{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T02:17:15Z","timestamp":1787797035244,"version":"build-2784847793"},"reference-count":39,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T00:00:00Z","timestamp":1773100800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100005897","name":"French Society of Dermatology","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005897","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,6,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Superpotent topical corticosteroids (STS) are highly effective in bullous pemphigoid (BP), but prolonged use is associated with practical limitations and a risk of relapse.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate whether combining short-term STS with methotrexate (MTX) could maintain efficacy, reduce relapses and preserve safety compared with prolonged STS alone.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this multicentre randomized open-label noninferiority trial, adults with BP were assigned to receive either STS (clobetasol propionate) for 1\u2005month plus low-dose MTX as maintenance (MTX + STS arm), or prolonged STS alone (STS arm). The primary endpoint was 9-month overall survival (OS), with a predefined noninferiority margin of 15%. Secondary outcomes included relapse-free survival (RFS) and serious adverse events (SAEs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 266 randomized patients (mean age 80.8\u2005years), 9-month OS was 86.5% in the MTX + STS arm and 83.5% in the STS arm [P = 0.498; hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.40\u20131.50]. The lower limit of the 90% CI for the difference in survival rates (\u22124.6%) remained within the predefined noninferiority margin, meeting the primary endpoint. Among the 87.4% of patients who achieved disease control within 28\u2005days, relapse occurred in 31 patients in the MTX + STS arm and 52 in the STS arm, corresponding to a 9-month RFS of 68.4% (95% CI 59.3\u201378.8) vs. 47.4% (95% CI 37.7\u201359.5), respectively (P = 0.042). SAEs were more frequent in the MTX + STS arm than in the STS arm [mean number per patient per month 0.40 (95% CI 0.23\u20130.57) vs. 0.19 (95% CI 0.01\u20130.36), P = 0.005]. One limitation of this study was its open-label design. Moreover, it did not include a validated disease activity score and was conducted in a selected BP population managed under clinical trial conditions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Maintenance therapy with low-dose MTX is noninferior to prolonged STS in terms of survival and is associated with a reduced risk of relapse, at the cost of increased toxicity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjd\/ljag094","type":"journal-article","created":{"date-parts":[[2026,3,7]],"date-time":"2026-03-07T12:45:10Z","timestamp":1772887510000},"page":"38-47","source":"Crossref","is-referenced-by-count":2,"title":["Combined methotrexate and short-term superpotent topical corticosteroids compared with prolonged superpotent topical corticosteroids alone in bullous pemphigoid: a multicentre, noninferiority randomized clinical trial"],"prefix":"10.1093","volume":"195","author":[{"given":"Olivier","family":"Dereure","sequence":"first","affiliation":[{"name":"Department of Dermatology and INSERM U1058 Pathogenesis and Control of Chronic Infections, University of Montpellier , Montpellier ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Bernard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8400-4310","authenticated-orcid":false,"given":"Olivier","family":"Chosidow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5383-7096","authenticated-orcid":false,"given":"Saskia","family":"Ingen-Housz-Oro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Machet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Duvert-Lehembre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herv\u00e9","family":"Maillard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Abasq","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Sassolas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Acquitter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Polina","family":"Konstantinou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillaume","family":"Chaby","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fr\u00e9d\u00e9ric","family":"Caux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christelle","family":"Le Roux-Villet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Prost","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martine","family":"Avenel-Audran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Delaporte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00e9raldine","family":"Jeudy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoine","family":"Mah\u00e9","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henri","family":"Montaudie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Picard-Dahan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ga\u00eblle","family":"Quereux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie-Aleth","family":"Richard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Bourgault-Villada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denis","family":"Jullien","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cl\u00e9mence","family":"Lepelletier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fanny","family":"Fichel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mich\u00e8le","family":"Sanchez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacques","family":"Rouanet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Labeille","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5780-1827","authenticated-orcid":false,"given":"Emmanuel","family":"Mah\u00e9","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Pham-Ledard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fanchon","family":"Herman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4204-7299","authenticated-orcid":false,"given":"Marie-Christine","family":"Picot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Joly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,3,10]]},"reference":[{"key":"2026062312162752600_ljag094-B1","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1007\/s12016-017-8633-4","article-title":"Autoimmune subepidermal bullous diseases of the skin and mucosae: clinical features, diagnosis, and management","volume":"54","author":"Amber","year":"2018","journal-title":"Clin Rev Allergy Immunol"},{"key":"2026062312162752600_ljag094-B2","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1007\/s12026-017-8975-2","article-title":"Subepidermal autoimmune bullous diseases: overview, epidemiology, and associations","volume":"66","author":"Kridin","year":"2018","journal-title":"Immunol Res"},{"key":"2026062312162752600_ljag094-B3","doi-asserted-by":"crossref","first-page":"1998","DOI":"10.1038\/jid.2012.35","article-title":"Incidence and mortality of bullous pemphigoid in France","volume":"132","author":"Joly","year":"2012","journal-title":"J Invest Dermatol"},{"key":"2026062312162752600_ljag094-B4","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1001\/jamadermatol.2020.5598","article-title":"Mixed individual-aggregate data on all-cause mortality in bullous pemphigoid: a meta-analysis","volume":"157","author":"Tedbirt","year":"2021","journal-title":"JAMA Dermatol"},{"key":"2026062312162752600_ljag094-B5","doi-asserted-by":"crossref","first-page":"1200","DOI":"10.1111\/bjd.12072","article-title":"British Association of Dermatologists\u2019 guidelines for the management of bullous pemphigoid 2012","volume":"167","author":"Venning","year":"2012","journal-title":"Br J Dermatol"},{"key":"2026062312162752600_ljag094-B6","doi-asserted-by":"crossref","first-page":"1102","DOI":"10.1111\/1346-8138.15111","article-title":"Japanese guidelines for the management of pemphigoid (including epidermolysis bullosa acquisita)","volume":"46","author":"Ujiie","year":"2019","journal-title":"J Dermatol"},{"key":"2026062312162752600_ljag094-B7","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1056\/NEJMoa011592","article-title":"A comparison of oral and topical corticosteroids in patients with bullous pemphigoid","volume":"346","author":"Joly","year":"2002","journal-title":"N Engl J Med"},{"key":"2026062312162752600_ljag094-B8","doi-asserted-by":"crossref","first-page":"1681","DOI":"10.1038\/jid.2008.412","article-title":"A comparison of two regimens of topical corticosteroids in the treatment of patients with bullous pemphigoid: a multicenter randomized study","volume":"129","author":"Joly","year":"2009","journal-title":"J Invest Dermatol"},{"key":"2026062312162752600_ljag094-B9","first-page":"CD002292","article-title":"Interventions for Bullous pemphigoid","volume":"8","author":"Singh","year":"2023","journal-title":"Cochrane Database Syst Rev"},{"key":"2026062312162752600_ljag094-B10","doi-asserted-by":"crossref","first-page":"1689","DOI":"10.1111\/jdv.18220","article-title":"Updated S2\u2005K guidelines for the management of bullous pemphigoid initiated by the European Academy of Dermatology and Venereology (EADV)","volume":"36","author":"Borradori","year":"2022","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"2026062312162752600_ljag094-B11","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1016\/j.jaad.2020.05.161","article-title":"Subepithelial autoimmune bullous dermatoses disease activity assessment and therapy","volume":"85","author":"Montagnon","year":"2021","journal-title":"J Am Acad Dermatol"},{"key":"2026062312162752600_ljag094-B12","doi-asserted-by":"crossref","first-page":"919","DOI":"10.1111\/bjd.14285","article-title":"Assessment of adherence to topical corticosteroids in patients with bullous pemphigoid","volume":"174","author":"Sobocinski","year":"2016","journal-title":"Br J Dermatol"},{"key":"2026062312162752600_ljag094-B13","doi-asserted-by":"crossref","first-page":"539","DOI":"10.1093\/bjd\/ljae219","article-title":"Risk of death, major adverse cardiac events and relapse in patients with bullous pemphigoid treated with systemic or topical corticosteroids","volume":"191","author":"Kridin","year":"2024","journal-title":"Br J Dermatol"},{"key":"2026062312162752600_ljag094-B14","doi-asserted-by":"crossref","first-page":"928621","DOI":"10.3389\/fimmu.2022.928621","article-title":"Rituximab, omalizumab, and dupilumab treatment outcomes in bullous pemphigoid: a systematic review","volume":"13","author":"Cao","year":"2022","journal-title":"Front Immunol"},{"key":"2026062312162752600_ljag094-B15","doi-asserted-by":"crossref","first-page":"244","DOI":"10.1093\/bjd\/ljad136","article-title":"Efficacy and safety of dupilumab in bullous pemphigoid: a retrospective multicentric study of 36 patients","volume":"189","author":"Moghadam","year":"2023","journal-title":"Br J Dermatol"},{"key":"2026062312162752600_ljag094-B16","doi-asserted-by":"crossref","first-page":"4844.","DOI":"10.3390\/jcm13164844","article-title":"Omalizumab and dupilumab for the treatment of bullous pemphigoid: a systematic review","volume":"13","author":"Granados-Betancort","year":"2024","journal-title":"J Clin Med"},{"key":"2026062312162752600_ljag094-B17","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1093\/bjd\/ljad369","article-title":"Omalizumab in the treatment of bullous pemphigoid resistant to first-line therapy: a French national multicentre retrospective study of 100 patients","volume":"190","author":"Chebani","year":"2024","journal-title":"Br J Dermatol"},{"key":"2026062312162752600_ljag094-B18","doi-asserted-by":"crossref","first-page":"501","DOI":"10.1093\/bjd\/ljae403","article-title":"Real-world evaluation of the effectiveness and safety of dupilumab in bullous pemphigoid: an ambispective multicentre case series","volume":"192","author":"Planella-Fontanillas","year":"2025","journal-title":"Br J Dermatol"},{"key":"2026062312162752600_ljag094-B19","author":"Sanofi"},{"key":"2026062312162752600_ljag094-B20","doi-asserted-by":"crossref","first-page":"1255","DOI":"10.1001\/archderm.138.9.1255","article-title":"Treatment of bullous pemphigoid by low-dose methotrexate associated with short-term potent topical steroids: an open prospective study of 18 cases","volume":"138","author":"Dereure","year":"2002","journal-title":"Arch Dermatol"},{"key":"2026062312162752600_ljag094-B21","doi-asserted-by":"crossref","first-page":"1506","DOI":"10.1001\/archderm.139.11.1506-b","article-title":"Methotrexate for bullous pemphigoid: preliminary study","volume":"139","author":"Bara","year":"2003","journal-title":"Arch Dermatol"},{"key":"2026062312162752600_ljag094-B22","doi-asserted-by":"crossref","first-page":"1337","DOI":"10.1111\/j.1365-2133.2011.10531.x","article-title":"Combined treatment with low-dose methotrexate and initial short-term superpotent topical steroids in bullous pemphigoid: an open, multicentre, retrospective study","volume":"165","author":"Du-Thanh","year":"2011","journal-title":"Br J Dermatol"},{"key":"2026062312162752600_ljag094-B23","first-page":"1075","article-title":"Evaluation of clinical criteria for diagnosis of bullous pemphigoid","volume":"134","author":"Vaillant","year":"1998","journal-title":"French Bullous Study Group. Arch Dermatol"},{"key":"2026062312162752600_ljag094-B24","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1159\/000075040","article-title":"Clinical criteria for the diagnosis of bullous pemphigoid: a reevaluation according to immunoblot analysis of patient sera","volume":"208","author":"Joly","year":"2004","journal-title":"Dermatology"},{"key":"2026062312162752600_ljag094-B25","doi-asserted-by":"crossref","first-page":"1363032.","DOI":"10.3389\/fimmu.2024.1363032","article-title":"State-of-the art diagnosis of autoimmune blistering diseases","volume":"15","author":"van Beek","year":"2024","journal-title":"Front Immunol"},{"key":"2026062312162752600_ljag094-B26","doi-asserted-by":"crossref","first-page":"479","DOI":"10.1016\/j.jaad.2011.06.032","article-title":"Definitions and outcome measures for bullous pemphigoid: recommendations by an international panel of experts","volume":"66","author":"Murrell","year":"2012","journal-title":"J Am Acad Dermatol"},{"key":"2026062312162752600_ljag094-B27","doi-asserted-by":"crossref","first-page":"M139","DOI":"10.1093\/geronj\/46.4.M139","article-title":"The use of the Karnofsky Performance Scale in determining outcomes and risk in geriatric outpatients","volume":"46","author":"Crooks","year":"1991","journal-title":"J Gerontol"},{"key":"2026062312162752600_ljag094-B28","author":"US Department of Health and Human Services"},{"key":"2026062312162752600_ljag094-B29","doi-asserted-by":"crossref","first-page":"1115","DOI":"10.1002\/sim.2476","article-title":"Non-inferiority trials: the \u2018at least as good as\u2019 criterion with dichotomous data","volume":"25","author":"Laster","year":"2006","journal-title":"Stat Med"},{"key":"2026062312162752600_ljag094-B30","doi-asserted-by":"crossref","first-page":"1353","DOI":"10.1002\/sim.4780121407","article-title":"How to establish equivalence when data are censored: a randomized trial of treatments for B non-Hodgkin lymphoma","volume":"12","author":"Com-Nougue","year":"1993","journal-title":"Stat Med"},{"key":"2026062312162752600_ljag094-B31","doi-asserted-by":"crossref","first-page":"691","DOI":"10.1001\/archderm.141.6.691","article-title":"Prediction of survival for patients with bullous pemphigoid: a prospective study","volume":"141","author":"Joly","year":"2005","journal-title":"Arch Dermatol"},{"key":"2026062312162752600_ljag094-B32","doi-asserted-by":"crossref","first-page":"2189","DOI":"10.1056\/NEJMsr077003","article-title":"Statistics in medicine\u2013reporting of subgroup analyses in clinical trials","volume":"357","author":"Wang","year":"2007","journal-title":"N Engl J Med"},{"key":"2026062312162752600_ljag094-B33","doi-asserted-by":"crossref","first-page":"612","DOI":"10.1001\/archderm.144.5.612","article-title":"A retrospective analysis of patients with bullous pemphigoid treated with methotrexate","volume":"144","author":"Kjellman","year":"2008","journal-title":"Arch Dermatol"},{"key":"2026062312162752600_ljag094-B34","doi-asserted-by":"crossref","first-page":"1532","DOI":"10.1016\/j.jaad.2020.01.084","article-title":"Low-dose methotrexate use and safety for older patients with bullous pemphigoid and impaired renal function: a cohort study","volume":"82","author":"Fisch","year":"2020","journal-title":"J Am Acad Dermatol"},{"key":"2026062312162752600_ljag094-B35","doi-asserted-by":"crossref","first-page":"3193","DOI":"10.3390\/jcm11113193","article-title":"Methylprednisolone plus low-dose methotrexate for bullous pemphigoid - a single center retrospective analysis","volume":"11","author":"Gravani","year":"2022","journal-title":"J Clin Med"},{"key":"2026062312162752600_ljag094-B36","doi-asserted-by":"crossref","first-page":"1638","DOI":"10.3390\/jcm12041638","article-title":"Can methotrexate be employed as monotherapy for bullous pemphigoid? Analysis of efficiency and tolerance of methotrexate treatment in patients with bullous pemphigoid","volume":"12","author":"Wojtczak","year":"2023","journal-title":"J Clin Med"},{"key":"2026062312162752600_ljag094-B37","doi-asserted-by":"crossref","first-page":"345","DOI":"10.1093\/bjd\/ljaf172","article-title":"Treatment of bullous pemphigoid with methotrexate is associated with a decreased mortality risk","volume":"193","author":"Leisti","year":"2025","journal-title":"Br J Dermatol"},{"key":"2026062312162752600_ljag094-B38","doi-asserted-by":"crossref","first-page":"1232","DOI":"10.1111\/bjd.20593","article-title":"International multicentre observational study to assess the efficacy and safety of a 0.5\u2005mg kg\u22121 per day starting dose of oral corticosteroids to treat bullous pemphigoid","volume":"185","author":"H\u00e9bert","year":"2021","journal-title":"Br J Dermatol"},{"key":"2026062312162752600_ljag094-B39","doi-asserted-by":"crossref","first-page":"1630","DOI":"10.1016\/S0140-6736(17)30560-3","article-title":"Doxycycline versus prednisolone as an initial treatment strategy for bullous pemphigoid: a pragmatic, non-inferiority, randomised controlled trial","volume":"389","author":"Williams","year":"2017","journal-title":"Lancet"}],"container-title":["British Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/bjd\/advance-article-pdf\/doi\/10.1093\/bjd\/ljag094\/67289693\/ljag094.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjd\/article-pdf\/195\/1\/38\/67289693\/ljag094.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjd\/article-pdf\/195\/1\/38\/67289693\/ljag094.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T16:16:37Z","timestamp":1782231397000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/bjd\/article\/195\/1\/38\/8513137"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,10]]},"references-count":39,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,3,10]]},"published-print":{"date-parts":[[2026,6,23]]}},"URL":"https:\/\/doi.org\/10.1093\/bjd\/ljag094","relation":{},"ISSN":["0007-0963","1365-2133"],"issn-type":[{"value":"0007-0963","type":"print"},{"value":"1365-2133","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,7]]},"published":{"date-parts":[[2026,3,10]]}}}