Icotrokinra extension reports sustained UC response; selected responders and exploratory design limit the findings

Johnson & Johnson-sponsored presentation OP41 at the American College of Gastroenterology meeting on October 13 reports long-term extension findings from ANTHEM-UC. Icotrokinra is an investigational oral peptide that targets the interleukin-23 receptor. The original Phase 2b trial was randomized, double-blind and placebo-controlled in adults with moderately to severely active ulcerative colitis; these new results concern its selected extension population, not a new randomized comparison.

The extension included 136 participants who had received icotrokinra and were in clinical response at week 28. The three original treatment groups contributed 48, 44 and 44 participants. Placebo was discontinued after unblinding, and changes to some accompanying medicines were permitted. Selection of earlier responders and the lack of a continuing placebo comparison limit what these outcomes can establish about all patients beginning treatment.

At week 76, clinical response was reported in 39 of 48 participants, 32 of 44 and 32 of 44 across the groups: 81.3%, 72.7% and 72.7%. Clinical remission was reported in 27 of 48, 25 of 44 and 26 of 44: 56.3%, 56.8% and 59.1%. The presentation labels the extension endpoints prespecified but exploratory and says statistical testing was not performed. These descriptive results do not establish a statistically tested advantage between groups.

The analysis counted specified treatment discontinuations and missing endpoint data as nonresponses. Week-76 Mayo-score endpoints used local endoscopy assessments, and no biopsies were collected at that visit. The slides report that 85% of the extension analysis set remained on treatment through week 76. That figure should not be replaced with a differently timed retention percentage from a secondary report.

Safety was summarized through week 78 in the broader safety analysis set, with no deaths reported. Average follow-up was about 27 weeks for placebo and about 59 to 62 weeks for the icotrokinra groups, making exposure and population differences important. The slides report a ductal breast carcinoma in situ during the extension that investigators considered unrelated to treatment. Small samples and unequal follow-up cannot prove the absence of rare or longer-term harms.

This is sponsor-supported conference evidence, not a full peer-reviewed long-term paper or a marketing-approval announcement. The presentation says icotrokinra is being evaluated in Phase 3 trials. Its findings concern adults with ulcerative colitis who entered the extension after earlier response; they do not show benefit for every patient or support unsupervised use. No dosing, buying or treatment instructions are provided, and the results are not a reason to change clinician-directed care.