Control Crohn Safe with episodic adalimumab monotherapy as first-line treatment study (CoCroS): study protocol for a...

Area of Science:

• Gastroenterology
• Immunology
• Clinical Trials

Background:

• Crohn's disease (CD) is a chronic inflammatory bowel disease with unpredictable clinical courses.
• Current treatment strategies often involve a step-up approach, starting with corticosteroids, which may lead to overtreatment in some patients.
• Predictive markers for disease progression at diagnosis are lacking, highlighting the need for refined therapeutic strategies.

Purpose of the Study:

• To evaluate the efficacy of episodic adalimumab monotherapy compared to standard step-up care in newly diagnosed or flaring CD patients.
• To assess if this strategy improves long-term outcomes, reduces drug-related side effects, and prevents overtreatment.
• To investigate the impact on clinical remission, biochemical markers, healthcare costs, and patient-reported outcomes.

Main Methods:

• A pragmatic, multicentre, randomised controlled trial comparing episodic adalimumab monotherapy (24 weeks) with step-up care (corticosteroids).
• Inclusion criteria: newly diagnosed or flaring CD patients, naive to thiopurines and biologicals.
• Primary outcome: yearly quarters of corticosteroid-free clinical and biochemical remission at 96 weeks.

Main Results:

• The study is ongoing, and results are not yet available.
• The primary outcome measure focuses on sustained remission and corticosteroid avoidance.
• Secondary outcomes include healthcare costs, endoscopic remission, quality of life, and safety events.

Conclusions:

• The study hypothesises that episodic adalimumab, combined with close monitoring, can optimize long-term outcomes in Crohn's disease.
• This approach aims to balance treatment efficacy with reduced side effects and healthcare costs.
• Findings will inform personalized treatment strategies for Crohn's disease management.