Background and importance Galcanezumab, a humanised monoclonal antibody that binds calcitonin gene-related peptide, has demonstrated a significant reduction in monthly migraine headache days.

Aim and objectives To perform a first preliminary evaluation 3 months after using galcanezumab in patients with migraine.

To compare the health results with the ones in the pivotal clinical trials REGAIN and EVOLVE.

Material and methods A retrospective, descriptive study was conducted. Data were collected from patients with migraine who had started treatment with galcanezumab from February 2020 to July 2021.

The data collected were: sex, age, type of migraine (episodic (EM) or chronic migraine (CM)), number of previously used preventive drugs, presence of analgesia abuse, dosage, date of start and end of treatment, reason for end of treatment, number of of monthly migraine headache days (MHD) prior to treatment, and number of MHD after 3 months. All the information was obtained from the electronic medical record.

Results 59 patients with a diagnosis of EM or CR were analysed (81.4% women), with a mean age of 53.8±12.2 years. 76.3% had CM (45) and only 14 patients suffered from EM. Patients had tried a mean of 4.2 preventive drugs. At least 44.1% of patients presented analgesia abuse.

All patients received the same posology: 120 mg monthly (with a 240 mg loading dose) of galcanezumab.

17 patients stopped treatment, the main reasons were: inefficacy (70.6%), stability (17.6%), no adherence (5.9%) and toxicity (5.9%). 6 patients were excluded from the study on account of them not having received the re-evaluation after 3 months of treatment. The mean of MHD in patients with EM was 11.6 before treatment and 5.2 after (–6.5 MHD). The mean of MHD in patients with CM was 16.5 before treatment and 8.2 after (–8.3 MHD). So, 69.2% and 57.5% of patients with EM and CM, respectively, reduced the number of MHD by at least half.

Conclusion and relevance For patients with EM, the results were better than in the pivotal clinical trial EVOLVE (–4.7 vs –6.5 MHD). The same was the case for patients with CM, the results are better than in REGAIN (–4.8 vs –8.3 MHD). Galcanezumab seems to present a better effect than expected in clinical trials. Thi si s, however, a first preliminary evaluation, and a follow-up would be necessary to see the long-term effect.

Conflict of interest No conflict of interest