity VAS0.17 (2.601)1.74 (2.599)1.57 (0.301)<.0011.09 (2.976)2.38 (2.889)1.28 (0.445)0.004GLM, golimumab; HAQ-DI, health assessment questionnaire disability index; HRQoL, health-related quality of life; MTX, methotrexate; RA, rheumatoid arthritis; SD, standard deviation; SE, standard error; SF-36 MCS, short-form 36 mental component score; SF-36 PCS, short-form 36 physical component score; VAS, visual analogue scale*N=105Figure 1.Proportion of Patients with Clinical Meaningful Improvements in HAQ and HRQoL: Randomised Subjects from China, Taiwan and KoreaDisclosure of Interests:Wen-Chan Tsai Consultant of: Pfizer, AbbVie, Roche, and Eli Lilly, Rong Mu: None declared, Chang-Hee Suh: None declared, Daniel Furtner Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson Pte. Ltd., 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