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OP34: VARSITY: A double-blind, double-dummy, randomised, controlled trial of vedolizumab versus adalimumab in patients with active ulcerative colitis
Year: 2019
Source: ECCO '19 Copenhagen
Authors:

Stefan. Schreiber1, Laurent. Peyrin-Biroulet2, Edward. V. LoftusJr.3, Silvio. Danese4, Jean-Frederic. Colombel5, Brihad. Abhyankar6, Jingjing. Chen7, Raquel. Rogers7, Richard. A. Lirio7, Jeffrey. D. Bornstein7, Bruce. E. Sands5

Created: Thursday, 28 February 2019, 8:13 AM
OP34: Whole blood profiling of T-cell derived miRNA allows the development of prognostic models in Inflammatory Bowel Disease
Year: 2020
Source: ECCO'20 Vienna
Authors: Rahul Kalla
Created: Tuesday, 23 June 2020, 5:40 PM
OP34: Whole blood profiling of T-cell derived miRNA allows the development of prognostic models in Inflammatory Bowel Disease
Year: 2020
Source: ECCO'20 Vienna
Authors: Rahul Kalla
Created: Tuesday, 23 June 2020, 4:58 PM
Files: 1
OP35 Treatment outcomes of inflammatory bowel disease in the biological era—a nationwide retrospective cohort study in three Nordic countries: Results from the TRINordic study
Year: 2020
Source:

ECCO'20 Vienna

Authors:

M. Zhao1, M. Lördal2, E. Langholz3, T. Knudsen4, M. Voutilainen5, M.L. Høivik6, B. Moum6, B. Saebo7, P. Haiko8, C. Malmgren9, M. Coskun10, H.O. Melberg11, J. Burisch12

Created: Thursday, 30 January 2020, 10:12 AM
OP35: Effect of maintenance ustekinumab on corticosteroid-free endoscopic and clinical outcomes in patients with Crohn's Disease - Week 48 analysis of the STARDUST trial
Year: 2021
Source: ECCO'21 Virtual
Authors: Danese, S.(1);Vermeire, S.(2);D’Haens, G.(3);Panés, J.(4);Dignass, A.(5);Magro, F.(6,7);Nazar, M.(8);Le Bars, M.(9);Lahaye, M.(10);Ni, L.(11);Bravatà, I.(12);Gaya, D.R.(13);Peyrin-Biroulet, L.(14)
Created: Wednesday, 2 June 2021, 4:12 PM
OP35: Effect of maintenance ustekinumab on corticosteroid-free endoscopic and clinical outcomes in patients with Crohn's Disease - Week 48 analysis of the STARDUST trial
Year: 2021
Source: ECCO'21 Virtual
Authors: Silvio Danese
Created: Friday, 1 October 2021, 12:41 PM
Background

The STARDUST study demonstrated that ustekinumab (UST), using either a treat-to-target (T2T) or standard of care (SoC) strategy, may induce and maintain endoscopic and clinical response and remission in Crohn’s disease (CD). Primary endpoint, safety, and efficacy have been reported previously.1 Because corticosteroid (CS) sparing is an important aim of CD management, we compared the efficacy of UST T2T vs SoC in achieving CS-free clinical remission and endoscopic response.

Methods

Adult patients (pts) with moderate–severely active CD who were CDAI 70 responders after 16 weeks (W) of induction, comprising a single dose of UST 6 mg/kg iv followed by UST 90 mg SC at W8, were randomized to either T2T or SoC arms. In the T2T arm, choice of UST maintenance dosage (q12w or q8w) was based on endoscopic improvement at W16, followed by clinical and biomarker-directed dose escalation up to q4w; in the SoC arm, UST q12w or q8w dosage was based on EU SmPC. Primary endpoint was endoscopic response (Simple Endoscopic Score in CD [SES-CD] decrease from baseline [BL] ≥50%) at W48. For pts on CS at W16, CS tapering was mandatory. At W48, CS-free clinical remission (CDAI <150 and no CS for ≥30 days) and CS-free endoscopic response (reduction from BL in SES-CD ≥50% and no CS for ≥30 days) were evaluated.

Results

Of 500 pts enrolled, 441 achieved a CDAI 70 response at W16 and were randomized to T2T (n=220) or SoC (n=221); 79.1% and 87.3%, respectively, completed W48. Among clinical remitters and responders at W16 (start of CS tapering), in both T2T and SoC arms more than 70% were still in remission or response at W48 (Figure 1). CS use throughout 48 weeks of treatment is summarized in Table 1. At W48, in T2T and SoC arms similar rates were noted for CS-free endoscopic response (33.6% and 28.5%, respectively) and CS-free clinical remission (56.4% and 63.3%, respectively). Notably, in T2T and SoC arms the CS-free clinical remission rate among pts on CS at BL was 44.1% and 45.1%, respectively (Figure 2). Among W48 endoscopic responders (T2T, n=83; SoC, n=66), CS-free endoscopic response rate was 89.2% and 95.5%, respectively; among W48 clinical remitters (T2T, n=135; SoC, n=154), CS-free clinical remission rate was 91.9% and 90.9%, in T2T and SoC arms, respectively.


Conclusion

Pts treated with UST under T2T or SoC strategies achieved similar rates of CS-free clinical remission and endoscopic response over 48 weeks. Overall for pts on CS at BL, UST reduced the need for CS while achieving response/remission. Most (>89%) pts with endoscopic response/clinical remission at W48 were also CS-free responders/remitters.  

1. Danese S, et al. United European Gastroenterol J. 2020;8:1264–1265 (Abstract LB11).

OP35: Efficacy and safety outcomes up to ~4 years of treatment with filgotinib 200 mg among patients with Ulcerative Colitis: Results from the SELECTIONLTE study
Year: 2023
Source: ECCO’23 Copenhagen
Authors: FeaganSenior Scientific Officer, B.G.(1)*;Matsuoka, K.(2);Rogler, G.(3);Faes, M.(4);Oortwijn, A.(5);de Haas, A.(6);Rudolph, C.(5);Peyrin-Biroulet, L.(7);
Created: Friday, 14 July 2023, 10:43 AM
OP35: Endoscopic and deep remission at 1 year prevents disease progression in early Crohn’s disease: long-term data from CALM
Year: 2019
Source:

ECCO '19 Copenhagen

Authors:

C. Yzet1, R. Ungaro*2, P. Bossuyt3, F. Baert4, T. Vanasek5, G. D’Haens6, V. Joustra6, R. Panaccione7, G. Novacek8, A. Armuzzi9, O. Golovchenko10, O. Prymak10, A. Goldis11, S. Travis12, X. Hébuterne13, M. Ferrante14, G. Rogler15, M. Fumery1, S. Danese16, G. Rydzewska17, B. Pariente18, E. Hertervig19, C. Stanciu20, J-C. Grimaud21, M-M. Diculescu22, L. Peyrin-Biroulet23, D. Laharie24, J. P. Wright25, F. Gomollón26, I. Gubonina27, S. Schreiber28, S. Motoya29, P. Hellström30, J. Halfvarson31, J-F. Colombel2

Created: Friday, 22 February 2019, 9:41 AM
OP35: Endoscopic and Deep Remission at 1 Year Prevents Disease Progression in Early Crohn’s Disease: Long-Term Data from CALM
Year: 2019
Source: ECCO'19 Copenhagen
Authors: Clara Yzet
Created: Tuesday, 28 May 2019, 3:32 PM
Natural history, Crohn’s disease, Prognosis, Adalimumab, Treat to target, Mucosal healing, Outcome measures, Mucosal healing
Files: 1
OP35: Natural history of anal ulcerations in pediatric-onset Crohn's Disease: A population-based study
Year: 2022
Source: ECCO'22
Authors: Mortreux, P.(1);Leroyer, A.(2);Dupont, C.(3);Ley, D.(4);Bertrand, V.(5);Spyckerelle, C.(6);Guillon, N.(2);Desreumaux, P.(1);Gower-Rousseau, C.(2);Savoye, G.(7);Fumery, M.(8);Turck, D.(4);Siproudhis, L.(9);Sarter, H.(2);
Created: Friday, 11 February 2022, 3:52 PM
OP36 Investigating the role of bioactives produced by gut bacteria to modulate immune response in inflammatory bowel disease
Year: 2020
Source:

ECCO'20 Vienna

Authors:

R. Giri1,2, K. Shamsunnahar3, A. Salim3, R. Capon3, M. Morrison4, P. O Cuiv4, J. Begun1,2

Created: Thursday, 30 January 2020, 10:12 AM
OP36: A colonic gene expression signature predicts non-response to anti-inflammatory therapies in inflammatory bowel disease
Year: 2019
Source:

ECCO '19 Copenhagen

Authors:

T. Sato*1, K. Li1, K. Hayden1, L. Tomsho1, F. Baribaud1, C. Brodmerkel1, L. E. Greenbaum1, J. R. Friedman1, M. Curran1, Y. Imai2, S. Plevy1, S. E. Telesco1

Created: Friday, 22 February 2019, 9:41 AM
OP36: Efficacy and safety of combination induction therapy with guselkumab and golimumab in participants with moderately-to-severely active Ulcerative Colitis: Results through week 12 of a phase 2a randomized, double-blind, active-controlled, parallel-group, multicenter, proof-of-concept study
Year: 2022
Source: ECCO'22
Authors: Sands, B.E.(1);Feagan, B.G.(2);Sandborn, W.J.(3);Shipitofsky, N.(4);Marko, M.(4);Sheng, S.(4);Johanns, J.(4);Germinaro, M.(4);Vetter, M.(4);Panés, J.(5);
Created: Friday, 11 February 2022, 3:52 PM
OP36: Investigating the role of bioactives produced by gut bacteria to modulate immune response in Inflammatory Bowel Disease
Year: 2020
Source: ECCO'20 Vienna
Authors: Rabina Giri
Created: Tuesday, 23 June 2020, 5:40 PM
OP36: Investigating the role of bioactives produced by gut bacteria to modulate immune response in Inflammatory Bowel Disease
Year: 2020
Source: ECCO'20 Vienna
Authors: Rabina Giri
Created: Tuesday, 23 June 2020, 4:58 PM
Files: 1
OP36: Real-world evidence on comparative effectiveness of Ustekinumab vs anti-TNF in Crohn's disease with propensity score adjustment: two-year maintenance phase results from the prospective observational RUN-CD study
Year: 2023
Source: ECCO’23 Copenhagen
Authors: Bokemeyer, B.(1,2,3)*;Plachta-Danielzik, S.(3);Deppe, H.(4);Mohl, W.(5);Teich, N.(6);Hoffstadt, M.(7);Schweitzer, A.(8);von der Ohe, M.(9);Gauss, A.(10);Atreya, R.(11);Krause, T.(12);Blumenstein, I.(13);Fajardo Salmon, S.(3);Hartmann, P.(4);Gilman, E.(3);Schreiber, S.(3,14);
Created: Friday, 14 July 2023, 10:43 AM