LAUSR

BACKGROUND Guidelines for migraine prophylaxis suggest stopping medication after 6-12 months to reevaluate treatment appropriateness. The Italian Medicines Agency (AIFA) set a mandatory regulation to stop anti-CGRP (calcitonin gene related protein) pathway monoclonal antibody (anti-CGRP mAbs) treatments for 3 months after 12-months of treatment. Herein, we assess the effects of discontinuation and retreatment of anti-CGRP mAbs in resistant chronic migraine patients, evaluating predictive factors of sustained response. METHODS A monocentric prospective cohort study, enrolling 44 severe (resistant to ≥3 preventive treatments) chronic migraine patients (all with medication-overuse), treated with erenumab (54.5%) or galcanezumab (45.5%) for 12-months, who discontinued treatment for three months and then restarted for one month. RESULTS Overall, patients reported an increasing deteriorating trend during the three months of discontinuation. Monthly migraine days (MMDs), number of analgesics, days with at least one analgesic used, a ≥50% response rate (reduction in MMDs), and MIDAS and HIT-6 total scores, remained lower than baseline values, but increased if compared to month-12 of treatment. All outcome measures decreased again during the month of retreatment. Patients who did not meet criteria for restarting treatment had lower MIDAS (p=0.03) and HIT-6 (p=0.01) scores at baseline and better outcome measures during discontinuation compared to patients who restarted treatment. CONCLUSIONS In most patients, the 3-month discontinuation of anti-CGRP mAbs resulted in progressive migraine deterioration that was rapidly reverted by retreatment. However, one-fourth of patients, who reported better quality of life indices before treatment, showed a sustained benefit during discontinuation and did not need retreatment.