Voclosporin for Lupus Nephritis: Great results in The Lancet

posted in Drugs used in lupus on May 10, 2021 by

Donald Thomas

Updated December 29, 2023

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NOTE: Johns Hopkins University Press, publisher of The Lupus Encyclopedia, is a nonprofit publisher. If you purchase JHUP books, like The Lupus Encyclopedia, you support projects like Project MUSE.

Note the impressively higher response rates in the blue bars (Lupkynis + mycophenolate + steroids) compared to pink (standard of care without Lupkynis). Impressive! This graph comes from the Lancet article referenced below. This is what pops up when you link the study

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 in The Lancet

Voclosporin for lupus nephritis impressively improves lupus nephritis compared to when patients get mycophenolate plus steroids alone.

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:

https:///www.lupusencyclopedia.com/blog/lupkynis-vs-benlysta-for-lupus-nephritis

Here is a link to the article itself:

https:///www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00578-X/fulltext?fbclid=IwAR1D44B63lJwDZvnYiUromEnP0gb2BugZuuE_AY5MJRiDVi8O6ScXlAoeB0

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.

For more in-depth information on lupus nephritis and voclosporin (Lupkynis):

Read chapters 12 and 34 of The Lupus Encyclopedia, edition 2

Look up your symptoms, conditions, and medications in the Index of The Lupus Encyclopedia

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Reference:

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

Author

Don Thomas, MD, author of “The Lupus Encyclopedia” and “The Lupus Secrets”

Disclaimer: Dr. Thomas is on the Speakers Bureau for Aurinia, the producer of voclosporin (Lupkynis)