P378. High restarting rate among patients with Crohn's disease after cessation of one-year treatment period with biologicals: Result of national RASH study


T. Molnár1, K. Farkas1, F. Nagy1, P. Lakatos2, Z. Szepes1, P. Miheller3, G. Horvath4, M. Papp5, K. Palatka5, T. Nyari6, T. Wittmann1

1University of Szeged, First Department of Medicine, Szeged, Hungary; 2Semmelweis University, 1st Department of Medicine, Budapest, Hungary; 3Semmelweis University, 2nd Department of internal Medicine, Budapest, Hungary; 4Health Centre of Miskolc, Miskolc, Hungary; 5University of Debrecen, 2nd Department of Medicine, Debrecen, Hungary; 6University of Szeged, Department of Medical Informatics, Szeged, Hungary



Background: Biological therapy proved to be effective in the treatment of Crohn's disease (CD) and ulcerative colitis (UC). One of the important questions about biological therapy is the duration of treatment and the relapse rate after discontinuation. The aim of the RASH (Relapse After Stopping biologicals in Hungary) study was to assess the frequency and the time to restart anti‑TNF therapy after one-year treatment period, and to evaluate predisposing factors. Data were collected from five Hungarian IBD centres.

Methods: Data of 187 IBD patients (152 CD, 35 UC; mean age at the diagnosis 27.6 years [range 8–70]) were analyzed. 68.4% of the CD patients received infliximab, 31.6% adalimumab. 21.1% of the CD patients received previous episodic/continuous biological therapy. Extraintestinal manifestations were present in 54.5% of the patients. Concomitant immunosuppressions at induction therapy were steroids in 62% and azathioprine in 81.8% of patients. Medical records were captured prospectively; data of the CD and UC groups were analyzed separately.

Results: 78.5% of the patients were in remission after a one-year treatment period. Dose intensification was needed in 13.8% of CD and in 11.4% of UC patients. Biological therapy had to be restarted because of clinical flare after remission in 45.9% of CD patients and in 28.6% of UC patients after a median of 8 months. 41.1% of these IBD patients with restarted biologics were in remission at the end of the second year. In a logistic regression analysis corticosteroid use at induction (p = 0.034, OR: 1.58, 95% CI: 1.04–2.41), previous anti-TNF-alpha therapy (p = 0.03, OR: 2.84, 95% CI: 1.11–7.30) and dose intensification (p = 0.008, OR: 6.25, 95% CI: 1.62–24.2) were associated with the need for restarting biological therapy in CD. Numerically, need for restarting of biological therapy was more common in men, in smokers and in patients who underwent appendectomy. None of the examined factors were associated to the need for restarting biological therapy in UC.

Conclusions: Biological therapy had to be restarted in almost half of the CD patients after the discontinuation within a median of 8 months after the discontinuation, despite being in remission at one-year. Steroid use, previous biological therapy and dose intensification but not CRP was identified as predictors for the need for restarting biological therapy.