Brodalumab, an anti-interleukin-17 receptor A monoclonal antibody, in axial spondyloarthritis : 68-week results from a phase 3 study
© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology..
OBJECTIVE: To evaluate the long-term efficacy and safety of brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, in patients with axial spondyloarthritis (axSpA).
METHODS: Patients receiving subcutaneous brodalumab 210 mg during the 16-week double-blind period of this multicentre, phase 3 study conducted across Japan, Korea and Taiwan continued the same during the 52-week open-label extension, whereas patients receiving placebo switched to brodalumab 210 mg at week 16. Efficacy [Assessment of SpondyloArthritis International Society (ASAS) 40 and ASAS 20 response rates; change from baseline in AS Disease Activity Score using CRP (ASDAS-CRP)] and safety were evaluated.
RESULTS: Overall, 145 patients (brodalumab, n = 77; placebo, n = 68) received brodalumab during the open-label extension. ASAS 40 response rates (95% CI) of 56.3% (44.7%, 67.3%) and 57.4% (44.1%, 70.0%) were achieved in the brodalumab and placebo groups, respectively, at week 68. ASAS 20 response rates (95% CI) achieved at week 68 in both treatment groups were similar [brodalumab, 71.3% (60.0%, 80.8%); placebo, 78.7% (66.3%, 88.1%)]. The least squares mean change (95% CI) in ASDAS-CRP at week 68 suggested a clinically important improvement (change, ≥1.1) in both treatment groups [brodalumab, -1.528 (-1.737, -1.319); placebo, -1.586 (-1.815, -1.357)]. The exposure-adjusted event rates (per 100 patient-years) for treatment-emergent adverse events (TEAEs) and drug-related TEAEs were 255.9 and 147.9, respectively; nasopharyngitis (35.6) and upper respiratory tract infection (14.7) were the most common TEAEs.
CONCLUSIONS: Brodalumab demonstrated sustained efficacy and a consistent safety profile in patients with axSpA over 68 weeks.
STUDY REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02985983.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:62 |
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| Enthalten in: |
Rheumatology (Oxford, England) - 62(2023), 5 vom: 02. Mai, Seite 1851-1859 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kim, Tae-Hwan [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 03.05.2023 Date Revised 04.05.2023 published: Print ClinicalTrials.gov: NCT02985983 Citation Status MEDLINE |
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| doi: |
10.1093/rheumatology/keac522 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM346466997 |
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| 100 | 1 | |a Kim, Tae-Hwan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Brodalumab, an anti-interleukin-17 receptor A monoclonal antibody, in axial spondyloarthritis |b 68-week results from a phase 3 study |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 03.05.2023 | ||
| 500 | |a Date Revised 04.05.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT02985983 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. | ||
| 520 | |a OBJECTIVE: To evaluate the long-term efficacy and safety of brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, in patients with axial spondyloarthritis (axSpA) | ||
| 520 | |a METHODS: Patients receiving subcutaneous brodalumab 210 mg during the 16-week double-blind period of this multicentre, phase 3 study conducted across Japan, Korea and Taiwan continued the same during the 52-week open-label extension, whereas patients receiving placebo switched to brodalumab 210 mg at week 16. Efficacy [Assessment of SpondyloArthritis International Society (ASAS) 40 and ASAS 20 response rates; change from baseline in AS Disease Activity Score using CRP (ASDAS-CRP)] and safety were evaluated | ||
| 520 | |a RESULTS: Overall, 145 patients (brodalumab, n = 77; placebo, n = 68) received brodalumab during the open-label extension. ASAS 40 response rates (95% CI) of 56.3% (44.7%, 67.3%) and 57.4% (44.1%, 70.0%) were achieved in the brodalumab and placebo groups, respectively, at week 68. ASAS 20 response rates (95% CI) achieved at week 68 in both treatment groups were similar [brodalumab, 71.3% (60.0%, 80.8%); placebo, 78.7% (66.3%, 88.1%)]. The least squares mean change (95% CI) in ASDAS-CRP at week 68 suggested a clinically important improvement (change, ≥1.1) in both treatment groups [brodalumab, -1.528 (-1.737, -1.319); placebo, -1.586 (-1.815, -1.357)]. The exposure-adjusted event rates (per 100 patient-years) for treatment-emergent adverse events (TEAEs) and drug-related TEAEs were 255.9 and 147.9, respectively; nasopharyngitis (35.6) and upper respiratory tract infection (14.7) were the most common TEAEs | ||
| 520 | |a CONCLUSIONS: Brodalumab demonstrated sustained efficacy and a consistent safety profile in patients with axSpA over 68 weeks | ||
| 520 | |a STUDY REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02985983 | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
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| 650 | 4 | |a IL-17 receptor A | |
| 650 | 4 | |a brodalumab | |
| 650 | 4 | |a non-radiographic axial spondyloarthritis | |
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| 700 | 1 | |a Kobayashi, Shigeto |e verfasserin |4 aut | |
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