Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.

Assessment was performed using the Mayo endoscopic subscore: endoscopic response was defined as a decrease in the Mayo endoscopic subscore by at least 1 point from baseline or a score of ≤1; endoscopic remission was defined as a Mayo endoscopic subscore of 0. For patients who completed the 48-week treatment, we evaluate endoscopic scores, and calculate the number/proportion of patients achieving endoscopic remission.

We apply the Geboes score, and histological remission is defined as a Geboes score ≤ 2B.0. The Nancy Histological Index (NHI) is assessed concurrently, with histological remission defined as an NHI = 0 (indicating no active inflammation). We performed Histological scoring for patients who complete the 48-week treatment course, and evaluate the number/proportion of patients achieving histological remission.

Clinical remission in UC is assessed using the partial Mayo score (pMayo) or PRO2. It's defined as either a pMayo score ≤ 2 with no individual subscore > 1, or meeting the symptomatic remission criteria of PRO2 (indicating improvement in both stool frequency and rectal bleeding scores to the mild or normal range).

• CRP normalization (≤5 mg/L) or reduction by ≥50% from baseline.
• Fecal calprotectin (FC) reduction to <250 μg/g or reduction by ≥50% from baseline.

Response to intestinal ultrasound (IUS) was defined as meeting both of the following criteria: 1) a decrease in bowel wall thickness (BWT) by ≥25% or a reduction of ≥1 mm from baseline; and 2) a reduction in blood flow signal (Limberg score) by ≥1 grade.

Intestinal ultrasound (IUS) remission was defined as meeting both of the following criteria: 1) bowel wall thickness (BWT) ≤ 3 mm; and 2) no detectable blood flow signal (Limberg grade 0).

Endoscopic response in UC was defined as a Mayo Endoscopic Score (MES) reduction of ≥1 point from baseline or a score of ≤1. Endoscopic remission was defined as an MES of 0.

Corticosteroid-free remission, a core treatment target recommended by the STRIDE-II guidelines, reflects a patient's ability to maintain clinical remission without the aid of systemic glucocorticoids. It is defined as achieving clinical remission at the assessment timepoint without the use of oral or intravenous glucocorticoids for at least 12 weeks prior to assessment. The proportion of UC patients achieving corticosteroid-free remission was documented to evaluate the sustainability and steroid-sparing capacity of the treatment.

Drug persistence rate is defined as the proportion of patients who continue to receive a given drug after initiation of treatment. It reflects the tolerability, adherence, and long-term benefit of the therapy, and serves as a core indicator in real-world evidence (RWE) studies. Patients who discontinue treatment due to objective non-medical reasons (e.g., relocation, change of healthcare system) may be excluded in sensitivity analyses.

• Incidence of hospitalizations due to inadequate disease control and cumulative length of hospital stay.
• Incidence and timing of intestinal resection or related surgeries performed due to disease activity or complications.

The clinical, endoscopic, intestinal ultrasound (IUS), and biochemical improvements were compared between biologic-naïve patients and patients with prior biologic therapy failure or intolerance. This analysis aimed to determine if previous biologic exposure influences treatment outcomes.

• A total score increase of ≥16 points from baseline is considered a clinically significant improvement.
• Restoration to a normal or near-normal level (score ≥ 170) from an active disease state is considered achievement of quality of life remission.

Patients with ulcerative colitis (UC) who had previously received vedolizumab (VDZ) treatment and had complete baseline and follow-up data were retrospectively enrolled from our center. Propensity score matching analysis was performed to compare the effects of GUS and VDZ on multidimensional outcomes in moderate-to-severe UC in a real-world setting, including clinical response and remission, endoscopic remission, histological remission, and treatment persistence.