The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study

Chen, Ruilin; Fu, Rong; Lin, Zeying; Huang, Chun; Huang, Wenhui

doi:10.1177/09612033221141253

Cited by 26 publications

(19 citation statements)

References 20 publications

(31 reference statements)

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“…Overall, the safety profile of telitacicept in our study was similar to previous reports. The percentage of infections (excluding COVID‐19) in our study was lower than those in the other studies 18,26 . The unexpected COVID‐19 outbreak in China did not increase severe infections during telitacicept treatment.…”

Section: Discussioncontrasting

confidence: 77%

“…Although not a head‐to‐head comparison between belimumab and telitacicept, telitacicept seemed to have a higher SRI‐4 rate, which varied between 68.3 and 82.6% (conference abstract) 13,16 . Other noncontrolled studies of telitacicept demonstrated a similar SRI‐4 rate between 66.7 and 80.9% 17–19 . But the baseline glucocorticoid dosage of these previous studies was much higher than ours.…”

Section: Discussionsupporting

confidence: 52%

“…The percentage of infections (excluding COVID-19) in our study was lower than those in the other studies. 18,26 The unexpected COVID-19 outbreak in China did not increase severe infections during telitacicept treatment. Another fusion protein that blocks BAFF and APRIL in the treatment of SLE is atacicept.…”

Section: Discussionmentioning

confidence: 99%

“…There were 35,18,32,27,11, and 8 patients with available data of lymphocytes subsets analysis at baseline, month 1, 3, 6, 9, and 12, respectively. In general, telitacicept treatment significantly reduced median levels of total B cells throughout 12 months (−2.14 to −72.7%, from month 1 to 12, p < 0.001), while preserving memory B cell populations.…”

Section: Effect Of Telitacicept On Lymphocyte Subpopulationsmentioning

confidence: 99%

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B cell pathway dual inhibition for systemic lupus erythematosus: a prospective single‐arm cohort study of telitacicept

Ji,

Geng,

Zhang

et al. 2024

MedComm

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Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease associated with B‐cell hyperactivity. Telitacicept is a transmembrane activator, calcium modulator, and cyclophilin ligand interactor‐Fc fusion protein, which can neutralize both B‐cell lymphocyte stimulator and a proliferation‐inducing ligand. Patients with active SLE who received telitacicept were prospectively followed at month 1, 3, 6, 9, and 12 after telitacicept initiation. Thirty‐seven participants were involved and followed for 6.00 [3.00, 6.00] months. SRI‐4 rate at month 6 was 44.7%. The median dosage of prednisone was decreased by 43.8% (from 10 to 5.62 mg/d) at month 6. The anti‐dsDNA level was significantly decreased, while complement levels were significantly increased at month 6 from baseline. Continuously significant reductions in serum immunoglobin (Ig)G IgA, and IgM levels were also observed. Patients experienced significant decreases in the numbers of total and naive B cells, whereas memory B cells and T cell populations did not change. The number of NK cells was significantly increased during the follow‐up. At month 6, 58.3% (14 out of 24) patients experienced improved fatigue accessed by FACIT–Fatigue score exceeding the minimum clinically important difference of 4. Most adverse events were mild, but one each case of severe hypogammaglobulinemia, psychosis with suicidal behavior, and B‐cell lymphoma were occurred. In our first prospective real‐world study, telitacicept treatment led to a significant clinical and laboratory improvement of disease activity, as well as fatigue amelioration in patients with SLE. Safety profile was favorable overall, but more studies are greatly needed.

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Section: Discussioncontrasting

confidence: 77%

Section: Discussionsupporting

confidence: 52%

Section: Discussionmentioning

confidence: 99%

Section: Effect Of Telitacicept On Lymphocyte Subpopulationsmentioning

confidence: 99%

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B cell pathway dual inhibition for systemic lupus erythematosus: a prospective single‐arm cohort study of telitacicept

Ji,

Geng,

Zhang

et al. 2024

MedComm

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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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Sicherheit und Wirksamkeit von Telitacicept bei Patienten mit refraktärem systemischem Lupus erythematosus und Therapieversagen von Belimumab

Fan,

Yang,

Liu

2023

Z Rheumatol

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Objective This study aimed to determine the effect and safety of telitacicept, an antagonist of BLyS/APRIL-mediated B cell activation, in patients with systemic lupus erythematosus (SLE) who failed treatment with belimumab and in whom telitacicept was administered combined with conventional therapy. A review of published reports on telitacicept for SLE was also performed. Methods A retrospective review was performed of the records of patients seen in the Department of Rheumatology at the Wuhan Hospital of Chinese and Western Medicine, Wuhan, China, with refractory SLE who had failed treatment with belimumab. The terms “systemic lupus erythematosus” and “telitacicept” were used to identify patients reported in the English medical literature. Results Identified were 14 refractory SLE patients, 3 males (21%) and 11 females (79%). The median age was 32.9 years. The median disease duration was 8.9 years. Patients in this cohort received telitacicept for an average of 34.1 weeks (17–62 weeks) and the total SLE responder index 4 (SRI-4) response rate was 78.9% (n = 11). The mean SLE Disease Activity Index (SLEDAI) score declined from 8.6 at baseline (95% confidence interval [CI] 7.87–9.28) to 4.29 at the endpoint (95% CI 3.4–5.16). All cases (100%) had hypocomplementemia at baseline, and 7 cases (50%) reported normal C3 and C4 levels at the follow-up endpoint. At the observation endpoint, the 24‑h urinary protein value of the 13 cases with proteinuria (baseline 24‑h urinary protein > 0.5 g/d) displayed a reduction, and 3 values turned negative. Although some patients had low serum total immunoglobulin (Ig) levels, subnormal IgG levels, and absolute counts of peripheral blood lymphocytes after treatment, no serious infection was reported. One case was refractory lupus hepatitis confirmed by liver pathology, and upon change to change to telitacicept treatment, liver function returned to normal. Conclusion This is the first case series in SLE patients who accepted telitacicept treatment after failed treatment with belimumab. Our case series and review of the literature show that telitacicept combined with the original standard treatment may significantly improve disease activity while reducing prednisone use. No major safety issues were seen in this group of patients. Telitacicept may be a promising drug for the treatment of refractory lupus hepatitis.

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The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study

Cited by 26 publications

References 20 publications

B cell pathway dual inhibition for systemic lupus erythematosus: a prospective single‐arm cohort study of telitacicept

B cell pathway dual inhibition for systemic lupus erythematosus: a prospective single‐arm cohort study of telitacicept

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

Sicherheit und Wirksamkeit von Telitacicept bei Patienten mit refraktärem systemischem Lupus erythematosus und Therapieversagen von Belimumab

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