Analysis of Over 1,000 Systemic Lupus Erythematosus Patients Reveals Real World Patient Populations are Not Representative of Clinical Trial Samples
While the systemic lupus erythematosus (SLE) pipeline has progressed with agents such as Janssen's Stelara, AstraZeneca/MedImmune's anifrolumab, Neovacs' INF-K, and ImmuPharma's Lupuzor, historically, most agents in development do not make it past phase III trials, resulting in an exceptionally high unmet need.
EXTON, Pa., July 25, 2018 /PRNewswire/ -- To better understand what "real world" SLE patients look like in terms of disease burden, physician touchpoints, and treatment journeys, Spherix Global Insights collaborated with 201 US rheumatologists to analyze the records of 1,032 SLE patients who are currently being treated with or who are candidates for systemic treatments. The majority of patients presented with joint, skin, and kidney manifestations despite their current treatment, and treating physicians typically report their condition as "fair" across a host of quality of life metrics (fatigue, sleep quality, activities of daily living, work performance, social/leisure, and pain). Those that have multiple manifestations have a significantly higher medication burden, experience treatment changes earlier on, and are perceived as having an overall worse quality of life than patients that experience only a few manifestations.
Patients treated with biologics present with more skin, joint, and kidney manifestations and are more likely to be treated with combination therapies such as steroids and immunosuppressants. As the only biologic currently approved for the treatment of SLE, audited Benlysta patients typically achieve a satisfactory response; however, the majority of SLE patients have never been exposed to the brand and rheumatologists estimate just 39% of their patients are not considered a candidate for the drug. Less than 10% of the audited population were previously treated with Benlysta and have since discontinued, largely due to insurance woes and patient out of pocket costs. Rheumatologists describe the ideal Benlysta patient as having failed prior treatments, experiencing active disease, and with little to no renal involvement.
With Benlysta being the only FDA approved biologic option and a sizeable portion of the SLE population not considered candidates, patients are dependent on chronic steroid use as well as off-label agents for treatment. Of those that prescribe Genentech/Biogen's Rituxan off-label, the majority are satisfied with their patient's response, though the lack of an indication and insurance coverage are commonly cited as barriers to use. Benlysta's shortfalls and the difficulty prescribing off-label treatments presents substantial opportunity for agents in development.
Although half of respondents indicated clinical trial populations were representative of their SLE patient population, further analysis on the clinical trial inclusion/exclusion criteria for investigational agents suggests otherwise. The majority of audited patients were not candidates for products in phase III clinical trials, which brings into question the real world utility of these agents, if approved.
Patients that were excluded from clinical trials have been treated with an assortment of steroids, immunosuppressants, and biologics across different time points. These patients also experienced more frequent and severe flares within the past year, experienced more severe manifestations, worse quality of life ratings, and had significantly more comorbidities. For example, Janssen's Stelara is currently recruiting for phase III clinical trials and less than one-third of the audited patients in this study would have been eligible to enroll as a result of the inclusion/exclusion criteria. Ineligible patients were on biologics in the past, experienced significantly more severe flares, and had severe and unstable manifestations. Ineligible patients also had significantly more comorbidities such as hyperlipidemia, renal dysfunction, and thyroid disease, as well as various autoimmune conditions. In addition, these patients experienced more severe quality of life ratings specifically with regard to fatigue, activities of daily life, work, socializing, and sleep quality. The percent of eligible patients for AstraZeneca's anifrolumab, Neovacs' INF-K, and ImmuPharma's Lupuzor all vary, relative to inclusion criteria.
The large number of ineligible patients for these clinical trials suggest that even if pipeline agents make it to market, post-marketing experience may be very different from clinical trial results. This audit helps pharmaceutical developers understand the various patient profiles and how current treatment regimens (many of which include off-label prescribing) are being utilized and highlights where opportunities may exist to claim a competitive advantage.
RealWorld Dynamix: Systemic Lupus Erythematosus USis based on a robust and deep patient chart analysis of ~1,000 patients who have been diagnosed with systemic lupus erythematosus and are either currently treated with Benlysta or considered candidates for systemic treatments.
About Spherix Global Insights Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.
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