Objective: Safe, effective, long-term oral therapies are needed for plaque psoriasis. This study aimed to assess the safety and effectiveness of tepilamide fumarate (a fumaric acid ester) extended-release tablets.
Methods: This Phase IIb, randomized, double-blind, placebo-controlled, 24-week, multicenter study treated adults with moderate-to-severe plaque psoriasis with tepilamide fumarate 400 mg once (QD) or twice daily (BID), 600 mg BID, or placebo. Coprimary endpoints were the proportion of patients achieving ≥75% reduction in the Psoriasis Area and Severity Index (PASI-75) and Investigator's Global Assessment (IGA) of clear or almost clear (≥2 points' reduction).
Results: A total of 426 patients were randomized (mean age 49.6 [±13.0] years). There was a ≥75% PASI reduction in 39.7%, 47.2%, 44.3%, and 20.0% in the 400 mg QD, 400 mg BID, 600 mg BID, and placebo groups, respectively; IGA treatment success was 35.7%, 41.4%, 44.4%, and 22.0%, respectively. Between 50%-66% of tepilamide fumarate and 48% of placebo patients experienced ≥1 treatment-emergent adverse event. Gastrointestinal intolerance (20%-42%), infection (6%-18%), and decreased lymphocyte count (4%-9%) were more common with tepilamide fumarate.
Limitations: High placebo response somewhat limits the utility of these findings.
Conclusion: Patients with moderate-to-severe plaque psoriasis treated with oral tepilamide fumarate demonstrated positive response.
Keywords: Body surface area (BSA) dermatology; Dermatology Life Quality Index (DLQI); Investigator’s Global Assessment (IGA); Nail Psoriasis Severity Index (NAPSI); PPC-06; Psoriasis Area and Severity Index (PASI); Psoriasis Scalp Severity Index (PSSI); XP23829; dimethyl fumarate; fumaric acid esters; gastrointestinal; immunomodulating; inflammatory cytokine; monomethyl fumarate; non-biologic; oral; plaque psoriasis; prodrug; psoriasis; systemic; tepilamide fumarate.
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