Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a 52-week real-life study in an Italian cohort

Colella, F. Molica; Zizzo, Gaetano; Parrino, Vincenzo; Filosa, Maria Teresa; Cavaliere, Riccardo; Fazio, Francesco; Colella, Aldo Biagio Molica; Mazzone, Antonino

doi:10.1186/s42358-023-00295-2

Cited by 7 publications

(8 citation statements)

References 51 publications

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“…Our findings demonstrated a high probability of secukinumab retention that is consistent with previous reports ( 34 , 39 , 40 , 46 , 49 , 61–63 ). The 12-month persistence rate was very similar to that obtained in EuroSpA study and the BIOBADASER Spanish registry ( 34 , 39 ).…”

Section: Discussionsupporting

confidence: 93%

“…On the contrary, an analysis of the Spanish BIOBADASER registry (two of the 28 participating centers overlap with the present study; N = 350) reported a slightly higher 2-year remission rate (77%) but with an almost identical change from baseline ( 39 ). Similarly, in a recent real-life study, Molica Colella et al also observed that, in a population ( N = 56) that was largely naive to bDMARDs, 68% of patients achieved remission (DAS28-CRP < 2.6) by week 52 of secukinumab treatment ( 40 ).…”

Section: Discussionmentioning

confidence: 86%

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Real-world effectiveness and persistence of secukinumab in the treatment of patients with psoriatic arthritis

Alegre-Sancho,

Núñez-Monje,

Campos-Fernández

et al. 2023

Front. Med.

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IntroductionPsoriatic arthritis (PsA) is a complex and heterogeneous inflammatory disease. Secukinumab, a biologic disease-modifying antirheumatic drug (bDMARD), has extensive clinical evidence of efficacy and safety in the treatment of PsA but data in clinical practice are still limited. This study aims to provide real-world evidence on secukinumab use, effectiveness, and persistence in PsA.MethodsA retrospective, multicenter study was conducted on patients diagnosed with PsA and treated with secukinumab up to June 2021 at 12 centers in the Valencian Community (Spain). Data on DAS28-CRP, DAPSA, Tender and Swollen Joint Counts (TJC, SJC), enthesitis, dactylitis, skin and nail involvement, pain, patient and physician global assessment (ptGA, phGA) using 100-mm visual analog scale (VAS), and persistence for up to 24 months were collected.ResultsA total of 178 patients were included (49% men; mean [standard deviation, SD] age: 51.4 [10.5] years; 39% obese). Secukinumab was used as a first-, second-, or ≥ third-line bDMARD in 37, 21, and 42% of patients, respectively. The percentage of patients achieving at least low disease activity (DAS28-CRP ≤ 3.2) increased from 25% at baseline to 66% at month 6 (M6) and was maintained (75%) up to M24. Mean (SD) DAS28-CRP baseline values (3.9 [1.2]) decreased to 2.9 (1.1) (p < 0.001) at M6 and remained low through M24 (2.6 [1.1]) (p < 0.001). Secukinumab also improved peripheral arthritis increasing the percentage of patients with TJC = 0 (20% baseline; 57% M24) and SJC = 0 (37% baseline; 80% M24). Treatment reduced the percentage of patients with enthesitis (25% baseline; 6% M24), dactylitis (20% baseline; 4% M24), and skin (70% baseline; 17% M24), and nail (32% baseline; 2% M24) involvement. Additionally, we observed improvements in the mean pain VAS (−26.4 mm M24), ptGA (−26.2 mm M24), and phGA (−24.8 mm M24). Secukinumab showed an overall 24-month persistence rate of 67% (95% confidence interval [CI]: 60–74%). Patients receiving first-line secukinumab showed the highest 24-month persistence rate (83, 95% CI: 73–92; p = 0.024).ConclusionSecukinumab showed long-term effectiveness across the six key PsA domains thus reducing disease activity and pain, which are major treatment goals. This was accompanied by high persistence rates, especially in bDMARD naive patients.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 86%

Real-world effectiveness and persistence of secukinumab in the treatment of patients with psoriatic arthritis

Alegre-Sancho,

Núñez-Monje,

Campos-Fernández

et al. 2023

Front. Med.

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“…Real-world evidence is gradually emerging from observational data, surveys, and registries ( 31 – 36 ). Our study contributes to the body of evidence, aligning with recent real-life Italian studies published on AS and axSpA ( 27 – 30 ).…”

Section: Discussionsupporting

confidence: 88%

“…In the context of axSpA, other RWE studies have investigated the effectiveness and safety of secukinumab in a real-life setting both in Italian ( 27 – 30 ) and international cohorts ( 31 – 36 ), even in comparison with TNFi ( 9 , 10 , 31 , 32 ), but only for a limited observational period. In addition, the impact of different lines of bDMARDs treatment (LoBT), axSpA subtype, and sex on the achievement of clinical remission and on secukinumab drug survival has not yet been fully investigated ( 28 , 29 ).…”

Section: Introductionmentioning

confidence: 99%

Four-year real-world experience of secukinumab in a large Italian cohort of axial spondyloarthritis

Ramonda,

Lorenzin,

Chimenti

et al. 2024

Front. Immunol.

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ObjectivesThis study aims to evaluate in a real-life Italian multicenter cohort of axial spondyloarthritis (axSpA) (1) the 4-year effectiveness and safety of secukinumab, (2) the drug retention rate (DRR), and (3) the impact of the line of bDMARDs treatment, subtype of axSpA, and sex on achieving low disease activity (LDA) and very low disease activity (VLDA).MethodsConsecutive axSpA patients receiving secukinumab between 2016 and 2023 were prospectively evaluated. Data on disease characteristics, previous/ongoing treatments, comorbidities, and follow-up duration were collected. Treatment response was evaluated at 6 and 12 months after initiation and yearly up to 48 months (T48). DRR and effectiveness outcomes were evaluated according to bDMARDs treatment, axSpA subtype, and sex. Infections and adverse events (AEs) were recorded.ResultsWe enrolled 272 patients (48.2% male; median age, 51; 39.7% HLA-B27+; 40.4% nr-axSpA), of whom 30.9% were naïve to secukinumab. Overall, secukinumab yielded improvement in effectiveness outcomes; the naïve patients maintained lower disease activity vs. the non-naïve ones. At T48, the LDA and VLDA rates were higher in naïve patients and in male individuals. Treatment was discontinued in 104 patients due to primary/secondary loss of effectiveness and in 34 patients due to AEs. The DRR at T48 was 67.4% in the whole population, regardless of treatment line, axSpA subtype, and sex.ConclusionsSecukinumab was safe and effective in all axSpA patients irrespective of treatment line, disease subtype, and sex. The patients achieved sustained 4-year remission and DRR.

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“… 7 Although IL-17A blockade has been greatly effective, remission is achieved in only a portion of AS patients (~65.5%). 8 These data suggest that AS pathogenesis can be driven by multiple disease mechanisms including those that are Th17-dependent and those that are Th17-independent.…”

Section: Introductionmentioning

confidence: 88%

Card9/neutrophil signalling axis promotes IL-17A-mediated ankylosing spondylitis

Rosenzweig,

Vance,

Asare-Konadu

et al. 2023

Ann Rheum Dis

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ObjectivePolymorphisms in the antifungal signalling moleculeCARD9are associated with ankylosing spondylitis (AS). Here, we investigated the cellular mechanism by which CARD9 controls pathogenic Th17 responses and the onset of disease in both experimental murine AS and patients.MethodsExperiments in SKG, Card9−/−SKG, neutrophil-deplete SKG mice along within vitromurine, neutrophil and CD4+T cell cocultures examined Card9 function in neutrophil activation, Th17 induction and arthritis in experimental AS. In AS patients the neutrophil: Bath Ankylosing Spondylitis Functional Index relationship was analysed.In vitrostudies with autologous neutrophil: T cell cocultures examined endogenous CARD9 versus the AS-associated variant (rs4075515) of CARD9 in T cellular production of IL-17A.ResultsCard9 functioned downstream of Dectin-1 and was essential for induction of Th17 cells, arthritis and spondylitis in SKG mice. Card9 expression within T cells was dispensable for arthritis onset in SKG mice. Rather, Card9 expression controlled neutrophil function; and neutrophils in turn, were responsible for triggering Th17 expansion and disease in SKG mice. Mechanistically, cocultures of zymosan prestimulated neutrophils and SKG T cells revealed a direct cellular function for Card9 within neutrophils in the potentiation of IL-17 production by CD4+T cells on TCR-ligation. The clinical relevance of the neutrophil-Card9-coupled mechanism in Th17-mediated disease is supported by a similar observation in AS patients. Neutrophils from HLA-B27+AS patients expanded autologous Th17 cellsin vitro, and the AS-associated CARD9S12Nvariant increased IL-17A.ConclusionsThese data reveal a novel neutrophil-intrinsic role for Card9 in arthritogenic Th17 responses and AS pathogenesis. These data provide valuable utility in our future understanding of CARD9-specific mechanisms in spondyloarthritis .

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Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a 52-week real-life study in an Italian cohort

Cited by 7 publications

References 51 publications

Real-world effectiveness and persistence of secukinumab in the treatment of patients with psoriatic arthritis

Real-world effectiveness and persistence of secukinumab in the treatment of patients with psoriatic arthritis

Four-year real-world experience of secukinumab in a large Italian cohort of axial spondyloarthritis

Card9/neutrophil signalling axis promotes IL-17A-mediated ankylosing spondylitis

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