Real-world therapy management of patients with multiple sclerosis receiving cladribine tablets beyond year 4 - Results from a German cladribine cohort.

BACKGROUND: The current approval of oral cladribine covers four years, with two treatment courses in the first two years, followed by two treatment-free years. For decision-making in year 5, experts recommend three scenarios: Extending the treatment-free period, retreatment with cladribine, or therapy switch. OBJECTIVE: To assess the implementation of the three year-5-scenarios in clinical practice in a large multicentric real-world cohort in Germany. METHODS: Data from adult patients diagnosed with highly active RMS (first dose between 8/2017 and 8/2018) were included. The primary outcome was the percentages of patients who remained treatment-free in year 5, were retreated with cladribine, or switched to another therapy. RESULTS: In total, 187 patients (75 % female, mean age 38.6 years, median EDSS 2.5, 21 % DMT-naive) were evaluated. Overall, 27 (14 %) switched treatment within year 1-4, 36 (19 %) continued therapy with cladribine tablets in year 5, and 8 (4 %) switched therapy in year 5. All other patients (n = 118, 63 %) continued to be monitored without therapy in year 5. CONCLUSION: The recommended three treatment scenarios in year 5 appear to be feasible in clinical practice. Treatment-free structured monitoring is the most frequently applied strategy, highly likely due to the prospect of continuing low disease activity under cladribine treatment.

Depression, fatigue and disability are independently associated with quality of life in patients with multiple Sclerosis: Results of a cross-sectional study.

BACKGROUND: Quality of life (QoL) is significantly impaired in patients with Multiple Sclerosis (MS). As the expanded disability status scale (EDSS) inadequately reflects the impact of clinical symptoms on QoL, the present study aimed to identify factors associated with reduced QoL in MS patients. DESIGN: Single-center cross-sectional study in 260 MS patients. METHODS: QoL was assessed by the Multiple Sclerosis International QoL Questionnaire (MusiQoL), depression by the Center for Epidemiological Studies Depression Scale (CES-D scale), and fatigue by the Fatigue Scale for motor function and cognition (FSMC). RESULTS: 79.6% patients were female and 21.4% male. The mean age was 44.5 ±â€¯11.2 years and the median EDSS 3.0 (range 0.0-8.5). 35.8% had depression and 56.9% moderate to severe fatigue. The mean MusiQoL index score was 73.9 ±â€¯11.3. Using linear regression, depression, fatigue, family status, physical activity, and occupation were associated with QoL. EDSS was only associated with QoL in patients with an EDSS 0.5.0. CONCLUSIONS: Depression, fatigue, family status, physical activity, and occupational status were closely associated with QoL in MS patients. Potential measures to improve QoL include assessment and treatment of depression, physical exercise, and maintaining patients employed in accordance with their physical and mental disabilities.

Efficacy of adapalene/benzoyl peroxide combination in moderate inflammatory acne and its impact on patient adherence.

BACKGROUND AND OBJECTIVES: Adapalene 0.1 %/benzoyl peroxide (BPO) 2.5 % (Epiduo®) is the first, fixed-dose topical combination gel developed for the once-daily treatment of acne. The objective of this observational study was to assess efficacy and patient adherence under daily clinical practice conditions in a large population of young adults and adolescents (12 to 20 years) with moderate inflammatory acne. PATIENTS AND METHODS: A total of 2 780 patients receiving adapalene-BPO were evaluated in this multicenter, open-label, prospective non-interventional observational study. Observation time per patient was approximately 12 weeks. Assessment parameters included changes in acne severity, treatment success, safety, and therapeutic adherence. RESULTS: After 12 weeks, the majority of patients (91.5 %) showed improvement of acne under adapalene-BPO treatment, with an initial therapeutic response noted after a median time of 14 days. Overall, 21.8 % of participants displayed complete resolution of visible acne lesions. Treatment adherence was assessed as good in 63.2 % of patients. The majority of individuals (69.5 %) experienced no or only mild local skin irritations. No serious adverse drug reactions (ADR) were reported during the course of the study. CONCLUSIONS: Adapalene-BPO is effective and safe in the treatment of moderate inflammatory acne. The fixed-dose combination and easy application simplifies the therapeutic regimen, leading to good treatment adherence in the majority of patients.