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.

GM-CSF Modulates Autoantibody Production and Skin Blistering in Experimental Epidermolysis Bullosa Acquisita

“…In experimental autoimmune encephalomyelitis, GM-CSF is required to sustain neuroinflammation via myeloid cells infiltrating the CNS (14). Given the rising incidence of autoimmune diseases in general and autoimmune bullous dermatoses specifically (53,54), the so far limited therapeutic options (55,56), and the high morbidity and mortality of the patients (54), there is a clear need for novel treatment strategies. In several autoimmune diseases, such as rheumatoid arthritis, inhibition of cytokines or growth factors has dramatically improved the management of these conditions (57)(58)(59)(60)(61).…”

Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study

“…Similar concerns about increased mortality and morbidity in bullous pemphigoid patients (that could be partly due to systemic therapies such as prednisolone), led to an RCT by Joly et al who found that mortality was reduced in those treated with potent topical steroids compared to those receiving systemic steroids. 11 The potential impact of PG on patients' quality of life is high. Baseline EQ-5D-3L scores of 0.59 (cohort study) and 0.48 (RCT) are comparable to patients with mild to severe heart failure; where EQ-5D-3L scores of 0.78 (SD 0.18) to 0.51 (SD 0.21) respectively have been reported.…”

Role of Corticosteroids in Oral Lesions

“…Recently, lower doses of topical clobetasol propionate (10-30g daily) were shown to have similar short-term efficacy but reduced side-effects compared to the high dose topical regimen (40g daily clobetasol propionate) (Joly 2009). …”