Galcanezumab May Result in Functional Improvements in Migraine
In a post-hoc analysis of a phase 2b study, individuals with migraine were randomly assigned to receive subcutaneous injections of galcanezumab 120 mg or placebo (n=127) over a 12-week period.
Galcanezumab treatment may result in functional improvements and a reduction in the impact of headaches on quality of life in patients with migraine, according to a study published in Headache.
In a post-hoc analysis of a phase 2b study, individuals with migraine were randomly assigned to receive subcutaneous injections of galcanezumab 120 mg (n=60) or placebo (n=127) over a 12-week period. Patient-related outcomes assessed in patients who completed the study included the 48-item Migraine-Specific Quality of Life Questionnaire (MSQ) v2.1, which evaluates the impact of headache on several quality-of-life parameters (eg, Role Function-Preventive [RFP], Role Function-Restrictive [RFR], and Emotional Function [EF]) and the 6-item Headache Impact Test (HIT-6), which assesses how often headache causes distress or affects everyday activities.
Patients who received galcanezumab vs placebo had a greater mean change in the frequency of migraine headache days at week 12 (4.3 vs −3.4, respectively; P =.0150), as well as significant differences in least square mean changes at 12 weeks compared with baseline scores for baseline MSQ total scores (8.7; 95% CI, 2.449-15.008; P =.0067), MSQ RFR (9.6; 95% CI, 2.636-16.518; P =.0071), MSQ RFP (6.3; 95% CI, 0.476-12.185; P =.0342), MSQ Emotional Function (9.7; 95% CI, 2.789-16.674; P =.0063), and in the mean number of migraine headache days (P =.0080).
The mean number of headache days at baseline (6.69 days per month) was found to be negatively correlated with MSQ RFP domain score (Spearman correlation coefficient of −0.16; P =.0246; 95% CI, −0.300, −0.021). The mean number of migraine headache days at 12-week follow-up for both treatment groups was found to correlate with HIT-6 scores and MSQ total and domain scores (P <.0001 for all).
Study limitations include a small cohort, a follow-up period, and the sole inclusion of patients with frequent headache days per month.
“This finding is particularly important when considering that that the prevalence of migraine peaks during the prime working ages of adulthood (ie, >18), with [women] age 18 to 50 experiencing the highest prevalence, from 17.1 to 26.1%,” noted the study authors.
Ayer DW, Skljarevski V, Ford JH, et al. Measures of functioning in patients with episodic migraine: findings from a double-blind, randomized, placebo- controlled phase 2b trial with galcanezumab [published online August 14, 2018]. Headache. doi:10.1111/head.13383