2. Academic Validation
  3. Tepilamide Fumarate (PPC-06) Extended Release Tablets in Patients with Moderate-to-Severe Plaque Psoriasis: Safety and Efficacy Results from the Randomized, Double-blind, Placebo-controlled AFFIRM Study

Tepilamide Fumarate (PPC-06) Extended Release Tablets in Patients with Moderate-to-Severe Plaque Psoriasis: Safety and Efficacy Results from the Randomized, Double-blind, Placebo-controlled AFFIRM Study

  • J Clin Aesthet Dermatol. 2022 Jan;15(1):53-58.
Ulrich Mrowietz 1 2 3 4 5,  Leon Kircik 1 2 3 4 5,  Kristian Reich 1 2 3 4 5,  Sagar Munjal 1 2 3 4 5,  Srinivas Shenoy 1 2 3 4 5,  Mark Lebwohl 1 2 3 4 5
Affiliations

Affiliations

  • 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.
PMID: 35309277
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.

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.

Figures
Products