Artikel
Real-world effectiveness and safety of apremilast treatment in German patients with psoriatic arthritis: subgroup analysis of an ongoing multicentre, prospective, non-interventional study
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Autoren
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Jürgen Wollenhaupt
- Schön Klinik Hamburg Eilbek, Klinik für Rheumatologie und Klinische Immunologie, Hamburg
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M. A. Vollmer
- Schwerpunktpraxis Rheumatologie, Dr. Vollmer, Mönchengladbach
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Thilo Klopsch
- Rheumatologische Praxis, Neubrandenburg
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Harald Strothmeyer
- Rheumatologische Gemeinschaftspraxis Düsseldorf, Rheumatologie, Immunologie, Osteologie, Düsseldorf
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Stephan Morys
- Celgene GmbH, München
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Christian Bach
- Celgene GmbH, München
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Natalie Nunez Gomez
- Celgene GmbH, München
| Veröffentlicht: | 5. Februar 2019 |
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Gliederung
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Background: The efficacy and safety of apremilast (APR) in patients with psoriatic arthritis (PsA) have been studied in an extensive phase III clinical program. There is a paucity of data on the effectiveness and safety of APR in PsA patients in a real-world setting.
Methods: In this multicentre, prospective, non-interventional study, the primary endpoint was the proportion of patients reaching ≥1 point (≥20%) improvement from the baseline Physician’s Global Assessment of Disease Activity (PGA) score. Other endpoints were changes in tender and swollen joint counts (TJC/SJC), enthesitis, dactylitis, Patient’s Global Assessment of Disease Activity (PtGA), pain and pruritus. Reported analyses are based on observed data.
Results: Interim analysis of the first 210 patients included in the study (biologic-naïve: n=149; biologic-experienced: n=61) are reported. A total of 202 patients receiving APR for ≥4 month (Visits 0-2 [V0-V2]) were evaluated. Groups appeared to be well-balanced except for a greater proportion of females in the biologic-experienced group (Table 1 [Tab. 1]). Rapid onset of action was observed in both groups after ≈1 month (V1) and further increased until V2. A 1-point increase in PGA was observed in 54.5% of biologic-experienced and 63.4% of biologic-naïve patients after ≈1 month (V1); at V2, this improved to 67% and 80%, respectively. Relative improvements in TJC and SJC were observed (Table 2 [Tab. 2]). In patients with enthesitis at baseline, 61.1% (biologic-naïve) and 53.6% (biologic-experienced) achieved a Leeds Enthesitis Index score of 0 at V2. In patients with dactylitis at baseline, 69.7% (biologic-naïve) and 61.5% (biologic-experienced) achieved a dactylitis count of 0 at V2. Improvements were also seen in patient-reported outcomes of PtGA, overall pain and pruritus (Table 2 [Tab. 2]).
Conclusion: This subgroup analysis of the real-world PsA study suggests biologic-naïve patients with PsA may benefit from APR treatment. In patients with ≥4 months of follow-up, APR treatment in general was associated with overall improvement in physician-assessed and patient-reported outcomes. Analysis of safety and tolerability data after V2 was consistent with the known overall safety profile of APR.
