Baricitinib trials included in the integrated analysis
| Study | Treatments | Analysis dataset | Baricitinib therapy | Treatment period | Database lock |
| Phase 2 | |||||
| NCT02708095 | Placebo, baricitinib 2 mg, baricitinib 4 mg | Placebo-controlled, extended exposure, All-Bari-SLE | In combination with background standard of care | 24 weeks | 4 December 2017 |
| Phase 3 | |||||
| SLE-BRAVE-I; NCT03616912 | Placebo, baricitinib 2 mg, baricitinib 4 mg | Placebo-controlled, extended exposure, All-Bari-SLE | In combination with background standard of care | 52 weeks | 3 December 2021 |
| SLE-BRAVE-II; NCT03616964 | Placebo, baricitinib 2 mg, baricitinib 4 mg | Placebo-controlled, extended exposure, All-Bari-SLE | In combination with background standard of care | 52 weeks | 10 November 2021 |
| LTE | |||||
| SLE-BRAVE-X; NCT03843125 | Baricitinib 2 mg, baricitinib 4 mg | Extended exposure, All-Bari-SLE | In combination with background standard of care | 156 weeks (planned)* | 22 April 2022 |
*SLE-BRAVE-X was terminated early. Maximum exposure was 130.6 weeks.
†Permitted concomitant standard of care medications included a glucocorticoid (up to 40 mg/day prednisone equivalent), a single antimalarial such as hydroxychloroquine, chloroquine or quinacrine; and/or a single immunosuppressant such as methotrexate, azathioprine, mycophenolate, tacrolimus, leflunomide or cyclosporine.
Bari, baricitinib; LTE, long-term extension; SLE, systemic lupus erythematosus.