Rosacea Treatment Satisfaction: Matching Adjusted Indirect Treatment Comparison Analysis of Metronidazole Gel or Cream vs Azelaic Acid Foam.

OBJECTIVE: To assess differences in patient-reported treatment side effects and concerns associated with azelaic acid 15% foam (AAF) vs metronidazole cream (MC) and metronidazole gel (MG). METHODS: This study used matching-adjusted indirect comparison (MAIC) to compare patient-reported outcomes from survey data evaluating rosacea treatments. Outcomes of interest included percentages of patients reporting concerns and side effects and measures of importance of the concerns and tolerability of the side effects. Patients in each analysis (MG vs AAF and MC vs AAF) were matched using stabilized inverse propensity scores. RESULTS: When compared to AAF, MG-treated patients more frequently reported concerns with treatment efficacy (54% vs 4%), application (7% vs 3%), and treatment side effects. MC-treated patients more frequently reported concerns with treatment efficacy (61% vs 5%) and dryness (8% vs 5%). AAF-treated patients more frequently reported concerns with cost of treatment compared with MG (7% vs 1%) and MC (9% vs 4%). Among patients reporting concerns, level of importance associated with these concerns was similar for AAF-treated patients compared with MG- and MC-treated patients. When compared to AAF-treated patients, MG-treated patients more frequently reported side effects of dryness (26% vs 15%) and uneven skin tone (3% vs 0%), and MC-treated patients more frequently reported side effects of burning (7% vs 3%), itching (7% vs 5%), and redness (7% vs 5%). MG- and MC-treated patients indicated greater intolerance for reported side effects than AAF-treated patients. CONCLUSIONS: MG- and MC-treated patients more frequently reported treatment concerns and side effects than AAF-treated patients, and tolerability of those side effects was higher for patients treated with AAF. While treatment cost is a more frequent concern in patients treated with AAF, these patients less frequently reported concerns with treatment efficacy and reported similar or greater tolerance to side effects than patients treated with either MC or MG. J Drugs Dermatol. 2020;19(3): doi:10.36849/JDD.2020.3679.

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

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.

Riociguat improves health-related quality of life for patients with pulmonary arterial hypertension: results from the phase 4 MOTION study.

Pulmonary arterial hypertension (PAH) is characterized by progressive dyspnea and exercise limitation and is associated with reduced health-related quality of life. Few clinical studies have evaluated the primary effects of treatment of PAH from the patient perspective. Here, we present the impact of riociguat on patient-reported outcomes (PROs) in treatment-naïve patients with PAH. MOTION (NCT02191137) was an open-label, phase 4 trial of riociguat monotherapy in treatment-naïve patients with PAH. The primary endpoint was the change in total score from baseline to Week 24 in the Living with Pulmonary Hypertension (LPH) questionnaire. The Short Form-12 Health Survey and Work Limitations Questionnaire 8 were also utilized to assess PROs. Other secondary endpoints included change from baseline in World Health Organization functional class (WHO FC), 6-min walk distance (6MWD), Modified Borg Dyspnea Scale, and safety. At week 24 (n = 66), the mean (standard deviation [SD]) total LPH score was 37.17 (24.61), for a mean (SD) change from baseline of -10.99 (22.51). At last visit, with week 24 imputed, the mean (SD) total score was 40.63 (28.38), for a mean (SD) change from baseline of -5.40 (27.8) (n = 75; P = 0.0484). Improvement in LPH questionnaire total score was observed by week 4 and was maintained through week 24. Improvements were observed in WHO FC, Modified Borg Dyspnea Scale, and accelerometer-measured 6MWD at week 24. Treatment with riociguat had a positive impact on PROs in treatment-naïve patients with PAH and was well tolerated, with a similar safety profile to that observed in placebo-controlled phase 3 trials.