N02 PREVIEW study: Factors associated with willingness to switch from intravenous to subcutaneous formulations of CT-P13 and vedolizumab in patients with Inflammatory Bowel Disease.
Asnong, K.(1);Hoefkens, E.(1);Lembrechts, N.(1);Van de Schoot, I.(1);Pouillon, L.(1);Bossuyt, P.(1);
(1)Imelda General Hospital Bonheiden, Imelda GI Clinical Research Center, Bonheiden, Belgium
Background
Subcutaneous (SC) formulations were recently approved for CT-P13 and vedolizumab (VED). No insights in the willingness of patients with Inflammatory Bowel Disease (IBD) to switch from intravenous (IV) to SC maintenance therapy with CT-P13 and VED are available. The aims of this study were (1) to evaluate the percentage of patients with IBD in favour of switching to SC formulations, (2) to define the factors influencing this decision, and (3) to explore the role of the IBD nurse in the process of switching.
Methods
This was a monocentric study in patients with IBD on maintenance IV CT-P13 or VED. All patients attending the infusion unit were invited to complete a survey exploring the willingness to switch to SC formulations. Prior to completing the survey, patients were informed on the new SC formulations and the accompanying care pathway. The survey was performed prior to the market introduction of SC CT-P13 and VED. Demographics, patient reported outcomes, willingness to switch and reason for IV vs. SC preferences were captured.
Results
In total, 183 (91%) patients completed the survey (m/f: 84/99; CD/UC/IBD-U: 120/57/6; median age 45 IQR 34-59; remission CD/UC: 67%/75%). The majority of patients preferred switching to SC (56% yes, 12% no, 32% doubt). The main driver to switch was an anticipated decrease in hospital visits (90%); the main reason to continue IV was fear of change (61%). Patients doubting to switch had a lower stool frequency compared with patients making a definite decision (p=0.012). Factors significantly associated with the willingness to switch in the univariate analysis were younger age (p<0.0001), experience with SC therapy (p=0.03), full time work occupancy (p=0.001), younger age at start IV therapy (p=0.001), shorter disease duration (p=0.012), and compliance level (p<0.0001). Multivariate analysis retained younger age as the only independent factor. For patients doubting to switch, an electronic alert (71%), an information brochure (69%), and a personal teaching moment (60%) were recognised as valuable support. An information package should cover patient-focused efficacy and safety data of SC therapy, therapeutic options in case of disease worsening, and practical concerns including information about administrative issues and travelling.
Conclusion
This is the first study exploring the willingness to switch from IV to SC maintenance therapy with CT-P13 and VED in patients with IBD. The majority prefers to switch to a SC formulation, with willingness to switch being most likely in younger patients. Further studies are required to investigate the impact of nurse led interventions on the willingness to switch, patient satisfaction, and treatment compliance.