Psoriatic arthritis patients may have a treatment they can stick with for the long run.
Simponi (golimumab), a biologic treatment for psoriatic arthritis, remained safe and effective throughout a five-year clinical trial, according to a recently published study.
Simponi has been on the market since 2009 as an approved treatment for psoriatic arthritis. Previous studies have shown positive results, but none measured the effects of Simponi over a five-year period.
"There have been studies of treatments for rheumatoid arthritis over five and even 10 years, but nothing nearly so long for psoriatic arthritis," said Dr. Arthur Kavanaugh, the lead author of the study.
The researchers previously released results from earlier stages of the trial, which began with 405 patients. More than two-thirds of the participants—279 patients—stayed on until the end.
Although the trial began by including a portion of patients on placebo, all patients who stayed in the trial after six months were sorted randomly to take either a 50 milligram (mg) or 100 mg dose of Simponi every four weeks. Approximately half of all patients also took methotrexate, which was permitted during the trial.
Simponi works by targeting tumor necrosis factor-alpha, a protein involved in systemic inflammation.
The majority of patients in the trial experienced at least a 20 percent improvement in their symptoms, as measured by American College of Rheumatology criteria. Approximately 50 percent of patients experienced at least 50 percent improvement, while as many as 35 percent experienced 70 percent improvement or greater.
On average, participants' Disease Activity Scores, which measure swollen, tender joints as well as other symptoms, fell from 5 to less than 3.2, which indicates a marked decrease in severity.
In addition, more than 60 percent of study participants achieved a 75 percent reduction in the severity of their psoriasis.
Patients taking biologic medications can sometimes form antibodies to the drug, which may decrease its effectiveness. In this study, only 6 percent of patients developed antibodies. Most who did were not taking methotrexate, which in some cases can help reduce the negative effects of antibodies.
No new safety concerns were raised that hadn't emerged in the shorter trials. Serious side effects, including infections, heart attacks, and skin cancer, occurred in 21 percent of patients.
These findings do not imply that Simponi is more effective than similar medications, said Kavanaugh, but they do show that patients can have a long, sustained response to the drug.
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