Association between improvement in enthesopathy and quality of life: Results from anti-TNF-naïve patients with psoriatic arthritis in two phase 3 ustekinumab trials

Objectives: To assess the relationship between changes in enthesopathy and in function/health-related quality of life (HRQoL) in anti-TNF-naïve patients (pts) with psoriatic arthritis (PsA) receiving treatment with ustekinumab (UST). Methods: Adult pts in 2 Phase 3 trials (n=747 anti-TNF naive) with active PsA (≥5 SJC and ≥5 TJC;CRP≥0.3mg/dL) despite DMARD and/or NSAIDs were randomized to UST45mg, 90mg, or PBO at weeks 0, 4, and q12weeks. Stable concomitant MTX was permitted but not mandated. At week16, pts with <5% improvement in TJC & SJC entered blinded early escape (PBO→UST45mg; UST45mg→90mg; 90mg→90mg). Presence or absence of enthesopathy, HAQDI, and SF-36 were assessed at baseline and week 24. In this post-hoc analysis, enthesopathy of the Achilles tendon and plantar fascia was assessed as present or absent. Pts were categorized thereafter as follows: improved (enthesopathy present at baseline, but not at week 24), worsened (enthesopathy present at week 24, but not at baseline), and unchanged. Pts with an enthesopathy assessment missing at either time point were included in the unchanged category; those with enthesopathy data missing at both time points were excluded. Early escape pts were also excluded from this analysis. Improvements in HRQoL (assessed by the SF-36 PCS and MCS and physical function (HAQ-DI) were assessed by enthesopathy response category. Results: A total of 591 anti-TNF-naïve pts from both trials were included in the analysis; 45% of pts were female, mean age was 47 years, mean PsA duration was 6.7 years, and 74% had ≥3% body surface area affected at baseline. The proportion of pts with enthesopathy at baseline was similar in the combined UST (46.5%) and placebo (49.4%) groups. At week 24, the proportions of pts with enthesopathy were 22.8% and 35.9% for the combined UST and placebo groups, respectively. Across all pts, those who had an improvement in enthesopathy had a greater improvement in functioning and HRQoL, compared with those who did not (p<0.05; Table). When the analysis was restricted to those who achieved an ACR 20 response, pts with an improvement in enthesopathy showed a trend of greater improvement in functioning and HRQoL compared to those who had worsened (Table). Conclusions: There is an association between improvement in enthesopathy of the Achilles tendon and plantar fascia and improvement in physical function and quality of life in anti-TNF-naïve pts with PsA in 2 UST trials. Some, but not all, of this improvement may be explained by improvements in peripheral arthritis. (Table Presented).