{
  "abstract": "Introduction Tulisokibart, a humanized tumor necrosis factor-like cytokine 1A (TL1A) monoclonal antibody, maintained clinical remission and endoscopic response through 50 weeks in participants with moderately to severely active ulcerative colitis (UC) in the phase 2, double-blind, placebo-controlled ARTEMIS-UC study ( NCT04996797). We assessed symptomatic relief through changes in stool frequency (SF) and rectal bleeding (RB) subscores, as well as disease clearance, defined as the combination of symptomatic relief and mucosal healing, through 50 weeks.Methods In ARTEMIS-UC, participants were randomized to receive intravenous (IV) tulisokibart 1000 mg on day 1 and 500 mg at weeks 2, 6, and 10 (n=68) or placebo (n=67). Responders (reduction of ≥2 points and ≥30% in modified Mayo score from baseline, and a reduction ≥1 in RB subscore or absolute RB subscore ≤1 at week 12) were randomized to receive open-label IV tulisokibart 100 mg (n=22) or 250 mg (n=25) every 4 weeks through week 170. SF normalization (score of 0 or 1 and no greater than baseline), resolution of RB (score of 0), symptomatic remission (achievement of both SF normalization and RB resolution), and disease clearance (symptomatic remission and mucosal healing [Geboes score ≤2B.1 and endoscopy subscore ≤1]) are reported via descriptive statistics in the full analysis set through week 12 and in induction responders through week 50. Participants with missing data were imputed as nonresponders.Results At week 12, a higher proportion of participants treated with tulisokibart compared with placebo achieved SF normalization (57.4% vs 17.9%, respectively), RB resolution (61.8% vs 34.3%), and symptomatic remission (47.1% vs 13.4%), with improvements observed as early as week 2. Among week 12 responders randomized to tulisokibart 100 mg or 250 mg, efficacy was sustained or continued to increase through week 50 in SF normalization (63.6% and 76.0%, respectively), RB resolution (63.6% and 72.0%), and symptomatic remission (54.5% and 68.0%). The proportion of participants who achieved disease clearance was also greater with tulisokibart (25.0%) vs placebo (1.5%) at week 12 and continued to increase among week 12 responders through week 50 in the tulisokibart 100 mg group (31.8%) and 250 mg group (44.0%).Conclusions Participants treated with tulisokibart achieved higher rates of SF normalization, resolution of RB, symptomatic remission, and disease clearance compared with placebo at week 12. Among week 12 responders treated with tulisokibart 250 mg, symptomatic remission and disease clearance were achieved in 68% and 44% of participants, respectively, by 1 year. A phase 3 trial to confirm these findings is ongoing.",
  "authors": [
    {
      "affiliations": [],
      "name": "Christopher Ma"
    },
    {
      "affiliations": [],
      "name": "Brigid S Boland"
    },
    {
      "affiliations": [],
      "name": "Jaroslaw Leszczyszyn"
    },
    {
      "affiliations": [],
      "name": "Zhi Jin Xu"
    },
    {
      "affiliations": [],
      "name": "Sami Hoque"
    }
  ],
  "title": "P170 Symptomatic relief and disease clearance with 50 weeks tulisokibart treatment in moderate to severe ulcerative colitis in phase 2 ARTEMIS-UC",
  "uid": "9dd5fbb6-578d-517f-8328-075ab8fcadfa"
}