Despite negative trial findings, belimumab (Benlysta) remains a valid option for black lupus patients, so long as they have high disease activity and positive serology.
Dr. Jinoos Yazdany
That was just one of the many useful messages from a robust question-and-answer session on Twitter April 23, about important findings from the recent LUPUS 2019 Congress in San Francisco. The Twitter chat was hosted by MDedge Rheumatology and led by Jinoos Yazdany, MD, and Gabriela Schmajuk, MD, both associate professors of rheumatology at the University of California, San Francisco (UCSF). The chat included scores of posts from over a dozen participants, most of them rheumatologists, and it’s worth a recap.
The EMBRACE trial
Dr. Gabriela Schmajuk
The belimumab EMBRACE trial was the first topic up to bat. The Food and Drug Administration ordered GlaxoSmithKline to conduct the trial as a condition of approval for lupus in 2011; phase 3 trials found no benefit among a small number of black subjects and even a suggestion of harm.
Although lupus is highly prevalent among black people, and outcomes are generally worse, EMBRACE was the first lupus trial to enroll an entirely black population; 345 patients were treated for a year at 10 mg/kg IV every 4 weeks. Inclusion criteria included disease activity scores of at least 8.
Overall, 49% of belimumab patients, and 42% on placebo, had a positive response, which meant a drop of 4 or more disease activity points, among other things. The difference was not statistically significant (P = .11).
However, GSK’s data showed a statistically significant benefit in favor of belimumab among people who entered with a disease activity score of at least 10 (53% vs. 41% for placebo), as well as for those with low complement levels (47% vs. 25%) and both anti–double stranded DNA antibodies and low complement (45% vs. 24%). Response rates were also significantly higher among the 57% of subjects who lived outside of the United States and Canada.