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LONG-TERM COMPARISON OF ADVANCED THERAPIES FOR INFLAMMATORY BOWEL DISEASE (IBD): RESULTS FROM THE TARGET REGISTER FOR PATIENTS WITH IBD IN GERMANY

Sandra Plachta-Danielzik 1, Elena Gilman 1, Philipp Efken 2, Wolfgang Mohl 3, Frank Holtkamp-Endemann 4, Manfred von der Ohe 5, Samantha Fajardo Salmon 1, Sina Langness 1, Ulrich Tappe 6, Stefan Schreiber 7, Bernd Bokemeyer 8

Affiliations

1 Competence Network IBD, Kiel, Germany

2 Gastroenterology Practice, Minden, Germany

3 Zentrum fur Gastroenterologie Saar MVZ GmbH, Saarbrücken, Germany

4 Gastroenterology Practice, Münster, Germany

5 Gastroenterologische Gemeinschaftspraxis Herne, Herne, Germany

6 Gastropraxis an der St. Barbaraklinik, Hamm, Germany

7 University Hospital Schleswig-Holstein, Kiel, Germany|||Competence Network IBD, Kiel, Germany

8 Interdisciplinary Crohn Colitis Center, Minden, Germany|||Competence Network IBD, Kiel, Germany

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Abstract

Introduction

The options for treating chronic inflammatory bowel disease (IBD) with biologics and small molecules (advanced therapies (AT)) have expanded considerably in recent years with the approval of new targeted drugs, some of which have novel mechanisms of action. Direct comparison of effectiveness in the real world is not easy. Therapy persistence measures the willingness of physicians and patients to continue treatment and is therefore a long-term indicator of the effectiveness and safety of a therapy.

Aims & Methods

The aim is to indirectly compare the treatment persistence of different ATs (adalimumab (ADA), infliximab (IFX), vedolizumab (VDZ), IL-12/23 and IL-23 inhibitors (IL-12/23) and JAK inhibitors (JAKi)) stratified by Crohn's disease (CD) and ulcerative colitis (UC).
The TARGET register collects data on the effectiveness and safety of ATs in IBD patients throughout Germany and is designed as a prospective, indication-stratified (CD and UC), multicentre, non-interventional cohort. Data are currently being collected after weekly follow-up during the induction phase and then every 6 months during maintenance therapy. In this analysis, data from 807 patients who were enrolled between November 2019 and December 2023 and followed in the TARGET registry for at least 12 months were analysed up to the cut-off date of 31 December 2024. Treatment persistence was calculated up to 5 years and compared using Kaplan-Meier (KM) curves (log-rank test).

Results

In patients with CD, there were 610 treatment courses with a newly started AT: 198 ADA, 161 IFX, 89 VDZ, 147 IL12/23 (140 UST, 7 RISA), 15 JAKi (1 TOFA, 14 UPA) with a mean observation period of 38, 38, 31, 31 and 9 months. The treatment groups differed in terms of disease duration and the proportion of biologic-experienced patients: both were lowest in the anti-TNF group (Table 1). The persistence rates at 5 years were 79.8% for ADA, 82.0% for IFX, 74.2% for VDZ, 85.7% for IL-12/23 and 100% for JAKi and were not statistically different (p=0.167).
In patients with UC, there were 339 treatment courses with newly initiated AT: 45 ADA, 102 IFX, 111 VDZ, 47 IL12/23 (46 UST, 1 MIRI), 34 JAKi (8 TOFA, 10 FIL, 16 UPA) with a mean observation period of 33, 35, 34, 23 and 16 months. The treatment groups differed in the proportion of patients with prior biologic exposure, which was lowest in the anti-TNF group (Table 1). The persistence rates at 5 years were 66.7% for ADA, 78.4% for IFX, 70.3% for VDZ, 59.6% for IL-12/23 and 91.2% for JAKi. IFX was statistically superior to IL-12/23 (p=0.014).

Table 1: Patient baseline characteristics at the start of therapy stratified by therapy
Therapy (n (CD/UC))	ADA (198/45)	IFX (161/102)	VDZ (89/111)	IL-12/23 (147/47)	JAKi (15/34)	p value
Crohn's Disease: age [years]	39.5 ± 13.0	38.8 ± 13.4	40.7 ± 13.3	41.7 ± 13.8	41.2 ± 13.9	0.188
disease duration [years]	11.9 ± 9.8	12.0 ± 9.9	14.1 ± 11.2	14.2 ± 10.9	12.2 ± 10.1	0.037*
biologic experienced [%]	43.9%	62.1%	84.3%	81.0%	100.0%	<0.001*
previous immunosuppressants [%]	67.7%	62.7%	71.9%	72.1%	93.3%	0.084
Ulcerative colitis: age [years]	40.5 ± 13.7	38.7 ± 14.3	41.3 ± 13.6	40.9 ± 13.3	40.8 ± 13.7	0.723
disease duration [years]	12.9 ± 10.7	10.2 ± 8.8	12.7 ± 10.9	10.9 ± 8.7	10.5 ± 8.4	0.296
biologic experienced [%]	51.1%	57.8%	58.6%	93.6%	100.0%	<0.001*
previous immunosuppressants [%]	53.3%	61.8%	64.9%	57.4%	76.5%	0.263

* significant differences between therapy groups (Kruskal-Wallis test/Chi-square test)

Conclusion

All patients showed high AT persistence rates of approximately 60-80% up to 5 years, with only minor differences between the different lines of therapy in this current analysis.

Disclosure

PE has received personal fees from: AbbVie, BMS, Galapagos, Janssen, and Amgen, outside the submitted work.
WM has received consulting fees from: AbbVie, Advanz, Amgen, Biogen, Bristol-Myers Squibb, Ferring, Fresenius Kabi, Galapagos, Hexal, Janssen, and Takeda, outside the submitted work. Fees for lectures and further education from: AbbVie, alanta health service, Bristol-Myers Squibb, Galapagos, Janssen, Pfizer, Takeda, and Tillotts, outside the submitted work. He is an active member of the following public law bodies: Advisory Commission of the Examination Office for the Saarland, the State Committee of Physicians and Health Insurance Companies and the Extended State Committee, and an employee in a company belonging to Alanta health group GmbH, Hamburg, Germany, outside the submitted work. Shares, other fees from: AbbVie outside the submitted work.
UT has served as a consultant for Ferring, Abbvie, Janssen-Cilag, Falk-Foundation outside the submitted work.
BB has served as a consultant or advisory board member for Abbvie, MSD, Shire, Ferring, Takeda, Movetis, Shield Therapeutics, Pfizer, Biogen, Janssen, Hexal, Cellgene, Allergan, Galapagos, Arena, BMS, Merckle, Falk and Celltrion outside the submitted work.
SS has served as a consultant or advisory board member for AbbVie, Amgen, Arena, Bristol Myers Squibb, Biogen, Celltrion, Celgene, Ferring, Fresenius, Galapagos, Gilead, HIKMA, IMAB, Janssen, Lilly, MSD, Mylan, Pfizer, Protagonist, Provention Bio, Sandoz/Hexal, Takeda, Theravance and UCB outside the submitted work.
SPD, EG, FHE, MvdO, SFS and TW have no relevant financial or non-financial interests to disclose.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Advanced IBD therapies: Lessons over time (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Bernd Bokemeyer

A	CD Age Family history of IBD Smoker Behaviour disease B1 (inflammatory) B2 (stricturing) B3 (fistulising) Perianal	HR (95% CI) 0.99 (0.98-1.00) 1.29 (1.06-1.57) 1.26 (1.06-1.50) Ref 1.89 (1.50-2.39) 2.35 (1.79-3.10) 1.86 (1.47-2.35)	P-value <0.001 0.010 0.002 <0.001 <0.001 <0.001
	UC Age Smoker Extension Proctitis Left-side colitis Pancolitis	0.99 (0.99-1.00) 0.56 (0.35-0.89) Ref 2.33 (1.62-3.36) 5.02 (3.59-7.03)	0.047 0.015 <0.001 <0.001
B	CD Behaviour disease B1 (inflammatory) B2 (stricturing) B3 (fistulising) Exposure to biologics/JAKi before surgery No exposure to treatment Exposure to treatment Early exposure to treatment Exposure to Immunomodulators before surgery No exposure to treatment Exposure to treatment Early exposure to treatment	HR (95% CI) Ref 5.52 (3.62-8.42) 8.68 (5.55-13.58) Ref 0.73 (0.45-1.78) 1.29 (0.84-1.98) Ref 0.23 (0.11-0.46) 0.33 (0.22-0.49)	P-value <0.001 <0.001 0.197 0.245 <0.001 <0.001
	UC Extension Proctitis Left-side colitis Pancolitis Exposure to biologics/JAKi before surgery No exposure to treatment Exposure to treatment Early exposure to treatment Exposure to Immunomodulators before surgery No exposure to treatment Exposure to treatment Early exposure to treatment	HR (95% CI) Ref 2.00 (0.53-7.53) 2.33 (0.64-8.45) Ref 2.70 (0.93-7.87) 11.86 (4.62-30.42) Ref 0.50 (0.16-1.58) 0.89 (0.37-2.15)	P-value 0.311 0.199 0.068 <0.001 0.238 0.973
C	CD Smoker Behaviour disease B1 (inflammatory) B2 (stricturing) B3 (fistulising) Exposure to biologics/JAKi before hospitalisation No exposure to treatment Exposure to treatment Early exposure to treatment Exposure to Immunomodulators before hospitalisation No exposure to treatment Exposure to treatment Early exposure to treatment	HR (95% CI) 1.31 (1.09-1.57) Ref 1.69 (1.33-2.15) 1.63 (1.27-2.09) Ref 0.37 (0.24-0.56) 0.48 (0.32-0.72) Ref 0.39 (0.25-0.60) 0.59 (0.44-0.79)	P-value 0.004 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
	UC Extension Proctitis Left-side colitis Pancolitis Exposure to biologics/JAKi before hospitalisation No exposure to treatment Exposure to treatment Early exposure to treatment Exposure to Immunomodulators before hospitalisation No exposure to treatment Exposure to treatment Early exposure to treatment	HR (95% CI) Ref 4.02 (1.62-3.36) 10.77 (0.67-8.65) Ref 0.45 (0.22-0.91) 0.63 (0.19-2.07) Ref 0.67 (0.34-1.31) 0.77 (0.38-1.57)	P-value <0.001 <0.001 0.027 0.444 0.245 0.475