Telitacicept yields ‘really exciting’ results in rheumatoid arthritis structural damage
Click Here to Manage Email Alerts
SAN DIEGO — Patients treated with telitacicept demonstrated improvements in American College of Rheumatology response and structural damage in patients with rheumatoid arthritis, according to data presented at ACR Convergence 2023.
“Telitacicept is a recombinant fusion protein targeting and neutralizing B lymphocyte stimulator (BlyS) and a proliferation-inducing ligand (APRIL),” Qing Zuraw, MD, of RemeGen Biosciences, in San Francisco, told attendees.
In the current 24-week, randomized, double-blind, placebo-controlled, phase 3 study, Zuraw and colleagues assessed the efficacy and safety of telitacicept (RC18, RemeGen) 160 mg vs. placebo in patients with RA who had failed to mount an adequate response to methotrexate. Medications were administered weekly.
The study also included an open-label period from week 25 to 48.
There were 479 patients with moderate to severe RA included in the analysis. The researchers assigned 360 patients to telitacicept and 119 to placebo.
“Eligibility criteria were adult patients with RA according to ACR and EULAR criteria who received methotrexate for at least 12 weeks,” Zuraw said. “It was a pretty typical population for RA patients as in other clinical trials.”
The proportion of patients who reached ACR20 response at week 24 served as the primary endpoint. ACR50 and ACR70, along with individual components of ACR response, DAS28-ESR and radiographic joint damage were secondary endpoints. The two study groups were similar in baseline demographics and disease characteristics. Patients in the active therapy group had higher C-reactive protein levels at baseline — 22.856 mg/L vs. 17.287 mg/L.
According to the researchers, ACR20 response rates at 24 weeks were 60% for telitacicept and 26.9% for placebo (P < .001). Similarly, ACR50 response rates at 24 weeks were 21.4% for the study drug and 5.9% for placebo (P < .001). Telitacicept also bested placebo in terms of change from baseline in DAS28-ESR response (P < .001) and individual components of ACR criteria.
“Significantly more patients in the telitacicept group compared with placebo have achieved ACR20 and ACR50 response,” Zuraw said. “Although ACR70 response did not reach statistical P value because there are not enough patients.”
Regarding joint parameters, telitacicept was significantly better than placebo in radiographic progression, as assessed by change in modified Total Sharp Score (mTSS), 90.2% vs. 66.4% (P < .001). In addition, patients on active therapy reported significantly less progression of joint damage, as assessed by mTSS, between baseline and week 24 compared with placebo.
“This is a really exciting result,” Zuraw said. “It is really important to see early action to prevent structural damage.”
Treatment-emergent adverse events occurred in 79.7% of patients in the active therapy arm, compared with 77.3% of those in the placebo arm. Serious event rates were 6.4% for telitacicept and 6.7% for placebo, while treatment-emergent adverse events leading to discontinuation were reported in 3.9% of patients in the study drug arm, compared with 3.4% of those in the placebo arm. There were no patient fatalities.
“We can see the two groups are very similar in terms of treatment-emergent adverse events,” Zuraw said. “Discontinuations were comparable between the two arms. The findings are very consistent with other clinical trials in terms of infection rates.”
Overall, the researchers were encouraged by the results.
“Telitacicept demonstrated clinical efficacy and does give us a favorable safety profile in RA patients who had an inadequate response to methotrexate,” Zuraw said.
Collapse
Zuraw A. Abstract L20. Presented at: ACR Convergence 2023; Nov. 10-15, 2023; San Diego.
Read more about
Click Here to Manage Email Alerts