Early Experiences and Perceptions of Recently Approved Lupus Nephritis Products BENLYSTA (GlaxoSmithKline) and LUPKYNIS (Aurinia) Begin to Drive Increased Prescribing Among Nephrologists and Rheumatologists

EXTON, Pa., June 8, 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] and as many as half of the patients with systemic lupus will develop lupus nephritis (LN).^[2] With the recent 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), practitioners now have valuable new treatment options to battle this complex disease.

While it is still substantial – specialists' perceptions on the unmet need for new products in lupus nephritis have begun to drop over the past few months. This is especially interesting given the very active pipeline for LN products, including BMS' TYK2 inhibitor (deucravacitinib), Roche-Genentech's Gazyva (obinutuzumab), Janssen's Tremfya, Novartis' Cosentyx, and AstraZeneca's anifrolumab. Understanding how well Benlysta and Lupkynis are addressing the unmet needs and where pipeline agents can expect to play will be critical as new products enter the space.

Spherix is closely tracking these new agents in their Launch Dynamix™ service, which couples monthly performance benchmarking with quarterly deep dive reports to understand perceptions of each brand, their evolving places in the treatment paradigm, and projections for future use. This research, in collaboration with 50 US nephrologists and 50 US rheumatologists each month, reveals specialists responding differently to Benlysta and Lupkynis in both perception and use. The fifth monthly tracking update releases this Friday to reveal the latest trajectories for these agents, as reported in the past week.

Given their history of using the drug in systemic lupus erythematosus (SLE), rheumatologists tend to gravitate towards Benlysta and deem more of their LN patients as candidates for the drug over Lupkynis. Alternatively, nephrologists report a slight favoring towards Lupkynis (due to their familiarity with the calcineurin inhibitor drug class) and increasingly see their patients as better suited for Aurinia's brand.

Spherix's Launch Dynamix™ service also includes quarterly deep dives allowing companies to look further into barriers, patient types, product perceptions, manufacturer launch performance, and messaging recall. Of interest, a "last patient prescribed" analysis for each product allows for an assessment of patient demographics, patients' therapy prior to Lupkynis or Benlysta, concomitant drug use, and expectations for the products. Some key highlights from the latest report, released June 4, 2021, are highlighted below.

Considering Benlysta versus Lupkynis across more than one-dozen metrics, rheumatologists are sold on Benlysta's safety profile, but divided on which drug is superior in onset of action, overall efficacy, and clinical data. Nephrologists, on the other hand, rate Lupkynis highly on ease of administration (thanks to its oral dosing) and lean towards the novel calcineurin inhibitor for its perceived superior efficacy and clinical data. Physicians overall say reducing the steroid burden for their patients is a clear driver towards use of both drugs. In recent interviews, physicians expanded on their preferences:

• "I think the toxicity and safety of Benlysta is just outstanding. I don't have patients stopping it because the tolerability issues." – Rheumatologist
• "When you have a patient whose kidney is going down the tubes, there is no time to waste. I cannot rely on [Benlysta,] that is going to take so much time to take effect." – Nephrologist
• "Yes, I would use both drugs. They are attractive and allow me to get rid of the steroids or to decrease the dosage faster." – Nephrologist

Early indicators show physicians beginning to identify patient types for the new drugs: Benlysta is seen as best for mild/moderate LN patients, given its perceived slower onset of action, while many report Lupkynis may be more appropriate for moderate/severe cases to aggressively treat progression. Analysis includes insights on prescribing for patients by LN classification and number of flares, to provide deeper perspective on which patients exactly are being prescribed each product. The study also explores co-management between rheumatologists and nephrologists.

Nephrologists are slightly more hesitant to initiate patients overall given their limited familiarity with Benlysta and a somewhat muted urgency to prescribe Lupkynis, due to cost- and risk-benefit uncertainty compared to other options like tacrolimus. As noted by one responding nephrologist: "Even though some of the Lupkynis lab values like proteinuria were good or the delaying of the kidney failure was marginally acceptable…it wasn't so much better that you could just flip-flop current therapy. You have to be sure the benefits outweigh the risks."

Sales representatives, who are still adapting to a very fractured sales model during COVID-19 times, are increasing their contact with physicians as the pandemic restrictions lift. Predictably, most surveyed rheumatologists have seen a Benlysta representative (given their longer standing relationships) and report being most compelled by the brand's long-term safety messaging. While contact rates with nephrologists have been lower, those who have been contacted feel Benlysta messaging about its likelihood of complete renal response is most believable and compelling.

Lupkynis representatives have hit the market aggressively; however, engagement rates mirror or slightly lag those of Benlysta representatives. One rheumatologist noted positively: "Aurinia did a good job getting out there. I think they're unique in that they're a smaller company that doesn't have the experience, but that might provide a little bit of a different feel, which is a welcome feel."

While the ideal patient type for each drug is still being determined, the user base for both products is likely to continue to grow gradually as appropriate patients present. Nephrologists and rheumatologists predict that in the future a substantial percentage of their patients may be candidates for the new treatment options. 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; the next monthly update releases June 11, 2021.

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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.

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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.

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1https://www.lupus.org/resources/lupus-facts-and-statistics

2https://www.mayoclinic.org/diseases-conditions/lupus-nephritis/symptoms-causes/syc-20354335

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