Table 2.
EIMs experienced by patients at baseline by treatment group following re-randomization into OCTAVE Sustain.
| EIM | Proportions of patients with active EIM at baseline of OCTAVE Sustain | ||
|---|---|---|---|
| EIM by category, n (%) | Placebo (N1 = 198) | Tofacitinib 5 mg BID (N1 = 198) | Tofacitinib 10 mg BID (N1 = 195) |
| Peripheral arthritis | 12 (6.1) | 6 (3.0) | 3 (1.5) |
| Oral ulcer/stomatitis | 0 (0.0) | 1 (0.5) | 1 (0.5) |
| Erythema nodosum | 0 (0.0) | 0 (0.0) | 1 (0.5) |
| Thromboembolic disordera | 1 (0.5) | 0 (0.0) | 1 (0.5) |
| Uveitis/iritis | 1 (0.5) | 0 (0.0) | 1 (0.5) |
| Sacroiliitis | 1 (0.5) | 3 (1.5) | 0 (0.0) |
| Scleritis/episcleritis | 0 (0.0) | 0 (0.0) | 1 (0.5) |
Percentages represent the proportion of patients with active EIMs at OCTAVE Sustain baseline in placebo (N1 = 198), tofacitinib 5 mg BID (N1 = 198), and tofacitinib 10 mg BID (N1 = 195) groups. No patients had active pyoderma gangrenosum, myopathy, or ankylosing spondylitis at OCTAVE Sustain baseline.
a
As reported by the investigator. Past medical history of thromboembolic events collected.
BID, twice daily; EIM, extraintestinal manifestation; n, number of patients in each category; N1, number of patients with non-missing data.