Treatment of plaque-type psoriasis with oral CF101: data from an exploratory randomized phase 2 clinical trial.

AIMS: CF101 demonstrated a marked anti-inflammatory effect in Phase 2 studies conducted in patients with rheumatoid arthritis and dry eye syndrome. The aim of this study was to evaluate the safety and efficacy of CF101 for the treatment of patients with moderate to severe plaque-type psoriasis. MATERIALS AND METHODS: This was a phase 2, multicentre, randomized, double-blind, dose-ranging, placebo-controlled study. Seventy five patients with moderate to severe plaque-type psoriasis were enrolled, randomized and treated with CF101 (1, 2, or 4 mg) or placebo administered orally twice daily for 12 weeks. Safety and change from base line of Psoriasis Area and Severity Index (PASI) score and physician's global assessment (PGA) score over 12 weeks. RESULTS: In the 2 mg CF101-treated group, a progressive improvement in the mean change from baseline in the PASI score vs. placebo throughout the study period was observed, with a statistically significant difference on weeks 8 and 12 (P = 0.047; P = 0.031, respectively). In this group, 35.3% of the patients achieved PASI ≥ 50 response, and 23.5% of the patients achieved a PGA score of 0 or 1. CF101 was safe and well tolerated. CONCLUSIONS: CF101 was well tolerated and demonstrated clear evidence of efficacy in patients with moderate to severe plaque psoriasis.

The novel protease inhibitor SRD441 ointment is not effective in the treatment of adult subjects with atopic dermatitis: results of a randomized, vehicle-controlled study.

BACKGROUND: There is evidence that excessive protease activity in the skin is an important factor in the development of atopic dermatitis. SRD44 is a topically formulated novel protease inhibitor that selectively inhibits Staphylococcal-derived aureolysin and matrix metalloproteinases (MMPs). METHODS: This was a double-blind, vehicle-controlled randomized trial conducted in thirteen hospital dermatology outpatient clinics in Germany (9), Bulgaria (3) and Finland (1). Ninety-three out of 103 screened adult subjects with confirmed atopic dermatitis affecting ≤ 20% of body surface area, with an IGA score of 2 or 3 at randomization were randomized following a washout period to either SRD441 ointment or matching vehicle twice daily for 28 days. The primary efficacy endpoint was the clearance of Atopic dermatitis (AD score of 0 or 1 IGA) at Day 21. Secondary endpoints included measures of SCORing Atopic Dermatitis, pruritus self-assessment, rescue medication use and occurrence of new exacerbations. A range of safety and tolerance endpoints were included. RESULTS: There were no significant treatment differences in IGA success rates at Day 21 (SRD441 ointment, 11.1%; vehicle ointment, 12.5%; P = 1.000). Evaluation of secondary efficacy variables revealed no clinical or important statistical differences between treatment groups. Eighteen subjects (19.4%) discontinued the study drug because of an AE (seven subjects [15.6%] in the SRD441 group and 11 subjects [22.9%] in the vehicle group). Twenty-seven subjects (60.0%) in the SRD441 group and 34 subjects (70.8%) in the vehicle group reported an adverse event (AE). CONCLUSIONS: SRD441 ointment did not demonstrate efficacy in the treatment of atopic dermatitis raising questions on the effectiveness of MMPs as a target for the treatment of atopic dermatitis. NCT00882245.

Depot sulfonamid associated linear IgA bullous dermatosis with erythema multiforme-like clinical features.

A case of erythema multiforme-like reaction, following therapy with sulfadimethoxynum is reported in a 19-year-old male patient. Histological examination demonstrated a subepidermal bulla and direct immunofluorescence revealed linear deposition of IgA at the dermoepidermal junction. These observations illustrate that linear IgA bullous dermatosis can mimic the clinical features of erythema multiforme and suggest the possibility of drug-induced pathogenesis.