OC-18 | Effectiveness of fremanezumab up to 12 months in different subgroups of participants: results from the Italian analysis of the PEARL study

Raffaele Ornello,¹ Gisella Airola,² Letizia Curto,³ Diletta Alivernini,⁴ Chiara Abagnale,⁵ Pinar Kokturk,⁶ Yan Tereshko⁷ | ¹Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila; ²Department of Surgical Sciences, Women's Headache Center, University of Turin; ³Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa; ⁴Department of Neuroscience, Mental Health and Sensory Organs (NESMOS), Sapienza University of Rome; ⁵Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo Pontino ICOT, Latina, Italy; ⁶TEVA Pharmaceuticals Europe B.V., Haarlem, The Netherlands; ⁷Clinical Neurology, Department of Head-Neck and Neuroscience, Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Udine, Italy

Background: Despite multiple studies reporting the efficacy of calcitonin gene-related peptide pathway monoclonal antibodies in controlled trials, there are limited real-world data identifying the subgroups who may benefit most from these treatments in clinical practice. The 24-month, prospective, observational Pan-European Real Life (PEARL; EUPAS35111) study assessed real-world effectiveness of fremanezumab in adults with episodic (EM) and chronic migraine (CM).

Methods: This subgroup analysis was conducted on PEARL participants enrolled in 30 Italian headache centres. We investigated the response rate (defined as the proportion of participants achieving ≥50% reduction in average monthly migraine days [MMD] from baseline) at Month 3, 6 and 12 across different participant subgroups: age, sex, years since migraine diagnosis, presence of medication overuse headache (MOH) and prior onabotulinumtoxinA use (BoNT-A; CM only).

Results: Of 354 eligible participants, 229 had CM and 125 had EM. Similar proportions of responders were reported in the following subgroups at Month 6: age (20–45 years, 66.7% [88/132]; 46–65 years, 67.0% [126/188]; >65 years, 65.5% [19/29]), sex (female, 64.2% [185/288]; male, 77.8% [49/63]), years since migraine diagnosis (<10 years, 67.7% [65/96]; 10–20 years, 72.5% [58/80]; >20 years, 67.4% [58/86]) and presence of MOH (yes, 69.6% [110/158]; no, 66.2% [45/68]); and at Month 12 for all subgroups except age. For participants with CM, the proportion of responders at Month 3 was lower in those with prior BoNT-A use compared with those with no prior BoNT-A use (44.9% [40/89] vs 66.2% [92/139]); proportions became similar at Months 6 (69.8% [97/139] vs 66.7% [58/87]) and 12 (58.1% [50/86] vs 67.1% [94/140]).

Conclusion: These findings suggest that the effectiveness of fremanezumab may be observed across different subgroups, regardless of age, sex, years since diagnosis or presence of MOH. Participants with CM and prior BoNT-A failure appeared to take longer to respond compared with those with CM and no prior BoNT-A use.