Abstract Background Subcutaneous infliximab (SC-IFX) has demonstrated efficacy and safety in maintaining clinical remission in patients with inflammatory bowel disease (IBD). However, its role in re-inducing remission in patients with active disease who have lost response to intravenous infliximab (IV-IFX) has been poorly studied. The aim of this study was to assess the usefulness of switching from IV-IFX to SC-IFX in patients with active IBD who had lost response to intravenous treatment. Methods A retrospective, observational, multicentre study was conducted using data from the ENEIDA registry of GETECCU. Patients with Crohn’s disease (CD), ulcerative colitis (UC), or unclassified IBD (IBDU) who switched from IV-IFX to SC-IFX while presenting clinical activity were included. Clinical, biochemical, and pharmacokinetic data were collected at the time of the switch and during follow-up (weeks 8 and 16, and at 6 and 12 months). Clinical activity was defined as a Harvey–Bradshaw Index (HBI) ≥5 for CD or a partial Mayo Index (PMI) 2 for UC; clinical response as a reduction of ≥ 3 points; and clinical remission as HBI 5 or PMI ≤2. Results A total of 95 patients were included (66 CD, 26 UC, 3 IBDU), with a mean age of 46.4 ± 15.5 years; 47.4% were female, see Table 1. The main reason for switching was pharmacokinetic failure (33.7%, n = 32). Treatment was withdrawn in 4.2% of patients before week 8. At week 8, 73.7% (n = 70) achieved clinical response and 48.4% (n = 46) achieved clinical remission. Clinical response/remission rates were 72.6/57.9% at week 16, 71.6/55.8% at 6 months, and 47.5/38.9% at 12 months. Faecal calprotectin decreased from 743 to 524 μg/g and C-reactive protein from 2.5 to 1.4 mg/dL at 12 months. IFX levels increased from 7.8 to 17.2 μg/mL at week 16. Treatment persistence with SC-IFX, assessed by Kaplan–Meier analysis, was high overall, with estimated survival probabilities of 88.5% at 12 months in CD and 69.2% in UC. Adverse events were reported in 7.4% of patients, with only two treatment discontinuations. Conclusion Switching from IV-IFX to SC-IFX may be a safe and effective strategy to re-induce clinical remission in patients with active IBD who lose response to IV-IFX. Conflict of interest: Brunet, Eduard: Dr. Altadill, Ariadna: No conflict of interest Vela Gonzalez, María Milagros: Abbvie, Lilly, Italfarmaco, Pfizer Calafat Sard, Margalida: Personal Fees: Advisory fees for Gilead Other: I have served as a speaker, or has received research or education funding for Takeda, Janssen, Faes Farma, Falk Pharma, Kern, Pfizer and MSD. Garcia De La Filia Molina, Irene: No conflict of interest López Ramos, Carmen: No conflict of interest Orenga, Carmen: No conflict of interest Iborra, Marisa: No conflict of interest Rivas, Coral: No conflict of interest Rueda Garcia, Jose Luis: José Luis Rueda García has received financial support for traveling and educational activities from Kern Pharma, Abbvie, Johnson&Johnson, Pfizer, Eli Lilly, Takeda, Ferring, Tillotts Pharma, Faes Farma, Norgine and Casen and he has received fees as a speaker from Abbvie, Johnson&Johnson, Pfizer, Eli Lilly and Takeda. Ceballos Santos, Daniel: No conflict of interest Rubín De Célix, Cristina: Cristina Rubín de Célix has received education funding from Ferring, Tillotts Pharma, AbbVie, Sandoz, Alfasigma, Lilly, Norgine, MSD, Pfizer, Takeda, and Janssen Botella Mateu, Belén: No conflict of interest Rodriguez-Moranta, Francisco: No conflict of interest Caballol Oliva, Berta: No conflict of interest Barreiro-de Acosta, Manuel: MBA has been speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Alphasigma, Lilly, Pfizer, Sandoz, Biocon, Abivax, Fresenius, Faes Farma, Ferring, Tillots, Chiesi, Adacyte, Diasorin, Oncostellae and SunRock. Busquets Casals, David: No conflict of interest Suria, Carles: No conflict of interest Bujanda, Luis: No conflict of interest Catala, Lourdes Maria: No conflict of interest Menacho, Margarita: No conflict of interest Moralejo Lozano, Óscar: I have received educational funding from Abbvie, Johnson & Johnson, Takeda, Kern Pharma, Alfasigma, Pfizer, Lilly, Sandoz, Dr. Falk Pharma, Ferring, and Tillotts. I have also served as a speaker for Abbvie, Takeda, Alfasigma, and Lilly. Diz Lois Palomares, Maria Teresa: No conflict of interest Ramos Lopez, Laura: L.R. has acted as a speaker or received funding for training from MSD, Abbvie, Adacyte, Takeda, Pfizer, Janssen, and Ferring. López, Laura: No conflict of interest Delia, Iolanda: No conflict of interest Domènech Moral, Eugeni: Personal Fees: I have served as a speaker, or has received research or education funding or advisory fees from AbbVie, Adacyte Therapeutics, Biogen, Celltrion, Gilead, Janssen, Kern Pharma, MSD, Pfizer, Roche, Samsung, Takeda, Tillots. Other: I have served as a speaker, or has received research or education funding or advisory fees from AbbVie, Adacyte Therapeutics, Alfasigma/Galapagos Biogen, Celltrion, Ferring, Gilead, GoodGut, Imidomics, Janssen, Kern Pharma, Lilly, MSD, Pfizer, Roche, Takeda, Tillots. Calvet Calvo, Xavier: Xavier Calvet has received grants for research from AbbVie Janssen, Kern and Vifor, and fees for advisory board services form Abbvie, MSD, Takeda and Vifor. He has also given lectures for Abbvie, Janssen and Takeda.
Brunet et al. (Thu,) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: