Early and sustained improvement in patient-reported outcomes and biomarker concentrations with tulisokibart induction in patients with moderately to severely active ulcerative colitis: a post-hoc analysis from ARTEMIS-UC

Introduction: In the phase 2 ARTEMIS-UC trial, [1] 12 weeks of induction treatment with tulisokibart led to significant rates of clinical remission, endoscopic improvement and mucosal healing, and improvement in patient-reported outcome (PRO) measures and disease surrogate biomarkers in patients with moderately to severely active ulcerative colitis (UC).

Objectives: This post-hoc analysis from ARTEMIS-UC examined the time course of improvement from baseline in PRO-2 score and biomarkers with tulisokibart.

Methodology: Patients were randomized 1:1 to receive i.v. placebo or tulisokibart (1000 mg on Day 1 and 500 mg at Weeks 2, 6, and 10). The study population consisted of 2 cohorts based on a genetic diagnostic test (Dx) assessing likelihood for responding to anti-TL1A treatment. Cohort 1 included participants stratified by Dx results while Cohort 2 included only Dx positive participants. Cohort 1 is the population used in this post-hoc analysis. Participants recorded stool frequency and rectal bleeding scores daily using an e-diary. Fecal calprotectin was assessed at baseline and Weeks 6 and 12, and hs-CRP was assessed at baseline and Weeks 2, 6, 10, and 12. Symptomatic response was defined as a reduction from baseline in PRO-2 score≥1 point. A mixed model repeated measures approach was used to compare tulisokibart to placebo for the difference in PRO-2 score for the first 14 days of treatment and the fold change from baseline in fecal calprotectin and hs-CRP at each timepoint.

Results: Among 135 randomized participants in Cohort 1, 60/67 (89.6%) receiving placebo and 68/68 (100%) receiving tulisokibart completed the 12-week induction period. The numerical difference in improvement of PRO-2 started as early as Day 2 and achieved significant improvement with tulisokibart compared to placebo at Day 9, with a sustained improvement persisting from the latter part of Week 2 through Week 12 ([Fig. 1] , Table 1). Significant improvements with tulisokibart compared to placebo in fecal calprotectin and hs-CRP were observed by Weeks 6 and 2 (the first time point when these biomarkers were measured), respectively, which were maintained through Week 12 (Table 1).

Fig. 1  

Conclusion: In patients with moderately to severely active UC, induction with tulisokibart led to early and sustained improvement in patient-reported outcomes. Induction with tulisokibart also led to early and persistent improvement in biomarkers ([Fig. 2]).

Fig. 2  

• References

• 1 Sands, et al. N Engl J Med. 2024 391. 1119-29