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Observational Study
. 2025 Jan;38(1):225-234.
doi: 10.1007/s40620-024-02071-x. Epub 2024 Oct 6.

The safety of corticosteroid therapy in IGA nephropathy: analysis of a real-life Italian cohort

Ivano Baragetti  1 , Lucia Del Vecchio  2 , Francesca Ferrario  1 , Federico Alberici  3 , Andrea Amendola  4 , Elisa Russo  5 , Serena Ponti  6 , Anna Maria Di Palma  7 , Antonello Pani  8 , Cristiana Rollino  9 , Domenico Giannese  10 , Giuliano Boscutti  11 , Annasara Sorrentino  12 , Carla Colturi  13 , Giuliano Brunori  14 , Roberta Lazzarin  15 , Fausta Catapano  16 , Mario Cozzolino  17 , Sandro Feriozzi  18 , Claudio Pozzi  1 ; Italian Group of Steroids in IgAN
Affiliations
Observational Study

The safety of corticosteroid therapy in IGA nephropathy: analysis of a real-life Italian cohort

Ivano Baragetti et al. J Nephrol. 2025 Jan.

Abstract

Background: Systemic steroids are recommended for patients with IgA nephropathy (IgAN) and proteinuria. However, there are concerns about their safety due to an excess of serious adverse events (SAEs) in previous randomised trials. This study evaluates the incidence of SAEs in IgAN patients receiving different treatment regimens in clinical practice.

Methods: Multicentre, retrospective, observational cohort study of 1209 patients (M/F: 864/345, mean age: 41.73 ± 14.92 years) with biopsy-proven IgAN treated with renin angiotensin system (RAS) inhibitors (RASI) (n = 285), intravenous + oral steroids (n = 633), oral steroids (n = 99), steroids + immunosuppressants (n = 192).

Results: A total of 119 (9.8%) adverse events were reported, of which 67 (5.5%) were considered treatment-emergent, and 36 (2.9%) were SAEs (n = 23, 63.8% were infections). One patient died due to sepsis. A significant association was observed between AEs and immunosuppression [8 (2.8%) in RASI, 60 (9.4%) in steroids + immunosuppressants, 14 in oral steroids (14.1%) and 37 pts (19.2%) in steroids + immunosuppressants (p < 0.01)], age and estimated glomerular filtration rate (eGFR), but not with proteinuria and sex. On multivariate analysis, only older age was associated with the occurrence of SAEs.

Conclusions: According to our findings, the incidence of SAEs during therapy with steroids alone or associated with immunosuppressors is lower in everyday clinical practice than in randomised clinical trials.

Keywords: IgA nephropathy; Immunosuppression; Safety; Steroid therapy.

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Conflict of interest statement

Declarations. Conflict of interest: Lucia Del Vecchio had speaker fees at meeting with indirect support of Vifor, AstraZeneca, Bayer, Amgen, Astellas; she participated to an Advisory board for Travere; she is National leader of the PROTECT study. Federico Alberici received Consulting fees from CSL-Vifor, Travere Therapeutics, Otsuka and Speaker fees from CSL-Vifor, Travere Therapeutics, Otsuka. Giuliano Boscuttihad Consulting fees from Alexion Pharma, Glaxo-Smith-Kline and Speaker fees at meeting with indirect support of Vifor Pharma, AstraZeneca, Alexion Pharma, Astellas Pharma. He received support for attending meetings from Bayer, Alnilam S.p.a., Sandoz S.p.a., Estor S.p.a. Ivano Baragetti, Francesca Ferrario, Andrea Amendola, Elisa Russo, Serena Ponti, Anna Maria Di Palma, Antonello Pani, Cristiana Rollino, Domenico Giannese, Annasara, Carla Colturi, Giuliano Brunori, Roberta Lazzarin, Fausta Catapano, Mario Cozzolino, Sandro Feriozzi, Claudio Pozzi have no Conflict of interests to declare. Ethical approval: The study was approved by the Central Ethics Committee of Milan Area n° 3, register number 113–032017, and was conducted according to the tenets of the Declaration of Helsinki: 113–032017, approval was received on 5 April, 2017) and then by the local ethics committees of the participating centres. Informed consent to participate: Informed consent was not required due to the nature of the study.

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