P586 Comparative effectiveness of vedolizumab and ustekinumab as induction therapy in anti-TNF refractory Crohn’s disease: a multi-centre retrospective cohort study

Townsend, Tristan; Razanskaite,; Michail, Stephanie; Morgan, James; Davies, Michael B.; Storey, Daniel; Watters, Christopher; Penman, Douglas; Swaminathan, M.; Sabine, Joseph; Chapman, Anne; Vyas, Arpita; Reilly, Ian; Flanagan, Paul; Bodger, Keith; Subramanian, Sreedhar

doi:10.1093/ecco-jcc/jjy222.710

Cited by 3 publications

(4 citation statements)

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“…However, approximately one-half of our patients in each group were in clinical remis sion, defined by HBI, at the start of bio logical treat-tients on steroids did not change during the VDZ treatment. This is in contrast to other retrospective comparative studies, which reported similar rates of steroid-free remis sion between VDZ and UST [6,7]. The dif erence observed in our cohort probably indicates the effect of treatment selection bias despite the similar baseline characteristics of the patients.…”

Section: Discussioncontrasting

confidence: 99%

“…Our find ing of a mostly comparable ef ficacy between VDZ and UST is in line with the previous retrospective comparative studies report ing similar therapeutic ef cacy between these agents in patients with CD [6,7]. Similarly, an indirect comparison of randomized control led trials (RCTs) of VDZ and UST revealed no dif erence regarding the clinical remis sion of induction and maintenance ther apy in patients with previous anti-TNF failure [8].…”

Section: Discussionsupporting

confidence: 90%

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Vedolizumab vs. ustekinumab as second-line therapy in Crohn’s disease in clinical practice

Kolář

Ďuricová²,

Bortlík³

et al. 2019

Gastroent Hepatol

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Background: Vedolizumab (VDZ) and ustekinumab (UST) have become available for the treatment of Crohn's dis ease (CD), however, due to limited clinical experience, the optimal treatment strategy after a failure of anti-tumor necrosis factor (anti-TNF) has yet to be elucidated. In our study, we aim to evaluate the ef ciency and safety of VDZ and UST as second-line clas ses of bio logical ther apy in a headto-head man ner in comparable populations of CD patients. Methods: Consecutive patients with CD who have previously been treated with anti-TNF ther apy were included. Patients were fol lowed at regular intervals coincident with drug applications and clinical activity (HBI-Harvey-Bradshaw Index), inflam matory markers (C-reactive protein, fecal calprotectin) and adverse events were recorded. The primary outcome was the proportion of patients in clinical remis sion in weeks 30-32 (HBI ≤ 4), the clinical response in terms of HBI decrease, and the withdrawal rate. Results: Forty-five patients with VDZ and 50 with UST were included. Both groups were comparable in all the evaluated parameters with the exception of the male-to-female ratio and the proportion of patients with penetrat ing dis ease phenotype. The proportion of patients in clinical remis sion increased from 44.4% at baseline to 58.1% in weeks 30-32 in the VDZ group and from 55.1% to 63.2% in the UST group; however, the increase was not statistical ly significant. The mean paired HBI dif erence between weeks 30-32 and baseline reached-1.94 ± 5.14 (p = 0.05) in the VDZ cohort and-2.94 ± 5.91 (p = 0.01) in the UST cohort. The proportion of patients in steroid-free clinical remis sion increased from 38.8% to 62.5% in the UST cohort (p = 0.04), and from 33.3% to 45.2% in the VDZ (p = 0.67). Six patients on VDZ and none on UST discontinued the treatment. Conclusion: Our study demonstrated a comparable ef cacy of VDZ and UST with respect to the rate of clinical remis sion and bio marker response; however, the steroid-spar ing ef ect of UST was more prominent. There is a need for prospective randomized head-to-head trials to as sess the optimal position of new bio logical agents in the treatment of patients with CD.

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Section: Discussioncontrasting

confidence: 99%

Section: Discussionsupporting

confidence: 90%

Vedolizumab vs. ustekinumab as second-line therapy in Crohn’s disease in clinical practice

Kolář

Ďuricová²,

Bortlík³

et al. 2019

Gastroent Hepatol

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“…In clinical practice, ~30% of biologics are prescribed alongside CS. [25][26][27] To test the sensitivity of the model, we simulated off-label use of VDZ before treatment with CS (Supplementary Table S9).…”

Section: Discussionmentioning

confidence: 99%

“…In clinical practice, ∼30% of biologics are prescribed alongside CS. 25 , 26 , 27 To test the sensitivity of the model, we simulated off‐label use of VDZ before treatment with CS (Supplementary Table S9 ). This approach yielded the best outcomes and indicated that the model can integrate the role of co‐medications in the treatment sequence; negative effects of CS were the predominant parameters in the model.…”

Section: Discussionmentioning

confidence: 99%

Therapeutic sequencing in inflammatory bowel disease: Determining the optimal position of vedolizumab for long‐term Crohn’s disease control using real‐world evidence

Louis,

Litkiewicz,

Agboton

et al. 2024

UEG Journal

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BackgroundSeveral biologics are available for the treatment of moderate to severe Crohn's disease, but data to optimize their use are scarce. Vedolizumab (VDZ) is a gut‐selective anti‐lymphocyte trafficking monoclonal antibody that was approved in 2014 for the treatment of moderate to severe Crohn's disease. Based on real‐world evidence, a model was developed to examine the effect of VDZ's position in the treatment sequence on clinical outcomes.ObjectiveThe aim of this study was to develop a model using real‐world data to investigate how the positioning of VDZ in a sequence of biologic therapies for CD affects clinical effectiveness outcomes of quality‐adjusted life‐years (QALYS), patient‐reported disease activity, and surgery rates.MethodsA semi‐Markov sequential model was developed to identify the optimal position of VDZ in a treatment sequence that included corticosteroids (CS), two biologics, and best supportive care (BSC). Using real‐world data, three sequences were compared: VDZ as first (position), second, and last biologic (with anti‐tumor necrosis factor alpha agents adalimumab (ADA) and infliximab (IFX) and the anti‐interleukin‐12 and ‐23 agent ustekinumab (UST) as alternative biologic treatments). Published real‐world evidence informed model inputs. Vedolizumab sequences were compared and ranked based on QALYS, patient‐reported outcomes from Crohn's disease activity index scores, or proportion of patients undergoing surgery by the 10‐year time horizon for model simulation. Sensitivity analyses were used to evaluate the impact of model input uncertainty.ResultsVedolizumab as the first biologic was the optimal position for this treatment according to all criteria, including yielding the highest QALYs (5.09) versus VDZ in second (4.97) and third (4.96) biologic sequence positions in sequences containing CS, anti‐TNFα (aggregated data), UST, and BSC; 1780/2000 (89%) probabilistic simulations. In sequences containing ADA, VDZ, and UST biologics, ADA and VDZ in the first‐line biologic position yielded QALYs of 5.09 versus 5.07, respectively. Adalimumab as the first biologic was best for clinical remission.ConclusionsThis simulation model using real‐world evidence indicates that positioning VDZ or ADA as the first biologic is likely to lead to improved long‐term patient outcomes when compared to administering these treatments later or starting with IFX monotherapy.

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Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

et al. 2021

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P586 Comparative effectiveness of vedolizumab and ustekinumab as induction therapy in anti-TNF refractory Crohn’s disease: a multi-centre retrospective cohort study

Cited by 3 publications

References 0 publications

Vedolizumab vs. ustekinumab as second-line therapy in Crohn’s disease in clinical practice

Vedolizumab vs. ustekinumab as second-line therapy in Crohn’s disease in clinical practice

Therapeutic sequencing in inflammatory bowel disease: Determining the optimal position of vedolizumab for long‐term Crohn’s disease control using real‐world evidence

Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

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