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.

Introduction Ulcerative colitis (UC) is an autoimmune disease characterized by the formation of erosions and ulcerations of the colonic mucosa. Exclusion of infections, including sexually transmitted disorders (STDs), is particularly important in the differential diagnosis. Aim The aim of...

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.