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Modified Mayo score versus Mayo score for evaluation of treatment efficacy in patients with ulcerative colitis: data
William J Sandborn1, Bruce E Sands2, Séverine Vermeire3
1Division of Gastroenterology, University of California San Diego, 9500 Gilman Drive, MC 0956, La Jolla, 92093, CA, USA.
Objectives:
The subjectivity of the Physician Global Assessment (PGA) is a limitation of the Mayo score in assessing severity of ulcerative colitis (UC). We compared treatment efficacy using endpoint definitions based on modified Mayo (mMayo) score, versus those based on Mayo score, using data from the tofacitinib OCTAVE program.
Design:
This post hoc analysis included data from two 8-week induction studies (OCTAVE Induction 1 and 2) and a 52-week maintenance study (OCTAVE Sustain).
Methods:
Remission and clinical response [with nonresponder imputation (NRI)] were assessed using mMayo (without PGA) and Mayo scores, and further stratified by prior tumor necrosis factor inhibitor (TNFi) failure status.
Results:
At week 8 of OCTAVE Induction 1 and 2, remission rates with placebo and tofacitinib 10 mg twice daily (BID), respectively, were 7.7% and 24.8% (mMayo) and 6.0% and 17.6% (Mayo). At week 52 of OCTAVE Sustain, remission rates with placebo, tofacitinib 5 and 10 mg BID, respectively, were 12.1%, 35.9%, and 42.1% (mMayo) and 11.1%, 34.3%, and 40.6% (Mayo). A statistically significant (p < 0.05) treatment effect of tofacitinib versus placebo was observed for remission and clinical response at all time points, regardless of scoring definition or prior TNFi failure status.
Conclusions:
A significant effect of tofacitinib versus placebo was demonstrated across efficacy endpoints using mMayo score, consistent with previously reported data using Mayo score. Treatment effect sizes were generally similar regardless of scoring definition. This observation may help contextualize tofacitinib therapy outcomes with those of new UC therapies and support the use of Mayo score-based endpoints in UC clinical trials.
Trail Registration:
ClinicalTrials.gov identifiers: NCT01465763; NCT01458951; NCT01458574.
Insights
The modified Mayo score (mMayo) and Mayo score showed similar efficacy for tofacitinib in ulcerative colitis (UC) trials. This finding supports using the Mayo score for assessing tofacitinib treatment effectiveness in UC patients.
Area of Science:
- Gastroenterology
- Clinical Pharmacology
- Biostatistics
Background:
- The Physician Global Assessment (PGA) component of the Mayo score introduces subjectivity in assessing ulcerative colitis (UC) severity.
- The modified Mayo (mMayo) score excludes PGA, potentially offering a more objective measure for UC clinical trials.
Purpose of the Study:
- To compare the efficacy of tofacitinib in ulcerative colitis (UC) using endpoint definitions based on the modified Mayo (mMayo) score versus the standard Mayo score.
- To evaluate if the choice of scoring system impacts the observed treatment effect of tofacitinib in UC.
Main Methods:
- Post hoc analysis of data from OCTAVE Induction 1, 2, and OCTAVE Sustain studies.
- Remission and clinical response were assessed using both mMayo and Mayo scores, with non-responder imputation (NRI).
- Analyses were stratified by prior tumor necrosis factor inhibitor (TNFi) failure status.
Main Results:
- At 8 weeks, mMayo remission rates were 24.8% (tofacitinib 10 mg BID) vs. 7.7% (placebo), and Mayo remission rates were 17.6% vs. 6.0%.
- At 52 weeks, mMayo remission rates were 35.9% (tofacitinib 5 mg BID) and 42.1% (10 mg BID) vs. 12.1% (placebo); Mayo remission rates were 34.3% and 40.6% vs. 11.1%.
- Tofacitinib demonstrated a statistically significant treatment effect versus placebo for both remission and clinical response at all time points, irrespective of scoring method or prior TNFi status.
Conclusions:
- A significant treatment effect of tofacitinib versus placebo was observed across efficacy endpoints using the mMayo score, consistent with the Mayo score.
- Treatment effect sizes were comparable between the mMayo and Mayo scoring definitions.
- These findings support the use of Mayo score-based endpoints in UC clinical trials and help contextualize tofacitinib outcomes.
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