Abstract
The aim of this study was to compare the outcomes of therapy with IFX and ADA in CD patients in daily clinical practice. Material and methods: All CD patients treated with anti TNF-alpha antibodies 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: A total of 188 patients (113 treated with IFX and 75 with ADA) were enrolled. The mean age at diagnosis was 29±12 (IFX) vs 34±14 (ADA) (p=0.003). The mean duration of disease was 8±6 years for both groups. Ileocolonic disease was significantly more frequent in IFX patients (45 vs 19 pts, p=0.03). 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) were the indications for therapy. All patients treated with ADA vs 66 (58%) treated with IFX received a maintenance therapy; the mean duration of treatment was 12±10 for ADA vs 6±6 months for IFX (p=0.0003). The response rate was similar (76% IFX and 67% ADA; p=0.17). Five of 6 patients (83%) non-responder to ADA and 7 of 10 patients refractory to IFX responded to the alternative anti-TNF (p=ns). 107 patients were treated with immunosuppressants (76 with IFX and 31 with ADA; p=0.0005). The response rate did not improve with the combo therapy in both groups. 74 patients were active smokers (49 treated with IFX and 25 with ADA; p=0.1). The response rate was significantly lower in smokers treated with IFX (71.4% vs 92%, p=0.005). 15 (13%) patients treated with IFX and 10 (14%) treated with ADA had adverse events (AEs) (p=ns). No differences in AE rate between patients in mono or combo therapy were found. Conclusions: IFX and ADA showed similar efficacy and safety. 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.
Published Version
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