Usability of mepolizumab single-use prefilled syringe for patient self-administration.

Abstract

Objective: A liquid mepolizumab formulation in a single-use prefilled syringe (PFS) is under development. We evaluated the usability of mepolizumab self-injected via PFS by patients with severe eosinophilic asthma (SEA), or their caregivers, in clinic and at home.Methods: This open-label, single-arm, Phase IIIa study included patients with SEA, aged ≥12 years, and receiving mepolizumab (100 mg subcutaneously) every 4 weeks for ≥12 weeks prior to screening. Patients with SEA not receiving mepolizumab at screening who met additional criteria were also included. Patients/caregivers self-administered mepolizumab (100 mg subcutaneously) via PFS every 4 weeks for 12 weeks. The first (Week 0) and third (Week 8) dose were observed in clinic; the second dose (Week 4) was unobserved at home. Primary and secondary endpoints were the proportion of patients who successfully self-administered their third and second doses, respectively. Injection success was determined by investigator/site staff. Patient experience, mepolizumab trough concentrations, blood eosinophil counts, and safety were also assessed.Results: Of the 56 patients/caregivers who self-administered ≥1 dose of mepolizumab, 55 completed the study. All patients were reported to have successfully self-administered their third mepolizumab dose in clinic (N = 55, 100%); this was further evidenced by trough concentrations/blood eosinophil counts. Most patients/caregivers found the PFS easy and convenient to use with 75% (n = 42) expressing little/no anxiety about using the device at home. Incidence of on-treatment drug-related adverse events was low (4%); none were fatal.Conclusions: Patients/caregivers successfully self-administered mepolizumab via the PFS both in clinic and at home, with no new safety concerns identified.

• Authors: Elisabeth H Bel, David I Bernstein, Leif Bjermer, Richard Follows, Jane H Bentley, Isabelle Pouliquen, Eric Bradford
• Journal: The Journal of asthma : official journal of the Association for the Care of Asthma (J Asthma) Vol. 57 Issue 7 Pg. 755-764 (07 2020) ISSN: 1532-4303 [Electronic] England
• PMID: 31017022 (Publication Type: Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• mepolizumab

Topics

• Adolescent
• Adult
• Aged
• Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects)
• Asthma (diagnosis, drug therapy)
• Drug-Related Side Effects and Adverse Reactions (epidemiology, etiology)
• Feasibility Studies
• Female
• Humans
• Incidence
• Injections, Subcutaneous
• Male
• Middle Aged
• Self Administration (adverse effects, instrumentation)
• Severity of Illness Index
• Syringes
• Young Adult