A comparison of two regimens of topical corticosteroids in the treatment of patients with bullous pemphigoid: a multicenter randomized study.
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.
Joly
Pascal
P
Department of Dermatology, INSERM U901, University of Rouen, Rouen, France. Pascal.Joly@chu-rouen.fr
Roujeau
Jean-Claude
JC
Benichou
Jacques
J
Delaporte
Emmanuel
E
D'Incan
Michel
M
Dreno
Brigitte
B
Bedane
Christophe
C
Sparsa
Agnes
A
Gorin
Isabelle
I
Picard
Catherine
C
Tancrede-Bohin
Emmanuelle
E
Sassolas
Bruno
B
Lok
Catherine
C
Guillaume
Jean-Claude
JC
Doutre
Marie-Sylvie
MS
Richard
Marie-Aleth
MA
Caux
Frédéric
F
Prost
Catherine
C
Plantin
Patrice
P
Chosidow
Olivier
O
Pauwels
Christine
C
Maillard
Hervé
H
Saiag
Philippe
P
Descamps
Vincent
V
Chevrant-Breton
Jacqueline
J
Dereure
Olivier
O
Hellot
Marie-France
MF
Esteve
Eric
E
Bernard
Philippe
P
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
D005938:Glucocorticoids; D002990:Clobetasol