| Title: |
DOP108 Randomised controlled trial of withdrawal of thiopurines in patients with IBD switching from intravenous to subcutaneous infliximab: Results of the MINIMISE study |
| Authors: |
Irving, P M; Centritto, A; Choon, X Y; Yeo, J H; Blad, W; Talbot, A; Fitzgerald, A L; Whitehead, E; Elford, A; Colwill, M; Baillie, S; Pramanik, R; Ayis, S; Goubar, A; Arenas Hernandez, M; Cordle, J; Lees, C; Pollok, R; Sebastian, S; Dart, R; Samaan, M; Harrow, P |
| Source: |
Journal of Crohn’s and Colitis ; volume 20, issue Supplement_1 ; ISSN 1873-9946 1876-4479 |
| Publisher Information: |
Oxford University Press (OUP) |
| Publication Year: |
2026 |
| Description: |
Background Combining thiopurines (TP) with intravenous (IV) infliximab (IFX) decreases the rate of immunogenicity. Subanalyses of registration studies show that subcutaneous (SC) IFX may be associated with a decreased chance of developing anti-drug antibodies (ADAb) compared to IV IFX. However, there are no randomised controlled trials (RCT) to inform the decision of whether to continue or discontinue TP when switching from IV to SC. Methods We conducted a multicentre, RCT of TP withdrawal in patients switching from IV to SC IFX. Patients with IBD in stable remission (HBI ≤4 or SCCAI ≤2) who had been receiving IV IFX for at least 22 weeks at stable doses of up to 5mg/kg q4w or 10mg/kg q8w along with a TP were randomised to continue or discontinue the TP. Patients had therapeutic IFX drug levels (DL) at screening and were stratified by HLA DQA1*05 status. Primary outcome was the proportion of patients who developed free antidrug antibodies (ADAb) at week 24 (ie detectable antibodies in the absence of detectable drug). Using a non-inferiority design to detect a 15% difference, 102 patients were required to meet the target of 88 evaluable patients at week 24. Results 102 patients (63=CD, 39=UC, 5=IBD-U) were randomised (Table 1). For the primary outcome, detection of free ADAb at 24W, 88 patients were evaluable (2 patients withdrew early, 8 patients attended outside 1 week window for week 24 assessment, 4 patients did not provide week 24 samples). TP withdrawal was non inferior to continuation (difference -2.4 (95% CI: -12.3 to 5.4) P = 0.46). 1/41 patients in the stop group developed free ADAb compared with 0/47 in the continue group; a sensitivity analysis including the samples from the early withdrawal patients and the patients who provided late samples at week 24, none of whom developed free ADAb, did not change the outcome. HLA DQA1*05 status did not affect IFX DL, nor free or total ADAb formation. Median IFX levels (ug/ml) at weeks 8, 16 and 24 were 15.5, 17.7 and 18.4 in the continue arm vs 17.0, ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1093/ecco-jcc/jjaf231.145 |
| Availability: |
https://doi.org/10.1093/ecco-jcc/jjaf231.145; https://academic.oup.com/ecco-jcc/article-pdf/20/Supplement_1/jjaf231.145/66498443/jjaf231.145.pdf |
| Rights: |
https://academic.oup.com/pages/standard-publication-reuse-rights |
| Accession Number: |
edsbas.DAC3F873 |
| Database: |
BASE |