Research studies had shown that during an attack of acute migraine and cluster headaches there is an elevation of humanized calcitonin gene-related peptide (CGRP) monoclonal antibodies in the jugular vein blood of patients. At the 59th Annual Scientific Meeting of the American Headache Society, encouraging data on four of these monoclonal antibodies—eptinezumab, renumab, fremazumab and galcanezumab—were presented to the audience.
Eptinezumab, injected as a single dose, decreased the monthly migraine days (MMD) as well as the number of severe migraines in the participants. Most of the patients in this multiple site study were women younger than 40 years old with an average MMD of approximately16 days. The initial 12 weeks-report (the study is scheduled to run for 48 weeks) showed that there were more patients with reduction of MMD when they took the 300 and 100 mgrs dosage—33 and 31% respectively—than the participants on placebo. Approximately half of the patients given Eptinezumab had a reduction of their MMD compared to 41% of placebo, which was statistically significant. The drug was well tolerated and there were no serious adverse instances.
Erenumab, which unlike the other three drugs that attack the CGRP ligand, is an anti-CGRP receptor monoclonal antibody. Almost 700 patients from all over the planet who had more than 15 MMD were enrolled in the 12 weeks-randomized controlled trial, lest they had failed with three other preventions; a subcutaneous injection of 70 or 140 mgr was given monthly. In both dosage groups there was an average reduction o 6.6 in MMD from a baseline of 18 days, compared to a 4.2 reduction in MMD in the placebo group. A greater number in both groups—40 and 41% respectively—had at least a 50% reduction in MMD, compared to the placebo group, which had 23%. Both groups had the same safety profile and there were no serious instances.
Galcanezumab was studied in EVOLVE-2, a six months phase III trial that recruited patients with at least 4 to 14 MMD with or without an aura. More than 900 patients were randomized in a 1:1: 2 proportion to receive a subcutaneous injection of galcanezumab of 120 mg/month, an injection of 240mg/month or a placebo. Patients in the 120 mg group had a reduction of 4.29 MMD and those in the 240 mg had 4.18 MMD, compared to 2.28 MMD for the placebo group. There was a 50% reduction in MMD for 59.3% in the 120 mgr group and 56.35 in the 240 mgr group compared to placebo. There was not a significant difference in safety and there were no instances.
Fremanezumab was studied for both quarterly and monthly regimes in patients that had had a previous 28 days run-in period. Moe than a thousand participants were randomized 1:1:1 to three monthly doses of placebo or 675 mgr for the first month followed by a placebo for 2 months or an initial dose of 675 mgr of the drug followed by two monthly doses of 225 mgr of it. Participants in the monthly regime had a reduction of 4.6 MMD and those in the quarterly regime had one of 4.3 MMD, compared to 2.5 for the placebo. The drug was well tolerated and on site injection pain was the only event.
For all the Migraine patients and their family members that have to live with its excruciating physical, emotional and economic burdens—as my family had to endure with the crippling attacks that my dear father Mario had—the possibility of relief, specially if it means less monthly attacks, is good news.
What do you think? Please tell us.
Don’t leave me alone.