While we don’t usually concern ourselves much with post-approval issues around drugs, such as marketing, prescribing or patient compliance, research and consulting firm GlobalData notes that low compliance rates among lupus patients on prescribed medication “pose a significant problem for their long-term survival, meaning improved treatment options for the disease are eagerly awaited by physicians and patients alike.”
Here at DDNews, we think (and GlobalData seems to agree, as well) that this has implications in the pre-marketing realm of R&D as well. Manufacturing of approved drugs has a huge role in this issue of compliance and survival, but so too does the discovery and development aspect of pharma/biotech work in the lupus realm. If drugs that are easier to take and to tolerate are identified and developed from the start, it will ease the burden farther down the pipeline and help patients sooner.
According to GlobalData’s most recent lupus report, the market covering systemic lupus erythematosus (SLE) and lupus nephritis (LN) is set to see strong growth from $1.2 billion in 2015 to $3.2 billion by 2025. However, treatment options for the disease are suboptimal, with high daily pill burdens and an increased rate of treatment-associated side effects over time, particularly for steroids.
“As there is currently no cure for SLE, sufferers are likely to take multiple immune-suppressing medications over the course of their lives,” says Dr. Sebastian S. Gehrke, a healthcare analyst for GlobalData. “The life expectancy of those living with SLE has almost doubled over the last 50 years, with survival rates approaching 90 percent. Improved supportive treatments, particularly the increasing use of antimalarial therapy, are among the main drivers for this prolonged survival.”
A recent systemic review of the literature identified 11 studies covering self-reported surveys, electronic monitoring devices, clinical records and prescription refill sources showing that more than half of all lupus patients are not taking their medication correctly, with antimalarial therapy showing particularly low compliance rates.
Gehrke notes: “Although this might be initially surprising, because antimalarials are known for their long-term beneficial effects and good safety profile, their therapeutic onset is slow and their benefits are not associated with the reduction of primary symptoms experienced by patients.
“GlobalData has identified six promising pipeline drugs in clinical development for lupus which are likely to combat low compliance rates. Five out of six of these drugs feature an improved dosing schedule of either weekly, biweekly, or monthly dosing, while one drug suffers still from a daily pill burden to lupus patients. However, all of these investigational drugs have the potential to transform the lupus treatment landscape in their unique ways over the next decade.”