Assessment of rituximab-abbs, a biosimilar, and rituximab outcomes in patients with CLL or NHL: A real-world UK study

McBride, Ali; Daniel, S.; Driessen, Maurice; Szende, Ágota; Choudhry, Azhar; Tian, Marc; Ariely, Rinat; Thompson, Stephen

doi:10.1016/j.leukres.2021.106671

Cited by 6 publications

(3 citation statements)

References 25 publications

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“…The IRRs rates observed in phase 3 studies ranged between 15 and 32% for CT-P10 and 9.5-30% for oRTX [10,12,21,22]. Although real-life data are limited in studies with CT-P10, it has been reported that IRRs rates are 16-27% in patients with lymphoma [23,24], and about 10% in rheumatologic populations [25,26]. Stubbs et al indicated that IRRs were observed in 40% and 33% of the CT-P10 and oRTX groups, respectively, in patients with immune-mediated thrombotic thrombocytopenic purpura patients [27].…”

Section: Discussionmentioning

confidence: 99%

Interchangeability and adverse events in originator-rituximab and its biosimilar (CT-P10) among rheumatic patients: a real-life experience

et al. 2023

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Biosimilars offer cost-effective and safe treatment options both for patients and healthcare systems. CT-P10 is the first biosimilar of rituximab approved in Europe for use in all indications of originator rituximab (oRTX). This study aimed to provide real-life data on treatment changes and adverse events in patients who received oRTX or CT-P10. We retrospectively reviewed treatment-related adverse events [infusion-related reactions (IRRs), infections, hypogammaglobulinemia] in patients treated with at least one dose of oRTX (MabThera ® ) or CT-P10 (Truxima ® ) between 2020 and 2021 and had at least 6 months follow-up after rituximab infusion in a rheumatology clinic. The switches between oRTX and CT-P10 were performed according to drug availability at the hospital pharmacy at the time of infusion according to the local hospital procedure. Physicians were not involved in the decision of biosimilar selection. A total of 128 patients (CT-P10, n = 64; oRTX, n = 64) were included. CT-P10 was switched in 52 (40.6%) patients who had previously used oRTX, and 48 (37.5%) patients remained on oRTX. We demonstrated no difference between patients treated with oRTX or CT-P10 in the rates of IRRs, in which all reactions were grade 1 and 2. Comparable rates of infections (p > 0.05) and the rate of hypogammaglobulinemia (p > 0.05) were found in both groups with no significant difference. CT-P10 provides a safe treatment alternative in patients who require rituximab therapy. The rational use of biosimilars can be supported by evolving evidence on interchangeability and switching in real-life settings, which will help clinicians in decision-making.

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Section: Discussionmentioning

confidence: 99%

Interchangeability and adverse events in originator-rituximab and its biosimilar (CT-P10) among rheumatic patients: a real-life experience

et al. 2023

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“…The above results suggest that combination therapy of copanlisib plus rituximab is a promising regimen for patients with R/R B-NHL. Rituximab, a CD20 monoclonal antibody, is often the first-choice treatment for patients with B-NHL and is one of the standard options for patients with R/R B-NHL (42). PI3K plays a part in the development of B-cell lymphoma.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of copanlisib in relapsed/refractory B-cell non-Hodgkin lymphoma: A meta-analysis of prospective clinical trials

Wang

Zhou

et al. 2022

Front. Immunol.

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BackgroundCopanlisib is an intravenously administered pan-class I PI3K inhibitor that has been demonstrated to have appreciable effects in the treatment of patients with lymphoma. The purpose of this meta-analysis was to evaluate the efficacy and safety of copanlisib for treating patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).MethodsPubMed, Web of Science, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for relevant studies published prior to July 2022. The efficacy evaluation included complete response rate (CR), partial response rate (PR), rate of stable disease (SDR), overall response rate (ORR), disease control rate (DCR), rate of progressive disease (PDR), median progression-free survival (PFS), and median overall survival (OS). Any grade adverse events (AEs) and grade ≥3 AEs were synthesized to assess its safety.ResultsEight studies with a total of 652 patients with R/R B-NHL were identified. The pooled CR, PR, ORR, SDR, DCR, and PDR from all 8 articles were 13%, 40%, 57%, 19%, 86%, and 9%, respectively. The CR and ORR of combination therapy with rituximab were higher than those with copanlisib monotherapy for R/R B-NHL (34% vs. 6%, p<0.01; 89% vs. 42%, p<0.01). For patients with R/R indolent B-NHL, CR and ORR were lower with copanlisib monotherapy than with combination therapy with rituximab (7% vs. 34%, p<0.01; 58% vs. 92%, p<0.01). In R/R B-NHL patients receiving copanlisib monotherapy and combination therapy with rituximab, the risk of any grade AEs was 99% and 96%, respectively, and the risk of grade ≥3 AEs was 84% and 91%, respectively. The common any grade AEs included hyperglycemia (66.75%), hypertension (48.57%), diarrhea (35.06%), nausea (34.98%) and fatigue (30.33%). The common grade ≥3 AEs included hyperglycemia (45.14%), hypertension (35.07%), and neutropenia (14.75%). The comparison of AEs between the copanlisib monotherapy and the combination therapy with rituximab showed that hyperglycemia of any grade (p<0.0001), hypertension of any grade (p=0.0368), fatigue of any grade (p<0.0001), grade ≥3 hypertension (p<0.0001) and grade ≥3 hyperglycemia (p=0.0074) were significantly different between the two groups.ConclusionOur meta-analysis demonstrated that the efficacy of both copanlisib monotherapy and combination therapy with rituximab in patients with R/R B-NHL was satisfactory, while treatment-related AEs were tolerable. Compared with copanlisib monotherapy, combination therapy with rituximab showed superior efficacy for treating R/R B-NHL, and its safety was manageable.Systematic Review Registrationhttps://inplasy.com/inplasy-2022-10-0008/, identifier INPLASY2022100008.

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“…Concurrently, loss of muscle mass in patients with hematological cancer is related to poor nutritional status, which is mainly described to be a result of the side effects of cytostatic treatment and/or the cancer disease itself [ 4 , 5 ]. Side effects with consequences for the patients’ nutritional status include nausea, vomiting, changes in the sense of smell and taste, mucositis, decreased energy levels, and intestinal disorders, which can lead to malabsorption, diarrhea, and constipation [ 6 , 7 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

Nutrition and Lifestyle-Related Factors as Predictors of Muscle Atrophy in Hematological Cancer Patients

Staxen,

Andersen,

Pedersen

et al. 2024

Nutrients

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Background: Cancer and side effects from cytostatic treatment commonly affect nutritional status manifested as a decrease in muscle mass. We aimed to investigate the impact of nutrition and lifestyle-related factors on muscle mass in patients with hematological cancer. Methods: Dietary intake, food preferences, quality of life (QoL), and physical activity level (PAL) were monitored during 1–2 cytostatic treatment series. Body composition was estimated using bioelectrical impedance analysis (BIA). Results: 61 patients were included. Weight loss and loss of muscle mass were detected in 64% and 59% of the patients, respectively. Muscle mass was significantly positively correlated to increasing PAL (p = 0.003), while negatively correlated to increasing age (p = 0.03), physical QoL (p = 0.007), functional QoL (p = 0.05), self-perceived health (p = 0.004), and self-perceived QoL (p = 0.007). Weight was significantly positively correlated to increased intake of soft drinks (p = 0.02) as well as the favoring of bitter grain and cereal products (p = 0.03), while negatively correlated to increasing age (p = 0.03) and increasing meat intake (p = 0.009) Conclusions: Several nutritional and lifestyle-related factors affected change in body composition. The clinical significance of these changes should be investigated in controlled, interventional studies.

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Assessment of rituximab-abbs, a biosimilar, and rituximab outcomes in patients with CLL or NHL: A real-world UK study

Cited by 6 publications

References 25 publications

Interchangeability and adverse events in originator-rituximab and its biosimilar (CT-P10) among rheumatic patients: a real-life experience

Interchangeability and adverse events in originator-rituximab and its biosimilar (CT-P10) among rheumatic patients: a real-life experience

Efficacy and safety of copanlisib in relapsed/refractory B-cell non-Hodgkin lymphoma: A meta-analysis of prospective clinical trials

Nutrition and Lifestyle-Related Factors as Predictors of Muscle Atrophy in Hematological Cancer Patients

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