Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N02CD01) erenumab
erenumab
(N02CD02) galcanezumab
galcanezumab
(N02CD03) fremanezumab
fremanezumab

Medical condition to be studied

Migraine
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

450
Study design details

Main study objective

1) To provide real-world evidence on patients initiating an anti-CGRP mAb (i.e. erenumab, fremanezumab, galcanezumab), 2) to describe the utilization pattern of these medications up to 15 months of follow-up and 3) to observe the consumption of triptans, proxy of migraine occurrence, before and after initiation of anti-CGRP therapy.

Outcomes

Mean monthly number of triptans dosage units dispensed

Data analysis plan

Descriptive analyses will be performed to assess demographic and clinical characteristics of selected anti-CGRP new users. All categorical variables will be shown as patient counts and percentages, while continuous variables will be described by means and standard deviation (SD). New users who discontinued and switched the initial anti-CGRP medication will be reported as the percentage of the total number of patients who started the anti-CGRP treatment. The mean monthly number of dosage units per patient will be used as the measure of triptan consumption before and after initiation of an anti-CGRP treatment. The difference (i.e. Δ) between the observed consumption of triptans during the follow-up window of interest and the baseline period will be reported and the statistical significance will be assessed through the application of the Wilcoxon's test for paired data (p≤0.05).