Table 2.

Post-hoc analysis of clinical trials in CM.

Objective	Main findings	Reference
Data from the PROMISE-2 study
To assess the effect of eptinezumab on PROMs in patients with CM and MOH	Eptinezumab resulted in clinically meaningful improvements in mean HIT-6 total scores by week 4 and were sustained up to week 24. Eptinezumab was also associated with numerically greater improvements in the PI-MBS and SF-36 scores compared with placebo.	Starling et al. (57)
To examine the relation between changes in PI-MBS and changes in MMDs and other PROMs	Improvements in the PI-MBS correlated with changes in MMDs and in the PROMs (PGIC, HIT-6, EQ-5D-5L VAS, and SF-36) at week 12. The magnitude of treatment effects on PI-MBS was greater for eptinezumab groups than for placebo.	Lipton et al. (20)
To evaluate the general consistency and predictability of early treatment response on later response	The percentage of patients who achieve ≥75% MRR at Month 1 and up to Month 6 was higher in eptinezumab-treated patients than in placebo-treated patients. Most patients attaining very much improved scores (PGIC) at Month 1 also had much or very much improved scores for all 5 subsequent months.	Buse et al. (19)
To evaluate the relationship between headache frequency reductions and changes in AHM use	Eptinezumab-treated patients presented fewer days with both headache and AHM use than placebo-treated patients. Triptans were the type of AHM that presented the highest reduction of use.	Cowan et al. (21)
To examine changes in the occurrence, severity, and symptoms of headache episodes	Monthly severity and frequency of headache days and episodes decreased more in eptinezumab-treated groups than in the placebo group throughout 24 weeks.	McAllister et al. (22)
To assess change in MMDs from baseline through 24 weeks in patients with a dual diagnosis of CM and MOH	A higher decrease in MMD occurred in patients treated with eptinezumab compared to placebo from week 1–24. Around half of patients receiving eptinezumab (vs one third receiving placebo) were below CM and MOH thresholds throughout this period.	Dienner et al. (58)
Data from the PREVAIL study
To assess item-level changes in the MIDAS over 2 years	Eptinezumab reduced headache days, headache pain severity, absenteeism and presenteeism at week 12 up to week 104.	Blumenfeld et al. (23)

AHM, Acute headache medication; EQ-5D-5L VAS, EuroQol-5-dimension visual analog scale; HIT-6, 6-item Headache Impact Test; MIDAS, Migraine Disability Assessment Test; MMD, monthly migraine days; MOH, medication-overuse headache; PGIC, Patient Global Impression of Change; PRO, patient-reported outcomes; SF-36, Short-Form Health Survey.