Modified Mayo score <i>versus</i> Mayo score for evaluation of treatment efficacy in patients with ulcerative colitis: data from the tofacitinib OCTAVE program

Sandborn, William J.; Sands, Bruce E.; Vermeire, Séverine; Leung, Yvette; Guo, Xiang; Modesto, Irene; Su, Chinyu; Wang, Wenjin; Panés, Julián

doi:10.1177/17562848221136331

Cited by 11 publications

(6 citation statements)

References 25 publications

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“…Thus, the partial Mayo Score comprised only of the stool frequency and bleeding can indicate the patient-perceived clinical response as well as the complete Mayo Score. In addition, Sandborn et al proposed a modified Mayo Score (mMayo) which excludes the subjectivity of the physical global assessment, by applying it over two 8-week induction studies (OCTAVE induction 1 and 2) and a 52-week maintenance study (OCTAVE sustain) [19]. Thus, a significant effect of tofacitinib versus placebo was highlighted using the mMayo, which is consistent with the previously reported data using the original Mayo Score.…”

Section: Variable Coefficientsupporting

confidence: 69%

Recent Trends in Non-Invasive Methods of Diagnosis and Evaluation of Inflammatory Bowel Disease: A Short Review

Vălean,

Zaharie,

Țaulean

et al. 2024

IJMS

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Inflammatory bowel diseases are a conglomerate of disorders causing inflammation of the gastrointestinal tract, which have gained a significant increase in prevalence in the 21st century. As they present a challenge in the terms of diagnosis as well as treatment, IBDs can present an overwhelming impact on the individual and can take a toll on healthcare costs. Thus, a quick and precise diagnosis is required in order to prevent the high number of complications that can arise from a late diagnosis as well as a misdiagnosis. Although endoscopy remains the primary method of evaluation for IBD, recent trends have highlighted various non-invasive methods of diagnosis as well as reevaluating previous ones. This review focused on the current non-invasive methods in the diagnosis of IBD, exploring their possible implementation in the near future, with the goal of achieving earlier, feasible, and cheap methods of diagnosis as well as prognosis in IBD.

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Section: Variable Coefficientsupporting

confidence: 69%

Recent Trends in Non-Invasive Methods of Diagnosis and Evaluation of Inflammatory Bowel Disease: A Short Review

Vălean,

Zaharie,

Țaulean

et al. 2024

IJMS

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“… 10 In a post hoc analysis of data from the OCTAVE program, clinical remission at week 52, defined by total Mayo score, was observed in 40.6% of patients who received tofacitinib (10 mg twice daily) compared with 42.1% when a modified Mayo score was used. 11 …”

Section: Discussionmentioning

confidence: 99%

Clinical Trial Design in Ulcerative Colitis: Interpreting Evolving Endpoints Based on Post Hoc Analyses of the Vedolizumab Phase 3 Trials GEMINI 1 and VISIBLE 1

Sandborn,

Sands,

Uddin

et al. 2023

Crohn's &Amp; Colitis 360

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Background The 12-point total Mayo score including a Physician’s Global Assessment (PGA) of disease activity has been used to assess outcomes in clinical trials for ulcerative colitis (UC). In 2016 the US Food and Drug Administration (FDA) issued guidance advising removal of the PGA in future trials. We examined how endpoints in UC trials have evolved and conducted a post hoc analysis of the GEMINI 1 and VISIBLE 1 trials to understand how use of a 9-point modified Mayo score, excluding PGA, compares with the total Mayo score. Methods Endpoint definitions of clinical remission in phase 3 trials were extracted from published literature and ClinicalTrials.gov. The difference (%Δ) between the proportions of patients in GEMINI 1 and VISIBLE 1 achieving clinical remission with vedolizumab versus placebo at week 52 was measured according to four endpoint definitions. Results Trials completed up to the end of 2019 used the total Mayo score to assess clinical remission. Most trials that were completed or estimated to be completed by June 2020 or later used modified Mayo scores. Post hoc analysis revealed decreasing endpoint stringency was associated with increasing %Δ values. The modified Mayo score definition most like the definition recommended by the FDA produced %Δ values like those reported using the total Mayo score in GEMINI 1 and VISIBLE 1. Conclusions Endpoint definitions for UC clinical trials have evolved following FDA guidance. The efficacy of vedolizumab, measured using modified Mayo scoring, was comparable to values reported using the total Mayo score.

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“…If not, the treatment was deemed to be invalid (bad short-term prognosis). The mMayo score comprises three subscores: endoscopic findings, stool frequency, and rectal bleeding, as recommended by the US Food and Drug Administration (FDA) [ 10 ]. Clinical response was defined as rapid relief of clinical symptoms including stool frequency and rectal bleeding.…”

Section: Methodsmentioning

confidence: 99%

Computed tomography-based body composition parameters can predict short-term prognosis in ulcerative colitis patients

Lu,

Xu,

Shi

et al. 2024

Insights Imaging

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Objectives Emerging evidence suggests a potential relationship between body composition and short-term prognosis of ulcerative colitis (UC). Early and accurate assessment of rapid remission based on conventional therapy via abdominal computed tomography (CT) images has rarely been investigated. This study aimed to build a prediction model using CT-based body composition parameters for UC risk stratification. Methods In total, 138 patients with abdominal CT images were enrolled. Eleven quantitative parameters related to body composition involving skeletal muscle mass, visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT) were measured and calculated using a semi-automated segmentation method. A prediction model was established with significant parameters using a multivariable logistic regression. The receiver operating characteristic (ROC) curve was plotted to evaluate prediction performance. Subgroup analyses were implemented to evaluate the diagnostic efficiency of the prediction model between different disease locations, centers, and CT scanners. The Delong test was used for statistical comparison of ROC curves. Results VAT density, SAT density, gender, and visceral obesity were significantly statistically different between remission and invalidation groups (all p < 0.05). The accuracy, sensitivity, specificity, and area under the ROC curve (AUC) of the prediction model were 82.61%, 95.45%, 69.89%, and 0.855 (0.792–0.917), respectively. The positive predictive value and negative predictive value were 70.79% and 93.88%, respectively. No significant differences in the AUC of the prediction model were found in different subgroups (all p > 0.05). Conclusions The predicting model constructed with CT-based body composition parameters is a potential non-invasive approach for short-term prognosis identification and risk stratification. Additionally, VAT density was an independent predictor for escalating therapeutic regimens in UC cohorts. Critical relevance statement The CT images were used for evaluating body composition and risk stratification of ulcerative colitis patients, and a potential non-invasive prediction model was constructed to identify non-responders with conventional therapy for making therapeutic regimens timely and accurately. Key points • CT-based prediction models help divide patients into invalidation and remission groups in UC. • Results of the subgroup analysis confirmed the stability of the prediction model with a high AUC (all > 0.820). • The visceral adipose tissue density was an independent predictor of bad short-term prognosis in UC. Graphical Abstract

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Modified Mayo score versus Mayo score for evaluation of treatment efficacy in patients with ulcerative colitis: data from the tofacitinib OCTAVE program

Cited by 11 publications

References 25 publications

Recent Trends in Non-Invasive Methods of Diagnosis and Evaluation of Inflammatory Bowel Disease: A Short Review

Recent Trends in Non-Invasive Methods of Diagnosis and Evaluation of Inflammatory Bowel Disease: A Short Review

Clinical Trial Design in Ulcerative Colitis: Interpreting Evolving Endpoints Based on Post Hoc Analyses of the Vedolizumab Phase 3 Trials GEMINI 1 and VISIBLE 1

Computed tomography-based body composition parameters can predict short-term prognosis in ulcerative colitis patients

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