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IMPROVEMENT IN INFLAMMATORY BIOMARKER LEVELS THROUGH WEEK 12 IN MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS PATIENTS TREATED WITH GUSELKUMAB: RESULTS FROM THE PHASE 3 QUASAR INDUCTION STUDY

Tadakazu Hisamatsu 1, Laurent Peyrin-Biroulet 2, Axel Dignass 3, Gary KH Huang 4, Matthew Germinaro 4, Nicole Houck 4, Ye Miao 4, Hongyan Zhang 4, Marjorie Costa Argollo 5, Ken Takeuchi 6, Rafal Filip 7, Jessica Allegretti 8, Brian G. Feagan 9, Bruce E. Sands 10

Affiliations

1 Kyorin University, Tokyo, Japan

2 Nancy University Hospital, Université de Lorraine, Nancy, France

3 Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany

4 Janssen Research & Development, LLC, Spring House, United States

5 Onco Star SP Oncologia Ltda, Sao Paulo, Brazil

6 Tsujinaka Hospital Kashiwanoha, Kashiwa, Japan

7 Clinical Hospital No. 2, Rzeszow, Poland

8 Brigham and Women´s Hospital, Boston, United States

9 Alimentiv Inc, London, Canada

10 Icahn School of Medicine at Mount Sinai, New York, United States

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Abstract

Introduction

C-reactive protein (CRP) and fecal calprotectin (FeCal) are non-invasive inflammatory biomarkers used to assess disease activity in UC. The Phase 3 QUASAR induction study evaluated the efficacy and safety of guselkumab (GUS), an IL-23 p19 subunit antagonist, in patients (pts) with moderately to severely active UC. Here, we analyze the effect of GUS treatment on CRP and FeCal through Week (Wk) 12 in pts with elevated CRP and/or FeCal.

Aims & Methods

Pts with a modified Mayo score of 5-9 and a Mayo endoscopy subscore ≥2 at baseline (BL) were randomized 3:2 to receive either GUS 200mg IV or placebo (PBO) IV at Wks0, 4, and 8. CRP and FeCal were assessed at BL, Wk4, Wk8 (for CRP only), and Wk12.

Results

A total of 701 pts were evaluated and approximately 50% of randomized pts had a history of inadequate response/intolerance to advanced therapies (ADT) for UC; 47.4% of these pts had inadequate response/intolerance to ≥2 ADT classes. Median BL concentrations of CRP and FeCal were similar between the GUS-treated and PBO-treated pts (4.34 vs 3.83mg/L and 1651 vs 1606mg/kg, respectively). Among pts with elevated CRP and/or FeCal at BL, greater reductions in CRP and FeCal were observed at the earliest timepoint assessed (Wk4) with GUS and continued through Wk12 compared with PBO (Table).
At BL, 248 GUS-treated pts and 160 PBO-treated pts had elevated CRP (>3mg/L); the proportions were similar between treatment groups (58.9% vs 57.1%, respectively). Among these pts, median change from BL in CRP concentration (mg/L) at Wk12 for the GUS and PBO cohorts were -3.99 and -0.51mg/L, respectively (nominal p<0.001); the proportions of pts achieving 50% and 75% reduction in CRP levels (or ≤3mg/L) at Wk12 were higher for GUS-treated pts than those receiving PBO (59.7% vs 28.1% and 47.2% vs 19.4%, respectively; both nominal p<0.001). Similarly, a higher proportion of GUS-treated pts achieved CRP≤3mg/L at Wk12 than PBO-treated pts (40.3% vs 16.3%, nominal p<0.001).
At BL, 333 GUS-treated pts and 225 PBO-treated pts had elevated FeCal (>250mg/kg); the proportions were similar between treatment groups (79.1% vs 80.4%, respectively). Median change from BL in FeCal concentration (mg/kg) for pts with elevated FeCal at BL at Wk12 were -800 and -86mg/kg for the GUS and PBO cohorts, respectively (nominal p<0.001); the proportions of pts achieving 50% and 75% reduction in FeCal levels (or ≤250 mg/kg) at Wk12 were higher for GUS-treated pts than those receiving PBO (51.1% vs 33.8% and 41.4% vs 23.6%, respectively; both nominal p<0.001). A larger percentage of pts treated with GUS achieved FeCal≤250mg/kg at Wk12 than pts treated with PBO (29.4% vs 17.3%, nominal p<0.001).

Table. Change from baseline in CRP and FeCal through Week 12 among patients with elevated CRP (>3mg/L) or FeCal (>250mg/kg) at baseline
	Placebo IV	Guselkumab 200 mg IV
CRP (mg/L) Baseline, N Median [IQR]	160 8.02 [5.40; 16.85]	248 9.26 [5.31; 18.05]
Wk 4, N Median change from baseline [IQR]	158 -2.06 [-5.70; 1.58]	245 -3.35 [-8.60; -0.23]***
Wk 8, N Median change from baseline [IQR]	156 -1.75 [-5.68; 1.46]	239 -3.80 [-10.77; -0.19]***
Wk 12, N Median change from baseline [IQR]	153 -0.51 [-4.64; 2.72]	239 -3.99 [-11.46; -0.85]***
FeCal (mg/kg) Baseline, N Median [IQR]	225 1743 [1120; 3395]	333 1787 [920; 4009]
Wk 4, N Median change from baseline [IQR]	213 -227 [-1041; 658]	308 -603 [-1866; 230]***
Wk 12, N Median change from baseline [IQR]	201 -86 [-1254; 504]	293 -800 [-2532; 0]***
***Nominal P≤0.001. Patients who had a prohibited change in UC medication, an ostomy or colectomy, or discontinued study agent due to lack of efficacy or an AE of worsening of UC or other reasons except for COVID-19 related reasons (excluding COVID-19 infection) or regional crisis in Russia and Ukraine prior to the designated timepoint had their baseline value carried forward from the time of the event onward. The p-values of treatment comparison were based on the mixed-effect model repeated measures with CRP and FeCal values being log-transformed.

Conclusion

In this phase 3 induction study, pts with moderately to severely active UC and elevated inflammatory markers treated with GUS 200mg IV induction showed greater improvement from BL in both CRP and FeCal levels compared with PBO. Differences were observed as early as the first assessments at Wk4 and continued through Wk12.

Disclosure

Tadakazu Hisamatsu received consulting fees from Janssen Research & Development, LLC.
Laurent Peyrin-Biroulet reports personal fees from Janssen.
Axel Dignass reports fees for participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees from Janssen; consultancy fees from Janssen; and payment from lectures including service on speakers bureaus from Janssen.
Kuan-Hsiang G. Huang, Matthew Germinaro, Nicole Houck,Ye Miao, and Hongyan Zhang are employees of Johnson & Johnson and own company stock/stock options.
Marjorie Argollo reports consulting fees from Janssen.
Ken Takeuchi has served as a speaker for Janssen.
Rafal Filip reports lecture fees and research/education support from Janssen.
Jessica R. Allegretti is a consultant and speaker for Janssen.
Brian G. Feagan received consulting fees from Janssen; a member of the speakers bureau for Janssen; support for attending meetings and/or travel from Janssen; and participation on a Data Safety Monitoring Board or Advisory Board from Janssen.
Bruce E. Sandsreports grants, consulting and speaking fees and other support from Janssen.

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

PP 05 IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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Table 1: IBDExplore Features With Highest Predictive Power of MES Severity
IBDExplore Feature	Feature Coefficient/Importance^a
DENSITY [PLASMA CELLS] IN [TISSUE SURROUNDING (40UM) SURFACE EPITHELIUM WITHIN LAMINA PROPRIA]_week14	−0.01230
DENSITY [PLASMA CELLS] IN [TISSUE SURROUNDING (20UM) SURFACE EPITHELIUM WITHIN LAMINA PROPRIA]_week14	−0.01229
DENSITY [GOBLET CELLS] IN [CRYPT EPITHELIUM]_week14	0.01062
DENSITY [GOBLET CELLS] IN [EPITHELIUM]_week14	0.01062
^aFeature coefficients indicate the direction and magnitude of predictive power. Higher values for positive coefficients increase the likelihood for response, whereas higher values for features with negative coefficients decrease the likelihood for response.