Background No data on the recently introduced infliximab (IFX) biosimilar SB2 in inflammatory bowel disease (IBD) are available. Methods The Sicilian Prospective Observational Study of Patients With IBD Treated With Infliximab Biosimilar SB2 is a multicenter, observational, prospective study performed among the cohort of the Sicilian Network for Inflammatory Bowel Disease. All consecutive IBD patients starting the IFX biosimilar SB2 from its introduction in Sicily (March 2018) to September 2019 (18 months) were enrolled. Results Two hundred seventy-six patients (Crohn disease: 49.3%, ulcerative colitis: 50.7%) were included: 127 (46.0%) were naïve to IFX and naïve to anti-tumor necrosis factor medications (anti-TNFs), 65 (23.5%) were naïve to IFX and previously exposed to anti-TNFs, 17 (6.2%) were switched from an IFX originator to SB2, 43 (15.6%) were switched from the biosimilar CT-P13 to SB2, and 24 (8.7%) were multiply switched (from IFX originator to CT-P13 to SB2). The cumulative number of infusions of SB2 was 1798, and the total follow-up time was 182.7 patient-years. Sixty-seven serious adverse events occurred in 57 patients (20.7%; incidence rate: 36.7 per 100 patient-year), and 31 of these events caused the withdrawal of the drug. The effectiveness after 8 weeks of treatment was evaluated in patients naïve to IFX (n = 192): 110 patients (57.3%) had steroid-free remission, while 56 patients had no response (29.2%). At the end of follow-up, 72 patients (26.1%) interrupted the treatment, without significant differences in treatment persistency estimations between the five groups (log-rank P = 0.15). Conclusions The safety and effectiveness of SB2 seem to be overall similar to those reported for the IFX originator and CT-P13.
Background and Aim Ustekinumab is approved in Europe for the treatment of moderate to severe Crohn's disease (CD). Italian real‐life data are scarce, so the aim of this study was to assess the effectiveness and safety of ustekinumab in an Italian cohort of CD patients. Methods Data of patients with CD who started using ustekinumab were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. Primary end‐points were steroid‐free clinical remission at 8, 24, and 52 weeks of therapy and reduction of C‐reactive protein. Secondary end‐points were treatment response, treatment persistence at 12 months, and safety. Results A total of 131 patients (males 56%; mean age 46 years ±15) were included. All patients were biologics experienced except for one. At 24 and 52 weeks, 40% and 43% of patients achieved steroid‐free clinical remission, and 64% and 62% had clinical response, respectively. At the end of follow‐up, there was a significant reduction of steroid use (P = 0.012) and of the Harvey‐Bradshaw Index (P = 0.001). The probability of persistence in therapy with ustekinumab after 12 months of treatment was 89%. The only factor associated with discontinuation was older age. Conclusions Data from our real‐life cohort of treatment‐refractory CD patients suggest the satisfactory effectiveness and safety profile of ustekinumab.
Background Data from the first wave of the coronavirus disease 2019 (COVID-19) pandemic suggested that patients with inflammatory bowel disease (IBD) are not at higher risk of being infected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) than the general population and that a worse prognosis is not associated with immunomodulatory drugs, with the possible exception of systemic steroids. Methods This retrospective, observational study included consecutive IBD patients from the Sicilian Network for Inflammatory Bowel Disease (SN-IBD) cohort who had a SARS-CoV-2 infection diagnosis (polymerase chain reaction–confirmed presence of the viral genome in a nasopharyngeal swab) during the second COVID-19 pandemic wave (September 2020 to December 2020). Data regarding demographics, IBD features and treatments, and comorbidities were analyzed in correlation with COVID-19 clinical outcomes. Results Data on 122 patients (mean age, 43.9 ± 16.7 years; males, 50.0%; Crohn’s disease, 62.3%; ulcerative colitis, 37.7%) were reported. Twelve patients developed COVID-19-related pneumonia (9.8%), 4 (3.3%) required respiratory assistance (nonmechanical ventilation or orotracheal intubation), and 4 died (case fatality rate, 3.3%). In a multivariable analysis, age (odds ratio [OR], 1.034; 95% CI, 1.006–1.147; P = .032) and severe IBD activity (OR, 13.465; 95% CI, 1.104–164.182; P = .042) were independent predictors of COVID-19-related pneumonia, while severe IBD activity (OR, 15.359; 95% CI, 1.320–178.677; P = .030) was the only independent predictor of severe COVID-19, a composite endpoint defined as the need for respiratory assistance or death. A trend towards a protective role of tumor necrosis factor α inhibitors on pneumonia development was reported (P = .076). Conclusions In this cohort of patients with IBD and SARS-CoV-2 infection, severe IBD activity was the only independent risk factor for severe COVID-19.
Linked ContentThis article is linked to Schmitz et al paper. To view these articles, visit https://doi.org/10.1111/apt.14453.
Background Prevalence of NAFLD has recently been reported increased in inflammatory bowel disease (IBD) with conflicting results due to heterogeneity of published studies, especially in the diagnostic definition of NAFLD. The increased risk of NAFLD might be related to traditional risk factors but also to IBD-related factors. The role of genetic markers has been addressed only in one study. The aim of our study has been to assess the prevalence of NAFLD and fibrosis in a homogeneous cohort of patients with IBD, assessing the role of metabolic, disease-related and genetic factors. Methods the diagnosis of NAFLD was based on transient fibroelastometry findings (CAP ≥288 dB/m) and HSI (Hepatic Steatosis Index). Demographic data, traditional risk factors for NAFLD (BMI, lipid profile), comorbities, laboratory tests, disease features (type of IBD, duration, extent, extraintestinal manifestations, relapses/year, disease activity, previous surgery, therapy) were registered in a dedicated database. PNPLA3 rs738409 C>G single nucleotide polymorphism, encoding for I148M protein variant, was investigated by Taqman assay. Results 208 consecutive patients were enrolled: 120 males, 121 Crohn’s disease, 87 ulcerative colitis, mean age 46,4 ± 15,2 years. 26 patients (12,5%) were on steroids, 121 on biologics. The prevalence of NAFLD was 20,7% with mean HSI being 38,3 ± 4,7.On univariate analysis, patients with NAFLD were older (54,6 ± 11,1 years), had higher BMI (28,1 ± 3,9 vs. 24,1 ± 3,8), had more frequently hypertension and high level of LDL and tryglicerides. No significant difference was found as far as concerns gender, number of relapses, extraintestinal manifestations, disease activity and duration and ongoing therapy. Medium stiffness value was higher in patients with NAFLD (6,4 ± 2,4 vs. 4,8 ± 2,2 KPa). CG phenotype of PNAPL3 was more frequent among NAFLD patients, though the result was not significant. On multivariate analysis age, BMI, previous surgery and level of stiffness > 6,9 kPa were independently related to NAFLD. Conclusion This single center cross-sectional study shows that, by using transient elastography, the prevalence of NAFLD in IBD is 20,7% with a significantly increase of liver stiffness and development of fibrosis. NAFLD was related to traditional risk factors (age, BMI, lipid profile) and to previous ileal resection, the last probably due to changes of gut microbiota. Neither intestinal inflammation and drugs nor genetic testing for PNAPL3 seem to be related to the development of NAFLD. Longitudinal studies are warranted to assess the progression of fibrosis and the role of therapeutic interventions.
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