A randomised clinical trial to assess the adjuvant potential of methotrexate to corticosteroids in mucosal or limited mucocutaneous pemphigus vulgaris

Glucocorticoids are the mainstay of treatment for pemphigus vulgaris (PV). However, the requirement of high doses for long durations often leads to serious adverse events. Methotrexate as an adjuvant has shown potential in retrospective studies but randomized trials are lacking. The objective of the...

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Autores principales: Jain, Khimit, Thakur, Vishal, Handa, Sanjeev, Thakur, Neha, Shilpa, Sachdeva, Naresh, Mahajan, Rahul, De, Dipankar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
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Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9085868/
https://www.ncbi.nlm.nih.gov/pubmed/35534494
http://dx.doi.org/10.1038/s41598-022-11387-2
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author Jain, Khimit
Thakur, Vishal
Handa, Sanjeev
Thakur, Neha
Shilpa
Sachdeva, Naresh
Mahajan, Rahul
De, Dipankar
author_facet Jain, Khimit
Thakur, Vishal
Handa, Sanjeev
Thakur, Neha
Shilpa
Sachdeva, Naresh
Mahajan, Rahul
De, Dipankar
author_sort Jain, Khimit
collection PubMed
description Glucocorticoids are the mainstay of treatment for pemphigus vulgaris (PV). However, the requirement of high doses for long durations often leads to serious adverse events. Methotrexate as an adjuvant has shown potential in retrospective studies but randomized trials are lacking. The objective of the study was to assess the adjuvant potential of methotrexate in mucosal/limited mucocutaneous PV. In this randomised prospective study, 44 patients with mucosal/limited mucocutaneous PV were randomised (1:1) to receive either prednisolone 1 mg/kg/day (later fixed at a maximum dose of 60 mg/day) alone or with methotrexate 0.3 mg/kg/week for 9-months study period. Prednisolone dose was tapered once there was an 80% reduction in Pemphigus Disease Activity Index. Outcome measures were total cumulative dose of prednisolone, the proportion of patients achieving disease control, time taken for disease control and remission on minimal treatment, and adverse effects. No significant difference in the total cumulative dose of prednisolone among the groups was observed (p = 0.68). Disease control was achieved in 95.5% and 86.4% of patients in the prednisolone alone group, and prednisolone and methotrexate group respectively (p = 0.61). No statistically significant difference was observed among the groups with respect to the proportion of patients achieving remission, time taken for disease control and remission, and the number of adverse events. Our study showed no additional benefit of methotrexate to prednisolone in the treatment of mucosal/limited mucocutaneous PV. Trial registration: CTRI/2018/07/015002; Registered on 23/07/2018]; Trial Registered Retrospectively. http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=24964&EncHid=&modid=&compid=%27,%2724964det%27.
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spelling pubmed-90858682022-05-11 A randomised clinical trial to assess the adjuvant potential of methotrexate to corticosteroids in mucosal or limited mucocutaneous pemphigus vulgaris Jain, Khimit Thakur, Vishal Handa, Sanjeev Thakur, Neha Shilpa Sachdeva, Naresh Mahajan, Rahul De, Dipankar Sci Rep Article Glucocorticoids are the mainstay of treatment for pemphigus vulgaris (PV). However, the requirement of high doses for long durations often leads to serious adverse events. Methotrexate as an adjuvant has shown potential in retrospective studies but randomized trials are lacking. The objective of the study was to assess the adjuvant potential of methotrexate in mucosal/limited mucocutaneous PV. In this randomised prospective study, 44 patients with mucosal/limited mucocutaneous PV were randomised (1:1) to receive either prednisolone 1 mg/kg/day (later fixed at a maximum dose of 60 mg/day) alone or with methotrexate 0.3 mg/kg/week for 9-months study period. Prednisolone dose was tapered once there was an 80% reduction in Pemphigus Disease Activity Index. Outcome measures were total cumulative dose of prednisolone, the proportion of patients achieving disease control, time taken for disease control and remission on minimal treatment, and adverse effects. No significant difference in the total cumulative dose of prednisolone among the groups was observed (p = 0.68). Disease control was achieved in 95.5% and 86.4% of patients in the prednisolone alone group, and prednisolone and methotrexate group respectively (p = 0.61). No statistically significant difference was observed among the groups with respect to the proportion of patients achieving remission, time taken for disease control and remission, and the number of adverse events. Our study showed no additional benefit of methotrexate to prednisolone in the treatment of mucosal/limited mucocutaneous PV. Trial registration: CTRI/2018/07/015002; Registered on 23/07/2018]; Trial Registered Retrospectively. http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=24964&EncHid=&modid=&compid=%27,%2724964det%27. Nature Publishing Group UK 2022-05-09 /pmc/articles/PMC9085868/ /pubmed/35534494 http://dx.doi.org/10.1038/s41598-022-11387-2 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Jain, Khimit
Thakur, Vishal
Handa, Sanjeev
Thakur, Neha
Shilpa
Sachdeva, Naresh
Mahajan, Rahul
De, Dipankar
A randomised clinical trial to assess the adjuvant potential of methotrexate to corticosteroids in mucosal or limited mucocutaneous pemphigus vulgaris
title A randomised clinical trial to assess the adjuvant potential of methotrexate to corticosteroids in mucosal or limited mucocutaneous pemphigus vulgaris
title_full A randomised clinical trial to assess the adjuvant potential of methotrexate to corticosteroids in mucosal or limited mucocutaneous pemphigus vulgaris
title_fullStr A randomised clinical trial to assess the adjuvant potential of methotrexate to corticosteroids in mucosal or limited mucocutaneous pemphigus vulgaris
title_full_unstemmed A randomised clinical trial to assess the adjuvant potential of methotrexate to corticosteroids in mucosal or limited mucocutaneous pemphigus vulgaris
title_short A randomised clinical trial to assess the adjuvant potential of methotrexate to corticosteroids in mucosal or limited mucocutaneous pemphigus vulgaris
title_sort randomised clinical trial to assess the adjuvant potential of methotrexate to corticosteroids in mucosal or limited mucocutaneous pemphigus vulgaris
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9085868/
https://www.ncbi.nlm.nih.gov/pubmed/35534494
http://dx.doi.org/10.1038/s41598-022-11387-2
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