J Rheum Dis 2017; 24(4): 227-235  
Comparing Effectiveness Rituximab (Mabthera) to Other Second-line Biologics for Rheumatoid Arthritis Treatment in Patients Refractory to or Intolerant of First-line Anti-tumor Necrosis Factor Agent: An Observational Study
Yong-Wook Park1, Ki-Jo Kim2, Hyung-In Yang3, Bo Young Yoon4, Sang Hyon Kim5, Seong-Ho Kim6, Jinseok Kim7, Ji Seon Oh8, Wan-Uk Kim9, Yeon-Ah Lee10, Jung-Yoon Choe11, Min-Chan Park12, Sang-Heon Lee13
1Department of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, 2Division of Rheumatology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, 3Division of Rheumatology, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, 4Department of Rheumatology, Inje University Ilsan Paik Hospital, Goyang, 5Division of Rheumatology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, 6Division of Rheumatology, Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, 7Department of Internal Medicine, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, 8Division of Rheumatology, Department of Internal Medicine, National Medical Center, Seoul, 9Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, 10Division of Rheumatology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, 11Division of Rheumatology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, 12Division of Rheumatology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, 13Division of Rheumatology, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea
Correspondence to: Sang-Heon Lee, Division of Rheumatology, Department of Internal Medicine, Konkuk University School of Medicine, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea. E-mail:shlee@kuh.ac.kr
Received: January 12, 2017; Revised: May 25, 2017; Accepted: June 13, 2017; Published online: August 31, 2017.
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Abstract
Objective. Failure of first-line anti-tumor necrosis factor (TNF) agents in in rheumatoid arthritis patients leads to decisions among second-line biologic agents. To better inform these decisions, the therapeutic effectiveness of rituximab is compared with other second-line biologic agents in this observational study. Methods. Between November 2011 and December 2014, study subjects were observed for 12 month periods. Patients with an inadequate response to initial anti-TNF agent received either rituximab or alternative anti-TNF agents (adalimumab/etanercept/infliximab) based on the preference of patients and physicians. The efficacy end point of this study was the change in 28-joint count Disease Activity Score (DAS28) at six and 12 months from baseline. Safety data were also collected. Results. Ninety patients were enrolled in the study. DAS28 at six months did not change significantly whether the patients were treated with rituximab or alternative anti-TNF agents in intention-to-treat analysis (n=34, −1.63±0.30 vs. n=31, −2.05±0.34) and standard population set analysis (n=31, −1.51±0.29 vs. n=24, −2.21±0.34). Similarly, the change in DAS28 at 12 months did not reach statistical significance (−1.82±0.35 in the rituximab vs. −2.34±0.44 in the alternative anti-TNF agents, p=0.2390). Furthermore, the incidences of adverse events were similar between two groups (23.5% for rituximab group vs. 25.8% for alternative anti-TNF agents group, p=0.7851). Conclusion. Despite the limitations of our study, switching to rituximab or alternative anti-TNF agents after failure of the initial TNF antagonist showed no significant therapeutic difference in DAS28 reduction.
Keywords: Rheumatoid arthritis, Rituximab, Anti-tumor necrosis factor agent, DAS28 score


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