Ulrich Mrowietz1,2,3,4,5, Leon Kircik1,2,3,4,5, Kristian Reich1,2,3,4,5, Sagar Munjal1,2,3,4,5, Srinivas Shenoy1,2,3,4,5, Mark Lebwohl1,2,3,4,5. 1. Dr. Mrowietz is with the Psoriasis Center at the Department of Dermatology at the University Medical Center Schleswig-Holstein in Campus Kiel, Germany. 2. Dr. Kircik is with DermResearch, PLLC, in Louisville, Kentucky. 3. Dr. Reich is with the Center of Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center in Hamburg, Germany Dr. Munjal is with Dr. Reddy's Laboratories Inc., in Princeton, New Jersey. 4. Dr. Shenoy is with Dr. Reddy's Laboratories Inc. in Princeton, New Jersey. 5. Dr. Lebwohl is with the Icahn School of Medicine at Mount Sinai in New York, New York.
Abstract
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.
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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