Histo-endoscopic mucosal healing linked with lower UC activity after induction of Stelara
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Achievement of histo-endoscopic mucosal healing after induction therapy of Stelara in patients with ulcerative colitis correlated with lower disease activity at the end of maintenance therapy compared with histologic or endoscopic improvement alone, according to results published in Gastroenterology.
“The complementary relationship between the histologic and endoscopic improvement supports
the use of the combined histo-endoscopic mucosal healing endpoint in the assessment of efficacy
in clinical studies of patients with UC,” Katherine Li, MD, from Immunology Translational Science at Janssen Research & Development LLC and colleagues wrote.
Li and colleagues evaluated histologic disease activity of 2,630 colonic samples from patients with UC were treated in the phase 3 study of Stelara (ustekinumab, Janssen). correlations between the histologic improvements and end of induction (week 8 and week 16) and maintenance (week 44). alidity of combined histologic and endoscopic improvement endpoint or histo-endoscopic mucosal healing.
Results showed a significant correlation between histologic improvement and clinical remission, lower mean disease activity scores and greater improvement in disease activity at the end of induction and maintenance studies. At induction week 8 and maintenance week 44, ustekinumab both and maintained significantly higher rates of histologic improvement compared with placebo.
“Histologic improvement and endoscopic improvement following induction were associated with 1020% higher rates of histo-endoscopic mucosal healing, clinical remission and corticosteroid-free remission at week 44 (all P<.05) in patients who received ustekinumab maintenance therapy,” the wrote.
Clinical remission was achieved in 61% of patients with histo-endoscopic mucosal healing at week 44 fter induction therapy compared with 39% of patients with endoscopic improvement and 34% of patients with histologic improvement.
“More research is needed to confirm the application of histologic improvement and histo-
endoscopic mucosal healing to the prediction of remission in research and daily clinical practice,” wrote.
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Li K, et al. Gastroenterology. 2020;doi:
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