Abby S Van Voorhees1, Linda Stein Gold2, Mark Lebwohl3, Bruce Strober4, Charles Lynde5, Stephen Tyring6, Ashley Cauthen7, Howard Sofen8, Zuoshun Zhang9, Maria Paris9, Yao Wang9. 1. Eastern Virginia Medical School, Norfolk, Virginia. Electronic address: vanvooas@evms.edu. 2. Henry Ford Health System, West Bloomfield, Missouri. 3. Icahn School of Medicine at Mount Sinai, New York, New York. 4. Yale University, New Haven, Connecticut; Central Connecticut Dermatology, Cromwell, Connecticut. 5. Lynde Institute for Dermatology, Markham, Ontario, Canada. 6. Department of Dermatology, Center for Clinical Studies, University of Texas Health Science Center, Houston, Texas. 7. MidState Skin Institute, Ocala, Florida. 8. Dermatology Research Associates, Los Angeles, California. 9. Celgene Corporation, Summit, New Jersey.
Abstract
BACKGROUND: Many patients with psoriasis are bothered by symptoms in highly visible, pruritic areas, such as the scalp. OBJECTIVE: To evaluate the efficacy and safety of apremilast for moderate to severe scalp psoriasis. METHODS: This phase 3b, double-blind, placebo-controlled study randomized adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to at least 1 topical scalp psoriasis therapy (NCT03123471). The primary endpoint was the proportion of patients who achieved Scalp Physician Global Assessment response, defined as score of 0 (clear) or 1 (almost clear), with at least a 2-point reduction, at week 16. Secondary endpoints included at least a 4-point improvement from baseline in Whole Body Itch and Scalp Itch Numeric Rating Scales (NRSs) and mean improvement in Dermatology Life Quality Index (DLQI) at week 16. RESULTS: There were 303 randomized patients (placebo: n = 102; apremilast: n = 201). With apremilast, significantly more patients achieved Scalp Physician Global Assessment (43.3% vs 13.7%), Scalp Itch NRS (47.1% vs 21.1%), and Whole Body Itch NRS (45.5% vs 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs -3.8; all P < .0001). Common adverse events with apremilast were diarrhea (30.5%), nausea (21.5%), headache (12.0%), and vomiting (5.5%). LIMITATIONS: Patients with mild disease were not enrolled. CONCLUSION: Apremilast showed efficacy for the treatment of moderate to severe scalp psoriasis.
RCT Entities:
BACKGROUND: Many patients with psoriasis are bothered by symptoms in highly visible, pruritic areas, such as the scalp. OBJECTIVE: To evaluate the efficacy and safety of apremilast for moderate to severe scalp psoriasis. METHODS: This phase 3b, double-blind, placebo-controlled study randomized adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to at least 1 topical scalp psoriasis therapy (NCT03123471). The primary endpoint was the proportion of patients who achieved Scalp Physician Global Assessment response, defined as score of 0 (clear) or 1 (almost clear), with at least a 2-point reduction, at week 16. Secondary endpoints included at least a 4-point improvement from baseline in Whole Body Itch and Scalp Itch Numeric Rating Scales (NRSs) and mean improvement in Dermatology Life Quality Index (DLQI) at week 16. RESULTS: There were 303 randomized patients (placebo: n = 102; apremilast: n = 201). With apremilast, significantly more patients achieved Scalp Physician Global Assessment (43.3% vs 13.7%), Scalp Itch NRS (47.1% vs 21.1%), and Whole Body Itch NRS (45.5% vs 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs -3.8; all P < .0001). Common adverse events with apremilast were diarrhea (30.5%), nausea (21.5%), headache (12.0%), and vomiting (5.5%). LIMITATIONS: Patients with mild disease were not enrolled. CONCLUSION: Apremilast showed efficacy for the treatment of moderate to severe scalp psoriasis.
Authors: Barbara Meier-Schiesser; Mark Mellett; Marigdalia K Ramirez-Fort; Julia-Tatjana Maul; Annika Klug; Nicola Winkelbeiner; Gabriele Fenini; Peter Schafer; Emmanuel Contassot; Lars E French Journal: Int J Mol Sci Date: 2021-11-28 Impact factor: 5.923
Authors: A S Van Voorhees; L Stein Gold; M Lebwohl; B Strober; H Sofen; K Papp; J Bagel; Z Zhang; M Paris; Y Wang Journal: Br J Dermatol Date: 2021-07-14 Impact factor: 9.302