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P185. Safety and efficacy of anti-TNFs in a consecutive series of Crohn's disease patients: A single center cohort study

F. Zorzi, S. Onali, E. Calabrese, C. Petruzziello, M. Ascolani, S. Zuzzi, F. Pallone, L. Biancone

Università Tor Vergata, Rome, Italy

Aim: No studies has compared the clinical outcome by using different anti-TNFs in Crohn's Disease (CD). We therefore evaluated the safety and efficacy of Infliximab and Adalimumab in a consecutive series of CD patients.

Materials and Methods: In a prospective monocentric study, all CD patients with clinical indication for anti-TNFs were enrolled from January 2007 to September 2010. Indications included: moderate-severe CD, refractory CD or perianal disease. Treatment was chosen on an individual basis, including previous responsiveness/intolerance to anti-TNFs. Infliximab (5 mg/Kg i.v.) was administered at 0, 2, 6 weeks followed by maintenance every 8 weeks and Adalimumab at 0, 2, 4 weeks (160, 80, 40 mg s.c.) followed by maintenance every 1–2 weeks (40 mg). Clinical activity (CDAI) and quality of life (IBDQ) were assessed at baseline (w0), at the end of induction and during maintenance at 3 (w12), 6 (w24) and 12 (w54) months. Concomitant medications were reported. Statistical analysis was performed by using the paired Student's t-test and Kaplan-Meyer survival analysis.

Results: Study population: Eighty patients were enrolled: 37 were treated with Infliximab and 43 with Adalimumab. Infliximab group (n = 37; 21 M, median age 35 years, range 19–65, 24 pts on steroids). Indications included: moderate-severe CD (n = 14), refractory CD (n = 12), perianal disease (n = 11). Induction was completed by 27/37 (72%) patients due to infusion or delayed reactions (n = 8) or no response (n = 2), while 2 patients required surgery after w6. Maintenance was started in 24/27, being completed by 17 (70%). Reasons for discontinuation included adverse events (n = 4) or no response (n = 3). Adalimumab group (n = 43; 16M, median age 37 years, range 21–66, 32 pts on steroids). Indications included: moderate-severe CD (n = 12), refractory CD (n = 25), perianal disease (n = 6). All patients completed the induction. Maintenance was started by all the 43 patients, being completed by 30 (70%). Reasons for discontinuation included adverse events (n = 8) or no response (n = 5).

Figure 1.

Clinical outcome: In both groups, the CDAI significantly reduced when comparing both w0 vs w6 and w0 vs each of the scheduled maintenance visits (p < 0.001). The remission (CDAI < 150) or improvement (ΔCDAI > 70) rates at w6 and w54 were 76% and 81% for Infliximab and 89% and 77% for Adalimumab. The remission rates and the time to remission were comparable in the two groups (Long rank test: p = n.s) (fig. 1). At w54, the percentage of patients able to wean off steroids were 57% and 62% in the Infliximab and in the Adalimumab group respectively (P < 0.001 vs baseline). In both groups the IBDQ significantly improved at w6 and w54 vs baseline (p < 0.01 for both). At w54, fistula closure was observed in 7/9 (78%) patients in the Inflximab and in 5/6 (83%) patients in the Adalimumab group.

Conclusions: In our CD population, an expected efficacy was observed for both anti-TNFs, while need of drug discontinuation due to adverse events was higher than expected, particularly in the Infliximab group.