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P211 Anti-tumour necrosis factor drugs levels and correlation with short-term clinical remission in Crohn’s disease patients: results from the Predicrohn Study

M. Chaparro*1, I. Guerra2, M. Iborra3, J. L. Cabriada4, L. Bujanda5, C. Taxonera6, V. García-Sánchez7, I. Marín-Jiménez8, M. Barreiro-de Acosta9, I. Vera10, M. D. Martín-Arranz11, B. Hernández-Breijo12, F. Mesonero13, L. Sempere14, F. Gomollón15, J. Hinojosa16, F. Bermejo2, B. Beltrán3, I. Rodriguez-Lago4, J. M. Banales5, D. Olivares17, P. Aguilar-Melero7, L. Menchén8, R. Ferreiro9, I. Blazquez10, B. Benítez García11, L. Guijarro12, P. M. Linares1, M. Ramas1, J. P. Gisbert1

1Hospital Universitario de La Princesa, IIS-IP and CIBERehd, Gastroenterology Unit, Madrid, Spain, 2Hospital Universitario de Fuenlabrada, Gastroenterology Unit, Madrid, Spain, 3Hospital Universitario La Fe and CIBERehd, Gastroenterology Unit, Valencia, Spain, 4Hospital Galdakao, Gastroenterology Unit, Vizcaya, Spain, 5Hospital de Donostia, Instituto Biodonostia, UPV/EHU and CIBEREHD, Gastroenterology Unit, Guipuzcoa, Spain, 6Hospital Clínico Universitario San Carlos and IdISSC, Gastroenterology Unit, Madrid, Spain, 7Hospital Universitario Reina Sofía, Gastroenterology Unit, Córdoba, Spain, 8Hospital Gregorio Marañón and IiSGM, Gastroenterology Unit, Madrid, Spain, 9Hospital Clínico Universitario de Santiago, Gastroenterology Unit, Santiago de Compostela, Spain, 10Hospital Universitario Puerta de Hierro, Gastroenterology Unit, Madrid, Spain, 11Hospital Universitario La Paz, Gastroenterology Unit, Madrid, Spain, 12Universidad de Alcalá and CIBERehd, Systems Biology, Alcalá de Henares, Spain, 13Hospital Universitario Ramón y Cajal, Gastroenterology Unit, Madrid, Spain, 14Hospital General Universitario de Alicante, Gastroenterology Unit, Alicante, Spain, 15Hospital Clínico Universitario Lozano Blesa and CIBERehd, Gastroenterology Unit, Zaragoza, Spain, 16Hospital de Manises, Gastroenterology Unit, Valencia, Spain, 17Hospital Universitario Clínico San Carlos and IdISSC, Gastroenterology Unit, Madrid, Spain

Background

The correlation between anti-tumour necrosis factor (TNF) serum levels and remission achievement during the induction phase in CD patients has not been studied.

Aims: to evaluate the correlation between anti-TNF levels and remission after the induction phase in CD patients and assess the accuracy of anti-TNF serum levels to predict short-term remission.

Methods

CD patients naïve to anti-TNF treatment with active disease at inclusion (CDAI > 150) were prospectively included in this multicentre study. Patients received 160/80 mg adalimumab (ADA) at weeks 0 and 2, and 40 mg every other week thereafter, or infliximab (IFX) 5 mg/kg at weeks 0, 2, 6, and every 2 months thereafter. Remission was defined as a CDAI score < 150, and response as a decrease of >70 points, after 14 weeks of treatment. Clinical activity was performed, and blood samples were obtained at baseline and at weeks 4, 8, and 14. Serum TNF serum levels were measured using the Singulex Erenna human TNF-alpha kit. ADA and IFX levels were measured using a homogeneous mobility shift assay (HMSA; Prometheus Lab, San Diego, California, United States). ROC curves were constructed and the area under the ROC curve (AUC) was calculated.

Results

Included were 71. At week 14, 52 patients (73%) had clinical remission and 11 (15.5%) were non-responders. There was no correlation between TNF concentration and clinical activity in any visit. Further 41 (57.8%) received IFX. There were no differences in IFX levels at week 4, 8, and 14 between patients with and without either remission or response (Table 1).

Table 1 Infliximab concentration in patients with or without short-term remission or response (week 14)

Remission (μg/mL)No remission (μg/mL)p
Week 433360.6
Week 832310.8
Week 1410.790.7
Response (μg/mLNo response (μg/mL)p
Week 43146.50.03
Week 830420.08
Week 1410.67.90.6

The AUC to predict remission at week 4, 8, and 14 were < 0.6. In the multivariate analysis, only the CDAI at baseline was significantly associated with a lower probability of remission (OR = 0.98, 95% CI = 0.96–0.99). Thirty patients (42.2%) received ADA. ADA concentration was slightly higher amongst patients that achieved remission, but the differences did not reach the statistical significance (Table 2).

Table 2 Adalimumab concentration in patients with or without short-term remission or response (week 14)

Remission (μg/mL)No remission (μg/
mL)p
Week 41615.40.83
Week 812.511.60.76
Week 1411.790.29
Response (μg/mL)No response (μg/mL)p
Week 416.610.70.1
Week 8137.10.1
Week 1411.68.30.3

The AUC to predict remission were < 0.7. In the multivariate analysis, only the CDAI at baseline was significantly associated with a lower probability of remission (OR = 0.98, 95% CI = 0.96–0.99).

Conclusion

Neither anti-TNF serum levels (IFX or ADA) nor TNF concentration correlate with remission or response during the induction phase in CD patients