Apremilast improves pain, disease activity in early oligoarticular psoriatic arthritis
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Key takeaways:
- Apremilast led to better clinical outcomes in early oligoarticular PsA vs. placebo at 16 weeks.
- Safety was consistent with the known profile of apremilast.
Treatment with apremilast led to improved clinical and patient-reported outcomes in early oligoarticular psoriatic arthritis at 16 weeks, according to data published in Annals of the Rheumatic Diseases.
“Despite fewer involved joints and generally lower rates of enthesitis and dactylitis, oligoarticular PsA can significantly impact the quality of life,” Laure Gossec, MD, a professor of rheumatology at Pitié-Salpêtrière University Hospital and Sorbonne University, in Paris, and colleagues wrote. “Additionally, similar levels of pain and disease burden, including a high proportion of patients who found the state of their symptoms to be unacceptable, have been seen in oligoarticular PsA compared with polyarticular PsA.”
“Apremilast is an oral phosphodiesterase 4 inhibitor approved for the treatment of active PsA,” they added. “The efficacy of apremilast in early oligoarticular PsA has not yet been evaluated.”
To examine the efficacy of apremilast (Otezla, Amgen) in patients with early oligoarticular PsA, Gossec and colleagues conducted a phase 4 randomized, double-blind, placebo-controlled, parallel-group study in 80 sites across 10 countries. The study involved 308 patients with PsA (mean age, 50.2 years) who had between two and eight total swollen or tender joints. Their average duration of disease was 9.9 months.
Participants were randomly assigned to receive either apremilast 30 mg (n = 203) or placebo (n = 105) twice per day for 24 weeks. Patients in the placebo group who demonstrated no improvement in swollen joint count at week 16 were eligible to switch to apremilast.
The main outcome was the proportion of patients achieving a modified version of minimal disease activity, MDA-Joints, which accounts for swollen and tender joints along with other measures of disease activity the researchers wrote. The primary assessment was made based on joints affected at baseline, or sentinel joints, while an exploratory analysis assessed MDA-Joints in all joints.
At week 16, MDA-Joints criteria were met by significantly more patients taking apremilast — 33.9% for sentinel joints, 21.3% for all — vs. placebo — 16% for sentinel joints, 7.9% for all — according to the researchers. The apremilast group also demonstrated an overall greater control of disease activity, measured by Clinical Disease Activity in Psoriatic Arthritis and Psoriatic Arthritis Disease Activity Score, as well as superior improvement in patient-reported outcomes.
Regarding safety, the occurrence of treatment-emergent adverse events was consistent with apremilast’s known profile, occurring in 59.3% of patients taking the drug, the researchers wrote. The most frequent adverse events, reported by 5% of patients or fewer in either group, were diarrhea, nausea and headache.
The study, called FOREMOST, was “unique as a global randomized controlled trial exclusively studying early oligoarticular PsA,” Gossec and colleagues wrote.
“We report the primary results of FOREMOST and show better disease control was achieved with apremilast, with greater MDA-Joints response compared with placebo at 16 weeks,” they added. “These findings show apremilast treatment of early oligoarticular PsA improved clinical and patient-reported outcomes. This study may inform the appropriate management of disease in these patients, but further studies are needed.”
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