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Observational Study
. 2024 Jul 15:15:1435599.
doi: 10.3389/fimmu.2024.1435599. eCollection 2024.

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

Roberta Ramonda #  1 , Mariagrazia Lorenzin #  1 , Maria Sole Chimenti  2 , Salvatore D'Angelo  3 , Antonio Marchesoni  4 , Carlo Selmi  5   6 , Ennio Lubrano  7 , Leonardo Santo  8 , Michele Maria Luchetti Gentiloni  9 , Fabiola Atzeni  10 , Alberto Cauli  11 , Maria Manara  12 , Maurizio Rossini  13 , Roberta Foti  14 , Giacomo Cozzi  1 , Laura Scagnellato  1 , Mario Ferraioli  2 , Antonio Carriero  3 , Nicoletta Luciano  5   6 , Francesca Ruzzon  13 , Mauro Fatica  2 , Elena Fracassi  13 , Andrea Doria  1 , Rosario Foti  14 , Antonio Carletto  13
Affiliations
Observational Study

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

Roberta Ramonda et al. Front Immunol. .

Abstract

Objectives: This 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).

Methods: Consecutive 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.

Results: We 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.

Conclusions: Secukinumab 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.

Keywords: IL17i drug retention rate; IL17i effectiveness; IL17i safety; axial spondyloarthritis; r-axSpA/nr-axSpA biological therapy; secukinumab (IL17i).

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Conflict of interest statement

RR has received honoraria and speaker fees from Novartis, Abbvie, Pfizer, MSD, and Janssen. CS has received consulting/speaker fees from AbbVie, Amgen, Alfa-Sigma, Biogen, Eli-Lilly, EUSA Pharma - Recordati, Galapagos, Janssen, Novartis, Octapharma, Pfizer, Recordati Rare Disease, SOBI and research support from AbbVie, Amgen, Janssen, Novartis, Pfizer. AM has received honoraria and speaker fees from Abbvie, Pfizer, MSD, UCB, Novartis, Janssen, and Eli-Lilly. LeS has received speaker fees from Jansen, Novartis, Pfizer, UCB, MSD, and Sanofi. AD has received honoraria and speaker fees from Novartis, AbbVie, Pfizer, MSD, Janssen.AC has received speaker fees from Novartis, Abbvie, Eli-Lilly and Janssen. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
(A–F) BASDAI <4 (percentage, %) of the overall study population and after their subdivision in two groups according to lines of biological treatment (LoBT) (naïve/non-naïve) (A), axSpA subtype (r-axSpA/nr-axSpA) (B), and sex (male/female) (C). BASDAI <2 (percentage, %) of the overall study population and after their subdivision in two groups according to lines of biological treatment (LoBT) (naïve/non-naïve) (D), axSpA subtype (r-axSpA/nr-axSpA) (E), and sex (male/female) (F).
Figure 2
Figure 2
(A–F) ASDAS <2.1 (percentage, %) of the overall study population and after their subdivision in two groups according to lines of biological treatment (LoBT) (naïve/non-naïve) (A), axSpA subtype (r-axSpA/nr-axSpA) (B), and sex (male/female) (C). ASDAS <1.3 (percentage, %) of the overall study population and after their subdivision in two groups according to lines of biological treatment (LoBT) (naïve/non-naïve) (D), axSpA subtype (r-axSpA/nr-axSpA) (E), and sex (male/female) (F).
Figure 3
Figure 3
(A–I) Drug survival in the overall study population and after their subdivision in two groups, according to lines of biological treatment (LoBT) (naïve/non-naïve) (A), axSpA subtype (r-axSpA/nr-axSpA) (B), sex (male/female) (C), age (>50 years old vs <50 years old) (D), disease duration (<5 years vs. >5 years) (E), HLA B27 (presence vs. absence) (F), active sacroiliitis on MRI (patients with MRI-SIJ+ vs. patients without MRI SIJ+) (G), smoking (yes vs. no) (H) and peripheral involvement (patients with peripheral arthritis vs. patients without peripheral arthritis (I).
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References

    1. Braun J, Sieper J. Ankylosing spondylitis. Lancet. (2007) 369:1379–90. doi: 10.1016/S0140-6736(07)60635-7 - DOI - PubMed
    1. Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet. (2017) 390:73–84. doi: 10.1016/S0140-6736(16)31591-4 - DOI - PubMed
    1. Braun J, Sieper J. Fifty years after the discovery of the association of HLA B27 with ankylosing spondylitis. RMD Open. (2023) 9:e003102. doi: 10.1136/rmdopen-2023-003102 - DOI - PMC - PubMed
    1. Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, et al. . The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. (2009) 68:777–83. doi: 10.1136/ard.2009.108233 - DOI - PubMed
    1. Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, Baraliakos X, et al. . ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. (2023) 82:19–34. doi: 10.1136/ard-2022-223296 - DOI - PubMed

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