FDA Approves New Pill for Psoriatic Arthritis
Apremilast, brand name Otezla, is the second new drug in six months for the skin and joint disease.
03/24/2014 | By Marianne Wait
The U.S. Food and Drug Administration (FDA) has approved a new oral medication for clinically active psoriatic arthritis. Apremilast (Otezla) is a type of drug known as a selective phosphodiesterase 4 (PDE4) inhibitor, which blocks an enzyme involved in inflammation.
“This is an additional treatment option for psoriatic arthritis, which is always a good thing because everyone responds differently to their medications,” says John Hardin, MD, vice president of research for the Arthritis Foundation and professor of medicine at Albert Einstein College of Medicine in New York.
Psoriatic arthritis is a chronic, autoimmune, inflammatory form of arthritis that causes painful, swollen joints as well as the skin symptoms associated with psoriasis. Some 30 percent of people with psoriasis develop psoriatic arthritis. Treatment goals are to improve both joint and skin symptoms, as well as to prevent permanent joint damage. Depending on its severity, psoriatic arthritis is treated using one or a combination of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids (oral or injectable), disease-modifying antirheumatic drugs (DMARDs) such as methotrexate, and biologics, including the tumor necrosis factor blockers adalimumab (Humira), etanercept (Enbrel), golimumab (Simponi) and infliximab (Remicade), and the interleukin-12 and interleukin-23 blocker ustekinumab (Stelara), which was approved six months ago.
In one phase 3 clinical trial (part of the PALACE series of studies looking at apremilast), people treated with apremilast showed significant improvement in signs and symptoms of psoriatic arthritis – including tender and swollen joints, physical function and skin symptoms – after 16 weeks on the drug. Specifically, 31 percent to 40 percent of patients (depending on the dose they took) saw at least a 20 percent improvement (on a measure called the American College of Rheumatology response criteria) compared with 19 percent of patients who took a placebo.
Doctors might use apremilast to treat people who have failed to see benefits from other drugs, or they might prescribe it earlier in the course of the disease. “It could be considered as a first-line therapy given its efficacy and safety profile,” says Philip Mease, MD, director of rheumatology research at Swedish Medical Center and clinical professor at University of Washington School of Medicine in Seattle. “However, in reality, given considerations of cost and the fact that it is new, most formulary managers at insurance companies as well as programs such as Medicare and Medicaid will likely request that clinicians first try a generic therapy such as methotrexate.”
Dr. Mease was a researcher in the PALACE-1 trial (and one of the co-authors of an article on it) and is the lead author of a study, not yet published, on the safety of apremilast across all of the PALACE trials; he has also served as a consultant and a speaker for Celgene Corp., the maker of apremilast (as well as other pharmaceutical companies).
Unlike most biologic drugs, apremilast does not appear to increase the risk of serious infections although he says, “It does have some tolerability issues, such as diarrhea and nausea, particularly when a patient is first using it.” He adds that these side effects tend to be mild-to-moderate and may improve with continued use.
Many psoriatic arthritis patients respond well to existing treatments, such as TNF blockers, but this approval provides another alternative, Dr. Mease notes.