Lupus has high unmet needs and a very active pipeline, including AstraZeneca’s anifrolumab, Eli Lilly’s Olumiant, novel TYK-2 inhibitors from Pfizer and Bristol Myers Squibb, as well as a potential label expansion for GlaxoSmithKline’s Benlysta for renal manifestations
EXTON, Pa., September 30, 2020 /PRNewswire/ — Rheumatologists have long struggled to effectively treat patients with systemic lupus erythematosus (SLE) given the wide heterogeneity of the disease and few effective treatment options. When it was approved in 2011, GSK’s Benlysta represented the first new product approved for SLE in more than 50 years, and no other novel products have been approved since.
Indeed, according to Spherix’s new research, Market Dynamix: Systemic Lupus Erythematosus (US), rheumatologists rank SLE as one of the most difficult diseases to manage and one with the greatest unmet need for new treatment options. Similarly, lupus nephritis, the renal manifestation of SLE, falls as an even greater unmet need and as more difficult to manage, given the nuances of kidney diseases. Nephrologists, as part of another study by Spherix, Market Dynamix: Lupus Nephritis (US), expressed very similar frustrations with patient management and unmet needs.
Over the past year, many surveyed rheumatologists have reported becoming more aggressive in managing their SLE patients, including using more combination therapies and more biologics. Additionally, a considerable percentage of rheumatologists have used on-market (but off-label) therapies, including ORENCIA (abatacept, Bristol Myers Squibb), ACTEMRA (tocilizumab, Genentech/Roche), OLUMIANT (baricitinib, Lilly), and even newcomer RINVOQ (upadacitinib, AbbVie), for their SLE patients in an attempt to provide relief.
This strong reliance on steroids to help treat patients, along with a strong push for steroid minimization, creates a complex (and often conflicting) clinical environment. As one rheumatologist noted: “The consensus in the rheumatology world is, number one, to do anything you can. Number two, go easy on the steroids, but the gas pedal on steroids should be very cautious. We want to keep the patient off steroids in the first place, so if you are starting steroids, get them off as soon as you can by using other drugs.” At this point, more than half of severe SLE patients, and many moderate and mild SLE patients, are currently on chronic, low dose steroids, which can carry their own risk of side effects.
Those patients with lupus nephritis present some of the greatest challenges in management and introduce a dynamic of patient co-management between nephrologists and rheumatologists. Depending on rheumatologists’ background, location, and affiliations, some will readily refer patients to nephrologists and defer to them on treatment decisions; others instead prefer to manage the patient’s kidney disease progression themselves and will only refer when renal function declines significantly. Recently released news on Benlysta’s success in trials for lupus nephritis (BLISS-LN) may further evolve this co-management landscape, as some nephrologists rely on rheumatologists to manage biologic therapies, especially if the rheumatology office offers infusion services (which most nephrology offices do not).
The pipeline is bursting with potential new products for lupus and lupus nephritis, both in the form of new mechanisms of action, such as AstraZeneca’s anifrolumab, and established therapies, such as JAK inhibitors, including Lilly’s OLUMIANT (baricitinib). New TYK2 inhibitors, including Bristol Myers Squibb’s BMS-986165 and Pfizer’s brepocitinib (a combination TYK2/JAK-1 inhibitor), along with BTK-inhibitors evobrutinib (EMD Serono) and fenebrutinib (Genentech/Roche), also rank as interesting prospects in the market. For lupus nephritis patients in particular, rheumatologists and nephrologists are optimistic about ORELVO (voclosporin, Aurinia) and GAZYVA (obinutuzumab, Genentech/Roche), as well as BENLYSTA, as the future hope. Details into specialists’ familiarity with each of these mechanisms, along with their expectations for the products, are detailed in recently released Spherix research.
To further examine the intricate patient journey, treatment patterns, and potential for new products, Spherix is introducing a new research study releasing later in 2020 on lupus nephritis. This research, RealWorld Dynamix: Lupus Nephritis (US), will examine more than 1,000 patient charts, including symptom development, lab test results, and detailed treatment histories through induction and maintenance, to uncover patterns and opportunities for new products to most impact patient outcomes across this highly heterogeneous patient population.
About Market Dynamix™
Market Dynamix™ is an independent, subscription-based service that explores future dynamics of evolving healthcare markets within specific indications to help your company make well-informed, strategic decisions. The Spherix research method pairs together both qualitative analyses, fueled by interviews with leading international opinion leaders, and quantitative analysis, leveraging a proprietary network of specialists “in the trenches.”
Market Dynamix™: Systemic Lupus Erythematosus (US) was shaped leveraging perspectives from key opinion leaders, qualitative responses from 101 rheumatologists, and follow-up discussions with several survey respondents.
Market Dynamix™: Lupus Nephritis (US) was shaped leveraging perspectives from key opinion leaders qualitative data from 100 nephrologists and 101 rheumatologists, and follow-up discussions with multiple survey respondents.
About RealWorld Dynamix™
RealWorld Dynamix™: Lupus Nephritis (US) is an independent, data-driven service unmasking real patient management patterns based on chart audits of ~1,000 patients, collected from both rheumatologists (n=~300) and nephrologists (n=~700). The report uncovers the “why” behind treatment decisions – including deep perspective on induction and maintenance therapies, key aspects of market evolution, and integrates specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.
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 immunology, nephrology, and neurology markets.
All company, brand or product names in this document are trademarks of their respective holders.