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P147. Predictors of efficacy, mucosal healing and need for dose intensification at 12-months of adalimumab therapy in patients with Crohn's disease. National data from Hungary

L.S. Kiss1, Z. Czegledi2, P. Miheller1, T. Molnar3, L. Lakatos4, A. Vincze5, K. Palatka6, B. Gasztonyi7, A. Salamon8, Z. Bartha6, G. Horvath9, G.T. Toth10, K. Farkas3, T. Szamosi2, Z. Tulassay1, M. Papp6, I. Altorjay6, F. Nagy3, J. Banai2, P.L. Lakatos1

1Semmelweis University, Budapest, Hungary; 2State Health Centre, Budapest, Hungary; 3Szeged University, Szeged, Hungary; 4Csolnoky F. Province Hospital, Veszprem, Hungary; 5Pecs University, Pecs, Hungary; 6Debrecen University, Debrecen, Hungary; 7County Hospital of Zala, Zalaegerszeg, Hungary; 8Szekszard County Hospital, Szekszard, Hungary; 9Miskolc County Hospital, Miskolc, Hungary; 10Szent Janos Hospital, Budapest, Hungary

Background and Aims: Adalimumab is a fully human monoclonal antibody targeting tumor necrosis factor with proven efficacy in the treatment of Crohn's disease (CD) in clinical trials. In the present study our aim was to investigate the accuracy of clinical and laboratory markers for the prediction of medium term efficacy and mucosal healing during adalimumab therapy in patients with CD in specialized centers approved for biological therapy in Hungary.

Methods: Data of 200 CD patients were analyzed (male/female: 111/89, median age: 33.0 years, duration: 8 years). Indication for biologic therapy was active luminal disease (61.8%) and fistulizing disease (34.8%) patients. Previous infliximab therapy was given in 97 (48.5%) patients, induction dose was 80/40 mg in 61.5%. Concomitant immunosuppression at induction therapy was steroids in 41.2%, azathioprine in 69.3% or combined in 26.5% of patients. Medical records were captured prospectively.

Results: Overall clinical response and remission rates at 24- and 52 weeks were 79.5% and 53.4% (n = 176), and 66.2% and 45.3% (n = 139). Endoscopic partial healing and healing was achieved in 34.8% and 19.1% of CD of the patients with available endoscopy or dropout due to clinical deterioration/surgery. Dose intensification to weekly dosing was needed in 17.4%. Need for combined concomitant immunosuppression at induction (p = 0.02, OR: 0.37, 95%CI: 0.16–0.87), frequency of previous relapses (p = 0.035, OR: 0.44, 95%CI: 0.20–0.95) and previous respective surgery (p = 0.03, OR: 0.46, 95%CI: 0.23–0.94) were associated with worse 52-week outcome. In a logistic regression model, need for combined concomitant immunosuppression at induction and relapse frequency were identified as independent predictors for 12-month outcome. Gender, disease duration, location, behavior, perianal disease, CRP, endoscopic severity or induction dose were not associated to medium term response or remission. Parallel azathioprine therapy was associated to escalation to weekly dosing (p = 0.008, OR: 0.35, 95%CI: 0.16–0.77) and in a Kaplan–Meier analysis to time to escalation to weekly dosing (pLogRank = 0.005, pBreslow = 0.004). Frequency of previous relapses (p = 0.034, OR: 0.36, 95%CI: 0.14–0.94) and luminal disease (p = 0.01, OR: 3.45, 95%CI: 1.28–9.17) were associated to endoscopic improvement/healing at 12-months.

Conclusion: Need for combined immunosuppression and relapse frequency were identified as predictors for clinical efficacy of adalimumab at 12-months, while parallel azathioprine therapy decreased the probability for dose escalation.