The interim results from the observational, prospective Phase IV Pan-European Real-Life (PEARL) study, presented at the 10th Congress of the European Academy of Neurology, indicate that treatment cessation and re-initiation can reduce the benefits of Teva Pharmaceutical’s Ajovy for migraine management. Continuous administration of Ajovy is crucial for effective prevention, challenging current guidelines that recommend a treatment pause after 12-18 months, according to GlobalData, a leading data and analytics company.

Pippa Salter, Managing Neurology Analyst at GlobalData, comments: “While these results clearly demonstrate the benefits of continued administration of Ajovy for the most effective prevention of migraine, the current European Headache Federation (EHF) guidelines, published in 2022, state that after 12–18 months of continuous treatment with an anti- calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb,) a pause in treatment should be considered.”

It is important to note that the PEARL data presented was only interim data, with only a small proportion of the total trial participants meeting the criteria for the analysis, so the results are unlikely to have an immediate impact on the EHF guidelines.

Salter continues: “If the trend of treatment cessation and re-initiation resulting in reduced efficacy for migraine prevention remains at the end of the study in a larger number of participants, along with corroborating real-world evidence from the use of the other anti-CGRP mAbs, further research into the long-term prevention of migraine with anti-CGRP mAbs will be required to fully understand the impact that treatment cessation can have.”

In the PEARL trial the majority (44.5%) of participants, who ceased treatment with Ajovy did so for reimbursement reasons.

Salter concludes: “Once sufficient evidence is available, a review of the current EHF guidelines may be warranted to ensure that the goal of migraine prevention, to minimize the impact of migraine-related disability, is truly reflected through the recommendations on how to manage the drugs used for prevention.”