Cargando…

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

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 Kor...

Descripción completa

Detalles Bibliográficos
Autores principales: Ahn, Ga Young, Suh, Chang-Hee, Kim, Yong-Gil, Park, Yong-Beom, Shim, Seung Cheol, Lee, Sang-Heon, Lee, Shin-Seok, Bae, Sang-Cheol, Yoo, Dae Hyun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Academy of Medical Sciences 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7521958/
https://www.ncbi.nlm.nih.gov/pubmed/32989931
http://dx.doi.org/10.3346/jkms.2020.35.e335
_version_ 1783588078730870784
author Ahn, Ga Young
Suh, Chang-Hee
Kim, Yong-Gil
Park, Yong-Beom
Shim, Seung Cheol
Lee, Sang-Heon
Lee, Shin-Seok
Bae, Sang-Cheol
Yoo, Dae Hyun
author_facet Ahn, Ga Young
Suh, Chang-Hee
Kim, Yong-Gil
Park, Yong-Beom
Shim, Seung Cheol
Lee, Sang-Heon
Lee, Shin-Seok
Bae, Sang-Cheol
Yoo, Dae Hyun
author_sort Ahn, Ga Young
collection PubMed
description 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.
format Online
Article
Text
id pubmed-7521958
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher The Korean Academy of Medical Sciences
record_format MEDLINE/PubMed
spelling pubmed-75219582020-10-05 Efficacy and Safety of Rituximab in Korean Patients with Refractory Inflammatory Myopathies Ahn, Ga Young Suh, Chang-Hee Kim, Yong-Gil Park, Yong-Beom Shim, Seung Cheol Lee, Sang-Heon Lee, Shin-Seok Bae, Sang-Cheol Yoo, Dae Hyun J Korean Med Sci Original Article 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. The Korean Academy of Medical Sciences 2020-09-08 /pmc/articles/PMC7521958/ /pubmed/32989931 http://dx.doi.org/10.3346/jkms.2020.35.e335 Text en © 2020 The Korean Academy of Medical Sciences. https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Ahn, Ga Young
Suh, Chang-Hee
Kim, Yong-Gil
Park, Yong-Beom
Shim, Seung Cheol
Lee, Sang-Heon
Lee, Shin-Seok
Bae, Sang-Cheol
Yoo, Dae Hyun
Efficacy and Safety of Rituximab in Korean Patients with Refractory Inflammatory Myopathies
title Efficacy and Safety of Rituximab in Korean Patients with Refractory Inflammatory Myopathies
title_full Efficacy and Safety of Rituximab in Korean Patients with Refractory Inflammatory Myopathies
title_fullStr Efficacy and Safety of Rituximab in Korean Patients with Refractory Inflammatory Myopathies
title_full_unstemmed Efficacy and Safety of Rituximab in Korean Patients with Refractory Inflammatory Myopathies
title_short Efficacy and Safety of Rituximab in Korean Patients with Refractory Inflammatory Myopathies
title_sort efficacy and safety of rituximab in korean patients with refractory inflammatory myopathies
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7521958/
https://www.ncbi.nlm.nih.gov/pubmed/32989931
http://dx.doi.org/10.3346/jkms.2020.35.e335
work_keys_str_mv AT ahngayoung efficacyandsafetyofrituximabinkoreanpatientswithrefractoryinflammatorymyopathies
AT suhchanghee efficacyandsafetyofrituximabinkoreanpatientswithrefractoryinflammatorymyopathies
AT kimyonggil efficacyandsafetyofrituximabinkoreanpatientswithrefractoryinflammatorymyopathies
AT parkyongbeom efficacyandsafetyofrituximabinkoreanpatientswithrefractoryinflammatorymyopathies
AT shimseungcheol efficacyandsafetyofrituximabinkoreanpatientswithrefractoryinflammatorymyopathies
AT leesangheon efficacyandsafetyofrituximabinkoreanpatientswithrefractoryinflammatorymyopathies
AT leeshinseok efficacyandsafetyofrituximabinkoreanpatientswithrefractoryinflammatorymyopathies
AT baesangcheol efficacyandsafetyofrituximabinkoreanpatientswithrefractoryinflammatorymyopathies
AT yoodaehyun efficacyandsafetyofrituximabinkoreanpatientswithrefractoryinflammatorymyopathies