Table 1 Summary of included studies

Petri 2023

NCT03616964

Phase 3

USA, Central America, Mexico, Argentina, Chile, Colombia, France, Italy, Poland, Romania, Spain, Japan, Korea, Philippines, India, Serbia, and South Africa.

52 weeks

Participants required to be at least 18 years old, have a clinical diagnosis of SLE at least 24 weeks before screening, and meet four out of the eleven updated ACR criteria for SLE categorization. They also had a total SLEDAI-2 K score of at least 6 at screening and a clinical SLEDAI-2 K score of at least 4 at baseline, at least one BILAG A score or two BILAG B scores and were positive for at least one of the following: ANA, anti-dsDNA, or anti-Smith.

If a participant had severe active lupus nephritis, active CNS lupus, or another systemic inflammatory disease besides SLE, they were excluded from the study.

Baricitinib was proposed as a potential treatment for SLE patients in phase 2 data, which was supported in SLE-BRAVE-I, however this finding was not repeated in SLE-BRAVE-II. There were no new warning signs of safety.

Morand 2023

NCT03616912

Phase 3

China, Taiwan, Central America, Mexico, Brazil, Austria, Belgium, Croatia, Czech Republic, Germany, Greece, Hungary, Switzerland, Netherlands, UK, USA, Australia, and Russia.

52 weeks

Participants required to be at least 18 years old, have a clinical diagnosis of SLE at least 24 weeks before screening, and meet four out of the eleven updated ACR criteria for SLE categorization. Additionally, they had at least one ANA (titre ≥ 1:80), anti-dsDNA, or anti-Smith positive screening result; active disease indicated by a screening SLEDAI-2 K score of at least 6; and at least one BILAG A score or two BILAG B scores despite SOC treatments.

Patients were disqualified if they had severe active CNS lupus, severe active lupus nephritis, had received treatment for, or were currently experiencing, another systemic inflammatory disease other than SLE.

The 4 mg baricitinib group in this study achieved the primary goal. However, important auxiliary endpoints weren’t. There were no new warning signs of safety.

Wallace 2018

NCT02708095

Phase 2

11 countries in Asia, Europe, North America, and South America.

24 weeks

Participants were to be 18 years of age or older and have received a diagnosis of SLE at least 24 weeks prior to screening by meeting four or more of the 2012 SLICC classification criteria or the new ACR criteria for SLE classification. Patients had to have a positive anti-dsDNA; ≥ 30 IU/mL, a positive ANA test (HEp-2 titre 1:80), a positive SLEDAI-2 K score of 4 or above based on clinical symptoms, or active arthritis or rash as defined by the SLEDAI-2 K. The study medicine was added to already-present stable background SOC, which may have included corticosteroids or nonsteroidal anti-inflammatory drugs.

Active severe lupus nephritis, active severe CNS lupus, a recent clinically acute infection, and a few specific test abnormalities were important exclusion criteria.

With a safety profile consistent with prior baricitinib studies, the 4 mg dose of baricitinib, but not the 2 mg dose, significantly improved the signs and symptoms of active SLE in patients who were not sufficiently managed despite SOC. This research lays the groundwork for upcoming phase 3 trials using the possible oral treatment for SLE, baricitinib.