The sicilian network for inflammatory bowel disease (SN-IBD): preliminary data on efficacy of biological therapy.
- Autori: Orlando, A.; Macaluso, F.; Fries, W.; Privitera, A.; 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: Proceedings (TIPOLOGIA NON ATTIVA)
- OA Link: http://hdl.handle.net/10447/279363
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.