@article{5099b53a10c4449c8735a9f3ca13f114,
title = "Calcitonin Gene–Related Peptide Monoclonal Antibody Use for the Preventive Treatment of Refractory Headache Disorders in Adolescents",
abstract = "Background: Monoclonal antibodies to calcitonin gene–related peptide or its receptor have clinical trial evidence in adults with headache, but data are lacking in adolescents. The objective of this study was to describe the safety and efficacy of calcitonin gene–related peptide monoclonal antibody treatment in adolescents with chronic headache disorders. Methods: We performed a retrospective multisite cohort study of patients less than 18 years of age who received a calcitonin gene–related peptide monoclonal antibody for headache prevention. Demographics, baseline headache characteristics, efficacy, and side effect data were collected. Results: The study population comprised 112 adolescents who received at least one dose of a calcitonin gene–related peptide monoclonal antibody. Mean (S.D.; range) age at first dose was 15.9 years (1.4; 10.3 to 17.8). Ninety-four patients (83.9%) had chronic migraine, 12 (10.7%) had new daily persistent headache, and six (5.4%) had persistent post-traumatic headache. At baseline, the mean (S.D.) number of headache days per month was 26.9 (6.1) (n = 109) and headache was continuous in 75 of 111 (67.6%). At first follow-up visit there was a significant reduction in headache frequency compared with baseline (−2.0 days; 95% confidence interval, −0.8 to −3.2). Significant benefit was perceived by 29.5% of patients at first follow-up visit (n = 33/112) and 30.1% (n = 22/73) at second follow-up visit. A significant functional improvement was perceived by 31% of patients (n = 31/94) at the first follow-up visit and 22.4% (n = 15/67) at the second follow-up visit. The most common side effects were injection site reactions in 17.0% (n = 19) and constipation in 8.0% (n = 9). Five patients (4.5%) discontinued because of side effects. Conclusions: Side effects with calcitonin gene–related peptide monoclonal antibody treatment in adolescents were similar to those reported in adult trials. Calcitonin gene–related peptide monoclonal antibody treatment appears to benefit a proportion of adolescents with chronic refractory headache disorders.",
keywords = "Adolescent, CGRP monoclonal antibodies, Chronic migraine, Migraine, New daily persistent headache, Pediatric, Post-traumatic headache, Refractory headache",
author = "Greene, {Kaitlin A.} and Gentile, {Carlyn P.} and Szperka, {Christina L.} and Marcy Yonker and Gelfand, {Amy A.} and Barbara Grimes and Irwin, {Samantha L.}",
note = "Funding Information: Conflict of interest and source of funding statement: Dr. Szperka has received grant support from Pfizer, and her institution has received compensation for her consulting work for Allergan and Teva. Dr. Szperka receives salary support (NIH funding) from the NIH NINDS K23NS102521. Dr. Yonker receives research support from PI-Impax IPX229, Amgen 20150125, Amgen 20160354, Nerivio, TCH-004, Lilly CGAS, Lilly CGAT, Lilly LAHV, Lilly LAHW, Upsher-Smith P255-501, Teva TV48125-CNS-30082, Teva TV48125-CNS-30083, Teva TV48125-CNS-30084, NCCIH 1U01AT010132-01A1. She also receives consulting support from Lilly and Upsher Smith. Dr. Gelfand has received consulting fees from Biohaven and Satsuma in the last 12 months. She has received honoraria from UpToDate (for authorship) and JAMA Neurology (as an associate editor) and grant support from Amgen and the Duke Clinical Research Institute. Her spouse reports research support (to UCSF) from Genentech for a clinical trial, honoraria for editorial work from Dynamed Plus, and personal compensation for medical-legal consulting. Dr. Irwin receives honoraria for authoring a chapter for the Canadian Pharmacy Association (CPhA) and research support from the Duke Clinical Research Institute. The remaining authors declare that there are no conflicts of interests regarding the publication of this article. Funding Information: Conflict of interest and source of funding statement: Dr. Szperka has received grant support from Pfizer, and her institution has received compensation for her consulting work for Allergan and Teva. Dr. Szperka receives salary support (NIH funding) from the NIH NINDS K23NS102521. Dr. Yonker receives research support from PI-Impax IPX229, Amgen 20150125, Amgen 20160354, Nerivio, TCH-004, Lilly CGAS, Lilly CGAT, Lilly LAHV, Lilly LAHW, Upsher-Smith P255-501, Teva TV48125-CNS-30082, Teva TV48125-CNS-30083, Teva TV48125-CNS-30084, NCCIH 1U01AT010132-01A1. She also receives consulting support from Lilly and Upsher Smith. Dr. Gelfand has received consulting fees from Biohaven and Satsuma in the last 12 months. She has received honoraria from UpToDate (for authorship) and JAMA Neurology (as an associate editor) and grant support from Amgen and the Duke Clinical Research Institute. Her spouse reports research support (to UCSF) from Genentech for a clinical trial, honoraria for editorial work from Dynamed Plus, and personal compensation for medical-legal consulting. Dr. Irwin receives honoraria for authoring a chapter for the Canadian Pharmacy Association (CPhA) and research support from the Duke Clinical Research Institute. The remaining authors declare that there are no conflicts of interests regarding the publication of this article. Publisher Copyright: {\textcopyright} 2020 Elsevier Inc.",
year = "2021",
month = jan,
doi = "10.1016/j.pediatrneurol.2020.09.014",
language = "English (US)",
volume = "114",
pages = "62--67",
journal = "Pediatric Neurology",
issn = "0887-8994",
publisher = "Elsevier Inc.",
}