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Patient-Reported Outcomes Trial Concludes Erenumab Improves QOL, Disability

Samantha DiGrande
In a recent study, researchers looked to determine the effect of erenumab (Aimovig) on health-related quality of life (HRQOL), headache impact, and disability in patients with chronic migraine.
In a recent study, researchers looked to determine the effect of erenumab (Aimovig) on health-related quality of life (HRQOL), headache impact, and disability in patients with chronic migraine (CM).

The study enrolled 667 patients with CM who were then randomized 3:2:2 to receive placebo, erenumab 70 mg, or erenumab 140 mg monthly. Exploratory endpoints included migraine-specific HRQOL, based upon a Migraine-Specific Quality-of-Life Questionnaire (MSQ); headache impact, determined by a Headache Impact Test-6 (HIT-6); migraine-related disability, determined using the Migraine Disability Assessment (MIDAS) test; and pain interference, assessed by Patient Reported Outcomes Measurement Information Systems Pain Interference Scale short form 6b.

According to the study, improvements were seen in all endpoints for both erenumab groups at month 3, though greater changes relative to placebo were observed at month 1 for many of the outcomes.

Study participants receiving erenumab 70 mg demonstrated mean changes from baseline of 17.7 in MSQ role function-restrictive (RFR), 13.0 in MSQ role function-preventative (RFP), and 18.2 in MSQ emotional function (EF). Patients receiving erenumab 140 mg had mean changes from baseline of 19.1 in MSQ-RFR, 13.8 in MSQ-RFP, and 18.8 in MSQ-EF. In patients receiving placebo, these changes were 11.8, 8.9, and 9.9, respectively.

Additionally, patients in both erenumab groups experienced a –5.6 change in HIT-6 scores when measured from baseline to 3 months compared with a –3.1 change in patients who received placebo. Also, at month 3, the study investigators saw MIDAS scores improved by –19.4 days in the erenumab 70 mg group, –19.8 days in the erenumab 140 mg group, and –7.5 days in the placebo group.

“Overall, these results demonstrate that erenumab led to sustained, significant improvements that are consistent across multiple measures of HRQOL, social and psychological effect, and disability in patients with CM. A comparison of this number of [patient-reported outcome] instruments has not been done in such detail in other migraine preventive trials,” wrote the study authors.

Reference

Lipton R, Tepper S, Reuter U, et al. Erenumab in chronic migraine: patient-reported outcomes in a randomized double-blind study [published online May 7, 2019]. Neurology. doi.org/10.1212/WNL.0000000000007452.

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