PRIME-Teen—Treatment Persistence and Outcomes Associated with CGRP Monoclonal Antibodies Compared with Conventional Oral Preventives in Adolescents with High-Burden Migraine: An Exploratory Real-World Analysis from the German Pain e-Registry (GPeR)

<b>Background</b>: Adolescent migraine is highly prevalent and associated with substantial functional and psychosocial burden. Conventional oral preventives are widely used off-label with limited pediatric efficacy and frequent tolerability problems. Real-world data on calcitonin gene-related peptide (CGRP) monoclonal antibodies in adolescents are scarce. <b>Methods</b>: We conducted an exploratory, retrospective cohort analysis of depersonalized routine-care data from adolescents with migraine in the German Pain e-Registry. Patients were eligible if they had at least one 6-month episode with high-evidence conventional oral preventives (HECP) and one 6-month episode with a CGRP monoclonal antibody (CGRP-mAb), each with baseline and follow-up documentation, enabling intra-individual descriptive comparisons. The primary endpoint was a pragmatic composite of 6-month treatment persistence and ≥50% reduction in monthly migraine days (MMD). Secondary outcomes included MMD, MMD with acute medication (MMDAM), migraine-related sick-leave days (MMSLD), disability (MIDAS), and patient-reported psychosocial outcomes. <b>Results</b>: A total of 422 adolescents contributed 1448 HECP and 422 CGRP-mAb episodes. Premature discontinuation occurred in 68.8% (HECP) and 11.9% (CGRP-mAb) of episodes; corresponding 6-month persistence was 30.6% and 88.2%, respectively. Mean MMD decreased from 11.7 to 9.4 during HECP episodes and from 11.6 to 4.4 during CGRP-mAb episodes. A ≥50% MMD reduction occurred in 25.4% (HECP) and 70.9% (CGRP-mAb) of episodes; the composite endpoint was met in 23.7% and 69.9%, respectively. CGRP-mAb episodes were associated with numerically larger improvements across secondary outcomes. <b>Conclusions</b>: In this high-burden adolescent cohort, CGRP-mAb treatment episodes were associated with higher persistence and broader improvements than prior conventional preventive episodes. Given the retrospective, non-randomized, sequential design, these findings are hypothesis-generating and do not constitute evidence of comparative effectiveness. Controlled pediatric trials and long-term safety studies are warranted.

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Publication Details

Journal
Journal of Clinical Medicine
Published
2026-03-04
DOI
https://doi.org/10.3390/jcm15051976
Primary Topic
Migraine and Headache Studies
Type
article
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article

PRIME-Teen—Treatment Persistence and Outcomes Associated with CGRP Monoclonal Antibodies Compared with Conventional Oral Preventives in Adolescents with High-Burden Migraine: An Exploratory Real-World Analysis from the German Pain e-Registry (GPeR)

Michael A. Überall
Journal of Clinical Medicine
Migraine and Headache Studies
article

PRIME-Teen—Treatment Persistence and Outcomes Associated with CGRP Monoclonal Antibodies Compared with Conventional Oral Preventives in Adolescents with High-Burden Migraine: An Exploratory Real-World Analysis from the German Pain e-Registry (GPeR)

Michael A. Überall
article en

Abstract

<b>Background</b>: Adolescent migraine is highly prevalent and associated with substantial functional and psychosocial burden. Conventional oral preventives are widely used off-label with limited pediatric efficacy and frequent tolerability problems. Real-world data on calcitonin gene-related peptide (CGRP) monoclonal antibodies in adolescents are scarce. <b>Methods</b>: We conducted an exploratory, retrospective cohort analysis of depersonalized routine-care data from adolescents with migraine in the German Pain e-Registry. Patients were eligible if they had at least one 6-month episode with high-evidence conventional oral preventives (HECP) and one 6-month episode with a CGRP monoclonal antibody (CGRP-mAb), each with baseline and follow-up documentation, enabling intra-individual descriptive comparisons. The primary endpoint was a pragmatic composite of 6-month treatment persistence and ≥50% reduction in monthly migraine days (MMD). Secondary outcomes included MMD, MMD with acute medication (MMDAM), migraine-related sick-leave days (MMSLD), disability (MIDAS), and patient-reported psychosocial outcomes. <b>Results</b>: A total of 422 adolescents contributed 1448 HECP and 422 CGRP-mAb episodes. Premature discontinuation occurred in 68.8% (HECP) and 11.9% (CGRP-mAb) of episodes; corresponding 6-month persistence was 30.6% and 88.2%, respectively. Mean MMD decreased from 11.7 to 9.4 during HECP episodes and from 11.6 to 4.4 during CGRP-mAb episodes. A ≥50% MMD reduction occurred in 25.4% (HECP) and 70.9% (CGRP-mAb) of episodes; the composite endpoint was met in 23.7% and 69.9%, respectively. CGRP-mAb episodes were associated with numerically larger improvements across secondary outcomes. <b>Conclusions</b>: In this high-burden adolescent cohort, CGRP-mAb treatment episodes were associated with higher persistence and broader improvements than prior conventional preventive episodes. Given the retrospective, non-randomized, sequential design, these findings are hypothesis-generating and do not constitute evidence of comparative effectiveness. Controlled pediatric trials and long-term safety studies are warranted.

Journal of Clinical MedicineVol. 15(5)
Institute of Neurological Sciences (IT)
Good health and well-being
Openalex Percentile: Top 42%
Migraine and Headache Studies
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