Ustekinumab is an effective biological agent for the treatment of ulcerative colitis (UC); however, real-world data on treatment persistence and factors affecting drug survival in biologic-experienced patients remain limited. This retrospective cohort study aimed to evaluate ustekinumab treatment persistence and identify factors associated with treatment discontinuation in UC patients treated between January 2021 and December 2025. Treatment persistence was defined as the time from treatment initiation to discontinuation and was analyzed using the Kaplan–Meier method. A total of 42 biologic-experienced UC patients were included. The 12-month and 24-month treatment persistence rates were 90.5% and 85.7%, respectively, and 14.3% of patients discontinued treatment during follow-up. Surgical history was significantly associated with higher treatment discontinuation rates (p=0.026), and patients with prior surgery had significantly lower treatment persistence (log-rank p<0.001). Female sex was also associated with lower treatment persistence (log-rank p=0.045). Other clinical variables, including smoking status, disease extent, prior biologic exposure, and extraintestinal manifestations, were not significantly associated with treatment persistence. In conclusion, ustekinumab demonstrates high treatment persistence in biologic-experienced UC patients in real-world practice, and surgical history and female sex may be associated with lower treatment persistence. Larger prospective studies are needed to confirm these findings.
Background and Objectives: Anti-hepatitis B core antibody (anti-HBc) is generally regarded as a lifelong serological marker of previous hepatitis B virus (HBV) infection. However, anti-HBc seroclearance has been increasingly reported in patients receiving anti-CD20 therapy, while its incidence, longitudinal serological dynamics, and clinical significance remain insufficiently characterized. In this study, we aimed to evaluate the incidence, timing, and predictors of anti-HBc seroclearance and investigate longitudinal changes in HBV serology in HBsAg-negative/anti-HBc-positive patients undergoing anti-CD20 therapy. Materials and Methods: This retrospective single-center cohort study included 230 HBsAg-negative/anti-HBc-positive adults who received anti-CD20 therapy between 2011 and 2025. Anti-HBc seroclearance was evaluated using Kaplan–Meier analysis and Cox proportional hazards regression. Longitudinal changes in anti-HBc and anti-HBs titers were assessed using linear mixed-effects models. Results: Confirmed anti-HBc seroclearance occurred in 38 of 230 patients (16.5%). Younger age (adjusted hazard ratio (aHR) 0.96, 95% confidence interval (CI) 0.93–0.98; p = 0.001), fewer anti-CD20 treatment cycles (aHR 0.90, 95% CI 0.83–0.99; p = 0.025), and mycophenolate mofetil therapy (aHR 2.52, 95% CI 1.14–5.56; p = 0.022) were independently associated with anti-HBc seroclearance. Anti-HBc titers progressively declined during follow-up, with a significantly steeper decline among patients receiving mycophenolate mofetil. HBV reactivation occurred in five of 230 patients (2.2%), including two who had developed anti-HBc seroclearance. HBsAg seroreversion occurred in all five patients. Conclusions: Anti-HBc seroclearance is a relatively frequent serological finding in HBsAg-negative/anti-HBc-positive patients receiving anti-CD20 therapy and is accompanied by progressive declines in anti-HBc titers. Despite seroclearance, HBV reactivation may still occur, indicating that anti-HBc loss should not be considered evidence of elimination of HBV-related immunological risk. These findings improve our understanding of HBV serological dynamics during anti-CD20 therapy and support maintaining current antiviral prophylaxis and virological monitoring strategies regardless of anti-HBc seroclearance.
Background and Objectives: Ustekinumab has demonstrated high treatment persistence in Crohn’s disease (CD), particularly in biologic-experienced populations. However, the impact of cumulative biologic exposure and disease severity on persistence remains insufficiently characterized in real-world settings. Methods: This single-center retrospective cohort study included adult CD patients initiating ustekinumab between 2017 and 2026. All patients had prior biologic exposure. Treatment persistence was evaluated using Kaplan–Meier analysis, and subgroup comparisons were performed using log-rank tests. Results: A total of 64 biologic-experienced patients were included (mean age 38.3 ± 13.2 years; 50% female). Treatment persistence was 89.7% at 12 months and 79.1% at 24 months, with a median follow-up of 25.5 months. A total of 13 discontinuation events occurred, most commonly due to lack of efficacy (10.9%), followed by extraintestinal manifestations (4.7%). Disease location and prior surgery were significantly associated with reduced persistence (log-rank p = 0.040 and p = 0.031, respectively). Log-rank analysis demonstrated significant differences in treatment persistence according to disease location (p = 0.040) and prior surgery (p = 0.031), while penetrating disease behavior showed a borderline association (p = 0.056). Conclusions: Ustekinumab demonstrated high treatment persistence in this biologic-experienced Crohn’s disease cohort. Lower treatment persistence appeared to be associated with ileocolonic disease location and prior surgery. Given the limited number of discontinuation events, these subgroup findings should be interpreted cautiously. Nevertheless, our findings support ustekinumab as a durable real-world treatment option for biologic-experienced Crohn’s disease patients.