Background and importance High-frecuency episodic migraine (HFEM) represents an important health problem due to its high prevalence and to the loss of quality of life. The therapeutic approach is based on prophylactic and symptomatic treatment.

Galcanezumab has been authorised by the European Medicines Agency (EMA) for the prophylaxis of migraine in adults with at least 4 days of migraine per month (MDM).

Aim and objectives To study the effectiveness and safety of galcanezumab in the prophylaxis of HFEM in real-life clinical practice.

Material and methods Observational, retrospective study of patients with HFEM who initiated treatment with galcanezumab between June 2020 and June 2021. Demographic data, number of prophylactic treatments received, date of diagnosis, mean MDM, and HIT-6 scale score at baseline and 3 months after treatment initiation were collected from the electronic medical record.

Results In the study period, 48 patients (81%, 39 women) with HFEM started treatment with galcanezumab. The median age was 47 (24–68) years. The time since diagnosis was 71 months. 52% had received more than five prophylactic drugs. Topiramate was used in 90% (43) of the patients, and was contraindicated in the remainder; it was discontinued in 56% (27) of the cases due to lack of response and in 33% (16) due to poor tolerance. Other treatments used were: amitriptyline (79%, 38); off-label botulinum toxin (77%, 37), flunarizine (75%, 36), propranolol (46%, 22), metoprolol (33%, 16) or valproic acid (38%, 18).

Three-month follow-up was carried out in 94% (25) of the patients. The median MDM at baseline was 10.5; and after treatment, 4; implying a median reduction in MDM of 58%. The median HIT-6 score at baseline was 68 (56–79). Variation in HIT-6 could not be assessed due to lack of data.

The median treatment duration at cut-off was 8 (3–15) months. Treatment was discontinued in 6 cases due to lack of response (3), adverse effects (2) or the patient’s decision (1). Adverse effects were reported in 23% (11) of the patients, the most frequent being dizziness and instability (4) and constipation (2).

Conclusion and relevance Galcanezumab appears to be an effective treatment in patients with multidrug-refractory HFEM. Further studies are needed to assess these results in the long term. Galcanezumab has an acceptable safety profile, with the incidence of dizziness and constipation being higher than described in clinical trials, but rarely leading to treatment discontinuation.

Conflict of interest No conflict of interest