A significantly larger portion of patients in the telitacicept 160 mg achieved SR14 response compared to the placebo group.
New data continues to support the use of telitacicept in patients with systemic lupus erythematosus (SLE).
A team, led by Di Wu, Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, evaluated the efficacy and safety of telitacicept 160 mg compared to placebo in combination with standard therapy in patients with SLE.
The data was presented as a late-breaking abstract during the 2022 American College of Rheumatology (ACR) Convergence Meeting in Philadelphia.
Telitacicept is a novel recombinant fusion protein developed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor receptor and the Fc domain of human immunoglobulin G1 targeting and neutralizing B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL).
In the 52-week, randomized, double-blind, placebo-controlled, phase 3 study, the investigators examined 335 patients with SLE aged 18-65 years with a positive ANA and/or anti-dsDNA and a SELENA-SLEDAI score of at least 8.
The patients were randomized to receive either telitacicept 160 mg (n = 167) or placebo (n = 168) subcutaneously weekly in combination with standard therapy. Baseline demographics and disease characteristics were similar between the 2 groups.
The investigators sought primary endpoints of the SLE Responder Index 4 (SRI4) response rate at Week 52, which was defined as a ≥4 points reduction from baseline in SELENA-SLEDAI score, and no new BILAG A organ domain score or ≤ 2 new BILAG B domain scores compared with baseline, and no worsening (an increase of <0.30 points from baseline) in Physician’s Global Assessment (PGA).
The final analysis included 236 (70.4%) patients who completed treatment.
Of this group, a significantly larger portion of patients in the telitacicept 160 mg achieved SR14 response compared to the placebo group (82.6% vs. 38.1%, P <0.001). The SR14 response was also significantly greater in the telitacicept group as early as week 4 compared to placebo. This significant difference was sustained for up to week 52 (P <0.01 for all time points).
For safety, the rates of treatment-emergent adverse events was fairly high, with 91.6% of the telitacicept group and 84.5% of the placebo group reporting events. There were also 17 serious adverse events observed in 12 participants (7.2%) in the telitacicept group and 36 serious adverse events in 24 participants (14.3%) of the placebo group.
However, there were no deaths reported in either group.
The rates of overall infections or infestations were similar between the 2 groups.
The most common adverse events were upper respiratory tract infections, blood igG decrease, blood IgM decrease, injection site reactions, and urinary tract infections in the telitacicept group.
However, the overall results of the study were promising.
“This phase 3 trial met the primary endpoint,” the authors wrote. “Telitacicept was well tolerated in SLE patients.”
The study, “Telitacicept, a Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Systemic Lupus Erythematosus (SLE): Results of a Phase 3 Study,” was published online by ACR Convergence.