A klinikai hatékonyság, a nyálkahártya- gyógyulás és a dózisemelés prediktorai az adalimumabkezelés elso évében Crohn-betegségben szenvedo betegekben Magyarországon

Translated title of the contribution: Predictors of effi cacy, mucosal healing and dose intensifi cation during the fi rst year of adalimumab therapy in patients with luminal and fi stulizing Crohn's disease. National data from Hungary

Lajos Sándor Kiss, Tamás Szamosi, Tamás Molnár, Pál Miheller, László Lakatos, Áron Vincze, Károly Palatka, Zsolt Bartha, Beáta Gasztonyi, Ágnes Salamon, Gábor Horváth, Gábor Tamás Tóth, Klaudia Farkas, János Banai, Zsolt Tulassay, Ferenc Nagy, Mária Szenes, Gábor Veres, Barbara Dorottya Lovász, Zsuzsanna VéghPetra Anna Golovics, Miklós Szathmári, Mária Papp, Péter László Lakatos

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Abstract

Adalimumab is a fully human monoclonal antibody targeting tumor necrosis factor with proven efficacy in the treatment of Crohn's disease in clinical trials. The aim of the present study was to investigate the predictors of medium term clinical efficacy and mucosal healing during adalimumab therapy in patients with Crohn's disease in specialized centers approved for biological therapy in Hungary. Methods: Data of 201 Crohn's disease patients were prospectively captured (male/female: 112/89, median age: 24 years, duration: 8 years). Previous infliximab therapy was given in 97 (48.3%) patients, concomitant steroids in 41.3% and azathioprine in 69.2% (combined: 26.4%) of patients. Results: Overall clinical response and remission rates at 24 and 52 weeks were 78% and 52%, and 69.4% and 44.4%, respectively. Endoscopic improvement and healing was achieved in 43.1% and 23.6%, respectively. In a logistic regression model, clinical efficacy and normalized C-reactive protein at week 12, need for combined immunosuppression at induction, shorter disease duration and smoking were identified as independent predictors for 12-month clinical outcome, while normalized C-reactive protein at week 12, clinical remission at week 24, frequency of previous relapses and smoking were associated to endoscopic improvement/healing. Dose intensification to weekly dosing was needed in 16.4%. Parallel azathioprine therapy and clinical remission at week 12 was inversely associated to dose escalation to weekly dosing. Conclusion: Clinical efficacy and normalized C-reactive protein at week 12, need for combined immunosuppression, luminal disease and smoking are predictors for medium term clinical efficacy/mucosal healing during adalimumab therapy, while parallel azathioprine therapy may decrease the probability for dose escalation.

Original languageHungarian
Pages (from-to)1433-1442
Number of pages10
JournalOrvosi hetilap
Volume152
Issue number36
DOIs
Publication statusPublished - Sep 1 2011

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ASJC Scopus subject areas

  • Medicine(all)

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