An Objective Comparison of Vedolizumab and Ustekinumab Effectiveness in Crohn's Disease Patients' Failure to TNF-Alpha Inhibitors

Onali, S.; Pugliese, Daniela; Caprioli, Flavio; Orlando, Ambrogio; Biancone, Livia; Nardone, Olga Maria; Imperatore, Nicola; Fiorino, Gionata; Cappello, Maria; Viola, Anna; Principi, M.B.; Bezzio, Cristina; Aratari, Annalisa; Carparelli, Sonia; Mazzuoli, S.; Manguso, Francesco; Grossi, Laurino; Bodini, Giorgia; Ribaldone, Davide Giuseppe; Mocci, Giammarco; Miranda, Agnese; Minerba, Luigi; Favale, Agnese; Grova, Mauro; Scucchi, Ludovica; Segato, S.; Fries, Walter; Castiglione, Fabiana; Armuzzi, Alessandro; Fantini, Massimo

doi:10.14309/ajg.0000000000001773

Cited by 31 publications

(52 citation statements)

References 23 publications

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“… 26 A recent multicentre-retrospective study from Italy displayed the equality of UST and VDZ in terms of achieving objective remission among patients with anti-TNF refractory CD at week 52; however, clinical remission rates differed. 27 Our study found 1-year persistence rates of 86.5% for UST and 57.9% for VDZ treatment, which are higher than the rates found by Ylisaukko-Oja et al of 46.2%–37.1% for ADA and 47.1% for UST during 12 months of treatment in a real-life setting. 28 …”

Section: Discussioncontrasting

confidence: 74%

Ustekinumab is associated with superior treatment persistence but not with higher remission ratesversusvedolizumab in patients with refractory Crohn’s disease: results from a multicentre cohort study

Bacsúr

Matuz

Resál

et al. 2022

Therap Adv Gastroenterol

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Background: Treatment with antitumor necrosis factor alpha (anti-TNF-α) is safe and effective as first-line therapy; however, its efficacy is limited due to primary nonresponse (PNR) and secondary loss of response (LOR), resulting in treatment discontinuation in approximately 40%–50% of cases. Vedolizumab (VDZ) and ustekinumab (UST) therapies could be good alternatives in patient with anti-TNF failure; however, no head-to-head randomized comparison of these drugs as second- or third-line treatments has been made. Objectives: This study aimed to assess the treatment persistence and comparative effectiveness of UST and VDZ in patients with refractory Crohn’s disease (CD). Design: In this nationwide retrospective study, patients with CD on UST or VDZ maintenance therapy were enrolled. Clinical data at baseline, after induction, and at week 52 were obtained. Methods: Clinical and biochemical activities as well as corticosteroid-free remission (SFR) rates were assessed, while concomitant medications, comorbidities, hospitalizations, and surgeries were recorded during the follow-up to detect any predictors. Results: A total of 161 UST- and 65 VDZ-treated patients completed the follow-up. No significant difference in clinical or biochemical remission rates was observed after induction between the two treatment groups; however, clinical remission rate at week 52 was higher in UST group. UST showed superior drug persistence than VDZ (86.5%, 57.9%, p < 0.0001). The drug type was predictive of clinical SFR at week 52 [ p = 0.011, odds ratio (OR) = 2.39 with UST]. Drug failure rates were higher for VDZ than those for UST (PNR rates: 21.54% and 4.97%, respectively, p < 0.001, OR = 8.267, p = 0.001). LOR and escalations were more common during UST treatment (61.5% versus 36.9%, p < 0.001; 64.2% versus 23.1%, p < 0.001). Hospital and surgical admission rates did not differ significantly. Only one adverse event occurred with VDZ at week 20, which led to drug cessation. Conclusions: VDZ and UST were safe and effective for treating patients with CD in whom anti-TNF therapy failed. UST showed superior drug persistence than VDZ, but dose escalation was more frequent. Biologicals used in lower treatment lines resulted in better drug persistence.

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Section: Discussioncontrasting

confidence: 74%

Ustekinumab is associated with superior treatment persistence but not with higher remission ratesversusvedolizumab in patients with refractory Crohn’s disease: results from a multicentre cohort study

Bacsúr

Matuz

Resál

et al. 2022

Therap Adv Gastroenterol

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“…Recent multicentre retrospective studies observed conflicting results regarding the rate of clinical remission in patients treated with ustekinumab as compared to patients treated with vedolizumab [10][11][12][13][14]. Nevertheless, in these studies, ustekinumab, and vedolizumab were not strictly used as second-line therapies, since approximately 70% of patients had previously received at least two anti-TNF agents, making direct comparison difficult.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of ustekinumab, vedolizumab, or a second anti-TNF agent after the failure of a first anti-TNF agent in patients with Crohn’s disease: a multicentre retrospective study

et al. 2022

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Background No study has performed a face-to-face comparison of biologics after the failure of the first anti-TNF agent in patients with Crohn’s disease (CD). The aim of the study was to compare the efficacy of biologics in this setting. Methods Patients with CD who were refractory to a first anti-TNF agent, and treated with ustekinumab (UST), vedolizumab (VDZ), or a second anti-TNF drug as a second-line biological agent at 10 French tertiary centres from 2013 to 2019 were retrospectively included in this study. Results Among the 203 patients included, 90 (44%) received UST, 42 (21%) received VDZ and 71 (35%) received a second anti-TNF agent. The first anti-TNF agent was discontinued due to a primary nonresponse in 42 (21%) patients. At weeks 14–24, the rates of steroid-free remission were similar between the UST, VDZ and second anti-TNF groups (29%, 38% and 44%, respectively, p = 0.15). With a mean follow-up of 118 weeks, drug survival was shorter for patients who received ustekinumab treatment (p = 0.001). In the case of trough level less than 5 µg/ml, patients treated with a second anti-TNF agent had a higher postinduction remission rate (p = 0.002), and drug survival (p = 0.0005). No other relevant factors were associated with treatment efficacy, including trough levels greater than 5 µg/ml. Conclusions VDZ, UST and a second anti-TNF agent exhibit similar efficacy in the short term, as second-biological line treatment in patients with CD who are refractory to a first anti-TNF agent, but shorter drug maintenance is observed for patients treated with UST.

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“…La presente valutazione economica è stata condotta con l'obiettivo di stimare, sulla base dei risultati clinici di uno studio osservazionale, retrospettivo e multicentrico condotto in Italia (13), il costo per responder di vedolizumab e di ustekinumab nel trattamento della malattia di Crohn in fase attiva da moderata a severa nei pazienti che hanno fallito una precedente terapia con uno o più inibitori del TNF-α.…”

Section: Obiettivounclassified

“…Premessa L'analisi è stata sviluppata in ambiente Microsoft® Excel®. In linea con i timepoint adottati nello studio osservazionale (13), il costo di trattamento associato a vedolizumab e a ustekinumab è stato calcolato considerando due differenti orizzonti temporali: 26 e 52 settimane. Il costo per responder, basato sulla remissione clinica e sulla risposta clinica, di vedolizumab e di ustekinumab è stato quindi calcolato dividendo il corrispondete costo totale di trattamento a 26 o a 52 settimane per gli endpoint clinici (remissione e risposta) valutati nello studio osservazionale (13).…”

Section: Metodiunclassified

Cost per responder for vedolizumab and ustekinumab in Crohn’s disease patients after failure of TNF-α inhibitors in Italy

Ravasio¹,

Viti

Roscini

2023

abtpn

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Background: The aim of this economic evaluation was to compare the cost per responder between vedolizumab and ustekinumab in patients with Crohn’s disease (CD) after failure of tumor necrosis factor-α inhibitors in Italy. Methods: Clinical efficacy was assessed using the results of an Italian large multicentre observational retrospective cohort study. The aim of the study was to compare the effectiveness of ustekinumab and vedolizumab as second line therapy in Crohn’s disease patients in which tumour necrosis factor-α inhibitors failed. Clinical efficacy of vedolizumab and ustekinumab was measured by clinical response and clinical remission. Treatment costs were based on the number of administrations at 26 or 52 weeks. Cost per responder, based on clinical efficacy and clinical response, was used as a cost-effectiveness indicator. Results: Regardless of the clinical efficacy measure used and the treatment duration considered, the cost per responder was consistently lower for vedolizumab compared with ustekinumab on all clinical measures. Considering the clinical response, the cost per responder at 26 weeks was € 15,640 for vedolizumab and € 23,667 for ustekinumab and at 52 weeks was € 23,927 for vedolizumab and € 30,820 for ustekinumab. Considering the clinical remission, the cost per responder at 26 weeks was € 22,832 for vedolizumab and € 33,786 for ustekinumab and at 52 weeks was € 29,488 for vedolizumab and € 46,847 for ustekinumab. Sensitivity analysis confirmed the validity of results. Conclusion: These results suggest that vedolizumab is a cost-effective option compared with ustekinumab from the perspective of the Italian health service in patients with CD after failure of TNF-α inhibitors.

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An Objective Comparison of Vedolizumab and Ustekinumab Effectiveness in Crohn's Disease Patients' Failure to TNF-Alpha Inhibitors

Cited by 31 publications

References 23 publications

Ustekinumab is associated with superior treatment persistence but not with higher remission ratesversusvedolizumab in patients with refractory Crohn’s disease: results from a multicentre cohort study

Ustekinumab is associated with superior treatment persistence but not with higher remission ratesversusvedolizumab in patients with refractory Crohn’s disease: results from a multicentre cohort study

Efficacy of ustekinumab, vedolizumab, or a second anti-TNF agent after the failure of a first anti-TNF agent in patients with Crohn’s disease: a multicentre retrospective study

Cost per responder for vedolizumab and ustekinumab in Crohn’s disease patients after failure of TNF-α inhibitors in Italy

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