Otezla (apremilast) continued to be a safe and effective treatment for people with psoriatic arthritis for up to two years, according to results from two clinical trials.
Results from the Phase III trials, which together involved more than 1,000 patients, were presented at the American College of Rheumatology (ACR) meeting earlier this month. Otezla was approved for the treatment of psoriatic arthritis in March. In September, it was also approved for the treatment of psoriasis.
The placebo-controlled randomized trials tested the safety and effectiveness of 20-milligram (mg) and 30-mg doses of the drug. Although the trials began with some patients randomly assigned to a placebo, after six months, all patients were assigned one of the Otezla doses. The results presented at ACR include data from patients who were on Otezla for two years.
Joint and skin improvements
In one of the trials, called PALACE 1, more than 61 percent of patients on the 20-mg dose achieved a 20 percent improvement in symptoms after two years as measured by ACR response criteria. About two-thirds of patients in the 30-mg group experienced this same improvement, known as ACR 20. The criteria evaluate tender and swollen joints, physical function and pain, among other factors.
In the same trial, 29.8 percent of patients taking the 20-mg dose and 35.6 percent of patients taking the 30-mg dose experienced 50 percent improvement, while almost 20 percent of patients taking the 30-mg dose and 16 percent on the 20-mg dose experienced 70 percent improvement.
Otezla also improved patients’ skin, according to the data. After two years, more than 36 percent of patients on the lower dose, and about 30 percent of patients on the higher dose experienced a 75 percent improvement in their psoriasis, as measured by the Psoriasis Area and Severity Index (known as PASI 75).
Patients enrolled in the other trial, called PALACE 4, experienced similar joint and skin improvements. More than 57 percent of patients on the higher dose, and almost 65 percent of patients on the lower dose, achieved ACR 20 after two years, researchers reported. In addition, 40 percent of patients in the 20-mg group and about 37 percent of patients in the 30-mg group achieved ACR 50, while almost 28 percent of patients in the 20-mg group and almost 19 percent of patients in the 30-mg group achieved ACR 70, according to the results.
Almost half the patients in the 20-mg group, and more than a third in the 30-mg group, also experienced clearer skin, achieving PASI 75, researchers reported.
No new safety issues
Both trials showed the drug to be well-tolerated by patients overall, and, in general, no new safety concerns resulted from long-term use, according to the results. Some side effects, such as diarrhea and nausea, occurred less frequently in the second year of treatment. In PALACE 1, serious side effects during their second year on the drug occurred in 6.4 percent of patients in the 20-mg group and 4.7 percent of patients in the 30-mg group. In PALACE 4, serious side effects occurred during the second year of treatment in about 5 percent of patients on both doses.
Common side effects in the trials included upper respiratory tract infection, headache and the common cold.
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