Long-term data on safety and efficacy of erenumab is still limited for the German population. Further, the impact and relevance of a drug holiday suggested by the German guidelines for migraine therapy by the DGN/DMKG, which is suggested after 6-12 months of treatment should be investigated.

In 2018, the FDA and EMA approved erenumab as the first monoclonal antibody targeting the CGRP-receptor specifically developed for prophylactic migraine treatment.  Recently, 5-year data from an open-label treatment phase confirmed the long-term safety profile of erenumab in an international cohort.

APOLLON (Assessment of Prolonged safety and tOLerability of erenumab in migraine patients in a Long-term OpeN-label study) is a 128-week open-label study of erenumab treatment, assessing long-term safety and tolerability data of migraine patients in Germany who previously participated in a 24-week head-to-head trial comparing the tolerability of erenumab and topiramate (HER-MES, NCT03828539). At scheduled visits, the treating physician can change the erenumab dose according to the approved label or initiate a drug holiday for up to 24 weeks. Thereby, impact of treatment discontinuation on monthly migraine days is assessed 4 weeks prior to, during and 12 weeks after the medication-free epoch.

Detailed study design and results of the first interim analysis describing the baseline characteristics of the total study population of approximately 700 enrolled patients will be presented. Number and time point of current or planned drug holidays will also be presented.

This analysis will provide insights into the patient population enrolled in the APOLLON study to assess long-term safety and tolerability of erenumab. Furthermore, common treatment algorithms will be elucidated by investigating the impact of drug holidays during prophylactic migraine treatment in the participating 80 headache centers in Germany.