Despite overall biologic growth in both geographies, use of advanced systemic treatments in the US outpaces the EU5.
EXTON, PA., October 4, 2023 – Prior to the initial approval of Benlysta in 2011, systemic lupus erythematosus (SLE) patients and prescribers had limited options for the management of this debilitating disease, often relying on symptom management and glucocorticoids to minimize disease impact and activity. While the introduction of Benlysta was certainly a welcomed advancement in the SLE treatment landscape, the heavy reliance on steroids remained a prominent approach.
In 2020, a significant milestone was reached when Benlysta received an expanded label approval in both the United States and the European Union, encompassing a specific subset of lupus nephritis (LN) patients. Shortly thereafter, AstraZeneca’s Saphnelo was granted approval for SLE treatment in 2021 and 2022 in the United States and European Union, respectively. Additionally, Aurinia’s Lupkynis, exclusively approved for LN, gained clearance in 2021 in the United States and in 2022 in the European Union. Armed with this expanded array of treatment options, healthcare providers in both the US and the EU5 have seen a notable increase in their utilization of biologics to address moderate-to-severe cases of SLE.
Spherix Global Insights recently published its 2023 updates of the annual Patient Chart Dynamix™: SLE (US) and Patient Chart Dynamix™: SLE (EU5) services (previously RealWorld Dynamix™: SLE), highlighting detailed comparisons of the progression in SLE treatment across these regions at the patient level. Key analyses reveal that SLE patients (n=1,011 in the US and n=1,257 in the EU5) are increasingly being treated with biologics. Indeed, year-over-year trends reveal that the percentage of audited patients receiving biologic treatment grew 32% in both geographies compared to 2022.
These increases in biologic utilization align with the current climate in SLE treatment recommendations, exemplified by the recent EULAR guideline updates, which are placing greater emphasis on the imperative role of biologic therapy in mitigating the glucocorticoid burden experienced by SLE patients. In fact, a substantial majority of rheumatologists in both the US and EU5 regions have indicated that their prescribing decisions for Benlysta and/or Saphnelo are significantly influenced by their desire to minimize glucocorticoid dosage for their patients.
While both the US and EU5 are increasingly turning to biologic-treatment options for their SLE patients, stateside rheumatologists’ use of the class outpaces their EU5 counterparts. Specifically, among the recently audited moderate-to-severe SLE patients, US patients were 20% more likely to be treated with a biologic than EU5 patients.
At the brand level, rheumatologists in both the United States and the EU5 have been increasingly incorporating Benlysta into their treatment strategies for SLE patients with renal involvement, irrespective of the severity of the condition. However, a notable divergence emerges when considering the utilization of Benlysta for patients without renal involvement. In this respect, US rheumatologists have expanded their use of Benlysta, while their EU5 counterparts have not, further widening the gap in biologic utilization between these two distinct SLE patient populations.
AstraZeneca’s Saphnelo has seen gradual adoption in both the US and EU5. Nevertheless, its growth has been hindered by challenges related to access and reimbursement in the US, compounded by the absence of an LN indication. To address this deficiency, AstraZeneca initiated a Phase III clinical trial for Saphnelo in LN during 2022, with anticipated results slated for 2028.
Spherix has been tracking the SLE and LN markets since 2018, prior to the approvals of Benlysta (for LN), Lupkynis, and Saphnelo, to help subscribed clients navigate the rapidly evolving SLE and LN landscapes and better understand complicated patient management patterns.
Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal and demographic data, connecting trends at the patient level to the prescribing physicians.
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