Autor:innen:
S. Tepper (Hanover, US)
R. Lipton (New York, US)
U. Reuter ( Berlin, DE)
S. Silberstein (Philadelphia, US)
W. Stewart (Walnut Creek, US)
D. Leonardi (Los Angeles, US)
P. Desai (Los Angeles, US)
S. Cheng (Los Angeles, US)
D. Mikol (Cambridge, US)
R. Lenz (Los Angeles, US)
Objectives: To evaluate patient‐reported outcomes in a phase 2 clinical trial of erenumab (AMG 334) for
chronic migraine (CM) (NCT02066415).
Introduction: Migraine is a disabling disease associated with substantial burden on patients and society.
Erenumab is a fully human anti‐CGRP receptor monoclonal antibody in clinical development for migraine
prevention.
Methods: 667 adults with CM were randomized (3:2:2) to monthly subcutaneous placebo or erenumab
70mg or 140mg. Primary and secondary endpoints were assessed at week 12. Exploratory endpoints
included: change from baseline in migraine‐specific QoL measured by the Migraine‐Specific Quality‐of‐
Life Questionnaire (MSQ), headache impact measured by the Headache Impact Test (HIT‐6), and
migraine‐related disability measured by the Migraine Disability Assessment Test (MIDAS). No formal
hypothesis was tested; p‐values (placebo vs erenumab dose‐groups) are descriptive.
Results: Baseline scores were similar between groups. Improvements were observed for all endpoints in
both erenumab groups at week 12. The mean (95% CI) changes for placebo vs 70mg and 140mg groups,
respectively, were 11.8 (9.4,14.1) vs 17.7 (14.9,20.6), p=0.002 and 19.1 (16.3,22.0), p<0.001 for MSQ
role function‐restrictive scores, 8.9 (6.8,11.0) vs 13.0 (10.5,15.6), p=0.013 and 13.8 (11.3,16.4), p=0.003
for MSQ role function‐preventive scores, and 9.9 (7.3,12.5) vs 18.2 (15.0,21.3), p<0.001 and 18.8
(15.6,21.9), p<0.001 for MSQ emotional‐function scores. Mean changes in HIT‐6 scores were ‐3.1 (‐3.9,‐
2.3) for placebo vs ‐5.6 (‐6.5,‐4.6), p<0.001 for both erenumab groups. Corresponding mean changes in
the placebo, 70mg, and 140mg dose‐groups were ‐7.5 days (‐12.4,‐2.7) vs ‐19.4 days (‐25.2,‐13.6),
p=0.002 and ‐19.8 days (‐25.6,‐14.0), p=0.001 for MIDAS days of lost productivity, ‐5.2 days (‐8.0,‐2.4) vs
‐10.3 days (‐13.6,‐6.9), p=0.023 and ‐10.2 days (‐13.6,‐6.8), p=0.024 for MIDAS‐absenteeism, and ‐1.9
days (‐4.7,0.8) vs ‐9.3 days (‐12.6,‐6.1), p<0.001 and ‐9.9 days (‐13.2,‐6.7), p<0.001 for MIDASpresenteeism.
Conclusions: Erenumab‐treated CM patients experienced consistent and clinically significant
improvements in migraine‐specific QoL and reductions in headache impact and disability.