Effect of Golimumab Dose Escalation in Japanese Patients With Rheumatoid Arthritis: Post-Hoc Analysis of Post-Marketing Surveillance Data

• Published in: Rheumatology and therapy. Vol. 7; no. 2; pp. 311 - 325
• Main Authors: Shimizu, Hirohito, Kobayashi, Hisanori, Kanbori, Masayoshi, Ishii, Yutaka
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01.06.2020; Springer Nature B.V; Adis, Springer Healthcare
• Subjects: Dose escalation; Family Medicine; General Practice; Golimumab; Internal Medicine; Medicine; Medicine & Public Health; Monoclonal antibodies; Original Research; Orthopedics; Post-marketing surveillance; Quality of Life Research; Real-world evidence; Rheumatoid arthritis; Rheumatology; Surveillance; Golimumab; Dose escalation; Rheumatoid arthritis; Post-marketing surveillance; Real-world evidence
• ISSN: 2198-6576; 2198-6584
• DOI: 10.1007/s40744-020-00198-4

Introduction While dose escalation of golimumab has been used for patients with rheumatoid arthritis who demonstrate an inadequate response to the standard dose, its effectiveness has not been fully evaluated. The aim of this study was to assess the clinical outcome observed by dose escalation of golimumab for patients with rheumatoid arthritis in the daily clinical setting. Methods A post hoc analysis was performed of data from the 24-week post-marketing surveillance conducted in Japan ( n  = 5154). A total of 301 patients with moderate or high disease activity at baseline who underwent dose escalation of golimumab were assessed for effectiveness at 24 weeks based on several variables, such as DAS28-CRP, SDAI, and CDAI, as well as for medication persistence through 24 weeks. In addition, the study population was stratified by the time to dose escalation, and effectiveness was likewise evaluated. Logistic regression analysis was performed to identify factors associated with a moderate/good EULAR response to golimumab at 24 weeks. Results Patients with golimumab dose escalation showed significant improvement of the clinical signs and symptoms of rheumatoid arthritis at 24 weeks, as indicated by reduction of the DAS28-CRP (∆0.89), SDAI (∆8.64), and CDAI (∆8.28) scores. This result was relatively consistent across the subgroups stratified by the timing of dose escalation. According to Kaplan-Meier analysis, 78.1% of the patients continued to receive golimumab at 24 weeks, and this was also similar among the subgroups stratified by the time to dose escalation. Multivariate analysis identified male sex and previous biologic therapy as factors that were significantly associated with the clinical response at 24 weeks. Conclusion In real-world clinical practice, improvement of disease activity was observed after uptitration of golimumab from 50 to 100 mg regardless of the timing. Male patients and biologic-naive patients were more likely to respond to dose escalation of golimumab. Trial Registration UMIN-CTR, Identifier: UMIN000015895.