Addressing unmet needs in migraine: Real-world fremanezumab effectiveness in participants of the PEARL study with at least three prior preventive treatment failures
Abstract
Background The Pan-European Real Life (PEARL) Phase 4 study evaluated real-world effectiveness and safety of fremanezumab for episodic migraine (EM) and chronic migraine (CM) prevention. This post-hoc analysis evaluated the effectiveness of fremanezumab in participants with three or more non-migraine-specific preventive treatment failures, including onabotulinumtoxinA. Methods Baseline daily headache diary data were compared with diary data following fremanezumab initiation. Primary endpoint: proportion of participants with ≥50% reduction in monthly migraine days (MMD) during the six months after fremanezumab initiation. Secondary endpoints included mean change from baseline in MMD at Months 1–12 and health-related quality of life. Safety was assessed through adverse events. Results Of 451 participants, 398 with three or more previous preventive treatment failures were included in the effectiveness analyses (EM, 40.2%; CM, 59.8%). Of the 290 participants with data available, the 50% responder rate was 53.8% (EM, 67.0%; CM, 46.5%) during the six months after fremanezumab initiation. The safety profile was consistent with previous findings. Conclusions This post-hoc analysis supports the effectiveness and safety of fremanezumab for migraine prevention in patients with three or more prior preventive treatment failures. These findings are consistent with those from a randomized controlled trial (RCT) in a similar population, illustrating the transferability of RCT data to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 451 participants or records.
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