Apremilast more efficacious in PsA patients with moderate vs high disease activity

Psoriatic arthritis (PsA) patients with moderate disease activity (MDA) at baseline who are treated with apremilast are more likely to achieve treatment targets than those with high disease activity (HDA), a recent study has shown.

In addition, patients in remission or low disease activity (LDA) have achieved resolution or near resolution of articular and extra-articular PsA manifestations at week 52.

“Our findings demonstrate that baseline disease activity, as measured by the Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA), is a predictor of achievement of treatment targets in disease-modifying antirheumatic drug (DMARD)-naïve patients following apremilast treatment,” said the researchers, led by Dr Philip J Mease from the Swedish Medical Center in Washington, US.

Mease and his team conducted a post hoc probability analysis of PALACE 4, a phase III, multicentre, randomized, placebo-controlled trial, to assess shifting across cDAPSA categories from baseline to week 52. They included 175 DMARD-naïve patients treated with apremilast 30 mg twice daily with available baseline cDAPSA data.

The researchers evaluated the changes in articular and extra-articular manifestations in patients with week 52 cDAPSA components. They also assessed cDAPSA treatment target achievement in a subgroup with baseline extra-articular PsA manifestations.

At baseline, 66.3 percent and 31.4 percent of patients were in HDA and MDA, respectively. Nearly twice as many patients in MDA at baseline achieved remission or LDA at week 52 compared to those in HDA (61.7 percent vs 28.2 percent). [J Rheumatol 2022;49:694-699]

Achieving cDAPSA treatment targets resulted in decreases in articular (ie, swollen/tender joints) and extra-articular (ie, enthesitis, dactylitis, skin involvement, and functional disability) disease activity. Rates of treatment target achievement were similar in the subgroup with ≥1 extra-articular PsA manifestation (n=126; MDA: 66.7 percent; HAD: 32.2 percent).

“These findings were similar to those observed in the PALACE 1–3 DMARD-experienced patient population, in which achievement of treatment targets was twice as likely in the group with ModDA vs HDA at baseline (46.9 percent vs 24.9 percent). [Arthritis Care Res 2020;72:814-821]

“This pattern also held true for patients in the subgroup with skin involvement, enthesitis, and/or dactylitis at baseline, with greater proportions of those in MDA at baseline attaining cDAPSA remission or LDA at week 52 of apremilast treatment than patients in HDA,” they added.

Treatment target

In treatment guidelines, the significance of remission or LDA as a treatment target is highlighted. The current findings add important insights into achieving targets in DMARD-naïve patients with PsA in MDA treated with apremilast. Furthermore, these findings offer insight into achieving treatment targets in those with extra-articular manifestations. [Ann Rheum Dis 2020;79:700-712]

The present study, however, had certain limitations. First, highly selected patients were enrolled with restricted inclusion criteria, which may represent PsA patients treated in real-world clinical settings. In addition, Maastricht Ankylosing Spondylitis Enthesis Score (MASES) was used to assess enthesitis. MASES measures peripheral enthesitis only in the Achilles tendon. However, cDAPSA may have indirectly captured peripheral enthesitis in other sites. [Arthritis Care Res 2011;63 Suppl 11:S64-85]

“Overall, this study supports apremilast as an effective treatment for DMARD-naïve patients with PsA regardless of the presence of extra-articular manifestations of the disease,” the researchers said.