Although there is no cure for rheumatoid arthritis, therapies have greatly improved in the past 30 years.
“The goals of RA treatment are to stop inflammation, relieve symptoms, prevent joint and organ damage, improve physical function and overall well-being, and reduce long-term complications,” explains Julie Rubin, director of clinical services for CompleteRx, a pharmacy management company in Houston.
According to the American College of Rheumatology, RA patients should begin their treatment with disease-modifying antirheumatic drugs (DMARDs) which slow the worsening of joint damage as well as relieve symptoms. Commonly prescribed DMARDs include methotrexate, leflunomide, sulfasalazine, and hydroxychloroquine.
“DMARDs have greatly improved symptoms, function and quality of life for nearly all patients with RA; however, RA treatment is complicated and often progressive in nature,” observes David Calabrese, RPh, MHP, senior vice president and chief pharmacy officer, OptumRx. It is common for patients to switch therapies multiple times in their lives, he notes. People with RA also take medications such as ibuprofen and corticosteroids to manage the pain and inflammation on an as-needed basis.
“While the last few years have seen a string of new drug approvals for RA, there are very few products in the drug pipeline now that are in late stage development,” observes Calabrese.
The most notable, he says, is filgotinib (Gilead Sciences and Galapagos NV), a highly selective, oral Janus kinase (JAK) inhibitor. Janus kinases are tyrosine kinases that play a critical role in the signaling pathways that are increasingly seen as critical to the pathogenesis of rheumatoid arthritis and a number of autoimmune diseases. The new drug application for filgotinib was submitted in December 2019, along with a priority review voucher, which should shorten the anticipated time for review.
Related: Biosimilars in the Pipeline
If gets approved and makes it on to the market, filgotinib would compete with previously approved JAK inhibitors, Xeljanz (tofacitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib), explains Calabrese. Rinvoq was just approved last year.
ATI-450 (Aclaris Therapeutics) is an oral MK2 (mitogen-activated protein kinase-activated protein kinase 2) inhibitor currently in Phase 1 trials for the treatment of RA. The FDA approved the investigational new drug application in May 2019, and Phase 1 clinical trials started in August 2019.
Rubin expects more DMARDs and new additions to the JAK inhibitor drug class.
“The RA drug pipeline is focused on minimizing disease progression and immune system malfunction,” she says. “These new drug classes could reduce and, in some cases, reverse clinical symptoms.”
Biosimilars may not be novel therapies, but they are one of the key areas to monitor in RA therapy in Calabrese’s opinion.
Acceptance of biosimilars—by providers and patients—will be key to determining uptake and realizing their savings potential, he says. Payers are attempting to transition patients from existing branded biologics to less costly biosimilar alternatives with the goal, he adds, “of improving patient care and lowering total cost of care.”
Erin Johanek, PharmD, RPh is a staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio.