gms | German Medical Science

Background: Psoriatic arthritis (PsA) is a chronic, progressive, inflammatory disorder of skin and joints, it impacts both physical and emotional well-being, and increases the risk of comorbidities. Thus, improvement of disease activity as well as emotional well-being is of utmost importance in treatment of PsA patients (pts). In clinical trials, secukinumab, an anti-interleukin (IL)-17A monoclonal antibody, has shown to significantly improve signs and symptoms of PsA [1].

Objectives: To evaluate real-world interim data on the effectiveness of secukinumab on treatment outcomes and quality of life (QoL) in pts with active PsA.

Methods: AQUILA is an ongoing, 52-week (wk) non-interventional study enrolling 2000 pts with active PsA and ankylosing spondylitis. Here, we report interim results of effectiveness in a subgroup of PsA pts treated with secukinumab.

Validated questionnaires were used to measure effectiveness of secukinumab on:

• disease activity
  • Physician´s Global Assessment (PhGA, 0=no disease activity, 10=most intense disease activity),
  • Psoriasis Area and Severity Index (PASI),
  • American College of Rheumatology (ACR) joint count and
  • C-reactive protein (CRP);
• and QoL
  • Psoriatic Arthritis Impact of Disease 12-item score (PsAID-12),
  • Medical Outcomes Study (MOS) Sleep scale and
  • Beck´s Depression Inventory II (BDI-II).

Pts who were already under secukinumab treatment or just about initiating secukinumab therapy, based on medical therapeutic need, were included; in both scenarios, disease activity at start of secukinumab treatment was used as starting point for analysis. Treatment decision was made independently of participating in this study. Pts were observed from BL up to wk 52 according to clinical routine. Real-world effectiveness of secukinumab was assessed prospectively and analyzed as observed.

Results: At BL, 641 PsA pts were included of whom 385 (60.1%) completed 52 wks so far (i.e. at the time of data cut-off for this interim analysis). 58.5% (n=375) of the pts were female and 41.5% (n=266) were male, mean age was 52.6 years. About 66% (n=424) were pre-treated with biologics. Mean PhGA improved from 5.3 at BL (n=571, 89.1%) to 2.5 at wk 52 (n=341, 53.2%). Mean absolute PASI improved from 8.1 at BL (n=211, 32.9%) to 1.2 at wk 52 (n=147, 22.9%). More than half of the documented pts (51 out of 94) achieved a 100% reduction (PASI 100) in skin symptoms at wk 52. The mean number of tender/swollen joints (ACR) was reduced from 7.6 (n=436, 68.0%)/3.9 (n=437, 68.2%) to 3.0 (n=241, 37.6%)/0.7 (n=242, 37.8%) at wk 52. The percentage of pts with CRP >5mg/L dropped from 43.0% at BL (n=230) to 36.6% at wk 52 (n=112). Mean PsAID-12 improved from 5.0 at BL (n=602, 93.9%) to 3.3 at wk 52 (n=343, 53.5%). The percentage of PsA pts with high disease activity (score ≥ 5) assessed by PsAID-12 dropped from 61.0% at BL (n=367) to 26.2% at wk 52 (n=90). MOS sleep scales did not change relevantly over time. With respect to pts with a BDI-II reduction of at least 3 score points, the mean value improved from 16.4 (mild depression) at BL to 8.0 (no depression) at wk 52 (n=123, 19.2%).

Conclusion: Secukinumab reduced disease activity and improved QoL already within this subgroup of PsA pts. Thus, real-world data from the AQUILA study show that, in clinical routine, secukinumab treatment up to one year provides a clear benefit for PsA pts in clinical and QoL parameters.