One in three Crohn’s disease patients undergo ustekinumab dose intensification

Intensifying the dose of ustekinumab to 4- or 6-weekly is a common recourse among Crohn’s disease (CD) patients, a recent study has found. Patients who had failed prior therapies are more likely to see such intensification.

A team of researchers conducted a retrospective observational cohort analysis of 163 CD patients (median age at diagnosis, 23 years, 43.6 percent men) who had been treated with ustekinumab. Over a median follow-up of 20.3 months, five patients (30.7 percent) saw dose intensification to 4-weekly, while another five (3.1 percent) were increased to 6-weekly.

Majority of these intensifications were due to the lack of steroid-free clinical remission (85.6 percent). Other major reasons included biochemical disease activity as assessed by C-reactive protein (61.8 percent) or faecal biomarkers (65.5 percent). In five patients, clinical disease activity alone was enough to trigger dose escalation.

Multivariable Cox regression analysis revealed that concomitant steroid use nearly doubled the risk of ustekinumab dose intensification to 4- or 6-weekly (hazard ratio [HR], 1.8, 95 percent confidence interval [CI], 1.0–3.1).

Prior exposure to and failure of antitumour necrosis factor and vedolizumab medication was also a strong risk factor, increasing the likelihood of intensification by nearly 10 times (HR, 9.5, 95 percent CI, 1.3–70.9).

“Patients who failed two or more biologics were more likely to dose intensify,” the researchers said. “These are a very refractory group of CD patients, of whom many have no licensed treatment options available.”