[Efficacy of Telitacicept combined with low-dose mycophenolate mofetil in the treatment of moderate-to-severe systemic lupus erythematosus].
In a randomized trial, telitacicept combined with low-dose mycophenolate mofetil was non-inferior to high-dose MMF for moderate-to-severe systemic lupus erythematosus, while achieving better glucocorticoid sparing and substantially fewer infections.
Background
Telitacicept is a fusion protein that neutralizes both B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), and standard mycophenolate mofetil (MMF) regimens for active systemic lupus erythematosus (SLE) carry a meaningful infection burden. This study evaluated whether adding telitacicept allows a lower MMF dose without losing efficacy.
Study design
This prospective, open-label, randomized controlled trial enrolled 84 patients with active SLE (SLEDAI-2K >= 10) at a single Chinese center. Participants were randomized to a telitacicept group (subcutaneous telitacicept 160 mg weekly plus MMF 1 g/day plus prednisone) or an MMF group (MMF 2 g/day plus prednisone), with the primary endpoint being non-inferiority in SLEDAI-2K reduction at week 24.
Key findings
Telitacicept plus low-dose MMF was non-inferior to high-dose MMF for SLEDAI-2K reduction. Compared with the MMF group, the telitacicept group achieved higher rates of prednisone tapering to 7.5 mg/day or less (83.72% vs 63.41%, p=0.034), a markedly lower incidence of infections (23.26% vs 68.29%, p < 0.001), and lower anti-dsDNA levels. In the lupus nephritis subgroup, the 12-week urinary protein remission rate was higher with telitacicept (90.48% vs 73.91%, p=0.042).
Clinical implications
These findings suggest telitacicept can enable a lower MMF dose in moderate-to-severe SLE while preserving disease control and improving safety, particularly through reduced infection risk and better glucocorticoid sparing. As a single-center, open-label trial, the results warrant confirmation in larger, more diverse, blinded studies.
Category
Research
Source
Zhonghua Yi Xue Za Zhi
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