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

Authors
 Ga Young Ahn  ;  Chang Hee Suh  ;  Yong Gil Kim  ;  Yong Beom Park  ;  Seung Cheol Shim  ;  Sang Heon Lee  ;  Shin Seok Lee  ;  Sang Cheol Bae  ;  Dae Hyun Yoo 
Citation
 JOURNAL OF KOREAN MEDICAL SCIENCE, Vol.35(38) : e335, 2020-09 
Journal Title
JOURNAL OF KOREAN MEDICAL SCIENCE
ISSN
 1011-8934 
Issue Date
2020-09
Keywords
Myositis ; Rituximab ; Safety ; Treatment Outcome
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.
Files in This Item:
T999202151.pdf Download
DOI
10.3346/jkms.2020.35.e335
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Otorhinolaryngology (이비인후과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Chang Hoon(김창훈) ORCID logo https://orcid.org/0000-0003-1238-6396
Park, Yong Beom(박용범)
Lee, Hyuk Min(이혁민) ORCID logo https://orcid.org/0000-0002-8523-4126
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/184925
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