PMID- 35538414 OWN - NLM STAT- MEDLINE DCOM- 20220512 LR - 20220514 IS - 1129-2377 (Electronic) IS - 1129-2369 (Print) IS - 1129-2369 (Linking) VI - 23 IP - 1 DP - 2022 May 11 TI - Twelve-month safety, tolerability and susceptibility to adverse events of prophylactic migraine therapy with erenumab: a retrospective real-world study. PG - 55 LID - 10.1186/s10194-022-01426-8 [doi] LID - 55 AB - BACKGROUND: Erenumab is a monoclonal antibody (mAb) against the calcitonin gene related peptide (CGRP) receptor and is commonly used in migraine prophylaxis. Pivotal and open-label studies show a good safety and tolerability. However, little is known about possible predictors, dose dependence and time course of development of adverse events (AEs) during the treatment under real-world conditions. METHODS: Clinical routine data of 128 patients with migraine treated in the West German Headache Center Essen were analyzed regarding AEs during a treatment interval of up to 12 months (3mo n = 128, 6mo n = 105, 9mo n = 74, 12mo n = 54). Patients obtained subcutaneous erenumab injections with either 70 mg or 140 mg per month. The occurrence and alterations of AEs were evaluated. All reported AEs, regardless of their severity, were included. AEs were graded using the common terminology criteria for adverse events (CTCAE). Possible parameters that could influence the occurrence of AEs (sex, episodic or chronic migraine, medication overuse headache, aura and the dosage of erenumab) were analyzed using the Chi-squared test, alpha adjustment was done using the Bonferroni's correction (6 tests, adjusted alpha = 0.0083). RESULTS: The proportion of patients who reported at least one AE were stable over the course of 12 months (after 3mo = 37%, 6mo = 36%, 9mo = 32%, 12mo = 35%). All reported AEs were grade 1 according to CTCAE with one exception (grade 2). Throughout the interval, five AEs were mostly reported: constipation, skin reactions, fatigue, sleep disturbances and nausea/emesis. Discontinuation of erenumab therapy was rarely caused by AEs (5/49). Increasing the dosage from 70 mg to 140 mg per month caused no higher frequency of AEs (Chi-squared test, p = 0.57). Significant more AEs were reported by females and by patients with aura (Chi-squared test, p < 0.001, respectively). CONCLUSION: In general, erenumab is well tolerated up to a treatment interval of 12 months and reported AEs rarely lead to discontinuation of therapy. A higher dosage does not increase the patient reported AEs. Furthermore, no habituation of AEs is observed. Nevertheless, females and patients with aura seem to be more prone to have AEs. TRIAL REGISTRATION: No registration, retrospective analysis. CI - (c) 2022. The Author(s). FAU - Schenk, Hannah AU - Schenk H AD - Department of Neurology and Center for Translational Neuro- and Behavioral Sciences (C-TNBS), West German Headache Center, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany. FAU - Holle, Dagny AU - Holle D AD - Department of Neurology and Center for Translational Neuro- and Behavioral Sciences (C-TNBS), West German Headache Center, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany. FAU - Nsaka, Michael AU - Nsaka M AD - Department of Neurology and Center for Translational Neuro- and Behavioral Sciences (C-TNBS), West German Headache Center, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany. FAU - Kleinschnitz, Christoph AU - Kleinschnitz C AD - Department of Neurology and Center for Translational Neuro- and Behavioral Sciences (C-TNBS), West German Headache Center, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany. FAU - Glas, Martin AU - Glas M AD - Department of Neurology and Center for Translational Neuro- and Behavioral Sciences (C-TNBS), West German Headache Center, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany. FAU - Scheffler, Armin AU - Scheffler A AD - Department of Neurology and Center for Translational Neuro- and Behavioral Sciences (C-TNBS), West German Headache Center, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany. armin.scheffler@uk-essen.de. LA - eng PT - Journal Article DEP - 20220511 PL - England TA - J Headache Pain JT - The journal of headache and pain JID - 100940562 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Calcitonin Gene-Related Peptide Receptor Antagonists) RN - 0 (Receptors, Calcitonin Gene-Related Peptide) RN - I5I8VB78VT (erenumab) SB - IM MH - Antibodies, Monoclonal, Humanized MH - Calcitonin Gene-Related Peptide Receptor Antagonists/therapeutic use MH - *Epilepsy/drug therapy MH - Female MH - Headache/drug therapy MH - Humans MH - *Migraine Disorders/chemically induced/drug therapy/prevention & control MH - Receptors, Calcitonin Gene-Related Peptide MH - Retrospective Studies MH - Treatment Outcome PMC - PMC9092816 OTO - NOTNLM OT - Adverse event OT - CGRP antibody OT - Erenumab OT - Migraine OT - Real-world OT - Safety and tolerability COIS- Dagny Holle has received scientific support and/or honoraria from Biogen, Novartis, Lilly, Sanofi-Aventis, Teva, Allergan, Hormosan. Christoph Kleinschnitz has received honoraria, a consulting or advisory role to declare from Novartis and Teva. Martin Glas received honoraria from Novartis, UCB, Teva, Bayer, Novocure, Medac, Merck, Kyowa Kirin, has a consulting or advisory role to declare for Roche, Novartis, AbbVie, Novocure, and Daiichi Synkyo, and received travel fees from Novocure and Medac. Michael Nsaka received travel fees from Licher MT. Armin Scheffler received travel fees from Teva and honoraria for participation on an advisory board of Novartis. Hannah Schenk declares that there is no conflict of interest. EDAT- 2022/05/11 06:00 MHDA- 2022/05/14 06:00 PMCR- 2022/05/11 CRDT- 2022/05/10 23:34 PHST- 2022/03/28 00:00 [received] PHST- 2022/04/30 00:00 [accepted] PHST- 2022/05/10 23:34 [entrez] PHST- 2022/05/11 06:00 [pubmed] PHST- 2022/05/14 06:00 [medline] PHST- 2022/05/11 00:00 [pmc-release] AID - 10.1186/s10194-022-01426-8 [pii] AID - 1426 [pii] AID - 10.1186/s10194-022-01426-8 [doi] PST - epublish SO - J Headache Pain. 2022 May 11;23(1):55. doi: 10.1186/s10194-022-01426-8.