Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis
Abstract Background Radiographic progression and course of inflammation over 2 years in patients with non-radiographic axial spondyloarthritis (nr-axSpA) from the phase 3, randomized, PREVENT study are reported here. Methods In the PREVENT study, adult patients fulfilling the Assessment of SpondyloA...
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| Format: | Article |
| Language: | English |
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BMC
2023-05-01
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| Series: | Arthritis Research & Therapy |
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| Online Access: | https://doi.org/10.1186/s13075-023-03051-5 |
| _version_ | 1797822768305143808 |
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| author | Juergen Braun Ricardo Blanco Helena Marzo-Ortega Lianne S. Gensler Filip Van den Bosch Stephen Hall Hideto Kameda Denis Poddubnyy Marleen van de Sande Désirée van der Heijde Tingting Zhuang Anna Stefanska Aimee Readie Hanno B. Richards Atul Deodhar |
| author_facet | Juergen Braun Ricardo Blanco Helena Marzo-Ortega Lianne S. Gensler Filip Van den Bosch Stephen Hall Hideto Kameda Denis Poddubnyy Marleen van de Sande Désirée van der Heijde Tingting Zhuang Anna Stefanska Aimee Readie Hanno B. Richards Atul Deodhar |
| author_sort | Juergen Braun |
| collection | DOAJ |
| description | Abstract Background Radiographic progression and course of inflammation over 2 years in patients with non-radiographic axial spondyloarthritis (nr-axSpA) from the phase 3, randomized, PREVENT study are reported here. Methods In the PREVENT study, adult patients fulfilling the Assessment of SpondyloArthritis International Society classification criteria for nr-axSpA with elevated CRP and/or MRI inflammation received secukinumab 150 mg or placebo. All patients received open-label secukinumab from week 52 onward. Sacroiliac (SI) joint and spinal radiographs were scored using the modified New York (mNY) grading (total sacroiliitis score; range, 0–8) and modified Stoke Ankylosing Spondylitis Spine Score (mSASSS; range, 0–72), respectively. SI joint bone marrow edema (BME) was assessed using the Berlin Active Inflammatory Lesions Scoring (0–24) and spinal MRI using the Berlin modification of the AS spine MRI (ASspiMRI) scoring (0–69). Results Overall, 78.9% (438/555) of patients completed week 104 of the study. Over 2 years, minimal changes were observed in total radiographic SI joint scores (mean [SD] change, − 0.04 [0.49] and 0.04 [0.36]) and mSASSS scores (0.04 [0.47] and 0.07 [0.36]) in the secukinumab and placebo-secukinumab groups. Most of the patients showed no structural progression (increase ≤ smallest detectable change) in SI joint score (87.7% and 85.6%) and mSASSS score (97.5% and 97.1%) in the secukinumab and placebo-secukinumab groups. Only 3.3% (n = 7) and 2.9% (n = 3) of patients in the secukinumab and placebo-secukinumab groups, respectively, who were mNY-negative at baseline were scored as mNY-positive at week 104. Overall, 1.7% and 3.4% of patients with no syndesmophytes at baseline in the secukinumab and placebo-secukinumab group, respectively, developed ≥ 1 new syndesmophyte over 2 years. Reduction in SI joint BME observed at week 16 with secukinumab (mean [SD], − 1.23 [2.81] vs − 0.37 [1.90] with placebo) was sustained through week 104 (− 1.73 [3.49]). Spinal inflammation on MRI was low at baseline (mean score, 0.82 and 1.07 in the secukinumab and placebo groups, respectively) and remained low (mean score, 0.56 at week 104). Conclusion Structural damage was low at baseline and most patients showed no radiographic progression in SI joints and spine over 2 years in the secukinumab and placebo-secukinumab groups. Secukinumab reduced SI joint inflammation, which was sustained over 2 years. Trial registration ClinicalTrials.gov, NCT02696031. |
| first_indexed | 2024-03-13T10:14:02Z |
| format | Article |
| id | doaj.art-ded6f481e2124265b7316b8ec19b458f |
| institution | Directory Open Access Journal |
| issn | 1478-6362 |
| language | English |
| last_indexed | 2024-03-13T10:14:02Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Arthritis Research & Therapy |
| spelling | doaj.art-ded6f481e2124265b7316b8ec19b458f2023-05-21T11:22:36ZengBMCArthritis Research & Therapy1478-63622023-05-0125111210.1186/s13075-023-03051-5Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritisJuergen Braun0Ricardo Blanco1Helena Marzo-Ortega2Lianne S. Gensler3Filip Van den Bosch4Stephen Hall5Hideto Kameda6Denis Poddubnyy7Marleen van de Sande8Désirée van der Heijde9Tingting Zhuang10Anna Stefanska11Aimee Readie12Hanno B. Richards13Atul Deodhar14Department of Rheumatology, Ruhr-University BochumDivision of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVALNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, LIRMM, University of LeedsUniversity of California, San FranciscoDepartment of Internal Medicine and Pediatrics, Ghent UniversityDepartment of Medicine, Monash UniversityToho UniversityGerman Rheumatism Research Centre, Charité - Universitätsmedizin BerlinAmsterdam Rheumatology and Immunology Center, Amsterdam UMC, University of AmsterdamLeiden University Medical CenterNovartis Pharmaceuticals CorporationNovartis Ireland LimitedNovartis Pharmaceuticals CorporationNovartis Pharma AGOregon Health & Science University, Division of Arthritis and Rheumatic DiseasesAbstract Background Radiographic progression and course of inflammation over 2 years in patients with non-radiographic axial spondyloarthritis (nr-axSpA) from the phase 3, randomized, PREVENT study are reported here. Methods In the PREVENT study, adult patients fulfilling the Assessment of SpondyloArthritis International Society classification criteria for nr-axSpA with elevated CRP and/or MRI inflammation received secukinumab 150 mg or placebo. All patients received open-label secukinumab from week 52 onward. Sacroiliac (SI) joint and spinal radiographs were scored using the modified New York (mNY) grading (total sacroiliitis score; range, 0–8) and modified Stoke Ankylosing Spondylitis Spine Score (mSASSS; range, 0–72), respectively. SI joint bone marrow edema (BME) was assessed using the Berlin Active Inflammatory Lesions Scoring (0–24) and spinal MRI using the Berlin modification of the AS spine MRI (ASspiMRI) scoring (0–69). Results Overall, 78.9% (438/555) of patients completed week 104 of the study. Over 2 years, minimal changes were observed in total radiographic SI joint scores (mean [SD] change, − 0.04 [0.49] and 0.04 [0.36]) and mSASSS scores (0.04 [0.47] and 0.07 [0.36]) in the secukinumab and placebo-secukinumab groups. Most of the patients showed no structural progression (increase ≤ smallest detectable change) in SI joint score (87.7% and 85.6%) and mSASSS score (97.5% and 97.1%) in the secukinumab and placebo-secukinumab groups. Only 3.3% (n = 7) and 2.9% (n = 3) of patients in the secukinumab and placebo-secukinumab groups, respectively, who were mNY-negative at baseline were scored as mNY-positive at week 104. Overall, 1.7% and 3.4% of patients with no syndesmophytes at baseline in the secukinumab and placebo-secukinumab group, respectively, developed ≥ 1 new syndesmophyte over 2 years. Reduction in SI joint BME observed at week 16 with secukinumab (mean [SD], − 1.23 [2.81] vs − 0.37 [1.90] with placebo) was sustained through week 104 (− 1.73 [3.49]). Spinal inflammation on MRI was low at baseline (mean score, 0.82 and 1.07 in the secukinumab and placebo groups, respectively) and remained low (mean score, 0.56 at week 104). Conclusion Structural damage was low at baseline and most patients showed no radiographic progression in SI joints and spine over 2 years in the secukinumab and placebo-secukinumab groups. Secukinumab reduced SI joint inflammation, which was sustained over 2 years. Trial registration ClinicalTrials.gov, NCT02696031.https://doi.org/10.1186/s13075-023-03051-5Axial spondyloarthritisNon-radiographic axial spondyloarthritisNr-axSpASecukinumabX-rayRadiograph |
| spellingShingle | Juergen Braun Ricardo Blanco Helena Marzo-Ortega Lianne S. Gensler Filip Van den Bosch Stephen Hall Hideto Kameda Denis Poddubnyy Marleen van de Sande Désirée van der Heijde Tingting Zhuang Anna Stefanska Aimee Readie Hanno B. Richards Atul Deodhar Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis Arthritis Research & Therapy Axial spondyloarthritis Non-radiographic axial spondyloarthritis Nr-axSpA Secukinumab X-ray Radiograph |
| title | Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis |
| title_full | Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis |
| title_fullStr | Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis |
| title_full_unstemmed | Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis |
| title_short | Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis |
| title_sort | two year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non radiographic axial spondyloarthritis |
| topic | Axial spondyloarthritis Non-radiographic axial spondyloarthritis Nr-axSpA Secukinumab X-ray Radiograph |
| url | https://doi.org/10.1186/s13075-023-03051-5 |
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