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Efficacy and safety of topical WBI-1001 in patients with mild to moderate psoriasis: results from a randomized double-blind placebo-controlled, phase II trial

Authors


  • Research funded and medication provided by Welichem Biotech Inc.

  • Conflicts of interest
    Robert Bissonnette has been a speaker, consultant, advisory board member and/or investigator and/or has received honoraria and grants from Abbott laboratories, Amgen, Astellas Pharma, Centocor, Janssen-Ortho, Novartis, Celgene, Boehringer, Leo Pharma, Merck, Galderma, Isotechnika, Pfizer and Welichem Biotech Inc. Chantal Bolduc has been a speaker, consultant, advisory board member and/or investigator and/or has received honoraria and grants from Abbott laboratories, Amgen, Astellas Pharma, Celgene, Centocor, Isotechnika, Janssen-Ortho, Leo Pharma, Merck, Merck-Serono, Novartis, Pfizer, Boehringer and Welichem Biotech Inc. Catherine Maari has been a speaker, consultant, advisory board member and/or investigator and/or has received honoraria and grants from Abbott laboratories, Amgen, Astellas Pharma, Centocor, Janssen-Ortho, Novartis, Celgene, Boehringer, Leo Pharma, Merck, Merck-Serono, Isotechnika, Pfizer and Welichem Biotech Inc. Simon Nigen has been a speaker, consultant, advisory board member and/or investigator and/or has received honoraria and grants from Abbott laboratories, Amgen, Astellas Pharma, Centocor, Janssen-Ortho, Novartis, Celgene, Boehringer, Leo Pharma, Merck, Merck-Serono, Isotechnika, Pfizer and Welichem Biotech Inc. Dr John M. Webster, Dr Liren Tang and Dr Michael Lyle are full time employees of Welichem Biotech Inc.

Correspondence: R. Bissonnette. E-mail:rbissonnette@innovaderm.ca

Abstract

Background  There is a need for the development of novel non-steroidal topical drugs for the treatment of psoriasis.

Objective  To assess the efficacy and safety of topical 1.0% WBI-1001 in patients with mild to moderate plaque psoriasis.

Methods  A total of 61 patients with 1–10% body surface area (BSA) covered with plaque psoriasis and a physician’s global assessment score (PGA) of 2–4 were randomized (2 : 1) to receive either 1% WBI-1001 in a cream formulation or placebo, applied twice daily for 12 weeks. Efficacy was evaluated using PGA, BSA and Psoriasis Area and Severity Index (PASI). The primary endpoint was the change from baseline (Day 0) in PGA at week 12.

Results  The improvement in PGA at week 12 was 62.8% for patients randomized to WBI-1001 when compared with 13.0% for patients randomized to placebo (< 0.0001). At week 12, the proportion of patients who achieved a PGA of clear or almost clear and the mean improvement in BSA were 67.5% and 79.1%, respectively, for patients randomized to WBI-1001, when compared with 4.8% (< 0.0001) and an increase of 9.4% (< 0.0001), respectively, for patients randomized to placebo. More application site adverse drug reactions were observed in patients randomized to WBI-1001 than in those randomized to placebo. These adverse drug reactions were all mild or moderate in intensity.

Conclusion  Topical WBI-1001 induces rapid and significant improvement in patients with plaque psoriasis.

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