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

Data de publicação: Data Ahead of Print:

Autores da FMUP

  • Fernando José Magro Dias

    Autor

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

ALIMENTARY PHARMACOLOGY & THERAPEUTICS  Wiley-Blackwell Publishing Ltd

Tipo:
Article
Páginas:
175-185
Link para outro recurso:
www.scopus.com

Citações Recebidas na Web of Science: 5

Citações Recebidas na Scopus: 4

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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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