Abstract
Aim: In this study, we retrospectively evaluate our center patients on the biological treatment of migraine with CGRP antibodies used after full reimbursement approval from March to the end of 2020. Only patients receiving erenumab and fremanezumab were enrolled, as galcanezumab was not approved until October 2020.
Patients and methods: The sample consists of 130 patients, including 118 women (90.8%) and 12 men (9.2%) with an average age of 46.2 (21-76) years. The primary objective was to evaluate the effect of therapy at 3, 6, 9, and 12 months, the number of non-responders (monthly migraine day [MMD] reduction lower than 50%), reduction of acute medication overuse (MOH) days, relationship to disease duration, number of previous prophylaxes, migraine in family history (FH) and comorbidities.
The incidence of adverse events (AE) was monitored. Results: The average number of MMD before treatment was 12.2.
After 3 months, the MMD decreased by 60.5% (to 4.7), and in the following months, the effectiveness increased even further to more than 70%; greater effectiveness was achieved in chronic migraine (CM) compared to episodic (EM). After 12 months, the decrease was 69.9% for EM and 75.9% for CM.
In contrast, the eff ectiveness of treatment in patients with and without positive FH was practically the same. After 12 months of treatment, the effect was more pronounced in patients with MOH (76.2% decrease) than without MOH.
Efficacy was similar in men and women. Fifty-two patients received two prophylactics before starting biological therapy, 45 patients had three prophylactic drugs and 29 patients used four prophylactic drugs.
The effectiveness of biological therapy was similar in all three groups (after 12 months, the decrease in MMD was 70.3 vs. 73.2 vs. 70.7%). The efficacy of erenumab and fremanezumab (administered in month or three-month intervals) was not significantly different.
Therapy was discontinued due to insufficient effect only in 6 patients. AE occurred in only 10 (7.7%) patients, of whom 9 (8.6%) were treated with erenumab and 1 (4.8%) was treated with fremanezumab.
Therapy was discontinued due to AE (constipation) only in 1 patient on erenumab. Conclusion: CGRP (calcitonin generelated peptide) antibodies in the treatment of migraine are significantly effective and well tolerated in our group of patients in accordance with previous randomized and observational trials.