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SALVATORE ACCOMANDO

The sicilian network for inflammatory bowel disease (SN-IBD): preliminary data on efficacy of biological therapy.

  • Autori: Orlando A., Macaluso F.S., Fries W., Privitera A.C., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello A., Carroccio A., Genova S., Bertolami C., Vassallo R., Romano C., Pellegrino S., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Vinci E., Cottone M.
  • Anno di pubblicazione: 2017
  • Tipologia: Poster pubblicato in rivista
  • OA Link: http://hdl.handle.net/10447/279363

Abstract

Introduction: The monitoring of appropriateness, costs, and clinical outcomes of biological therapy in inflammatory bowel disease (IBD) is a relevant need. Aims & Methods: We aimed to evaluate all these issues in Sicily through a webbased network of all prescribing centers. The Sicilian Network for Inflammatory Bowel Disease (SN-IBD) is composed by a super Hub coordinator centre and five Hub plus ten Spoke centres. From January 2013, all IBD patients starting a biological agent (incident cases) or already on treatment (prevalent cases) were entered in a web based software. Herein we report data of incident cases about the efficacy of biological therapy after twelve weeks and one year of treatment. As clinical end-point, we set remission (corresponding to a Mayo Partial Score 52 for UC, and to a Harvey-Bradshaw Index 55 for CD), and response (reduction of Harvey-Bradshaw Index <3 for CD and Mayo Partial Score <2 for UC compared with baseline). Results: From January 2013 to January 2017, 1578 patients were included. Incident cases were 1151 (808 Crohn’s disease [CD], 335 ulcerative colitis [UC], 8 unclassified colitis). Considering that 22.2% of patients experienced more than one line of therapy, a total of 1407 treatments were reported. CD: there was a higher proportion of patients naive to biologics among those on adalimumab (ADA) compared with infliximab (IFX) and vedolizumab (VDZ) (89.3% vs. 53.3% vs. 30.6%, p < 0.001). At week 12, there was a higher rate of response/remission for adalimumab (ADA) compared with infliximab (IFX) and vedolizumab (VDZ) (79.8% vs. 71.8%, p = 0.005, and 79.8% vs. 47.2%, p < 0.001, respectively), and a higher efficacy of IFX compared with VDZ (71.8% vs. 47.2%, p = 0.004). The superiority of ADA over IFX remained significant in naive patients (81.5% vs. 73.7%, OR 1.581, p = 0.026), but not in non-naive. At week 52, ADA had a higher rate of response compared to IFX (65.4% vs. 56.0%, p = 0.018). However, there was no statistical difference between the two drugs when patients were stratified in naive and non-naive, while ADA was superior over IFX in patients with ileo-colic disease (68.8% vs. 48.4%, OR 2.282, p = 0.001). UC: there was a higher proportion of patients naive to biologics among those on IFX compared with GOL and ADA (91.6% vs. 44.1% vs. 55.4%, p < 0.001). At week 12, there was a higher rate of response/remission for IFX compared with golimumab (GOL) (71.8% vs. 56.6%, p = 0.034), but this difference was lost when patients were stratified in naive and non-naive. At week 52, IFX had a higher rate of response/remission compared to GOL (58.2% vs. 38.2%, p = 0.039) and ADA (58.2% vs. 33.9%, p = 0.002). However, IFX was superior to GOL in naive patients only (60.2% vs. 26.7%, OR 4.165, p = 0.018; interaction test: p = 0.02), but non in non-naive, and IFX was superior to ADA in naive patients only (60.2% vs. 37.8%, OR 2.650, p = 0.029). For both CD and UC, no significant difference in efficacy was observed between IFX originator and biosimilars. Several factors were identified as predictor of response independently of the drug employed - at multivariable logistic regression analysis. Conclusion: In one of the largest ‘‘real-life’’ series of IBD patients on biological therapy reported to date, ADA in CD had a higher success compared to IFX at both 12 and 52 weeks; however, this results could be influenced by the preference of ADA as first-line anti-TNF drug in CD. IFX in UC was superior to GOL and ADA at 52 weeks; once again, this result could be influenced by the preference of IFX as first-line anti-TNF agent in UC; no difference was found between GOL and ADA in UC. Being naive to biologics is a relevant predictor of response in both CD and UC at any time point. No significant difference in efficacy was observed between IFX originator and biosimilars.