PMID- 30271122 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230928 IS - 1177-889X (Print) IS - 1177-889X (Electronic) IS - 1177-889X (Linking) VI - 12 DP - 2018 TI - Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies. PG - 1785-1795 LID - 10.2147/PPA.S170636 [doi] AB - PURPOSE: The aim of this study was to compare the usability and patient-rated experiences of an autoinjector with a prefilled syringe in patients with migraine, who self-administered galcanezumab, and to compare pharmacokinetic parameters between these devices. MATERIALS AND METHODS: Patient-rated experiences with an investigational autoinjector and a prefilled syringe were compared in an open-label, 12-month study of once-monthly injections of galcanezumab 120 or 240 mg (NCT02614287). Patient-rated ease of usability was assessed with the Subcutaneous Administration Assessment Questionnaire (SQAAQ) and compared between devices. Positive responses on the SQAAQ were rated as "agree or strongly agree" to 12 statements. Tolerability was assessed by the frequency of injection-site-related adverse events (AEs) by device and injection location. In a separate study, galcanezumab pharmacokinetics in healthy subjects was compared between the devices (NCT02836613). RESULTS: In the open-label clinical trial, 179 patients used both the prefilled syringe and autoinjector at least once. The majority of patients (91%-97%) had positive responses on the SQAAQ to the use of autoinjector across the items assessed. There were 23 injection-site-related AEs with the first self-administered injection with the prefilled syringe (N=7) or autoinjector (N=16; P=0.061), with the most common AE for either device being injection-site pain. There were no significant between-device differences in injection-site-related AEs. For pharmacokinetics, the 90% CI for the ratio (autoinjector/prefilled syringe) of geometric least-square means for the galcanezumab area under the curve (AUC) concentration and maximum concentration (C(max)) was between 0.8 and 1.25, indicating no statistically significant difference in the galcanezumab concentrations regardless of the device used. CONCLUSION: The ease of usability with either device was comparable, and there were no significant differences in tolerability between the prefilled syringe and autoinjector with the first self-administration; however, the analysis was not powered to detect a clinically significant difference. Galcanezumab pharmacokinetics were comparable between devices. FAU - Stauffer, Virginia L AU - Stauffer VL AD - Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, stauffer_virginia@lilly.com. FAU - Sides, Ryan AU - Sides R AD - Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, stauffer_virginia@lilly.com. FAU - Lanteri-Minet, Michel AU - Lanteri-Minet M AD - Pain Department, CHU Nice, Nice, France. AD - Universite Cote d'Azur, FHU InovPain, CHU de Nice, Nice, France. FAU - Kielbasa, William AU - Kielbasa W AD - Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, stauffer_virginia@lilly.com. FAU - Jin, Yan AU - Jin Y AD - Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, stauffer_virginia@lilly.com. FAU - Selzler, Katherine J AU - Selzler KJ AD - Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, stauffer_virginia@lilly.com. FAU - Tepper, Stewart J AU - Tepper SJ AD - Geisel School of Medicine at Dartmouth, Hanover, NH, USA. LA - eng SI - ClinicalTrials.gov/NCT02836613 PT - Journal Article DEP - 20180917 PL - New Zealand TA - Patient Prefer Adherence JT - Patient preference and adherence JID - 101475748 PMC - PMC6147689 OTO - NOTNLM OT - *SQAAQ OT - *devices OT - *galcanezumab OT - *pharmacokinetics OT - *self-administered injections COIS- Disclosure VLS, RS, WK, YJ, and KJS are full-time employees and minor shareholders of Eli Lilly and Company. ML-M in the past 5 years has received honoraria for advisory boards and has been in speaker panels or investigation studies from Allergan, Amgen, Astellas, ATI, BMS, Boehringer, Boston Scientific, CoLucid, Convergence, GlaxoSmithKline, Grunenthal, Eli Lilly, Medtronic, Menarini, MSD, Novartis, Pfizer, Reckitt Benckiser, Saint-Jude, Sanofi-Aventis, Teva, UCB, and Zambon. SJT in the last year has research grants paid to Dartmouth without personal compensation from Alder, Allergan, Amgen, ATI, Dr Reddy's, ElectroCore, eNeura, Scion Neurostim, Teva, and Zosano. He has received honoraria for consultation from Acorda, Alder, Allergan, Amgen, ATI, Cefaly, Charleston Laboratories, DeepBench, Dr Reddy's, ElectroCore, Eli Lilly, eNeura, GLG, Guidepoint Global, Impax, Neurolief, Pfizer, Scion Neurostim, Slingshot Insights, Supernus, Teva, and Zosano. He has stock options in ATI, receives royalties for textbooks from Springer, and receives salary from Dartmouth-Hitchcock Medical Center and the American Headache Society. The authors report no other conflicts of interest in this work. EDAT- 2018/10/03 06:00 MHDA- 2018/10/03 06:01 PMCR- 2018/09/17 CRDT- 2018/10/02 06:00 PHST- 2018/10/02 06:00 [entrez] PHST- 2018/10/03 06:00 [pubmed] PHST- 2018/10/03 06:01 [medline] PHST- 2018/09/17 00:00 [pmc-release] AID - ppa-12-1785 [pii] AID - 10.2147/PPA.S170636 [doi] PST - epublish SO - Patient Prefer Adherence. 2018 Sep 17;12:1785-1795. doi: 10.2147/PPA.S170636. eCollection 2018.