Study of rituximab efficacy, cost, safety, and compliance of its package leaflet in a tertiary hospital

García, Marta; Feijoo, M.A. Fernández; Hernández, Miguel Ángel Calleja

doi:10.1016/s2173-5085(09)70094-2

Cited by 4 publications

(5 citation statements)

References 22 publications

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“…Haematological diseases were also frequent off-label indications of rituximab in other studies [14,15]. Nevertheless, in our study non-haematological indications such as kidney and systemic connective tissue diseases have also been frequent.…”

Section: Discussionmentioning

confidence: 38%

“…Off-label use of rituximab in different indications has also been assessed in other studies [13][14][15], although this study is the largest one in which evidences-based indications as well as patients' short and long-term outcomes and cost have been evaluated.…”

Section: Discussionmentioning

confidence: 99%

“…Although several authors have analyzed the off-label use of rituximab in patients with specific diseases, mainly systemic lupus erythematosus, lupus nephritis and other severe refractory systemic autoimmune diseases [6][7][8][9][10][11][12], data on its use in different off-label indications are scarce [13][14][15]. The aim of this study was to analyze the indications for off-label use of rituximab in our centres, the available evidence when it was used, the outcomes of treated patients, as well as the cost.…”

Section: Introductionmentioning

confidence: 99%

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Available evidence and outcome of off-label use of rituximab in clinical practice

Danés

Agustí

Vallano

et al. 2013

Eur J Clin Pharmacol

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Purpose: To analyze the therapeutic indications for off-label use of rituximab, the available evidence for its use, the outcomes, and the cost. Conclusions:Off-label rituximab is mainly used for the treatment of haematological, kidney and systemic connective tissue disorders, and the response was variable depending on the diseases. The level of evidence in these indications was low and the cost very high. More clinical trials are needed, although they can be difficult in some rare diseases. Data from observational studies may provide useful information to assist prescribing in clinical practice.

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Section: Discussionmentioning

confidence: 38%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Available evidence and outcome of off-label use of rituximab in clinical practice

Danés

Agustí

Vallano

et al. 2013

Eur J Clin Pharmacol

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“…In this study, rituximab was used off label in approximately 30% of patients. Previous studies have demonstrated that rituximab is used off label to treat a range of autoimmune diseases . Furthermore, a systematic review conducted by the European Commission showed that the off‐label use of rituximab was particularly high in patients with autoimmune disease .…”

Section: Discussionmentioning

confidence: 99%

Rituximab utilization for approved and off‐label nononcology indications and patients’ experiences with the Patient Alert Card

Sarsour¹,

Beckley-Kartey

Melega

et al. 2020

Pharmacology Res & Perspec

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This study used retrospective chart review and survey data to evaluate: (1) off‐label use of rituximab (MabThera®/Rituxan®) in autoimmune conditions and (2) patients’ receipt and knowledge of the Patient Alert Card (PAC), a risk minimization measure for progressive multifocal leukoencephalopathy (PML) and serious infections. Anonymized patient data were collected from infusion centers in Europe from December 2015 to July 2017. Adults receiving rituximab in the same centers were provided a self‐administered survey. Outcomes included patterns of off‐label rituximab use for nononcology indications, and evaluation of patients’ receipt and knowledge of the PAC and its impact. Of 1012 patients in the retrospective chart review, 70.2% received rituximab for rheumatoid arthritis or granulomatosis with polyangiitis/microscopic polyangiitis, and 29.8% received rituximab off label. Among 524 survey participants, 32.8% reported receiving the PAC, 59.3% reported not receiving the PAC and 7.9% did not know whether they received the PAC. A total of 72.4% of patients reported that they were unaware that some patients receiving rituximab experience PML. A higher proportion of PAC recipients identified PML as a potential risk of rituximab than nonrecipients (37.8% vs 19.9%); 58.3% of PAC recipients had poor awareness of PML. Most PAC recipients (90.0%) and nonrecipients (85.5%) correctly answered that they should seek medical attention for infection symptoms. In conclusion, approximately 30% of patients received off‐label rituximab. Most patients reported not receiving the PAC or having knowledge of PML but demonstrated understanding of the recommended action in the event of infection symptoms, regardless of PAC receipt.

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“…The financial aspect of treatment remains the crucial point. A Spanish study reported the mean cost per treatment episode for ITP at 11 683 euros (Conde García et al , ). Although, we have to temperate use of rituximab according to local resources, we cannot only compare cost of splenectomy versus rituximab.…”

Section: Discussionmentioning

confidence: 99%

Rituximab before splenectomy in adults with primary idiopathic thrombocytopenic purpura: a meta‐analysis

et al. 2012

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SummaryPrimary immune thrombocytopenia (ITP) is an acquired immune-mediated disorder with absence of any underlying cause. Corticosteroids are the standard initial treatment. Splenectomy is the main second-line treatment. A trend to delay or avoid splenectomy has developed thanks to new agents like rituximab. Few studies have assessed the response rate to rituximab in chronic ITP. We performed the first meta-analysis of randomized clinical trials and observational studies on rituximab as an effective splenectomyavoiding option in adult chronic ITP. Overall methods were adapted from published guidelines for meta-analysis (meta-analysis of observational studies in epidemiology and preferred reporting items for systematic reviews and meta-analyses). Two haematologist investigators carried out study selection and data extraction independently, recording overall response rate (ORR) and complete response (CR) as primary assessment criteria. Of 364 records were identified through electronic databases. Of 19 retrospective or prospective observational studies were retained after removing duplicate studies and full-text analyses. The ORR was 57% (95% confidence interval [CI]: 48-65), for 368 non-splenectomized patients after rituximab; CR was 41% (95% CI: 0·33-0·51) for 346 patients. Results were stable for ORR and CR in all sub-analyses. In univariate or multivariate mixed-effect metaregression, age was the most relevant effect. According to our results, rituximab should be used in earlier in non-splenectomized patients.

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Study of rituximab efficacy, cost, safety, and compliance of its package leaflet in a tertiary hospital

Cited by 4 publications

References 22 publications

Available evidence and outcome of off-label use of rituximab in clinical practice

Available evidence and outcome of off-label use of rituximab in clinical practice

Rituximab utilization for approved and off‐label nononcology indications and patients’ experiences with the Patient Alert Card

Rituximab before splenectomy in adults with primary idiopathic thrombocytopenic purpura: a meta‐analysis

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