TY - JOUR
T1 - Secukinumab in non-radiographic axial spondyloarthritis
T2 - subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT
AU - Braun, Jürgen
AU - Blanco, Ricardo
AU - Marzo-Ortega, Helena
AU - Gensler, Lianne S.
AU - van den Bosch, Filip
AU - Hall, Stephen
AU - Kameda, Hideto
AU - Poddubnyy, Denis
AU - van de Sande, Marleen
AU - Wiksten, Anna S.
AU - Porter, Brian O.
AU - Shete, Abhijit
AU - Richards, Hanno B.
AU - Haemmerle, Sibylle
AU - Deodhar, Atul
N1 - Funding Information:
The study was funded by Novartis Pharma AG, Basel, Switzerland.
Funding Information:
The authors thank the patients who participated in the study, the study investigators, and John Gallagher, Novartis Pharmaceuticals UK Limited, for the medical guidance and editorial support. HMO is supported by the National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (LBRC). The views expressed are those of the authors and not necessarily those of the (UK) National Health Service (NHS), NIHR, or (UK) Department of Health. The first draft of the manuscript was written by medical writers, employed by the study sponsor (Niladri Maity and Kamalakkannan Narasimha Naidu, senior scientific writers, Novartis Healthcare Private Limited, India), under the guidance of the authors. Statistical analyses were performed by the statisticians employed by the study sponsor (Novartis Pharma AG, Basel, Switzerland).
Funding Information:
The authors thank the patients who participated in the study, the study investigators, and John Gallagher, Novartis Pharmaceuticals UK Limited, for the medical guidance and editorial support. HMO is supported by the National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (LBRC). The views expressed are those of the authors and not necessarily those of the (UK) National Health Service (NHS), NIHR, or (UK) Department of Health. The first draft of the manuscript was written by medical writers, employed by the study sponsor (Niladri Maity and Kamalakkannan Narasimha Naidu, senior scientific writers, Novartis Healthcare Private Limited, India), under the guidance of the authors. Statistical analyses were performed by the statisticians employed by the study sponsor (Novartis Pharma AG, Basel, Switzerland).
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: To investigate the efficacy of secukinumab in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) grouped by disease activity as assessed by C-reactive protein (CRP) levels and/or magnetic resonance imaging (MRI) scores, human leukocyte antigen (HLA)-B27 status, and sex. Methods: The phase III PREVENT study randomized (1:1:1) 555 patients to receive subcutaneous secukinumab 150 mg with (LD) or without (NL) loading dose or placebo weekly, followed by every 4 weeks starting at week 4. Here, we report the results of a post hoc analysis reporting the efficacy outcomes (pooled secukinumab) to 16 weeks by CRP, MRI, HLA-B27, and sex. Results: Efficacy differences between the secukinumab and the placebo groups were highest in the CRP+, MRI+, HLA-B27+, and male subgroups, particularly for Ankylosing Spondylitis Disease Activity Score-CRP inactive disease and Assessment of SpondyloArthritis international Society (ASAS) partial remission outcomes. ASAS40 response rates in the CRP+/MRI+ subgroup was 52.3% (secukinumab) versus 21.8% (placebo; P < 0.0001) at week 16. ASAS40 response rates (secukinumab versus placebo) were 43.9% versus 32.6% in HLA-B27+, 32.7% versus 16.4% in HLA-B27− subgroups, 51.2% versus 30.8% in male, and 31.7% versus 25.3% in female patients, respectively. Conclusions: Secukinumab improved the signs and symptoms of nr-axSpA across patients grouped by CRP (+/−) and/or MRI (+/−) status, HLA-B27 (+/−) status, and sex. The highest treatment differences between secukinumab and placebo were observed in patients with both elevated CRP and evidence of sacroiliitis on MRI. Treatment difference was minimal between HLA-B27 (+) and (−) subgroups. Male patients had higher relative responses than female patients. Trial registration: ClinicalTrials.gov, NCT02696031.
AB - Background: To investigate the efficacy of secukinumab in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) grouped by disease activity as assessed by C-reactive protein (CRP) levels and/or magnetic resonance imaging (MRI) scores, human leukocyte antigen (HLA)-B27 status, and sex. Methods: The phase III PREVENT study randomized (1:1:1) 555 patients to receive subcutaneous secukinumab 150 mg with (LD) or without (NL) loading dose or placebo weekly, followed by every 4 weeks starting at week 4. Here, we report the results of a post hoc analysis reporting the efficacy outcomes (pooled secukinumab) to 16 weeks by CRP, MRI, HLA-B27, and sex. Results: Efficacy differences between the secukinumab and the placebo groups were highest in the CRP+, MRI+, HLA-B27+, and male subgroups, particularly for Ankylosing Spondylitis Disease Activity Score-CRP inactive disease and Assessment of SpondyloArthritis international Society (ASAS) partial remission outcomes. ASAS40 response rates in the CRP+/MRI+ subgroup was 52.3% (secukinumab) versus 21.8% (placebo; P < 0.0001) at week 16. ASAS40 response rates (secukinumab versus placebo) were 43.9% versus 32.6% in HLA-B27+, 32.7% versus 16.4% in HLA-B27− subgroups, 51.2% versus 30.8% in male, and 31.7% versus 25.3% in female patients, respectively. Conclusions: Secukinumab improved the signs and symptoms of nr-axSpA across patients grouped by CRP (+/−) and/or MRI (+/−) status, HLA-B27 (+/−) status, and sex. The highest treatment differences between secukinumab and placebo were observed in patients with both elevated CRP and evidence of sacroiliitis on MRI. Treatment difference was minimal between HLA-B27 (+) and (−) subgroups. Male patients had higher relative responses than female patients. Trial registration: ClinicalTrials.gov, NCT02696031.
KW - Biologicals
KW - C-reactive protein
KW - Gender
KW - Human leukocyte antigen B27
KW - Interleukins
KW - Magnetic resonance imaging
KW - Non-radiographic axial spondyloarthritis
UR - http://www.scopus.com/inward/record.url?scp=85114297491&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85114297491&partnerID=8YFLogxK
U2 - 10.1186/s13075-021-02613-9
DO - 10.1186/s13075-021-02613-9
M3 - Article
C2 - 34481517
AN - SCOPUS:85114297491
SN - 1478-6354
VL - 23
JO - Arthritis Research and Therapy
JF - Arthritis Research and Therapy
IS - 1
M1 - 231
ER -