Open-Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast

October 2018 | Volume 17 | Issue 10 | Original Article | 1078 | Copyright © 2018

Jerry Bagel MD MS,a Ahmed S. Samad MD,b Bradley S. Stolshek PharmD,b Girish A. Aras PhD,b James B. Chung MD PhD,b Gregory Kricorian MD,b Leon H. Kircik MDc

aPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ bAmgen Inc., Thousand Oaks, CA cIndiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; Icahn School of Medicine at Mount Sinai, New York, NY

Abstract

INTRODUCTION: Response to etanercept therapy in patients who have failed apremilast therapy has not been well characterized. METHODS: In this multicenter, open-label, single-arm, phase 4, estimation study, subjects with moderate to severe plaque psoriasis received etanercept 50 mg SC twice weekly for 12 weeks, followed by etanercept 50 mg SC once weekly for an additional 12 weeks. Subjects had BSA greater than equal to 10%, PASI greater than equal to 10, and sPGA greater than equal to 3 at screening and baseline; and had failed apremilast—because of either failure to achieve or loss of adequate clinical response, or intolerability to apremilast in the opinion of the investigator. Primary endpoint was PASI 75 at week 12. Secondary endpoints included PASI 75 at week 24, PASI 90 at weeks 12 and 24, and patient-reported outcomes: Psoriasis Symptom Inventory (PSI) score (total and individual items) at baseline and weeks 12 and 24, and over time; DLQI responder analysis (5-point improvement in DLQI from baseline or score of 0) at weeks 12 and 24; and patient assessment of treatment satisfaction at baseline and weeks 12 and 24. RESULTS: Among 80 patients, PASI 75 at weeks 12 and 24 was 41.6% (95% CI, 30.4%-53.4%) and 45.5% (34.1%-57.1%), respectively; PASI 90 was 13.0% (6.4%-22.6%) and 22.1% (13.4%-33.0%), respectively. Mean total PSI score (LOCF) improved from 16.6 (95% CI, 15.1-18.0) at baseline to 8.8 (7.3-10.2) and 9.6 (7.9-11.4) at weeks 12 and 24, respectively; improvements in item PSI scores were similar. The percentage of DLQI responders was 66.2% (95% CI, 54.3%-76.8%) and 57.3% (45.4%-68.7%) at weeks 12 and 24, respectively. The percentage of subjects who were satisfied/very satisfied with their psoriasis treatment improved from 5.0% at baseline to 60.8% and 53.3% at weeks 12 and 24, respectively. During the 24-week study, 23.8% and 2.5% of subjects reported an adverse event and serious adverse event, respectively; there were no new safety signals in this study. DISCUSSION: In patients who have failed apremilast, etanercept may represent an effective therapeutic option. Trial Registration: ClinicalTrials.gov: NCT02749370 J Drugs Dermatol. 2018;17(10):1078-1082.

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INTRODUCTION

Psoriasis is a chronic, inflammatory disease of the skin that affects 2% of the population.1 Psoriasis may be treated by topical agents (eg, corticosteroids, vitamin D3), phototherapy, oral systemic therapies (eg, apremilast, cyclosporine, methotrexate), and biologic agents (eg, adalimumab, etanercept, infliximab, secukinumab, ustekinumab). Despite these treatment options, many patients remain untreated, fail to respond or lose response to therapy, or experience toxicities associated with therapy.Apremilast is a small-molecule inhibitor of phosphodiesterase 4 (PDE4) that is indicated for the treatment of moderate to severe plaque psoriasis. ESTEEM-1 and ESTEEM-2—2 phase 3 randomized, placebo-controlled clinical trials for apremilast demonstrated that treatment with apremilast resulted in a significantly greater number of subjects achieving 75% improvement in the Psoriasis Area and Severity Index (PASI 75) compared with placebo: 33% vs 5% in ESTEEM-12 and 29% vs 6% in ESTEEM-2.3 Not all patients respond adequately or maintain response to apremilast, and some patients experience intolerability to apremilast. The response to biologic therapies in this clinical setting has not been well characterized to date.Etanercept is a fusion protein that links the ligand-binding portion of the tumor necrosis factor (TNF) receptor with the fragment crystallizable (Fc) portion of immunoglobulin G1. Etanercept, the first TNF inhibitor approved for the treatment of moderate to severe plaque psoriasis, is a treatment op-

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