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* = Presenting author

P627 Correlation between adalimumab serum levels and remission after the induction phase in Crohn's Disease patients

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, Y. Ber15, M.D. Hinojosa16, M. Ramas1, F. Bermejo2, B. Beltrán3, I. Rodriguez-Lago4, J.M. Banales17, J.L. Mendoza6, P. Aguilar-Melero7, L. Menchén8, R. Ferreiro9, I. Blazquez10, B. Benítez García11, L. Guijarro12, P.M. Linares1, 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 General Universitario Gregorio Marañón, Gastroenterology Unit, Madrid, Spain, 9Complejo Hospitalario 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 de Donostia, Instituto Biodonostia, UPV/EHU and CIBEREHD, Gastroenterology Unit, San Sebastián, Spain

Background

Detectable adalimumab trough levels have been associated with higher rates of clinical remission. However, the correlation between adalimumab trough levels and remission during the induction phase in Crohn's disease (CD)patients has not been studied so far

Aim:To evaluate the correlation between adalimumab levels and remission after the induction phase in CD patients. To evaluate the accuracy of adalimumab serum levels to predict short-term remission

Methods

CD patients with active disease (CDAI>150) naïve to anti-TNF treatment were included. Patients received 160/80mg adalimumab at weeks 0 and 2 and 40mg every-other-week thereafter. Remission was defined as a CDAI score < 150 and response as a decrease of >70 points after 14 weeks of treatment. Clinical evaluation was assessed and blood samples were drawn at baseline and weeks 4,8 and 14. Adalimumab and antibodies to adalimumab (ATA) were measured using a homogeneous mobility shift assay (HMSA; Prometheus Lab, San Diego, USA). Correlation between adalimumab trough levels during the induction phase and response at week 14 was calculated. Receiver operating characteristic (ROC) curves were constructed and the area under the ROC curve (AUC) was calculated. Determination of predictive adalimumab trough concentration thresholds were based on the choice of the corresponding specificity and sensitivity pair determined from the ROC curves

Results

Twenty-two patients were included (54% male, 91% ileal or ileocolonic involvement, 73% inflammatory behaviour, 23% previous surgery and 82% on concomitant immunosuppressants). At week 14, 80% of patients had remission, 10% partial response and 10% non-response. Patients that reached remission were younger than those who did not (37 vs. 54 years, p=0.03). Mean adalimumab trough levels at week 8 were higher among patients that achieved remission at week 14 compared with those who did not (12 vs. 7 μ g/mL, p=0.02). Mean adalimumab trough levels at weeks 4 and 14 were also higher among patients in remission at week 14, but the differences did not reach the statistical significance (week 4: 16 vs. 11 μ g/mL, p=0.19; and week 14: 13 vs. 8 μ g/mL, p=0.08). The AUC for adalimumab trough levels to predict remission and response at week 14 and the best thresholds are shown in table 1

 

“Table 1. Area under the ROC curves (AUC) for adalimumab trough levels to predict response and remission at week 14”

ECCOJC jju027 P627 F0001

 

Conclusion

CD patients that reached response and remission at week 14 showed higher adalimumab trough levels during the induction phase than those who did not. We could identify the threshold concentrations of adalimumab that predict response and remission with a high accuracy