P053 | LONG-TERM EFFECTIVENESS AND SAFETY OF FREMANEZUMAB FOR MIGRAINE PREVENTION: 24-MONTH OUTCOMES FROM THE ITALIAN COHORT OF THE PEARL STUDY
S. Guerzoni1, C. Aurilia2, A. Doretti3, E. Maria Piella4, R. Ornello5, P. Kokturk6, M. Cepparulo7 | 1Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology- Headache Center and Drug Abuse, Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico di Modena, Italy; 2Headache and Pain Unit, IRCCS San Raffaele, Rome, Italy; 3Department of Neurology-Laboratory of Neuroscience, IRCCS, Istituto Auxologico Italiano, Milan, Italy; 4Neurosciences Department, University of Turin, Italy; 5Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, Italy; 6Teva Netherlands B.V., Haarlem, The Netherlands; 7Teva Italia Srl, Milan, Italy
Abstract
Background. Fremanezumab is a calcitonin gene-related peptide pathway monoclonal antibody approved for the prevention of episodic (EM) and chronic migraine (CM). In Italy, fremanezumab reimbursement is subject to Italian Medicines Agency criteria (≥8 monthly migraine days [MMD], a Migraine Disability Assessment [MIDAS] score of ≥11 before treatment and ≥3 prior preventive treatment failures). Here, we report effectiveness and safety of fremanezumab for migraine prevention in Italian participants enrolled in the observational, Phase 4 Pan-European Real Life (PEARL; EUPAS35111) study after 24 months of follow-up.
Methods. Eligible participants were adults with high-frequency EM (HFEM) and CM receiving monthly (225 mg) or quarterly (675 mg) fremanezumab in routine clinical practice. A mandatory ≥1 month treatment discontinuation period occurred following 12 months of continuous treatment. The primary endpoint was the proportion of participants achieving ≥50% reduction in MMD during the 6 months following fremanezumab initiation. Secondary endpoints included mean change from baseline in MMD at Months 1 and 24, and mean MIDAS scores over 24 months. Safety was assessed through adverse event (AE) reporting.
Results. This analysis included 354 participants (HFEM, n=125; CM, n=229) from 30 Italian centres (female, 82.2%; CM, 64.7%; baseline MMD, 15.6 days). In total, 61.9% (n=219/354) of participants achieved ≥50% reduction in MMD during the 6-month period after fremanezumab initiation. Mean change from baseline in MMD was sustained from Month 1 (total, –8.2; HFEM, –5.4; CM, –9.8) to Month 24 (total, –10.5; HFEM, –6.5; CM, –12.7). In participants with documented cessation and reinitiation, mean MIDAS scores decreased from 93.7 at baseline (HFEM, 67.8; CM, 107.8) to 22.0 at Month 12 after fremanezumab initiation (HFEM, 14.0; CM, 26.0), and from 37.5 at baseline of reinitiation (HFEM, 29.9; CM, 42.6) to 25.3 at Month 12 after reinitiation (HFEM, 11.7; CM, 31.5). Drug-related AEs were reported in 62/354 (17.5%) participants, with 2/354 (0.6%) reporting drug-related serious AEs and 4/354 (1.1%) reporting AEs that led to discontinuation.
Conclusions. These results underscore the long-term effectiveness and safety of fremanezumab for the preventive treatment of HFEM and CM and the importance of continued treatment now that treatment pauses are no longer mandated.
Methods. Eligible participants were adults with high-frequency EM (HFEM) and CM receiving monthly (225 mg) or quarterly (675 mg) fremanezumab in routine clinical practice. A mandatory ≥1 month treatment discontinuation period occurred following 12 months of continuous treatment. The primary endpoint was the proportion of participants achieving ≥50% reduction in MMD during the 6 months following fremanezumab initiation. Secondary endpoints included mean change from baseline in MMD at Months 1 and 24, and mean MIDAS scores over 24 months. Safety was assessed through adverse event (AE) reporting.
Results. This analysis included 354 participants (HFEM, n=125; CM, n=229) from 30 Italian centres (female, 82.2%; CM, 64.7%; baseline MMD, 15.6 days). In total, 61.9% (n=219/354) of participants achieved ≥50% reduction in MMD during the 6-month period after fremanezumab initiation. Mean change from baseline in MMD was sustained from Month 1 (total, –8.2; HFEM, –5.4; CM, –9.8) to Month 24 (total, –10.5; HFEM, –6.5; CM, –12.7). In participants with documented cessation and reinitiation, mean MIDAS scores decreased from 93.7 at baseline (HFEM, 67.8; CM, 107.8) to 22.0 at Month 12 after fremanezumab initiation (HFEM, 14.0; CM, 26.0), and from 37.5 at baseline of reinitiation (HFEM, 29.9; CM, 42.6) to 25.3 at Month 12 after reinitiation (HFEM, 11.7; CM, 31.5). Drug-related AEs were reported in 62/354 (17.5%) participants, with 2/354 (0.6%) reporting drug-related serious AEs and 4/354 (1.1%) reporting AEs that led to discontinuation.
Conclusions. These results underscore the long-term effectiveness and safety of fremanezumab for the preventive treatment of HFEM and CM and the importance of continued treatment now that treatment pauses are no longer mandated.
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