On the Heels of Recent FDA Approvals, GlaxoSmithKline's BENLYSTA (belimumab) and Aurinia Pharmaceuticals' LUPKYNIS (voclosporin) Emerge as Practical and Effective Tools in the Treatment of Lupus Nephritis

EXTON, Pa., March 12, 2021 /PRNewswire/ -- The Lupus Foundation of America estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus.^[1] As many as half of the patients with systemic lupus will develop lupus nephritis (LN),^[2] and the unmet need for new treatment options remains exceptionally high. However, the FDA approvals of GlaxoSmithKline's Benlysta at the end of last year (December 17, 2020) and Aurinia's Lupkynis at the beginning of this year (January 22, 2021) for the treatment of LN have greatly expanded practitioners' toolkit to treat this disease.

As both nephrologists and rheumatologists begin to trial patients on these new options and determine line of therapy and patient types, Spherix is closely tracking promotional activity, uptake, and experience with these agents through their new Launch Dynamix™ service. The service includes access to monthly benchmarking and quarterly deep dive reports of the two launch brands for the first eighteen months of commercial availability.

In the second month of tracking, survey results from 50 nephrologists and 50 rheumatologists, fielded between March 4^th and March 8^th, revealed that awareness of both products is increasing, and user bases are beginning to expand. Tracking these trends closely will be crucial as practitioners begin to settle into optimal lines of therapy for their patients. Will they reach for Benlysta or Lupkynis off the shelf first? How will they use the products together, if at all, to treat patients?

In early reporting and trending, rheumatologists are leading the charge on Benlysta initiations in LN patients, thanks to their long-standing history with the product for the treatment of systemic lupus erythematosus (SLE). In a recent interview, one rheumatologist expanded on his excitement: "Even before Benlysta was approved for lupus nephritis, I was using it in my patients…and I found success. So, I am very excited that now it has officially been approved [for lupus nephritis] and we can use it now more and more."

Nephrologists are only just beginning to identify proper patients and initiate Lupkynis, with a user base in the single-digits as of early March. While users of the brand expect their scripts to more than double over the next month, uptake will not be automatic. Spherix's in-depth interviews with prescribers brought to light some skepticism on the cost-benefit of Lupkynis. One nephrologist directly called out the comparison to tacrolimus, stating: "I guess the gap in tacrolimus is so well known and it has gotten really dirt cheap for patients. It is hard to switch gears and go to a newer drug [Lupkynis] now because it's more expensive…cost becomes part of the equation, I wish it did not, but it does."

Conversely, many surveyed nephrologists were able to cite Lupkynis's positive trial data and express optimism that the product is in fact more efficacious and safer than existing calcineurin inhibitors. Their familiarity with calcineurin inhibitors overall gives them an edge in likely prescribing over rheumatologists (who are less familiar with this class). While optimism is guarded, one nephrologist did note: "I am not quite sure that Lupkynis is going to totally change the way we do things, although it may replace tacrolimus as our calcineurin drug of choice."

Combination use, which is already well established for LN patients due to the difficulty in treating the disease, may factor in significantly to the evolution of patient care. In many cases, practitioners are thinking of both products as add-on therapies. As confidence grows, both nephrologists and rheumatologists are more likely to start gravitating towards one option or the other earlier in the treatment algorithm. Spherix will capture this data in the quarterly deep dive reports, along with qualitative insights, to provide real-time tracking of this phenomena and specific patient prescribing trends as physicians profile their "most recent patient" prescribed each brand.

Sales representatives, who are trying to adapt to a very fractured sales model during COVID-19 times, will be crucial to educating and inspiring confidence in prescribing the new treatment options. As of early March, less than one-half of nephrologists report contact by a Lupkynis representative (compared to two-thirds of rheumatologists). One nephrologist noted: "No, I have not heard from anybody about that drug yet, to be honest with you … they may be running by rheumatology first and then they run by us next?"

Predictably, nearly all surveyed rheumatologists had seen a Benlysta representative, given their longer standing relationships (which was not the case for nephrologists). Spherix will continue to track not only contact rates, but also messaging recall and representative performance on key launch metrics in both the monthly and quarterly reports.

Looking towards the future, practitioners are optimistic and consider many of their current LN patients to be candidates for Benlysta or Lupkynis. While the ideal patient type for each drug is still being determined, user base is likely to vacillate and grow slowly – patient by patient (as appropriate patients present). With the newness of Benlysta's LN indication and Lupkynis' recent approval, insights on usage and patient type are nascent, but data released days after fielding each month in Spherix's Launch Dynamix™ service will give a real-time read on uptake, perceptions, and experiences across both nephrologists and rheumatologists.

About Our Services
Launch Dynamix™ is an independent service providing monthly benchmarking of newly-launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.

Learn more about our services here.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select dermatology, gastroenterology, nephrology, neurology, and rheumatology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Kristen Henn, Business Development Manager
Email: [email protected]
www.spherixglobalinsights.com

1. https://www.lupus.org/resources/lupus-facts-and-statistics
2. https://www.mayoclinic.org/diseases-conditions/lupus-nephritis/symptoms-causes/syc-20354335

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