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Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis.

ABSTRACT: 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.

SUBMITTER: Feagan BG

PROVIDER: S-EPMC6499937 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis.

Feagan Brian G BG Schreiber Stefan S Wolf Douglas C DC Axler Jeffrey L JL Kaviya Arpeat A James Alexandra A Curtis Rebecca I RI Geransar Parnia P Stallmach Andreas A Ehehalt Robert R Bokemeyer Bernd B Khalid Javaria Mona JM O'Byrne Sharon S

Inflammatory bowel diseases 20190501 6

<h4>Background</h4>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.<h4>Methods</h4>Sustained clinical remission (primary endpoint) was evaluated using 2 definitions: (1) a partial Mayo Score (pMS) of ≤2 with no subscore >1 ...[more]

PMID: 30365009

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Project description:BackgroundCorticosteroid-free clinical remission is important in ulcerative colitis.ObjectiveThis GEMINI 1 post hoc analysis evaluated vedolizumab efficacy in achieving sustained corticosteroid-free clinical remission in moderately to severely active ulcerative colitis.Materials and methodsGEMINI 1 included a 6-week induction period followed by a 46-week maintenance period. Patients received stable corticosteroid dosing at baseline/during induction and tapered dosing during maintenance. Analysis groups included vedolizumab (induction and maintenance); vedolizumab/placebo (vedolizumab induction, placebo maintenance); and placebo (induction and maintenance). The primary endpoint was sustained corticosteroid-free clinical remission (partial Mayo score ≤2, no individual subscore >1, for ≥32 weeks). Multivariate analyses identified covariates associated with the primary endpoint. Safety endpoints included adverse events.ResultsBaseline demographics and concomitant corticosteroid use were similar across groups (n=454). A greater proportion (95% confidence interval) of the vedolizumab group achieved sustained corticosteroid-free clinical remission (10.2% [6.9 to 13.6]) vs the placebo group (1.4% [0.0 to 7.3]; difference 8.9% [-3.8 to 21.4]). Proportions were similar between the vedolizumab/placebo and placebo groups. Covariates associated with sustained corticosteroid-free clinical remission (odds ratio [95% confidence interval]) were treatment (vedolizumab vs placebo: 9.35 [1.25 to 71.43]; p=0.0605), anti-tumor necrosis factor alpha exposure (yes vs no: 0.26 [0.12 to 0.57]; p=0.0008), and disease duration (≤2 vs >2 years: 2.66 [0.99-7.19]; p=0.0531). Adverse events were similar across groups.ConclusionA numerically greater proportion of vedolizumab-treated patients with ulcerative colitis achieved sustained corticosteroid-free clinical remission. Vedolizumab treatment, no previous anti-tumor necrosis factor alpha exposure, and shorter disease duration were associated with sustained corticosteroid-free clinical remission.ClinicaltrialsgovNCT00783718.

Project description:BACKGROUND:Vedolizumab (VDZ) was approved by the Japanese Ministry of Health, Labor and Welfare in 2018 for the treatment of patients with moderate-to-severe active ulcerative colitis (UC). The comparative cost-effectiveness of VDZ compared with other biologics is unknown in Japan. This information could be useful for decision makers at the time of repricing biologics for the treatment of patients with moderate-to-severe UC. OBJECTIVE:The aim was to assess the cost-effectiveness of VDZ versus other branded biologics for the treatment of patients with moderate-to-severe UC who were anti-tumor necrosis factor (TNF)-naïve, from the Japanese public healthcare payer perspective. METHODS:A hybrid decision tree/Markov model was developed to predict the number of patients who achieved response and remission at the end of the induction phase and sustained it during the maintenance phase, translating this into quality-adjusted life-years (QALYs) and costs. Treatment-related adverse events, discontinuation and surgery, and their impact on QALYs and costs were also modeled. A systematic literature review and network meta-analysis were conducted to estimate the comparative efficacy of each treatment versus placebo. Rates of adverse events, surgery, surgery complications, and utilities were from the literature. Costs (2018 Japanese yen) were obtained from the Japanese National Health Insurance drug price list and medical fee table and local claims databases. Clinical and economic outcomes were projected over a lifetime and discounted at 2% annually. RESULTS:Over a lifetime, VDZ yielded greater QALYs and cost savings compared with golimumab and was cost-effective compared with adalimumab and infliximab (incremental cost-effectiveness ratios ¥4,821,940 and ¥4,687,692, respectively). Deterministic and probabilistic analyses supported the robustness of the findings in the base-case analysis, indicating that VDZ was either dominant or cost-effective in most scenarios and replications. The main limitations of this analysis include excluding tofacitinib and infliximab biosimilar as comparators, health-state utility estimates were obtained from population studies in the United Kingdom, and the impact of subsequent (i.e., second-line) biologic treatment was not evaluated. CONCLUSION:Our analysis suggests that VDZ is dominant or cost-effective compared with other branded biologics for the treatment of anti-TNF-naïve patients with moderate-to-severe UC in Japan.

Project description:Objective: To evaluate the cost effectiveness of vedolizumab vs. infliximab in the treatment of anti-tumor necrosis factor-alpha (TNF-α)-naïve patients with moderate-to-severe active ulcerative colitis (UC) in China. Methods: The costs and effectiveness of vedolizumab and infliximab in the treatment of anti-TNF-α naïve patients with moderate-to-severe active UC were compared using a hybrid decision tree model and a Markov model. From the perspective of the Chinese healthcare system, this study simulated the lifetime health benefits [quality-adjusted life-years (QALYs)] and costs (USD) for patients with UC from the induction phase to the maintenance phase, with an annual discount rate of 5%. The clinical efficacy and transition probability data were based on a previously published network meta-analysis. The health utility, surgical risk, biologic drug discontinuation rate, and mortality were derived from previous literature and the Chinese statistical yearbook. The cost data were based on China's drug purchase and biding platform and the results of a survey sent to clinicians in 18 tertiary hospitals. One-way and probabilistic sensitivity analyses (PSAs) were performed to validate the robustness of the models' assumptions and specific parameter estimates. Results: The results of the base-case analyses showed that compared with infliximab, vedolizumab led to a gain of 0.25 QALYs (9.56 vs. 9.31 QALYs) and was less expensive by $7,349 ($180,138 vs. 187,487), indicating that the use of vedolizumab was a dominant strategy. The results of one-way sensitivity analyses suggested that the annual discount rate and health-state costs had the greatest impact, but the results were otherwise consistent with those of the base-case analyses. The PSAs suggested that vedolizumab had a 98.6% probability of being effective at a threshold of 3 times the gross domestic product (GDP) per capita in China in 2020. Conclusion: Compared with infliximab, vedolizumab appears to be a more cost-effective option in the treatment of anti-TNF-α naïve adult patients with moderate-to-severe, active UC in China.

Dataset Information

Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis.

Publications

Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis.

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