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Patient-reported outcomes inadequate for UC disease activity measurement
Patient-reported outcomes did not appear to be fully capable of identifying patients with mild-to-moderate ulcerative colitis who were in endoscopic remission, according to study results.
Vipul Jairath, MD, of the division of gastroenterology at Western University in London, Ontario, Canada, and colleagues wrote that endoscopic remission is an important target in the management of UC, but certain barriers exist.
“Considerations of cost, invasiveness, and practicality may limit the ability to perform serial endoscopy in routine practice, particularly for patients with mild-to-moderate UC who may be less willing to undergo repeated procedures in the absence of severe symptoms,” they wrote. “Therefore, an understanding of the operating properties of patient-reported outcomes for predicting endoscopic remission in this population is necessary.”
Researchers performed a post-hoc analysis of data from a phase 3 non-inferiority study comprising 817 patients with mild to moderate UC who underwent mesalamine therapy. They obtained information on rectal bleeding, stool frequency and Mayo Endoscopic subscores (MESs) at weeks 0, 8 and 38.
Investigators determined the sensitivity, specificity and positive and negative predictive values with which rectal bleeding and stool frequency identified patients with MESs of 0 and/or 1.
In patients with a MES of 0, 9% had a rectal bleeding score 1 or more and 49% of patients had a stool frequency score of 1 or more at week 8. At week 38, 4% had a rectal bleeding score of 1 or more and 38% had a stool frequency score of 1 or more.
Among patients with MESs of 0 or 1, 16% had a rectal score of 1 or more and 52% had a rectal bleeding score of 1 or more at week 8. At week 38, 5% had a rectal bleeding score of 1 or more while 39% had a stool frequency score of 1 or more.
“While the absence of rectal bleeding or stool frequency is associated with endoscopic remission, a substantial proportion of patients will continue to have residual increased stool frequency despite achieving a MES of 0 or 1, particularly during induction,” Jairath and colleagues wrote. “Our findings highlight the limitations of using PROs alone for assessment of treatment response and the importance of objective endoscopic evaluation even in patients with mild-to-moderate UC.” – by Alex Young
Disclosures: Jairath reports receiving consulting fees from AbbVie, Arena, Celltrion, Eli Lilly, Genentech, GlaxoSmithKline, Janssen, Merck, Pendopharm, Robarts Clinical Trials, Sandoz, Takeda and Topivert. He also reports receiving speaker’s fees from AbbVie, Janssen, Shire and Takeda. Please see the full study for all other authors’ relevant financial disclosures.