EAN 2025 | The PEARL study: real-world effectiveness of fremanezumab for the preventive treatment of migraine

Fremanezumab is a fully humanized monoclonal antibody that selectively binds to and neutralizes calcitonin gene-related peptide, CGRP, a neuropeptide implicated in migraine pathophysiology. By preventing CGRP from activating its receptor, fremanezumab reduces neurogenic inflammation, vasodilation within the trigeminal vascular system. And thereby, it lowers the frequency of migraine attacks. The primary objectives and design of the Pearl Study. The Pearl Study was a 24-month prospective observational phase 4 trial, which was conducted across 11 European countries. The study enrolled 1,140 adults with episodic and chronic migraine, and they were prescribed fremanezumab either 225 mg monthly or 675 mg quarterly. Its core primary objectives were to evaluate real-world effectiveness, and that was by measuring reduction in monthly migraine days, plus to assess long-term safety and tolerability in daily practice, meaning routine practice. This year, during the European Academy of Neurology meeting in Helsinki, we presented key findings on efficacy and safety from the final Pearl results. What we showed that in terms of efficacy, 56.5% of participants achieved at least 50% reduction in monthly migraine days during the first six months. This effect was sustained through the whole period up to month 24. What we saw that the mean reduction of monthly migraine days was something like approximately between 9 and 12 days compared to baseline. And this was maintained throughout the study. Another thing, it was important in this study that injection adherence remained above 90% through all the period, meaning up to month 24. But treatment persistence declined gradually from almost 97% at month 3 to 60% at month 24, which corresponds to what we also seen in pivotal clinical trials and also later in our clinical practice. In terms of safety, what we saw that fremanezumab was still exhibited a favorable long-term safety profile, which was pretty much consistent with the randomized clinical trials. We saw no new safety signals over the 24 months. And the most common drug-related adverse events observed in this study was a mild injection site reaction. And some other very rare drug-related adverse events were observed at 0.4%, so almost nothing. Those are the key findings on efficacy and safety.

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