Abstract Background Randomised controlled trials have demonstrated the efficacy of subcutaneous (SC) infliximab and its non-inferiority to intravenous (IV) infliximab in patients with IBD. However, real-world evidence on its effectiveness in improving disease control from a patient perspective remains limited. An increasing number of patients prefer SC medications, which can be self-administered, rather than IV therapies requiring regular hospital visits. Therefore, the aim of the present study was to analyse real-world data from patients with IBD who transitioned from IV to SC infliximab therapy. In addition to objective clinical outcomes, patient-reported outcome measures (PROMs) were evaluated. Methods Prospective, observational healthcare data were collected from the telemonitoring tools (myIBDcoach, Luscii) and from patients’ medical records. Patients were eligible if they had received IV infliximab as maintenance therapy for at least three months and switched to SC infliximab. The first SC infliximab dose was administered at the end of the regular IV dosing interval. Maintenance therapy consisted of 120mg SC infliximab administered every two weeks in accordance with the drug label or every week based on physician’s clinical judgement. The primary endpoint was sustained remission for at least one year after switch to SC infliximab. Sustained remission was defined as biochemical (C-reactive protein CRP ≤10 mg/L and faecal calprotectin FCP ≤250 µg/g), clinical (Monitor IBD At Home MIAH score ≥3.5, Harvey-Bradshaw Index HBI 5, or Simple Clinical Colitis Activity Index SSCAI 3), and corticosteroid-free remission. The secondary endpoint was sustained positive perceived disease control, defined as an IBD Control score ≥13. We also measured the infliximab through levels at the different timepoints. Results A total of 77 patients from five Dutch hospitals were included in this study. As not all participating centres had implemented telemonitoring as part of their standard care pathway, disease control from patient perspective was not available for all participants. Median baseline CRP and FCP levels were 3 mg/L and 87 µg/g, respectively. At baseline, 53% of patients were in clinical remission according to either the HBI/SSCAI or MIAH score (Table 1). At the end of one year follow-up, 82% of patients remained in sustained remission, while 71% achieved sustained positive perceived disease control. During follow-up, no corticosteroids were started. Infliximab trough levels during follow-up are presented in Figure 1. Conclusion Our findings demonstrate that SC infliximab is effective in maintaining biochemical remission as well as subjective disease control in clinical practice. Conflict of interest: Ms. Aliu, Arta: Investigator initiated grant by Alfasigma and speakers fee by Johsnon & Johnson, all outside the submitted work. Lourens, Leonie: No conflict of interest Mujagic, Zlatan: Zlatan Mujagić reports grants from ZonMw, MLDS, Niels Stensen Fellowship, and Galapagos, and has served as speaker for Galapagos, adviser for Johnson and Johnson, Pfizer, Galapagos, AbbVie and Lilly, all outside the submitted work. Verleye, Loriane: No conflict of interest Van der Meulen - de Jong, Andrea Elisabeth: A.E.v.d.M.-d.J. has received research grants from Norgine, Cablon, Alfasigma, and ZonMw, including speaker’s fees from Tramedico, Janssen Pharmaceuticals, Takeda, Alfasigma, Vedanta, Ferring, and AbbVie. These fees and payments are not related to this abstract. Pierik, Marieke: Marieke J. Pierik reports non-restricted research grants from Horizon 2020, ZONMW (Dutch national research fund), Maag Lever Darm stichting, Takeda, Johnson and Johnson, Abbvie and Galapagos, non-financial support from Immunodiagnostics, speaker’s fee from BMS, Janssen Cilag and Takeda all outside the submitted work. Part of the work of Daisy M.A.E. Jonkers, outside the submitted paper has been financed the public-private partnership grants of Top Knowledge Institute Agri&Food and Health Holland, by the Carbokinetics program as part of the NWO-CCC Partnership Program, by Organic A2BV/Mothersfinest BV and by H2020 DISCOvERIE/848228. All outside the submitted work. Derijks, Luc: L.D. has served as a speaker for AbbVie, Celltrion, Janssen-Cilag and Takeda and has developed continuing education materials for Ferring, all outside the submitted work.
Aliu et al. (Thu,) studied this question.