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Randomised controlled trial of withdrawal of thiopurines in patients with IBD switching from intravenous to subcutaneous infliximab: Results of the MINIMISE study

P.M. Irving, A. Centritto, X.Y. Choon, J.H. Yeo, W. Blad, A. Talbot, A.L. Fitzgerald, E. Whitehead, A. Elford, M. Colwill, S. Baillie, R. Pramanik, S. Ayis, A. Goubar, M. Arenas Hernandez, J. Cordle, C. Lees, R. Pollok, S. Sebastian, R. Dart, M. Samaan, P. Harrow

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Slides compiled by Dr. Sally Lawrence 

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Introduction

Background & Objectives

    • Combination IV infliximab (IFX) + thiopurine (TP) reduces immunogenicity risk and increases efficacy.
    • Registration study sub-analyses suggest SC IFX may have lower anti-drug antibody (ADAb) risk vs IV IFX. However, immunogenicity and the need for and the effect of combination therapy with SC IFX has not been evaluated in a randomized controlled setting.
    • Objective: In IBD patients in stable remission switching IV to SC IFX, to compare TP continuation vs TP withdrawal on immunogenicity.

TP, thiopurines; IFX, infliximab; ADAb, anti-drug antibody; IV, intravenous; SC, sub-cutaneous; HBI, Harvey-Bradshaw index; SCCAI, simple clinical colitis activity index; FC, fecal calprotectin; CRP, C-reactive protein

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

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Methods

    • Primary endpoint: free ADAb in the absence of detectable drug at w24
    • Key secondary endpoints: disease activity at w24 (HBI >4, SSCI >2), IFX drug levels at w8, 16, 24
  • Multicenter investigator initiated RCT of TP continuation vs. TP withdrawal after switch from IV to SC IFX (non inferiority design)

CD / UC in stable remission

IV IFX +TP ≥22 weeks

Stable dosing

Therapeutic IFX drug level

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Results: Subject flow through trial

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

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Randomized

n = 102

Continue

n = 52

Stop

n = 50

Week 24

n = 45

Week 24

n = 43

2 – Lost to FU

1 – Non compliance

4 – Outside 1 week window @ week 24

1 – Reversion to IV IFX

6 – Outside 1 week window @ week 24

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Baseline Demographics

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

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Characteristic

Overall (n=102)

Continue (N=52)

Stop (N=50)

Patient demographics

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Female n (%)

38 (37.3)

22 (42.3)

16 (32)

Male n (%)

64 (62.7)

30 (57.7)

34 (68)

Weight - Kg (med [range])

80.6 [51.3, 147.0]

83.5 [51.3, 147.0]

76.9 [52.3, 115.4]

Disease demographics

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Crohn’s disease n (%)

63 (62)

35 (67.3)

28 (56)

HBI (median [range])

0.0 [0.0, 6.0]

0.0 [0.0, 6.0]

0.0 [0.0, 3.0]

Ulcerative colitis/IBD-U* n (%)

39 (38)

17 (32.7)

22 (44.0)

SCCAI (median [range])

0.0 [0.0, 2.0]

0.0 [0.0, 2.0]

0.5 [0.0, 2.0]

Disease duration - years (med [range])

7.1 [0.5 to 38.0]

7.4 [0.5 to 35.0]

7.0 [1.0 to 38.0]

HLA DQA1*05 status n (%)

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Negative

63 (61.8)

32 (61.5)

31 (62)

Positive

39 (38.2)

20 (38.5)

19 (38)

Time on IV IFX - years

2.26 [0.3 to 19.0]

2.41 [0.3 to 19.0]

2.2 [0.3 to 16.2]

Immunomodulator

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Azathioprine n (%)

93 (91.2)

47 (90.4)

46 (92)

Mercaptopurine n (%)

9 (8.8)

5 (9.6)

4 (8)

Biomarkers (median [range])

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CRP - mg/L

1.0 [0.0, 7.0]

1.0 [0.0, 7.0]

1.0 [0.0, 6.0]

Faecal calprotectin - µg/g

38.0 [4.0, 4690]

40.5 [6.0, 1840]

29.0 [4.0, 4690]

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Results

TP, thiopurines; IFX, infliximab; ADAb, anti-drug antibody

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

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Primary Outcome: Free antibody positivity at w24

Patients with free antibodies

ITT cohort

N = 88

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Results: Secondary outcomes

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

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Drug levels

Total antibodies

Disease activity

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Conclusions

    • Discontinuation of thiopurine therapy was not associated with an increased incidence of free antibody production at 6 months following transition from maintenance IV to SC IFX in stable patients in clinical and biochemical remission.
    • Withdrawal of combination therapy did not appear to influence total antibody formation, SC IFX drug concentrations or clinical disease activity over 6 months.

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Significance to clinical practice

    • These findings suggest that SC IFX monotherapy may be a reasonable strategy following transition from maintenance IV combination therapy in clinically stable IBD patients.
    • Further prospective evaluation is warranted to characterize the pharmacokinetic, immunogenic and clinical implications of transitioning to SC IFX monotherapy during the induction phase of IFX therapy.

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Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

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