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P291. Infliximab versus adalimumab in Crohn's disease patients in daily clinical practice. A prospective single center experience

F. Bossa1, V. Annese2, D. Scimeca1, G. Biscaglia1, E. Colombo1, G. Martino1, E. De Santo1, A. Andriulli1

1IRCSS-CSS Hospital, Unit of Gastroenterology, San Giovanni Rotondo, Italy; 2University Hospital Careggi, Dept. Medical & Surgical Sciences, Division of Gastroenterology, Florence, Italy

Background: Infliximab (IFX) and Adalimumab (ADA) are currently used in Crohn's Disease (CD) patients. Their efficacy and safety seem similar but no head to head studies have been performed so far. We prospectively compare the outcomes of therapy with IFX and ADA in CD patients in daily clinical practice.

Methods: All CD patients treated with IFX or ADA form July 1999 to September 2011 at “Casa Sollievo della Sofferenza” Hospital were enrolled. Demographical and clinical data were collected in an electronic database for the analysis.

Results: 188 patients (113 treated with IFX and 75 with ADA) were enrolled. The mean age at diagnosis and at first treatment were 29±12 (IFX) vs 34±14 (ADA) (p = 0.003), and 38±14 (IFX) vs 42±15 (ADA) (p = 0.03). The mean duration of disease was similar (8±6 years) for both therapies. Ileocolonic disease and perianal involvement were significantly more frequent in patients treated with IFX (45 vs 19 pts, p = 0.03 and 31 vs 9 pts, p = 0.01). The indications for therapy were luminal disease (74 IFX vs 61 ADA, p = 0.02), fistulizing disease (28 IFX vs 12 ADA, p = 0.004) and extraintestinal manifestations (11 IFX vs 2 with ADA, p = 0.07). Patients treated with ADA received a maintenance therapy for a significant longer time (12±10 months vs 6±6 months, p = 0.0003). The response rate was 76% (IFX) and 67% (ADA) (p = 0.17). Five out of 6 patients (83%) non-responder to ADA and 7 out of 10 patients refractory to IFX responded to the other antiTNF (p = ns). Seventy-six (67%) patients treated with IFX and 31 (41%) treated with ADA received a combo therapy with immunosuppressants (p = 0.0005). The response rate was not statistically different between the patients in mono or combo therapy for both antiTNF. Eight-four patients (49 IFX and 25 ADA) were active smokers (p = 0.1). The response rate was significantly lower in smokers treated with IFX group (71.4% vs 92%, p = 0.005) but not with ADA (73% vs 62%, p = 0.4). Fifteen (13%) patients treated with IFX and 10 (14%) treated with ADA had adverse events (AEs) (p = ns). No significant differences in AEs rate between patients in mono or combo therapy were found.

Conclusions: IFX and ADA showed similar efficacy and safety in patients with CD. Efficacy and safety were not modified from concomitant use of immunosuppressants. Current smokers showed a significant lower response rate only in patients treated with IFX. Most patients refractory to an antiTNF may respond to the other. Prospective, randomized head to head studies comparing IFX to ADA are strongly desiderable.