title: A comparison of two regimens of topical corticosteroids in the treatment of patients with bullous pemphigoid: a multicenter randomized study.
abstract: Superpotent topical corticosteroids (CS) have been demonstrated to improve bullous pemphigoid (BP) patients' survival. We assessed whether a mild regimen using lower doses of topical CS and a shorter duration could improve the outcome of BP patients even more. Three-hundred and twelve BP patients were included in a multicenter randomized controlled trial and stratified depending on the extent of BP as moderate (n=134) or extensive (n=178). Patients were randomly assigned to the standard regimen (clobetasol propionate cream, 40 g per day initially, with CS tapering over 12 months) or the mild regimen (10-30 g per day), with CS tapering over 4 months. A noninferior rate of BP control was obtained with the mild regimen 156/159 (98%) as compared with the standard regimen 150/150 (100%; P=0.005). Event-free survival, that is, the combined outcome of deaths and life-threatening adverse events did not differ between the two treatment groups (P=0.77). However, upon adjusting through the Cox model for age and Karnofsky score, a strong beneficial effect of the mild regimen was observed in patients with moderate BP, with an almost twofold decrease in the risk of death or life-threatening adverse events relative to the standard regimen (hazard ratio=0.54; 95% confidence interval, 0.30-0.97; P=0.039). This mild regimen allows a 70% reduction of the cumulative doses of CS and improves BP patients' outcome.
authors.affiliation: Department of Dermatology, INSERM U901, University of Rouen, Rouen, France. Pascal.Joly@chu-rouen.fr
authors.forename: Pascal
authors.initials: P
authors.lastname: Joly
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Roujeau
authors.forename: Jacques
authors.initials: J
authors.lastname: Benichou
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Delaporte
authors.forename: Michel
authors.initials: M
authors.lastname: D'Incan
authors.forename: Brigitte
authors.initials: B
authors.lastname: Dreno
authors.forename: Christophe
authors.initials: C
authors.lastname: Bedane
authors.forename: Agnes
authors.initials: A
authors.lastname: Sparsa
authors.forename: Isabelle
authors.initials: I
authors.lastname: Gorin
authors.forename: Catherine
authors.initials: C
authors.lastname: Picard
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Tancrede-Bohin
authors.forename: Bruno
authors.initials: B
authors.lastname: Sassolas
authors.forename: Catherine
authors.initials: C
authors.lastname: Lok
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Guillaume
authors.forename: Marie-Sylvie
authors.initials: MS
authors.lastname: Doutre
authors.forename: Marie-Aleth
authors.initials: MA
authors.lastname: Richard
authors.forename: Frédéric
authors.initials: F
authors.lastname: Caux
authors.forename: Catherine
authors.initials: C
authors.lastname: Prost
authors.forename: Patrice
authors.initials: P
authors.lastname: Plantin
authors.forename: Olivier
authors.initials: O
authors.lastname: Chosidow
authors.forename: Christine
authors.initials: C
authors.lastname: Pauwels
authors.forename: Hervé
authors.initials: H
authors.lastname: Maillard
authors.forename: Philippe
authors.initials: P
authors.lastname: Saiag
authors.forename: Vincent
authors.initials: V
authors.lastname: Descamps
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Chevrant-Breton
authors.forename: Olivier
authors.initials: O
authors.lastname: Dereure
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Hellot
authors.forename: Eric
authors.initials: E
authors.lastname: Esteve
authors.forename: Philippe
authors.initials: P
authors.lastname: Bernard
mesh_terms: D000287:Administration, Topical; D000311:Adrenal Glands / Q000187:drug effects; D000368:Aged; D000369:Aged, 80 and over; D002990:Clobetasol / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects; D008297:Male; D010391:Pemphigoid, Bullous / Q000188:drug therapy*; D016016:Proportional Hazards Models; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D002990:Clobetasol