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wrote a column · Jul 9 11:01

Clinical data on orelabrutinib for the treatment of systemic lupus erythematosus published in the international academic journal Journal of Autoimmunity

The Journal of Autoimmunity recently published research findings on orelabrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of systemic lupus erythematosus (SLE). This study is the first to confirm that orelabrutinib is well tolerated and demonstrates clear efficacy in patients with active SLE, marking it as a potential candidate to become the world’s first BTK inhibitor approved for SLE treatment. Professor Li Ru and Associate Chief Physician Li Xue from the Department of Rheumatology and Immunology/Institute at Peking University People's Hospital are co-first authors of the paper, and Professor Li Zhanguo is the corresponding author.
The Journal of Autoimmunity recently published research findings on orelabrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of systemic lupus erythematosus (SLE). This study is the first to confirm that orelabrutinib is well tolerated and demonstrates clear efficacy in patients with active SLE, marking it as a potential candidate to become the world’s first BTK inhibitor approved for SLE treatment. Professor Li Ru and Associate Chief Physician Li Xue from the Department of Rheumatology and Immunology/Institute at Peking University People's Hospital are co-first authors of the paper, and Professor Li Zhanguo is the corresponding author. This study conducted a multicenter, double-blind, randomized, placebo-controlled, parallel-group Phase Ib/IIa clinical trial across 11 centers in China, in which patients were randomly assigned to receive once-daily oral doses of orelabrutinib at 50 mg, 80 mg, 100 mg, or placebo for a total of 12 weeks. Among all evaluable patients, the SLE Responder Index-4 (SRI-4) response rates in the 50 mg, 80 mg, and 100 mg groups were 50%, 62%, and 64%, respectively—significantly higher than the 36% rate in the placebo group—demonstrating a dose-dependent trend in efficacy improvement. Notably, in patients with moderate-to-severe disease activity at screening (SLEDAI-2K > 8), the response rates in the respective dose groups reached 80%, 83%, and 100%, significantly outperforming the placebo group (0%). Additionally, the study observed...
This study conducted a multicenter, double-blind, randomized, placebo-controlled, parallel-group Phase Ib/IIa clinical trial across 11 centers in China, in which patients were randomly assigned to receive once-daily oral doses of orelabrutinib at 50 mg, 80 mg, 100 mg, or placebo for a total of 12 weeks.
Among all evaluable patients, the SLE Responder Index-4 (SRI-4) response rates in the 50 mg, 80 mg, and 100 mg groups were 50%, 62%, and 64%, respectively—significantly higher than the 36% rate in the placebo group—demonstrating a dose-dependent trend in efficacy improvement. Notably, in patients with moderate-to-severe disease activity at screening (SLEDAI-2K > 8), the response rates in the respective dose groups reached 80%, 83%, and 100%, significantly outperforming the placebo group (0%). Additionally, the study observed reductions in proteinuria, decreased anti-dsDNA antibodies and immunoglobulins IgG/IgM, and increased complement C4 levels, indicating immunological improvements.
In terms of safety, the majority of treatment-related adverse events (TRAEs) were Grade 1–2.
Notably, the large-sample Phase IIb clinical trial of orelabrutinib for SLE also met both its primary and secondary endpoints, making orelabrutinib the first BTK inhibitor globally to demonstrate efficacy in a Phase II clinical trial for SLE. The related results were presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress.
Currently, the registrational Phase III clinical trial of orelabrutinib for the treatment of SLE is accelerating patient enrollment.
The Journal of Autoimmunity is an internationally recognized academic journal in the field of immunology, published by Academic Press, a division of Elsevier. Founded in 1988, it primarily focuses on research into autoimmune mechanisms, regulation, and the diagnosis and treatment of autoimmune diseases.
Note: The content of this press release is derived from the aforementioned published article.
Risk Disclaimer: The above content only represents the author's view. It does not represent any position or investment advice of Futu. Futu makes no representation or warranty.Read more
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