medwireNews: Telitacicept, a recombinant fusion protein targeting B-lymphocyte stimulator and the APRIL proliferation-inducing ligand, has shown potential for the treatment of systemic lupus erythematosus (SLE) in a phase IIb trial conducted in China.
As reported at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, the study included 249 autoantibody-positive SLE patients with a SELENA-SLEDAI score of at least 8 points who were randomly assigned to receive once-weekly telitacicept at a dose of 80 mg, 160 mg, or 240 mg, or to receive placebo, alongside standard therapy.
Almost all (98.4–100%) patients across the four groups were receiving concomitant treatment with corticosteroids, while 83.9–90.3% were taking antimalarials and 54.0–69.4% immunosuppressants. The average age of participants across the groups ranged from 33.5 to 34.9 years, and 91.9–96.8% were female.
Presenting author Di Wu (Peking Union Medical College Hospital, Beijing, China) said that patients in the telitacicept groups were significantly more likely to achieve an SRI-4 response at week 48 than those in the placebo arms, at rates of 71.0%, 68.3%, and 75.8% for those given the 80 mg, 160 mg, and 240 mg doses, respectively, compared with 33.9% for those given placebo.
Similarly, the proportion of patients achieving at least a 4-point reduction in SELENA-SLEDAI score from baseline to week 48 was significantly higher in the telitacicept 80 mg, 160 mg, and 240 mg versus placebo groups (75.8, 77.8, and 79.0 vs 50.0%, respectively).
In all, adverse events (AEs) occurred in 90.3%, 92.1%, 93.5%, and 82.3% of patients in the 80 mg, 160 mg, 240 mg, and placebo groups, respectively. The corresponding rates of infections were 69.4%, 73.0%, 75.8%, and 64.5%, and a respective 11.3%, 19.0%, 9.7%, and 6.5% experienced injection site reactions.
Together, these findings demonstrate “remarkable efficacy” of once-weekly telitacicept, with a “safety profile comparable to placebo,” said Wu.
He added that a confirmatory phase III trial has commenced in China, and urged global development of the agent in future studies.
In response to a question from a delegate about the lack of dose-dependent efficacy, Wu said that the safety profile of telitacicept was “quite good, so we think the dosages tested in this trial are enough, so we will choose between these three dosages” in future phase III studies.
However, speaking from the audience, Roy Fleischmann (University of Texas Southwestern Medical Center, Dallas, USA) pointed out that because good efficacy was seen in all the groups, lower doses should be investigated in future studies.
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