Abstract text (incl. figure legends and references)

Fremanezumab has demonstrated to be effective and safe for migraine prevention in randomized, placebo-controlled trials. Real-life studies are needed to evaluate effects in patients in routine practice.

Methods. This retrospective, observational study included 1-month baseline and 6- and 12-month follow-up. Patients with migraine (M) (ICHD-3. 2018) visited University Headache Clinic from 01.09.2020 till 01.09.2022 and were given subcutaneous fremanezumab were included. All included patients were keeping E-headache diary "Migrebot" 1 month prior the first injection and then all the treatment period. Primary study endpoint was the change in monthly migraine days (MMD) from baseline to 12 weeks of the treatment.

Results. We included 113 patients (38,5±11,0 y.o. 91,2% - women). 36,3% had episodic M, 63,7% - chronic. 52% had medication overuse headache. 32,7% previously failed ≥2 classes of preventive treatment. 31.1% were naïve (fremanezumab was the first prevention). Only 1 patient preferred 675mg once per 3 months". 47,3% had depression, 45,5% had somatic disorders including allergy and arterial hypertension. The change MDD was -3,7 days to 12 weeks (р<0,001), and -9.0 to 12 month. ≥50% response rate was 82,3%. 76,6% of the responders had ≥50% MDD reduction at the first treatment month. Predictors of efficacy were episodic M, response to previous therapy, and good response to triptans. 20% of the responders had significant MDD increasing during the treatment, usually on the 4th or 6th month. They were advised to continue fremanezumab or other preventives were added. After continuing with fremanezumab, MDD became less frequent again after 3 months. 11,5% had adverse events: local allergic reactions and triptans efficacy reduction.

Conclusions. Our study reproduces data from studies in other countries. However, in Russia, when prescribing fremanezumab, ≥2 treatment fails are not required. Therefore, the ≥50% response rate is slightly better than in other countries.