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DOP085. Success rate of dose de-escalation in patients with inflammatory bowel disease treated with intensified anti-TNF therapy

N. Viazis, J. Anastasiou, T. Koukouratos, M. Giakoumis, E. Anastasopoulos, M. Chanias, K. Markoglou, D. Karamanolis, Evangelismos Hospital, Gastroenterology Department, Athens, Greece

Background

The efficacy of anti tumor necrosis factor therapy in patients with inflammatory bowel disease (IBD) has been demonstrated in several randomized clinical trials. However, some patients do not respond to standard dose and therapy needs to be intensified. The aim of our study was to evaluate how often patients with ulcerative colitis or Crohn's disease treated with intensified infliximab or adalimumab therapy in a tertiary hospital setting, can successfully return to the standard anti-TNF dosage regimen.

Methods

Prospective analysis of our IBD patients started on anti-TNF therapy for maintenance of remission. All patients were anti-TNF naïve, while concomitant azathioprine was administered for 6 months. Outcome of anti-TNF therapy was evaluated every 2 months throughout the follow up period. Standard dose of maintenance infliximab therapy was considered that of 5 mg/kg of body weight administered every 2 months and standard dose of adalimumab therapy was considered that of 40 mg administered every 2 weeks. In patients initially responding to anti-TNF and subsequently losing clinical response (symptoms reappearance, CRP re-elevation) at any time period after the first 14 weeks of therapy, dose escalation was scheduled. During the follow up period and after 1 year of intensified administration, anti-TNF was de-escalated in patients in remission (absence of symptoms, normal CRP).

Results

As of September 2010, a total of 161 IBD patients were started on infliximab (n = 96) or adalimumab (n = 65) therapy in our Department (CD = 133, UC = 28). Among them, 29 (18.0%) patients did not respond to anti-TNF administration and were excluded from further analysis. From the remaining 132 patients (CD = 113, UC = 19, infliximab = 77, adalimumab = 5), 31 (23.5%) needed a dose escalation for maintenance of remission (CD = 30, UC = 1), at some point during the median follow up period of 26 months (range 2–36 months). The vast majority of patients that needed a dose escalation achieved clinical remission (n = 25, 80.6%) without any other intervention, while in 3 patients methotrexate had been added (1 responded, 2 were finally switched to a different anti-TNF agent), 2 had been operated for their disease and 1 entered a clinical trial investigating a new drug. Among those 25 patients that needed dose escalation and regained clinical remission, 16 (64%) were successfully de-escalated to the standard maintenance infliximab or adalimumab dose schedule, after 1 year of intensified anti-TNF administration.

Conclusion

The majority of inflammatory bowel disease patients managed with anti-TNF dose escalation that regain clinical remission can successfully return to standard dose therapy after 12 months of intensified administration.