Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy

April 2019 | Volume 18 | Issue 4 | Original Article | 336 | Copyright © April 2019

Munirah Aljaser MD,a Laetitia Amar,b Leon H. Kircik MDc

aDermatology Department, Al-Farwaniya Hospital, Kuwait bMcGill University, Montreal, Canada cIcahn School of Medicine at Mount Sinai, New York, NY; Indiana School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; DermResearch, PLLC, Louisville, KY; Skin Sciences, PLLC, Louisville, KY

Abstract

OBJECTIVE: To explore the impact of adding apremilast to a regimen of topical corticosteroids in patients with moderate plaque-type psoriasis.

RESEARCH DESIGN AND METHODS: This was an open label, 16-week study of apremilast in combination with topical steroids with a 4-week follow up off-treatment. Twenty qualified subjects were enrolled. Assessments included investigators assessments: sPGA, PASI, BSA; and subject assessments: DLQI, pruritis, and TSQM-2 (treatment satisfaction questionnaire). The primary efficacy measure was mean change and mean percent change in product of BSA (%) x sPGA at week 16 compared to baseline. Assessments were made at baseline (week 0), week 4, week 8, week 16, and week 20.

RESULTS: There was a statistically significant improvement in the mean change and mean percent change from baseline in product of sPGA x BSA at week 16, compared to baseline. Mean and median reductions in BSA achieved statistical significance by week 8. By week 16, there was a 36% improvement in median BSA from baseline (P equals .006). The proportion of patients achieving PASI-50 at weeks 8 and 16 was 15% and 40%, respectively. Thirty percent of subjects achieved PASI-75 at week 16. Subject quality of life was statistically significantly improved from baseline at weeks 8 and 16, as evidenced by deceases in DLQI scores. Reductions in pruritus were evident at week 4 and achieved statistical significance at week 8. Two of the four domains of the TSQM domains achieved statistical significance by week 4 and through week 20. A total of 34 adverse events were reported in 17 subjects, the majority of the events were related to the gastrointestinal system and determined to be related to the study medication.

CONCLUSION: The addition of apremilast for subjects with moderate plaque-type psoriasis, who are not satisfied by topical treatment alone, produced a statistically significant improvement in the improvement of their disease despite experienced adverse events.

J Drugs Dermatol. 2019;18(4):336-340.

INTRODUCTION

Psoriasis is a chronic disease that requires long-term treatment, ideally with effective agents that offer convenient dosing and a low incidence of adverse events. Current guidelines of care for the management of psoriasis from the American Academy of Dermatology recommend use of topical treatments for patients with localized disease and for those with mild to moderate psoriasis, suggesting topical therapy is appropriate for the approximately 80 percent of psoriasis patients who fall into these categories.1 Among topical agents prescribed for psoriasis, topical corticosteroids (TCS) are most commonly used.Multiple biologic agents—some now used for more than a decade in dermatology—have received US Food and Drug Administration (FDA) approval to treat moderate to severe plaque psoriasis in patients for whom phototherapy or systemic therapy is appropriate. More recently, an oral phosphodiesterase 4 (PDE4) inhibitor (Apremilast, Otezla, Celgene) has been approved with a similar indication. Taken together, these guidelines and FDA-approved labeling coupled with long-term physician practice has created something of an artificial dichotomy among prescribers, who may be inclined to think of topicals and systemic agents as an either/or proposition for patients with moderate psoriasis. Prescribers may be reluctant to offer systemic therapy to patients who achieve any degree of control with TCS therapy, even if patients are not satisfied with the degree of improvement.Although topical steroids may be appropriate for many patients with moderate plaque-type psoriasis, they may not be sufficient for others. Evidence suggests that many patients are dissatisfied with treatment as they continue to be prescribed the same topical treatment despite lack of efficacy and patient satisfaction.2 Therefore, a systemic treatment with a favorable safety profile and no monitoring requirement may be an ideal option for these patients.Approved by the FDA for the treatment of moderate to se-