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4CPS-002 Effectiveness and safety of monoclonal antibodies for migraine prevention after two and a half years of clinical experience
  1. D Fresan,
  2. A Yerro,
  3. A Pastalle,
  4. C Garcia,
  5. M Calvo,
  6. I Ortega,
  7. E Lacalle,
  8. R Juanbeltz,
  9. AI Idoate,
  10. MT Sarobe,
  11. MM Noceda
  1. Hospital Universitario de Navarra, Pharmacy, Pamplona, Spain


Background and Importance Erenumab, galcanezumab and fremanezumab were approved in 2019 for migraine crisis prevention. Efficacy and safety were demonstrated in three-months lasting clinical trials. At present, long-term effectiveness and safety can be analysed.

Aim and Objectives To evaluate the effectiveness and safety of monoclonal antibodies (mAb) utilised in migraine after two-and-a-half years of clinical use.

Material and Methods Prospective, observational study conducted in a tertiary hospital (December 2019 to June 2022). Data were obtained from patients’ medical records (approved by our Ethics Committee).

Effectiveness and tolerance are evaluated 3 months after initiation and if it is effective and well tolerated it is maintained up to 12 months. Response is defined as a decrease in headache and/or migraine days per month ≥50% compared to baseline and/or a significant improvement in quality of life (measured by HIT-6 and MIDAS scales). If partial response (PR) (decrease ≤50%) or adverse effects (AE) another mAb can be employed with different mechanism of action. If lack of response (LR) (decrease ≤25%) treatment is suspended. If response is achieved during the last months, the mAb can be maintained for another year.

Results 253 patients initiated treatment with a mAb. 69% (n:175) completed 12 months of treatment with effectiveness (responders) and 31% (n:78) stopped at third-month evaluation (PR/LR patients and AE-suffering patients), 42 of which changed to a second mAb. Ending reasons were: PR/LR (n:52), PR/LR and AE (n:9), AE (n:8) and others not related to the treatment (n:9).

After completing 12 months, 140 patients stopped the treatment; 25 maintained it for another treatment course, some of which have already started a third course (median duration: 23 [17-37]), and 10 switched to a second mAb.

Regarding safety, 33% (n:83) of patients reported at least one AE during the treatment with the first and/or second mAb, being the reason for discontinuation in 7% (n:17) of patients (due to vertigo and constipation, mainly). Most frequent AE were vertigo/dizziness (17%, n:45), constipation (13%, n:33) and skin rashes after injection (4%, n:11).

Conclusion and Relevance Anti-CGRP mAb are effective and safe treatments that improve migraine suffering patients’ quality of life. A significant percentage of patients completes the treatment course and only 7% of patients discontinues the mAb due to intolerance.

Conflict of Interest No conflict of interest

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