Early Disease and Low Baseline Damage as Predictors of Response to Belimumab in Patients With Systemic Lupus Erythematosus in a Real‐Life Setting
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- Mariele Gatto
- University of Padua Padua Italy
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- Francesca Saccon
- University of Padua Padua Italy
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- Margherita Zen
- University of Padua Padua Italy
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- Francesca Regola
- ASST Spedali Civili di Brescia Brescia Italy
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- Micaela Fredi
- ASST Spedali Civili di Brescia Brescia Italy
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- Laura Andreoli
- ASST Spedali Civili di Brescia Brescia Italy
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- Angela Tincani
- ASST Spedali Civili di Brescia Brescia Italy
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- Maria Letizia Urban
- University of Florence Florence Italy
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- Giacomo Emmi
- University of Florence Florence Italy
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- Fulvia Ceccarelli
- Sapienza University Rome Italy
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- Fabrizio Conti
- Sapienza University Rome Italy
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- Alessandra Bortoluzzi
- University of Ferrara and Azienda Ospedaliera–Universitaria di Ferrara Cona Ferrara Italy
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- Marcello Govoni
- University of Ferrara and Azienda Ospedaliera–Universitaria di Ferrara Cona Ferrara Italy
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- Chiara Tani
- University of Pisa Pisa Italy
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- Marta Mosca
- University of Pisa Pisa Italy
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- Tania Ubiali
- ASST Gaetano Pini Milan Italy
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- Maria Gerosa
- ASST Gaetano Pini Milan Italy
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- Enrica Bozzolo
- IRCCS Ospedale San Raffaele Milan Italy
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- Valentina Canti
- IRCCS Ospedale San Raffaele Milan Italy
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- Paolo Cardinaletti
- Università Politecnica delle Marche Ancona Italy
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- Armando Gabrielli
- Università Politecnica delle Marche Ancona Italy
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- Giacomo Tanti
- Università Cattolica del Sacro Cuore Sede di Roma Rome Italy
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- Elisa Gremese
- Università Cattolica del Sacro Cuore Sede di Roma and Fondazione Policlinico Universitario A. Gemelli‐IRCCS Rome Italy
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- Ginevra De Marchi
- University of Udine Udine Italy
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- Salvatore De Vita
- University of Udine Udine Italy
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- Serena Fasano
- Università degli Studi della Campania Luigi Vanvitelli Naples Italy
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- Francesco Ciccia
- Università degli Studi della Campania Luigi Vanvitelli Naples Italy
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- Giulia Pazzola
- Azienda Unità Sanitaria Locale di Reggio Emilia IRCCS Reggio Emilia Italy
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- Carlo Salvarani
- Azienda Unità Sanitaria Locale di Reggio Emilia IRCCS, and Università degli Studi di Modena e Reggio Emilia Reggio Emilia Italy
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- Simone Negrini
- Università degli Studi di Genova Genoa Italy
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- Francesco Puppo
- Università degli Studi di Genova Genoa Italy
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- Andrea Di Matteo
- Università Politecnica delle Marche Ancona Italy
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- Rossella De Angelis
- Università Politecnica delle Marche Ancona Italy
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- Giovanni Orsolini
- University of Verona Verona Italy
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- Maurizio Rossini
- University of Verona Verona Italy
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- Paola Faggioli
- ASST Ovest Milanese Milan Italy
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- Antonella Laria
- ASST Ovest Milanese Milan Italy
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- Matteo Piga
- Azienda Ospedaliera Universitaria di Cagliari University Clinic and University of Cagliari Cagliari Italy
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- Alessandro Mathieu
- Azienda Ospedaliera Universitaria di Cagliari University Clinic and University of Cagliari Cagliari Italy
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- Salvatore Scarpato
- Ospedale M. Scarlato Scafati Italy
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- Francesca W. Rossi
- University of Napoli Federico II Naples Italy
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- Amato de Paulis
- University of Napoli Federico II Naples Italy
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- Enrico Brunetta
- Humanitas Research Hospital and Università degli Studi di Milano Milan Italy
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- Angela Ceribelli
- Reumatologia ed Immunologia Clinica IRCCS Istituto Clinico Humanitas Milan Italy
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- Carlo Selmi
- Università degli Studi di Milano and Reumatologia ed Immunologia Clinica IRCCS Istituto Clinico Humanitas Milan Italy
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- Marcella Prete
- University of Bari Bari Italy
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- Vito Racanelli
- University of Bari Bari Italy
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- Angelo Vacca
- University of Bari Bari Italy
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- Elena Bartoloni
- University of Perugia Perugia Italy
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- Roberto Gerli
- University of Perugia Perugia Italy
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- Maddalena Larosa
- University of Padua Padua Italy
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- Luca Iaccarino
- University of Padua Padua Italy
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- Andrea Doria
- University of Padua Padua Italy
Description
<jats:sec><jats:title>Objective</jats:title><jats:p>To investigate predictors of response, remission, low disease activity, damage, and drug discontinuation in patients with systemic lupus erythematosus (<jats:styled-content style="fixed-case">SLE</jats:styled-content>) who were treated with belimumab.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>In this retrospective study of a multicenter cohort of <jats:styled-content style="fixed-case">SLE</jats:styled-content> patients who received intravenous belimumab, the proportion of patients who achieved remission, low disease activity, and treatment response according to the <jats:styled-content style="fixed-case">SLE</jats:styled-content> Responder Index 4 (<jats:styled-content style="fixed-case">SRI</jats:styled-content>‐4) was determined, and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (<jats:styled-content style="fixed-case">SDI</jats:styled-content>) was used to score disease damage yearly over the follow‐up. Predictors of outcomes were analyzed by multivariate logistic regression with the results expressed as odds ratios (<jats:styled-content style="fixed-case">OR</jats:styled-content>s) and 95% confidence intervals (95% <jats:styled-content style="fixed-case">CI</jats:styled-content>s).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The study included 466 patients with active <jats:styled-content style="fixed-case">SLE</jats:styled-content> from 24 Italian centers, with a median follow‐up period of 18 months (range 1–60 months). An <jats:styled-content style="fixed-case">SRI</jats:styled-content>‐4 response was achieved by 49.2%, 61.3%, 69.7%, 69.6%, and 66.7% of patients at 6, 12, 24, 36, and 48 months, respectively. Baseline predictors of response at 6 months included a score of ≥10 on the <jats:styled-content style="fixed-case">SLE</jats:styled-content> Disease Activity Index 2000 (<jats:styled-content style="fixed-case">SLEDAI</jats:styled-content>‐2K) (<jats:styled-content style="fixed-case">OR</jats:styled-content> 3.14 [95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 2.033–4.860]) and a disease duration of ≤2 years (<jats:styled-content style="fixed-case">OR</jats:styled-content> 1.94 [95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 1.078‐3.473). Baseline predictors of response at 12 months included a score of ≥10 on the <jats:styled-content style="fixed-case">SLEDAI</jats:styled-content>‐2K (<jats:styled-content style="fixed-case">OR</jats:styled-content> 3.48 [95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 2.004–6.025]) and an <jats:styled-content style="fixed-case">SDI</jats:styled-content> score of 0 (<jats:styled-content style="fixed-case">OR</jats:styled-content> 1.74 [95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 1.036–2.923]). Baseline predictors of response at 24 months included a score of ≥10 on the <jats:styled-content style="fixed-case">SLEDAI</jats:styled-content>‐2K (<jats:styled-content style="fixed-case">OR</jats:styled-content> 4.25 [95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 2.018–8.940]) and a disease duration of ≤2 years (<jats:styled-content style="fixed-case">OR</jats:styled-content> 3.79 [95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 1.039–13.52]). Baseline predictors of response at 36 months included a score of ≥10 on the <jats:styled-content style="fixed-case">SLEDAI</jats:styled-content>‐2K (<jats:styled-content style="fixed-case">OR</jats:styled-content> 14.59 [95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 3.54–59.79) and baseline status of current smoker (<jats:styled-content style="fixed-case">OR</jats:styled-content> 0.19 [95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 0.039–0.69]). Patients who were in remission for ≥25% of the follow‐up period (44.3%) or who had low disease activity for ≥50% of the follow‐up period (66.1%) accrued significantly less damage (<jats:italic>P</jats:italic> = 0.046 and <jats:italic>P</jats:italic> = 0.007). A baseline <jats:styled-content style="fixed-case">SDI</jats:styled-content> score of 0 was an independent predictor of achieving low disease activity in ≥50% of the follow‐up period and remission in ≥25% of the follow‐up period. Our findings suggest that the lower the baseline damage, the greater the probability of achieving remission over the course of ≥25% of the follow‐up. Further, there was a negative association between the number of flares reported prior to belimumab initiation and the frequency of belimumab discontinuation due to inefficacy (<jats:italic>P</jats:italic> = 0.009).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>In patients with active <jats:styled-content style="fixed-case">SLE</jats:styled-content> and low damage at baseline, treatment with belimumab early in the disease may lead to favorable outcomes in a real‐life setting.</jats:p></jats:sec>
Journal
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- Arthritis & Rheumatology
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Arthritis & Rheumatology 72 (8), 1314-1324, 2020-06-12
Wiley
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Details 詳細情報について
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- CRID
- 1360576123041865600
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- ISSN
- 23265205
- 23265191
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- Data Source
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- Crossref