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Anifrolumab in Refractory Systemic Lupus Erythematosus: A Real-World, Multicenter Study.
Tani, Chiara; Cardelli, Chiara; Zen, Margherita; Moroni, Luca; Piga, Matteo; Ceccarelli, Fulvia; Fasano, Serena; De Marchi, Ginevra; Coladonato, Laura; Emmi, Giacomo; Gatto, Mariele; Trentin, Francesca; Ramirez, Giuseppe A; Chessa, Elisabetta; Gallina, Gabriele; Picciariello, Licia; Patrone, Martina; Urban, Maria L; Biancalana, Edoardo; Quartuccio, Luca; Ciccia, Francesco; Conti, Fabrizio; Cauli, Alberto; Dagna, Lorenzo; Doria, Andrea; Mosca, Marta.
Afiliación
  • Tani C; C. Tani, MD, F. Trentin, MD, M. Mosca, MD, Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; chiara.tani@unipi.it.
  • Cardelli C; C. Cardelli, MD, Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, and Department of Medical Biotechnologies, University of Siena, Siena, Italy.
  • Zen M; M. Zen, MD, A. Doria, MD, Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padua, Italy.
  • Moroni L; L. Moroni, MD, G.A. Ramirez, MD, G. Gallina, MD, L. Dagna, MD, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele - Vita-Salute San Raffaele University, Milan, Italy.
  • Piga M; M. Piga, MD, A. Cauli, MD, Rheumatology Unit, University Clinic, AOU Cagliari, Monserrato, and Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
  • Ceccarelli F; F. Ceccarelli, MD, L. Picciarello, MD, F. Conti, MD, Lupus Clinic, Rheumatology, Department of Clinical Internal, Anaesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy.
  • Fasano S; S. Fasano, MD, M. Patrone, MD, F. Ciccia, MD, Rheumatology Unit, Department of Precision Medicine, Università Degli Studi Della Campania "Luigi Vanvitelli," Naples, Italy.
  • De Marchi G; G. De Marchi, MD, L. Quartuccio, MD, Division of Rheumatology, Department of Medicine (DAME), University of Udine, Presidio Ospedaliero Santa Maria della Misericordia, ASUFC, Udine, Italy.
  • Coladonato L; L. Coladonato, MD, Department of Emergency and Organ Transplantation, Rheumatology Unit, University of Bari, Bari, Italy.
  • Emmi G; G. Emmi, MD, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy, and Centre for Inflammatory Diseases, Monash University Department of Medicine, Monash Medical Centre, Clayton, Victoria, Australia.
  • Gatto M; M. Gatto, MD, Department of Medical Biotechnologies, University of Siena, Siena, and Academic Rheumatology Centre, Department of Clinical and Biological Sciences, University of Turin, Mauriziano Hospital, Turin, Italy.
  • Trentin F; C. Tani, MD, F. Trentin, MD, M. Mosca, MD, Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
  • Ramirez GA; L. Moroni, MD, G.A. Ramirez, MD, G. Gallina, MD, L. Dagna, MD, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele - Vita-Salute San Raffaele University, Milan, Italy.
  • Chessa E; E. Chessa, MD, Rheumatology Unit, University Clinic, AOU Cagliari, Monserrato, Cagliari, Italy.
  • Gallina G; L. Moroni, MD, G.A. Ramirez, MD, G. Gallina, MD, L. Dagna, MD, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele - Vita-Salute San Raffaele University, Milan, Italy.
  • Picciariello L; F. Ceccarelli, MD, L. Picciarello, MD, F. Conti, MD, Lupus Clinic, Rheumatology, Department of Clinical Internal, Anaesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy.
  • Patrone M; S. Fasano, MD, M. Patrone, MD, F. Ciccia, MD, Rheumatology Unit, Department of Precision Medicine, Università Degli Studi Della Campania "Luigi Vanvitelli," Naples, Italy.
  • Urban ML; M.L. Urban, MD, E. Biancalana, MD, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
  • Biancalana E; M.L. Urban, MD, E. Biancalana, MD, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
  • Quartuccio L; G. De Marchi, MD, L. Quartuccio, MD, Division of Rheumatology, Department of Medicine (DAME), University of Udine, Presidio Ospedaliero Santa Maria della Misericordia, ASUFC, Udine, Italy.
  • Ciccia F; S. Fasano, MD, M. Patrone, MD, F. Ciccia, MD, Rheumatology Unit, Department of Precision Medicine, Università Degli Studi Della Campania "Luigi Vanvitelli," Naples, Italy.
  • Conti F; F. Ceccarelli, MD, L. Picciarello, MD, F. Conti, MD, Lupus Clinic, Rheumatology, Department of Clinical Internal, Anaesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy.
  • Cauli A; M. Piga, MD, A. Cauli, MD, Rheumatology Unit, University Clinic, AOU Cagliari, Monserrato, and Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
  • Dagna L; L. Moroni, MD, G.A. Ramirez, MD, G. Gallina, MD, L. Dagna, MD, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele - Vita-Salute San Raffaele University, Milan, Italy.
  • Doria A; M. Zen, MD, A. Doria, MD, Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padua, Italy.
  • Mosca M; C. Tani, MD, F. Trentin, MD, M. Mosca, MD, Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
J Rheumatol ; 51(11): 1096-1101, 2024 Nov 01.
Article en En | MEDLINE | ID: mdl-38950957
ABSTRACT

OBJECTIVE:

To report real-world experience on the use of anifrolumab (ANI) in refractory systemic lupus erythematosus (SLE).

METHODS:

The present study is a multicenter, retrospective study involving 9 Italian SLE referral centers participating in a compassionate use program for the use of ANI in adult patients with active SLE in whom all the available treatment choices failed, were not tolerated, or were contraindicated. At baseline and 1, 3, 6, 9, and 12 months of treatment, overall and organ-specific disease activity, flares, daily glucocorticoid (GC) dose, and adverse events were recorded.

RESULTS:

A total of 26 patients were enrolled. At 4 weeks after starting ANI, a significant decrease in the Systemic Lupus Erythematosus Disease Activity Index 2000 (P = 0.01), Systemic Lupus Erythematosus-Disease Activity Score (P = 0.01), and physician global assessment (P = 0.001) was recorded, and the same trend was maintained over time. A significant reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index-activity (P < 0.001) and in tender (P = 0.03) and swollen (P = 0.02) joint counts was also recorded. At 3 months of follow-up, 33% of patients already achieved a remission state, whereas 46% were in Lupus Low Disease Activity State (LLDAS); at 6 months, 50% were in remission and 80% were in LLDAS. A significant reduction in the mean GC daily dose was observed, starting from week 4 (P = 0.04). A total of 4 disease flares according to the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index were recorded (3 mild-moderate and 1 severe). Overall, 4/20 patients with at least 24 weeks of follow-up (20%) were considered nonresponders.

CONCLUSION:

This study provides real-world experience on the use of ANI in patients with refractory SLE, confirming its rapid effectiveness and an overall acceptable safety profile.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Índice de Severidad de la Enfermedad / Anticuerpos Monoclonales Humanizados / Lupus Eritematoso Sistémico Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: J Rheumatol Año: 2024 Tipo del documento: Article Pais de publicación: Canadá
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Índice de Severidad de la Enfermedad / Anticuerpos Monoclonales Humanizados / Lupus Eritematoso Sistémico Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: J Rheumatol Año: 2024 Tipo del documento: Article Pais de publicación: Canadá