Randomized controlled open-label trial of four treatment regimens for pemphigus vulgaris.

BACKGROUND: Pemphigus is a severe autoimmune blistering disease affecting the skin and mucosa. Mortality is high in the absence of treatment. Nowadays, treatment is based mainly on corticosteroids and cytotoxic drugs; however, because of the rarity of the disease worldwide, there is not yet a standard treatment based on randomized controlled trials, and the treatment used is based mainly on the experience of experts. OBJECTIVE: The aim of this study was to compare the efficacy and safety of 4 treatment regimens for pemphigus vulgaris: prednisolone alone, prednisolone plus azathioprine, prednisolone plus mycophenolate mofetil, and prednisolone plus intravenous cyclophosphamide pulse therapy. METHODS: One hundred twenty new cases of pemphigus vulgaris were enrolled. These patients were randomly allocated into 1 of 4 treatment groups (each comprising 30 patients) and received prednisolone (P), prednisolone and azathioprine (P/A), prednisolone and mycophenolate mofetil (P/MM), and prednisolone and intravenous cyclophosphamide pulse therapy (P/PC). They were followed up for 1 year at the Pemphigus Research Unit. RESULTS: In groups P, P/A, P/MM, and P/PC, 23 (76.5%), 24 (80%), 21 (70%), and 22 (73.3%) of the patients, respectively, followed the regimen for the full 1-year period. The mean total dose of prednisolone administered in groups P, P/A, P/MM, and P/PC was 11631 mg (standard deviation [SD] = 7742), 7712 mg (SD = 955), 9798 mg (SD = 3995), and 8276 mg (SD = 810), respectively. The mean total dose of prednisolone in group P (prednisolone alone) was 11,631 mg, The mean total dose of prednisolone in the 3 cytotoxic groups was 8652 mg. By using analysis of variance, the difference was statistically significant (P = .047). In the cytotoxic groups, there was a significant difference between the P/A and P/MM groups (P = .007), but not between P/A and P/PC (P = .971), and P/MM and P/PC (P = .670). Side effects were not significantly different among the 4 groups. LIMITATIONS: Larger sample sizes and blind design are suggested for future studies. CONCLUSION: The efficacy of prednisolone is enhanced when it is combined with a cytotoxic drug. The most efficacious cytotoxic drug to reduce steroid was found to be azathioprine, followed by cyclophosphamide (pulse therapy), and mycophenolate mofetil.

Allergic contact dermatitis in Iran.

The frequency of sensitization to contact allergens varies in different countries because of both genetic and, more importantly, allergen exposure variations. The objective is to determine the frequency of sensitization to contact allergens in Iranian patients with dermatitis. 250 patients with a clinical diagnosis of contact dermatitis and/or atopic dermatitis were evaluated with a 28-allergen screening series recommended by the German Contact Dermatitis Research Group from September 2002 to April 2004 in Tehran, Iran. The patches were applied on the back of the patients, removed after 24 hr and the readings were taken on 24 hr, 48 hr and 72 hr after application. 126 patients (50.4%) showed at least 1 positive reaction, and 23 patients (9.2%) had more than 2 positive reactions. 189 (84.4%) of 224 positive reactions had past and/or present clinical relevance. The 5 most common allergens were nickel sulfate 70 (28.0%), cobalt chloride 32 (12.8%), para-tertiarybutyl phenol formaldehyde resin 20 (8.0%), potassium dichromate 13 (5.2%) and colophony 13 (5.2%). Contact allergy to nickel sulfate was significantly more common in female patients and in patients under 40 years of age (P < 0.05). Nickel sulfate is the most common contact allergen in Iran, mostly affecting women and younger patients probably because of more exposure.