Amsterdam institute for Immunology and Infectious diseases

A novel biological therapy, telitacicept, is emerging as a promising treatment for systemic lupus erythematosus (SLE) and other autoimmune diseases. Telitacicept is a dual antagonist of the Blys and APRIL pathways, both of which play key roles in the survival and activity of B cells, immune cells that are central to the development of autoimmune diseases. Prof. van Vollenhoven, member of the Amsterdam institute for Immunology and Infectious diseaess, was one of the lead researchers involved in this clinical trial.

A recently completed phase 3 clinical trial investigated the efficacy and safety of telitacicept in patients with SLE, a chronic autoimmune disease characterized by widespread inflammation and tissue damage. The study was designed as a double-blind, randomized, placebo-controlled trial, ensuring robust and unbiased results. The trial demonstrated that telitacicept was effective in reducing disease activity compared to placebo, with a favorable benefit/risk profile. Patients receiving telitacicept experienced better disease control and limited side effects Prof. van Vollenhoven notes: ‘While direct comparisons with other B-cell targeted therapies are still pending, the effect size observed in this study appears particularly favorable’.

International Collaboration and Approval in China

The research journey began years ago, involving international collaboration in study design, data acquisition, analysis, and interpretation. Ultimately, the decision was made to conduct the trial in China. The results were compelling enough that telitacicept has already received regulatory approval in China, where it has been used to treat more than 80,000 patients with SLE.

Expanding Potential in Autoimmune Diseases

Beyond lupus, telitacicept is also showing promise in other autoimmune conditions. Recent data presented at an international congress highlighted encouraging results in Sjögren’s
disease, and further studies are underway to evaluate its efficacy in
additional autoimmune disorders.

Implications and Future Directions

For patients in China, telitacicept is now a realistic treatment option. However, in Europe and other regions, the medication is not yet available. Additional clinical trials will be required to obtain marketing authorization in the European Union and beyond. ‘Meanwhile, I am actively participating in several other trials investigating promising therapies for SLE and other rheumatological diseases,’ says Prof. van Vollenhoven.

Ongoing research continues to explore new medications for autoimmune diseases, with telitacicept representing a significant step forward in the search for effective and safe therapies. ‘In China, where telitacicept has been approved for several years and used by over 80,000 patients, extensive long-term follow-up data on efficacy and safety are being collected and analyzed in real time by regulators and academicians,’ says Prof. van Vollenhoven.

For more information contact Ronald van Vollenhoven (r.vanvollenhoven@amsterdamumc.nl) or read the scientific publication below:

Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial - PMC

Funding

The development and trial of telitacicept were fully sponsored by the Chinese-American company Remegen, which originally owned the rights to the molecule. The rights have recently been transferred to Vor Bio, which will oversee future development and potential global expansion.

Text: Esmée Vesseur and Ronald van Vollenhoven