A Comparison of Two Regimens of Topical Corticosteroids in the Treatment of Patients with Bullous Pemphigoid: A Multicenter Randomized Study

JOURNAL OF INVESTIGATIVE DERMATOLOGY

卷:129

Article

Joly, Pascal¹  Roujeau, Jean-Claude²  Benichou, Jacques³  Delaporte, Emmanuel⁴  D'Incan, Michel⁵  Dreno, Brigitte⁶  Bedane, Christophe⁷  Sparsa, Agnes⁷  Picard, Catherine⁹  Tancrede-Bohin, Emmanuelle¹⁰  Sassolas, Bruno¹¹  Lok, Catherine¹²  Guillaume, Jean-Claude¹³  Doutre, Marie-Sylvie¹⁴  Richard, Marie-Aleth¹⁵  Caux, Frederic¹⁶  Prost, Catherine¹⁶  Plantin, Patrice¹⁷  Chosidow, Olivier¹⁸  Pauwels, Christine¹⁹  Maillard, Herve²⁰  Saiag, Philippe⁸  Descamps, Vincent¹⁹  Chevrant-Breton, Jacqueline²¹  Dereure, Olivier²²  Hellot, Marie-France³  Esteve, Eric²³  Bernard, Philippe²⁴ 

[1] Univ Rouen, INSERM, Dept Dermatol, U901, Rouen, France

[2] Univ Paris 12, Dept Dermatol, Creteil, France

[3] Univ Rouen, INSERM, Dept Biostat, U657, Rouen, France

[4] Univ Lille, Dept Dermatol, Lille, France

[5] Univ Clermont Ferrand 2, Dept Dermatol, Clermont Ferrand, France

[6] Univ Nantes, Dept Dermatol, Nantes, France

[7] Univ Limoges, Dept Dermatol, Limoges, France

[8] Univ Paris 05, Dept Dermatol, Paris, France

[9] Univ Paris 10, Bichat Hosp, Dept Dermatol, Paris, France

[10] Univ Paris 10, St Louis Hosp, Dept Dermatol, Paris, France

[11] Brest Univ Hosp, Dept Dermatol, Brest, France

[12] Amiens Univ Hosp, Dept Dermatol, Amiens, France

[13] Gen Hosp Colmar, Dept Dermatol, Colmar, France

[14] Univ Bordeaux, Dept Dermatol, Bordeaux, France

[15] Univ Marseille, Dept Dermatol, Marseille, France

[16] Univ Paris 13, Dept Dermatol, Bobigny, France

[17] Gen Hosp Quimper, Dept Dermatol, Quimper, France

[18] Univ Paris 06, Tenon Hosp, Dept Dermatol, Paris, France

[19] Poissy St Germain en Laye Intercommunal Hosp, Dept Dermatol, St Germain En Laye, France

[20] Gen Hosp Le Mans, Dept Dermatol, Le Mans, France

[21] Univ Rennes, Dept Dermatol, Rennes, France

[22] Univ Montpellier, Dept Dermatol, F-34059 Montpellier, France

[23] Reg Hosp Orleans, Dept Dermatol, Orleans, France

[24] Univ Reims, Dept Dermatol, Reims, France

DOI  :  10.1038/jid.2008.412

来源: Elsevier

【 摘 要 】

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 (10-30g 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.

【 授权许可】

Free