Preference for a prefilled syringe or an auto-injection device for delivering golimumab in patients with moderate-to-severe ulcerative colitis: a randomized crossover study

Abstract

PurposeSimponi® (golimumab, MSD) is a fully human monoclonal antibody against tumor necrosis factor alpha administered subcutaneously using an autoinjector or a prefilled syringe. This study examined preference for administration of golimumab by autoinjector or prefilled syringe in patients with moderate-to-severe ulcerative colitis (UC).Patients and methodsThis was a multicenter, open-label, randomized crossover trial (EudraCT no 2014-000656-29). Patients with moderate-to-severe UC were randomized 1:1 to receive 2 subcutaneous injections of 50 mg golimumab with the autoinjector followed by 2 injections of 50 mg with the prefilled syringe or the same 4 injections administered in the opposite order. Patients assessed preference, ease of use, and discomfort immediately after the injections and 2 weeks later.ResultsNinety-one patients were included (median age=42.7 years [range, 19.7–93.7]; 58% male). The autoinjector was preferred by 76.9% of patients immediately after injections and by 71.4% 2 weeks later. The autoinjector was more often considered extremely easy or easy to use (94.5%) than the prefilled syringe (73.6%). Moderate discomfort or worse was reported by more patients when using the prefilled syringe (20.9%) than when using the autoinjector (5.5%), and severe discomfort or discomfort preventing injection of future doses was reported by 8.8% for the pre-filled syringe but not at all when using the autoinjector. A favorable or extremely favorable overall impression was reported by 89.0% for the autoinjector and 72.5% for the prefilled syringe.ConclusionMost patients with moderate-to-severe UC preferred to self-administer golimumab with the autoinjector over a prefilled syringe.

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

“…As this study was performed for healthy volunteers, and each volunteer received a single injection with only one device, one limitation was that patient preference for the AI or APFS device was not explored. Patient preference for AI over APFS has been reported for selfadministration of arthritis medication, while no device preference was described in a migraine study (8)(9)(10). Future studies should be performed to determine device preference for patients receiving benralizumab.…”

“…It is important to provide patients device options to support their satisfaction and adherence. 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).…”

Subcutaneous immunoglobulin in primary immunodeficiency – impact of training and infusion characteristics on patient-reported outcomes

“…Ease of training and total training time variables varied significantly (p = 0.01 and p = < 0.001, respectively) between the four training locations (home, hospital, doctor's office, or other) ( Table 7). Overall, the median rating (interquartile range [IQR]) for ease of training was higher for respondents trained in hospital or a doctor's office (7 [6,7] for both locations), compared with respondents trained at home (6 [5,7]) or in other locations (6 [4,7]). The total training time was lowest in those trained in hospital, with a median time of 1 h, whereas in all other locations (home, doctor's office, and other), the median time was 4 h. No significant difference was found between the knowledge of trainer and the different training locations (p = 0.21).…”

“…Favorable infusion and training characteristics were defined as follows: a) Favorable training: (i) efficiency of training, (ii) the respondent's self-perception of their trainer (high [6,7] scores for competence and knowledge of trainer, and satisfaction with quality of training), and (iii) absence of training barriers. Efficient training characteristics included: requiring ≤3 training sessions; a total SCIG training time ≤4 h; individual training sessions ≤2 h; ease of training rated 6-7; and confidence after training rated 6-7. b) Efficient infusions: defined as reported actual infusion time of ≤2 h; infusion preparation duration of ≤20 min; and total infusion duration (including preparation and clean-up) of ≤3 h, or lower frequency of infusions.…”

“…Quality of life (QOL) assessments typically focus on disease-related aspects of patient well-being but can also reflect the impact of treatment on patients [5,6]. Chronic diseases place a long-term burden on general satisfaction, physical function, emotional well-being, work productivity, and family life [7].…”