A Prospective, Observational, Multicenter Study Assessing Adherence to Interferon Beta-1b Therapy and Patient Satisfaction Using the BETACONNECT Auto-Injector.

INTRODUCTION: It is important to achieve good persistence and adherence to disease-modifying therapies (DMTs) to achieve the best outcomes in chronic diseases such as multiple sclerosis (MS). The BETACONNECT device is an electronic auto-injector for the DMT interferon beta-1b (Betaseron), designed to improve patients' injection experience and to monitor adherence. This observational study aimed to assess patient adherence to and persistence with interferon beta-1b therapy as well as patient-reported satisfaction in a US population. METHODS: A prospective, observational, multicenter study was conducted in 146 adult patients with relapsing-remitting MS or clinically isolated syndrome, newly prescribed or currently established on interferon beta-1b therapy and naïve to the BETACONNECT device, and followed up during a 6-month observation period. RESULTS: Among the 91 patients who completed the study, the overall mean adherence rate was 82.5%, with 65.9% of patients adherent for at least 80% for the duration of the 6-month period. At 6 months, 98.9% of patients had less than a 60-day gap in therapy. Of the 115 patients who provided satisfaction data, 90.5% of patients were either very satisfied or satisfied with the BETACONNECT device. CONCLUSION: This study shows that the BETACONNECT device was associated with high adherence to interferon beta-1b therapy in patients with MS. Patients also reported high degrees of satisfaction with the device. Therefore, this may be a viable delivery option to help with adherence and persistence, potentially leading to improved clinical outcomes.

Six-Month Use of Droxidopa for Neurogenic Orthostatic Hypotension.

BACKGROUND: Droxidopa is approved for adult patients with symptomatic neurogenic orthostatic hypotension (nOH); there is limited information regarding effects on symptoms, outcomes, and quality of life (QOL) beyond two weeks of treatment. OBJECTIVE: Examine the real-world experience of patients taking droxidopa after six months of treatment. METHODS: This non-interventional, US-based, prospective cohort study utilized a pharmacy hub, identifying patients who recently started droxidopa for nOH treatment. Questionnaires for fall frequency and other patient-reported outcomes (PROs) were completed at baseline and one, three, and six months following droxidopa initiation. RESULTS: 179 enrolled patients completed baseline surveys. Droxidopa continuation rates were high at months one, three, and six (87%, 79%, and 75%, respectively). From baseline to month one, there was significant reduction in the proportion of patients reporting falling at least once (54.1% vs. 43.0%; P = 0.0039), with similar observations at month three (52.9% vs. 44.5%; P = 0.0588) and month six (51.4% vs. 40.0%; P = 0.0339). Significant improvements from baseline to month one were observed and maintained at months three and six for most PROs, including the Orthostatic Hypotension Symptom Assessment Item 1, Short Falls Efficacy Scale-International, Sheehan Disability Scale, Physical Component of the 8-item Short-Form Health Survey, and Patient Health Questionnaire-9. CONCLUSIONS: In this non-interventional prospective study, fewer nOH patients reported falling after one, three, and six months of droxidopa treatment. Further, improvements reported in nOH symptoms, physical function, and QOL measures were maintained for six months following treatment initiation. Results from randomized clinical trials are required to validate the findings.

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.