Clinical trial: Clinical and endoscopic outcomes with ustekinumab in patients with Crohn's disease: Results from the long-term extension period of STARDUST

Autores da FMUP
Participantes de fora da FMUP
- Peyrin-Biroulet, Laurent
- Vermeire, Severine
- D'Haens, Geert
- Panes, Julian
- Dignass, Axel
- Nazar, Maciej
- Le Bars, Manuela
- Lahaye, Marjolein
- Ni, Lioudmila
- Bravata, Ivana
- Lavie, Frederic
- Daperno, Marco
- Lukas, Milan
- Armuzzi, Alessandro
- Loewenberg, Mark
- Gaya, Daniel R.
- Danese, Silvio
Unidades de investigação
Abstract
Background: STARDUST, a phase 3b randomised trial, compared ustekinumab therapeutic strategies in patients with Crohn's disease (CD) using early endoscopic assessment and treat-to-target (T2T) versus standard of care (SoC). Aim: To assess the efficacy of ustekinumab extended treatment in a long-term extension (LTE) of up to 104 weeks with dosing adapted according to clinical, biomarker and endoscopy outcomes. Methods: Adults with moderately-to-severely active CD received intravenous ustekinumab approximating 6 mg/kg at Week 0 and subcutaneous ustekinumab 90 mg at Week 8. At Week 16, 440 >= 70-point responders were randomised to T2T or SoC and 323 entered the LTE. At Week 48, a unified, protocol-defined ustekinumab dose frequency escalation/de-escalation was applied based on achieving endoscopic remission and corticosteroid-free clinical remission. Achieving corticosteroid-free clinical remission and biomarker remission at consecutive visits determined ustekinumab dosing frequency. Dichotomous variables were analysed using non-responder imputation. Results: Among patients who entered the LTE, 7.7%, 48.6% and 43.7% received doses every 4, 8 and 12 weeks, respectively. Ustekinumab dose frequency was escalated in 23.5% and de-escalated in 19.7%. Endoscopic response and remission rates were 28.9% and 10.73% (all randomised) and 39.3% and 14.6% (patients entering the LTE), respectively, at Week 104. Clinical remission(a) rates at week 104 were 50.2% (all randomised) and 68.4% (patients entering the LTE). There were no new safety signals. Conclusion: STARDUST LTE is the first interventional ustekinumab efficacy study to show a favourable benefit-risk profile with preservation of clinical and endoscopic outcomes through Week 104 using flexible, algorithm-driven dose adjustment including de-escalation.
Dados da publicação
- ISSN/ISSNe:
- 0269-2813, 1365-2036
- Tipo:
- Article
- Páginas:
- 175-185
- DOI:
- 10.1111/apt.17751
- Link para outro recurso:
- www.scopus.com
ALIMENTARY PHARMACOLOGY & THERAPEUTICS Wiley-Blackwell Publishing Ltd
Citações Recebidas na Web of Science: 5
Citações Recebidas na Scopus: 4
Documentos
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Filiações
Keywords
- Adult; Biomarkers; Crohn Disease; Endoscopy, Gastrointestinal; Humans; Remission Induction; Treatment Outcome; Ustekinumab; adalimumab; azathioprine; beclomethasone dipropionate; biological marker; budesonide; calgranulin; certolizumab pegol; infliximab; new drug; ustekinumab; biological marker; ustekinumab; abdominal pain; adult; adverse drug reaction; arthralgia; Article; backache; clinical outcome; colonoscopy; controlled study; Crohn disease; demographics; drug blood level; drug dose escalation; drug efficacy; drug response; drug safety; drug withdrawal; feces level; female; fever; headache; health care quality; human; immunogenicity; infection; injection site reaction; long term care; major clinical study; male; malignant neoplasm; methodology; remission; rhinopharyngitis; statistical analysis; treat to target; treatment outcome; clinical trial; Crohn disease; gastrointestinal endoscopy; phase 3 clinical trial
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Citar a publicação
Peyrin L,Vermeire S,D'Haens G,Panes J,Dignass A,Magro F,Nazar M,Le M,Lahaye M,Ni L,Bravata I,Lavie F,Daperno M,Lukas M,Armuzzi A,Loewenberg M,Gaya DR,Danese S. Clinical trial: Clinical and endoscopic outcomes with ustekinumab in patients with Crohn's disease: Results from the long-term extension period of STARDUST. Aliment. Pharmacol. Ther. 2024. 59. (2):p. 175-185. IF:7,600. (1).