Usability of mepolizumab single-use prefilled syringe for patient self-administration
(2020) In Journal of Asthma 57(7). p.755-764- 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;... (More)
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.
(Less)
- author
- Bel, Elisabeth H. ; Bernstein, David I. ; Bjermer, Leif LU ; Follows, Richard ; Bentley, Jane H. ; Pouliquen, Isabelle and Bradford, Eric
- publishing date
- 2020
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- at home, blood eosinophil count, caregiver, Clinicaltrials.gov identifier: NCT03021304, device, dose, self-injected, Severe eosinophilic asthma
- in
- Journal of Asthma
- volume
- 57
- issue
- 7
- pages
- 755 - 764
- publisher
- Taylor & Francis
- external identifiers
-
- pmid:31017022
- scopus:85065181147
- ISSN
- 0277-0903
- DOI
- 10.1080/02770903.2019.1604745
- language
- English
- LU publication?
- no
- id
- e5ac962f-649a-4eb7-a912-88c193f3e711
- date added to LUP
- 2019-05-24 13:43:49
- date last changed
- 2024-05-14 09:13:07
@article{e5ac962f-649a-4eb7-a912-88c193f3e711, abstract = {{<p>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.</p>}}, author = {{Bel, Elisabeth H. and Bernstein, David I. and Bjermer, Leif and Follows, Richard and Bentley, Jane H. and Pouliquen, Isabelle and Bradford, Eric}}, issn = {{0277-0903}}, keywords = {{at home; blood eosinophil count; caregiver; Clinicaltrials.gov identifier: NCT03021304; device; dose; self-injected; Severe eosinophilic asthma}}, language = {{eng}}, number = {{7}}, pages = {{755--764}}, publisher = {{Taylor & Francis}}, series = {{Journal of Asthma}}, title = {{Usability of mepolizumab single-use prefilled syringe for patient self-administration}}, url = {{http://dx.doi.org/10.1080/02770903.2019.1604745}}, doi = {{10.1080/02770903.2019.1604745}}, volume = {{57}}, year = {{2020}}, }