As October is Lupus Awareness Month in the UK, GlobalData has taken a comprehensive look at the systemic lupus erythematous (SLE) clinical trial landscape spanning the last decade to identify trial-related trends. Trials with a start date between 18 October 2009 and 18 October 2019 were included in the analyses.
What is systemic lupus erythematous?
SLE is a chronic inflammatory autoimmune disorder where the dysregulation of the immune system produces anti-nuclear antibodies that target tissues and organs. This leads to a variety of manifestations that may be dermatological, arthritic, hematological, renal or neurological. The condition predominantly affects women. The cause of SLE is not clear, but genetic, environmental, and hormonal factors are thought to be involved. The lack of understanding surrounding the etiology of lupus makes direct mechanisms for treatment difficult. Currently, there is no cure for SLE and management of the disorder involves careful monitoring coupled with a customised treatment plan to alleviate the effects of the disease.
US dominates trial locations
The majority of clinical trials carried out during this period are early stage, with 43.4% of trials in Phase II of development and 29.5% of trials in Phase I. Regarding later-stage trials, Phase IV studies (15.6%) outnumber Phase III (11.5%). There are over three times the numbers of single-country trials (78.6%) compared with multinational trials (21.4%). Out of all trial locations, the US takes the lead with 12.2% of total trial locations, with China in second place with 5.5% and Japan in third place with 3.7% of clinical trial locations.
6.8% termination rate
SLE trials have a termination rate of 6.8%, which is 1.3% greater than average during this period for all clinical trials; this is unsurprising given the difficulty in bringing SLE therapies to market. When other and unspecified reasons for termination are removed, low accrual rates serve as the top reason for termination in SLE trials (42.1%), followed by adverse events (21.1%) and a lack of efficacy (15.8%).
GSK strong in SLE trials
As shown in Figure 1, big pharma dominates the research space with GlaxoSmithKline (GSK) serving as the top sponsor for SLE trials (4.1%) largely because GSK manufactures Belimumab, which is the agent used in the highest number of clinical trials within this period (6.0%). Bristol-Myers Squibb follows with 3.6% of trials. Eli Lilly and Co is third place with 3.0% of trials, followed by AstraZeneca and Pfizer (1.9%).
The existing treatment options for SLE are tailored to the patient’s needs. Nonsteroidal anti-inflammatory drugs (NSAIDs) target inflammation and immunomodulatory agents (including antimalarial drugs such as hydroxychloroquine) target autoimmune effects.
Belimumab is centre stage
Belimumab is an immunosuoressive agent that serves as an add-on to standard SLE therapy and is the most commonly researched drug in SLE trials. In 2011, Belimumab was the first drug approved specifically for SLE in 56 years, and no drugs have gained approval since. The lack of new SLE therapies indicates that there is a significant need for advancements in SLE treatments. It is therefore unsurprising that big pharma leads the way in SLE research to try to find an innovative product that can function as a monotherapy. If such efforts are successful, they would be extremely lucrative due to the lack of current direct treatments for SLE.