Integrating efficacy and safety of vedolizumab compared with other advanced therapies to assess net clinical benefit of ulcerative colitis treatments: a network meta-analysis

Jairath, Vipul; Chan, Kin‐Sang; Lasch, Karen; Keeping, Sam; Agboton, Christian; Blake, Aimee; Patel, Haridarshan

doi:10.1080/17474124.2021.1880319

Cited by 10 publications

(22 citation statements)

References 62 publications

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“…Furthermore, NMAs were used to assess the relative efficacy of multiple treatments in the absence of head-to-head RCTs, which is a common and accepted approach [39]. We extracted data via a systematic literature review and evidence from the VISIBLE 1 trial for the NMA [10,20]. Despite the differences in RCT designs, outcome definitions for response and remission at 52, 54, and 60 weeks were comparable and consistent between rerandomized trials and treat-through studies.…”

Section: Discussionmentioning

confidence: 99%

“…A systematic literature review and a NMA of clinical trials was conducted to allow indirect comparisons of advanced therapies (biologics and the small molecule, tofacitinib) used in the treatment of moderately to severely active UC, and networks of evidence were developed separately for the overall combined anti-TNF-naïve and anti-TNF-experienced population, and each subgroup separately [20]. Because of differences in trial design, population, and reported results among the clinical trials of advanced therapies, a connected network of clinical trials to compare all the treatments of interest for the outcomes of interest in the NMA was not available for all patient subgroups (e.g., anti-TNF-α-naïve, exposed, and mixed) in the model.…”

Section: Treatment Efficacymentioning

confidence: 99%

“…responders at weeks 6-10, while other trials used a treatthrough design, in which all patients received the same treatment for 52 weeks during induction and maintenance. To account for the differences in the maintenance phase in this NMA, data from treat-through study designs were converted and re-randomized to estimate sustained response (RR for maintenance response on advanced therapy vs conventional therapy, conditional on the induction response for advanced therapy) and remission (RR for maintenance remission on advanced therapy vs conventional therapy, conditional on the induction response to advanced therapy) [20]. The treatment efficacy values produced for the model are summarized in Table 1.…”

Section: Treatment Efficacymentioning

confidence: 99%

“…Incidence rates of discontinuation because of AEs reported in the induction and maintenance phases were obtained from the NMA and calculated as a base-case 10-week probability for the induction phase and annual probability for the maintenance phase (Table 3 in the ESM) [20]. Not all reported AEs led to treatment discontinuation.…”

Section: Treatment Discontinuation Because Of Aesmentioning

confidence: 99%

“…Up-dosing was assumed in the base-case analysis for tofacitinib, infliximab IV, and golimumab SC, but not for vedolizumab SC or IV and adalimumab SC, as up-dosing is not permitted according to product labeling in Canada. For ustekinumab SC, dose de-escalation from every 8 weeks to every 12 weeks was assumed [20]. A sequential analysis of cost effectiveness was conducted following standard rules for estimating ICERs [19].…”

Section: Base-case Analysismentioning

confidence: 99%

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Cost Effectiveness of Subcutaneous Vedolizumab for Maintenance Treatment of Ulcerative Colitis in Canada

Fenu

Lukyanov

Acs

et al. 2022

PharmacoEconomics Open

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Background and Objectives Ulcerative colitis is highly prevalent in Canada and cost-effective ulcerative colitis therapies are warranted. Vedolizumab subcutaneous (SC) formulation was recently approved for ulcerative colitis maintenance therapy. We assessed vedolizumab SC cost effectiveness vs conventional and advanced therapeutics in patients with moderately to severely active ulcerative colitis from a Canadian public healthcare payer perspective. Methods A hybrid decision tree/Markov model was developed to evaluate vedolizumab SC costs, quality-adjusted lifeyears, and cost effectiveness vs conventional therapy, adalimumab SC, infliximab intravenous, golimumab SC, tofacitinib, ustekinumab SC, and vedolizumab intravenous. This model predicts the number of patients achieving clinical response and remission after treatment induction, and sustained benefit during maintenance treatment. To account for statistical uncertainties, the base-case analysis was conducted in a probabilistic manner. Scenario analyses examined the impact of previous treatment with anti-tumor necrosis factor agents, dose escalation, loss of efficacy, and treatment adherence. Results In the base-case analysis, conventional therapy was the most cost-effective therapeutic option in the overall population. Vedolizumab SC was cost effective and dominant compared with other advanced therapies

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Section: Discussionmentioning

confidence: 99%

Section: Treatment Efficacymentioning

confidence: 99%

Section: Treatment Efficacymentioning

confidence: 99%

Section: Treatment Discontinuation Because Of Aesmentioning

confidence: 99%

Section: Base-case Analysismentioning

confidence: 99%

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Cost Effectiveness of Subcutaneous Vedolizumab for Maintenance Treatment of Ulcerative Colitis in Canada

Fenu

Lukyanov

Acs

et al. 2022

PharmacoEconomics Open

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Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis

Jarrett

Sadler

et al. 2022

Int J Clin Pharm

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Background Only one head-to-head comparison of advanced treatments in moderately to severely active ulcerative colitis (UC) has been published; therefore, there remains a need for further comparisons. Aim The relative treatment effects of filgotinib and adalimumab, golimumab, infliximab, tofacitinib, ustekinumab and vedolizumab were estimated using a network meta-analysis (NMA). Method Systematically identified studies (MEDLINE, Embase and Cochrane Library; searched: inception–May 2019, updated November 2020) investigating treatments for moderately to severely active UC were re-evaluated for inclusion in a Bayesian NMA (fixed-effects model). Relative treatment effects were estimated using different permutations of patient population (biologic-naïve or biologic-experienced), treatment phase (induction or maintenance) and outcomes (MCS response/remission or endoscopic mucosal healing). Results Seventeen trials (13 induction; 9 maintenance) were included in the NMA; 8 treatment networks were constructed. Most targeted therapies were superior to placebo in terms of MCS response/remission and endoscopic mucosal healing; filgotinib 200 mg was similar to most other treatments. Infliximab 5 mg/kg was superior to filgotinib 200 mg (biologic-naïve; induction) for MCS response/remission (mean relative effect, 0.34 [95% credible interval: 0.05, 0.62]). Filgotinib 200 mg was superior to adalimumab 160/80/40 mg for MCS response/remission (biologic-experienced; induction; – 0.75 [– 1.16, – 0.35]), and endoscopic mucosal healing (biologic-naïve; maintenance; – 0.90 [– 1.89, – 0.01]); and to golimumab 50 mg every 4 weeks (biologic-naïve; maintenance; – 0.46 [– 0.94, 0]) for MCS response/remission. Conclusion The current treatment landscape benefits patients with moderately to severely active UC, improving key outcomes; filgotinib 200 mg was similar to current standard of care in most outcomes.

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Cost-Effectiveness of Vedolizumab as a First-Line Advanced Therapy Versus Adalimumab Treatment Sequences for Ulcerative Colitis in Italy

Salcedo,

Hill-McManus,

Hardern

et al. 2024

PharmacoEconomics Open

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Background Today, there are many treatment options available for the management of ulcerative colitis, creating challenges in selecting the most efficacious and cost-effective treatment sequences. Treatments in the anti-tumor necrosis factor alpha (TNFα) therapeutic class, as well as vedolizumab, are widely used and endorsed as first-line options according to treatment guidelines. The aim of this study was to compare treatment sequences involving vedolizumab and the anti-TNFα treatment adalimumab in terms of cost-effectiveness in the treatment of moderately to severely active ulcerative colitis in Italy. Methods A cost-effectiveness model comparing treatment sequences within the Italian National Health Service in terms of costs and quality-adjusted life years (QALYs) with a lifetime horizon was developed. The analysis focused on the relative positioning of vedolizumab and adalimumab, leveraging the results of the landmark head-to-head VARSITY clinical trial as key inputs. The robustness of the results was investigated through a range of sensitivity and scenario analyses. ResultsThe strategy of vedolizumab as a first-line advanced therapy followed by adalimumab was associated with higher costs and health benefits compared with first-line adalimumab followed by vedolizumab. The incremental cost-effectiveness ratio was €16,146/QALY, which was found to be robust to changes to inputs associated with areas of high uncertainty. Conclusion This economic evaluation estimated a 94% probability that vedolizumab as a first-line advanced therapy is costeffective at a threshold of €33,004/QALY when compared with first-line adalimumab sequences. Using clinical trial evidence to inform the efficacy of second-line treatments estimated that the effectiveness of anti-TNFα treatments is not substantially reduced by vedolizumab exposure.

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Integrating efficacy and safety of vedolizumab compared with other advanced therapies to assess net clinical benefit of ulcerative colitis treatments: a network meta-analysis

Cited by 10 publications

References 62 publications

Cost Effectiveness of Subcutaneous Vedolizumab for Maintenance Treatment of Ulcerative Colitis in Canada

Cost Effectiveness of Subcutaneous Vedolizumab for Maintenance Treatment of Ulcerative Colitis in Canada

Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis

Cost-Effectiveness of Vedolizumab as a First-Line Advanced Therapy Versus Adalimumab Treatment Sequences for Ulcerative Colitis in Italy

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