Background
In Italy, monoclonal antibodies targeting the CGRP pathway are subsidized for the preventive treatment of high frequency and chronic migraine (CM) in patients with a MIgraine Disability ASsessment (MIDAS) score ≥ 11. Eligibility to treatment continuation requires a ≥ 50% MIDAS score reduction at three months (T3). In this study, we evaluate whether a ≥ 50% MIDAS score reduction at T3 is a reliable predictor of response to one-year erenumab treatment.
Methods
In this prospective, open-label, real-world study, 77 CM patients were treated with erenumab 70–140 mg s.c. every 28 days for one year (T13). We collected the following variables: monthly migraine days (MMDs), monthly headache days (MHDs), days of acute medication intake, MIDAS, HIT-6, anxiety, depression, quality of life and allodynia. Response to erenumab was evaluated as: i) average reduction in MMDs during the 1-year treatment period; and ii) percentage of patients with ≥ 50% reduction in MMDs during the last 4 weeks after the 13
th
injection (Responders
T13
).
Results
Erenumab induced a sustained reduction in MMDs, MHDs and intake of acute medications across the 12-month treatment period, with 64.9% of patients qualifying as Responders
T13
. At T3, 55.8% of patients reported a ≥ 50% reduction in MIDAS score (MIDAS
Res
) and 55.4% of patients reported a ≥ 50% reduction in MMDs (MMD
Res
). MIDAS
Res
and MMD
Res
patients showed a more pronounced reduction in MMDs during the 1-year treatment as compared to NON-MIDAS
Res
(MIDAS
Res
: T0: 23.5 ± 4.9 vs. T13: 7.7 ± 6.2; NON- MIDAS
Res
: T0: 21.6 ± 5.4 vs. T13: 11.3 ± 8.8,
p
= 0.045) and NON-MMD
Res
(MMD
Res
: T0: 23.0 ± 4.5 vs. T13: 6.6 ± 4.8; NON-MMD
Res
: T0: 22.3 ± 6.0 vs. T13: 12.7 ± 9.2,
p
< 0.001) groups. The percentage of Responders
T13
did not differ between MIDAS
Res
(74.4%) and NON-MIDAS
Res
(52.9%) patients (
p
= 0.058), while the percentage of Responders
T13
was higher in the MMD
Res
group (83.3%) when compared to NON-MMD
Res
(42.9%) (
p
= 0.001). MMD
Res
predicted the long-term outcome according to a multivariate analysis (Exp(B) = 7.128;
p
= 0.001), while MIDAS
Res
did not. Treatment discontinuation based on MIDAS
Res
would have early excluded 36.0% of Responders
T13
. ...