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ACCELERATED OR ESCALATED INDUCTION REGIMENS OF INFLIXIMAB FOR STEROID-REFRACTORY ACUTE SEVERE ULCERATIVE COLITIS IN CLINICAL PRACTICE: DATA FORM THE ENEIDA REGISTRY

Jordina Llaó 1, Jordi Guardiola 2, Pilar Nos Mateu 3, Isabel Pérez-Martínez 4, Beatriz Sicilia Aladrén 5, Irene Moraleja 6, María José García 7, Lorena Bernal 8, Patricia Suárez 9, Carlos González-Muñoza 10, Javier P. Gisbert 11, Ignacio Marín-Jiménez 12, Fernando Gomollón 13, RAMÓN DOSDÁ 14, Elena Betoré 15, Xavier Calvet Calvo 16, Ángel Ponferrada-Díaz 17, Carlos Taxonera Samso 18, Miquel Marquès-Camí 19, Fernando Bermejo 20, Francisco Mesonero Gismero 21, Berta Caballol Oliva 22, Manuel Barreiro de Acosta 23, Marta Teller 1, Lidia Cabrinety 24, Isabel Pascual-Moreno 25, Pilar Varela Trastoy 26, Manuel Van Domselar 27, Milagros Vela Gonzalez 28, Luis Bujanda Fernández de Piérola 29, Begoña Álvarez 30, Guillermo Alcain Martinez 31, Carles Leal 32, Miriam Mañosa Ciria 33, Eugeni Domenech Morral 34

Affiliations

1 Althaia Xarxa Assistencial universitaria de Manresa, Manresa, Spain

2 Hospital Universitari de Bellvitge, L'Hospitalert de LLobregat (Barcelona), Spain

3 Hospital Universitari i Politècnic La Fe,, València, Spain

4 Hospital Universitario Central de Asturias, Oviedo, Spain

5 H Universitario de Burgos, Burgos, Spain

6 Hospital de Galdakao, Galdakao, Spain

7 Marqués de Valdecilla University Hospital, Santander, Spain

8 Hospital General Universitario Dr Balmis e ISABIAL, Alicante., Alicante, Spain

9 Complejo Asistencial Universitario de León, León, Spain

10 Hospital de la Sta Creu i Sant Pau, Barcelona., Barcelona, Spain

11 Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa and CIBEREHD, Madrid, Spain

12 Hospital Gregorio Marañón, Madrid, Spain

13 Hospital Clínico Universitario Lozano Blesa, CIBEREHD, Zaragoza, Spain

14 Hospital General de Castellón, Castellón, Spain

15 Hospital San Jorge, Huesca, Spain

16 Hospital de Sabadell, Institut Universitari Parc Tauli, UAB, Barcelona, Spain

17 Hospital Infanta Leonor, Madrid, Spain

18 Hospital Clinico San Carlos and Instituto de Investigación del Hospital Clínico San Carlos, Madrid, Spain

19 Hospital Universitari Arnau de Vilanova., Lleida, Spain

20 H Fuenlabrada, Fuenlabrada, Spain

21 Hospital Ramon y Cajal, Madrid, Spain

22 Hospital Clinic de Barcelona, Barcelona, Spain

23 University Hospital of Santiago, Santiago de Compostela, Spain

24 Hospital Joan XXIII, Tarragona, Spain

25 Hospital Clinico Universitario, Valencia, Spain

26 Hospital Universitario de Cabueñes, Gijón, Spain

27 Hospital Universitario de Torrejón. Universidad Francisco de Vitoria., Torrejón de Ardoz, Spain

28 Hospital Nuestra Senora de la Candelaria, Santa Cruz de Tenerife, Spain

29 Instituto Biodonostia, CIBEREHD, San Sebastián, Spain

30 Hospital Universitario de Álava, Vitoria, Spain

31 Hospital Virgen de la Victoria, Málaga, Spain

32 Consorci Hospitalari de Vic, Universitat de Vic-UCC, Vic, Spain

33 Hospital Universitari Germans Trias i Pujol, CIBEREHD, Badalona, Spain

34 Hospital Universitari Germans Trias i Pujol, CIBEREHD & Universitat Autònoma de Barcelona, Badalona, Spain

Summary

AI Generated

In a retrospective study of 339 patients with steroid-refractory acute severe ulcerative colitis treated with infliximab, conventional induction dosing was associated with significantly lower colectomy rates than escalated or accelerated regimens.

Patients receiving conventional infliximab induction (5mg/kg at 0, 2, and 6 weeks) had colectomy rates of 1.5% at 30 days, 3.9% at 90 days, and 9.6% at one year, compared to 12.9%, 15.2%, and 20.9% respectively in those receiving escalated or accelerated regimens.
Conventional induction was the only protective factor against colectomy at 30 days (OR 0.08) and 90 days (OR 0.19) in logistic regression analysis.
Patients who received escalated or accelerated regimens had significantly lower baseline albumin levels and lower rates of prior thiopurine exposure, suggesting these regimens were used in patients with more severe disease presentations.
No differences were observed between conventional and intensified regimens in rates of steroid reintroduction or infliximab discontinuation within the first year.
This registry study may be of interest to gastroenterologists managing acute severe ulcerative colitis and considering infliximab induction strategies.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Acute severe flares occur in 15% of patients with ulcerative colitis (UC). Intravenous corticosteroids induce clinical remission in up to 50-60% of cases. Infliximab (IFX) and cyclosporin (CsA) are the only evidence-based alternatives to colectomy in steroid-refractory acute severe UC (SRASUC), with a similar efficacy. It has been suggested that a more aggressive induction regimen of IFX might decrease the rate of colectomy.

Aims & Methods

To evaluate the short and mid-term outcomes of patients with SRASUC treated with IFX regarding the used induction regimen.
Methods: Retrospective, observational study including adult patients included in the ENEIDA registry supported by GETECCU, treated with IFX (at least two doses) due to SRASUC and available follow-up of at least 3 months or until colectomy or death. Dates and dosing of the first three IFX infusions, dose-escalation or treatment discontinuation, colectomy and date were collected. Induction regimens were grouped as follows: CONVENTIONAL (IFX 5mg/kg at 0, 2 and 6 weeks), ESCALATED (any of the first three infusions >5mg/kg) and ACCELERATED (second infusion administered before 11 days of the first one, or third infusion administered before 21 days of the second one).

Results

A total of 339 patients were included, 59% with extensive UC and 34% previously exposed to thiopurines. At the time of the first IFX infusion, median partial Mayo score was 7 (IQR, 6-8), median Mayo endoscopic subscore 3 (IQR, 2-3) and median C-reactive protein 49 mg/L (IQR, 18-99). IFX was started after a median of 7 days (IQR, 6-8) on iv steroids, with concomitant thiopurines in 51% of the cases. The induction regimen was conventional in 207 patients (61%), escalated in 81 (24%), and accelerated in 99 (29%), although 48 (14%) used escalated and accelerated regimens together. Partial Mayo score, Mayo endoscopic subscore and C-reactive protein levels at the time of the first IFX infusion were not significantly different between those patients following conventional regimen and those who did not; baseline serum albumin levels (29.9±0.7 vs 32.3±0.9 g/L; P=0.002) and prior exposure to thiopurines (38.2% vs 25.9%; P=0.022) were significantly lower in patients who followed escalated or accelerated regimens. One hundred and thirty-three patients (39%) discontinued IFX within the first year due to failure (no response or partial response) in 72 (21%), adverse event in 45 (13%), complete remission in 9 (3%) and patient’s willingness in 5 (2%).
The colectomy rate at 30 days, 90 days and 12 months in the whole series was 6%, 8% and 13%, respectively. Patients who followed a full conventional regimen had significantly lower rates of colectomy at 30 (1.5% vs 12.9%; p<0.0001), 90 days (3.9% vs 15.2%; p<0.0001) and 1 year (9.6% vs 20.9%; p=0.004). In the logistic regression analysis, following a conventional induction regimen was the only protective factor of colectomy at 30 (OR 0.08 95%CI 0.02-0.36) and 90 days (OR 0.19 95%CI 0.07-0.54).
No differences were observed among conventional and intensified induction regimens in terms of steroid reintroduction and IFX discontinuation within the first year.

Conclusion

In clinical practice, accelerated and/or escalated induction regimens of IFX are used in almost half of the patients with SRASUC. Accelerated and escalated induction regimens were associated with significantly higher rates of colectomy at one and three months. Therefore, no benefit of using these modified induction regimens was found on the basis of current clinical practice decision-making criteria.

Disclosure

Eugeni Domènech has served as a speaker, or has received research or education funding or advisory fees from AbbVie, Adacyte Therapeutics, Biogen, Celltrion, Galapagos, Gilead, GoodGut, Imidomics, Janssen, Kern Pharma, MSD, Pfizer, Roche, Samsung, Takeda, Tillots.

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

PP 05 IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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