Fremanezumab Combo Effective in Reducing Monthly Migraine Days

Combination therapy with fremanezumab-vfrm (Ajovy; Teva Pharmaceuticals) injection plus gepants showed a decrease in monthly migraine days (MMD), according to a poster presented during the 2022 American Headache Society (AHS) Annual Meeting.

Other poster presentations at AHS highlighted results of a subgroup analysis from the phase 3b FOCUS study evaluating fremanezumab-vfrm in patients with difficult-to-treat migraine and comorbid obesity, as well as the real-world efficacy of the drug in patients with refractory migraine from a US tertiary headache center who switched from erenumab.

“The breadth of real-world evidence presented at this year’s AHS meeting across different patient populations and practice settings underscores the value of Ajovy in helping to manage this disabling neurological disease,” said Denisa Hurtukova, MD, VP, head of North America Medical Affairs for Teva, said in a press release. “As the migraine treatment landscape continues to advance, these data provide important insights about Ajovy in real-world settings and its use as a migraine preventive treatment across a spectrum of patients.”

In 2018, the FDA approved fremanezumab-vfrm for the preventive treatment of migraine in adults. Fremanezumab-vfrm is the second FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks. The first in this class, erenumab-aooe (Aimovig) was approved in 2018.

Fremanezumab-vfrm is available as a 225 mg/1.5 mL single-dose injection in a prefilled syringe or autoinjector. The treatment has 2 dosing options at 225 mg administered monthly as 1 subcutaneous injection or 675 mg every 3 months administered as 3 subcutaneous injections.

In a retrospective chart review study presented at AHS, investigators evaluated the electronic medical records of 55 patients 18 years of age and older administered fremanezumab-vfrm for preventive migraine treatment and concomitant gepants for acute migraine treatment between January 1, 2020, and May 1, 2021. The researchers gathered data on patients with chronic and episodic migraine.

Patients were administered gepant for 1 or more months pre- and post-initiation of fremanezumab as an add-on therapy. Patients with 3 or more measurements of MMD were analyzed at the pre-index date of gepant initiation, at the fremanezumab initiation date, and at the post-index period with gepant plus fremanezumab.

At the time of fremanezumab initiation, patients had an average 15.8 (7.4) MMD and the average time from the index date to the last visit was 9.4 (4.5) months. The average change in MMD from index to post-index date was -6.5 (1.0) days, which translates to a 41.1% reduction. There were 5 patients (9.1%) who experienced adverse events post-index, 3 of which were injection site reactions, 1 was uveitis and 1 was upset stomach.

“Millions of people suffer from migraine and its debilitating effects, and finding the right treatment combination can be challenging. Different treatment approaches can be used synergistically, but given that these are relatively new treatments, real-world data on the concomitant use of Ajovy and gepants are limited,” said Jennifer McVige, MD, MA, attending neurologist, DENT Neurologic Institute in Amherst, NY. “This study provides some of the first evidence that this treatment combination resulted in reductions in monthly migraine days. Continued investigation into this treatment approach is warranted.”

Reference

New Real-World Data Evaluating AJOVY® (fremanezumab-vfrm) Injection Use in Patients With Migraine Presented at 2022 American Headache Society Annual Meeting. Teva Pharmaceuticals. News release. June 9, 2022. https://www.tevapharm.com/news-and-media/latest-news/new-real-world-data-evaluating-ajovy-fremanezumab-vfrm-injection-use-in-patients-with-migraine-present/