Malignancies in children and young adults on etanercept: summary of cases from clinical trials and post marketing reports

Hooper, Michele; Wenkert, Deborah; Bitman, Bojena; Dias, Virgil C.; Bartley, Yessenia

doi:10.1186/1546-0096-11-35

Cited by 23 publications

(11 citation statements)

References 24 publications

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“…These results are in line with several previous studies that either found no increased incidence of malignancies in JIA patients [ 13 – 15 ] or an increased risk for cancer independent of TNF-α-treatment [ 1 , 16 – 20 ]. However, some studies suggested that new therapeutics might be responsible for an increased risk of cancer in JIA patients [ 13 , 21 ].…”

Section: Discussionsupporting

confidence: 93%

Association between drug intake and incidence of malignancies in patients with Juvenile Idiopathic Arthritis: a nested case–control study

et al. 2016

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BackgroundSeveral medications for treatment of Juvenile Idiopathic Arthritis (JIA) are considered to be carcinogenic. Therefore, the aim was to assess whether there is an association between therapeutic interventions and malignancies in JIA patients.FindingsA nested case–control study was carried out within a retrospective cohort study of 3698 JIA patients diagnosed between 1952 and 2010. All 48 JIA patients with a diagnosis of a malignant tumour and up to four matched controls for each received a questionnaire about their use of medication. Subsequently treatment was compared between cases and controls and analyses performed for 37 cases and 125 controls (response 88.5 %). Treatment with DMARD (84 %) was most frequently used, followed by glucocorticoids (66 %) and immunosuppressives (65 %). Twenty percent reported to have ever been taking biologics. Medication use did not differ significantly between cases and controls.ConclusionsOur results did not show an association between medications used and malignancies in JIA patients.Electronic supplementary materialThe online version of this article (doi:10.1186/s12969-016-0066-8) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 93%

Association between drug intake and incidence of malignancies in patients with Juvenile Idiopathic Arthritis: a nested case–control study

et al. 2016

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“…After screening all participants with including and excluding criteria, 201 patients were selected, randomly and evenly assigned in three groups: ETA (receiving 50 mg of etanercept twice weekly, etanercept was purchased from Amgen, Thousand Oaks, USA) (Hooper et al 2013) as a control group, ETABJ (receiving 50 mg of etanercept twice weekly, 50 ml blueberry juice daily) as a blueberry plus group and ETAPJ (matched etanercept and placebo juice) as a blueberry minus group. Since fifty ml blueberry juice was used for each patient (more than 50 kg) in an experimental group daily, the concentration of used blueberry juice was less than 0.1% (v/w).…”

Section: Methodsmentioning

confidence: 99%

Blueberry Improves the Therapeutic Effect of Etanercept on Patients with Juvenile Idiopathic Arthritis: Phase III Study

Zhong

Wang

Guo

et al. 2015

Tohoku J. Exp. Med.

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Juvenile idiopathic arthritis (JIA) is the most common arthritis in the adolescents under the age of 16. Etanercept, an inhibitor of tumor necrosis factor, is often used to treat JIA despite its significant side effects. Homeopathic remedies, such as blueberries, have anti-inflammatory properties with fewer unwanted effects and should be considered as a primary treatment. We aimed to explore the efficacy and safety of combination therapy of blueberry and etanercept for JIA. Two hundred and one JIA patients were selected, and randomly and evenly assigned to three groups: ETA (50 mg of etanercept twice weekly), ETABJ (matched etanercept and 50 ml blueberry juice daily) and ETAPJ (matched etanercept and placebo juice). The severity of JIA was measured using American College of Rheumatology scales (ACR) 20, 50 and 70. The levels of pro-inflammatory cytokines, interleukin-1 (IL1) alpha and IL1 beta, and interleukin-1 receptor antagonist (IL1RA) were measured by qRT-PCR and ELISA. After a 6-month follow-up, the ACR20, ACR50 and ACR70 in an ETABJ group were higher than those in other two groups (P < 0.05), suggesting clinically meaningful improvement in JIA. Meanwhile, the symptoms and side effects were reduced significantly or absent in an ETABJ group, including mental diseases, retrobulbar optic neuritis, gaining weight, infection, cutaneous vasculitis, diarrhea, uveitis and pancytopenia. Blueberries reduced the levels of IL1 alpha and beta, and increased the level of IL1RA. Thus, a combination therapy of blueberry and etanercept can reduce the severity of JIA and should be developed as a new method for JIA therapy.

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“…Hooper et al 66 conducted a review on malignancies in children and young adults exposed to etanercept using the Amgen clinical trial database and postmarketing global safety database. For the 0- to 17-year age group, the reported rate appeared higher than incidence rates from a general pediatric population of similar ages and was primarily due to an increase in Hodgkin lymphoma.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of ustekinumab in adolescents

Kellen¹,

Silverberg²,

Lebwohl³

2016

PHMT

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The biologic agent ustekinumab is a human monoclonal antibody that binds to the p40 subunit shared by interleukins (ILs) 12 and 23. The antibody is able to prevent binding of cytokines to the IL-12Rβ1 cell surface receptor and therefore may prevent IL-23 driven activation of the IL-23/Th 17 axis of inflammation. The anti-inflammatory activity has been beneficial in adult psoriasis. Ustekinumab has been approved in the United States for the treatment of adults with psoriasis and psoriatic arthritis. Approval in children and adolescents has not been granted by the US Food and Drug Administration. Subcutaneous injections of ustekinumab are administered at baseline, week 4 and every 12 weeks thereafter, a regimen that is particularly appealing to young patients who do not like more frequent injections at home. The product is attractive because, although it works through an immune system mechanism, the selective activity is such that the drug has not been associated with many of the side effects attributed to other immunosuppressive medications. Case reports of ustekinumab for pediatric psoriasis have shown promising results, and the recent Phase III CADMUS trial tested the agent in adolescents aged 12–17 years with psoriasis, using standard dose 0.75 mg/kg (≤60 kg), 45 mg (>60–≤100 kg), and 90 mg (>100 kg) or half-standard dosing 0.375 mg/kg (≤60 kg), 22.5 mg (>60–≤100 kg), and 45 mg (>100 kg) with a loading dosage at week 0 and week 4. Psoriasis area and severity index-75 was achieved in more than three-quarters of patients in full and half dosing by 12 weeks, and psoriasis area and severity index-90 in 54.1% and 61.1% of half and full dosage by 12 weeks, respectively. Ustekinumab was generally well tolerated in adolescents, with some patients developing antibodies, and nasopharyngitis being the major adverse event. Ustekinumab is a promising agent in adolescent psoriasis that appears to be well tolerated. The best monitoring plan and usage in younger patients still remain to be defined.

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Malignancies in children and young adults on etanercept: summary of cases from clinical trials and post marketing reports

Cited by 23 publications

References 24 publications

Association between drug intake and incidence of malignancies in patients with Juvenile Idiopathic Arthritis: a nested case–control study

Association between drug intake and incidence of malignancies in patients with Juvenile Idiopathic Arthritis: a nested case–control study

Blueberry Improves the Therapeutic Effect of Etanercept on Patients with Juvenile Idiopathic Arthritis: Phase III Study

Efficacy and safety of ustekinumab in adolescents

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