PMID- 35978286 OWN - NLM STAT- MEDLINE DCOM- 20220819 LR - 20220821 IS - 1129-2377 (Electronic) IS - 1129-2369 (Print) IS - 1129-2369 (Linking) VI - 23 IP - 1 DP - 2022 Aug 18 TI - Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. PG - 104 LID - 10.1186/s10194-022-01470-4 [doi] LID - 104 AB - BACKGROUND: Erenumab, a fully human monoclonal antibody that targets the calcitonin gene-related peptide receptor, has demonstrated efficacy and safety in the prevention of episodic and chronic migraine. There exists an unmet need to establish the safety of erenumab in older individuals, in view of existing multiple comorbidities, polypharmacy, and age-related physiological changes. This pooled analysis of five large migraine-prevention studies examined the safety of erenumab stratified across age groups, particularly in older populations. METHODS: Pooled and age-stratified analysis of safety data from the 12-week double-blind treatment phase (DBTP) of five randomized, placebo-controlled Phase 2 and 3 studies of erenumab in participants with episodic or chronic migraine across the age groups < 40 years, 40-49 years, 50-59 years, and >/= 60 years was completed. The safety of erenumab across age groups was determined by assessing safety endpoints including treatment-emergent adverse events (AEs), serious AEs, and events leading to study drug discontinuation. RESULTS: Overall, 3345 participants across five studies were randomized to receive either placebo (n = 1359), erenumab 70 mg (n = 1132) or erenumab 140 mg (n = 854); 3176 (94.9%) completed the DBTP, and 169 (5.1%) discontinued, mainly due to participant decision (110; 3.3%). Overall, 1349 (40.6%), 1122 (33.8%), and 850 (25.6%) participants received at least one dose of placebo, erenumab 70 mg, and erenumab 140 mg, respectively. Incidence of treatment-emergent AEs was similar across all age groups for both doses of erenumab (70 mg or 140 mg) and placebo (< 40 years, 44.0% vs 44.4%; 40-49 years, 42.5% vs 49.2%; 50-59 years, 46.5% vs 41.6%; >/= 60 years, 43.8% vs 59.4%). Incidence of treatment-emergent serious AEs overall, and stratified by age groups for both doses and placebo was low (< 40 years, 0.9% vs 1.2%; 40-49 years, 1.7% vs 1.9%; and 50-59 years, 1.6% vs 1.1%), with no serious AEs reported in participants aged >/= 60 years. No deaths were reported. CONCLUSIONS: Erenumab (70 mg or 140 mg) exhibited a similar safety profile compared with placebo across age groups in individuals with episodic or chronic migraine, with no increased emergence of events due to age. Erenumab was well tolerated in older participants with multiple comorbidities, polypharmacy, and age-related physiological changes. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifiers: NCT02066415, NCT02456740, NCT02483585, NCT03096834, NCT03333109. CI - (c) 2022. The Author(s). FAU - Lampl, Christian AU - Lampl C AUID- ORCID: 0000-0003-1756-1181 AD - Department of Neurology, Konventhospital Barmherzige Bruder Linz, Seilerstatte 2, 4020, Linz, Austria. Christian.Lampl@bblinz.at. FAU - Kraus, Viktoria AU - Kraus V AD - Department of Neurology, Konventhospital Barmherzige Bruder Linz, Seilerstatte 2, 4020, Linz, Austria. FAU - Lehner, Katrina AU - Lehner K AD - Department of Neurology, Konventhospital Barmherzige Bruder Linz, Seilerstatte 2, 4020, Linz, Austria. FAU - Loop, Brett AU - Loop B AD - Novartis Pharmaceuticals, Cambridge, MA, USA. FAU - Chehrenama, Mahan AU - Chehrenama M AD - Amgen Inc, Thousand Oaks, CA, USA. FAU - Maczynska, Zofia AU - Maczynska Z AD - Novartis Pharma AG, Basel, Switzerland. FAU - Ritter, Shannon AU - Ritter S AD - Novartis Pharmaceutical Corporation, East Hanover, NJ, USA. FAU - Klatt, Jan AU - Klatt J AD - Merck KgaA, Darmstadt, Germany. FAU - Snellman, Josefin AU - Snellman J AD - Novartis Pharma AG, Basel, Switzerland. LA - eng SI - ClinicalTrials.gov/NCT02066415 SI - ClinicalTrials.gov/NCT02483585 SI - ClinicalTrials.gov/NCT02456740 SI - ClinicalTrials.gov/NCT03096834 SI - ClinicalTrials.gov/NCT03333109 GR - NA/Novartis Pharma AG, Basel, Switzerland/ GR - NA/Novartis Pharma AG, Basel, Switzerland/ GR - NA/Novartis Pharma AG, Basel, Switzerland/ GR - NA/Novartis Pharma AG, Basel, Switzerland/ GR - NA/Novartis Pharma AG, Basel, Switzerland/ GR - NA/Novartis Pharma AG, Basel, Switzerland/ PT - Journal Article PT - Meta-Analysis DEP - 20220818 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 - Aged MH - Antibodies, Monoclonal, Humanized/adverse effects MH - *Calcitonin Gene-Related Peptide Receptor Antagonists/adverse effects MH - Double-Blind Method MH - Humans MH - *Migraine Disorders/prevention & control MH - Randomized Controlled Trials as Topic MH - Receptors, Calcitonin Gene-Related Peptide MH - Treatment Outcome PMC - PMC9386939 OTO - NOTNLM OT - Advanced age OT - Calcitonin gene-related peptide OT - Cardiovascular OT - Cerebrovascular OT - Erenumab OT - Gastrointestinal OT - Monoclonal antibody OT - Older individuals OT - Randomized controlled trial OT - Safety OT - Tolerability COIS- Christian Lampl received honoraria from Novartis for given lectures and his participation in Advisory Board Meetings. Victoria Krauss declares that they have no competing interests. Katharina Lehner declares that they have no competing interests. Mahan Chehrenama is an employee of, and holds stock in Amgen Inc. Zofia Maczynska is a former employee of Novartis. Jan Klatt is a former employee of, and holds stock in Novartis. Brett Loop was an employee of Amgen Inc., US at the time of study conduct. Brett Loop, Shannon Ritter and Josefin Snellman are employees of, and hold stocks in Novartis. EDAT- 2022/08/18 06:00 MHDA- 2022/08/20 06:00 PMCR- 2022/08/18 CRDT- 2022/08/17 23:43 PHST- 2022/06/22 00:00 [received] PHST- 2022/07/23 00:00 [accepted] PHST- 2022/08/17 23:43 [entrez] PHST- 2022/08/18 06:00 [pubmed] PHST- 2022/08/20 06:00 [medline] PHST- 2022/08/18 00:00 [pmc-release] AID - 10.1186/s10194-022-01470-4 [pii] AID - 1470 [pii] AID - 10.1186/s10194-022-01470-4 [doi] PST - epublish SO - J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.