Teva’s Ajovy Studied for Possible Change to Migraine Treatment Pause Protocols

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Data from a Pan-European Real Life (PEARL) Phase IV study of fremanezumab, which is marketed by Teva Pharmaceutical Industries as Ajovy, may challenge prevalent opinions on treatment pauses in adult patients with episodic or chronic migraines, according to a press release from Teva on June 28, 2024 (1).

Such pauses, Teva said, are recommended or even mandated for calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs; fremanezumab is a CGRP-pathway mAb) by some reimbursement authorities after one year of continuous use (1). However, the data showed that pausing treatment with fremanezumab may result in increased monthly migraine days (MMDs), when treatment is typically ceased and reinitiated, and decreased effectiveness when the treatment is resumed.

More specifically, the study found that more than 40% of patients reported a rapid worsening of their migraines, or greater than or equal to a 50% increase in MMD, at months 1 and 2 post-cessation, while the proportion of patients who had greater than or equal to a 50% reduction in MMD in months 1 and 3, respectively, was 49.0% and 58.9% in the first treatment period before cessation, versus 35.7% and 45.5% in the second period after reinitiation (1).

“The PEARL Study analysis is significant for clinicians treating people with episodic and chronic migraine as it shows that treatment cessation and reinitiation can disrupt the progress made in managing the condition in some of them,” said Dimos Mitsikostas, professor of neurology, Aeginition Hospital, Medical School of the National & Kapodistrian University of Athens, in the press release. Mitsikostas is presenting the study data at the European Academy of Neurology in Helsinki, Finland, beginning June 29, 2024 (2). “It is important that we are guided by the evidence and adopt a more personalized treatment approach and not a ‘one-size-fits-all’ strategy in helping people with migraine long-term.”

“This new sub-analysis may challenge the rationale for mandatory treatment pauses and highlights the potential for these breaks to diminish the benefits achieved in reducing migraine for some patients," said Pinar Kokturk, MD, vice president and head of medical affairs for Teva in Europe. “The PEARL study demonstrates the long-term effectiveness and safety of fremanezumab in preventing both episodic and chronic migraine in a real-world setting and underscores the benefit of treatment continuity and individualized, uninterrupted patient management strategies.”

A consensus on halting migraine therapy has been difficult to ascertain. The European Headache Federation suggests a pause after 12 to 18 months of treatment—but recommends continuing indefinitely, if necessary. Some countries, across Europe and elsewhere, mandate one-year treatment pauses, primarily because of differing reimbursement conditions (1). Still elsewhere, one literature review suggests stopping the use of CGRP-pathway mAbs as soon as a lack of remaining need for prevention is necessary, meaning fewer than four MMDs.

Ajovy is indicated for prophylaxis of migraines in adults who have four MMDs per month or greater. It is a subcutaneous injection that can be administered either by a healthcare professional, or at home by a patient or caregiver.

References

1. Teva Pharmaceutical Industries. New AJOVY (fremanezumab) Migraine Prevention Data Challenges Treatment Pauses. Press Release. June 28, 2024.
2. Mitsikostas, D.; et al. Impact of Fremanezumab Cessation and Reinitiation in Migraine Management: PEARL Study 4th Interim Analysis. Presentation at European Academy of Neurology, Helsinki, Finland, June 29–July 2, 2024.