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2024-01-30T16:27:09.000Z

Case series: Telitacicept in patients with SLE and LN after suboptimal response to belimumab

Jan 30, 2024
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Learning objective: After reading this article, learners will be able to cite a new development in systemic lupus erythematosus.

Belimumab inhibits B-cell activating factor and is approved for the treatment of patients with systemic lupus erythematosus (SLE) and lupus nephritis, alongside standard therapy, by the U.S. Food and Drug Administration (FDA).1,2 However, the treatment can be ineffective for some patients.3 Telitacicept inhibits both B-cell activating factor and a proliferation-inducing ligand simultaneously and is approved in China for the treatment of active SLE.1,3

Below, we summarize the efficacy and safety of telitacicept in cases published by Fan et al. in Zeitschrift für Rheumatologie1 and Huang et al. in Lupus,3 where belimumab did not yield an adequate response.

Methods1

For the case series by Fan et al., the records of patients diagnosed with SLE at the Wuhan Hospital of Chinese and Western Medicine, China, between March 2022 and July 2023, were assessed.

Key findings1,3

Case series by Fan et al.1

A total of 14 patients with refractory SLE were treated with telitacicept 160 mg (n = 7) and 80 mg (n = 7) after suboptimal response with belimumab plus standard therapy. The mean age was 32.9 years; 79% were female. Before telitacicept, five patients received ≥2 immunosuppressants, and all had discontinued belimumab for ≥6 months due to persistent and recurrent conditions and difficulty in tapering steroids.

Treatment with telitacicept for an average of 34.1 (17–62) weeks (observational endpoint) resulted in:

  • total SLE Responder Index-4 response rate of 78.9%
  • reduction of the mean SLE Disease Activity Index score from 8.6 at baseline to 4.3 (Figure 1A)
  • 100% achievement of no additional organ reaching British Isles Lupus Assessment Group Grade A or ≤1 additional organ elevating to Grade B
  • no increase of Physician Global Assessment ≥0.3, suggesting stability or improvement without deterioration (Figure 1B)
  • tapering of glucocorticoid use by >25% or a maintenance dose of ≤7.5 mg/day in 12 cases and no increase in glucocorticoid dosage in any of the patients (Figure 1C)
  • normalized complement levels in seven cases
  • reduction in 24-hour urinary protein value in 13 cases
  • normalized plasma albumin levels in four cases
  • negative anti-dsDNA antibody titer in three out of seven cases subjected to reexamination
  • non-significant reduction of serum total immunoglobulin (Ig) in nine patients, serum IgG in four patients, and peripheral blood lymphocyte in six patients
  • no serious infection
  • restoration of normal liver function in a refractory patient with lupus hepatitis where belimumab plus standard treatment for 6 months proved ineffective

Figure 1. Reduction in A SLEDAI score, B PGA score, and C glucocorticoid use in patients receiving telitacicept after inadequate response with belimumab* 

PGA, Physician Global Assessment; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index.
*Data from Fan, et al.1

 A case report by Huang et al.3

Figure 2 elucidates a case report, wherein SLE, unresponsive to ten doses of belimumab, was effectively controlled following a switch to telitacicept.

Figure 2. Clinical case overview of a 35-year-old female* 

ANA, anti-nuclear antibody; CT, computed tomography; dsDNA, double-stranded DNA; MMF, mycophenolate mofetil; MP, methylprednisolone; WBC, white blood cell.
*Data from Huang, et al.2

Key learnings1,3

Telitacicept appears to be an effective and safe alternative treatment in patients with SLE who show inadequate response to belimumab.

  1. Fan Q, Yang H, Liu Y. Safety and efficacy of telitacicept in refractory systemic lupus erythematosus patients who failed treatment with belimumab: A case series. Z Rheumatol. Published online Dec 29, 2023. DOI: 1007/s00393-023-01461-z.
  2. Belimumab [Prescribing Information]. Philadelphia, PA. GlaxoSmithKline LLC. 2023.
  3. Huang L, Qian G, Zhang H, et al. Efficacy of telitacicept in a systemic lupus erythematosus patient with suboptimal response to belimumab: A case report. Lupus. Published online December 11, DOI: 10.1177/09612033231221911.

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