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OP015 Biomarker correlation with endoscopic outcomes in patients with Crohn’s disease: data from CALM

W. Reinisch1*, R. Panaccione2, P. Bossuyt3, F. Baert4, A. Armuzzi5, S. Travis6, S. Danese7, W.J. Sandborn8, G. D'Haens9, S. Berg10, J.-F. Maa11, J. Petersson11, E. Neimark11, A.M. Robinson11, J.-F. Colombel12

1Medical University of Vienna, Vienna, Austria, 2University of Calgary, Calgary, Canada, 3Imelda General Hospital, Bonheiden, Belgium, 4AZ Delta Roeselare-Menen, Menen, Belgium, 5Presidio Columbus, Fondazione Policlinico Gemelli Università Cattolica, Rome, Italy, 6Oxford University Hospitals, Oxford, UK, 7Istituto Clinico Humanitas, Milan, Italy, 8University of California San Diego, La Jolla, USA, 9Academic Medical Center, Amsterdam, The Netherlands, 10AbbVie AB, Solna, Sweden, 11AbbVie Inc., North Chicago, USA, 12Icahn School of Medicine at Mount Sinai, New York, USA

Background

Management of Crohn’s disease (CD) is moving towards the therapeutic goal of mucosal healing using biomarkers of inflammation, faecal calprotectin (FC) and C-reactive protein (CRP), to optimise therapy. CALM demonstrated superior endoscopic outcomes in patients whose treatment was escalated based on a tight control algorithm using symptoms and biomarkers than in patients managed conventionally,1 but the optimal biomarker cut-offs to predict mucosal healing have not been established. In this analysis from CALM, association of endoscopic outcomes with FC and CRP cut-offs was investigated.

Methods

Adult patients with CD (N = 244) were assessed for association of mucosal healing (CD Endoscopic Index of Severity [CDEIS] < 4) and no deep ulcers (primary endpoint in CALM) and endoscopic response (CDEIS decrease >5 from baseline [BL]) with levels of FC and CRP at 48 weeks using Chi-square test. Analysed cut-offs for FC (<250 or ≥250 µg/g) and CRP (<5 or ≥5 mg/l) at 48 weeks were based on criteria for treatment escalation in the tight control group. Data are summarised as observed in patients with both endoscopic outcome and biomarker level.

Results

Association between the two endoscopic endpoints and CRP and FC cut-offs at 48 weeks is shown in Table. Significantly greater proportions of patients with CRP concentrations of <5 mg/l achieved endoscopic outcomes in CALM. Similar findings, to a greater extent, were associated with FC <250 μg/g. Even higher proportion of patients achieved the two endoscopic endpoints when both CRP and FC were considered.

Table. Proportion of patients meeting endoscopic endpoints by biomarker status at 48 weeks.

Conclusion

Correlation of biomarker cut-offs with endoscopic outcomes is an important finding for future management of CD. Additional studies are needed to further define the biomarker cut-offs.

Reference

1.Colombel J-F, et al. Lancet, 2017.