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P521 Anti-TNF serum level and clinical, radiological or endoscopical response in luminal and perianal Crohn’s disease: results of the OPTIMIZA study

A. Echarri*1, R. Ferreiro2, R. Fraga1, J. Cid3, M. Barreiro de Acosta2, S. Pereira4, J. Pineda4, D. Carpio5, S. Soto6, E. Castro7, J. Gallego8, B. Gonzalez9, A. Carmona10

1Complejo Hospitalario Ferrol, Gastroenterology, Ferrol, Spain, 2Complejo Hospitalario Universitario Santiago, Gastroenterology, Santiago, Spain, 3Complejo Hospitalario Coruña, Immunology, Coruña, Spain, 4Complejo Hospitalario Vigo, Gastroenterology, Vigo, Spain, 5Complejo Hospitalario Pontevedra, Gastroenterology, Pontevedra, Spain, 6Complejo Hospitalario Orense, Gastroenterology, Orense, Spain, 7Complejo Hospitalario Lugo, Gastroenterology, Lugo, Spain, 8Complejo Hospitalario Ferrol, Radiology, Ferrol, Spain, 9Complejo Hospitalario Coruña, Gastroenterology, Coruña, Spain, 10Povisa, Gastroenterology, Vigo, Spain

Background

The aim of our study was to determine the optimal anti-TNF trough level (TL) associated with clinical, endoscopical and radiological remission for luminal and perianal Crohn’s disease (CD) in clinical practice conditions.

Methods

In a prospective study, 32 patients with moderate-to-severe luminal (n = 24; mean HBI index 12.3) and perianal CD (n = 8; mean PDAI, index 11.2) were evaluated. Patients were under anti-TNF treatment over 24m (IFX 15 and ADA 17). Management of patients was based on clinical assessment. Investigators were blinded of serum TL results. TL measurements (ELISA) were performed just before anti-TNF injection concomitantly with faecal calprotectin (FC).Endoscopic evaluation using Simple Endoscopic Score for CD (SES-CD) was performed at weeks 0 and 54 (SES-CD remission < 2). In case of ileal location or perianal disease, magnetic resonance enterography (MRE) or pelvic resonance were performed at the same time points and activity was assessed with our own validated MRE index (remission < 3) and the Van Assche Index for perianal disease.

Results

In total, 84% of patients were in clinical remission (CR) at 54 weeks. Deep remission (clinical with endoscopical/radiological remission) was observed in 56.2% of patients; 84% of patients in CR but not endoscopical or radiological remission showed FC > 250 ug/g. IFX and ADA TL associated with clinical remission was significantly lower than anti-TNF TL associated with endoscopical or radiological remission (2.1 and 6.51 μg/mL (IFX/ ADA) vs 3.51 and 10.4 μg/mL) in luminal CD but not in perianal disease, where IFX and ADA TL were similar for clinical, endoscopical, and radiological remission. The PPV for week 54 drug trough level (IFX > 1.1μg/mL; ADA > 2.51 μg/mL) in predicting clinical remission in luminal disease was > 80%. A similar PPV for week 54 in predicting endoscopical or radiological remission was obtained with higher drug TL (IFX > 2.7μg/mL; ADA > 5.4μg/mL). In perianal disease IFX/ADA TL above 2.7 and 5.4 had a positive predictive value of both clinical and radiological remission of > 0.74%.

Conclusion

1. Serum antiTNF TL associated to endoscopical or radiological remission are higher than TL associated to CR in luminal CD, but not in perianal disease where TL were similar for clinical or radiological remission. 2. AntiTNF trough level at week 54 can be useful to predict clinical/endoscopical or radiological efficacy and to optimise results. 3. AntiTNF TL and calprotectin could be useful to decide upon the need of endoscopical or radiological explorations.