TABLE 1.
Cohort | Description | |
---|---|---|
Induction | Patients | Patients who received either placebo or tofacitinib 10 mg twice daily in OCTAVE Induction 1 or 2 for 8 weeks |
Treatment groups | Placebo, tofacitinib 10 mg twice daily | |
Exposure time | 0–9 weeks | |
Maintenance | Patients | Patients who completed induction treatment with either placebo or tofacitinib 10 mg twice daily demonstrated a clinical response and entered the phase 3 maintenance study |
Treatment groups | Placebo, tofacitinib 5 mg twice daily, tofacitinib 10 mg twice daily | |
Exposure time | 0–53 weeks | |
Overall | Patients | All patients who received at least one dose of tofacitinib 5 mg or 10 mg twice daily in induction studies, the maintenance study, and ongoing OLE studies |
Treatment groups | Tofacitinib All, predominant-dose tofacitinib 5 mg twice daily, predominant-dose tofacitinib 10 mg twice daily | |
Exposure time | Up to 6.8 years |
Abbreviations: OLE, open-label, long-term extension