Voclosporin for Lupus Nephritis Studied in 2 Phase-III Clinical Trials! It is a new treatment for lupus in 2021.
Voclosporin for Lupus Nephritis: Impressive Results
Updates September 2021 included below (including voclosporin side effects) because is it is a new treatment for lupus as of January 2021.
Voclosporin side effects included elevated blood pressure, low kidney function, and stomach upset. However, these were easily managed by the ability to lower the dose. When this was done, there were no major differences compared to the placebo group.
Voclosporin FDA approval = January 22, 2021. (AUPH FDA approval for Lupkynis)
Voclosporin cost: expensive. UpToDate in September 2021 estimated its cost at around $14,000 per month ($170,000 a year) for 3 capsules at a time taken twice daily. However, it can markedly reduce the chances for kidney failure, dialysis, and kidney transplantation all of which are very expensive over the lifetime of the patient.
We can now read the data ourselves, and it is impressive. Voclosporin for lupus nephritis was shown to be highly effective and safe in the MUSE phase-2 clinical trial and in the TULIP-1 and TULIP-2 phase-3 clinical trials. Note that the BICLA was used as the primary end point for TULIP-2 and the SRI-4 was used in TULIP-1.
Here is where I break down the numbers into easier to understand language:
Here is a link to the article itself:
Treatments are getting better and better for lupus patients. Now, if only anifrolumab (Saphnelo) can get approved ASAP!
IMPORTANT UPDATE SEP 2021:
The FDA approved the use of voclosporin (Saphnelo) for lupus nephritis on January 22, 2021.
Prof Brad H Rovin, MD, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. The Lancet May 07, 2021 Online; DOI:https://doi.org/10.1016/S0140-6736(21)00578-XDOI
Disclaimer: Dr. Thomas is on the Speakers Bureau for Aurinia, the producer of voclosporin (Lupkynis)