Galcanezumab effective in patients with treatment-resistant migraine

Galcanezumab was more effective than placebo in preventing migraine among patients with treatment-resistant migraine who also had other pain disorders, according to research presented at this year’s virtual PAINWeek.

“Patients who are treated with galcanezumab had significantly greater mean reductions in the number of monthly migraine headache days compared to patients treated with placebo as early as month 1 and continuing through month 3,” Charles E. Argoff, MD, a professor of neurology at Albany Medical College, said during the presentation.

Argoff and colleagues evaluated participants from the CONQUER study, a phase 3, randomized, double-blind, placebo-controlled study of galcanezumab (Emgality; Eli Lilly & Co.) in adults who had treatment-resistant chronic or episodic migraine and at least one other concomitant pain disorder. The findings were previously presented at the virtual American Headache Society meeting.

Adults who had failed two to four migraine prevention medications due to inadequate efficacy or for safety reasons in the last 10 years were considered to have treatment-resistant migraine.

Participants were randomly assigned to receive 120 mg per month of galcanezumab after a 240 mg loading dose or placebo over 3 months. Researchers performed subpopulation analyses on participants who had at least one concomitant pain disorder. They assessed participants’ migraine and headache endpoints using information collected through an electronic diary.

A total of 100 patients were assigned to receive galcanezumab and 97 patients were assigned to placebo. Among all participants, 18.8% experienced back pain, 12.2% had osteoarthritis, 11.7% had neck pain, 10.2% had intervertebral disc protrusion and 7.6% had irritable bowel syndrome.

Compared with those who received placebo, the researchers found that patients who received galcanezumab experienced significantly greater reductions in monthly migraine headache days at month 1 (least square mean difference = –2.37 days, p < .001), month 2 (least square mean difference = –1.81 days, P < .05) and month 3 (least square mean difference = –2.34 days, P <.01).

Additionally, response rates of 50% and 100% were significantly higher at month 1 and month 3 in patients who received galcanezumab compared with those who received placebo.

Argoff and colleagues also found that response rates of 75% were numerically but not statistically significantly higher in those who received galcanezumab compared with those who received placebo.

They also determined that participants who received galcanezumab had greater improvements on the Migraine Specific Quality of Life - Role Function Restrictive domain score compared with those who received placebo.

Argoff noted that as the study is a post-hoc analysis and had a small sample size, more research is needed.

“Galcanezumab was effective in reducing monthly migraine headache days compared to placebo,” he said. “Overall, patients treated with galcanezumab had higher 50%, 75% and 100% response rates, and galcanezumab was effective in improving functional quality of life.”