Lupus science & medicine · 2026
Real-world experience of anifrolumab treatment in patients with moderate-to-severe SLE: a retrospective study of patients in early access programmes.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Vital Edward M, Chasset François, Faria Raquel, Carter Lucy M, Kielar Danuta, Chen Stephanie Y, Chen Samuel, Nåtman Jonatan, Waratani Miina
Аннотация
OBJECTIVE: The multinational ERYTHRO (NCT06046534) study investigated the experience of patients with moderate-to-severe SLE initiating anifrolumab treatment through routine clinical practice as part of two early access programmes.
METHODS: Retrospective data were extracted from medical charts of adults with SLE who received intravenous anifrolumab 300 mg every 4 weeks alongside standard therapy during AMANA (NCT04750057) or the France Temporary Authorisation for Use (ATUc). The baseline period included ≥6 months of data collection before anifrolumab initiation; follow-up data were collected for as long as data were available in the chart. Outcomes, including SLE Disease Activity Index-2000 (SLEDAI-2K), Physician Global Assessment (PGA) scores and rates of Definition of Remission in SLE (DORIS) and Lupus Low Disease Activity State (LLDAS) attainment, were assessed at baseline and at 6 months from the first anifrolumab dose. Outcome estimation at the 6-month follow-up time point was performed using data from two different windows (primary analysis: 6±1 month; sensitivity analysis: 6±2.5 months).
RESULTS: Of 47 enrolled patients who initiated anifrolumab, treatment was ongoing in 41 patients (87.2%) at the end of the ERYTHRO study; 6 patients (12.8%) withdrew from anifrolumab (4 (8.5%) due to worsening symptoms, 1 (2.1%) due to improving symptoms and 1 (2.1%) for other reasons). SLEDAI-2K and PGA scores (median (IQR)) decreased over 6 months of treatment (SLEDAI-2K, baseline: 6.0 (8.0), n=47; and 6±1 month: 2.0 (4.0), n=40; PGA, baseline: 1.8 (1.0), n=39; and 6±1 month: 0.3 (1.0), n=29). DORIS remission and LLDAS attainment rates increased from baseline over time (DORIS, baseline: 0/39; 6±1 month: 9/29, 31.0%; and LLDAS, baseline: 3/39, 7.7%; 6±1 month: 17/29, 58.6%).
CONCLUSIONS: Based on the changes in disease activity and attainment of DORIS remission and LLDAS seen within 6 months of anifrolumab initiation, this study supports anifrolumab use in a real-world population of patients with moderate to severe SLE.
METHODS: Retrospective data were extracted from medical charts of adults with SLE who received intravenous anifrolumab 300 mg every 4 weeks alongside standard therapy during AMANA (NCT04750057) or the France Temporary Authorisation for Use (ATUc). The baseline period included ≥6 months of data collection before anifrolumab initiation; follow-up data were collected for as long as data were available in the chart. Outcomes, including SLE Disease Activity Index-2000 (SLEDAI-2K), Physician Global Assessment (PGA) scores and rates of Definition of Remission in SLE (DORIS) and Lupus Low Disease Activity State (LLDAS) attainment, were assessed at baseline and at 6 months from the first anifrolumab dose. Outcome estimation at the 6-month follow-up time point was performed using data from two different windows (primary analysis: 6±1 month; sensitivity analysis: 6±2.5 months).
RESULTS: Of 47 enrolled patients who initiated anifrolumab, treatment was ongoing in 41 patients (87.2%) at the end of the ERYTHRO study; 6 patients (12.8%) withdrew from anifrolumab (4 (8.5%) due to worsening symptoms, 1 (2.1%) due to improving symptoms and 1 (2.1%) for other reasons). SLEDAI-2K and PGA scores (median (IQR)) decreased over 6 months of treatment (SLEDAI-2K, baseline: 6.0 (8.0), n=47; and 6±1 month: 2.0 (4.0), n=40; PGA, baseline: 1.8 (1.0), n=39; and 6±1 month: 0.3 (1.0), n=29). DORIS remission and LLDAS attainment rates increased from baseline over time (DORIS, baseline: 0/39; 6±1 month: 9/29, 31.0%; and LLDAS, baseline: 3/39, 7.7%; 6±1 month: 17/29, 58.6%).
CONCLUSIONS: Based on the changes in disease activity and attainment of DORIS remission and LLDAS seen within 6 months of anifrolumab initiation, this study supports anifrolumab use in a real-world population of patients with moderate to severe SLE.