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P186 Association between anti-TNF serum levels and mucosal healing in inflammatory bowel disease

Chaparro M.*1, Barreiro-de Acosta M.2, Echarri A.3, Almendros R.4, Barrio J.5, Llao J.6, Gomollόn F.7, Vera M.8, Cabriada J.L.9, Guardiola J.10, Guerra I.11, Beltrán B.12, Roncero O.13, Busquets D.14, Taxonera C.15, Calvet X.16, Ferreiro R.2, Ollero Pena V.3, Donday M.G.17, Garre A.17, Godino A.18, Díaz A.18, Gisbert J.P.17

1Hospital Universitario de La Princesa, IIS-IP and CIBERehd, Madrid, Spain 2Hospital Clínico Universitario de Santiago, Gastroenterology Unit, Santiago de Compostela, Spain 3Complejo Hospitalario Universitario de Ferrol, Gastroenterology Unit, Coruña, Spain 4Hospital Universitario Rio Hortega, Pharmacy Unit, Valladolid, Spain 5Hospital Universitario Rio Hortega, Gastroenterology Unit, Valladolid, Spain 6Hospital de la Santa Creu i Sant Pau, Gastroenterology Unit, Barcelona, Spain 7Hospital Clínico Universitario Lozano Blesa, IIS Aragόn and CIBERehd, Gastroenterology Unit, Zaragoza, Spain 8Hospital Universitario Puerta de Hierro, Gastroenterology Unit, Majadahonda, Spain 9Hospital Galdakao-Usansolo, Gastroenterology Unit, Vizcaya, Spain 10Hopital Universitari de Bellvitge-IDIBELL, Gastroenterology Unit, Barcelona, Spain 11Hospital Universitario de Fuenlabrada, Gastroenterology Unit, Madrid, Spain 12Hospital Universitari La Fe, Gastroenterology Unit, Valencia, Spain 13Complejo Hospitalario la Mancha Centro, Gastroenterology Unit, Ciudad Real, Spain 14Hospital Universitari de Girona Doctor Josep Trueta, Gastroenterology Unit, Girona, Spain 15Hospital Clínico San Carlos, Gastroenterology Unit, Madrid, Spain 16Corporaciό Sanitària Parc Taulí and CIBERehd, Gastroenterology Unit, Sabadell, Spain 17Hospital Universitario de La Princesa, IIS-IP and CIBERehd, Gastroenterology Unit, Madrid, Spain 18Hospital Universitario de La Princesa, IIS-IP, Clinical analysis Unit, Madrid, Spain

Methods

Multicenter, prospective study. IBD patients under anti-TNF treatment for at least 6 months that had to undergo an endoscopy for medical indication were included. Patients with incomplete endoscopy, those with intestinal segments affected by the disease non-accessible to endoscopy, and those receiving anti-TNF to prevent postsurgical recurrence were excluded. MH was defined as: Simplified Endoscopic Score for Crohn's Disease (SES-CD)<3, Rutgeerts score <i2 or Mayo endoscopic score <2.

Anti-TNF concentrations were measured using SMART ELISAs (Sanquin Reagents, Amsterdam, The Netherlands)

Results

182 patients were included; 50% were male, 70% had Crohn's disease and 49% had MH. 52% of patients were under adalimumab (ADA) and 48% under infliximab (IFX) treatment; 51% of patients had previously received another anti-TNF agent. 32% of patients were on concomitant treatment with thiopurines. IFX through levels (median) were significantly higher among patients that had MH than among those who did not (4.8 vs. 3 μg/mL, p=0.04). Similarly, ADA through levels were significantly higher among patients with MH (9.8 vs. 6.6 μg/mL, p=0.04). The accuracy of anti-TNF through levels to predict MH is shown in table 1. Concomitant treatment with immunomodulators had no impact on anti-TNF drug levels. In the multivariate analysis, to have anti-TNF drug levels above the threshold (3.4 μg/mL for IFX, and 7.2 μg/mL for ADA) and to have ulcerative colitis (instead of Crohn's disease) were the variables associated with a higher probability of having MH (OR=3.1, 95% CI: 1.5–6.5 and OR=4, 95% CI: 1.7–9.5, respectively). On the other hand, to have needed an escalated dosage (OR=0.2, 95% CI: 0.08–0.45) and to be current smoker (vs. non-smoker) (OR=0.2, 95% CI: 0.09–0.52) were associated with a lower probability of MH

Table 1. Accuracy of anti-TNF through serum levels to predict mucosal healing in inflammatory bowel disease patients

Anti-TNFArea under the ROC curveBest cut-off pointSensitivitySpecifityPositive predictive valueNegative predictive value
Infliximab0.633.460%60%73%42%
Adalimumab0.607.265%56%46%72%

Conclusion

There was an association between anti-TNF through levels and MH in IBD patients; however, the accuracy of the determination of both IFX and ADA concentrations to predict MH was suboptimal. To have IFX through levels above 3.4 μg/mL had a positive predictive value for MH of >70%.