Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies

Abstract

PurposeThe 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 methodsPatient-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).ResultsIn 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 (Cmax) was between 0.8 and 1.25, indicating no statistically significant difference in the galcanezumab concentrations regardless of the device used.ConclusionThe 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.

Comparison of autoinjector with accessorized prefilled syringe for benralizumab pharmacokinetic exposure: AMES trial results

“…As injection site flexibility may be relevant for patients because of factors such as personal preference and potential sensitivity for specific injection sites, we compared benralizumab PK exposure between three injection sites: upper arm, abdomen, and thigh. We determined that benralizumab PK exposure was similar between injection sites with either device, although overall exposures were greater for thigh injections than for other injection sites (10,18). Because consistent eosinophil depletion was observed following administration at all injection sites with both devices, the greater exposure for thigh injections was unlikely to be clinically relevant.…”

“…Several studies for patients with arthritis and ulcerative colitis have indicated that patients prefer AI over APFS for selfadministration of their medications, with reasons including ease of use, satisfaction, and acceptability (8,9). In a report on self-administration of migraine medication, patients found both devices equally easy to use and were comfortable using either (10).…”

Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of Phase 3 studies in participants with migraine

“…In Study CGAJ, patients selfadministered galcanezumab either with the prefilled syringe or the autoinjector devices. The injection experience and tolerability of self-administration with both devices has been published elsewhere [15].…”

“…In the EVOLVE and REGAIN studies, study site personnel administered the injections using prefilled syringes. In Study CGAJ, injections were self-administered by participant or caregiver using prefilled syringes for up to nine months, and then participants were switched to self-administer galcanezumab using an autoinjector [15]. Notably the autoinjector was not available for administration at the time of study initiation and was available approximately one year after the start of the study.…”

Anti‐Calcitonin Gene‐Related Peptide (CGRP) Therapies: Update on a Previous Review After the American Headache Society 60th Scientific Meeting, San Francisco, June 2018

“…26 OLE Galcanezumab Data.-Galcanezumab Self-Injector.-The investigators at the AHS meeting compared migraine patients who self-injected galcanezumab monthly with an autoinjector vs a prefilled syringe in a 12-month OLE trial, and this study has subsequently been fully published in a peer-reviewed journal. 34,35 The patients were given a Subcutaneous Administration Assessment Questionnaire and also queried as to AEs. There were 170 patients who used both injection methods at least once.…”