Oral Paper Presentation
Annual Scientific Meeting
Edward V. Loftus, Jr., MD, FACG
Professor of Medicine
Division of Gastroenterology and Hepatology, Mayo Clinic
Rochester, MN
Primary and key secondary endpoints, % | UPA 45 mg QD at Week 16 (induction)a (N=125) | UPA 15 mg QD at Week 52 (maintenance)b (N=34) | UPA 30 mg QD at Week 52 (maintenance)b (N=39) |
Primary endpoint: Clinical remissionc | 5.6 | 26.5 | 43.6 |
Clinical responsed |
58.4 | (N=25) 49.1 | (N=32) 78.1 |
No abdominal pain | 40.0 | 38.2 | 48.7 |
No bowel urgency | 30.4 | 32.4 | 59.0 |
Endoscopic improvemente Endoscopic remissionf | 14.3 4.9 | 34.3 12.2 | 51.3 17.9 |
Histologic-endoscopic mucosal improvementg Mucosal healingh | 11.0 3.4 | 21.9 12.0 | 41.0 12.8 |
Among patients who achieved clinical remission at the end of induction: Clinical remissionc Clinical remissionc and corticosteroid free for ≥90 days immediately prior to Week 52 |
N/A N/A | (N=3)
0 0 | (N=4)
100 100 |
Among patients who achieved endoscopic improvement at the end of induction: Endoscopic improvemente |
N/A | (N=7) 42.9 | (N=9) 66.7 |
Data are presented for the ITT population comprising patients who achieved a clinical response with 16-week UPA 45 mg QD induction therapy and were re-randomized to receive UPA 15 mg or 30 mg QD maintenance therapy. aTwo patients were excluded from analysis owing to site non-compliance as prespecified in the statistical analysis plan. bIncluded patients who had completed, or had the potential to complete, 52 weeks’ maintenance treatment. cPer Adapted Mayo score ≤2: stool frequency subscore ≤1 and not greater than induction baseline, RBS=0, and ES ≤1. dInduction therapy (UPA 45 mg QD): Clincal response, defined as a decrease in Adapted Mayo score ≥2 and ≥30% from induction baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1, at Week 16. Maintenance therapy (UPA 15 mg or 30 mg, QD): Maintenance of clinical response at Week 52 among patients who achieved clinical response at the end of the 16-week induction therapy. eES ≤1. fES=0. gES ≤1 and Geboes score ≤3.1. hES=0 and Geboes score < 2. ES, endoscopic subscore; ITT, intent-to-treat; N/A, not applicable; QD, once daily; RBS, rectal bleeding subscore; UPA, upadacitinib. |
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