乌鸦传媒

LAS VEGAS -- Chronic migraine patients continued to experience fewer monthly headache days 1 year after starting treatment with fremanezumab, an investigational monoclonal antibody that targets calcitonin gene-related peptide (CGRP), according to presented in a poster session at the.

"In patients with chronic migraine, long-term treatment (up to 12 months) with fremanezumab monthly or quarterly continued to reduce the number of headache days of at least moderate severity from baseline, as well as to decrease acute headache medication use and headache-related disability from baseline," wrote Peter McAllister, MD, of the New England Institute for Neurology and Headache in Stamford, Connecticut, and colleagues in their poster.

The research -- funded by fremanezumab's developer, Teva Pharmaceuticals, supplements earlier studies about fremanezumab's efficacy and adds to recent findings that support migraine prevention with three other CGRP inhibitors -- erenumab (Aimovig), eptinezumab, and galcanezumab.

This 52-week, multicenter, randomized, double-blind parallel-group study (n=1,110) assigned patients to receive subcutaneous injections of fremanezumab either quarterly (675 mg) or monthly (675 mg starting dose and 225 mg every month). Participants took the Headache Impact Test (HIT-6) to determine migraine-related disability.

At the end of 12 months, 54% of patients receiving monthly doses and 51% receiving quarterly doses of fremanezumab achieved ≥50% reduction in the average number of moderate or worse headache days per month. Six-month interim data showed that patients receiving quarterly fremanezumab used acute headache medications on 5.8 fewer days than baseline levels, and patients receiving quarterly treatments used them on 5.2 fewer days. Both groups showed a drop in HIT-6 scores over 12 months from baseline.

In both groups, the most common adverse events were injection site induration, injection site pain, or injection site erythema. Upper respiratory tract infections were reported in 12% of the quarterly group and 10% of the monthly group.

"We have now one-year data on two of these drugs -- fremanezumab and erenumab," noted Stewart Tepper, MD, of the Geisel School of Medicine at Dartmouth College in Hanover, N.H., who participated in fremanezumab studies as an investigator. "I think, overall, we can be reassured that the overall safety and tolerability are both good, and that the efficacy is maintained."

In some of the CGRP drug trials, "there has been a slight concern about upper respiratory stuff," he noted. At recent meetings, there have been discussions about how serious the upper respiratory tract findings are and what the cause could be. The respiratory effect seems to be mild, Tepper said: "It's not an increase in anaphylaxis or those kinds of symptoms, but it is there."

"The general feeling is that this is not of consequence, but I think we just need to keep an eye on it. We don't know why it's occurring. But it's 10% to 12% in the fremanezumab study, where you didn't really see it with erenumab."

Elizabeth Loder, MD, of Brigham and Women's Hospital in Boston, called it "disappointing" that only adverse events occurring in 6% or more of patients were presented in this analysis. "With a new class of drugs, it is especially important to report adverse events thoroughly," she told 乌鸦传媒.

As with other CGRP antibody studies, this study enrolled a group of participants who may not fully represent patients most likely to receive the treatment in practice, Loder noted: "People who had failed two or more preventive medications or who had common comorbidities were excluded."

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