Study endpoints
The primary endpoint of the present study was to evaluate the
effectiveness and safety of two CGRP antibodies, erenumab and
galcanezumab, in real-world patients suffering from either chronic or
episodic migraine. To do so, two objective parameters, monthly headache
days (MHD) and acute migraine-specific medication days (AMSMD), were
evaluated before starting the treatment as well as after 3 and 6 doses
of each CGRP MoAb. In addition, three patient reported outcomes (PROs)
questionnaires were also evaluated, the Migraine Disability Assessment
(MIDAS) questionnaire, Headache Impact Test (HIT-6) and Visual Analogue
Scale (VAS), at the same timepoints: baseline and after the
administration of 3 and 6 doses of each CGRP MoAb. Timepoints were
selected as suggested by clinical guidelines. These recommend a
treatment period of at least 3 months to provide more stable estimates
of outcomes, while encouraging long-term observation26. Regarding tolerability and safety, drug-related
adverse events reported by patients throughout the study period were
reported during clinical interview, collected and organized according to
MedDRA category. A secondary endpoint to evaluate effectiveness was to
analyse the proportion of patients who experienced a reduction ≥ 50% of
AMSMD.