Comparative Study of the Effectiveness of Vedolizumab Versus Ustekinumab After Anti-TNF Failure in Crohn’s Disease (Versus-CD): Data from the ENEIDA Registry

García, Maria José; Rivero, Montserrat; Fernández-Clotet, A; Francisco, Ruth de; Sicilia, B; Mesonero, Francisco; Castro, María Luisa de; Casanova, M J; Bertoletti, Federico; García‐Alonso, Francisco Javier; López-García, Alicia; Vicente, Raquel; Calvet, Xavier; Acosta, Manuel Barreiro‐de; Rosique, Juan; Trastoy, Pilar Varela; Nuñez, Alejandro; Ricart, Elena; Riestra, Sabino; García, Lara Arias; Rodríguez, Maria Teresa Bravo; Arranz, Laura; Pajares, Ramón; Mena, Raquel; Calafat, Margalida; Camo, Patricia; Bermejo, Fernando; Ponferrada, Ángel; Madrigal, R; Llaó, Jordina; Sesé, E; Sánchez, Eugenia; Mariño, Juan Ramón Pineda; Muñoza, C González; López, Ana Y. Carbajo; Julián, A B; Ferrer, Albert Villoria; Baston‐Rey, Iria; Jara, L; Almela, Pedro; Codesido, Laura; Maza, Saioa de la; Leal, Carles; Caballol, Berta; Pérez‐Martínez, Isabel; Campo, Raquel Vinuesa; Crespo, Javier; Domènech, Eugeni; Chaparro, María; Gisbert, Javier P.

doi:10.1093/ecco-jcc/jjad124

Cited by 8 publications

(7 citation statements)

References 36 publications

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“…Nine studies reported clinical or steroid-free clinical remission after the induction doses of ustekinumab and vedolizumab (Table 2A) [8,[11][12][13][14][15][16]18,20]. Four studies reported that ustekinumab was superior in achieving clinical remission after induction therapy compared to vedolizumab [8,14,18,20], and the rest (five studies) did not show any statistical differences in outcome after induction therapy [10][11][12][13]15].…”

Section: Discussionmentioning

confidence: 99%

“…Among studies which reported clinical outcomes at the end of the first year (week 48-week 52) of treatment (Table 2B), eight studies showed a superior clinical response rate and or steroid-free clinical remission for ustekinumab compared to vedolizumab [7,8,11,12,14,17,18,20], four studies showed no difference in the clinical response rate or steroid-free clinical remission between both drugs [9,10,13,19], and only a single study showed that vedolizumab achieved a superior clinical response rate [16]. However, in that study by Onali et al, no differences were observed when objective markers of inflammation were considered [16].…”

Section: Discussionmentioning

confidence: 99%

“…Eight studies reported ustekinumab was superior to vedolizumab in achieving clinical response and/or steroid-free clinical remission or treatment persistence (Table 2B) [7,8,11,12,14,17,18,20]. Four studies did not find any difference in outcome among both groups [9,10,13,19].…”

Section: Maintenance Phase-clinical Response Remission and Steroid-fr...mentioning

confidence: 98%

“…Four studies reported a baseline BMI [8][9][10][11], and one study reported body weight [12] which was equally distributed across both groups. Ten included studies corrected for imbalances among baseline variables between ustekinumab-and vedolizumab-treated patients using propensity score matching [7,8,[12][13][14][15][16][17][18][19]. Table 1 provides a summary of the included studies.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

“…Among the studies that reported clinical outcomes at weeks 14-20 (induction period) (Table 2A), four studies showed superior clinical response, treatment persistence, and/or clinical steroid-free remission to be higher in patients treated with ustekinumab [8,14,18,20]. The sample size for these studies ranged from 130 to 835, and three of these studies adjusted for confounders using propensity weighting [9,11,19].…”

Section: Induction Phase-clinical Response Remission and Steroid-free...mentioning

confidence: 99%

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Ustekinumab or Vedolizumab after Failure of Anti-TNF Agents in Crohn’s Disease: A Review of Comparative Effectiveness Studies

Sharip,

Nishad,

Pillay

et al. 2024

JCM

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Background: Anti-tumour necrosis factor (TNF) agents are effective in Crohn’s disease (CD), but some patients lose responsiveness and require alternative biologic therapy. Until recently, ustekinumab and vedolizumab were the only other biological agents approved for use in CD. There are no randomised trials which compare the efficacy of these two agents in patients with anti-TNF refractory disease, but several retrospective cohort studies have compared their effectiveness in this setting. Aim: To review the effectiveness of ustekinumab and vedolizumab in anti-TNF refractory patients with CD. Methods: We included studies that compared the effectiveness of ustekinumab and vedolizumab in treating patients with anti-TNF refractory CD. We recorded the sample size, primary and secondary outcome measures and whether the studies employed adjustments for appropriate confounders. Results: Fourteen studies were included with a total sample size of 5651, of whom 2181 (38.6%) were treated with vedolizumab and the rest were treated with ustekinumab (61.4%). Of the fourteen studies included, eight found ustekinumab to be more effective in achieving clinical remission/steroid-free remission in the induction phase or during maintenance therapy (at least 1-year post-treatment) or that treatment persistence rates with ustekinumab were higher than with vedolizumab. Only one study reported vedolizumab to be superior during the maintenance phase in terms of clinical remission or treatment persistence rates. Biochemical outcomes were reported in five studies, two of which showed superiority for ustekinumab at 14 weeks and the other at 52 weeks. Only two studies reported endoscopic and/or radiologic outcomes; of these, one study showed ustekinumab to be significantly better at achieving endoscopic and radiologic responses. Adverse outcomes were broadly comparable, barring a single study which reported a lower hospitalisation rate for severe infection with ustekinumab. Conclusions: Most studies found ustekinumab to be more effective or non-inferior to vedolizumab in treating patients with anti-TNF refractory CD. Although many studies adjusted appropriately for confounders, the possibility of residual confounding remains and further data from prospective studies are warranted to confirm these findings. Further studies are required to compare these two therapies to other emerging therapies, such as Janus-kinase inhibitors.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Maintenance Phase-clinical Response Remission and Steroid-fr...mentioning

confidence: 98%

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Section: Induction Phase-clinical Response Remission and Steroid-free...mentioning

confidence: 99%

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Ustekinumab or Vedolizumab after Failure of Anti-TNF Agents in Crohn’s Disease: A Review of Comparative Effectiveness Studies

Sharip,

Nishad,

Pillay

et al. 2024

JCM

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Simulated cost‐effectiveness of a novel precision‐guided dosing strategy in adult patients with Crohn's disease initiating infliximab maintenance therapy

Alizadeh,

Dervieux,

Vermeire

et al. 2024

Pharmacotherapy

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BackgroundPatients with Crohn's disease (CD) who lose response to biologics experience reduced quality of life (QoL) and costly hospitalizations. Precision‐guided dosing (PGD) provides a comprehensive pharmacokinetic (PK) profile that allows for biologic dosing to be personalized. We analyzed the cost‐effectiveness of infliximab (IFX) PGD relative to two other dose intensification strategies (DIS).MethodsWe developed a hybrid (Markov and decision tree) model of patients with CD who had a clinical response to IFX induction. The analysis had a US payer perspective, a base case time horizon of 5 years, and a 4‐week cycle length. There were three IFX dosing comparators: PGD; dose intensification based on symptoms, inflammatory markers, and trough IFX concentration (DIS1); and dose intensification based on symptoms alone (DIS2). Patients that failed IFX initiated ustekinumab, followed by vedolizumab, and conventional therapy. Transition probabilities for IFX were estimated from real‐world clinical PK data and interventional clinical trial patient‐level data. All other transition probabilities were derived from published randomized clinical trials and cost‐effectiveness analyses. Utility values were sourced from previous health technology assessments. Direct costs included biologic acquisition and infusion, surgeries and procedures, conventional therapy, and lab testing. The primary outcomes were incremental cost‐effectiveness ratios (ICERs). The robustness of results was assessed via one‐way sensitivity, scenario, and probabilistic sensitivity analyses (PSA).ResultsPGD was the cost‐effective IFX dosing strategy with an ICER of 122,932 $ per quality‐adjusted life year (QALY) relative to DIS1 and dominating DIS2. PGD had the lowest percentage (1.1%) of patients requiring a new biologic through 5 years (8.9% and 74.4% for DIS1 and DIS2, respectively). One‐way sensitivity analysis demonstrated that the cost‐effectiveness of PGD was most sensitive to the time between IFX doses. PSA demonstrated that joint parameter uncertainty had moderate impact on some results.ConclusionsPGD provides clinical and QoL benefits by maintaining remission and avoiding IFX failure; it is the most cost‐effective under conservative assumptions.

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How comparative studies can inform treatment decisions for Crohn’s disease

Privitera,

Bezzio,

Dal Buono

et al. 2024

Expert Opinion on Biological Therapy

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Comparative Study of the Effectiveness of Vedolizumab Versus Ustekinumab After Anti-TNF Failure in Crohn’s Disease (Versus-CD): Data from the ENEIDA Registry

Cited by 8 publications

References 36 publications

Ustekinumab or Vedolizumab after Failure of Anti-TNF Agents in Crohn’s Disease: A Review of Comparative Effectiveness Studies

Ustekinumab or Vedolizumab after Failure of Anti-TNF Agents in Crohn’s Disease: A Review of Comparative Effectiveness Studies

Simulated cost‐effectiveness of a novel precision‐guided dosing strategy in adult patients with Crohn's disease initiating infliximab maintenance therapy

How comparative studies can inform treatment decisions for Crohn’s disease

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