Highlights
- •High costs limit rituximab wide off-label administration in IgG4-related disease
- •Biosimilars are used in alternative to originators in many autoimmune disorders
- •Rituximab biosimilar CT-P10 is safe and effective in IgG4-related disease
- •This study first reports on a rituximab biosimilar in IgG4-related disease
Abstract
Objective
Rituximab is increasingly used in IgG4-related disease (IgG4-RD) but high costs limit
its wide off-label administration. European and US regulatory agencies have recently
approved rituximab biosimilars for the treatment of different rheumatologic and hematological
conditions. No data are available, yet, on the efficacy and safety of rituximab biosimilars
for the treatment of IgG4-RD. Scope of the present work is to evaluate the efficacy
and safety of the rituximab biosimilar CT-P10 (RTX-B) in patients with IgG4-RD.
Methods
Patients with active IgG4-RD, naïve to rituximab or switched from the originator (RTX-O)
to the biosimilar were treated with RTX-B and prospectively followed-up for 18 months.
Safety and efficacy were assessed at six months. Relapse rate was assessed at 18 months.
Disease activity was assessed by means of the IgG4-RD Responder Index (IgG4-RD RI).
Results
Thirty-eight patients were included in this study. Thirty-three patients (87%) were
naïve to RTX. Five patients (13%) relapsed after RTX-O and were switched to RTX-B.
After six months, 21 patients (60%) achieved disease remission. The median serum IgG4
concentration decreased from 1344 to 575 mg/L (p < 0.01), and the median IgG4-RD RI
decreased from 7.5 to 0 (p < 0.01). B-cell depletion was observed in all patients.
Eight patients (36%) relapsed within 18 months. Side effects related to RTX-B administration
were observed in 14 patients (37%). These results are in line with our previous experience
with RTX-O.
Conclusions
The (TruximaTM) rituximab biosimilar CT-P10 represents a safe and effective alternative to rituximab
originator for the treatment of IgG4-RD.
Keywords
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Article info
Publication history
Published online: December 29, 2020
Accepted:
December 8,
2020
Received in revised form:
November 29,
2020
Received:
October 1,
2020
Identification
Copyright
© 2020 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
