Topical Steroids Alone or Associated With Methotrexate in Bullous Pemphigoid

Summary

This controlled multi-center randomized clinical trial, with direct individual benefit, will compare efficacy and safety of two strategies in non-localized BP care: a combined regimen using initial superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9 months (current standard of care). The expected result is an equivalence between the two compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase being easier to manage and therefore associated with better compliance than topical steroids with less cutaneous side effects and most cost-effective.

Timeline

Start

2008-01-22

Primary completion

2015-05-26

Completion

2015-12-31

Outcome

Met primary endpoint

paper The lower limit of the 90% confidence interval for the difference in survival rates (-4.6%) remained within the predefined non-inferiority margin, meeting the primary endpoint. PMID 41807108 ↗

Publications

• Results Dereure O, Bernard P, Chosidow O, Ingen-Housz-Oro S, Machet L, Duvert-Lehembre S, Maillard H, Abasq C, Sassolas B, Acquitter M, Konstantinou MP, Chaby G, Caux F, Le Roux-Villet C, Prost C, Avenel-Audran M, Delaporte E, Jeudy G, Mahe A, Montaudie H, Picard-Dahan C, Quereux G, Richard MA, Bourgault-Villada I, Jullien D, Lepelletier C, Fichel F, Sanchez M, Rouanet J, Labeille B, Mahe E, Pham-Ledard A, Herman F, Picot MC, Joly P. Combined methotrexate and short-term superpotent topical corticosteroids compared with prolonged superpotent topical corticosteroids alone in bullous pemphigoid: a multicentre, noninferiority randomised clinical trial. Br J Dermatol. 2026 Mar 10:ljag094. doi: 10.1093/bjd/ljag094. Online ahead of print.

Drugs

Indications