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P502 Correlation between soluble suppression of tumorigenicity 2 (sST2) and endoscopic activity in patients with moderate to severe ulcerative colitis under golimumab treatment: results of the EVOLUTION study

F. Magro*1,2, S. Lopes1, M. Silva1, R. Coelho1, F. Portela3, D. Branquinho3, L. Correia4, S. Fernandes4, M. Cravo5, P. Caldeira6, H. Sousa6,7, M. Patita8, P. Lago9, J. Ramos10, J. Afonso2, I. Redondo11, P. Machado11, G. Philip12, J. Lopes2, F. Carneiro2,13

1Centro Hospitalar São João, Gastrenterology, Porto, Portugal, 2Faculdade de Medicina, Universidade do Porto, Pharmacology, Porto, Portugal, 3Centro Hospitalar Universitário de Coimbra, Gastrenterology, Coimbra, Portugal, 4Centro Hospitalar Lisboa Norte, Gastrenterology, Lisboa, Portugal, 5Hospital Beatriz Ângelo, Gastrenterology, Loures, Portugal, 6Centro Hospitalar Universitário do Algarve, Gastrenterology, Faro, Portugal, 7Universidade do Algarve, Faro, Portugal, 8Hospital Garcia de Orta, Gastrenterology, Almada, Portugal, 9Centro Hospitalar do Porto, Gastrenterology, Porto, Portugal, 10Centro Hospitalar Lisboa Central, Gastrenterology, Lisboa, Portugal, 11MSD Portugal, Medical Affairs, Paço de Arcos, Portugal, 12Merck and Co., Inc., Kenilworth, NJ, USA, 13IPATIMUP, i3S‐Instituto de Investigação e Inovação em Saúde, Universidade do Porto, Porto, Portugal

Background

Suppressor of Tumorigenicity 2 (ST2) is an IL33 receptor detected in mucosa and serum of ulcerative colitis (UC) patients. We aimed to evaluate soluble ST2 (sST2) as a surrogate biomarker of disease activity and therapeutic response in subjects with moderately to severely active UC under golimumab and to compare with standard biomarkers such as faecal calprotectin (FC) and C-reactive protein (CRP).

Methods

Open-label single-arm multi-centre prospective study. At screening/baseline, Week 6 (W6) and Week 16 (W16), clinical and endoscopic activity (total Mayo score), histological activity (Geboes index) and biomarkers were evaluated. Biomarkers levels by UC activity were compared using Mann–Whitney test and t-test. Receiver-operating characteristic curves (ROC), Wilcoxon signed rank test and Spearman correlations (rs) were also used (α = 0.05).

Results

Thirty-four patients (89.5%) completed W6 and 29 (76.3%) completed W16. Mean ± sd age was 34.6 ± 12.6 years; 55.9% were female. At W16, 62.1% (18/29) achieved clinical response by total Mayo score. At W6, sST2 levels correlated with endoscopic activity (rs=0.45, p = 0.007) but not with histological activity (rs = 0.25, p = 0.151). W16 correlations were not significant. Patients with endoscopic activity at W6 had higher sST2 baseline levels: median, 24.5 vs. 18.7 ng/ml (p = 0.026) and showed no decrease of sST2 levels (median change, 0.8 vs. −2.7, p = 0.029). The best sST2 cut-off for endoscopic activity was 16.9 ng/ml (specificity=71%; sensitivity=85%). sST2 did not correlate with FC nor with CRP (Table 1).

Accuracy of sST2, FC and CRP measurement to predict endoscopic and histological activity at Week 6.

Conclusion

sST2 may be a surrogate biomarker of UC activity and therapeutic response. sST2, FC and CRP may be biomarkers of different components of the UC inflammatory process during early treatment with golimumab.