Lupus and Benlysta research
Benlysta was developed and researched specifically for people with lupus.
The initial clinical trials were able to pool the data for the trial groups because there were no differences in safety at various dosing strengths. Participants received either Benlysta or a placebo as an addition to their standard care.
The population in the initial trial was:
- Average age: 39 years old
- 94% Female
- 52% Caucasian
93% of people in the Benlysta groups experienced an adverse reaction compared to 92% of people in the placebo group. The most common adverse reaction was a serious infection (6% in the Benlysta group compared to 5.2% in the placebo group).
3 clinical trials were used to test for the efficacy of the medication. The first helped researchers define a subpopulation, with a positive autoantibody result for whom the medication could be effective. Future studies limited enrollment to those with positive autoantibody scores and SELENA-SLEDAI scored greater than or equal to 6.
The primary endpoint (necessary measure to equal a successful trial) was a decrease of the SELENA-SLEDAI score of greater than or equal to 4 points. A significantly greater number of people in the Benlysta cohort saw this decrease in disease activity as compared to the placebo group for people taking the 10 mg/kg dose of Benlysta.
There was not a significant difference between the placebo group and the Benlysta cohort at the 76 week mark.
Due to lack of diversity and some variable scores, there are still outstanding questions about the efficacy of Benlysta for black or African-American people with lupus. Additional studies are underway to explore any variability in dosing or effectiveness. The FDA label notes that caution should be used when considering Benlysta as a treatment.
Additionally, the researchers noted that taking Benlysta did not significantly reduce a person’s chance of having a severe flare OR enable a person to take significantly less steroids.