Background: The Crohn’s Disease (CD) Activity Index (CDAI), Inflammatory Bowel Disease (IBD) Questionnaire (IBDQ), and IBD-Fatigue (IBD-F) scale are useful patient-reported outcome (PRO) tools for assessing the treatment benefits of vedolizumab (VDZ) beyond clinical trial endpoints in patients with CD.Objectives: To assess clinical response, clinical remission, steroid-free remission, changes from baseline for PROs, and safety in a real-world cohort of patients with moderate-to-severe active CD treated with VDZ.Design: POLONEZ II was a multicenter, observational, prospective study across 10 Polish centers from April 2020 to October 2023 for 54 weeks in patients with CD eligible for reimbursed VDZ.Methods: Primary endpoints at week 54 (W54) were clinical response (⩾70-point reduction in CDAI and >25% reduction vs baseline), remission (CDAI score ⩽150), and steroid-free remission. Other outcomes were changes in PROs (CDAI score and health-related quality of life) and safety. Kaplan–Meier survival analyses were performed.Results: Of 98 patients with CD, the mean age was 35.2 years, 57.1% were male, and 72.4% had an ileocolonic disease. At W54 ( n = 98), 63.3% of patients achieved clinical response, 48.0% remission, and 36.0% steroid-free remission. The durability of clinical response, remission, and steroid-free remission (W14–W54) were 68.9%, 62.9%, and 57.1%, respectively. By W54, a significant reduction in the PROs, such as the total CDAI score ( p < 0.001), stool frequency ( p < 0.001), abdominal pain score ( p < 0.001), IBDQ ( p < 0.001), IBD-F ( p < 0.05), and fatigue impact on daily activities ( p < 0.001), was observed. During VDZ treatment, arthralgia (23.7%–8.7%) and anemia (22.6%–15.9%) decreased between baseline and W54. Non-serious adverse events (SAEs; 12.2%), SAEs (7.1%), and VDZ-related rash (1.0%) were reported. Mean CD-related hospitalization duration decreased from baseline (10.2 days) to the end of the study (5.3 days).Conclusion: POLONEZ II demonstrated long-term real-world benefits of VDZ toward effectiveness, safety, and improved PROs and patients’ quality of life.Trial registration: ENCePP (EUPAS32716).

Background: Upadacitinib (UPA) is a new oral selective Janus Kinase (JAK) inhibitor that has shown high efficacy in the treatment of ulcerative colitis (UC). We present data from a multicenter real-world study. Methods: To assess efficacy of UPA, Total Mayo Score (TMS), fecal calprotectin (FC), endoscopy, and intestinal ultrasonography (IUS) were performed. Results: The study population included 76 patients. An amount of 26.3% of the patients were biologics and small molecules-naive, while 73.7% were exposed. By Week 8, 93.4% of the patients had achieved a clinical response (94.7% naive vs. 92.9% exposed), 72.4% achieved endoscopic improvement (78.9% vs. 71.4%), and 57.9% had clinical remission (78.9% vs. 51.8%). Endoscopic remission was achieved in 31.6% of patients (35.0% vs. 30.4%) and biochemical remission in 82.1% (53.3% vs. 68.3%). All of the results were not significantly different apart from the steroid-free clinical remission—36.8% (68% vs. 26.8%, p = 0.002) after 8 weeks of follow-up. IUS was performed in 33 patients. Bowel wall thickness (BWT), inflammatory fat (iFAT), color Doppler signal (CDS), loss of bowel wall stratification (BWS), and Milano Ultrasound Criteria (MUC) had decreased significantly by Weeks 4 and 8 (p < 0.005 for all). Correlation between the IUS results and TMS, FC and endoscopic remission in Week 8 was confirmed (p < 0.001). UPA was well tolerated, and no new safety signals were registered in our group. Conclusions: In this study, UPA was confirmed to be safe and highly effective in inducing remission in UC patients in both the naive group and the biologically exposed patients. The correlation between the IUS results and TMS, FC, and endoscopic remission provides valuable information for clinicians.

Background: Inflammatory bowel disease (IBD) encompasses chronic gastrointestinal disorders that significantly impact patients’ quality of life (QoL). While clinical trials support the efficacy and safety of vedolizumab, real‐world data linking its effectiveness to QoL‐related patient‐reported outcomes remain limited. This prospective observational study assessed the effects of 14‐week vedolizumab induction therapy on QoL (i.e., fatigue, mood, and sleep disturbances), clinical response, safety, and predictors of response. Methods: A total of 257 patients with ulcerative colitis (UC; n = 205) and Crohn’s disease (CD; n = 52) received 14‐week vedolizumab induction therapy. Disease activity, QoL (assessed using the total Inflammatory Bowel Disease Questionnaire [IBDQ]), fatigue (Functional Assessment of Chronic Illness Therapy‐Fatigue [FACIT‐Fatigue]), mood and sleep disturbances (PROMIS Depression and Sleep Disturbance scales), and selected biomarkers were evaluated. Clinical response was assessed using the Mayo score for UC and Crohn’s Disease Activity Index (CDAI) score for CD. Results: At Week 14, clinical response was observed in 82% of UC patients and 82.7% of CD patients. Median total IBDQ scores increased by 45.0 points in UC and 31.5 points in CD ( p < 0.001). Median prorated FACIT‐Fatigue scores increased by 5.0 points in both groups ( p < 0.001), while median prorated PROMIS Sleep Disturbance and Depression T‐scores decreased ( p < 0.05). Improvement in QoL was moderately correlated with clinical response ( r = 0.5). In logistic regression analysis, baseline patient characteristics indicative of advanced disease were associated with a reduced likelihood of clinical and QoL response to treatment. A total of 28 adverse events were reported, including 11 serious events and four treatment‐related events. Conclusions: Vedolizumab reduced disease activity and led to a rapid improvement in QoL during the 14‐week induction therapy in patients with IBD. Clinical response was positively correlated with QoL improvement. Predictors of reduced response were consistent with features of advanced disease.