Concerns and Treatment Satisfaction in Patients Being Treated With Azelaic Acid Foam for Rosacea

April 2019 | Volume 18 | Issue 4 | Original Article | 381 | Copyright © April 2019

Todd Williamson MSc,a Jennifer Cameron MHA,a Kim McLeod MPH,b Beni Turner,b Apryl Quillen MS,b Anneliese LaRose MS,a Jason Lott MD MHS MSHP FAAD,a Andrew Gaiser PharmD RPhb

aBayer HealthCare Inc., Whippany, NJ bXcenda, Palm Harbor, FL

Abstract

Objective: To describe patient characteristics, concerns, side effects, treatment satisfaction, and quality of life (QoL) of rosacea patients currently being treated with monotherapy azelaic acid foam based on patient-reported data.

Methods: The study utilized a non-interventional, prospective, observational design. Patients were recruited in the United States and were eligible if the following criteria were met: diagnosed with rosacea by a medical professional, ≥18 years of age, currently receiving monotherapy with azelaic acid foam, and able to provide informed consent. Patients using other topical treatments for rosacea during enrollment were excluded. An online tool administered a survey of 3 questionnaires including the Rosacea Treatment Preference Questionnaire, Treatment Satisfaction with Medicines Questionnaire (SATMED-Q), and Dermatology Life Quality Index (DLQI). The survey collected demographics, clinical characteristics, treatment history, adverse events, and patient-reported outcomes related to treatment with azelaic acid foam and QoL with rosacea.

Results: 54 patients met eligibility criteria. Participants were primarily female (90.7%), ranging from 26 to 63 years of age. The most common subtypes reported were erythematotelangiectatic and papulopustular (74.1% each) with 59.3% of participants reporting mild symptoms (16.7% “absent”; 24.1% “moderate”) in the 4 weeks before enrollment. The majority reported no concerns (74.1%) with their treatment. The biggest concern was cost (11.1%), with a mean importance score (IS) on a 10-point scale of 9.3. A majority (77.8%) of patients reported no side effects. Side effects reported included dryness (13%; IS: 5.3), stinging (7.4%, IS: 2.5), itching (5.6%; IS: 4.7), or burning (3.7%; IS: 7.0). Global satisfaction (SATMED-Q) mean score was 79.0 and treatment effectiveness mean score was 70.8. QoL impact of rosacea was minimal (mean DLQI score: 2.35). In regression models, increasing dryness was significantly associated with worsening outcomes in SATMED-Q and DLQI.

Conclusions: Patient characteristics of the study population closely mirror the distribution of rosacea by gender and subtype as in previous estimates. Findings indicate minimal patient concerns with azelaic acid foam and primarily pertained to cost. Patient-reported side effects were rare. Minor patient-reported side effects and concerns do not appear to affect rosacea-related QoL and medication satisfaction. Compared to a previously conducted study of similar design with patients using metronidazole gel and metronidazole cream, more patients in the current study reported no concerns with their treatment, while the number of patients reporting no side effects, as well as mean SATMED-Q and DLQI scores, were similar. Further research is necessary to directly compare the results of these 2 studies.

J Drugs Dermatol. 2019;18(4):381-386.

INTRODUCTION

Rosacea is a chronic, inflammatory facial skin condition of unknown cause and is characterized by involvement of the convexities of the central face.1-3 The exact prevalence of rosacea is unknown but estimates of rosacea range from 1% to 10% of the adult population depending on the study populations and criteria, and it is more common among women and in certain ethnic groups such as Caucasians.1,4Treatment decisions for rosacea are selected based on the patient’s clinical manifestations. Typically, topical agents including metronidazole, ivermectin, and azelaic acid are used as first-line pharmacological therapy in the treatment of mild to moderate rosacea, as they have shown efficacy compared to placebo in reducing inflammatory lesion counts.1,5,6 Patients using these topical therapies have also reported higher incidences of skin discomfort compared to placebo.2,7 Patients who experience adverse events (AEs) are likely to discontinue treatment, but newer treatments are aimed at countering this limitation. Of those who are initiated on topical therapies, the vast majority of patients who report AEs (90%) discontinue treatment in the first 3 months.8 Such patients also incur significantly greater medical and pharmacy costs.Newer therapies have been developed, such as azelaic acid foam, which aim to reduce side effects including burning, itching, and stinging sensations.9-11 Therefore, it is important to