Efficacy and safety outcomes of patients with systemic lupus erythematosus in a phase 2 study of baricitinib
| PBO(n=105) | Bari 2 mg (n=105) | Bari 4 mg (n=104) | |
|---|---|---|---|
| Efficacy measure | Week 24 | ||
| Resolution of arthritis or rash (SLEDAI-2K) | 56 (53.3) | 61 (58.1) | 70 (67.3)* |
| SRI-4 | 50 (47.6) | 54 (51.4) | 67 (64.4)* |
| Flare (SFI, any severity) | 54 (51.4) | 45 (42.9) | 34 (32.7)* |
| Flare (SFI, severe) | 12 (11.4) | 10 (9.5) | 6 (5.8) |
| LLDAS | 27 (25.7) | 35 (33.3) | 40 (38.5)* |
| Δ Tender joint count | −5.59 | −6.50 | −6.86* |
| Δ Swollen joint count | −4.60 | −4.12 | −4.76 |
| Δ Physician’s Global Assessment | −26.3 | −25.9 | −32.2* |
| Δ Complement C3, g/L | 0 | 0 | −0.02 |
| Δ Complement C4, g/L | 0.01 | −0.01 | −0.01 |
| Safety measure | Weeks 0–24‡ | ||
| TEAEs | 68 (64.8) | 75 (71.4) | 76 (73.1) |
| SAEs | 5 (4.8) | 11 (10.5) | 10 (9.6) |
| Serious infections | 1 (1.0) | 2 (1.9) | 6 (5.8) |
| Deep vein thrombosis | 0 | 0 | 1 (1.0) |
Δ=least squares mean change from baseline; Bari=baricitinib; LLDAS=Lupus Low Disease Activity State; n=number of patients in the analysis population; n=number of patients in the specified category; PBO=placebo; SAEs=serious adverse events; SFI=Safety of Estrogens in Lupus Erythematosus National Assessment [SELENA]-Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index; SLEDAI-2K=Systemic Lupus Erythematosus Disease Activity Index 2000; SRI-4=Systemic Lupus Erythematosus Responder Index-4; TEAEs=treatment emergent adverse events.Data are n (%) patients, unless otherwise indicated.*p≤0.05 vs placebo.‡Includes up to 30 days post-treatment.Wallace et al. Baricitinib in patients with systemic lupus erythematosus: results from a phase 2, randomized, double-blind, placebo-controlled study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10).Wallace et al. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2018; 392: 222–31.