A pilot study of orelabrutinib treatment in three cases of refractory/relapsed autoimmune haemolytic anaemia/Evans syndrome

Review Medicine, General & Internal

Autoimmune haemolytic anaemia

Maria Arguello Marina et al.

Summary: Autoimmune haemolytic anaemias (AIHA) are acquired haematological disorders caused by autoantibodies against erythrocyte antigens, and they can be classified into primary and secondary according to the aetiology, and into warm antibody AIHA (w-AIHA) and cold antibody AIHA (c-AIHA) based on the type of antibody and reaction temperature. Glucocorticoid therapy is the main treatment for w-AIHA, and recent studies have shown that the early addition of rituximab has good results. Primary c-AIHA is mainly treated with rituximab, alone or in combination with chemotherapy. New drugs such as Syk inhibitors, anti-FcRn Ig, and complement inhibitors are being developed and will expand the therapeutic arsenal, especially for refractory or relapsed cases.

MEDICINA CLINICA (2023)

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Article Hematology

Orelabrutinib in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma patients: Multi-center, single-arm, open-label, phase 2 study

Wei Xu et al.

Summary: Orelabrutinib demonstrated significant efficacy and safety in patients with refractory or relapsed CLL/SLL, with an overall response rate of 92.5%. The median progression-free survival had not been reached at a 32.3-month median follow-up. Moreover, Orelabrutinib showed promising response in patients with high prognostic risks.

AMERICAN JOURNAL OF HEMATOLOGY (2023)

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Article Rheumatology

Efficacy and Safety of the Bruton's Tyrosine Kinase Inhibitor Evobrutinib in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Trial

Daniel J. Wallace et al.

Summary: Evobrutinib, a highly selective BTK inhibitor, was evaluated for efficacy and safety in patients with active autoantibody-positive systemic lupus erythematosus (SLE). The study did not demonstrate a treatment effect of evobrutinib compared to placebo at any dose. However, evobrutinib was generally well tolerated. These results suggest that BTK inhibition is not an effective therapeutic intervention for patients with SLE.

ACR OPEN RHEUMATOLOGY (2023)

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Article Oncology

Orelabrutinib-bruton tyrosine kinase inhibitor-based regimens in the treatment of central nervous system lymphoma: a retrospective study

Jing-Jing Wu et al.

Summary: The study evaluated the efficacy and safety of orelabrutinib-based regimens in patients with CNSL, showing good effectiveness and tolerability, providing a new potential therapeutic strategy for CNSL patients.

INVESTIGATIONAL NEW DRUGS (2022)

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Article Medicine, General & Internal

Evaluation of orelabrutinib monotherapy in patients with relapsed or refractory Waldenstrom's macroglobulinemia in a single-arm, multicenter, open-label, phase 2 study

Xin-Xin Cao et al.

Summary: Orelabrutinib has shown good efficacy and manageable safety profiles in patients with relapsed or refractory Waldenstrom's macroglobulinemia (R/R WM). The primary endpoint of this prospective study was to evaluate the major response rate (MRR) of orelabrutinib, which was found to be 80.9%, with an overall response rate of 89.4%.

ECLINICALMEDICINE (2022)

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Review Pharmacology & Pharmacy

Orelabrutinib: First Approval

Sohita Dhillon

Summary: Orelabrutinib is a highly selective BTK inhibitor developed for the treatment of B cell malignancies and autoimmune diseases. It has received its first approval in China for specific types of lymphoma or leukemia patients. Future clinical development is ongoing in the USA and China.

DRUGS (2021)

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Article Clinical Neurology

Safety and efficacy of tolebrutinib, an oral brain-penetrant BTK inhibitor, in relapsing multiple sclerosis: a phase 2b, randomised, double-blind, placebo-controlled trial

Daniel S. Reich et al.

Summary: Tolebrutinib, an irreversible inhibitor of Bruton's tyrosine kinase, showed a dose-dependent reduction in new gadolinium-enhancing lesions in patients with relapsing multiple sclerosis. The 60 mg dose was the most efficacious and well tolerated among the tested doses. These findings provide a scientific rationale to pursue phase 3 clinical trials of tolebrutinib in patients with relapsing and progressive forms of multiple sclerosis.

LANCET NEUROLOGY (2021)

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Article Hematology