Apremilast shows promise for treating psoriatic diseases
About a year ago, Susan Freeman, 67, started donning a bathing suit and taking aqua aerobics two to three evenings a week. The New Yorker even bought sleeveless dresses this summer.
Freeman, who has had psoriasis since she was in her 20s, said she would never have done either before she started taking the oral anti-inflammatory drug apremilast. But she's had such success on the new medication that she's now willing to bare her arms in public.
"The drug has absolutely made me not have to think about my skin," said Freeman, whose psoriasis — which was under control in her middle years — worsened as she got older.
Freeman had success with a biologic in the past but stopped taking it when her copayment became too expensive. For two to three years, she wasn't on any treatment. Then, in the fall of 2011, Freeman learned about a trial for apremilast from her dermatologist at Mount Sinai Medical Center and was eager to participate.
At first, she was on a placebo and saw no improvement. But in December, after 16 weeks, she was given apremilast, and her skin cleared almost immediately.
Freeman has had no real side effects after taking the drug for a year and a half.
"I did have some gastrointestinal discomfort, but it didn't last long," she said. "Now I take a pill in the morning and a pill at night," she said. "And I don't have a spot on my body."
The global pharmaceutical company Celgene, headquartered in Summit, N.J., produces apremilast. Earlier this year, the company filed for FDA approval for use of the drug in the treatment of psoriatic arthritis. Celgene plans to file for approval for its use in the treatment of psoriasis, as well, said Brian Gill, head of Celgene communications.
Apremilast works by regulating the inflammatory network within the body's cells. It targets an enzyme known as phosphodiesterase 4, or PDE4, which promotes the production of pro-inflammatory messengers and decreases the production of anti-inflammatory messengers within cells. Better regulating PDE4 can help reduce inflammation in skin and joints.
Dermatologists and rheumatologists say they are impressed with what they've seen in clinical trials and expect that apremilast eventually could compete with established biologics.
The major advantage is that, unlike biologics, which are injected, apremilast is taken orally, said Dr. Abrar Qureshi, vice chairman of dermatology at Brigham and Women's Hospital in Boston. He said he is excited about a possible new tool in the arsenal for fighting psoriatic diseases.
Dr. Elaine Husni, vice chair of rheumatology and director of the Arthritis & Musculoskeletal Center at the Cleveland Clinic, said the results she's seen from clinical trials with psoriatic arthritis patients are encouraging. Celgene's 500-patient Phase III trial, called Palace-1, showed meaningful improvement in patients' arthritis symptoms. It appears apremilast can be another option for patients with psoriatic arthritis, she said.
In the trials, the patients' response rates to the medication increased over time. About 31.3 percent of patients on a twice-daily 20-milligram dose of apremilast saw a reduction in pain and other symptoms of at least 20 percent at week 16. At week 52, 63 percent of patients in the study on a 20-milligram dose saw those benefits.
Dr. Arthur Kavanaugh, professor of clinical medicine and director of the Center for Innovative Therapy at the University of California, San Diego, School of Medicine, presented the trial data at the European League Against Rheumatism's annual meeting in June in Madrid. Kavanaugh said there is an unmet medical need for additional effective, well-tolerated options for patients with psoriatic arthritis.
However, he cautions that while apremilast shows promise for treating psoriatic arthritis, the jury is still out.
"At the end of the day, patients want to know, 'Is it going to work for me?'" he said. "But, as is true for all arthritis therapies, we don't know until we try it."