Clinical decision support tool-guided, selective intensive induction strategy of ustekinumab in patients with Crohn's disease: A multicenter cohort study

Objectives: We aimed to evaluate the effectiveness and safety of clinical decision support tool (CDST)-guided initial selective intensive induction therapy (IIT) for patients with Crohn's disease (CD) who were treated with ustekinumab (UST) and to identify those most likely to benefit from IIT.

Methods: Patients with active CD were included in this multicenter retrospective study and were categorized as low-, intermediate-, and high-probability responders according to the UST-CDST. IIT was defined as intensive induction by two or three initial doses of weight-based intravenous UST administration. Patients treated with standard therapy (ST) served as controls. The primary end-point was corticosteroid-free clinical remission (CFCR) at Week 24. Secondary end-points included clinical remission, clinical response, endoscopic remission, endoscopic response, and C-reactive protein (CRP) normalization at Week 24. Propensity score adjustments was conducted to ensure comparability.

Results: A total of 296 patients were included. At Week 24, IIT was associated with higher rates of CFCR (72.3% vs 43.0%, p < 0.001), clinical remission (77.3% vs 47.1%, p < 0.001), clinical response (78.1% vs 60.1%, p = 0.001), endoscopic remission (26.1% vs 9.9%, p = 0.024), and endoscopic response (58.6% vs 36.9%, p = 0.018) in low-intermediate-probability responders compared with ST. CRP normalization was comparable between groups. No significant differences were found in any end-points in high-probability responders. No serious adverse events were observed.

Conclusion: The efficacy of IIT was superior to that of ST in patients with predicted poor response to UST, which may be regarded as a novel strategy for stratifying patients at baseline.