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Stelara Every 8 Weeks Helps Improve Histologic Response in Crohn’s
Patients with Crohn’s disease who underwent either induction or maintenance therapy with Stelara experienced better histologic improvement compared with placebo, and those who received the drug every 8 weeks saw the greatest improvement, according to study results.
Gert De Hertogh, MD, PhD, of University Hospitals KU Leuven in Belgium, and colleagues wrote in Gastroenterology that Stelara (ustekinumab, Janssen) induces and maintains clinical response in patients with CD, but most previous studies have not explored histologic endpoints.
“A sub-study of the phase 3 program was conducted to evaluate ustekinumab for
induction and maintenance of endoscopic healing,” they wrote. “We utilized this sub-study to assess histological changes related to ustekinumab induction and maintenance therapies and their association with endoscopic changes and clinical response in patients with moderately-to-severely active CD.”
Researchers analyzed data from phase 3 induction and maintenance studies comprising 251 patients. Each patient underwent two endoscopic biopsies at weeks 0, 8 and 44 from the ileum, splenic flexure and rectum. They used global histology activity scores (GHASs) to measure histologic activity.
At week 8, patients who underwent ustekinumab induction had reduced mean GHAS (10.4±7 to 7.1±5.9; P < .001), while patients who received placebo did not. After week 44 in the randomized maintenance therapy population, patients who received ustekinumab every 8 weeks had a mean GHAS that remained reduced from week 8 (7.4±7.7 to 6.1±4.7). However, patients who received the drug every 12 weeks and patients who received placebo did not (5.3±3.9 to 8.7±4.1 and 9.2±3.8 to 10.9±7.1, respectively).
Looking at randomized and pooled populations, researchers found that a greater proportion of patients who received ustekinumab every 8 weeks achieved histologic response (50% and 54%) compared with every 12 weeks (17% and 39%) and placebo (0% and 22%).
“This study indicates that the previously observed clinical and endoscopic benefits of ustekinumab in moderately-to-severely active CD are also associated with improvements at the level of the primary disease process, namely infiltration and damage of the mucosa by inflammatory cells,” De Hertogh and colleagues wrote. “Histologic assessments provide microscopic sensitivity in assessing therapy response; long-term follow-up results are needed to establish the clinical benefits associated with histologic resolution of disease.” – by Alex Young
Disclosures: De Hertogh reports receiving consulting fees from Fast Forward Pharmaceuticals, Galapagos, Genentech, GlaxoSmithKline, Janssen R&D, Novartis Pharma, Shire, Takeda and Teva Pharma. Please see the full study for all other authors’ relevant financial disclosures.