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Mapping of Crohn's disease outcomes to faecal calprotectin levels in patients maintained on biologic therapy.

ABSTRACT: Faecal calprotectin (FC) is a sensitive marker of intestinal mucosal inflammation. The gold standard in Crohn's disease management is mucosal healing. The role of FC to support clinical practice in Crohn's disease is not yet defined.To determine, in patients with Crohn's disease established on biologic therapy: (1) the correlation between disease activity and FC levels, (2) whether FC can predict for relapse and (3) the sensitivity and specificity of the C-reactive protein (CRP) when compared with FC.In this retrospective, single-site study, Crohn's disease activity, clinical outcomes, FC and CRP of 76 patients established on biologic therapy were reviewed and mapped over time.Patients were mapped for a median of 34 months (IQR 21-57.5). FC levels were determined every 7 (4-13) months on average. Mean FC in quiescent disease was 105 μg/g (SEM 19); in mild disease, 282 (SEM 71); in moderate disease, 611 (SEM 80) and in severe disease, 1314 (SEM 224) (p<0.001). In asymptomatic patients who relapsed at 6 months, the optimal FC, with an area under the curve of 0.886 (p<0.001), was 357.5. In discriminating quiescent from active disease (FC>100 μg/g) the sensitivity and specificity of CRP were 0.48 (0.36-0.61) and 0.73 (0.6-0.85), and in mild from moderate or active disease (FC>250 μg/g), 0.60 (0.43-0.74) and (0.72 (0.60-0.82).FC is an accurate marker of Crohn's disease activity and predicts for relapse, thus providing the clinician time to optimise therapy. FC is a more sensitive marker of Crohn's disease activity than CRP.

SUBMITTER: Turvill J

PROVIDER: S-EPMC5369738 | biostudies-other | 2014 Jul

REPOSITORIES: biostudies-other

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Project description:Background & aimsLittle is known about the effects of discontinuing mesalamine therapy for patients with Crohn's disease (CD) who initiate therapy with an anti-tumor necrosis factor (anti-TNF) agent. We analyzed data from 2 national population cohorts to compare outcomes of patients with CD already on mesalamine therapy who started treatment with an anti-TNF agent and then either stopped or continued mesalamine.MethodsThe primary outcome was any adverse clinical event, defined as a composite of new corticosteroid use or CD-related hospitalization or surgery. We collected data from the Truven MarketScan (IBM, Armonk, NY) health claims database in the United States and the Danish health registers. Our analysis included patients with CD who started anti-TNF therapy after at least 90 days of oral mesalamine therapy. Patients were classified as stopping mesalamine if therapy was discontinued within 90 days of starting anti-TNF. We performed multivariable Cox regression models controlling for demographics, clinical factors, and health care utilization. Adjusted hazard ratios with 95% CIs were calculated, comparing stopping mesalamine with continuing mesalamine.ResultsA total of 3178 patients with CD were included in our final analysis (2960 in the United States and 218 in Denmark). Stopping mesalamine after initiating anti-TNF therapy was not associated with an increased risk of adverse clinical events in the US cohort (adjusted hazard ratio, 0.89; 95% CI, 0.77-1.03; P = .13) or in the Danish cohort (adjusted hazard ratio, 1.13; 95% CI, 0.68-1.87; P = .63). Similar results were obtained from sensitivity analyses of concomitant immunomodulator use and duration of mesalamine treatment before initiation of anti-TNF therapy.ConclusionsIn a retrospective analysis of 2 national databases, we found that stopping mesalamine therapy for patients with CD who were starting anti-TNF therapy did not increase their risk of adverse clinical events. These results should be validated in a prospective study.

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Mapping of Crohn's disease outcomes to faecal calprotectin levels in patients maintained on biologic therapy.

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