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MYCOPHENOLATE MOFETIL IS SUPERIOR FOR THE INDUCTION OF REMISSION TO AZATHIOPRINE IN NEWLY DIAGNOSED AUTOIMMUNE HEPATITIS [CAMARO TRIAL]

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Introduction

In all present guidelines the classical predniso(lo)ne/azathioprine regimen is recommended to induce complete remission in patients with autoimmune hepatitis (AIH). Cessation of azathioprine is, however, necessary in approximately 15% of patients due to side effects. In uncontrolled studies, mycophenolate mofetil (MMF) has demonstrated a potent effect in achieving complete remission in the majority of patients with AIH, and seems to have less adverse events. The aim of this study was to compare the potential benefits of first-line MMF over azathioprine, both in combination with predniso(lo)ne, as induction therapy in patients with treatment-naive AIH.

Aims & Methods

In this 24-week, prospective, randomised, open-label, multicentre superiority trial we enrolled 70 patients with AIH. Treatment was started with predniso(lo)ne at 40 or 60 mg daily (depending on weight) and subsequently tapered to a minimum of 5 mg daily according to a dosing scheme. After 4 weeks, patients were randomly allocated (1:1) to either MMF (max. daily dose 2000 mg) or azathioprine (max. daily dose 100 mg). The primary endpoint was biochemical remission at 24 weeks, defined as serum levels of alanine aminotransferase and immunoglobulin G below the upper limit of normal (intention-to-treat population). Secondary endpoints included safety and tolerability of MMF and azathioprine, time to remission, and adverse events. Safety was assessed in all patients having taken at least one dose of the study drug. The trial was registered with ClinicalTrials.gov, #NCT02900443.

Results

70 patients (mean 57.9 years (standard deviation (SD) 14.0); 72.9% female) were randomly assigned to MMF plus prednis(ol)one (n=39) or azathioprine plus prednis(ol)one (n=31). The primary endpoint was met in 55.3% of patients assigned to MMF and in 25.8% assigned to azathioprine (difference, 29.5 percentage points; 95% confidence interval, 6.1 to 48.5; p=0.014). Treatment-related severe adverse events were absent with MMF and occurred in 3 patients in the azathioprine group (9.7%) (p=0.082). In the azathioprine group there was a higher discontinuation rate due to adverse events compared to MMF (25.8% vs. 5.1%, resp., p=0.018). There was no difference in the mean cumulative prednis(ol)one dose between the azathioprine group and MMF group (1834 mg (SD 544) vs.1944 mg (SD 475), resp., p=0.369). The mean azathioprine dose was 1.16 mg/kg/day (SD 0.22). The mean MMF dose was 1853.4 mg/day (SD 168.75).

Conclusion

In this prospective, randomised trial, MMF was superior to azathioprine for induction of remission in treatment-naive patients with AIH. Adverse events led to cessation of the immunomodulator more often with azathioprine than with MMF.

Disclosure

Prof. Thomas Vanwolleghem has received grants from Gilead Sciences, Roche, Bristol Myers Squibb; a consultant for Janssen Pharmaceuticals, Gilead Sciences, Abbvie, Bristol Myers Squibb; sponsored lecturer for W.L. Gore, Gilead Sciences, Bristol Myers Squibb

MYCOPHENOLATE MOFETIL IS SUPERIOR FOR THE INDUCTION OF REMISSION TO AZATHIOPRINE IN NEWLY DIAGNOSED AUTOIMMUNE HEPATITIS [CAMARO TRIAL]

Anna Stoelinga 1, Romee Snijders 2, Maaike Biewenga 1, Simon Pape 2, Tom Johannes Gerardus Gevers 2, Maarten Tushuizen 1, Robert C. Verdonk 3, Hendrik J.M. de Jonge 4, Jan Maarten Vrolijk 5, Sjoerd Bakker 6, Thomas Vanwolleghem 7, Ynto De Boer 8, Martine A.C. Baven-Pronk 9, Ulrich Beuers 10, Adriaan J. Van Der Meer 11, nicole van gerven 12, Marijn Sijtsma 13, BC Eijck 14, Manon van IJzendoorn 15, Margot van Herwaarden 16, Floris van den Brand 17, Kerem Sebib Korkmaz 18, Aad P. van den Berg 19, Maureen M. J. Guichelaar 20, Amar D. Levens 1, Bart van Hoek 1, Joost Drenth 21

1 Leiden University Medical Center, Leiden, Netherlands

2 Radboud University Medical Center, Nijmegen, Netherlands

3 St. Antonius Hospital, Nieuwegein, Netherlands

4 Jeroen Bosch Hospital, 's-Herotgenbosch, Netherlands

5 Rijnstate Hospital, Arnhem, Netherlands

6 Elisabeth-Tweesteden Hospital, Tilburg, Netherlands

7 Antwerp University Hospital, Antwerpen, Belgium

8 Amsterdam University Medical Centers, location VU Medical Center, Amsterdam, Netherlands

9 Groene Hart Hospital, Gouda, Netherlands

10 Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands

11 Erasmus MC, Rotterdam, Rotterdam, Netherlands

12 Rode Kruis Hospital, Beverwijk, Netherlands

13 Sint Jansdal Hospital, Harderwijk, Netherlands

14 Spaarne Gasthuis, Haarlem, Netherlands

15 Hospital Bernhoven, Uden, Netherlands

16 Deventer Ziekenhuis MDL, Gorssel, Netherlands

17 OLVG Oost, Amsterdam, Netherlands

18 IJselland Hospital, Capelle aan den Ijssel, Netherlands

19 University Medical Center Groningen, Groningen, Netherlands

20 Medisch Spectrum Twente, Enschede, Netherlands

21 Radboudumc University Nijmegen Medical Centre, Nijmegen, Netherlands

Event

UEG Week Copenhagen 2023

Topics

Hepatobiliary

Submission format

Abstract

Session

Autoimmune hepatitis and colangiopathies: Update on management and outcome

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

UEG Presentation

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Familial pancreatic cancer: Yes or no to screening

Thomas M. Gress 1, Kasper Overbeek 2

1 Philipps Universität Marburg, Marburg, Germany

2 Erasmus MC Cancer Institute, University Medical Center, Rotterdam, Netherlands

Event

UEG Postgraduate Teaching Programme Berlin 2025

Session

Hereditary GI cancer syndromes: Surveillance strategies

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

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Introduction

Treatment goals in inflammatory bowel disease (IBD) have evolved beyond symptom control to include mucosal healing, prevention of disease-related complications, improvement of health-related quality of life, and reduction of long-term disability, as outlined by the STRIDE II initiative¹. Despite significant progress in the development of advanced therapies (ADTs), up to 50% of IBD patients fail to respond to currently available treatments, underscoring the urgent need for new therapies, which are investigated in randomized clinical trials (RCTs). However, stringent eligibility criteria in RCTs limit the inclusion of real-world IBD patients, potentially compromising the generalizability of trial findings to daily clinical practice.

Aims & Methods

The aim of this study was to evaluate the proportion of real-life IBD patients who would be eligible for ongoing RCTs and to assess the representativeness of this population. Moreover, we aimed to identify the most frequently unmet eligibility criteria leading to patient exclusion and to characterize the clinical profiles that differentiate eligible from ineligible patients.
This prospective, observational, multicenter study was conducted between October 2023 and October 2024 at 2 tertiary IBD referral centers: the Fondazione Policlinico Universitario “A. Gemelli” in Rome, Italy, and the Crohn’s & Colitis Center at the University of Miami, USA. Consecutive patients with IBD indicated for a new ADT were enrolled. Each patient was systematically screened for inclusion and exclusion criteria across all actively recruiting phase 2b and 3 RCTs available at each center at the time of evaluation (6 RCTs in Rome: 4 UC and 2 CD; 5 RCTs in Miami: 3 UC and 2 CD).

Results

A total of 166 IBD patients (69 UC and 97 CD) were enrolled, with 129 patients from the Italian cohort and 37 from the American cohort. Among UC patients, only 16 (23.2%) met the eligibility criteria for at least 1 RCT, whereas 53 (76.8%) were deemed ineligible (p<0.001). In the CD group, just 10 patients (10.3%) were eligible for at least 1 RCT, compared to 87 (89.7%) who were not (p<0.001). The most common reasons for ineligibility among UC patients included: Modified Mayo score not within the required range of 5–9 (50.7%), absence of bowel urgency (63.8%), Mayo Endoscopic Subscore <2 (39.1%), failure to comply with ADT washout requirements (56.5%), insufficient number of prior ADT failures (39.0%), and recent use of topical 5-ASA or steroids within 4 weeks prior to screening (62.3%).
In CD patients, the most frequently unmet criterion was a CDAI between 220 and 450 (92.8%), followed by insufficiently liquid stool frequency (≥4 very soft or liquid stools/day; 75.3%), SES-CD<6 (39.2%), and the presence of CD-related complications such as strictures or fistulas (13.1%).

Conclusion

The majority of real-life IBD patients, particularly those with CD, are ineligible for participation in current RCTs—primarily due to relatively mild disease activity or ongoing need for concomitant therapies that are not permitted by trial protocols. Importantly, many real-world CD patients initiate new ADTs based on radiologic signs of disease activity, the presence of disease complications, or as prophylaxis for post-surgical recurrence, rather than clinical activity scores alone. Similarly, UC patients may require ADTs even in the context of corticosteroid dependence and low-grade disease activity. These findings underscore the need to revisit and broaden eligibility criteria in future RCTs to ensure greater external validity and alignment with the heterogeneity of real-life IBD population.

References

1. Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Schölmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19. PMID: 33359090.

REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

Federica Di Vincenzo 1, Stephanie Ioannou 2, Chiara Principessa 3, Ivan Capobianco 1, Antonio Gasbarrini 4, Lucrezia Laterza 4, Maria T. Abreu 5, Franco Scaldaferri 4

1 Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy

2 University of Miami - Jackson Health System, Miami, United States

3 Università Cattolica del Sacro Cuore, Roma, Italy

4 Fondazione Policlinico Universitario "A. Gemelli", IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy

5 University of Miami Miller School of Medicine, Department of Medicine, Division of Gastroenterology, Miami, FL 33136; F. Widjaja Inflammatory Bowel Disease Institute, Cedars-Sinai Medical Center, Los Angeles, United States