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

Abstract

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.