Highlights from

European League Against Rheumatism

meeting 2018

Amsterdam 13-16 June 2018

Apremilast significantly improves psoriatic arthritis in the long-term

Apremilast has demonstrated sustained and clinically meaningful improvements in signs and symptoms of PsA, as well as in physical function in patients who continued treatment over 5 years. Apremilast also demonstrated a favourable safety profile and was generally well tolerated at 5 years.

Apremilast is an oral phosphodiesterase 4 inhibitor that inhibits the PDE4 intracellular pathway of inflammatory mediators associated with the pathogenesis of PsA.[1] Long-term efficacy and safety of treatment with apremilast were evaluated for up to 5 years in patients with active PsA by using data from the phase 3 PALACE 1, 2, and 3 studies. Eligible patients had active PsA (duration >6 months, meeting CASPAR criteria, ≥3 SJC, and ≥3 TJC) despite prior conventional treatment with DMARDs and/or biologics.

A total of 1,493 patients were randomised at baseline (1:1:1) to receive placebo, 30 mg apremilast BID, or 20 mg apremilast BID. Placebo subjects were re-randomised 1:1 to 30 mg apremilast BID or 20 mg BID at week 16 or week 24. All randomised subjects received ≥1 dose of study medication (placebo: n=496; 30 mg apremilast: n=497; 20 mg apremilast: n=500). Of the patients randomised to 30 mg apremilast at baseline, 66.6% continued 30 mg apremilast BID treatment until week 260.

The results showed that at week 260, modified ACR20, ACR50, and ACR70 responses were achieved by 67.2%, 44.4%, and 27.4% of these patients, respectively. Mean percent changes were -82.3% for SJC and -72.7% for TJC. For patients who had enthesitis or dactylitis at baseline, the number of patients who achieved a Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) of 0 or a dactylitis count of 0 increased over 52 weeks. At week 260, 60.4% of patients achieved a Clinical Disease Activity in Psoriatic Arthritis (cDAPSA) score ≤13 with continued 30 mg apremilast BID treatment.[2] Furthermore, mean improvement in the HAQ-DI of -0.33 at week 52 was maintained through week 260 (-0.42) in patients who received continuous 30 mg apremilast BID. In patients with baseline psoriasis body surface area (BSA) involvement ≥3% mean improvement in the Psoriasis Area and Surface Severity Index (PASI) score at week 52 (-3.54) was maintained throughout week 260 (-4.63) with continued 30 mg apremilast BID. At week 260, 65.8% and 43.6% of patients who received 30 mg apremilast BID achieved a PASI-50 or a PASI-75 response. Notably, all efficacy results were similar for subjects receiving 20 mg apremilast BID.

Finally, most adverse events were mild to moderate in severity over weeks 0 to ≤52, and no new safety concerns or increases were observed with longer-term (up to 260 weeks) exposure to apremilast. Adverse events, occurring in ≥5% of apremilast-exposed patients during week 0 to ≤52, were diarrhoea, nausea, headache, upper respiratory tract infection, and nasopharyngitis.[3]

  1. Gossec L, et al. Ann Rheum Dis. 2016;75:499–510.
  2. Kavanaugh A, et al. Abstract THU0294. EULAR 2018.
  3. Edwards C, et al. Ann Rheum Dis. 2016;75:1065-1073.

Article image: iStockphoto

The content and interpretation of these conference highlights are the views and comments of the speakers/authors.