Real-World Experience of Erenumab in Patients with Migraine in Germany: The SPECTRE Study.

Introduction: To provide real-world insights into migraine patient population in Germany treated with erenumab, focusing on the prescription patterns and reasons for the initial dosage choice. Methods: SPECTRE was an observational, non-interventional, multicenter, open-label, single-arm study in patients treated with erenumab according to approved local dose and guidelines. The study enrolled adult patients (n = 571; Germany: 105 sites) with migraine who had received erenumab for not more than 3 months before the start of the study. Results: The mean (standard deviation) patient age was 45.0 (12.3) years, and most patients were female (89.0%), Caucasian (97.6%), and non-smokers (85.1%). The starting dose of erenumab was 70 mg in 68.5% of patients and 140 mg in 31.5%. The proportion of patients with 140 mg as the starting dose was the highest (43.5%) in those aged 30–40 years. The most common reason for starting a higher dose of erenumab 140 mg was severity of migraine (47.4%). During the observational period, the proportion of patients taking erenumab 140 mg increased to 64.6% (visit 5; V5) after 12 months. Due to attrition of patients towards the end of the study (V9: 90 participants), data at V9 must be interpreted with caution. At least one dose change was performed in 45.3% of patients (i.e., erenumab 70 to 140 mg or 140 to 70 mg), 21.2% of patients attempted at least once to discontinue treatment (i.e., period with erenumab discontinuation and no other antibody treatment for migraine prevention), and 15.3% discontinued erenumab treatment, mainly because of no or insufficient treatment response (13.5%). The mean time until the first omission attempt was 332.3 (range 37–633) days. Constipation (12.1%) was the most frequently reported adverse event, in line with the summary of product characteristics (SmPC) of erenumab. Conclusion: Most patients with migraine were prescribed erenumab 70 mg as the starting dose. No new safety signals were observed for erenumab versus the previous trials. Plain Language Summary: Erenumab, a fully human monoclonal antibody against the calcitonin gene-related peptide receptor, was approved by the US Food and Drug Administration (FDA) and the European Medicines Agency for the prevention of migraine in adults as a monthly treatment with a 70 mg and 140 mg dose. SPECTRE was a multicenter, open-label, prospective non-interventional observational study in patients treated with erenumab as per local approved dose and clinical practice. The study was aimed at providing real-world insights into migraine patient population in Germany treated with erenumab, focusing on the prescription patterns and reasons for the initial dosage choice. Of the 571 enrolled patients (mean age: 45.0 years; Germany: 105 sites), 556 were included in the full and safety analysis. In the majority of the patients (68.5%) erenumab was initiated using the lower starting dose of 70 mg (erenumab 140 mg: 31.5% of patients). Patients (43.5%) who started with erenumab 140 mg were most frequently 30–40 years old, which represents the second youngest age group in the study. In total, 776 adverse events (AE) were reported in 294 patients (52.9%). According to the Summary of Product Characteristics of erenumab, the most frequent AE was constipation (12.1%). Safety data were in accordance with the known safety profile of erenumab. Data from the SPECTRE study reveal the real-world treatment patterns and disease characteristics of migraine patients in Germany who were treated with erenumab. [ABSTRACT FROM AUTHOR]