The Migraine Physical Function Impact Diary (MPFID) was assessed in the STRIVE study. As measured by the MPFID, the numerical differences in the domain scores observed were in favor of erenumab 140 versus 70 mg for the impact on everyday activities (MPFID-EA) and physical impairment (MPFID-PI) (Table 8). Again, however, the Phase 2 EM study in the Japanese population showed that the mean change in MPFID was similar between erenumab 70 and 140 mg.
A post-hoc analysis of the STRIVE study showed that over Months 4–6 there were numerically greater improvements with erenumab 140 mg than 70 mg across all patient-reported outcomes (PROs) as assessed by modified Migraine Disability Assessment (mMIDAS), headache impact test (HIT-6™), and migraine-specific quality-of-life questionnaire (MSQ; Table 8). These PRO measures show the benefit of erenumab treatment in reducing migraine burden and improving quality-of-life. Furthermore, a recent post-hoc analysis of the STRIVE study in subgroups of EM participants with severe functional impairment at baseline (HIT-6™ total score ≥60 subgroup or monthly mMIDAS total score ≥7 subgroup) showed greater improvements in the HIT-6™ total scores and mMIDAS total scores with erenumab (70 and 140 mg) treatment versus placebo over 4 to 6 months; and these improvements were similar across the two erenumab doses within each subgroup (Table 8). An exploratory analysis of data from the regulatory Phase 2 CM study showed improvements with the two erenumab doses (70 and 140 mg) across a broad range of PRO measures (HIT-6™, migraine disability assessment questionnaire [MIDAS], patient-reported outcomes measurement information system, and MSQ). Moreover, an exploratory analysis of the Phase 2 pivotal CM study was performed to contextualize actual treatment benefits in participants achieving ≥50%, ≥75%, and 100% response thresholds or not, by assessing HIT-6™ and MIDAS total scores. The mean change in HIT-6™ and MIDAS total scores from baseline at Month 3 was numerically greater with erenumab 140 mg than 70 mg across the spectrum of response threshold (Table 8).
Overall, although improvement was observed for the two erenumab doses across a range of different domains of PROs evaluated in erenumab clinical studies, the results for erenumab 140 mg tended to show a numerical benefit. These outcomes assess important additional aspects of the disease state and provide complementary information in the evaluation of erenumab, including the comparative effects of each dose, for migraine prevention.
Headache. 2022;62(4):420-435. © 2022 Blackwell Publishing