A Comparison of Mycophenolate Mofetil with Ciclosporine for the Treatment of Chronic Plaque-Type Psoriasis

Aims: To compare the efficacy of ciclosporine (CsA) versus mycophenolate mofetil (MMF) in psoriasis, a randomized trial was conducted. Methods: A prospective multicenter randomized open-label clinical trial was performed to compare two parallel groups of patients with chronic plaque psoriasis undergoing different treatments. Therefore, a total of 54 patients with psoriasis were randomly assigned to treatment with either CsA (2.5 mg/kg body weight) or MMF (2 g daily) for 12 weeks, and the drug doses were adjusted according to response. The psoriasis area and severity index (PASI) was used to assess the clinical severity of psoriasis. The primary outcome of this trial was the time to disease relapse. Safety, PASI scores and psoriasis disability index (PDI) were assessed as secondary outcome. Results: There was no difference in time to disease relapse between the two groups. After 12 weeks of treatment, the mean PASI score ( 8 SD) decreased from 24.6 8 11.1 to 6.6 8 7.3 in the CsA group (n = 27) and from 22.4 8 9.2 to 10.6 8 6.7 in the MMF group (n = 27; p = 0.02). The side effects, time to remission and PDI were similar in both groups. Conclusions: After 12 weeks, CsA demonstrated a significantly superior efficacy in psoriasis compared to MMF

Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis

Background: Telazorlimab is a humanized anti-OX40 monoclonal antibody being studied for treatment of T-cell–mediated diseases. Objective: This randomized, placebo-controlled, phase 2b dose-range finding study investigated efficacy, safety, pharmacokinetics, and immunogenicity of telazorlimab in subjects with atopic dermatitis. Methods: In this 2-part study (NCT03568162), adults (≥18 years) with moderate-to-severe disease were randomized to various regimens of subcutaneous telazorlimab or placebo for 16 weeks’ blinded treatment, followed by 38 weeks’ open-label treatment and 12 weeks’ drug-free follow-up. Telazorlimab treatment groups (following a loading dose) in part 1 were 300 mg every 2 weeks; 300 mg every 4 weeks; or 75 mg every 4 weeks. Part 2 evaluated telazorlimab 600 mg every 2 weeks. The primary end point was percentage change from baseline in Eczema Area and Severity Index (EASI) at week 16. Safety assessments included incidence of treatment-emergent adverse events. Results: The study randomized 313 subjects in part 1 and 149 in part 2. At 16 weeks, the least squares mean percentage change from baseline in EASI was significantly greater in subjects receiving telazorlimab 300 mg every 2 weeks (part 1) and 600 mg every 2 weeks (part 2) versus placebo (−54.4% vs −34.2% for part 1 and −59.0% vs −41.8% for part 2, P = .008 for both). Telazorlimab was well tolerated, with similar distribution of adverse events between telazorlimab- and placebo-treated subjects in both part 1 and part 2. Conclusion: Telazorlimab, administered subcutaneously at 300 mg every 2 weeks or 600 mg every 2 weeks following a loading dose, was well tolerated and induced significant and progressive clinical improvement in adults with moderate-to-severe atopic dermatitis