The following article is part of conference coverage from the 2019 American Academy of Neurology Annual Meeting (AAN 2019) in Philadelphia, PA. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAN 2019.
PHILADELPHIA – Improvements in depressive symptoms were observed in patients with chronic migraine and comorbid moderate to severe depression with long-term fremanezumab use, according to research presented at the 2019 American Academy of Neurology Annual Meeting, held May 4 to 10, 2019, in Philadelphia, Pennsylvania.
Investigators conducted a 12-month, multicenter, randomized, double-blinded phase 3 study (ClinicalTrials.gov Identifier: NCT02638103) to evaluate the safety and efficacy of fremanezumab in patients with chronic migraine and comorbid moderate to severe depression. Participants were enrolled from 2 phase 3 studies, the HALO Chronic Migraine (ClinicalTrials.gov Identifier: NCT02621931) and HALO Episodic Migraine (ClinicalTrials.gov Identifier: NCT02629861) trials. A subset of new patients not enrolled in the HALO studies was also included.
Participants aged 18 to 70 years were included if they had a history of migraine for ≥12 months prior to screening and a confirmed diagnosis of chronic migraine during the pretreatment baseline period. Participants from the HALO studies were allowed to continue using 1 concomitant preventative migraine medication, while new participants were allowed to continue use of 2 medications if dosing had been stable for ≥2 consecutive months before screening.
Participants in the HALO Chronic Migraine study continued the same active treatment they were assigned to in the previous trial (fremanezumab quarterly: 675 mg at baseline and placebo at week 4 and 8; or fremanezumab monthly: 675 mg at baseline and 225 mg at weeks 4 and 8), while new participants and those previously assigned to receive placebo were randomly assigned to receive either fremanezumab quarterly or monthly.
Investigators evaluated the difference in monthly average number of migraine days, monthly average number of headache days of at least moderate severity, and change in the 9-item Patient Health Questionnaire (PHQ-9) from baseline. Baseline referred to the 28-day pretreatment period or day 0 for the double-blinded, placebo-controlled study rollover participants and for new study participants.
Investigators enrolled 1110 participants with chronic migraine who were either rolled over from the previous HALO studies or were randomly assigned to fremanezumab. Of the 1110 participants, 873 completed the treatment and 229 participants had comorbid moderate to severe depression (PHQ-9 score ≥10) at baseline.
In patients with chronic migraine and moderate to severe depression, the monthly average number of headache days of moderate severity werewas reduced from baseline to the 12-month endpoint (mean change, -6.3 ± 0.71 days and -7.0 ± 0.60 days for the fremanezumab quarterly and monthly groups, respectively). In addition, the monthly average number of migraine days was reduced in both groups (mean change, -7.2 ± 0.82 days and -8.6 ± 0.71 days in the fremanezumab quarterly and monthly groups, respectively). There was also a reduction in the severity of depressive symptoms from baseline to month 12 (mean change in PHQ-9 score, -10.3 ± 0.60 and -10.5 ± 0.69 for the fremanezumab quarterly and monthly groups, respectively).
Overall, 52 patients in the fremanezumab quarterly group and 73 participants in monthly group reported ≥1 treatment-related adverse event. At least 1 serious adverse event was reported in 9 patients in the fremanezumab quarterly group and 11 patients in the monthly group. Adverse events leading to discontinuation of the study were reported in 4 patients in the fremanezumab quarterly group and 6 patients in the monthly group. The most commonly reported adverse events were injection-site reactions including pain, induration, erythema, hemorrhage, and pruritus.
Investigators concluded that “fremanezumab treatment may be beneficial for the subgroup of [patients with chronic migraine and] moderate to severe depression; however, addition research is needed to understand the observed improvements in depressive symptoms.”
This study was funded by Teva pharmaceuticals.
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Lipton RB, Cohen JM, Yeung PP, Yang R, Ning X, Buse DC. Long-term efficacy of fremanezumab in patients with chronic migraine and comorbid moderate to severe depression. Presented at: 2019 American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA.