The use of apremilast over 3 years demonstrated sustained response and improvements in patients with psoriatic arthritis whose symptoms included swollen and tender joint counts, enthesitis, dactylitis and psoriasis, according to study results presented at the American College of Rheumatology Annual Meeting.
Alvin F. Wells, MD, PhD, FACP, FACR, director of the Rheumatology and Immunotherapy Center in Franklin, Wisconsin, and colleagues conducted a randomized trial using findings from the PALACE 4 study to assess the long-term efficacy and safety of apremilast (Otezla, Celgene) monotherapy in disease-modifying antirheumatic drug (DMARD)–naïve patients.
Wells and colleagues randomized patients to receive either placebo (n = 176), apremilast at 20 mg (n = 175) and apremilast at 30 mg (n = 176). Patients whose swollen and tender joint counts had not improved by 20% or more at week 16 were considered non-responders and were required to be randomly reassigned to either apremilast at 30 or 20 mg if they were initially randomized to placebo, or continued on their initial apremilast dose. At week 24, all patients remaining on placebo were re-randomized to either remaining therapy.
Eighty-eight percent of the remaining 309 patients entering the third year of therapy completed the 156-week visit.
At week 52, 58% of patients (n = 119 of 205) who received 30 mg of apremilast and 55.4% (n = 107 of 193) who received 20 mg of apremilast achieved a 20% improvement in modified American College of Rheumatology (ACR20) response.
Rates of improvement in psoriatic arthritis signs and symptoms and physical function were sustained at week 156, according to modified ACR20/ACR50/ACR70 responses. In addition, mean percent change in swollen and tender joint counts, mean change in Health Assessment Questionnaire-Disability Index (HAQ-DI) score, proportion of patients with HAQ-DI exceeding the minimal clinically important difference of 0.3 or greater were sustained.
Sixty-three percent of patients who received apremilast at 30 mg (n = 79) at week 156 achieved a Maastricht Ankylosing Spondylitis Enthesitis Score of 0, and 60.4% of patients who received apremilast at 20 mg (n = 91) achieved the same score.
Between weeks 104 and 156, the most common adverse events included upper respiratory tract infection (3.2%) and nasopharyngitis (3.9%). Serious adverse events occurred in 5.2% of patients, however no opportunistic infections occurred and there were no changes in the types of adverse events. In addition, there was no increase in the incidence or severity of adverse events during long-term treatment. – by Ryan McDonald
Wells AF, et al. Abstract 1680. Presented at: The American College of Rheumatology Annual Meeting; Nov. 11-16, 2016; Washington.
Disclosure: Wells reports an association with Celgene. Please see the full study for a list of all other researchers’ relevant disclosures.