ST. LOUIS ― The migraine-prevention drug fremanezumab (Ajovy, Teva Pharmaceutical Industries), a humanized monoclonal antibody (IgG2a) that targets calcitonin gene–related peptide (CGRP), is effective and well tolerated in some of the toughest-to-treat migraine patients, new research suggests.
The phase 3b FOCUS trial, which was funded by Teva Pharmaceutical Industries, included more than 800 patients with episodic or chronic migraine who had experienced an inadequate response to up to four previous classes of preventive medications.
Results at 3 months showed that 34% of the participants who received fremanezumab had a 50% or greater reduction in number of migraine days compared with 9% of those who received placebo.
“The study shows that fremanezumab is helpful in patients who have failed multiple attempts at preventive treatment with approximately the same efficacy [as treatment of other migraine patients],” lead author Egilius H. H. Spierings, MD, PhD, Medvadis Research Corporation, Watertown, Massachusetts, told Medscape Medical News. Spierings is a member of Teva Phamaceutical’s speakers’ bureau.
The findings were presented here at ANA 2019: 144th Annual Meeting of the American Neurological Association.
Important Treatment Alternative
Fremanezumab received approval from the US Food and Drug Administration (FDA) in 2018 for the treatment of migraine. It is in the group of self-administered CGRP-targeting drugs that have gained recognition as potent vasodilators with long-lasting effects.
Most drugs in this class are administered monthly, although fremanezumab also has a quarterly dose option.
The drug class is viewed as an important alternative to other migraine prevention therapies, such as antidepressants, antiepileptic drugs, and beta blockers. With these other therapies, patients often do not adhere to their regimens.
One study of more than 4600 patients showed that 73% of patients stopped using their medications within 6 months of treatment.
The FOCUS trial was conducted at 104 sites in Europe, the United Kingdom, and the United States. It included 838 patients (average age, 46 years) who had experienced an insufficient response to two to four classes of migraine preventive medications during the past 10 years. Of these patients, 329 had episodic and 509 had chronic migraine headache.
All patients received either quarterly fremanezumab (month 1: 675 mg; months 2 and 3: placebo), monthly fremanezumab (month 1: 225 mg for episodic migraine and 675 mg for chronic migraine; months 2 and 3: 225 mg for both migraine types), or matched monthly placebo for 12 weeks.
Reduced Migraine Days
Over 12 weeks, a 50% or greater reduction in migraine days was shown in more group members treated with monthly (34%) and quarterly fremanezumab (34%) than in the group that received monthly placebo (9%; P < .0001).
The rates were also significantly higher for the episodic migraine subgroup (43% monthly and 47% quarterly vs 10% placebo; for both comparisons, P < .0001) and the chronic migraine subgroup (29% and 27% vs 8%; for both, P < .0001).
Fewer patients achieved a 75% or greater reduction in migraine days (12% in the full monthly and 8% in the full quarterly fremanezumab groups). However, these rates were still significantly greater than the 2% of affected members in the placebo group (P ≤ .0021).
Among those with episodic migraine, the rates of 75% or greater improvement were 15% of the monthly and 15% of the quarterly active-treatment groups vs 3% of the placebo group (for both comparisons, P ≤ .0043).
In the chronic migraine group, the rates were 10% of the monthly group vs 2% of the placebo group (P = .0033). However, the improvement was not significant in the quarterly fremanezumab group (4%).
The improvements were achieved in the monthly and quarterly fremanezumab regimens within 4 weeks after starting treatment in the overall population (all comparisons, P ≤ .01).
There were no significant differences in adverse events (AEs) between the placebo and fremanezumab groups. Serious AEs were reported for 4 of 277 patients (1%) who received placebo, 2 of 276 (<1%) who received quarterly fremanezumab, and 4 of 285 (1%) who received monthly fremanezumab.
The findings also were published in the September issue of the Lancet.
A Step Forward, but No Panacea
“The significance is that it replicates the real-world requirement by insurance companies for clinicians to use these treatments: failure of other therapies first,” Matthew S. Robbins, MD, commented to Medscape Medical News. Robbins is director of the Neurology Residency Program at Weill Cornell Medicine, New York–Presbyterian Hospital and was not involved in the research.
He noted that the results further support the benefits previously seen with the CGRP-targeting therapies.
“The treatment class is a breakthrough, as it is the first major class of designer drugs specifically for migraine prevention widely available,” Robbins said.
A key attribute of the study is “that it addresses a real-world patient population in need that is traditionally excluded from other clinical trials: those who have failed other treatments,” he noted.
He added that in his own experience of prescribing anti-CGRP migraine therapies, the results can in some cases be life-changing, but not always.
“I have had many patients whose lives have been remarkably improved. However, I have had patients who have not improved at all on any or all of these treatments, and some who have improved to a more modest degree,” he reported.
In general, “the efficacy rates seem similar to older treatments, but they are significantly more tolerable and may work more quickly,” Robbins said.
“By no means are they a panacea or a cure for migraine, but [they are] an excellent advance for our patients,” he added.
ANA 2019: 144th Annual Meeting of the American Neurological Association: Abstract M195, presented October 14, 2019.