Topical Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Maintains Efficacy of Etanercept After Step-Down Dose in Patients With Moderate-to-Severe Plaque Psoriasis: Results of an Open Label Trial
August 2011 | Volume 10 | Issue 8 | Original Article | 878 | Copyright © August 2011
Leon H. Kircik MDa,b
aMount Sinai Medical Center, New York, NY and bIndiana University School of Medicine, Indianapolis, IN
Abstract
Etanercept is approved for the treatment of plaque psoriasis at a subcutaneous (SC) dosage of 50 mg twice-weekly for three months, followed
by 50 mg SC once-weekly thereafter. It is of note, however, that many patients experience loss of efficacy when they step down to etanercept 50 mg/week, often instigating a switch to another biological. The current pilot study investigated the adjunctive use of a topical calcipotriene 0.005% and betamethasone dipropionate 0.064% combination ointment, approved for the treatment of psoriasis, to sustain the original efficacy of etanercept by augmenting response to the 50 mg/week SC dose, thus stabilizing the disease.
Trial Design: In this single-center, open-label study, subjects (n=20) underwent 12 weeks treatment with etanercept 100 mg/week (50 mg, 2x week; weeks –12 to -1), followed by etanercept 50 mg/week maintenance therapy for 40 weeks (weeks 0 to 40). Subjects were followed at four-week intervals. Starting at week 4, subjects who demonstrated an increase from baseline (week 0) body surface area (BSA) of >2% initiated therapy with calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment for four weeks. The study is limited by its small sample size, open-label nature, and lack of blinding.
Findings: Mean BSA involvement decreased significantly from week –12 to 0 with etanercept 50 mg twice a week. At week 4, on the etanercept 50 mg/week dose, mean BSA increased to 9.42±9.39 compared to week 0. With introduction of calcipotriene 0.005%/betamethasone dipropionate 0.064% ointment at week 4, mean BSA decreased to 4.62±8.19 by week 24 and was relatively stable for the remainder of the study period. Similarly, mean PASI (Psoriasis Area and Severity Index) scores improved from week -12 to week 0, increased at week 4, then decreased significantly by week 24 with adjunctive topical treatment.
Conclusion: Topical calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment is a safe and effective adjunct to etanercept
50 mg/week maintenance therapy.
J Drugs Dermatol. 2011;10(8):881-885.
INTRODUCTION
Etanercept is a fusion protein with affinity for soluble tumor necrosis factor alpha (TNF-a) that has been approved
by the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis at a dosage of 50 mg subcutaneous (SC) twice-weekly for three months, followed by 50 mg subcutaneously dosed once-a-week thereafter. Results
of clinical trials demonstrate good efficacy for etanercept induction therapy, with roughly 50 percent of patients treated with 50mg SC twice per week achieving Psoriasis Area and Seventy Score (PASI) of 75 or better.1,2 However, perception of clinical experience is that many patients experience loss of efficacy when they step down from etanercept 100 mg/week to etanercept 50 mg/week,3,4 often instigating an automatic switch to another biological. As an alternative to step-down, continuous treatment with 50 mg twice-weekly has been shown to be safe and effective.5 Nonetheless, data suggest that most managed care patients receiving etanercept for psoriasis
receive on-label dosing.6
Despite the potential for loss of response upon dosage step-down, etanercept has had a high level of physician and patient uptake due to its favorable safety profile and low rate of adverse events.7 In a phase 3 open-label extension study, exposure-
adjusted rates of adverse events, serious adverse events
