Maintenance of remission of ANCA vasculitis by rituximab based on B cell repopulation versus serological flare : a randomised trial
© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ..
OBJECTIVE: To compare two long-term remission maintenance strategies for antineutrophil cytoplasmic antibody (ANCA) vasculitis.
METHODS: We conducted a prospective, single-centre, open-label, randomised controlled trial of patients with ANCA vasculitis in remission after completing at least 2 years of fixed-schedule rituximab. In the B cell arm, rituximab was reinfused upon B cell repopulation; in the ANCA arm, rituximab was reinfused upon significant rise in ANCA level. Evaluations were conducted every 3 months. The primary endpoint was clinical relapse, defined as a modified BVAS/WG >0 by 36 months. Secondary endpoints included serious adverse events (SAEs) and rituximab exposure.
RESULTS: 115 patients were enrolled. Median follow-up time was 4.1 years (IQR 2.5-5.0). By Kaplan-Meier analysis, 4.1% (95% CI 1.0 to 15.6) of patients had a clinical relapse in the B cell arm, compared with 20.5% (95% CI 11.9 to 34.1) in the ANCA arm, at 3 years after study entry (log-rank p=0.045). Total SAEs, including infectious SAEs, and deaths did not differ. The number of SAEs due to COVID-19 was higher in the B cell arm (p=0.049). In the B cell arm, patients received a mean of 3.6 (SD 2.4) infusions (3.6 g) per person over the median study follow-up time of 4.1 years, compared with 0.5 (SD 1.4) infusions (0.5 g) per patient in the ANCA arm (p<0.001).
CONCLUSIONS: Rituximab dosed for B cell repopulation results in fewer clinical relapses than when dosed for a rise in ANCA level in maintenance of remission for ANCA vasculitis. Overall safety was equivalent; SAEs due to COVID-19 and rituximab exposure were higher with the B cell strategy.
TRIAL REGISTRATION NUMBER: NCT02749292.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:83 |
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| Enthalten in: |
Annals of the rheumatic diseases - 83(2024), 3 vom: 15. Feb., Seite 351-359 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zonozi, Reza [VerfasserIn] |
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| Links: |
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| Themen: |
4F4X42SYQ6 |
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| Anmerkungen: |
Date Completed 19.02.2024 Date Revised 19.02.2024 published: Electronic ClinicalTrials.gov: NCT02749292 Citation Status MEDLINE |
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| doi: |
10.1136/ard-2023-224489 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM366145797 |
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| 100 | 1 | |a Zonozi, Reza |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Maintenance of remission of ANCA vasculitis by rituximab based on B cell repopulation versus serological flare |b a randomised trial |
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| 500 | |a Date Completed 19.02.2024 | ||
| 500 | |a Date Revised 19.02.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02749292 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a OBJECTIVE: To compare two long-term remission maintenance strategies for antineutrophil cytoplasmic antibody (ANCA) vasculitis | ||
| 520 | |a METHODS: We conducted a prospective, single-centre, open-label, randomised controlled trial of patients with ANCA vasculitis in remission after completing at least 2 years of fixed-schedule rituximab. In the B cell arm, rituximab was reinfused upon B cell repopulation; in the ANCA arm, rituximab was reinfused upon significant rise in ANCA level. Evaluations were conducted every 3 months. The primary endpoint was clinical relapse, defined as a modified BVAS/WG >0 by 36 months. Secondary endpoints included serious adverse events (SAEs) and rituximab exposure | ||
| 520 | |a RESULTS: 115 patients were enrolled. Median follow-up time was 4.1 years (IQR 2.5-5.0). By Kaplan-Meier analysis, 4.1% (95% CI 1.0 to 15.6) of patients had a clinical relapse in the B cell arm, compared with 20.5% (95% CI 11.9 to 34.1) in the ANCA arm, at 3 years after study entry (log-rank p=0.045). Total SAEs, including infectious SAEs, and deaths did not differ. The number of SAEs due to COVID-19 was higher in the B cell arm (p=0.049). In the B cell arm, patients received a mean of 3.6 (SD 2.4) infusions (3.6 g) per person over the median study follow-up time of 4.1 years, compared with 0.5 (SD 1.4) infusions (0.5 g) per patient in the ANCA arm (p<0.001) | ||
| 520 | |a CONCLUSIONS: Rituximab dosed for B cell repopulation results in fewer clinical relapses than when dosed for a rise in ANCA level in maintenance of remission for ANCA vasculitis. Overall safety was equivalent; SAEs due to COVID-19 and rituximab exposure were higher with the B cell strategy | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT02749292 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Autoantibodies | |
| 650 | 4 | |a B-Lymphocytes | |
| 650 | 4 | |a Rituximab | |
| 650 | 4 | |a Systemic vasculitis | |
| 650 | 7 | |a Rituximab |2 NLM | |
| 650 | 7 | |a 4F4X42SYQ6 |2 NLM | |
| 650 | 7 | |a Antibodies, Antineutrophil Cytoplasmic |2 NLM | |
| 650 | 7 | |a Immunosuppressive Agents |2 NLM | |
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| 700 | 1 | |a Rosenthal, Jillian M |e verfasserin |4 aut | |
| 700 | 1 | |a Sipilief, Alexander |e verfasserin |4 aut | |
| 700 | 1 | |a Cosgrove, Katherine |e verfasserin |4 aut | |
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| 700 | 1 | |a Pendergraft, William F |c 3rd |e verfasserin |4 aut | |
| 700 | 1 | |a Niles, John L |e verfasserin |4 aut | |
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