Poster Session B - Monday Morning
Category: IBD
David T. Rubin, MD, FACG
University of Chicago Medicine Inflammatory Bowel Disease Center
Chicago, IL
Patients with UC in OCTAVE Induction 1&2 (8 weeks [NCT01465763; NCT01458951]), OCTAVE Sustain (52 weeks [NCT01458574]) and OCTAVE Open (OLE study [NCT01470612]) were evaluated. All patients had prior TNFi exposure aData were taken from baseline of the respective studies in which the colectomy occurred bData were taken from baseline of OCTAVE Induction 1&2 cRisk factors for colectomy included: age < 40 years at diagnosis, extensive colitis, severe endoscopic disease (MES of 3), hospitalization for colitis within 12 months, CRP > 3 mg/L, and serum albumin < 3.5 g/dL BID, twice daily; CRP, C-reactive protein; MES, Mayo endoscopic subscore; OLE, open-label, long-term extension; TNFi, tumor necrosis factor inhibitor; UC, ulcerative colitis | |||||||||
Table. Baseline Demographics and Clinical Characteristics of Patients Who Underwent Colectomy in the OCTAVE Clinical Program | |||||||||
---|---|---|---|---|---|---|---|---|---|
Treatment group at time of colectomy | Sex, Age at diagnosis (years), Disease duration (years)a | Disease extent | MES at baseline | Hospitalization for colitis within 12 months | Baseline | Baseline albumin (g/dL) | Days of treatment prior to colectomy | Total Mayo score at last visit prior to colectomy | Risk factors presentb,c |
OCTAVE Induction 1&2 | |||||||||
Tofacitinib 10 mg BID | Male, 26, ≥ 6 | Left-sided colitis | 3 | No | 53.53 | 4.0 | 21 | 11 | 3 |
Tofacitinib 10 mg BID | Male, 41, < 6 | Left-sided colitis | 3 | No | 1.90 | 4.3 | 38 | 11 | 1 |
Placebo | Female, 14, < 6 | Extensive/pancolitis | 2 | No | 4.36 | 3.6 | 58 | 9 | 3 |
OCTAVE Sustain | |||||||||
Placebo | Female, 52, ≥ 6 | Extensive/pancolitis | 3 | Yes | 4.65 | 4.0 | 126 | 6 | 4 |
Placebo | Female, 67, < 6 | Left-sided colitis | 3 | Yes | 19.59 | 3.9 | 143 | 10 | 3 |
Placebo | Female, 23, ≥ 6 | Left-sided colitis | 3 | No | 1.08 | 4.5 | 63 | 4 | 2 |
OCTAVE Open | |||||||||
Tofacitinib 10 mg BID | Female, 35, ≥ 6 | Extensive/pancolitis | 3 | No | 13.42 | 4.1 | 62 | 12 | 4 |
Tofacitinib 10 mg BID | Female, 22, ≥ 6 | Extensive/pancolitis | 3 | No | 4.02 | 4.2 | 132 | 6 | 4 |
Tofacitinib 10 mg BID | Male, 44, < 6 | Proctosigmoiditis | 3 | No | 4.50 | 3.7 | 44 | 11 | 2 |
Tofacitinib 10 mg BID | Female, 20, ≥ 6 | Extensive/pancolitis | 3 | No | 36.80 | 4.2 | 92 | 4 | 4 |
Tofacitinib 10 mg BID | Male, 31, < 6 | Extensive/pancolitis | 3 | Yes | 1.71 | 4.3 | 56 | 8 | 4 |
Tofacitinib 10 mg BID | Male, 45, ≥ 6 | Extensive/pancolitis | 3 | Yes | 40.53 | 3.2 | 375 | 11 | 5 |
Tofacitinib 10 mg BID | Female, 31, ≥ 6 | Left-sided colitis | 3 | Yes | 4.34 | 4.1 | 47 | 11 | 4 |
Tofacitinib 10 mg BID | Female, 29, < 6 | Extensive/pancolitis | 3 | Yes | 7.50 | 4.0 | 174 | 6 | 5 |