A multicenter prospective observational study on the safety and efficacy of tacrolimus in patients with myasthenia gravis

Suk Won Ahn, In Soo Joo, Byung Jo Kim, Jung Joon Sung, Sa Youn Kang, Jeeyoung Oh, Yang Ki Minn, Bum Chun Suh, Sun Young Oh, Yoon Ho Hong, Tai Seung Nam, Jung Im Seok, Young Eun Park, Ha Young Shin, Eun Bin Cho, Je Young Shin, Hung Youl Seok, Jin Sung Park, Ju Hong Min, Jin Myoung SeokByoung Joon Kim

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Introduction Several clinical studies using tacrolimus revealed reasonable therapeutic mechanisms and efficacy in patients with myasthenia gravis (MG). However, long-period studies in a large number of patients with MG are limited; therefore, the aim of this study was to investigate the therapeutic efficacies and safety of tacrolimus in patients with MG during a 12-month follow-up period. Methods Tacrolimus was administered to 150 patients with MG who were recruited based on the inclusion criteria. Fifteen medical centers in Korea participated in this study. The efficacy of tacrolimus was assessed using MG composite scales (MGCS) and the prednisolone-sparing effect. And the adverse drug reactions (ADRs) of tacrolimus were monitored in each patient from the beginning of tacrolimus treatment to the end of the follow-up period. Results After starting tacrolimus, the 32 patients were affected by ADRs, and consequentially 134 patients of the enrolled patients were followed up for 12 months. They showed that the mean prednisolone dosage significantly decreased (6.1 ± 7.6 mg/day), compared to that in the baseline (11.3 ± 9.5 mg/day), and MGCS significantly improved after 12 months of tacrolimus treatment, compared to that at the baseline. Conclusions Our study showed that tacrolimus would be an effective immunosuppressant as an initial therapeutic agent in patients with MG; in addition, it showed tolerable safety profiles during the 12-month follow-up evaluation.

Original languageEnglish
Pages (from-to)271-275
Number of pages5
JournalJournal of the Neurological Sciences
Volume379
DOIs
Publication statusPublished - 2017 Aug 15

Fingerprint

Myasthenia Gravis
Tacrolimus
Observational Studies
Prospective Studies
Safety
Prednisolone
Drug-Related Side Effects and Adverse Reactions
Therapeutics
Proxy
Immunosuppressive Agents
Korea

Keywords

  • ADR
  • MG
  • MGCS
  • Myasthenia gravis
  • Prednisolone
  • Tacrolimus

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

A multicenter prospective observational study on the safety and efficacy of tacrolimus in patients with myasthenia gravis. / Ahn, Suk Won; Joo, In Soo; Kim, Byung Jo; Sung, Jung Joon; Kang, Sa Youn; Oh, Jeeyoung; Minn, Yang Ki; Suh, Bum Chun; Oh, Sun Young; Hong, Yoon Ho; Nam, Tai Seung; Seok, Jung Im; Park, Young Eun; Shin, Ha Young; Cho, Eun Bin; Shin, Je Young; Seok, Hung Youl; Park, Jin Sung; Min, Ju Hong; Seok, Jin Myoung; Kim, Byoung Joon.

In: Journal of the Neurological Sciences, Vol. 379, 15.08.2017, p. 271-275.

Research output: Contribution to journalArticle

Ahn, SW, Joo, IS, Kim, BJ, Sung, JJ, Kang, SY, Oh, J, Minn, YK, Suh, BC, Oh, SY, Hong, YH, Nam, TS, Seok, JI, Park, YE, Shin, HY, Cho, EB, Shin, JY, Seok, HY, Park, JS, Min, JH, Seok, JM & Kim, BJ 2017, 'A multicenter prospective observational study on the safety and efficacy of tacrolimus in patients with myasthenia gravis', Journal of the Neurological Sciences, vol. 379, pp. 271-275. https://doi.org/10.1016/j.jns.2017.05.060
Ahn, Suk Won ; Joo, In Soo ; Kim, Byung Jo ; Sung, Jung Joon ; Kang, Sa Youn ; Oh, Jeeyoung ; Minn, Yang Ki ; Suh, Bum Chun ; Oh, Sun Young ; Hong, Yoon Ho ; Nam, Tai Seung ; Seok, Jung Im ; Park, Young Eun ; Shin, Ha Young ; Cho, Eun Bin ; Shin, Je Young ; Seok, Hung Youl ; Park, Jin Sung ; Min, Ju Hong ; Seok, Jin Myoung ; Kim, Byoung Joon. / A multicenter prospective observational study on the safety and efficacy of tacrolimus in patients with myasthenia gravis. In: Journal of the Neurological Sciences. 2017 ; Vol. 379. pp. 271-275.
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abstract = "Introduction Several clinical studies using tacrolimus revealed reasonable therapeutic mechanisms and efficacy in patients with myasthenia gravis (MG). However, long-period studies in a large number of patients with MG are limited; therefore, the aim of this study was to investigate the therapeutic efficacies and safety of tacrolimus in patients with MG during a 12-month follow-up period. Methods Tacrolimus was administered to 150 patients with MG who were recruited based on the inclusion criteria. Fifteen medical centers in Korea participated in this study. The efficacy of tacrolimus was assessed using MG composite scales (MGCS) and the prednisolone-sparing effect. And the adverse drug reactions (ADRs) of tacrolimus were monitored in each patient from the beginning of tacrolimus treatment to the end of the follow-up period. Results After starting tacrolimus, the 32 patients were affected by ADRs, and consequentially 134 patients of the enrolled patients were followed up for 12 months. They showed that the mean prednisolone dosage significantly decreased (6.1 ± 7.6 mg/day), compared to that in the baseline (11.3 ± 9.5 mg/day), and MGCS significantly improved after 12 months of tacrolimus treatment, compared to that at the baseline. Conclusions Our study showed that tacrolimus would be an effective immunosuppressant as an initial therapeutic agent in patients with MG; in addition, it showed tolerable safety profiles during the 12-month follow-up evaluation.",
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T1 - A multicenter prospective observational study on the safety and efficacy of tacrolimus in patients with myasthenia gravis

AU - Ahn, Suk Won

AU - Joo, In Soo

AU - Kim, Byung Jo

AU - Sung, Jung Joon

AU - Kang, Sa Youn

AU - Oh, Jeeyoung

AU - Minn, Yang Ki

AU - Suh, Bum Chun

AU - Oh, Sun Young

AU - Hong, Yoon Ho

AU - Nam, Tai Seung

AU - Seok, Jung Im

AU - Park, Young Eun

AU - Shin, Ha Young

AU - Cho, Eun Bin

AU - Shin, Je Young

AU - Seok, Hung Youl

AU - Park, Jin Sung

AU - Min, Ju Hong

AU - Seok, Jin Myoung

AU - Kim, Byoung Joon

PY - 2017/8/15

Y1 - 2017/8/15

N2 - Introduction Several clinical studies using tacrolimus revealed reasonable therapeutic mechanisms and efficacy in patients with myasthenia gravis (MG). However, long-period studies in a large number of patients with MG are limited; therefore, the aim of this study was to investigate the therapeutic efficacies and safety of tacrolimus in patients with MG during a 12-month follow-up period. Methods Tacrolimus was administered to 150 patients with MG who were recruited based on the inclusion criteria. Fifteen medical centers in Korea participated in this study. The efficacy of tacrolimus was assessed using MG composite scales (MGCS) and the prednisolone-sparing effect. And the adverse drug reactions (ADRs) of tacrolimus were monitored in each patient from the beginning of tacrolimus treatment to the end of the follow-up period. Results After starting tacrolimus, the 32 patients were affected by ADRs, and consequentially 134 patients of the enrolled patients were followed up for 12 months. They showed that the mean prednisolone dosage significantly decreased (6.1 ± 7.6 mg/day), compared to that in the baseline (11.3 ± 9.5 mg/day), and MGCS significantly improved after 12 months of tacrolimus treatment, compared to that at the baseline. Conclusions Our study showed that tacrolimus would be an effective immunosuppressant as an initial therapeutic agent in patients with MG; in addition, it showed tolerable safety profiles during the 12-month follow-up evaluation.

AB - Introduction Several clinical studies using tacrolimus revealed reasonable therapeutic mechanisms and efficacy in patients with myasthenia gravis (MG). However, long-period studies in a large number of patients with MG are limited; therefore, the aim of this study was to investigate the therapeutic efficacies and safety of tacrolimus in patients with MG during a 12-month follow-up period. Methods Tacrolimus was administered to 150 patients with MG who were recruited based on the inclusion criteria. Fifteen medical centers in Korea participated in this study. The efficacy of tacrolimus was assessed using MG composite scales (MGCS) and the prednisolone-sparing effect. And the adverse drug reactions (ADRs) of tacrolimus were monitored in each patient from the beginning of tacrolimus treatment to the end of the follow-up period. Results After starting tacrolimus, the 32 patients were affected by ADRs, and consequentially 134 patients of the enrolled patients were followed up for 12 months. They showed that the mean prednisolone dosage significantly decreased (6.1 ± 7.6 mg/day), compared to that in the baseline (11.3 ± 9.5 mg/day), and MGCS significantly improved after 12 months of tacrolimus treatment, compared to that at the baseline. Conclusions Our study showed that tacrolimus would be an effective immunosuppressant as an initial therapeutic agent in patients with MG; in addition, it showed tolerable safety profiles during the 12-month follow-up evaluation.

KW - ADR

KW - MG

KW - MGCS

KW - Myasthenia gravis

KW - Prednisolone

KW - Tacrolimus

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