Safety summary through weeks 12 and 24
| Weeks 0–12 Baricitinib | Weeks 12–24 Baricitinib | Weeks 0–24 Baricitinib | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo once daily (N=98) | 1 mg once daily (N=49) | 2 mg once daily (N=52) | 4 mg once daily (N=52) | 8 mg once daily (N=50) | Combined 2 mg twice daily*† (N=61) | Combined 4 mg once daily*† (N=61) | 2 mg once daily (N=52) | 4 mg once daily (N=52) | 8 mg once daily (N=50) | |
| TEAE, n (%) | 45 (46) | 20 (41) | 24 (46) | 22 (42) | 26 (52) | 29 (48) | 27 (44) | 31 (60) | 32 (62) | 36 (72) |
| SAE, n (%) | 3 (3) | 0 | 3 (6) | 0 | 1 (2) | 3 (5)‡ | 1 (2)‡ | 3 (6) | 0 | 4 (8) |
| Serious infection, n (%) | 0 | 0 | 2 (4) | 0 | 0 | 0 | 0 | 2 (4) | 0 | 1 (2) |
| Discontinuations due to AEs, n (%) | 5 (5) | 1 (2) | 1 (2) | 1 (2) | 1 (2) | 1 (2) | 0 | 1 (2) | 2 (4) | 1 (2) |
*Patients originally assigned to placebo or baricitinib 1 mg once daily at study entry and re-randomised to receive baricitinib 2 mg twice daily or 4 mg once daily for an additional 12 weeks.
†Data for baricitinib combined 2 mg twice daily or combined 4 mg once daily are reported for weeks 12–24.
‡One SAE in each of the baricitinib combined 2 mg twice daily (hyperglycaemia) or combined 4 mg once daily (haematuria) groups began prior to week 12 and continued into weeks 12–24.
AE, adverse event; N, number of patients randomised and treated; n, number of patients with event; SAE, serious adverse event; TEAE, treatment-emergent adverse event.