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- Title
A Comparison of Two Regimens of Topical Corticosteroids in the Treatment of Patients with Bullous Pemphigoid: A Multicenter Randomized Study.
- Authors
Joly, Pascal; Roujeau, Jean-Claude; Benichou, Jacques; Delaporte, Emmanuel; D'Incan, Michel; Dreno, Brigitte; Bedane, Christophe; Sparsa, Agnes; Gorin, Isabelle; Picard, Catherine; Tancrede-Bohin, Emmanuelle; Sassolas, Bruno; Lok, Catherine; Guillaume, Jean-Claude; Doutre, Marie-Sylvie; Richard, Marie-Aleth; Caux, Frédéric; Prost, Catherine; Plantin, Patrice; Chosidow, Olivier
- 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.Journal of Investigative Dermatology (2009) 129, 1681–1687; doi:10.1038/jid.2008.412; published online 29 January 2009
- Subjects
CORTICOSTEROIDS; CLINICAL trials; SKIN diseases; DERMATOLOGY; PATIENT participation
- Publication
Journal of Investigative Dermatology, 2009, Vol 129, Issue 7, p1681
- ISSN
0022-202X
- Publication type
Article
- DOI
10.1038/jid.2008.412