gms | German Medical Science

Background: Long-term apremilast (APR) treatment is being assessed in patients with active psoriatic arthritis (PsA) in routine clinical practice in Germany.

Methods: In this multicentre, prospective, non-interventional study, the primary endpoint was the proportion of patients reaching ≥20% (≥1 point) improvement from baseline in Physician Global Assessment of Disease Activity Score (PGA). Other endpoints included effects on enthesitis, swollen / tender joint counts, Patient Global Assessment of Disease Activity (100-mm visual analogue scale [VAS]), and pruritus. Unique data were generated accross multiple disease aspects using the Psoriatic Arthritis Impact of Disease Tool (PsAID), German "Funktionsfragebogen Hannover," and Patient Preference Questionnaire.

Results: The first 111 of a planned 500 patients received APR for ≥4 months (Visits 0-2 [V0-V2]). Mean age was 54 years, mean body mass index was 30 kg / m², and 62% were female; mean psoriasis history was 27 years and mean PsA history was 18 years. Mean ± SD baseline PGA was 2.5 ± 0.57. One third were biologic-experienced. After ∼1 month (V1), 62.5% achieved improvement in PGA ≥1 point, which increased to 77.8% (V2). Mean PGA decreased to 1.6 ± 0.70 (V1) and 1.3 ± 0.72 (V2). Achievement of PGA=0 or 1 increased from 0%of patients at baseline to 39.6% (V1) and 64.7% (V2). At baseline, 50.5% had enthesitis; 45% reached Leeds Enthesitis Index = 0 by V1, which increased to 64% (V2). Mean baseline pruritus score was 36.1 mm (100 mm VAS); mean reductions were 31% (V1) and 44% (V2). At V0, mean PsAID score was 5.3 (maximum = 10), which decreased to 4.4 (V1) and 3, 7 (V2). Preliminary tolerability analysis was consistent with known data for APR; safety reports were consistent with the known overall safety profile.

Conclusion: These data, the first from a large non-interventional PsA study of APR in routine clinical practice in Germany, reinforce previous clinical trial results. New APR and PsA treatment data were generated using unique, PsA assessment tools. Physicians and patients assessed therapeutic success of APR similarly; high patient satisfaction with APR supports the trend towards a holistic evaluation of treatment efficacy beyond ACR response.