Functional outcome measures over 112 weeks of the LIBERTY study (open-label analysis set)
Outcomes | Time point (weeks) | Participants continuing on erenumab 140 mg, N=118 | Participants switching from placebo to erenumab 140 mg, N=122 | Overall population entering OLEP, N=240 |
Change from baseline in HIT-6* | 12 | −5.2 (6.6), n=116 | −2.3 (5.9), n=122 | −3.7 (6.4), n=238 |
16 | −5.9 (6.6), n=114 | −6.9 (7.6), n=120 | −6.4 (7.2), n=234 | |
36 | −7.9 (8.2), n=103 | −8.6 (9.0), n=105 | −8.3 (8.6), n=208 | |
48 | −7.9 (7.6), n=97 | −10.6 (9.2), n=99 | −9.2 (8.6), n=196 | |
60 | −8.5 (7.4), n=88 | −9.7 (10.0), n=82 | −9.0 (8.7), n=170 | |
72 | −8.2 (7.7), n=94 | −9.3 (9.3), n=97 | −8.7 (8.5), n=191 | |
84 | −8.8 (8.0), n=91 | −8.9 (8.5), n=97 | −8.8 (8.2), n=188 | |
96 | −9.2 (8.0), n=88 | −10.4 (9.6), n=89 | −9.8 (8.8), n=177 | |
108 | −8.5 (8.0), n=91 | −10.4 (9.3), n=90 | −9.5 (8.7), n=181 | |
Change from baseline in MPFID-PI† | 9–12 | −2.0 (8.8), n=117 | 1.3 (8.9), n=120 | −0.3 (9.0), n=237 |
13–16 | −1.3 (8.5), n=116 | −2.4 (8.7), n=121 | −1.9 (8.6), n=237 | |
37–40 | −3.2 (8.7), n=102 | −4.7 (8.6), n=103 | −3.9 (8.7), n=205 | |
49–52 | −4.6 (7.8), n=93 | −5.5 (8.7), n=94 | −5.1 (8.2), n=187 | |
61–64 | −5.2 (6.9), n=70 | −4.5 (8.4), n=67 | −4.9 (7.6), n=137 | |
73–76 | −3.2 (8.3), n=95 | −4.8 (9.7), n=92 | −4.0 (9.0), n=187 | |
85–88 | −3.8 (8.1), n=89 | −4.5 (9.4), n=93 | −4.1 (8.8), n=182 | |
97–100 | −2.2 (10.5), n=90 | −4.3 (10.3), n=89 | −3.2 (10.4), n=179 | |
109–112 | −4.1 (9.1), n=88 | −5.0 (11.4), n=86 | −4.5 (10.3), n=174 | |
Change from baseline in MPFID-EA† | 9–12 | −3.3 (8.8), n=117 | 0.4 (8.9), n=120 | −1.4 (9.0), n=237 |
13–16 | −2.6 (9.1), n=116 | −3.7 (8.5), n=121 | −3.2 (8.8), n=237 | |
37–40 | −4.6 (8.8), n=102 | −5.5 (8.8), n=103 | −5.0 (8.8), n=205 | |
49–52 | −5.7 (7.6), n=93 | −6.7 (8.5), n=94 | −6.2 (8.1), n=187 | |
61–64 | −6.6 (7.7), n=70 | −5.1 (9.3), n=67 | −5.9 (8.5), n=137 | |
73–76 | −4.4 (9.1), n=95 | −5.6 (9.8), n=92 | −5.0 (9.5), n=187 | |
85–88 | −4.9 (8.2), n=89 | −5.4 (9.4), n=93 | −5.2 (8.8), n=182 | |
97–100 | −3.4 (11.1), n=90 | −5.4 (10.5), n=89 | −4.4 (10.8), n=179 | |
109–112 | −4.9 (9.7), n=88 | −6.0 (10.9), n=86 | −5.4 (10.3), n=174 |
Data are presented as mean (SD). Change from baseline=postbaseline−baseline. The baseline period is defined as the period between week −4 visit and the day prior to first dose. The baseline value is the prorated number to 28-day equivalents during baseline period.
*HIT-6 total score was assessed by visit.
†At each time point, mean (SD) values for week are determined for a daily collection during the respective 4-week periods.
EA, everyday activities; HIT-6, Headache Impact Test; MPFID, Migraine Physical Function Impact Diary; N, number of participants included in the analysis set; n, number of participants who responded; OLEP, open-label extension phase; ; PI, physical impairment.