Cargando…
A Randomized Open-Labeled Trial of Methotrexate as a Steroid-Sparing Agent for Patients With Generalized Myasthenia Gravis
BACKGROUND AND PURPOSE: Two clinical trials assessing the steroid-sparing effect of methotrexate (MTX) yielded conflicting results. Our objective was to investigate whether MTX would show a steroid-sparing effect in the treatment of generalized myasthenia gravis (MG) patients who fitted Myasthenia G...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8971191/ https://www.ncbi.nlm.nih.gov/pubmed/35371086 http://dx.doi.org/10.3389/fimmu.2022.839075 |
_version_ | 1784679591926824960 |
---|---|
author | Di, Li Shen, Faxiu Wen, Xinmei Lu, Yan Zhu, Wenjia Wang, Min Da, Yuwei |
author_facet | Di, Li Shen, Faxiu Wen, Xinmei Lu, Yan Zhu, Wenjia Wang, Min Da, Yuwei |
author_sort | Di, Li |
collection | PubMed |
description | BACKGROUND AND PURPOSE: Two clinical trials assessing the steroid-sparing effect of methotrexate (MTX) yielded conflicting results. Our objective was to investigate whether MTX would show a steroid-sparing effect in the treatment of generalized myasthenia gravis (MG) patients who fitted Myasthenia Gravis Foundation of America (MGFA) Class II and Class III. METHODS: We performed an 18-month prospective, randomized, open-labeled trial of prednisone combined with MTX 10 mg orally every week versus prednisone alone in 40 recently diagnosed MG patients of MGFA Class II and Class III between July 2014 and July 2018. The primary endpoint was the prednisone area under the dose–time curve (AUDTC) from months 3 to 18. Secondary endpoints included changes of the Quantitative Myasthenia Gravis Score (QMG), the Myasthenia Gravis Activity of Daily Living Score (MG-ADL), initial time of prednisone reduction, the median prednisone daily dose in each month, adverse events, and treatment failures in each group. RESULTS: Forty participants were included; among those, 5 individuals withdrew. A total of 35 participants completed 18 months of follow-up (18 in prednisone+MTX, 17 in prednisone group). Combined use of MTX reduced the month 3–18 prednisone AUDTC (prednisone+MTX 5,663.44 ± 1,678.08 mg, prednisone 6,683.94 ± 678.08 mg, p = 0.03, 95% confidence interval -1916.01 to -124.98). The initial times of prednisone reduction were 4.34 ± 1.44 months in the prednisone+MTX group and 5.56 ± 2.05 months in the prednisone group (p = 0.04, 95% CI -2.41 to -0.03). The median daily prednisone dose was significantly lower in the prednisone+MTX group at month 6 and months 9–18. No significant differences were found in QMG and MG-ADL scores between the two groups. No serious drug-related adverse events were observed in both groups. CONCLUSIONS: This study provides evidence that MTX has the steroid-sparing ability in generalized MG patients of MGFA Class II and Class III. CLINICAL TRIAL REGISTRATION: http://www.chictr.org.cn/showproj.aspx?proj=10563 identifier ChiCTR-IPR-15006081. |
format | Online Article Text |
id | pubmed-8971191 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-89711912022-04-02 A Randomized Open-Labeled Trial of Methotrexate as a Steroid-Sparing Agent for Patients With Generalized Myasthenia Gravis Di, Li Shen, Faxiu Wen, Xinmei Lu, Yan Zhu, Wenjia Wang, Min Da, Yuwei Front Immunol Immunology BACKGROUND AND PURPOSE: Two clinical trials assessing the steroid-sparing effect of methotrexate (MTX) yielded conflicting results. Our objective was to investigate whether MTX would show a steroid-sparing effect in the treatment of generalized myasthenia gravis (MG) patients who fitted Myasthenia Gravis Foundation of America (MGFA) Class II and Class III. METHODS: We performed an 18-month prospective, randomized, open-labeled trial of prednisone combined with MTX 10 mg orally every week versus prednisone alone in 40 recently diagnosed MG patients of MGFA Class II and Class III between July 2014 and July 2018. The primary endpoint was the prednisone area under the dose–time curve (AUDTC) from months 3 to 18. Secondary endpoints included changes of the Quantitative Myasthenia Gravis Score (QMG), the Myasthenia Gravis Activity of Daily Living Score (MG-ADL), initial time of prednisone reduction, the median prednisone daily dose in each month, adverse events, and treatment failures in each group. RESULTS: Forty participants were included; among those, 5 individuals withdrew. A total of 35 participants completed 18 months of follow-up (18 in prednisone+MTX, 17 in prednisone group). Combined use of MTX reduced the month 3–18 prednisone AUDTC (prednisone+MTX 5,663.44 ± 1,678.08 mg, prednisone 6,683.94 ± 678.08 mg, p = 0.03, 95% confidence interval -1916.01 to -124.98). The initial times of prednisone reduction were 4.34 ± 1.44 months in the prednisone+MTX group and 5.56 ± 2.05 months in the prednisone group (p = 0.04, 95% CI -2.41 to -0.03). The median daily prednisone dose was significantly lower in the prednisone+MTX group at month 6 and months 9–18. No significant differences were found in QMG and MG-ADL scores between the two groups. No serious drug-related adverse events were observed in both groups. CONCLUSIONS: This study provides evidence that MTX has the steroid-sparing ability in generalized MG patients of MGFA Class II and Class III. CLINICAL TRIAL REGISTRATION: http://www.chictr.org.cn/showproj.aspx?proj=10563 identifier ChiCTR-IPR-15006081. Frontiers Media S.A. 2022-03-18 /pmc/articles/PMC8971191/ /pubmed/35371086 http://dx.doi.org/10.3389/fimmu.2022.839075 Text en Copyright © 2022 Di, Shen, Wen, Lu, Zhu, Wang and Da https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Immunology Di, Li Shen, Faxiu Wen, Xinmei Lu, Yan Zhu, Wenjia Wang, Min Da, Yuwei A Randomized Open-Labeled Trial of Methotrexate as a Steroid-Sparing Agent for Patients With Generalized Myasthenia Gravis |
title | A Randomized Open-Labeled Trial of Methotrexate as a Steroid-Sparing Agent for Patients With Generalized Myasthenia Gravis |
title_full | A Randomized Open-Labeled Trial of Methotrexate as a Steroid-Sparing Agent for Patients With Generalized Myasthenia Gravis |
title_fullStr | A Randomized Open-Labeled Trial of Methotrexate as a Steroid-Sparing Agent for Patients With Generalized Myasthenia Gravis |
title_full_unstemmed | A Randomized Open-Labeled Trial of Methotrexate as a Steroid-Sparing Agent for Patients With Generalized Myasthenia Gravis |
title_short | A Randomized Open-Labeled Trial of Methotrexate as a Steroid-Sparing Agent for Patients With Generalized Myasthenia Gravis |
title_sort | randomized open-labeled trial of methotrexate as a steroid-sparing agent for patients with generalized myasthenia gravis |
topic | Immunology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8971191/ https://www.ncbi.nlm.nih.gov/pubmed/35371086 http://dx.doi.org/10.3389/fimmu.2022.839075 |
work_keys_str_mv | AT dili arandomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT shenfaxiu arandomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT wenxinmei arandomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT luyan arandomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT zhuwenjia arandomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT wangmin arandomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT dayuwei arandomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT dili randomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT shenfaxiu randomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT wenxinmei randomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT luyan randomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT zhuwenjia randomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT wangmin randomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis AT dayuwei randomizedopenlabeledtrialofmethotrexateasasteroidsparingagentforpatientswithgeneralizedmyastheniagravis |