Sicilian Network for Inflammatory Bowel Disease (SN-IBD). A propensity score-matched comparison of infliximab and adalimumab in naïve and non-naïve patients with Crohn’s disease
التفاصيل البيبلوغرافية
العنوان:
Sicilian Network for Inflammatory Bowel Disease (SN-IBD). A propensity score-matched comparison of infliximab and adalimumab in naïve and non-naïve patients with Crohn’s disease
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 N., Carroccio A., Genova S., Bertolami C., Vassallo R., Ventimiglia M., Renna S., Orlando R., Rizzuto G, Cottone M.
Background: In the absence of head-to-head trials, there is an unmeet need to better understand the relative effectiveness of different biologics in inflammatory bowel disease (IBD). The Sicilian Network for Inflammatory Bowel Disease (SN-IBD) is a group composed by all Sicilian centres which continuously enter in a web-based software all clinical data of IBD patients treated with biologics. Methods: Data of all incident Crohn’s disease (CD) patients treated with infliximab (IFX) and adalimumab (ADA) from January 2013 to April 2017 were extracted from the cohort of SN-IBD. Patients were divided in biologic-naïve and non-naïve, and the two groups were analysed singularly. We used a one-to-two propensity score matching (1 IFX: 2 ADA) accounting for the main baseline characteristics in naïve patients, and a one-to-one propensity score matching (1 IFX: 1 ADA) in non-naïve. Results: Seven hundred and forty-seven naïve and 188 non-naïve patients were included. After propensity score matching, 453 naïve (IFX: 151; ADA: 302) and 100 non-naïve patients (total treatments: 122; IFX: 61; ADA: 61) were analysed. Among naïve patients, the rates of response/remission at 12 weeks for IFX and ADA were 80.1% and 81.1%,, respectively (adjusted OR 0.97, p = 0.923); over a median follow-up of 11.8 months, the rates of response/remission for IFX and ADA were 70.2% and 66.2%, respectively, without significant differences (adjusted OR 1.14, p = 0.401). Among non-naïve patients, the rates of response/remission at 12 weeks for IFX and ADA were 68.9% and 60.7%, respectively (adjusted OR 1.54, p = 0.320); over a median follow-up of 8.9 months, the rates of response/remission for IFX and ADA were 57.4% and 54.1%, respectively, without significant differences (adjusted OR 1.96, p = 0.297). Cox regression analysis showed no differences in risk of treatment failure between ADA and IFX, neither in naïve (adjusted HR 1.23, p = 0.381) nor in non-naïve patients (adjusted HR 1.23, p = 0.488). At multivariable conditional logistic regression analysis of naïve CD patients, upper GI involvement (OR 0.18, p = 0.038), previous surgery (OR 0.24, p = 0.003), and older age (OR 0.97, p = 0.036) were associated with lower clinical benefit at 12 weeks, while previous surgery was the only independent predictor of treatment failure at the end of follow-up (HR 2.13, p = 0.03). Mixed effect Cox analysis showed that non-naïve patients experiencing more than one previous line of treatment with biologics have a significant higher risk of treatment failure compared with those previously treated with one biologic only (HR 2.57, p = 0.002) Conclusions: In this large, propensity score matched, real-life, multicentre, cohort study of CD patients, there was no significant difference in the effectiveness of ADA and IFX. Both drugs showed a good efficacy.