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Background Few data are currently available about SB5 in inflammatory bowel diseases (IBD). The aim of this study was to assess the effectiveness and safety of SB5 in a cohort of patients with IBD in stable remission switched from the adalimumab (ADA) originator and in a cohort of patients with IBD naïve to ADA. Methods We prospectively enrolled patients with IBD who started ADA treatment with SB5 (naïve cohort) and those who underwent a nonmedical switch from the ADA originator to SB5 (switching cohort). Clinical remission and safety were assessed at baseline and at 3, 6, and 12 months. In addition, in a small cohort of patients who were switched, we assessed the ADA serum trough levels and antidrug antibodies at baseline, 3, and 6 months. Results In the naïve cohort, the overall remission rate at 12 months was 60.42%, whereas in the switching cohort it was 89.02%. Fifty-three (36.3%) patients experienced an adverse event, and injection site pain was the most common; it was significantly more frequent in the switching cohort (P = 0.001). No differences were found in terms of ADA serum trough levels at baseline, 3, and 6 months after switching. No patient developed antidrug antibodies after the switch. Conclusions We found that SB5 seemed effective and safe in IBD, both in the naïve cohort and in the switching cohort. Further studies are needed to confirm these data in terms of mucosal healing.

Vedolizumab is a gut-selective anti-integrin (α4β7) antibody for the treatment of inflammatory bowel disease with a well-known optimal safety profile. We aimed to compare its risk of infections with that of anti-TNF drugs and ustekinumab in patients with both ulcerative colitis and Crohn's disease.All Crohn's disease and ulcerative colitis patients undergoing biological treatment at our centre between 2013 and 2019 were retrospectively included. All infectious complications were registered, considering both inpatient and outpatient events. A comparison of the exposure-adjusted infection rates of vedolizumab, anti-TNF drugs and ustekinumab was carried out, with a specific focus on the rate of gut infections. All infection rates were expressed in events per patient-years (PYs).The overall exposure-adjusted infection rate was 11.5/100 PYs. The most common infections were respiratory tract infections, cutaneous infections, HSV infections/reactivations and gut infections. The rate of serious infections was 1.3/100 PYs. The infection rate of vedolizumab was 17.5/100 PYs, with Crohn's disease patients having a lower infection risk compared with ulcerative colitis patients (P = 0.035). Gut infections were observed in 3.0% of the whole patient population (1.5/100 PYs) and were more common in the vedolizumab group (P = 0.0001).Our study confirms the good safety profile of vedolizumab. Among patients treated with vedolizumab, those with ulcerative colitis have a higher risk of developing infectious complications. Patients treated with vedolizumab have a higher risk of gut infections compared with patients treated with anti-TNF drugs or ustekinumab. Presumably, this is due to the gut-selective mechanism of action of vedolizumab.

Background Intestinal ultrasound (IUS) is being widely accepted as a reliable tool to objectively monitor Crohn’s disease (CD) activity. Recently, an international panel of experts developed an IUS score, called IBUS-SAS (International Bowel Ultrasound Segmental Activity Score). Our aim was to validate this index in a real-life cohort and find a cut-off score that correlates with common lab results of intestinal inflammation. Methods All CD patients referred to our unit for IUS examination between November 2020 and February 2021 were scored with the IBUS-SAS. Clinical activity at the time of presentation using Harvey-Bradshaw Index (HBI) was recorded, with remission defined as HBI Results In total, 40 CD patients were included. The characteristics of the cohort are reported in Table 1. In patients in clinical remission, IBUS-SAS was 27.52±17.42 (mean ±SD); in patients with clinical activity, it was 59.23±22.36. In individuals with negative FC, IBUS-SAS mean value was 26.59±16.85; in case of FC >150 µg/g, it was 50.13±22.16. IBUS-SAS score directly correlated with all parameters considered: clinical activity (ρ=0.38, P=0.01), CRP (ρ=0.33, P=0.04) and FC (ρ=0.42, P=0.007). ROC analysis of IBUS-SAS for CBR revealed an area under the curve of 0.92 (95% CI 0.86–0.97), with a sensitivity of 83.3% and a specificity of 91.3% for a cut-off value of 42.9. Conclusion This pilot analysis of IBUS-SAS confirmed its potential to precisely define CD activity, correlating both with clinical scores and biomarkers. An IBUS-SAS cut-off value of 42.9 has demonstrated the highest sensitivity and specificity in predicting normal values of both CRP and FC. A comparison of IBUS-SAS with endoscopic activity and a larger cohort are needed to confirm these findings.

Azathioprine is a cornerstone of the therapy of Crohn’s disease. Unfortunately, infections and malignancies are relatively common adverse effects related to this drug; however, cirrhosis is exceptionally reported as a side effect. We report the case of a 49-year-old male patient with ileocolonic steno-penetrating Crohn’s disease who developed hepatic cirrhosis while treated with azathioprine. After taking azathioprine for 3 years with regular follow-up, he developed pancytopenia, and liver cirrhosis was diagnosed with ultrasound, abdomen computed tomography scan, transient elastography, and liver biopsy. As all other causes of liver damage were excluded, azathioprine was believed to be the cause of liver injury and therefore was interrupted.

Stevens–Johnson syndrome (SJS) is a severe mucocutaneous adverse drug reaction with a relatively high mortality rate. SJS is described during herpes simplex virus type 1 (HSV1) infection and, rarely, even during adalimumab therapy. We report the case of a patient with Crohn’s disease who developed SJS during an HSV1 infection and a contemporaneous anti-TNFα therapy with adalimumab. Remission was achieved with suspension of adalimumab and high doses of intravenous steroids and antivirals. Patients with HSV1 infection and on adalimumab therapy have a combined risk of SJS and should be monitored closely.

Background Vedolizumab (VDZ) is a gut selective anti-α 4β 7 integrin antibody for the treatment of Inflammatory Bowel Disease with a well-known optimal safety profile. We aimed to compare the risk of infections of VDZ with that of anti-TNF drugs and ustekinumab, in patients with both ulcerative colitis (UC) and Crohn’s disease (CD). Methods All CD and UC patients undergoing biological treatment at our centre between June 2013 and June 2020 were retrospectively included. All infectious complications were registered, considering both inpatient and outpatient events. A comparison of exposure-adjusted infection rate of vedolizumab with that of anti-TNF drugs and ustekinumab was carried out, with a specific focus on the rate of gut infections. All infection rates were expressed in events per patient-years (PYs). Results The overall exposure-adjusted infection rate was 11.5/100 PYs. Detailed information about the infectious complications related to the different biologics is reported in Table 1. The most common infections were respiratory tract infections, cutaneous infections, HSV infections/reactivations, and gut infections. The rate of serious infections was 1.3/100 PYs. Among the 85 patients who were on a VDZ therapy, 17 (3 CD and 14 UC, median age 64, IQR 31–68) suffered an infectious complication. The exposure-adjusted incidence rate for vedolizumab was 17.5/100 PYs, with CD patients having a lower infection risk compared with UC patients (p = 0.035). Gut infections were observed in 3.0% of the whole patient population (1.5/100 PYs) and were more common in the VDZ group (p = 0.0001). Conclusion Our study confirms the good safety profile of vedolizumab. Among patients treated with vedolizumab, those with UC have a higher risk of developing infectious complications. Patients treated with vedolizumab have a higher risk of gut infections compared with patients treated with anti-TNF drugs or ustekinumab. Presumably, this could be due to the gut-selective mechanism of action of vedolizumab.