Seculdnumab efficacy in psoriatic arthritis: individual patient meta analysis of four phase 3 trials in 2049 patients

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Gottlieb, A
Mease, P
Kirkham, B
Nash, P
Balsa, A
Combe, B
Rech, J
Ruvie, M
Ligozio, G
Abrams, K
Pricop, L
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2019
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Paris, France

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Abstract

Background: Secukinumab (Sec) provided rapid, significant and sustained improvement in the signs and symptoms of psoriatic arthritis (PsA) in multiple Phase 3 studies.1‐4

Objectives: To report individual patient meta‐analysis data for Sec on achievement of high hurdle efficacy endpoints versus placebo (PBO) at Week (Wk) 16 in patients (pts) with PsA from four Phase 3 studies: FUTURE 2, 3, 4 and 5. Analyses in subgroups by baseline (BL) disease activity, BL psoriasis, prior Anti–TNF and concomitant Methotrexate (MTX) use were also evaluated.

Methods: Overall, 397, 414, 341, and 996 pts with active PsA were randomized in FUTURE 2, 3, 4, and 5 studies, respectively. Sec doses included subcutaneous 300 mg and 150 mg administered at BL with loading doses (LD) at Wks 1, 2, and 3, followed by maintenance dose every 4 wks (q4w) starting at Wk 4. Data collected up to Wk 16 were pooled. Assessments included: ACR 50/70, PASI90 responses, PASDAS‐Low Disease Activity (PASDAS‐LDA), and Minimal Disease Activity (MDA) in overall population. ACR 50/70 and PASI 90 responses by BL Disease Activity Score (DAS) 28‐C‐Reactive Protein (CRP) (≤5.1 and > 5.1), BL CRP (≤10 mg/L and > 10 mg/L), BL Body Surface Area (BSA) (≥3%–<10%, and ≥ 10%) with psoriasis and prior Anti–TNF and concomitant MTX use were also assessed. Results are reported after application of non‐responder imputation.

Results: 2049 pts were included in the meta‐analysis (461, 572, 335, and 681 pts received Sec 300 mg, 150 mg, 150 mg without LD and PBO, respectively). Improvements were observed with Sec (300 mg, 150 mg, and 150 mg without LD) vs PBO for all endpoints at Wk 16 in the overall population (Table) and in all subgroups (data not shown). Sec 300 mg was associated with greater improvements compared to the 150 mg dose for all endpoints in overall population and in subgroups.

Conclusions: Sec provided improvements in high hurdle efficacy endpoints in pts with active PsA in the overall population and in subgroups with various levels of BL disease activity and psoriasis.

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Journal of the European Academy of Dermatology and Venereology

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33

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S3

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Clinical sciences

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Life Sciences & Biomedicine

Dermatology

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Gottlieb, A; Mease, P; Kirkham, B; Nash, P; Balsa, A; Combe, B; Rech, J; Ruvie, M; Ligozio, G; Abrams, K; Pricop, L, Seculdnumab efficacy in psoriatic arthritis: individual patient meta analysis of four phase 3 trials in 2049 patients, Journal of the European Academy of Dermatology and Venereology, 2019, 33 (S3), pp. 83-84