2019: Unprecedented Year in Lupus Drug Development
When it comes to lupus treatment news, 2019 was a year of tremendous progress! Because of the complexity of lupus, drug research and development can be especially challenging. But this year we have seen decades of hard work lead to investigational treatments clearing hurdles at an exciting pace, bringing us closer to potential new FDA-approved treatment options for people living with lupus.
In the last few months alone, we have seen two potential treatments report positive results following successful Phase 3 trials, each with plans to move forward with regulatory review. Having two potential new treatments for lupus within reach is a historic position for the lupus community.
The Lupus Foundation of America is proud to play a central role in the advancement of lupus treatment development and care, from providing much needed research funding to working tirelessly to find ways to improve trial design – including working with the FDA to create a path forward for treatment development. We have also educated people with lupus and connected them to important clinical trial information – participation is critical to successful trials.
Here is just a snapshot of the latest developments we’re buzzing about:
Benlysta: Lupus Treatment Reports Positive Phase 3 Results for Potential Use for Lupus Nephritis
GSK announced that Benlysta® (belimumab) met all targeted endpoints in its phase 3 trial for lupus nephritis (LN) (lupus-related kidney disease). Benlysta is already approved and available for the treatment of mild to moderate lupus, but this latest trial success suggests it may be an effective new therapy for LN as well. The two-year study showed that significantly more people with LN receiving Benlysta plus standard therapy achieved improved kidney function compared to the placebo group. GSK is on track for FDA submission during the first half of next year.
Voclosporin: Monumental Treatment Breakthrough for Lupus Kidney Disease
On December 4, Aurinia Pharmaceuticals Inc. announced exciting results of a Phase 3 clinical study of voclosporin, a potential new treatment for active lupus nephritis (LN) (lupus-related kidney disease). The study met all of its primary and secondary endpoints of achieving complete remission in a statistically significant number of study participants who received voclosporin in combination with standard of care.
The safety profile demonstrated in the trial suggests a new, effective treatment for LN may be on the horizon, possibly leading to reduced reliance on large doses of steroids. In the first half of 2020, Aurinia plans to submit voclosporin to the FDA for regulatory approval.
Anifrolumab: Achieves Another Milestone and Advances toward Approval
AstraZeneca shared encouraging news from its Phase 3 trial of anifrolumab, a potential new medicine for the treatment of moderate to severe systemic lupus erythematosus (SLE). The results show anifrolumab outperformed the placebo on multiple outcomes, including overall disease activity, skin disease and corticosteroid tapering. Anifrolumab is also being evaluated in a Phase 3 long-term extension trial in SLE and a Phase 2 trial in LN. AstraZeneca plans to file the treatment for approval in the second half of 2020.
BIIB059: Trial Therapy for Cutaneous and Systemic Lupus Erythematosus Makes Major Headway
Biogen Inc. announced that its Phase 2 LILAC study revealed positive top-line results for investigational drug, BIIB059. The drug demonstrated statistically significant reduction of disease activity in people with cutaneous lupus (CLE) and SLE compared to those who received placebo. In addition, improvements in skin disease and overall disease activity were consistently observed across multiple secondary endpoints.
A Potentially Pivotal Moment in Lupus Research and Treatment
There’s an undeniable surge in research momentum, and the lupus community is feeling the excitement. “We have never before had a year of such progress in lupus. This has truly been an inspiring year! The Lupus Foundation of America joins the global lupus community in this excitement. We’re looking ahead to 2020 with tremendous eagerness and optimism,” says Leslie M. Hanrahan, Senior Vice President for Research and Education, Lupus Foundation of America.
And, even more potential treatments have made positive strides lately. Learn about additional treatment updates from ACR 2019, and continue to follow the Lupus Foundation of America’s Inside Lupus Research for the latest updates in lupus research news.