Study shows a significantly greater proportion of patients with Crohn disease who were administered ustekinumab every 8 weeks achieved a histologic response.
A study that evaluated the effects of ustekinumab, a commonly used therapy to treat moderate to severe Crohn disease (CD), found histologic improvement in a greater proportion of patients with the drug compared with placebo.
The study, published in Gastroenterology, included the data of 251 patients from prior phase 3 induction and maintenance studies who had a Simple Endoscopic Score for CD of ≥3 at the start. Researchers collected 2 endoscopic biopsy samples at weeks 0, 8, and 44 from the ileum, splenic flexure, and rectum, and assessed histologic activity based on global histology activity scores (GHASs).
The mean GHAS was significantly reduced 8 weeks after ustekinumab induction treatment (10.4±7.0 to 7.1±5.9; P <.001), while the same success was not found in the placebo group (9.2±6.4 to 7.8±6.2).
At week 44 in the randomized maintenance therapy population, the mean GHAS remained reduced from the week 8 results in patients who received subcutaneous ustekinumab treatments of 90 mg every 8 weeks (7.4±7.7 to 6.1±4.7), but not every 12 weeks (5.3±3.9 to 8.7±4.1) or in the placebo group (9.2±3.8 to 10.9±7.1).
The investigators found a significantly greater proportion of patients who achieved a histologic response at week 44 for the patients who received ustekinumab every 8 weeks (50% in the randomized maintenance population and 54% in the pooled maintenance population) compared with every 12 weeks (17% and 39% in the randomized and pooled populations, respectively) or placebo (0% and 22% in the randomized and pooled populations, respectively).
Histologic assessment of intestinal biopsy samples often provides more information than video endoscopy because they can show the tissue architecture and composition at the cellular level, according to the study. Histologic inflammation is present in approximately 33% of patients, despite the presence of endoscopic healing.