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Abstract Details

Design and Population characteristics of patients treated with monoclonal antibody erenumab for assessment of long-term safety and tolerability and frequency of drug holidays in Germany (APOLLON)
Headache
Headache Posters (7:00 AM-5:00 PM)
047

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.

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.

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.

Authors/Disclosures
Sonja Ortler, MD
PRESENTER
Dr. Ortler has received personal compensation for serving as an employee of Novartis Pharma GmbH.
Hartmut Gobel Hartmut Gobel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Hartmut Gobel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Elli Lilly. Hartmut Gobel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Hartmut Gobel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Hartmut Gobel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Elli Lilly. Hartmut Gobel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Hartmut Gobel has received publishing royalties from a publication relating to health care. Hartmut Gobel has received personal compensation in the range of $10,000-$49,999 for serving as a Innovator with Ministry of Health.
Mirja Koch Mirja Koch has received personal compensation for serving as an employee of Novartis.
Monika Maier Peuschel Monika Maier Peuschel has received personal compensation for serving as an employee of Novartis Pharma . Monika Maier Peuschel has received stock or an ownership interest from Novartis Pharma AG.