Photo Credit: Ilya Lukichev
Telitacicept demonstrated clinical efficacy with a favorable safety profile in patients with rheumatoid arthritis with inadequate response to methotrexate.
Telitacicept demonstrated clinical efficacy with a favorable safety profile in rheumatoid arthritis (RA) participants with inadequate response to methotrexate. In a phase 3 study, the primary endpoint was met, with telitacicept 160 mg eliciting a significantly higher ACR20 response than placebo.
Telitacicept is a recombinant fusion protein that targets and neutralizes the cytokines B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). It was approved in 2021 to treat moderate-to-severe systemic lupus erythematosus (SLE) in China. A randomized, double-blind study (NCT03016013) compared the efficacy and safety of telitacicept 160 mg with placebo in RA participants with an inadequate response to methotrexate. Participants were randomized 3:1 to receive telitacicept 160 mg or placebo once weekly for 24 weeks. This double-blind study was followed by an open-label extension for another 24 weeks, in which participants in the placebo arm switched to telitacicept. The primary endpoint was an ACR20 response at week 24.
Of 719 screened RA participants, 479 were randomized to receive telitacicept 160 mg (n=360) or placebo (n=119). In the experimental and the control group, 90% and 88% completed the double-blind period, respectively. An ACR20 response at week 24 was significantly higher in the telitacicept group than in the placebo group: 60% and 29.6%, respectively (P<0.001). The ACR50 response at week 24 was also significantly higher in the experimental group (21.4% vs 5.9%; P<0.001). Significantly more participants in the telitacicept group achieved DAS28-ESR ≤3.2 (14.7% vs 5.0%; P<0.05). Telitacicept was also associated with significant improvements in other secondary outcomes: HAQ-DI score, patient assessment of pain, patient and physician global assessment of disease activity, and erythrocyte sedimentation rate.
The authors stressed the highly significant differences in radiographic outcomes. At week 24, the rate of participants with no radiographic progression (△mTSS ≤0) was 90.2% and 66.4% with telitacicept and placebo, respectively (P<0.001). The telitacicept group also showed significantly less progression of joint damage.
Treatment-emergent adverse events (TEAEs), serious adverse events, TEAEs leading to discontinuation from study treatment, and infections were similar in both groups. In the telitacicept group, there were 8 serious infections (2.2%), including 4 cases of pneumonia, while in the placebo group, 4 serious infections (3.4%) were observed, including 2 with herpes zoster.
Copyright ©2023 Medicom Medical Publishers
