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Ulcerative colitis histologic activity indices equally reliable
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Four disease activity indices are equally reliable and responsive for the assessment of histological remission in ulcerative colitis, according to research published in Gut.
Vipul Jairath , PhD, of the University of Western Ontario in London, Canada, and colleagues wrote that histologic remission is becoming more important as a therapeutic endpoint for UC. However, currently available index scores lack the full validation required for clinical use.
“Before histological remission can be routinely incorporated as a treatment target in clinical practice or clinical trials, validated evaluative instruments are needed,” they wrote.
The two most common indices used to assess histological inflammation – the Geboes Score (GS) and the modified Riley Score (MRS) – did not undergo formal validation during their development. Two newer scores – the Robarts Histopathological Index (RHI) and the Nancy Hospital Index (NHI) – were both designed using single datasets without external validation.
Jairath and colleagues compared these four indices by using them to assess biopsies taken in a phase 2, placebo-controlled ozanimod trial comprising 197 patients with moderately-to-severely active UC. They determined reliability using intraclass correlation coefficients (ICCs), evaluated index responsiveness by assessing longitudinal validity, and calculated standardized effect size (SES) using two criteria for change: treatment assignment and greater than 2-point reduction in total Mayo Clinic score.
After disease activity was evaluated using all four activity indices by four blinded pathologists, Jairath and colleagues found that the inter-rater reliability of all four were substantial to “almost perfect” (ICC > 0.61).
When treatment assignment was the standard for change, response was moderate-to-large (SES estimates > 0.5; GS = 0.81, 95% CI, 0.52-1.1; MRS = 0.87, 95% CI, 0.58-1.17; RHI = 0.57, 95% CI, 0.3-0.84; NHI = 0.81, 95% CI, 0.52-1.09). When researchers used change in Mayo score as the standard for change, they found the responsiveness to change for each index was 1.05 (95% CI, 0.8-1.31), 1.13 (95% CI, 0.87-1.39), 0.88 (95% CI, 0.64-1.12) and 1.06 (95% CI, 0.8-1.31) respectively.
Jairath and colleagues wrote that these indices could help assess mucosal healing both in clinical practice, as well as in the development of new therapies. However, further research is needed.
“All four of the existing histological indices were found to have similar operating characteristics in terms of reliability and responsiveness in this single dataset,” they wrote. “Further validation in other datasets is essential to determine the relative responsiveness of the indices and the most appropriate index for use in particular populations of patients.” – by Alex Young
Disclosures: Jairath reports financial ties to AbbVie, Sandoz, Ferring, Janssen, Takeda and Vifor Pharmaceuticals. Please see the full study for all other authors’ relevant financial disclosures.
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