OP40 Analysis of clinical features associated with favourable outcomes from ustekinumab treat-to-target strategy in Crohn’s Disease patients in the STARDUST trial

Autor:	M Lahaye, Silvio Danese, M Le Bars, Laurent Peyrin-Biroulet, I Bravatà, M Nazar, Daniel R. Gaya, Fernando Magro, Axel Dignass, Julià Panés, Severine Vermeire, G R D’Haens, Lioudmila Ni
Rok vydání:	2021
Předmět:	medicine.medical_specialty Crohn's disease Standard of care business.industry Gastroenterology Signs and symptoms Treat to target General Medicine medicine.disease Crohn's Disease Activity Index Illness length Internal medicine Ustekinumab Medicine Pathologic fistula business medicine.drug
Zdroj:	Journal of Crohn's and Colitis. 15:S039-S039
ISSN:	1876-4479 1873-9946
DOI:	10.1093/ecco-jcc/jjab075.039
Popis:	Background The 48-week (W) interventional STARDUST trial assessed whether a treat-to-target (T2T) strategy using ustekinumab (UST) may optimize Crohn’s disease (CD) outcomes; primary efficacy and safety data have been reported before.1 Here we assessed which patient (pt) subgroups may benefit from T2T vs standard of care (SoC) in achieving endoscopic response after 1 year of UST treatment. Methods Adult pts with moderate–severely active CD (CD activity index [CDAI] 220–450) and Simple Endoscopic Score in CD [SES-CD] ≥3) who failed conventional therapy and/or 1 biologic were included. Pts received iv, weight-based UST ~6 mg/kg at W0 (baseline [BL]); then SC UST 90 mg at W8. At W16, CDAI 70 responders were randomized (1:1) to T2T or SoC arms. Pts in the T2T arm were assigned to SC UST q12w or q8w based on 25% improvement in SES-CD score vs BL. From W16–48, UST dose was further intensified up to q4w if the following were not met: CDAI 16] at BL) as independent variables. Results Of 500 pts enrolled, 441 were randomized to T2T (n=220) or SoC (n=221); 79.1% and 87.3% completed W48. At W48, pts randomized to T2T were more likely to achieve endoscopic response compared to SoC (pmedian [79.1 months]; OR 2.2; 95%CI 1.17–3.94); (ii) clinically moderate disease (CDAI ≤300; OR 1.7; 95%CI 1.03–2.76); (iii) normal FCal (≤250; OR 3.0; 95%CI 1.22–7.56), (iv) endoscopically active CD (SES-CD ≥4 for ileal or ≥6 for colonic and/or ileocolonic disease; OR 1.8; 95%CI 1.10–2.91); and (v) history or presence of strictures/fistula or occurrence of an intra-abdominal abscess (OR 2.3; 95%CI 1.06–5.01 and OR 3.5; 95%CI 1.07–11.19, respectively; Figure 1). Conclusion T2T was more effective than SoC (p Reference
Databáze:	OpenAIRE
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