PMID- 34806783 OWN - NLM STAT- MEDLINE DCOM- 20220221 LR - 20220722 IS - 1526-4610 (Electronic) IS - 0017-8748 (Print) IS - 0017-8748 (Linking) VI - 62 IP - 1 DP - 2022 Jan TI - Tolerability and safety of galcanezumab in patients with chronic cluster headache with up to 15 months of galcanezumab treatment. PG - 65-77 LID - 10.1111/head.14234 [doi] AB - OBJECTIVE: The objective of the study was to assess the tolerability and safety of galcanezumab in patients with chronic cluster headache (CH) with up to 15 months of treatment. BACKGROUND: Chronic CH is a highly debilitating disease with a substantial and unmet medical need. METHODS: Patients were randomized to receive placebo or galcanezumab (300 mg) monthly for 12 weeks, followed by an optional 52-week open-label extension and 16-week posttreatment follow-up (washout). This is a secondary analysis and long-term follow-up of a previously conducted clinical trial. The safety analysis included patients who received galcanezumab at any time during the study. Outcomes included adverse events (AEs), discontinuations, laboratory values, vital signs, electrocardiograms (ECGs), and suicidality ratings. RESULTS: A total of 233 patients received at least one galcanezumab dose. The mean exposure was 341 days. Galcanezumab-treated patients were mostly male (n = 169/233; 72.5%) with a mean age of 44.9 (+/-10.9) years. Treatment-emergent adverse events (TEAEs) were reported by 185 patients (n = 185/233; 79.4%), 23 patients (n = 23/233; 9.9%) reported serious adverse events (SAEs), and 18 patients (n = 18/233; 7.7%) discontinued due to AEs. The SAE CH was reported by three patients. The most common TEAEs (>10%) were nasopharyngitis (n = 41/233; 17.6%) and injection site pain (n = 33/233; 14.2%). 27.5% of patients (n = 64/233) had TEAEs related to injection sites. Likely hypersensitivity events, including injection site rash, injection site urticaria, and injection site hypersensitivity were reported (n = 14/233; 6.0%). There were past histories of suicidal ideation (n = 55/237; 23.2%) and suicidal behavior (n = 9/236; 3.8%). During the study, 15 patients (n = 15/230; 6.5%), seven with previous history, reported suicidal ideation. One patient had a nonfatal suicide attempt during the open-label extension and an aborted attempt during the washout. There were no new safety findings compared with the placebo-controlled treatment period in laboratory values, vital signs, or ECGs. CONCLUSIONS: Galcanezumab 300 mg monthly had a favorable tolerability and safety profile in patients with chronic CH with up to 15 months of treatment. CI - (c) 2021 Eli Lilly and Company. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society. FAU - Lainez, Miguel J A AU - Lainez MJA AD - Hospital Clinico Universitario, Universidad Catolica de Valencia, Valencia, Spain. FAU - Schoenen, Jean AU - Schoenen J AD - Department of Neurology, Headache Research Unit, Citadelle Hospital, Liege University, Liege, Belgium. FAU - Stroud, Chad AU - Stroud C AD - Eli Lilly and Company, Indianapolis, Indiana, USA. FAU - Bardos, Jennifer AU - Bardos J AD - Eli Lilly and Company, Indianapolis, Indiana, USA. FAU - Bangs, Mark AU - Bangs M AD - Eli Lilly and Company, Indianapolis, Indiana, USA. FAU - Kemmer, Phebe AU - Kemmer P AD - Eli Lilly and Company, Indianapolis, Indiana, USA. FAU - Wenzel, Richard AU - Wenzel R AD - Eli Lilly and Company, Indianapolis, Indiana, USA. FAU - Kuruppu, Dulanji K AU - Kuruppu DK AD - Eli Lilly and Company, Indianapolis, Indiana, USA. FAU - Martinez, James Michael AU - Martinez JM AD - Eli Lilly and Company, Indianapolis, Indiana, USA. FAU - Oakes, Tina M AU - Oakes TM AD - Eli Lilly and Company, Indianapolis, Indiana, USA. LA - eng GR - Eli Lilly and Company/ PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20211122 PL - United States TA - Headache JT - Headache JID - 2985091R RN - 0 (Antibodies, Monoclonal, Humanized) RN - 55KHL3P693 (galcanezumab) SB - IM EIN - Headache. 2022 Apr;62(4):536. PMID: 35438800 MH - Adult MH - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects/*pharmacology MH - Chronic Disease MH - Cluster Headache/*drug therapy MH - Double-Blind Method MH - Female MH - Follow-Up Studies MH - Humans MH - Male MH - Middle Aged MH - Outcome Assessment, Health Care PMC - PMC9299588 OTO - NOTNLM OT - adverse events OT - calcitonin gene-related peptide monoclonal antibody OT - long-term exposure COIS- Chad Stroud, Jennifer Bardos, Mark Bangs, Phebe Kemmer, Richard Wenzel, Dulanji K. Kuruppu, James Michael Martinez, and Tina M. Oakes are employees and minor stockholders of Eli Lilly and Company. Miguel J. A. Lainez has received honoraria, consultation fees, and research grants from Allergan, Amgen, Bayer, Bial, Boehringher, Chiesi, ElectroCore, Eli Lily, Medtronic, Novartis, Otsuka, PRIM, Roche, Teva, and UCB. Jean Schoenen has received honoraria and speaker's fees from Teva, Novartis, Eli Lilly, Allergan, Amgen, Electrocore, Cefaly Technology, and Man & Science. EDAT- 2021/11/23 06:00 MHDA- 2022/02/22 06:00 PMCR- 2022/07/20 CRDT- 2021/11/22 08:56 PHST- 2021/08/23 00:00 [revised] PHST- 2021/03/23 00:00 [received] PHST- 2021/09/20 00:00 [accepted] PHST- 2021/11/23 06:00 [pubmed] PHST- 2022/02/22 06:00 [medline] PHST- 2021/11/22 08:56 [entrez] PHST- 2022/07/20 00:00 [pmc-release] AID - HEAD14234 [pii] AID - 10.1111/head.14234 [doi] PST - ppublish SO - Headache. 2022 Jan;62(1):65-77. doi: 10.1111/head.14234. Epub 2021 Nov 22.