The Food and Drug Administration (FDA) has approved a medication for treatment of psoriatic arthritis, which causes joint pain, swelling and stiffness in patients with psoriasis. Drug maker Celgene Corporation is studying Otezla (generic name apremilast) as a possible treatment for psoriasis. The medication is expected to be available to patients this month.
Otezla is the first oral therapy for psoriatic arthritis approved by the FDA. Reception to Otezla is expected to be bright due to positive results from three clinical trials involving 1493 patients with psoriatic arthritis. Considering the specificity of the disease and general dissatisfaction with current treatments, drug companies are highly competitive about getting their medications on the market. The approval of the medication is timely because some 74 percent of patients change treatment due to unsatisfactory results, while 45 percent are unhappy with their current arthritis treatment.
Dr. Alvin Wells, the director of the Rheumatology and Immunotherapy Center in Wisconsin says, “OTEZLA offers physicians and patients a meaningful new treatment option, with the potential to benefit psoriatic arthritis patients irrespective of prior treatment.” Otezla is also being studied as a possible treatment for rheumatoid arthritis, psoriasis and ankylosing spondylitis.
The 1493 patients with active psoriatic arthritis who participated in the three drug trials showed improvement in their symptoms compared with those who were given placebos. Joint pain and swelling decreased, and physical functioning increased. Discernible side effects were nausea, diarrhea and headaches. Weight loss (five to 10 percent) and depression were also side effects so patients who take Otezla are advised to seek medical advice if these two side effects cannot be accounted for by something else.
Otezla has not been tested in pregnant or nursing mothers, so caution must be used when administering this medication. A pregnancy registry is being set up by the FDA to track use by this group of women.
Otezla eases psoriatic arthritis symptoms by targeting the phosphodiesterase 4 (PDE4), an enzyme that causes inflammation. This treatment focus is different from previous drugs which are injectable. Current treatment for the disease is corticosteroids and tumor necrosis factor (TNF) blockers, such as Humira and Enbrel. But these two medications, while effective, do cause serious side effects so Otezla appears to be a promising alternative.
What is psoriatic arthritis?
Psoriatic arthritis is an inflammatory disease that causes pain, stiffness and swelling of the joints, tendons and ligaments. Because of the pain associated with this condition, it can affect daily life and inhibit work functioning. About 38 million people worldwide suffer from psoriatic arthritis. Approximately 70 percent of patients develop psoriasis prior to arthritic symptoms, while arthropathy (joint disease) starts prior to psoriasis in approximately 2o percent of psoriatic arthritis sufferers. About 10 percent of patients develop both psoriasis and arthritis at the same time.
Psoriatic arthritis goes largely undiagnosed or misdiagnosed. Despite its specific symptoms, it can be confused with other chronic diseases, such as rheumatoid arthritis. Patients who receive treatment often change or stop therapy altogether. Reasons for this include medication safety concerns, poor efficacy of medication and lack of health insurance.
By Juana Poareo
Wall Street Journal