Apremilast Treatment Leads to Long-Term Work Productivity Improvement in Patients with Psoriatic Arthritis

Analysis of 3 apremilast trials finds that the medication increases workplace productivity and reduces workplace limitations for at least a year in patients who began trials with inadequately controlled psoriatic arthritis.

Analysis of 3 apremilast trials finds that the medication increases workplace productivity and reduces workplace limitations for at least a year in patients who began trials with inadequately controlled psoriatic arthritis.

The 3 PALACE trials randomized 1,493 patients almost equally to placebo, twice-daily apremilast 20 mg (APR20) and twice-daily apremilast 30 mg (APR30). Non-responders whose swollen and tender joint counts had not improved 20% or more by week 16 either continued on their initial apremilast dose or, if they begun on placebo, were re-randomized equally between APR20 and APR30. All patients remaining on placebo at week 24 were re-randomized to APR20 or APR30.

Patients filled out the Work Limits Questionnaire (WLQ) at baseline and again at week 16 and week 52. The 25-question survey is a validated tool for assessing work productivity limitations in patients with chronic health problems, and it divides limitations into 4 categories: physical demands (PDS), mental demands (MDS), time management demands (TMS), and output demands (ODS). Week 16 results were calculated for the intent-to-treat population. Week 52 data were presented as observed.

At week 16, physical-demand limitations had fallen, on average, by 1.66 among APR20 patients and 2.45 among APR30 patients compared to 0.75 among placebo patients. Mental-demand limitations had fallen by 3.23 among APR20 patients and 4.83 among APR30 patients but risen by 1.29 among placebo patients. Time-management limitations had fallen by 4.64 among APR20 patients and 8.03 among APR30 patients compared to 0.88 among placebo patients. Output-demand limitations had fallen 3.97 among APR20 users and 8.26 among APR30 users but risen 0.28 among placebo users.

Overall WLQ scores, which can range anywhere from 0 (best) to 100 (worst), therefore fell by an average of 13.5 points among APR20 patients and 23.57 points among APR30 patients while they held almost exactly even among placebo patients.

At week 52, total WLQ scores fell an average of 22.05 points among APR20 patients and 29.20 points among APR30 users.

“APR20 and APR30 treatment increased work productivity and improved work limitations among patients with active psoriatic arthritis who were not adequately controlled with prior or concurrent conventional disease-modifying antirheumatic drugs and/or prior biologics,” wrote the study authors in an abstract they presented at the congress of the European League Against Rheumatism. “Improvements in productivity loss were maintained at week 52 of treatment.”

The pooled data from the 3 trials were largely consistent with productivity data from the first PALACE trial, which were presented at the last congress of the European League Against Rheumatism by investigators from Celgene Corp., which sells apremilast under the trade name Otezla.

“At Week 16, APR20 and APR30, vs. placebo, were associated with a greater mean change from baseline in PDS (-5.58 and -6.24 vs. -2.14), MDS (-2.22 and -5.18 vs. 1.15), TMS (-4.03 and -8.76 vs. -4.25), and ODS (-5.92 and -10.3 vs. -1.34), resulting in a greater mean improvement in the WLQ index (-0.01 and -0.03 vs. 0.00), which corresponds to a higher median percent improvement of productivity loss (18.9% and 24.7% vs. -3.7%).”