LIVERPOOL -- The improvements in joint and skin disease manifestations among patients with psoriatic arthritis treated with apremilast (Otezla) were sustained through 4 years, according to a phase III study reported here.
Among 249 patients who were still enrolled in the PALACE 3 trial at the beginning of year 4 of treatment, 20% improvements on the arthritis criteria of the American College of Rheumatology (ACR20) were seen in 66.4% of patients at week 208, reported Christopher Edwards, MBBS, MD, of University Hospital Southampton in England.
And for the Psoriasis Area and Severity Index, 75% improvements were seen for 45.2% at that time point, Edwards said during a poster session at the .
"These are reassuring data," he told 鶹ý.
"The long-term treatment goals for active psoriatic arthritis include achieving clinically important changes in disease activity, joint, and skin disease assessments."
Apremilast is an oral phosphodiesterase 4 inhibitor. A total of 505 patients in the study were randomized to receive apremilast, 20 mg or 30 mg twice daily. , ACR20 responses were seen in 28% and 41% of the 20 and 30 mg groups, respectively, compared with 18% of those receiving placebo.
Among patients who remained in the study at the start of year 4, a total of 227 completed the week 208 visit. At that time point, with all patients receiving the 30 mg dose, the mean change from baseline in the Disease Activity Score in 28 joints (DAS28) was -1.66, and 50.4% had achieved DAS28 remission. In addition, 80.3% had achieved good or moderate responses on the criteria of the European League Against Rheumatism, while 39.8% and 24.4% had ACR50 and ACR70 responses, respectively.
On swollen joint counts, mean changes were -77.4%, and by the end of 4 years of treatment, 64.8% had swollen joint counts of zero.
The mean decrease in disability as evaluated on the Health Assessment Questionnaire Disability Index (HAQ-DI) at 4 years was -0.42, and the proportion of patients who had a minimal clinically important difference of 0.30 or more on the HAQ-DI was 48.8%.
Most adverse events continued to be mild or moderate, and the only adverse events that occurred in 5% or more of patients were nasopharyngitis and upper respiratory tract infections.
The incidence of adverse events declined over time. For instance, during year 1, diarrhea was reported in 13.6% of patients on the 30 mg dose and in 13.3% on the 20 mg dose, while nausea was reported in 15.7% and 10%, respectively. During the fourth year of treatment, diarrhea was reported in 0.7% and 2.7% of the 30 and 20 mg groups, while nausea occurred in 0.7% and 1.8%. No patients discontinued treatment during the fourth year because of gastrointestinal adverse events. "No scary side effects were reported," Edwards said.
Disclosures
The study was sponsored by Celgene, maker of apremilast. Edwards reported relationships with Celgene, Pfizer, Roche, and Samsung. Several co-authors were Celgene employees.
Primary Source
British Society for Rheumatology
Edwards C, et al "Long-term (4 year) 28-joint count disease activity score (C-reactive protein remission and improvements in skin disease with apremilast: phase III results from PALACE3" BSR 2018; abstract 164.