The role of anifrolumab in reshaping the treatment landscape of extra-renal systemic lupus erythematosus

Objective. Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disorder that typically requires management with immunosuppressive and anti-inflammatory treatments. The 2023 guidelines of the European Alliance of Associations for Rheumatology now recommend lowering maintenance glucocorti...

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Main Authors: Fulvia Ceccarelli, Matteo Piga, Alessandra Bortoluzzi, Laura Coladonato, Micaela Fredi, Daniele Mauro, Chiara Tani, Luca Iaccarino
Format: Article
Language:English
Published: PAGEPress Publications 2025-07-01
Series:Reumatismo
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Online Access:https://www.reumatismo.org/reuma/article/view/1830
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author Fulvia Ceccarelli
Matteo Piga
Alessandra Bortoluzzi
Laura Coladonato
Micaela Fredi
Daniele Mauro
Chiara Tani
Luca Iaccarino
author_facet Fulvia Ceccarelli
Matteo Piga
Alessandra Bortoluzzi
Laura Coladonato
Micaela Fredi
Daniele Mauro
Chiara Tani
Luca Iaccarino
author_sort Fulvia Ceccarelli
collection DOAJ
description Objective. Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disorder that typically requires management with immunosuppressive and anti-inflammatory treatments. The 2023 guidelines of the European Alliance of Associations for Rheumatology now recommend lowering maintenance glucocorticoid doses to ≤5 mg/day to reduce long-term health risks, a decrease from the previous 7.5 mg/day threshold set in 2019. To help achieve these reduced doses, early initiation of biologic therapies is suggested, even before conventional immunosuppressants. Belimumab and anifrolumab, the biologics currently approved for SLE treatment, have shown greater efficacy than placebo in clinical trials and similar safety profiles, supporting their use in achieving remission and enabling glucocorticoid tapering or discontinuation. This review evaluates the role of biologics, especially anifrolumab, in treating extra-renal SLE in Italy, using clinical scenarios to illustrate situations where early anifrolumab therapy could be beneficial. Methods. Hypothetical scenarios derived from clinical practice were examined to identify real-life contexts suitable for the early initiation of anifrolumab treatment. Results. Anifrolumab represents an effective therapeutic option for various extra-renal SLE patients. These include those who have failed to achieve or maintain remission with standard care, have contraindications to conventional immunosuppressants, are glucocorticoid-dependent, or experience mucocutaneous and musculoskeletal manifestations. Anifrolumab also offers potential benefits for patients planning pregnancy by promoting remission or low disease activity. Conclusions. Despite its recent approval and limited real-world evidence, anifrolumab has emerged as a promising therapeutic option for non-renal lupus. We hope this review will encourage further studies on the efficacy and safety of anifrolumab in real-life SLE patient cohorts.
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spelling doaj-art-a1b0fbf78d69466492dc284da39f7d322025-08-20T02:48:01ZengPAGEPress PublicationsReumatismo0048-74492240-26832025-07-0110.4081/reumatismo.2025.1830The role of anifrolumab in reshaping the treatment landscape of extra-renal systemic lupus erythematosusFulvia Ceccarelli0https://orcid.org/0000-0001-5026-8783Matteo Piga1https://orcid.org/0000-0002-1126-8315Alessandra Bortoluzzi2https://orcid.org/0000-0003-2416-8134Laura Coladonato3https://orcid.org/0000-0001-8833-7289Micaela Fredi4Daniele Mauro5Chiara Tani6Luca Iaccarino7Rheumatology, Department of Clinical, Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University of RomeRheumatology Unit, AOU Cagliari; Department of Medical Sciences and Public Health, University of CagliariSection of Rheumatology, Department of Medical Sciences, University of Ferrara and Azienda Ospedaliero-Universitaria of FerraraUnit of Rheumatology, Department of Precision and Regenerative Medicine, Ionian Area, University of BariRheumatology and Clinical Immunology Unit, Clinical and Experimental Science Department, ASST Spedali Civili, University of BresciaDepartment of Precision Medicine, University of Campania Luigi Vanvitelli, NaplesRheumatology Unit, Department of Clinical and Experimental Medicine, University of PisaRheumatology Unit, Department of Medicine, University of Padua Objective. Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disorder that typically requires management with immunosuppressive and anti-inflammatory treatments. The 2023 guidelines of the European Alliance of Associations for Rheumatology now recommend lowering maintenance glucocorticoid doses to ≤5 mg/day to reduce long-term health risks, a decrease from the previous 7.5 mg/day threshold set in 2019. To help achieve these reduced doses, early initiation of biologic therapies is suggested, even before conventional immunosuppressants. Belimumab and anifrolumab, the biologics currently approved for SLE treatment, have shown greater efficacy than placebo in clinical trials and similar safety profiles, supporting their use in achieving remission and enabling glucocorticoid tapering or discontinuation. This review evaluates the role of biologics, especially anifrolumab, in treating extra-renal SLE in Italy, using clinical scenarios to illustrate situations where early anifrolumab therapy could be beneficial. Methods. Hypothetical scenarios derived from clinical practice were examined to identify real-life contexts suitable for the early initiation of anifrolumab treatment. Results. Anifrolumab represents an effective therapeutic option for various extra-renal SLE patients. These include those who have failed to achieve or maintain remission with standard care, have contraindications to conventional immunosuppressants, are glucocorticoid-dependent, or experience mucocutaneous and musculoskeletal manifestations. Anifrolumab also offers potential benefits for patients planning pregnancy by promoting remission or low disease activity. Conclusions. Despite its recent approval and limited real-world evidence, anifrolumab has emerged as a promising therapeutic option for non-renal lupus. We hope this review will encourage further studies on the efficacy and safety of anifrolumab in real-life SLE patient cohorts. https://www.reumatismo.org/reuma/article/view/1830Systemic lupus erythematosusanifrolumabbiologicsremissionlow disease activity
spellingShingle Fulvia Ceccarelli
Matteo Piga
Alessandra Bortoluzzi
Laura Coladonato
Micaela Fredi
Daniele Mauro
Chiara Tani
Luca Iaccarino
The role of anifrolumab in reshaping the treatment landscape of extra-renal systemic lupus erythematosus
Reumatismo
Systemic lupus erythematosus
anifrolumab
biologics
remission
low disease activity
title The role of anifrolumab in reshaping the treatment landscape of extra-renal systemic lupus erythematosus
title_full The role of anifrolumab in reshaping the treatment landscape of extra-renal systemic lupus erythematosus
title_fullStr The role of anifrolumab in reshaping the treatment landscape of extra-renal systemic lupus erythematosus
title_full_unstemmed The role of anifrolumab in reshaping the treatment landscape of extra-renal systemic lupus erythematosus
title_short The role of anifrolumab in reshaping the treatment landscape of extra-renal systemic lupus erythematosus
title_sort role of anifrolumab in reshaping the treatment landscape of extra renal systemic lupus erythematosus
topic Systemic lupus erythematosus
anifrolumab
biologics
remission
low disease activity
url https://www.reumatismo.org/reuma/article/view/1830
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