Patient populations and studies
| Patients included in analysis, N (FAS) | ||||
| Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Placebo | Total | |
| RA csDMARD-IR analysis population | ||||
| ORAL Scan (A3921044; NCT00847613)35 A 24-month phase III study in MTX-IR patients with active RA receiving background MTX (tofacitinib 5 or 10 mg BID or placebo; n=797) | 826 | 821 | 419 | 2066 |
| ORAL Sync (A3921046; NCT00856544)34 A 12-month phase III study in patients with active RA and inadequate response to ≥1 csDMARD or bDMARD who were receiving background csDMARDs (tofacitinib 5 or 10 mg BID or placebo; n=792) | ||||
| ORAL Standard* (A3921064; NCT00853385)36 A 12-month phase III study in MTX-IR patients with active RA receiving background MTX (tofacitinib 5 or 10 mg BID, adalimumab 40 mg Q2W or placebo; n=717) | ||||
| RA TNFi-IR analysis population | ||||
| ORAL Step (A3921032; NCT00960440)33 A 6-month phase III study in TNFi-IR patients with active RA receiving background MTX (tofacitinib 5 or 10 mg BID or placebo; n=399) | 133 | 134 | 132 | 399 |
| PsA csDMARD-IR analysis population | ||||
| OPAL Broaden (A3921091; NCT01877668)38 A 12-month phase III study in TNFi-naïve csDMARD-IR patients with active PsA receiving a background csDMARD (tofacitinib 5 or 10 mg BID, adalimumab 40 mg Q2W or placebo; n=442) | 107 | 104 | 105 | 316 |
| PsA TNFi-IR analysis population | ||||
| OPAL Beyond (A3921125; NCT01882439)37 A 6-month phase III study in TNFi-IR patients with active PsA receiving a background csDMARD (tofacitinib 5 or 10 mg BID or placebo; n=395) | 131 | 132 | 131 | 394 |
| AS NSAID-IR analysis population | ||||
| A3921119 (NCT01786668)29 A 16-week (12-week treatment, 4-week washout) phase II study in patients with active AS and inadequate response to ≥2 NSAIDs or intolerance to prior NSAIDs (tofacitinib 2, 5 or 10 mg BID or placebo; n=208) | 52 | 52 | 51 | 155 |
*After the publication of ORAL Standard, one study site (nine patients randomised) was found to be non-compliant to study procedures, and those patients were removed from efficacy analyses.
AS, ankylosing spondylitis; bDMARD, biologic DMARD; BID, twice daily; csDMARD, conventional synthetic DMARD; DMARD, disease-modifying antirheumatic drug; FAS, full analysis set; IR, inadequate response; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; PsA, psoriatic arthritis; Q2W, once every 2 weeks; RA, rheumatoid arthritis; TNFi, tumour necrosis factor inhibitor.