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Efficacy and Safety of Rituximab in Korean Patients with Refractory Inflammatory Myopathies

Journal of Korean Medical Science 2020년 35권 38호 p.335 ~ 335
안가영, 서창희, 김용길, 박용범, 심승철, 이상헌, 이신석, 배상철, 유대현,
소속 상세정보
안가영 ( Ahn Ga-Young ) - Hanyang University Hospital for Rheumatic Diseases Department of Rheumatology
서창희 ( Suh Chang-Hee ) - Ajou University School of Medicine Department of Rheumatology
김용길 ( Kim Yong-Gil ) - University of Ulsan College of Medicine Asan Medical Center Department of Internal Medicine
박용범 ( Park Yong-Beom ) - Yonsei University College of Medicine Department of Internal Medicine
심승철 ( Shim Seung-Cheol ) - Chungnam National University Hospital Department of Rheumatology
이상헌 ( Lee Sang-Heon ) - Konkuk University School of Medicine Department of Internal Medicine
이신석 ( Lee Shin-Seok ) - Chonnam National University Medical School Chonnam National University Hospital Department of Internal Medicine
배상철 ( Bae Sang-Cheol ) - Hanyang University Hospital for Rheumatic Diseases Department of Rheumatology
유대현 ( Yoo Dae-Hyun ) - Hanyang University Hospital for Rheumatic Diseases Department of Rheumatology

Abstract


Background: Rituximab (RTX), a monoclonal antibody that selectively binds to CD20+ B cells, showed favorable outcomes in patients with idiopathic inflammatory myopathies (IIM) in small case series, but the evidence is still not enough. Our goal was to determine the efficacy and safety of RTX for Korean patients with refractory IIM.

Methods: We retrospectively analyzed the medical records of 16 patients with refractory IIM treated with RTX in seven tertiary rheumatology clinics in the Korea. The efficacy of RTX was evaluated with the improvement of serum creatine phosphokinase (CPK) level and physician's global assessment (PGA), and daily corticosteroid dose reduction. A > 25% decrease in CPK level, corticosteroid dose, or PGA was considered significant. A complete response (CR) was designated by meeting three efficacy criteria and a partial response (PR) by only two criteria.

Results: Sixteen patients with IIM were evaluated (13 female; median age, 51.8 years). All patients had received at least one conventional immunosuppressive agent (median, 3.6 [2.0?5.0]) and concomitant corticosteroids. The median CPK level and median dose of prednisolone was 421.0 units/L and 20.0 mg/day respectively. Eleven patients were treated with intravenous immunoglobulin. Seven patients received 2,000 mg of RTX and the others received lower dose. Twenty-four weeks after RTX treatment, 11 patients achieved a > 25% reduction in corticosteroid dose and CPK levels, and nine showed improved PGA. The overall response rate was 68.8% (11 patients). At the end of follow-up (median 24 weeks), 12 (75.0%) patients responded overall: four (25.0%) and eight (50.0%) patients achieved CR and PR, respectively. Baseline muscle enzyme levels were higher in responders than non-responders, but disease duration, RTX dose, ESR and serum CRP were not significantly different between the two groups. The rate of adverse event was 25.4/1,000 person-years.

Conclusion: RTX could be an effective and relatively safe therapeutic option in patients with refractory IIM.

키워드

Myositis; Rituximab; Treatment Outcome; Safety

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