On 30 June, at the tenth Congress of the European Academy of Neurology (EAN), during an e-presentation session on the topic of ‘Headache’, interim analysis from the observational, prospective Phase IV Pan-European Real-Life (PEARL) study of Teva Pharmaceuticals’ Ajovy for the management of migraine was presented.
The results focused on the effects of treatment cessation and reinitiation.
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Ajovy is an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) that was approved in Europe in 2019 as a preventive treatment for adults with episodic and chronic migraine.
The aim of preventive therapy is to reduce the frequency, severity, or duration of attacks, with the anti-CGRP mAbs commonly used as third-line options following failure to respond to at least two oral preventive therapies.
The PEARL study is an ongoing 24-month study evaluating Ajovy for migraine prevention in 1,140 adults across 11 European countries.
Interim analysis from the PEARL study focused on 220 participants who had a documented treatment cessation, with 192 of those also having a documented treatment reinitiation.
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By GlobalDataThe data presented showed that one month and two months after cessation of Ajovy, 41.3% (n=179) and 41.8% (n=158) of participants experienced worsening migraine, defined as a greater than 50% increase in monthly migraine days (MMD), respectively.
Further, the PEARL study also showed that the effectiveness of Ajovy decreased when there were interruptions in continuous treatment.
Only 45.5% of participants achieved a greater than 50% reduction in MMD at month three during their second period of receiving Ajovy following treatment cessation (n=134), compared with 58.9% of participants receiving Ajovy for the first time who achieved a greater than 50% reduction in MMD at month three (n=1,065).
On average, patients had received Ajovy for 11.2 months prior to cessation, with a gap of 2.6 months between treatment cessation and reinitiation.
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-CGRP mAb, a pause in treatment should be considered.
Indeed, in the PEARL trial of the 220 participants, the majority (44.5%) of participants who ceased treatment with Ajovy did so for reimbursement reasons.
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.
However, if the trend of treatment cessation and reinitiation 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.
Once sufficient evidence is available, a review of the current EHF guidelines may be warranted to ensure that the goal of migraine prevention, to minimise the impact of migraine-related disability, is truly reflected through the recommendations on how to manage the drugs used for prevention.
