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Risk panel, serum levels predicted long-term outcome from infliximab therapy for UC
A risk panel that included serologic markers, clinical response and mucosal healing predicted long-term outcomes of patients receiving infliximab for treating ulcerative colitis, according to new research data.
Marc Ferrante, MD, department of gastroenterology, University of Leuven, Belgium, and colleagues identified independent predictors of relapse- and colectomy-free survival in 285 patients with refractory ulcerative colitis (UC; median age, 39.1 years; 41% women) who were treated with infliximab before July 2012 at the University Hospitals Leuven. Serum levels were collected prospectively in a subgroup of 112 patients, and mucosal healing was assessed endoscopically in 200 patients.
Marc Ferrante
Throughout a median follow-up of 5 years, relapse occurred in 61% of the cohort, 20% of whom required colectomy. Independent factors that predicted relapse-free survival were short-term complete clinical response (OR=3.75; 95% CI, 2.35-5.97), short-term mucosal healing (OR=1.87; 95% CI, 1.17-2.98) and absence of atypical perinuclear anti-neutrophil cytoplasmic antibodies (pANCA; OR=1.96; 95% CI, 1.23-3.12).
Independent factors that predicted colectomy-free survival were short-term clinical response (OR=7.74; 95% CI, 2.76-21.68), short-term mucosal healing (OR=4.02; 95% CI, 1.16-13.97), and baseline levels of C-reactive protein (CRP) of no more than 5 mg/L (OR-2.95; 95% CI, 1.26-6.89) and at least 35 g/L albumin (OR=3.03; 95% CI, 1.12-8.22). Subgroup analysis of serologic infliximab levels greater than 2.5 micrograms/mL at week 14 was associated with absence of clinical relapse within 6 months (AUC=0.77; 95% CI, 0.66-0.88; sensitivity, 81%; specificity, 75%) and predicted relapse-free survival (P<.001) and colectomy-free survival (P=.34). The resulting risk panel that included CRP, albumin and pANCA levels as well as short-term complete clinical response and mucosal healing identified patients at risk for UC relapse or colectomy (both P<.001).
“The application of this risk panel in daily clinical practice could help us in stratifying patients prior to, and early after initiation of [infliximab] therapy,” the researchers concluded. “The observation of a better long-term outcome in patients with [infliximab] serum levels above 2.5 micrograms/mL may guide treatment optimization prior to clinical relapse, but the benefit of such tailored approach needs confirmation in a prospective setting.”
Disclosure: See the study for a full list of relevant financial disclosures.