Real world safety of CT-P10 (anti-CD 20 monoclonal antibodies biosimilar) in rheumatic and autoimmune diseases

Background: Rituximab (RTX), anti-CD 20 monoclonal antibodies, has been approved for many rheumatic and autoimmune diseases, the use of RTX is still limited due to financial constrain. Biosimilar RTX may increase access by offering patients a more affordable option, lead to improved patient outcomes...

Full description

Saved in:
Bibliographic Details
Main Author: Katchamart W.
Other Authors: Mahidol University
Format: Article
Published: 2023
Subjects:
Online Access:https://repository.li.mahidol.ac.th/handle/123456789/85214
Tags: Add Tag
No Tags, Be the first to tag this record!
Institution: Mahidol University
id th-mahidol.85214
record_format dspace
spelling th-mahidol.852142023-06-19T00:37:27Z Real world safety of CT-P10 (anti-CD 20 monoclonal antibodies biosimilar) in rheumatic and autoimmune diseases Katchamart W. Mahidol University Medicine Background: Rituximab (RTX), anti-CD 20 monoclonal antibodies, has been approved for many rheumatic and autoimmune diseases, the use of RTX is still limited due to financial constrain. Biosimilar RTX may increase access by offering patients a more affordable option, lead to improved patient outcomes. However, real-world data related to its immediate and short-term safety is scarce. This study aimed to evaluate the real-world immediate and short-term safety profiles of CT-P10, a biosimilar of Rituximab, in patients with rheumatic and autoimmune diseases. Methods: This prospective study included patients diagnosed with rheumatic or autoimmune diseases, aged ≥ 18 years, who were treated with biosimilar RTX at Siriraj or Ramathibodi Hospital during February 2019 to May 2019. Patients were followed up through 6 months after the infusions. Results: Of the 74 patients, with 124 infusions, 84% were females with mean age (SD) of 49.4 (15.7) years. The most common rheumatic and autoimmune disease included in this study was systemic lupus erythematosus (26%). All immediate adverse events (AEs) (15 out of 124 infusions) were mild requiring only symptomatic and supportive treatment. Short-term AEs included infection (N = 35), hematologic abnormalities (N = 33), chylous ascites (N = 1), and others (N = 10). Two deaths were related to serious bacterial and viral infection. Hematologic AEs comprised anemia (N = 5), neutropenia (N = 10), lymphopenia (N = 15), and thrombocytopenia (N = 3). Conclusion: In this real-world study, biosimilar RTX (CT-P10) has favorable immediate and short-term safety profiles. However, further studies with large sample size and long-term follow-up in real-world practice are still required to confirm the result. 2023-06-18T17:37:27Z 2023-06-18T17:37:27Z 2022-12-01 Article BMC Rheumatology Vol.6 No.1 (2022) 10.1186/s41927-022-00306-7 25201026 2-s2.0-85142871129 https://repository.li.mahidol.ac.th/handle/123456789/85214 SCOPUS
institution Mahidol University
building Mahidol University Library
continent Asia
country Thailand
Thailand
content_provider Mahidol University Library
collection Mahidol University Institutional Repository
topic Medicine
spellingShingle Medicine
Katchamart W.
Real world safety of CT-P10 (anti-CD 20 monoclonal antibodies biosimilar) in rheumatic and autoimmune diseases
description Background: Rituximab (RTX), anti-CD 20 monoclonal antibodies, has been approved for many rheumatic and autoimmune diseases, the use of RTX is still limited due to financial constrain. Biosimilar RTX may increase access by offering patients a more affordable option, lead to improved patient outcomes. However, real-world data related to its immediate and short-term safety is scarce. This study aimed to evaluate the real-world immediate and short-term safety profiles of CT-P10, a biosimilar of Rituximab, in patients with rheumatic and autoimmune diseases. Methods: This prospective study included patients diagnosed with rheumatic or autoimmune diseases, aged ≥ 18 years, who were treated with biosimilar RTX at Siriraj or Ramathibodi Hospital during February 2019 to May 2019. Patients were followed up through 6 months after the infusions. Results: Of the 74 patients, with 124 infusions, 84% were females with mean age (SD) of 49.4 (15.7) years. The most common rheumatic and autoimmune disease included in this study was systemic lupus erythematosus (26%). All immediate adverse events (AEs) (15 out of 124 infusions) were mild requiring only symptomatic and supportive treatment. Short-term AEs included infection (N = 35), hematologic abnormalities (N = 33), chylous ascites (N = 1), and others (N = 10). Two deaths were related to serious bacterial and viral infection. Hematologic AEs comprised anemia (N = 5), neutropenia (N = 10), lymphopenia (N = 15), and thrombocytopenia (N = 3). Conclusion: In this real-world study, biosimilar RTX (CT-P10) has favorable immediate and short-term safety profiles. However, further studies with large sample size and long-term follow-up in real-world practice are still required to confirm the result.
author2 Mahidol University
author_facet Mahidol University
Katchamart W.
format Article
author Katchamart W.
author_sort Katchamart W.
title Real world safety of CT-P10 (anti-CD 20 monoclonal antibodies biosimilar) in rheumatic and autoimmune diseases
title_short Real world safety of CT-P10 (anti-CD 20 monoclonal antibodies biosimilar) in rheumatic and autoimmune diseases
title_full Real world safety of CT-P10 (anti-CD 20 monoclonal antibodies biosimilar) in rheumatic and autoimmune diseases
title_fullStr Real world safety of CT-P10 (anti-CD 20 monoclonal antibodies biosimilar) in rheumatic and autoimmune diseases
title_full_unstemmed Real world safety of CT-P10 (anti-CD 20 monoclonal antibodies biosimilar) in rheumatic and autoimmune diseases
title_sort real world safety of ct-p10 (anti-cd 20 monoclonal antibodies biosimilar) in rheumatic and autoimmune diseases
publishDate 2023
url https://repository.li.mahidol.ac.th/handle/123456789/85214
_version_ 1781414719966412800