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

Danés, Imma; Agustí, Antònia; Vallano, Antonio; Martínez, José Manuel Lavié; Alerany, Carmen; Ferrer, Adelaida; López, Andrés; Cortés-Hernández, Josefina; Bosch, J.

doi:10.1007/s00228-013-1518-4

Cited by 20 publications

(18 citation statements)

References 26 publications

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“…Azathioprine (first line drug), mycophenolate mofetil and methotrexate are immunosuppressant drugs that seem to be safe and significantly reduce annual relapses rate (ARR) and improve or stabilize Expanded Disability Status Scale (EDSS) [61,65,66]. Other alternatives are available: rituximab, for instance, is a promising drug in refractory cases reducing ARR and EDSS [67][68][69]. A new alternative is eculizumab (monoclonal IgG) that neutralizes complement protein C5 and seems to reduce ARR and stabilize or improve EDSS [70].…”

Section: Treatmentmentioning

confidence: 99%

Neuromyelitis optica spectrum disorders associated with other autoimmune diseases

Freitas

Guimarães

2014

Rheumatol Int

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Neuromyelitis optica (NMO) is an inflammatory demyelinating autoimmune disease with severe, tremendously incapacitating, consequences in the patient's health and wellbeing. Until 2004, NMO was considered a restricted type of multiple sclerosis but in the same year an auto-antibody reacting against aquaporin-4 (NMO-IgG) was found to be related with NMO and it was considered the main etiologic agent of this disease. Its detection is very sensitive and specific allowing an early diagnosis and a better treatment and prognosis. With this tool, a spectrum of diseases including other autoimmune diseases was found to have NMO-IgG antibodies and a new classification named NMO spectrum disorders was created. In this review, we sum up the developments in this field associated with other autoimmune diseases. We approach the latest discoveries in the diagnosis like the new biomarkers that will possibly be used in the close future or the developments in the neuroimaging techniques. We reviewed the literature and synthesized case reports of NMO patients with concurrent autoimmune diseases and the information from useful larger studies. Finally, we summarize the commonly used treatments in NMO and we try to specify the best treatment for NMO with simultaneous autoimmune disease. This review updates the information about this issue and raises the awareness of rheumatologists for these severe diseases.

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Section: Treatmentmentioning

confidence: 99%

Neuromyelitis optica spectrum disorders associated with other autoimmune diseases

Freitas

Guimarães

2014

Rheumatol Int

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“…It was initially approved for the treatment of non-Hodgkin's lymphoma and later indicated for autoimmune rheumatic diseases such as rheumatoid arthritis and antineutrophil cytoplasmic antibody-associated vasculitis [1–3]. Furthermore, rituximab has been used as a second-line treatment for systemic lupus erythematosus (SLE), especially in refractory nephritis, cerebritis, and hematological disorders [1, 4–6]. In general, rituximab has a favorable safety profile; however, several adverse events have been described.…”

Section: Introductionmentioning

confidence: 99%

Early-Onset Neutropenia Induced by Rituximab in a Patient with Lupus Nephritis and Hemolytic Anemia

Arroyo-Ávila

Fred-Jiménez

Vilá

2015

Case Reports in Rheumatology

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Rituximab is an anti-CD20 monoclonal antibody that has been used to treat several complications of systemic lupus erythematosus (SLE) including nephritis, cerebritis, and hematological disorders. Neutropenia is among the adverse events associated with rituximab; this usually occurs several weeks after therapy. However, early-onset neutropenia has been reported only in a few cases. Herein, we describe a 36-year-old Hispanic SLE woman who developed severe early-onset neutropenia (0.3 × 109/L) after the second weekly rituximab infusion (375 mg/m2 weekly × 4) given for nephritis and hemolytic anemia. She also had early-onset thrombocytopenia after rituximab therapy. Both hematological disorders resolved 12 days after the fourth and final dose. This case, together with few others, suggests that early-onset neutropenia may occur during rituximab therapy. Even though rituximab-induced neutropenia seems to be transient, it may predispose SLE patients to severe complications such as infections.

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“…However, one out of four treated patients had adverse events, and the median cost of off-label treatments was relatively high. Although several articles have reported the use of off-label medicines, few of them have assessed outcomes in clinical practice, and most have focused on one specific medicine [ 12 , 18 ]. We believe this is the first study where the outcomes of patients treated with different off-label medicines have been reported.…”

Section: Discussionmentioning

confidence: 99%

“…Several studies have evaluated the use of off-label medicines, but they have often focused on specific groups of drugs or medicines, such as anticancer drugs [ 9 – 11 ] or rituximab [ 12 , 13 ], or on specific populations, such as children [ 14 – 17 ]. However, very few studies have evaluated the clinical outcomes of off-label medicines in terms of effectiveness and safety as well as the associated costs [ 12 , 18 , 19 ]. The aim of our study was to assess the clinical and economic outcomes and the clinical evidence for off-label use of medicines in the hospital setting.…”

Section: Introductionmentioning

confidence: 99%

Outcomes of off-label drug uses in hospitals: a multicentric prospective study

Danés

Agustí

Vallano

et al. 2014

Eur J Clin Pharmacol

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PurposeThe study aims to assess the clinical evidence, outcome and cost of off-label use of medicines in the hospital setting.MethodsA multicentric prospective cohort study of patients treated with off-label medicines was carried out in five tertiary hospitals from May 2011 to May 2012. Information on clinical characteristics of patients, drugs, outcomes and costs was collected. Patients were followed up to 6 months, and information was assessed by reviewing clinical records and interviewing physicians.ResultsA total of 226 patients were included. The median (interquartile range (IQR)) age of patients was 46 (33–62) years; 59 % were women. Patients had received a median of three previous treatments, and a lack of response (or suboptimal) was the main reason for off-label use (72.1 %). A total of 232 off-label medicines were administered for 102 different indications. The most frequent medicines were rituximab (49; 21.1 %), botulinum toxin (25; 10.7 %) and omalizumab (14; 6.0 %). In 117 (51.8 %) cases, the level of clinical evidence for their use was low. A partial clinical response was observed in 82 patients (36.3 %), complete response in 71 (31.4 %) and stabilization in 11 (4.9 %). A total of 58 (26.5 %) patients had adverse effects, which in 11 (4.9 %) were severe. The median (IQR) cost per patient was €2,943.07 (541.9–5,872.54).ConclusionsThere was a high variability of off-label medicines and indications. Although the clinical evidence of off-label medicines was often low, clinical response was observed in many patients with previous multiple treatment failure, but at the expense of some adverse effects and a high cost. Registers of patients would be helpful for clinical decisions, although clinical trials are needed.Electronic supplementary materialThe online version of this article (doi:10.1007/s00228-014-1746-2) contains supplementary material, which is available to authorized users.

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

Cited by 20 publications

References 26 publications

Neuromyelitis optica spectrum disorders associated with other autoimmune diseases

Neuromyelitis optica spectrum disorders associated with other autoimmune diseases

Early-Onset Neutropenia Induced by Rituximab in a Patient with Lupus Nephritis and Hemolytic Anemia

Outcomes of off-label drug uses in hospitals: a multicentric prospective study

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