medwireNews: Addition of the recombinant fusion protein telitacicept to standard care may reduce disease activity and is well tolerated in people with systemic lupus erythematosus (SLE), suggests research reported at ACR Convergence 2022 in Philadelphia, Pennsylvania, USA.
As outlined in a poster presentation, the phase 3 study included 335 patients from China with active SLE who were positive for antinuclear and/or anti-double stranded DNA antibodies and had a SELENA-SLEDAI score of at least 8 points. Participants were randomly assigned to receive once-weekly subcutaneous telitacicept 160 mg or placebo, both given alongside ongoing standard therapy, and 236 patients completed 52 weeks of treatment.
Dan Ross (RemeGen Co, San Diego, California, USA) reported that participants given telitacicept experienced a significantly greater reduction in disease activity during the study period than those given placebo, with SRI4 response rates of 82.6% versus 38.1% at week 52.
The presenter pointed out that the SRI4 response rate with telitacicept was “more than double the placebo response rate” at the end of the follow-up period, and significant between-group differences were seen from 4 weeks.
He said that the agent was “well tolerated in SLE patients.” Overall, treatment-emergent adverse events (TEAEs) occurred in 91.6% of patients in the telitacicept group and 84.5% in the placebo arm. The most frequent TEAEs among telitacicept-treated patients were upper respiratory tract infection (42.5 vs 32.7% with placebo), decreased blood immunoglobulin (Ig)G (16.2 vs 1.8%) or IgM (15.6 vs 0.6%), injection site reactions (12.6 vs 0.6%), and urinary tract infection (11.4 vs 15.5%).
There were no deaths during the study, and the investigators report that overall rates of infections/infestations were comparable in the telitacicept and placebo arms, at 65.3% and 60.1%, respectively.
Telitacicept consists of the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor fused to the Fc domain of human IgG1, and the recombinant protein was designed to inhibit B-lymphocyte stimulator and the APRIL proliferation-inducing ligand.
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