AB0758 REAL-WORLD EFFICACY AND SAFETY OF APREMILAST IN BELGIAN PATIENTS WITH PSORIATIC ARTHRITIS: FINAL ANALYSIS OF THE MULTICENTRE, PROSPECTIVE APOLO STUDY
Background: Real-world evidence on the efficacy and safety for patients (pts) with psoriatic arthritis (PsA) treated with apremilast (APR) is lacking but required to understand the uptake and potential of the drug. Objectives: To assess the efficacy and safety of APR in pts with active PsA from routine clinical practice in Belgium. Methods: In this multicentre, prospective study, the primary endpoint was the PsA Response Criteria (PsARC) response 6 months after APR initiation, defined as improvement in ≥2 (at least 1 must be joint swelling or tenderness) and no worsening in any of 4 criteria:... Mehr ...
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Dokumenttyp: | conferenceObject |
Erscheinungsdatum: | 2020 |
Verlag/Hrsg.: |
BMJ
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Schlagwörter: | Immunology / General Biochemistry / Genetics and Molecular Biology / Immunology and Allergy / Rheumatology |
Sprache: | Englisch |
Permalink: | https://search.fid-benelux.de/Record/base-26526921 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | http://hdl.handle.net/2078.1/248958 |
Background: Real-world evidence on the efficacy and safety for patients (pts) with psoriatic arthritis (PsA) treated with apremilast (APR) is lacking but required to understand the uptake and potential of the drug. Objectives: To assess the efficacy and safety of APR in pts with active PsA from routine clinical practice in Belgium. Methods: In this multicentre, prospective study, the primary endpoint was the PsA Response Criteria (PsARC) response 6 months after APR initiation, defined as improvement in ≥2 (at least 1 must be joint swelling or tenderness) and no worsening in any of 4 criteria: swollen joint count (SJC [0-66]), tender joint count (TJC [0-68]), Physician’s Global Assessment of Disease Activity and Pt’s Global Assessment of Disease Activity. Other endpoints included the 12-item PsA Impact of the Disease (PsAID12) questionnaire, Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician’s and Pt’s Numerical Rating Scale assessing disease activity for the most affected joint, psoriasis-involved body surface area, enthesitis, dactylitis and pain. Results: In total, 107 pts were enrolled and included in the baseline (BL) demographics/disease characteristics and safety analyses. The efficacy population comprised 69 pts (pts who started APR ≤30 days before inclusion in the study and completed ≥150 days of treatment). Mean age was 53 years, mean body mass index was 29 kg/m2 and 56% were female. Mean duration of PsA was ≈8 years (87.1 months). One-third of pts presented with short disease duration (time since diagnosis of PsA: ≤2 years); 84% were biologic naive. The most frequently reported comorbidities were cardiovascular disease (30%) and hypercholesterolemia (24%). At BL, mean (SD) SJC was 8.0 (6.5); mean (SD) TJC was 14.2 (12.5). Pts from the efficacy population were representative of the overall population. Fifty-four pts (60%) continued APR treatment for 6 months; 38 (36%) had discontinued APR (insufficient efficacy: n=15; adverse events [AEs]: n=16; intolerance: n=6; other reason: n=1). ...