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
Authors Vermeire S, D'heyghere F, Nakad A, Franchimont D, Fontaine F, Louis E, Van Hootegem P, Dewit O, Lambrecht G, Strubbe B, Baert F
Received 15 October 2017
Accepted for publication 9 May 2018
Published 6 July 2018 Volume 2018:12 Pages 1193—1202
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 3
Editor who approved publication: Dr Johnny Chen
Séverine Vermeire,1 François D’heygere,2 Antoine Nakad,3 Denis Franchimont,4 Fernand Fontaine,5 Edouard Louis,6 Philippe Van Hootegem,7 Olivier Dewit,8 Guy Lambrecht,9 Beatrijs Strubbe,10 Filip Baert11
1Department of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium; 2Department of Gastroenterology, AZ Groeninge, Kortrijk, Belgium; 3Department of Gastroenterology, CHWAPI, Tournai, Belgium; 4Department of Gastroenterology, Erasme Hospital, Brussels, Belgium; 5Department of Gastroenterology, CHC St Joseph, Liège, Belgium; 6Department of Gastroenterology, University Hospital CHU Sart Tilman, Liège, Belgium; 7Department of Gastroenterology, AZ St Lucas, Brugge, Belgium; 8Department of Gastroenterology, UCL St Luc, Brussels, Belgium; 9Department of Gastroenterology, AZ Damiaan, Oostende, Belgium; 10Department of Gastroenterology, OLV Hospital, Aalst, Belgium; 11Department of Gastroenterology, AZ Delta, Roeselare-Menen, Belgium
Purpose: Simponi® (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 methods: This 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.
Results: Ninety-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 prefilled 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.
Conclusion: Most patients with moderate-to-severe UC preferred to self-administer golimumab with the autoinjector over a prefilled syringe.
Keywords: autoinjector, adherence, anti-TNF, subcutaneous injection, treatment, self-injection
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