Abstract
Aims: Anti-CD20 antibodies are increasingly being used to treat idiopathic nephrotic syndrome (INS) in children. While they may allow steroid and calcineurin inhibitor withdrawal, repeated infusions of anti-CD20 antibodies are often required to maintain remission. Data on their potential toxicity in INS are needed, to consider repeated infusions. Methods: We investigated the side effects associated with the use of rituximab (a chimeric antibody; 130 patients) and ofatumumab (a humanized antibody; 37 patients) in children with INS (steroid-dependent and steroid/calcineurin inhibitor-dependent disease) treated at a national referral centre over a 9-year period (400 treatments; follow-up 1–9 years). Results: Infusion reactions were mainly absent in children with steroid-dependent disease. Rash, dyspnoea, fever, cough and itchy throat (5% and 18% following rituximab and ofatumumab infusion, respectively) were resolved by using premedication with salbutamol. Other short-term reactions (up to 3 months), including arthritis (2%) and lung injury (1%), were more common with rituximab. Infections were observed 3–9 months following infusion, were similarly common in the two groups and resolved with targeted therapies [antibiotic, fluconazole, immunoglobulins (Igs), etc.]. The number of circulating CD19/20 cells fell to 0 at month 1 and were reconstituted at month 3; circulating IgG antibodies remained within the normal range for 1 year. Tetanus and hepatitis B virus immunization was not modified by either treatment; Epstein–Barr virus and John Cunningham virus activation markers were occasionally observed. Conclusion: Overall, the toxicity of anti-CD20 monoclonal antibodies was limited to post-infusion side effects in children with more complex disease. The relatively safe profile of anti-CD20 antibodies supports their use as steroid-sparing agents in children with INS.
| Original language | English |
|---|---|
| Pages (from-to) | 1238-1249 |
| Number of pages | 12 |
| Journal | British Journal of Clinical Pharmacology |
| Volume | 84 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Jun 1 2018 |
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Keywords
- nephrotic syndrome
- ofatumumab
- rituximab
- side effects
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)
Cite this
Adverse events linked with the use of chimeric and humanized anti-CD20 antibodies in children with idiopathic nephrotic syndrome. / Bonanni, Alice; Calatroni, Marta; D'Alessandro, Matteo; Signa, Sara; Bertelli, Enrica; Cioni, Michela; Di Marco, Eddi; Biassoni, Roberto; Caridi, Gianluca; Ingrasciotta, Giulia; Bertelli, Roberta; Di Donato, Armando; Bruschi, Maurizio; Canepa, Alberto; Piaggio, Giorgio; Ravani, Pietro; Ghiggeri, Gian Marco.
In: British Journal of Clinical Pharmacology, Vol. 84, No. 6, 01.06.2018, p. 1238-1249.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Adverse events linked with the use of chimeric and humanized anti-CD20 antibodies in children with idiopathic nephrotic syndrome
AU - Bonanni, Alice
AU - Calatroni, Marta
AU - D'Alessandro, Matteo
AU - Signa, Sara
AU - Bertelli, Enrica
AU - Cioni, Michela
AU - Di Marco, Eddi
AU - Biassoni, Roberto
AU - Caridi, Gianluca
AU - Ingrasciotta, Giulia
AU - Bertelli, Roberta
AU - Di Donato, Armando
AU - Bruschi, Maurizio
AU - Canepa, Alberto
AU - Piaggio, Giorgio
AU - Ravani, Pietro
AU - Ghiggeri, Gian Marco
PY - 2018/6/1
Y1 - 2018/6/1
N2 - Aims: Anti-CD20 antibodies are increasingly being used to treat idiopathic nephrotic syndrome (INS) in children. While they may allow steroid and calcineurin inhibitor withdrawal, repeated infusions of anti-CD20 antibodies are often required to maintain remission. Data on their potential toxicity in INS are needed, to consider repeated infusions. Methods: We investigated the side effects associated with the use of rituximab (a chimeric antibody; 130 patients) and ofatumumab (a humanized antibody; 37 patients) in children with INS (steroid-dependent and steroid/calcineurin inhibitor-dependent disease) treated at a national referral centre over a 9-year period (400 treatments; follow-up 1–9 years). Results: Infusion reactions were mainly absent in children with steroid-dependent disease. Rash, dyspnoea, fever, cough and itchy throat (5% and 18% following rituximab and ofatumumab infusion, respectively) were resolved by using premedication with salbutamol. Other short-term reactions (up to 3 months), including arthritis (2%) and lung injury (1%), were more common with rituximab. Infections were observed 3–9 months following infusion, were similarly common in the two groups and resolved with targeted therapies [antibiotic, fluconazole, immunoglobulins (Igs), etc.]. The number of circulating CD19/20 cells fell to 0 at month 1 and were reconstituted at month 3; circulating IgG antibodies remained within the normal range for 1 year. Tetanus and hepatitis B virus immunization was not modified by either treatment; Epstein–Barr virus and John Cunningham virus activation markers were occasionally observed. Conclusion: Overall, the toxicity of anti-CD20 monoclonal antibodies was limited to post-infusion side effects in children with more complex disease. The relatively safe profile of anti-CD20 antibodies supports their use as steroid-sparing agents in children with INS.
AB - Aims: Anti-CD20 antibodies are increasingly being used to treat idiopathic nephrotic syndrome (INS) in children. While they may allow steroid and calcineurin inhibitor withdrawal, repeated infusions of anti-CD20 antibodies are often required to maintain remission. Data on their potential toxicity in INS are needed, to consider repeated infusions. Methods: We investigated the side effects associated with the use of rituximab (a chimeric antibody; 130 patients) and ofatumumab (a humanized antibody; 37 patients) in children with INS (steroid-dependent and steroid/calcineurin inhibitor-dependent disease) treated at a national referral centre over a 9-year period (400 treatments; follow-up 1–9 years). Results: Infusion reactions were mainly absent in children with steroid-dependent disease. Rash, dyspnoea, fever, cough and itchy throat (5% and 18% following rituximab and ofatumumab infusion, respectively) were resolved by using premedication with salbutamol. Other short-term reactions (up to 3 months), including arthritis (2%) and lung injury (1%), were more common with rituximab. Infections were observed 3–9 months following infusion, were similarly common in the two groups and resolved with targeted therapies [antibiotic, fluconazole, immunoglobulins (Igs), etc.]. The number of circulating CD19/20 cells fell to 0 at month 1 and were reconstituted at month 3; circulating IgG antibodies remained within the normal range for 1 year. Tetanus and hepatitis B virus immunization was not modified by either treatment; Epstein–Barr virus and John Cunningham virus activation markers were occasionally observed. Conclusion: Overall, the toxicity of anti-CD20 monoclonal antibodies was limited to post-infusion side effects in children with more complex disease. The relatively safe profile of anti-CD20 antibodies supports their use as steroid-sparing agents in children with INS.
KW - nephrotic syndrome
KW - ofatumumab
KW - rituximab
KW - side effects
UR - http://www.scopus.com/inward/record.url?scp=85044385046&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85044385046&partnerID=8YFLogxK
U2 - 10.1111/bcp.13548
DO - 10.1111/bcp.13548
M3 - Article
AN - SCOPUS:85044385046
VL - 84
SP - 1238
EP - 1249
JO - British Journal of Clinical Pharmacology
JF - British Journal of Clinical Pharmacology
SN - 0306-5251
IS - 6
ER -