Patients with UC experienced clinical and HRQL improvements with continued vedolizumab treatment. Increased dosing frequency to every 4 weeks was beneficial in patients who had loss of response to 8-weekly dosing.
Background
Sustaining clinical remission is an important treatment goal in moderate-to-severe UC. This post hoc exploratory analysis assessed the long-term efficacy of vedolizumab in the subset of patients with UC in the GEMINI 1 study who were in clinical remission by week 14 after 3 induction doses, administered at weeks 0, 2, and 6.
Methods
Sustained clinical remission (primary endpoint) was evaluated using 2 definitions: (1) a partial Mayo Score (pMS) of ≤2 with no subscore >1 and (2) a rectal bleeding subscore (RBS) of 0 throughout weeks 14, 26, 38, and 52.
Results
The proportion of patients in clinical remission at week 14 was significantly higher in patients receiving vedolizumab (n = 620) compared with placebo (n = 149) (pMS: 32.7% vs 20.1% [percentage-point difference (∆) 12.6%; 95% confidence interval [CI], 5.2–20.0]; RBS: 47.3% vs 28.9% [∆18.4%; 95% CI, 10.1–26.7]). Of patients in clinical remission at week 14, a significantly higher proportion of vedolizumab-treated patients achieved sustained clinical remission compared with placebo (pMS: 66.5% vs 26.7%; ∆39.8%; 95% CI, 22.7–56.9; RBS: 56.7% vs 20.9%; ∆35.7%; 95% CI, 22.3–49.1). Findings were consistent in tumor necrosis factor (TNF) antagonist-naive and antagonist-failure patients.
Conclusion
Compared with placebo, 35%–40% more patients receiving a full induction course of vedolizumab had sustained clinical remission after 52 weeks of therapy. This result was observed irrespective of TNF antagonist treatment history. Clinical remission at week 14 may therefore be a predictor for sustained clinical remission with vedolizumab.
Objectives: To examine trends in hospital length of stay and total costs in PID patients. MethOds: The latest available 2015 National Inpatient Sample (NIS) data set of hospital admissions from the Healthcare Cost and Utilization Project was utilized in order to determine the number of hospital admissions for patients with PID (identified by ICD-9 for Q1-Q3 and ICD-10 codes for Q4). The LOS and costs were compared by payer type, race and age groups. Results: Based on our inclusion criteria we found 13,393 admissions, representing 0.155% of all hospitalizations. The mean age was 50.04 years (SD: 25.46, Median 57 years). The overall mean LOS was 8.05 days (SD: 13.61, Median 5 days). Majority of the hospitalizations were in patients age 60+ (46%), followed by age 45-59 (20%). Mean (SD) LOS by age: 0-18: 11 days (SD: 25, n= 1725), 18-45: 7.1 days (SD: 10.98, n= 1696), 45-59: 7.11 days (SD: 10.14, n= 2002) and 60+: 7.39 days (SD: 8.48, n= 4622). The mean LOS by payer: Medicare: 7.22 days (SD: 7.82), Medicaid: 9.99 days (SD: 21.48) and Private: 7.94 days (SD: 13.23). The overall mean charges were $90,602
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