Clinical outcomes and factors for response prediction after the first course of corticosteroid therapy in patients with active ulcerative colitis

2011 ◽  
Vol 26 (7) ◽  
pp. 1114-1122 ◽  
Author(s):  
Jin Young Yoon ◽  
Jae Hee Cheon ◽  
Jae Jun Park ◽  
Sung Pil Hong ◽  
Tae Il Kim ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Outcomes ◽  
Corticosteroid Therapy ◽  
Response Prediction ◽  
Active Ulcerative Colitis

scholarly journals P536 Early prediction of intravenous corticosteroid therapy failure in moderate–severe ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S458-S458
Author(s):  
A Croft ◽  
A Lord ◽  
G Radford-Smith
Keyword(s):  
Ulcerative Colitis ◽  
High Risk ◽  
Clinical Outcomes ◽  
Corticosteroid Therapy ◽  
Risk Score ◽  
Risk Scores ◽  
Albumin Concentration ◽  
Therapy Failure ◽  
Severe Ulcerative Colitis ◽  
Intravenous Corticosteroid

Abstract Background An episode of acute severe ulcerative colitis (UC) is a watershed event during the disease course with a heightened risk of colectomy during and following these episodes.1 The prompt identification of these events followed by the early implementation of appropriate treatment is essential to obtaining the best clinical outcomes for these unwell patients. The majority of published risk scores predicting the important clinical outcomes of intravenous corticosteroid therapy failure and colectomy-by-discharge rely on clinical data from days 1–3 of therapy.2 There is a paucity of tools that allow for a simple and individualised prediction of risk of corticosteroid therapy failure during the earliest stages of admission. Methods Data were prospectively obtained from 349 presentations of moderate–severe UC requiring hospital admission to a tertiary referral hospital. The failure of intravenous corticosteroid therapy was strictly defined by the (Oxford) Day 3 and Day 7 criteria.3 Seventeen clinical, laboratory and endoscopic variables all available within 24 h of hospital presentation were assessed for their ability to differentiate intravenous corticosteroid therapy responders from non-responders. A stepwise generalised linear model was formulated based on the results of the initial univariate analyses. Results Intravenous corticosteroid therapy failure occurred in 208/349 (60%) of presentations. The formulated risk score included the variables of oral corticosteroid therapy failure, bowel frequency and serum albumin concentration with or without the Mayo endoscopic subscore (MES). With the addition of the MES, the area under the curve (AUC) of the risk score was 0.758. When the positive predictive value of the score (threshold) for correctly predicting intravenous corticosteroid therapy failure was set at 85%, 105/275 (38%) of presentations with available data were identified as high risk for corticosteroid therapy failure (Figure 1). Conclusion This practical risk assessment tool provides clinicians with a personalised prediction of the likelihood of success of a course of intravenous corticosteroid therapy in moderate–severe UC. It enables the identification of individuals at high risk of treatment failure who may be suitable for consideration of early treatment escalation or screening for appropriate clinical trials. References

scholarly journals P607 Cost-effectiveness of vedolizumab IV vs. adalimumab SC for moderately to severely active ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S508-S508
Author(s):  
R Schultz ◽  
I Diakite ◽  
J Carter ◽  
S Snedecor ◽  
R Turpin
Keyword(s):  
Ulcerative Colitis ◽  
Cost Effectiveness ◽  
Clinical Outcomes ◽  
Time Horizon ◽  
Relative Effectiveness ◽  
Drug Acquisition ◽  
Medical Costs ◽  
Inadequate Response ◽  
Active Ulcerative Colitis ◽  
Direct Medical Costs

Abstract Background VARSITY (NCT02497469) is the first head-to-head trial comparing two biologic therapies, intravenous vedolizumab (VDZ IV) and subcutaneous adalimumab (ADA), in adults with moderately to severely active ulcerative colitis (UC). We evaluated the cost-effectiveness of VDZ IV vs. ADA from a US payor perspective using efficacy data from VARSITY. Methods We used a cohort decision tree model with a time horizon up to 2 years. Simulated cohorts included patients with or without prior biologic therapy who initiated treatment with VDZ IV (300 mg in weeks 0, 2, and 6) or ADA (day 1: 160 mg; day 15: 80 mg) for a 6-week induction period. Initial responders proceeded to maintenance treatment with VDZ IV (300 mg every 8 weeks) or ADA (40 mg every 2 weeks); maintenance phase remitters continued treatment for 2 years. Patients with inadequate response to induction or a serious adverse drug reaction (ADR) switched to treatment with biologics (tofacitinib, infliximab, or golimumab). Patients who were intolerant to biologics received corticosteroids with or without curative surgery. The relative effectiveness of VDZ IV vs. ADA was derived from network meta-analyses of published randomised controlled trials. Model outcomes included total direct medical costs associated with drug acquisition, administration, routine monitoring, toxicity management, ADRs, and cost per remission achieved. Costs (eg, drug, monitoring, healthcare resource utilisation, administration) were expressed in 2019 US$. Results Based on our model, VDZ IV was associated with greater induction response (52.92% vs. 45.07%) and remission 2 (21.95% vs. 14.36%) rates at year 2 compared with ADA. Total direct medical costs were $90,673 for VDZ IV and $137,007 for ADA. After 2 years of treatment, more patients in the VDZ IV cohort were in remission and for lower costs compared with ADA. Conclusion The clinical foundation of this model is predicated primarily on head-to-head evidence from the Phase 3 VARSITY trial. This allowed us to extrapolate clinical outcomes out to 2 years and estimate direct medical costs over that timeframe. These modelled outcomes indicate that over a 2-year time horizon adults with moderately to severely active UC are expected to achieve better clinical outcomes and incur lower direct medical costs vs. ADA.

scholarly journals Clinical Outcomes and Predictors of Response for Adalimumab in Patients with Moderately to Severely Active Ulcerative Colitis: A KASID Prospective Multicenter Cohort Study

2020 ◽  
Author(s):  
Seung Yong Shin ◽  
Soo Jung Park ◽  
Young Kim ◽  
Jong Pil Im ◽  
Hyo Jong Kim ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Clinical Outcomes ◽  
Response Rate ◽  
Drug Level ◽  
Mucosal Healing ◽  
Clinical Response Rate ◽  
Active Ulcerative Colitis ◽  
Multicenter Cohort Study ◽  
Tnf Α

Abstract A prospective, observational, multicenter study was conducted over 56 weeks in 146 adult patients with moderately to severely active ulcerative colitis (UC) who received adalimumab (ADA) at 17 Korean academic hospitals. Clinical response rates were 52.1% and 37.7% and clinical remission rates were 24.0% and 21.9% at weeks 8 and 56, respectively. Mucosal healing rates were 39.0% and 30.1% at weeks 8 and 56, respectively. Prior use of anti-tumor necrosis factor-α (anti-TNF-α) did not affect clinical outcomes. The ADA drug level was significantly higher in patients with better outcomes at week 8. In patients with lower endoscopic activity, higher body mass index, and higher serum albumin levels at baseline, the clinical response rate was higher at week 8. In patients with lower Mayo scores and C-reactive protein levels, clinical responses, and mucosal healing at week 8, the clinical response rate was higher at week 56. Serious adverse drug reactions were identified in 2.7% of patients. ADA is effective and safe for induction and maintenance in Korean patients with UC, regardless of prior anti-TNF-α therapy. The ADA drug level is associated with the efficacy of induction therapy. Patients with better short-term outcomes were predictive of those with an improved long-term response

Sign in / Sign up

Export Citation Format

Share Document