The emergence of rituximab biosimilars offers the prospect of significant savings to the healthcare system. However, these drugs have never been evaluated for treating immune thrombocytopenia (ITP). This was an observational, matched study. We included adults who received a rituximab biosimilar for ITP. Each rituximab-naïve biosimilar patient was matched with two controls from the historic ITP-ritux registry. For non-naïve patients, we compared the response to the biosimilar with that observed with the reference product. Response status was defined according to international criteria. We included 107 patients; 55 receiving Rixathon™ and 52 Truxima™. Three months after the first infusion of rituximab biosimilars, the overall response rate was 47/74 (63.5%) versus 76/142 (53.5%) for the matched controls receiving the reference product ( = .13). The 3-month overall response rate was 76.5% for Rixathon™ versus 51.5% for the matched control group ( = .01) and 21/40 (52.5%) for Truxima™ versus 41/74 (55.4%) for the matched controls ( = .81). For non-naïve patients, the response pattern was similar to that observed previously with the reference product. Safety was analogous to that observed with the reference product. Rituximab biosimilars seemed safe and effective for ITP treatment.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1080/09537104.2023.2200848 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Biosimilars in pediatric rheumatology: innovations, challenges, and opportunities.
Expert Opin Biol Ther
January 2025
Department of Pediatric Rheumatology, Kocaeli University, Kocaeli, Turkey.
Article Synopsis
- Biosimilars are biologic drugs that mimic established medications for treating rheumatic diseases and become available as cost-effective alternatives once original patents expire.
- Since their introduction in pediatric rheumatology in 2013, several biosimilars have been launched, offering more treatment options for children with conditions like juvenile idiopathic arthritis.
- The article emphasizes the need for education and effective communication among healthcare providers and patients to enhance understanding and ensure proper use of biosimilars.
Uptake of rituximab biosimilars in Medicare and Medicaid in 2019-2022.
Am J Manag Care
December 2024
Department of Health Outcomes Research and Policy, Auburn University Harrison College of Pharmacy, 4306D Walker Building, Auburn University, Auburn, AL 36849-5506. Email:
Objectives: This study evaluated the uptake and costs of 3 biosimilars among Medicare and Medicaid populations for 2019 to 2022: rituximab-abbs (Truxima), rituximab-pvvr (Ruxience), and rituximab-arrx (Riabni).
Study Design: A retrospective, descriptive study.
Methods: Using the annually aggregated, product-level utilization and cost data of biologic and biosimilar rituximab products from CMS drug spending data, total claims and costs (reimbursement and out of pocket) for all rituximab products were identified and extracted from Medicare Part B, Medicare Part D, and Medicaid.
Outcomes of a 12-month course of early and late rituximab BCD020 biosimilar administration in juvenile systemic lupus erythematosus: A retrospective study.
World J Nephrol
December 2024
Hospital Pediatry, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Sankt-Peterburg, Russia.
Background: Juvenile systemic lupus erythematosus (SLE) is a severe, life-threatening disease. However, the role of rituximab in managing juvenile SLE remains undefined, although early biological intervention may improve disease outcomes.
Aim: To assess the differences in the outcomes of different types of rituximab administration (early and late).
Comparing immunogenicity and safety following transition from reference rituximab to biosimilar rituximab (DRL_RI) in patients with rheumatoid arthritis: a randomized, double-blind, phase 3 study.
Arthritis Res Ther
December 2024
Memorial Herman Northwest Hospital, Houston, TX, 77089, USA.
Objectives: To assess immunogenicity and safety in patients with active rheumatoid arthritis (RA) transitioning from rituximab [US-licensed rituximab: Reference Product (RP); EU-approved rituximab: Reference Medicinal Product (RMP)] to DRL_RI (proposed rituximab biosimilar), in comparison to those continuing on RP/RMP.
Methods: This double-blind, randomized, Phase 3 study included 140 RA patients having prior exposure to RP/RMP; transitioned to DRL_RI (n = 70) or continued with RP/RMP (n = 70) for two 1000 mg infusions on Days 1 and 15. Assessments included Time-matched Rituximab Concentration (TMRC), anti-drug antibodies (ADAs), neutralizing antibodies (NAbs) and ADA titre over 12 weeks, and safety follow-up till 26 weeks.
Switching from rituximab originator to GP2013 or CT-P10 biosimilars in autoimmune rheumatic diseases: drug retention rate and safety data from a multicentric retrospective cohort.
Ther Adv Musculoskelet Dis
November 2024
Department of Medicine, Surgery and Neurosciences, Rheumatology Unit of Azienda Ospedaliero-Universitaria Senese, University of Siena, Siena, Italy.
Article Synopsis
- The study evaluates the safety and effectiveness of switching from the original rituximab (RTX-O) to its biosimilars (RTX-B) in patients with autoimmune rheumatic diseases (ARDs), with a focus on long-term drug retention and safety.
- It included 181 patients who switched to either GP2013 or CT-P10, finding that the drug retention rates were high over 36 months, particularly for GP2013.
- The transition to CT-P10 showed a higher risk of discontinuation, but overall, the switch to RTX-B was deemed safe with a low incidence of adverse events.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!