A sub-analysis of the 16-week CELEST data evaluated the onset of achieving clinical response and remission with upadacitinib, an oral Janus kinase (JAK)1 inhibitor . The patient group had moderate-to-severe active CD.
With upadacitinib 6, 12, and 24 mg BID, relatively more patients achieved modified clinical remission already at week 4 compared with placebo (P≤0.05 for each). Over time, this clinical measure was sustained in patients receiving the upadacitinib 24 mg BID induction dose for up to 16 weeks. Patients (n=220) were randomised double-blindly to placebo or immediate release upadacitinib 3, 6, 12, 24 mg BID, or 24 mg once daily for 16 weeks. Admission criteria were CDAI 220-450, average daily liquid/very soft stool frequency ≥2.5 or daily abdominal pain score ≥2.0, and SES-CD ≥6 (or ≥4 for those with isolated ileal disease). The mean age was 40.7 years, CDAI 302.8, and mean CD duration was 13.2 years.
Patients were randomised at baseli...
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