Migraine treatment with CGRP monoclonal antibodies: patient evaluation of a mandatory treatment holiday in Belgium.

Background: Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway have emerged as a promising preventive treatment for migraine. In Belgium, patients receiving these antibodies must adhere to a mandatory treatment holiday of three months. This study investigated the patients' experiences during this treatment holiday.

Methods: A prospective study was conducted among 243 patients from nine headache clinics in Belgium receiving treatment with erenumab, fremanezumab or galcanezumab. Participants completed a structured questionnaire during their yearly follow-up visit after the treatment holiday. The questionnaire assessed the subjective migraine evolution and anxiety levels, and perceived usefulness of the treatment holiday.

Results: The majority of patients (86.0%) reported worsening of migraine symptoms during the treatment holiday, 59.4% of them experiencing deterioration already within the first month. For 5.9% of patients, this occurred beyond the 3-month mandatory holiday period, delaying treatment resumption. Improvement was reported by 3.0% of patients, while 11.0% experienced no change. Anxiety surrounding the treatment holiday was reported by 45.0% of participants, with 18.6% experiencing very high levels of anxiety. A significant association was found between anxiety and subjective migraine deterioration (p = 0.012). Nearly half (49.1%) of the respondents found the drug holiday overall useful in gaining insight into the need for continued treatment, 22.6% considered it even very useful.

Conclusion: A rigid, mandatory treatment holiday of two to three months poses significant challenges for a substantial subset of patients, leading to rapid migraine deterioration and increased anxiety. The observed association between migraine deterioration and anxiety highlights the need for patient education strategies. Policy makers should consider these findings to develop more flexible, patient-centered treatment approaches that optimize outcomes.