Prophylactic injectable monoclonal antibody reduced migraine days, industry trial finds
Compared with nonspecific oral drugs, patients treated with erenumab were six times more likely to achieve 50% or more reduction in monthly migraine days and were 11 times more likely to complete the treatment on the first attempt, authors reported.
For patients with episodic migraine in whom one or two previous preventive treatments failed, erenumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) pathway, provided greater benefit than oral medications, an industry-funded study found.
Researchers conducted a pragmatic trial comparing erenumab qm and oral drugs in adult migraine patients from May 2019 to October 2021 at 84 centers across 17 countries. Patients with a 12-month or longer history of migraine and between four and 15 monthly migraine days (MMDs) were randomized to injectable erenumab or oral migraine drugs.
The primary end point was the proportion of patients completing a year of the initial treatment and achieving a reduction of 50% or greater from baseline in monthly migraine days at month 12. Secondary end points included the cumulative mean change from baseline in monthly migraine days and the proportion of responders, defined as a score of 5 or more on the Patients' Global Impression of Change (PGIC) scale at month 12. The study was funded by Novartis Pharma AG. Results were published March 25 by JAMA Neurology.
Of the 621 randomized patients (mean age, 41.3 years; 87.8% women; 413 [66.5%] in the erenumab group and 208 [33.5%] in the oral drug group), 523 (84.2%) completed the treatment phase. At month 12, significantly more patients assigned to erenumab achieved the primary end point (56.2% vs. 16.8%; odds ratio [OR], 6.48 [95% CI, 4.28 to 9.82]; P<0.001). Compared with oral drugs, erenumab resulted in more responders on the PGIC scale (76.0% vs. 18.8%; OR, 13.75 [95% CI, 9.08 to 20.83]; P<0.001). Cumulative average monthly migraine days were decreased more with erenumab (−4.32 vs. −2.65; P<0.001). Substantially fewer patients in the erenumab arm compared with the oral drug arm switched medication (2.2% vs. 34.6%) or discontinued treatment due to adverse events (2.9% vs. 23.3%). No new safety signals were identified.
The study authors concluded, "Earlier initiation of erenumab may ultimately lead to fewer patients discontinuing or switching medication in a real-world clinical practice. Moreover, these findings may help reduce health care resource utilization, decrease disability, and increase better quality of life."
They noted that the findings support a guideline update issued by the European Headache Federation recommending this drug class as a first-line treatment option for patients with migraine who require preventive treatment.