A real-world study found that the Patient Global Impression of Change (PGIC) and Migraine-Specific Quality of Life (MSQ) were most highly associated with medical decision making among patients receiving calcitonin gene related peptide monoclonal antibody (CGRP-mAbs) therapy for migraine prevention. These findings were published in The Journal of Headache and Pain.
Patients (N=359) who received monthly CGRP-mAbs at the Vall d’Hebron Research Institute in Spain between 2019 and 2021 were evaluated for patient reported outcome measurements (PROMs). Changes to monthly migraine days (MMD), monthly headache days (MHD), headache pain intensity (INT), acute medication intake days (AMD), and number of pills per month (AMPM) were assessed for their association with PGIC, MSQ, Headache Impact Test (HIT-6), Migraine Disability Assessment (MIDAS), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI), and MIGraine attacks-Subjective COGnitive impairments scale (MIG-SCOG).
Patterns of changes from baseline to 12 weeks were compared between patients who continued treatment after week 12 (n=219) or discontinued treatment (n=44).
The patient population was aged mean 46.9 (standard deviation [SD], 10.3) years, 81.7% were women, 87.8% had chronic migraine, the duration of disease was 25.4 (SD, 13.5) years, 28.5% had aura, 62.4% received 140 mg erenumab, and 37.6% 120 mg galcanezumab.
The patients who did not continue with CGRP-mAbs had higher MHD, MMD, INT, acute medication burden, and more used concomitant preventative treatment (all P <.001).
At week 12, the average change in MMD was -7.9±7.4 days/month (P <.0001) and more than half of patients (54.4%) had ≥50% reduction in MMD. There was no difference in the response rate between erenumab and galcanezumab (57.9% vs 48.5%; P =.160).
More patients who continued with treatment had ≥50% in MMD (P <.0001) and MHD (P <.0001). In addition, those who continued using CGRP-mAbs reported significant reductions to all PROMs except MIG-SCOG.
The PROMs which best correlated with efficacy outcomes was MSQ, correlating with MMD (r, 0.321; P <.0001), MHD (r, 0.243; P <.0001), INT (r, 0.285; P <.0001), AMD (r, 0.172; P =.004), and AMPM (r, 0.147; P =.016).
Treatment continuation was associated with PGIC (odds ratio [OR], 15.569; 95% CI, 6.254-31.533; P <.001), concomitant preventative treatment (OR, 3.629; 95% CI, 1.114-14.994; P =.037), and change in MSQ (OR, 0.840; 95% CI, 0.619-0.973; P =.047). These predictors had an area under the receiving operator characteristic curve (AUC ROC) of 0.766 (95% CI, 0.683-0.849).
This study was limited by not including a control cohort and it remains unclear whether these findings are applicable to other migraine prevention strategies.
This study found the PROMs which best predicted CGRP-mAbs outcomes were MSQ and PGIC at 12 weeks.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Alpuente A, Gallardo VJ, Caronna E, Torres-Ferrus M, Pozo-Rosich P. In search of a gold standard patient reported outcome measure to use in the evaluation and treatment-decision making in migraine prevention. A real-world evidence study.J Headache Pain. 2021;22(1):151. doi:10.1186/s10194-021-01366-9