Original article
Moderate to severe plaque psoriasis with scalp involvement: A randomized, double-blind, placebo-controlled study of etanercept

Some of the data included in this manuscript were previously presented at the Fall Clinical Dermatology meeting, Oct 8-11, 2010, in Las Vegas, NV, and at the American Academy of Dermatology’s 69th Annual Meeting, Feb 4-8, 2011, in New Orleans, LA.
https://doi.org/10.1016/j.jaad.2011.07.034Get rights and content

Background

Biologic therapies are used to treat moderate to severe psoriasis, but evidence from randomized, controlled studies is lacking regarding scalp-related effectiveness.

Objective

To evaluate the efficacy and safety of etanercept for scalp symptoms (erythema, induration, scale, and percentage of scalp involvement) in patients with moderate to severe plaque psoriasis and scalp involvement.

Methods

In this randomized, placebo-controlled study, adult patients with stable plaque psoriasis and significant scalp symptoms received etanercept 50 mg twice weekly (BIW) by subcutaneous injection (SC) for 12 weeks, followed by etanercept 50 mg once weekly (QW) and placebo QW (Group A, n = 62) or SC placebo BIW for 12 weeks, followed by etanercept 50 mg BIW for 12 weeks (Group B, n = 62). The primary end point was percentage change in Psoriasis Scalp Severity Index (PSSI) at week 12.

Results

Demographics and disease characteristics were balanced: 56% men, 73% white, median age 41 years, median BMI 30.2 kg/m2. At week 12, mean PSSI improvement was 86.8% (standard deviation [SD], 18.0%) in Group A and 20.4% (SD, 39.3%) in Group B (P < .0001). At week 24, mean PSSI improvements were as follows: Group A, 90.6% (SD 13.1%); Group B, 79.1% (SD 33.6%). At week 12, 51 of 59 (86%) Group A patients and 7 of 61 (11%) Group B patients achieved PSSI 75 (P <.0001). Three patients (2.7%) reported 5 serious adverse events: cholecystitis/cholelithiasis, fall/rib fracture, and metastatic malignant melanoma.

Limitations

The study was insufficiently powered to detect rare adverse events potentially associated with etanercept.

Conclusions

Etanercept is an effective, well-tolerated treatment for plaque psoriasis involving the scalp.

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

References (10)

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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.

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