Original articleModerate to severe plaque psoriasis with scalp involvement: A randomized, double-blind, placebo-controlled study of etanercept
Introduction
Psoriatic scalp symptoms, reported by 50% to 80% of patients with psoriasis, are characterized by erythema, scaling, and induration, resulting in pain and pruritus.1, 2 Topical preparations are widely used to treat scalp psoriasis, but patients’ hair may prevent sufficient quantities of the topical treatment from reaching psoriatic lesions on the scalp surface.1 The limited effectiveness and inconvenience of topical agents contribute to low patient satisfaction and poor compliance with topical therapy regimens for scalp psoriasis. Although topical therapies are the recommended first line of treatment in U.S. and European guidelines, patient satisfaction and compliance with topical therapy regimens are low.1, 2, 3, 4
Biologic therapies are used in patients with moderate to severe psoriasis4 and those unresponsive to other therapies,2 but evidence is limited regarding the effectiveness of biologic agents for treating scalp symptoms.2, 4 Etanercept is effective in treating skin symptoms in patients with moderate to severe plaque psoriasis.5, 6, 7 We report a randomized, placebo-controlled trial of etanercept for the treatment of patients with moderate to severe plaque psoriasis with scalp involvement. This study assesses plaque psoriasis by means of the Psoriasis Scalp Severity Index (PSSI), a scalp-specific modification of the Psoriasis Area and Severity Index (PASI) based on the extent of involvement and the severity of erythema, infiltration, and desquamation. Involvement and severity of psoriasis on the PSSI is scored by physicians on a scale from 0 to 72, where 0 = no psoriasis and higher scores indicate more severe disease.
Section snippets
Patients
This randomized, double-blind, placebo-controlled, multicenter North American study enrolled patients 18 years and older with stable moderate to severe plaque psoriasis covering 10% or more of body surface area (BSA) for ≥6 months. Patients had PASI scores of 10 or higher and 30% or higher of the scalp surface area (SSA) affected, with PSSI scores of 15 or higher (of 72); investigators considered them candidates for phototherapy or systemic therapy. Patients were excluded if they had guttate,
Patients
The total study enrollment was 124 patients, 62 in each treatment group; 59 Group A patients and 62 Group B patients received study treatments. Discontinuation rates were similar between groups; 49 patients in each group completed 24 weeks in the study. The most common reasons for withdrawal were adverse events (5 patients in Group A, none in Group B) and withdrawal of consent (5 patients in Group B, 1 in Group A). One Group A patient, who had baseline SSA and PSSI scores below inclusion
Discussion
In this double-blind, placebo-controlled 24-week study, etanercept-treated patients experienced consistent, significant improvement in psoriasis scalp and skin symptoms. Improvements in scalp psoriasis mirrored those for the skin in both the degree and time course of response. Placebo-group patients experienced similar results after they started receiving etanercept at week 12. Etanercept-treated patients continued to experience skin and scalp psoriasis improvements after they stepped down to a
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Cited by (87)
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
2020, Journal of the American Academy of DermatologyCitation Excerpt :The efficacies of other systemic treatments, such as etanercept and secukinumab, were also shown in phase 3 studies of patients with moderate to severe plaque psoriasis of the scalp.15,16 It is difficult to make direct comparisons between these studies and the current phase 3 study of apremilast because they used different definitions of moderate to severe scalp psoriasis and different primary measures of improvement.15,16 Nonetheless, findings from the current study show that apremilast may be an efficacious oral treatment option for patients with moderate to severe plaque psoriasis of the scalp.
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Funding source: Immunex Corporation, a wholly owned subsidiary of Amgen Inc., Thousand Oaks, California.
Disclosures: (past 5 years): Dr Bagel receives a salary as founder of the Psoriasis Treatment Center of Central New Jersey. He has received speaker honoraria from Leo Pharma, Galderma, Centocor, Abbott, and Amgen. He has also been compensated as a consultant for Galderma and has served as an investigator for Centocor, Abbott, and Amgen. Dr Lynde has received research grants and honoraria from Amgen, Abbott, Merck, Ortho Biotech, Leo Pharma, and Galderma, for whom he has served as an advisory board member, consultant, and speaker. He has also served as an investigator for Amgen, Abbott, Merck, Ortho Biotech, and Leo Pharma. Dr Tyring has received a research grant and honoraria from Amgen, for whom he has served as a consultant, investigator, and speaker. He has also served as an investigator and/or speaker for Abbott, Leo Pharma, Galderma, GSK, Novartis, Merck, Epiphany, Inhibitex, AiCuris, and Pfizer. Dr Kricorian, Yifei Shi, and Dr Klekotka are employees of Amgen Inc. and have received Amgen stock/stock options.