Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study - 09/04/20

Doi : 10.1016/j.jaad.2020.01.072

Abby S. Van Voorhees, MD ^a,^⁎ , Linda Stein Gold, MD ^b, Mark Lebwohl, MD ^c, Bruce Strober, MD ^d,^e, Charles Lynde, MD ^f, Stephen Tyring, MD ^g, Ashley Cauthen, MD ^h, Howard Sofen, MD ⁱ, Zuoshun Zhang, PhD ^j, Maria Paris, MD ^j, Yao Wang, MD ^j
^a Eastern Virginia Medical School, Norfolk, Virginia
^b Henry Ford Health System, West Bloomfield, Missouri
^c Icahn School of Medicine at Mount Sinai, New York, New York
^d Yale University, New Haven, Connecticut
^e Central Connecticut Dermatology, Cromwell, Connecticut
^f Lynde Institute for Dermatology, Markham, Ontario, Canada
^g Department of Dermatology, Center for Clinical Studies, University of Texas Health Science Center, Houston, Texas
^h MidState Skin Institute, Ocala, Florida
ⁱ Dermatology Research Associates, Los Angeles, California
^j Celgene Corporation, Summit, New Jersey

^∗Correspondence to: Abby S. Van Voorhees, MD, 721 Fairfax Ave, Ste 200, Andrews Hall, Norfolk, VA 23507.721 Fairfax AveSte 200Andrews HallNorfolkVA23507

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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.

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Key words : apremilast, itching, pruritus, psoriasis, quality of life, scalp

Abbreviations used : AE, BSA, CI, DLQI, ESTEEM, ITT, LIBERATE, LOCF, MI, NRI, NRS, PASI, ScPGA, sPGA, STYLE

Plan

Primary endpoint: ScPGA response

	Funding sources: The authors acknowledge financial support for this study from Celgene Corporation. Editorial support was also sponsored by Celgene Corporation. The authors, however, directed and are fully responsible for all content and editorial decisions for this report.
	Disclosure: Dr Van Voorhees has received honoraria for advisory board and/or consulting from AbbVie, Allergan, Celgene Corporation, Derm Tech, Dermira, Novartis, and Valeant. Dr Stein Gold has been an investigator and/or consultant for Celgene Corporation, LEO Pharma, Novartis, Pfizer, and Stiefel/GlaxoSmithKline. Dr Lebwohl is employed by Mount Sinai, which receives funds from Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Janssen/Johnson & Johnson, Kadmon, MedImmune/AstraZeneca, Novartis, Pfizer, and Vidac. Dr Strober has received honoraria as a consultant and advisory board member from AbbVie, Almirall, Amgen, Arena, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corporation, Dermavant, Dermira, Eli Lilly, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, LEO Pharma, Medac, Meiji Seika Pharma, Menlo Therapeutics, Novartis, Ortho Dermatologics/Valeant, Pfizer, Regeneron, Sanofi Genzyme, Sebela Pharmaceuticals, Sun Pharma, and UCB Pharma; has received payments (to the University of Connecticut) as an investigator from AbbVie, Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Galderma, GlaxoSmithKline, Janssen, Merck, Pfizer, and Sienna; has received fees as a scientific director from the Corrona Psoriasis Registry; and has received grant support (to the University of Connecticut for Fellowship Program) from AbbVie and Janssen. Dr Lynde has served as principal investigator/consultant for AbbVie, Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sun Pharma, and Valeant. Dr Cauthen has served as an investigator for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Celgene Corporation, Dermira, Eli Lilly, Janssen, Maruho, Novartis, Pfizer, Stiefel/GlaxoSmithKline, Sun Pharma, and UCB and as a consultant for Celgene Corporation. Dr Sofen has received grants received as an investigator from Celgene Corporation, Janssen, Lilly, and Novartis. Drs Zhang, Paris, and Wang were employees of Celgene Corporation at the time of study conduct. Dr Tyring has no conflicts of interest to declare.
	IRB approval status: Reviewed and approved by the Schulman IRB.