medwireNews: Apremilast is an effective treatment for enthesitis and dactylitis in individuals with psoriatic arthritis (PsA), according to a pooled analysis of three phase III trials.
In the PALACE 1, 2, and 3 studies, individuals with active PsA despite treatment with conventional DMARDs or biologic therapy were randomly assigned to receive apremilast 30 or 20 mg twice a day or placebo for 24 weeks, after which all participants received the phosphodiesterase 4 inhibitor for up to 5 years. For the current analysis, the researchers pooled the results of 945 individuals with enthesitis and 633 with dactylitis to evaluate the therapeutic benefit of apremilast for these difficult-to-treat conditions over 156 weeks.
Patients achieved significantly greater improvements in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) with apremilast 30 mg twice daily versus placebo by week 24.
And the improvements with apremilast were maintained at week 156, such that individuals taking apremilast 30 mg twice daily showed a mean change in MASES from baseline of–2.7, mean percent change from baseline of –65.2%, and median percent change from baseline of –100%, while 55.0% of patients achieved a MASES of 0. Similar results were seen with the 20 mg twice daily dose.
For dactylitis, the mean and median changes at week 24 from baseline were numerically better with apremilast than placebo, but the differences were not statistically significant. However, Dafna Gladman (Toronto Western Hospital, Ontario, Canada) and co-researchers note that “the mean change in dactylitis count at week 24 was significant and sustained through 156 weeks in the population of patients continuing treatment.”
Furthermore, at the week 156 timepoint, the mean percent change in dactylitis count among those given apremilast 30 mg twice daily was –83.6%, the median percent change from baseline was –100%, and 79.6% of patients achieved a dactylitis count of 0.
“When assessing new therapies for the treatment of PsA, it is important to understand the impact treatment has on hallmark features of PsA such as enthesitis and dactylitis,” write the researchers in RMD Open, noting that these conditions “are associated with impaired function, may negatively impact quality of life and are difficult to treat using conventional treatments.”
The results from this analysis demonstrate that “apremilast is effective in reducing the severity of both conditions in the population of patients remaining on apremilast through 3 years of treatment,” they conclude.
By Catherine Booth
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