Safety, efficacy and pharmacokinetics of low‐dose telitacicept in an elderly immunocompromised patient with systemic lupus erythematosus

Guan, Xin; Zhao, Zerui; Xia, Guangtao; Xin, Miaomiao; Yang, Qingrui; Sun, Hongling; Fu, Min

doi:10.1111/1756-185x.14613

Cited by 6 publications

(2 citation statements)

References 9 publications

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“…Telitacicept inhibits the development and maturation of abnormal B cells by blocking BLyS, and also inhibits antibody production by abnormal plasma cells by blocking APRIL, which in turn inhibits plasma cell survival (13)(14)(15)26). Telitacicept is currently used for a variety of immune system disorders, including systemic lupus erythematosus, desiccation syndrome, and IgG4-associated diseases, as well as many other immune system disorders (17,(27)(28)(29)and various renal diseases (17,30)). Based on the infiltrated plasma cells in kidney tissue and pulmonary nodule puncture in this patient, it was considered that RTX had no effect on the tissue infiltrated plasma cells, and telitacicept inhibited the further development and maturation of immature B cells by blocking BLyS.…”

Section: Discussionmentioning

confidence: 99%

Combination treatment with telitacicept, cyclophosphamide and glucocorticoids for severe Granulomatous polyangiitis: a case report and literature review

Huang,

Lin,

Liu

et al. 2023

Front. Immunol.

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Granulomatous polyangiitis (GPA) is a rare autoimmune disease that can involve multiple systems throughout the body, including the ear, nose, upper and lower respiratory tracts. It is classified as an antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Telitacicept is a novel recombinant fusion protein targeting B-lymphocyte stimulator (BLyS). Telitacicept can inhibit the development and maturation of abnormal B cells by blocking BLyS, and inhibit the production of antibodies by abnormal plasma cells by blocking APRIL (A proliferation-inducing ligand), which is expected to become a new drug for the treatment of GPA. We report a 64-year-old man diagnosed at our hospital with GPA involving multiple systems including kidneys, lungs, nose and ears. Renal involvement was severe, with a clinical characteristic of rapidly progressive glomerulonephritis and a pathologic manifestation of crescentic nephritis with plasma cell infiltration. The patient was treated with hormones, immunoglobulins and cyclophosphamide (CYC) with the addition of telitacicept and a rapid reduction in hormone dosage. The patient’s renal function improved significantly within a short period of time, and his hearing and lung lesions improved significantly. At the same time, he did not develop serious infections and other related complications. Our report suggests that short-term control of the patient’s conditions is necessary in GPA patients with organ-threatening disease. Telitacicept combined with CYC and glucocorticoids may be an induction therapy with safety and feasibility. However, more clinical trials are needed to validate the efficacy and safety of the therapeutic regimen.

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Section: Discussionmentioning

confidence: 99%

Combination treatment with telitacicept, cyclophosphamide and glucocorticoids for severe Granulomatous polyangiitis: a case report and literature review

Huang,

Lin,

Liu

et al. 2023

Front. Immunol.

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“…Preliminary investigations have examined the pharmacokinetics and pharmacodynamics of telitacicept in Chinese patients with SLE and rheumatoid arthritis. [16][17][18][19][20] Here we report the efficacy and safety results of this phase 2b clinical trial of telitacicept at a range of doses versus placebo in patients with active SLE when added to standard therapy.…”

Section: Systemic Lupus Erythematosusmentioning

confidence: 99%

Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial

Wu,

Li,

et al. 2023

Ann Rheum Dis

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ObjectivesThis phase 2b, randomised, double-blind, placebo-controlled trial evaluated the efficacy and safety of telitacicept, a novel fusion protein that neutralises signals of B lymphocyte stimulator and a proliferation-inducing ligand, in active systemic lupus erythematosus (SLE).MethodsAdult patients with active SLE (n=249) were recruited from 29 hospitals in China and randomised 1:1:1:1 to receive subcutaneous telitacicept at 80 mg (n=62), 160 mg (n=63), 240 mg (n=62) or placebo (n=62) once weekly in addition to standard therapy. The primary endpoint was the proportion of patients achieving an SLE Responder Index 4 (SRI-4) response at week 48. Missing data were imputed using the last observation carried forward method.ResultsAt week 48, the proportion of patients achieving an SRI-4 response was 75.8% in the 240 mg telitacicept group, 68.3% in the 160 mg group, 71.0% in the 80 mg group and 33.9% in the placebo group (all p<0.001). Significant treatment responses were observed in secondary endpoints, including a ≥4-point reduction on the Systemic Lupus Erythematosus Disease Activity Index, a lack of Physician’s Global Assessment score worsening and a glucocorticoid dose reduction in the 240 mg group. Telitacicept was well tolerated, and the incidence of adverse events and serious adverse events was similar between the telitacicept and placebo groups.ConclusionsThis phase 2b clinical trial met the primary endpoint. All telitacicept groups showed a significantly higher proportion of patients achieving an SRI-4 response than the placebo group at week 48, and all doses were well tolerated. These results support further investigations of telitacicept in clinical trials involving more diverse populations and larger sample sizes.Trial registration numberClinicalTrials.gov Registry (NCT02885610).

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Efficacy and safety of telitacicept in patients with lupus nephritis: a single-center, real-world retrospective study

Huang,

Lin,

Chen

2024

Clin Exp Nephrol

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Safety, efficacy and pharmacokinetics of low‐dose telitacicept in an elderly immunocompromised patient with systemic lupus erythematosus

Cited by 6 publications

References 9 publications

Combination treatment with telitacicept, cyclophosphamide and glucocorticoids for severe Granulomatous polyangiitis: a case report and literature review

Combination treatment with telitacicept, cyclophosphamide and glucocorticoids for severe Granulomatous polyangiitis: a case report and literature review

Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial

Efficacy and safety of telitacicept in patients with lupus nephritis: a single-center, real-world retrospective study

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