A klinikai hatékonyság, a nyálkahártya-gyógyulásés a dózisemelés prediktorai az adalimumabkezelés első évében Crohn-betegségben szenvedő betegekben Magyarországon = Predictors of efficacy, mucosal healing and dose intensification during the first year of adalimumab therapy in patients with luminal and fistulizing Crohn’s disease. National data from Hungary

Az adalimumab a tumornekrozis-faktor-alfat celzo, teljesen human monoklonalis antitest, amely randomizalt klinikai vizsgalatokban hatekonynak bizonyult a Crohn-betegseg kezeleseben. A jelen tanulmanyban a szerzők celja a kozeptavu klinikai hatasossag es a nyalkahartya-gyogyulas prediktorainak meghatarozasa volt a magyarorszagi specialis gasztroenterologiai centrumokban adalimumabkezelesben reszesulő Crohn-betegekben. Modszer: A tanulmanyba 201 Crohn-beteget vontak be. A klinikai adatok prospektiven kerultek rogzitesre, majd kesőbb feldogozasra (ferfi/nő arany: 112/89; median eletkor: 24 ev; időtartam: nyolc ev). Korabbi infliximabterapiaban 97 (48,3%) beteg reszesult, parhuzamosan kortikoszteroidot kapott a betegek 41,3%-a es azathioprint a betegek 69,2%-a (mindkettőt: 26,4%). Eredmenyek: A klinikai javulas es remisszio aranya a 24. heten 78% es 52%, illetve az 52. heten 69,4% es 44,4% volt. Az endoszkopos kep javulasa, illetve a nyalkahartya-gyogyulas a betegek 43,1 es 23,6%-aban volt kimutathato. Logisztikus regresszios modellben a 12 honapos klinikai kimenetel fuggetlen prediktorai a klinikai valasz es normalis C-reaktiv feherje a kezeles 12. heteben, a kombinalt immunszuppresszio szuksegessege az indukcios kezeles soran, a rovidebb betegsegtartam es a dohanyzas voltak. A kezeles 12. heteben mert normalis C-reaktiv feherje, a 24. heten tapasztalt klinikai remisszio, a korabbi relapsusok gyakorisaga es a dohanyzas allt osszefuggesben a nyalkahartya-gyogyulas mertekevel. A dozis emelesere a betegek 16,4%-anak volt szuksege. A parhuzamos azathioprinkezeles es a 12. heten tapasztalt klinikai remisszio csokkentette a dozisemeles eselyet. Kovetkeztetes: Az adalimumabkezeles soran a kozeptavu klinikai hatekonysag es a nyalkahartya-gyogyulas előrejelzeseben meghatarozo tenyezők a 12. heten tapasztalt klinikai hatekonysag es normalis C-reaktiv feherje, a kombinalt immunszuppresszio szuksegessege, a luminalis betegseg es a dohanyzas voltak. A parhuzamos azathioprinkezeles csokkentheti a dozisemeles valoszinűseget. Orv. Hetil., 2011, 152, 1433–1442. | 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. Orv. Hetil., 2011, 152, 1433–1442.