Phase 2b Trial Shows Telitacicept Safe, Effective for Treatment of Lupus

Results of a phase 2b study presented during the late breaking session at the 2019 American College of Rheumatology annual meeting demonstrate telitacicept’s ability to be efficacious and well-tolerated in patients with systemic lupus erythematosus (SLE).

With all dosages achieving at least twice the proportion of patients achieving SRI4 response at 48 weeks compared to placebo, the APRIL study showcased telitacicept efficacy and safety in a study cohort of 249 patients.

The APRIL study included 249 SLE patients between the ages of 18 and 65 years old with positive ANA and a SELENA-SLEDAI score of 8 or greater. Patients included in the trial were randomized in a 1:1:1:1 ratio to receive subcutaneous telitacicept in doses of 80 mg, 160 mg, 240 mg, or placebo once a week. Primary endpoint measure of APRIL was response rate of SRI4 at week 48. Of the 249 patients included, 62 received placebo while 62 received telitacicept in an 80 mg dose, 63 received a 160 mg dose, and 62 received a 240 mg dose.

Analyses of the study revealed significantly higher SRI4 with telitacicept 80 mg (71%, P<0.0001), 160 mg (68.3%, P=0.0001), and 240 mg (75.8%, P<0.0001) than with placebo therapy (33.9%) at 48 weeks. Investigators found no worsening in Physician’s Global Assessment score among more patients receiving telitacicept 80 mg (96.8%, P<0.001), 160 mg (92.1%, P=0.013), and 240 mg (96.8%, P<0.001) than with placebo (75.8%).

In regard to safety, investigators observed the incidence of adverse events was 93.5% with 240 mg telitacicept, 92.1% with 160 mg, 90.3% with 80 mg compared to 82.3% with placebo. A total of 13 serious adverse events occurred in 8 subjects receiving 240 mg telitacicept, 16 in 10 subjects in the 160 mg group, 12 in 8 patients in the 80 mg group compared to 12 in 10 subjects with placebo. This translates to rates of 12.9%, 15.9%, 12.9%, and 16.1% for the 240 mg, 160 mg, 80 mg, and placebo groups, respectively.

For more on what these results mean for patients with SLE and their clinicians, MD Magazine® sat down with Jianmin Fang, PhD, chief executive officer and founder of Remegen Ltd.—the developer of telitacicept, at ACR 2019.

MD Mag: What did you find in the phase 2b trial examining RC18 (telitacicept) for SLE?

Fang: So SLE, the disease is very hard to treat and the drug development for SLE is very complex, it's difficult. So, we are happy that we are in this phase 2 trial we achieved the primary endpoint, which SRI4 response and basically measures of activity SLE in the patients and we see the significant response in SRI4, so it met the primary endpoint.

Not only this, we also saw good response in biomarkers and other endpoints. So, everything is good, they support each other, showing that this drug is efficacious. Also, the other hand we also see this drug is safe and the patient is well tolerant and they safety profile we see is a pretty good.