Background/Objectives: Therapeutic management of inflammatory bowel diseases (IBD) is rapidly evolving in the era of novel biological therapies. However, real-world data relating to the usage trends and treatment persistence remain inconsistent. This study aimed to investigate trends in biological use, dose intensification, and treatment persistence in IBD patients, who received treatment in a large tertiary center in Greece. Methods: Patients with IBD who underwent at least one biological treatment between 2018 and 2022 were included in this retrospective study. Data on patients’ demographics, type of disease, use of biologicals, dose intensification, and treatment persistence were analyzed for time trends. Results: Data from 409 patients with IBD (mean age 39 (range 17–87), female 51%, 56.9% CD, mean duration of disease: 9.3 years) were included in the study. The number of patients on biologics was raised from 133 in 2018 to 368 in 2022 (a 28.1% yearly increase), while the percentage of patients who were treated with anti-TNF biosimilars increased to >60% of the total anti-TNF population in 2022. We observed a gradual increase in non-anti-TNF therapies in bio-naïve patients, in particular vedolizumab (46% of all biologicals in UC; 16% in CD) and ustekinumab (16.3% of all biologicals in UC, 31% in CD). The 3-year persistence rate of IFX was 64% in CD and 56% in UC, whereas it was 61% for ADA in CD. Dose intensification of anti-TNF was efficient in >50% of CD patients and >30% of UC patients; however, the majority of patients who required dose escalation within the first year eventually became unresponsive. The 3-year persistence of vedolizumab as a first-line treatment was 82% for CD and 69% for UC, respectively. The 3-year persistence of ustekinumab as first-line treatment for CD was 65%. No significant differences regarding the efficacy of anti-TNF, ustekinumab, or vedolizumab were detected when they were used as first-line treatments for Crohn’s disease; similarly, no significant differences were detected between infliximab and vedolizumab as first-line treatments for UC. Conclusions: There was a gradual increase in the use of biologicals, including biosimilars, between the years 2018–2022, reflecting adherence to current guidance with adoption of an early escalation strategy. Newer, post-anti-TNF biologics such as vedolizumab and ustekinumab have been rapidly incorporated into therapeutic approaches for both CD and UC.

Background/Objectives: Cytomegalovirus (CMV) is an opportunistic pathogen, complicating acute severe ulcerative colitis (ASUC), and its role in ASUC prognosis remains a debate. This study aims to report the rates and identify predictors for colectomy at 12 months, following an episode of ASUC with concomitant CMV colonic infection. Methods: This is a retrospective cohort study of patients with ASUC and CMV colonic infection confirmed by PCR or Immunohistochemistry. Baseline clinical, biochemical, endoscopic and disease-related characteristics were recorded. Patients were followed-up for 12 months to calculate the one-year colectomy rate. Predictors of colectomy were identified via multivariate logistic regression. Results: Forty-five cases of CMV colonic infection in 37 patients with ASUC were recorded [66.7% men, mean age: 47.0 years (SD = 18.5)]. At diagnosis, 20% were on monotherapy with advanced treatment and 37.8% on advanced treatment plus corticosteroids and/or immunomodulators. Twenty-three (51.1%) were receiving corticosteroids, while 17.8% did not receive any immunosuppressive agent. Forty (88.9%) patients were treated with ganciclovir and valganciclovir and one (2.2%) with foscarnet for at least 21 days. Eleven patients (24.4%) required colectomy, two (4.4%) during their initial hospitalization and nine (20%) during the follow-up period. The recurrence of CMV was recorded in nine (20.9%) cases, three of which required colectomy. Patients with hemoglobin < 12 g/dL (p = 0.023) and patients on vedolizumab at diagnosis (p = 0.050) had a higher probability of colectomy. Conclusions: We report a 25% one-year colectomy rate in our cohort with ASUC and superimposed CMV colonic infection. At baseline, anemia and vedolizumab treatment were associated with a higher probability of colectomy.

Background/Objectives: Ustekinumab has been approved for the treatment of moderate to severe ulcerative colitis. Real-world data regarding its efficacy and the discovery of predictive factors of response need to be studied further. We aimed to evaluate the efficacy and identify predictors of response to induction treatment with ustekinumab in patients with ulcerative colitis. Methods: This is a multicenter, prospective cohort study. Clinical response (CR) at week 16 was the primary endpoint, and steroid-free clinical remission (SFCRem) and endoscopic response were the secondary endpoints. Baseline histology, mucosal gene expression, and pharmacokinetics were studied for their effect on response to treatment. Results: We included 123 patients (mean age = 50.3 years). CR was recorded in 70.8% (75/106), SFCRem in 48% (59/123), endoscopic improvement in 71.4% (40/56), and mucosal healing in 28.6% (16/56). Higher PRO-stool frequency (OR = 0.49, p = 0.027), concomitant use of 5-ASA (OR = 3.69, p = 0.021), platelet number of ≥284 × 10⁹/L (OR = 6.52, p = 0.001) at baseline, and a drop in the total count of platelets by 10⁸/L (OR = 1.23, p = 0.022) at week 8 were independently associated with CR. Elevated trough levels of ustekinumab at week 16 were associated with a higher probability of endoscopic improvement (median difference = 3784 ng/mL, p = 0.013), with an optimal cut-off value of 3500 ng/mL (AUC = 0.82, 95% CI: 0.66–0.96). Increased mucosal mRNA expression for IL-23 (p = 0.007) and IL-23R (p = 0.031) at baseline was associated with increased probability of CR. Higher continuous Geboes scores at baseline were associated with a lower probability of CR (OR = 0.80, p = 0.045), with an optimal cut-off value of 14 (AUC = 0.75, 95% CI: 0.57–0.93). Conclusions: Clinical, laboratory, and molecular markers may identify patients with ulcerative colitis who are more likely to respond to ustekinumab.