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5PSQ-053 Effectiveness and safety of galcanezumab. Real-life results
  1. S García Lastra,
  2. E Crespo Rodriguez,
  3. P Andreu Margullon,
  4. A Romero Garcia,
  5. I Zapico Garcia,
  6. AI Plano Sánchez,
  7. C Carriles Fernandez,
  8. N Perez Domínguez,
  9. JA Valdueza Beneitez,
  10. N Gonzalez Sanchez
  1. Hospital San Agustín, Pharmacy, Avilés, Spain


Background and Importance Galcanezumab is a monoclonal antibody that binds the calcitonin gene-related peptide, indicated for migraine prophylaxis.

Aim and Objectives To assess the effectiveness and safety of galcanezumab six months after initiation of treatment.

Material and Methods A retrospective observational study including patients treated with galcanezumab, from September 2020 to August 2023 was conducted. Collected variables comprised age, sex, type of migraine, median number of migraine days per month (MDM), HIT-6 score, galcanezumab treatment duration, and adverse effects. Treatment with galcanezumab was considered effective if a reduction of at least 50% in MDM or a reduction of more than 5 points on the HIT-6 scale was achieved at 6 months of treatment. For the assessment of drug safety, adverse effects reported by the patient were considered.

Results A total of 32 cases were reviewed (median age 49 years; 25 women [71.4%]), 75% (n=24) of patients had chronic migraine without aura, 9.4% (n=3) had chronic migraine with aura, and 15.6% (n=5) had high-frequency episodic migraine. The change in MDM before and after six months of treatment was 15 versus 5, and the HIT-6 index was 69 versus 57. Median duration of galcanezumab treatment was 19 months. At the end of the study period, 84.6% of patients continued with the treatment, while 15.4% discontinued it due to side effects or ineffectiveness. Regarding the type of adverse effects, two patients reported dizziness (7.7%), and one reported intense itching (3.8%). The observed frequencies are higher than those reported in pivotal clinical trials, with an incidence of 1.2% for dizziness and itching. The adverse effects reported were in all cases, mild or moderate, and the discontinuation rate awed to this reason was less than 4%.

Conclusion and Relevance Treatment with galcanezumab has proved to be effective and safe in most patients. Despite adequate monitoring at six months from the initiation of monoclonal antibody treatment, further and longer-term studies would be necessary to establish the utility of this drug, its impact on quality of life, and its long-term safety.

Conflict of Interest No conflict of interest.

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