Until apremilast was approved earlier this year, patients with psoriatic arthritis had to rely primarily on injectable therapies, which contributed to less than optimal treatment adherence in many patients.
After reviewing three clinical trials involving 1,493 people diagnosed with active psoriatic arthritis, the FDA approved Otezla (apremilast), a phosphodieasterase-4 (PDE-4) inhibitor, in March, 2014. That was welcome news for people who had been relying on injectable biologics as part of their treatment plan to reduce swollen, tender joints commonly associated with the disease.
Since apremilast is the first oral medication in this class of drugs to treat PsA, now patients have more treatment options. Until apremilast hit the market, “tumor necrosis factor inhibitors, an interleukin-12/23 inhibitor and corticosteroids” were the only treatment options available to treat PsA, according to the Dermatology Times.
Compared to interventions or subcutaneous treatments for PsA, having this oral medication offers more convenience to patients, say some medical experts, who commented to NPF about the new treatment
Whether apremilast will help improve treatment adherence remains unknown, but it will be interesting to watch as more people choose this new oral treatment over their usual injectable therapies.
According to Celgene, the New Jersey-based drug manufacturer that makes apremilast, the treatment targets characteristic symptoms in people with PsA. Those include “specific disease manifestations” like inflamed fingers and toes (dactylitis), and inflammation where tendons and ligaments connect with bone (enthesitis).
“Treatment with OTEZLA resulted in improvement in dactylitis and enthesitis in patients with these pre-existing symptoms,” the company said in a press release.
Researchers concerned about quality of life in patients with PsA also took notice of apremilast and published findings from a randomized clinical trial that involved 204 people with active PsA. The study results, published in the Journal of Rheumatology, suggest that apremilast helped people “improve quality of life” while on the treatment.
Keep in mind, apremilast is only FDA-approved at 20 mg and 30 mg doses; however, people in the study who were prescribed 20 mg and 40 mg doses “reported significant improvements that were clinically meaningful, eg, ≥ minimum clinically important differences (MCID) in global VAS (visual analog scale) scores and FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) versus placebo, and significant improvements in pain VAS scores,” according to the study authors.
Compared to the placebo group, researchers concluded that “Apremilast 20 and 40 mg BID resulted in statistically significant and clinically meaningful improvements in physical and mental component summary scores and 7 and 6 SF-36 domains, respectively… Moderate-high, significant correlations were evident between SF-36 domains and other PRO (patient reported outcomes).”
Lead author Vibeke Strand, MD, FACP, Stanford University School of Medicine, said, “Essentially skin manifestations already impact HRQOL through social functioning and role emotional but also pain; but psoriatic arthritis impacts pain, physical function, role physical.”
The NPF Annual Patient Survey Panel reported that 44% of non-working people with psoriatic arthritis blame the disease for their lower quality of life—citing examples like “bodily pain and physical functioning.”
In another study, NPF reported that 88% of people surveyed reported that psoriatic arthritis affected their “overall emotional well-being.”
In clinical trials, the most common side effects of apremilast were diarrhea, nausea, and headache and elevated depression, according to an FDA statement. Risks among pregnant women and their unborn babies also are not yet known.