Lupus & antiphospholipid syndrome
Safety profile of baricitinib in patients with systemic lupus erythematosus: an integrated analysis
Authors' conclusion
The results of this integrated safety analysis in patients with SLE are not substantially different to the established safety profile of baricitinib. No increased venous thromboembolism was found.
Study context
- Population
- Adults with systemic lupus erythematosus (SLE) receiving stable background therapyreceived baricitinib
- Participants
- 1,655 adults
- Comparison
- Baricitinib 4 mg vs baricitinib 2 mg vs placebo
- Primary endpoint
- Safety: treatment-emergent adverse events (AEs), AEs of special interest (infections, cardiovascular and thromboembolic events) and abnormal laboratory changes
Methodological detailsthree randomised, placebo-controlled studies (one phase 2 and two phase 3), one long-term extension study, placebo-controlled, extended exposure and all-baricitinib data sets, Baricitinib exposure up to 3.5 years (median duration 473 days)
- Three randomised, placebo-controlled studies (one phase 2 and two phase 3)
- One long-term extension study
- Placebo-controlled, extended exposure and all-baricitinib data sets
- Baricitinib exposure up to 3.5 years (median duration 473 days)
Primary result
As reported in the abstract
At least one infection
Safety
Serious infection
Herpes zoster
| Outcome | Baricitinib 4 mg | Baricitinib 2 mg | Placebo |
|---|---|---|---|
| At least one positively adjudicated MACE | |||
| IR | 0.9 | 0.2 | — not stated in the abstract |
| At least one positively adjudicated VTE | |||
| IR | — not stated in the abstract | 0.6 | 0.4 |
— not stated in the abstract
Most common treatment-emergent infections
- Urinary tract infection, COVID-19, upper respiratory tract infection and nasopharyngitis
Original publication
Safety profile of baricitinib in patients with systemic lupus erythematosus: an integrated analysis. RMD Open. Published 21 August 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →