Efficacy and Safety of Adalimumab as the First and Second Biologic Agent in Juvenile Idiopathic Arthritis: The German Biologics JIA Registry

Schmeling, Heinrike; Minden, Kirsten; Foeldvari, Ivan; Ganser, Gerd; Hospach, T.; Horneff, Gerd

doi:10.1002/art.38741

Cited by 74 publications

(59 citation statements)

References 36 publications

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“…However, ADA showed a better safety profile than IFX (p = 0.008). Interestingly, we found a much lower rate of AE for ADA than in the German Biologics JIA registry (10.6 vs 50.9 per 100 PY, respectively) 14 . In this registry, however, all JIA subtypes with various comorbidities are included and this may explain the difference.…”

Section: Rheumatologycontrasting

confidence: 52%

Longterm Safety and Efficacy of Adalimumab and Infliximab for Uveitis Associated with Juvenile Idiopathic Arthritis

Cecchin

Zannin²,

Ferrari³

et al. 2018

J Rheumatol

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Objective.Anti-TNF-α agents have significantly changed the management of juvenile idiopathic arthritis (JIA). We evaluated the safety and efficacy of adalimumab (ADA) and infliximab (IFX) for the treatment of JIA-associated uveitis in patients treated for ≥ 2 years.Methods.Patients with JIA-associated uveitis treated with IFX and ADA were managed by a standardized protocol and data were entered in the ORCHIDEA registry. At baseline, all patients were refractory to standard immunosuppressive treatment or were corticosteroid-dependent. Data recorded every 3 months were uveitis course, number/type of ocular flares and complications, drug-related adverse events (AE), and treatment switch or withdrawal. Data of patients treated for ≥ 2 years were analyzed by descriptive statistics.Results.Up to December 2014, 154 patients with ≥ 24 months followup were included in the study. Fifty-nine patients were treated with IFX and 95 with ADA. Clinical remission, defined as the absence of flares for > 6 months on treatment, was achieved in 69 patients (44.8%), with a better remission rate for ADA (60.0%) as compared to IFX (20.3%; p < 0.001). A significant reduction of flares was observed in all patients without difference between the 2 treatment modalities. The number of new ocular complications decreased in both groups but was lower for ADA (p = 0.015). No serious AE were recorded; 16.4% of patients experienced 35 minor AE and the incidence rate was lower with ADA than with IFX.Conclusion.At the 2-year followup, ADA showed a better efficacy and safety profile than IFX for the treatment of refractory JIA-associated uveitis.

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Section: Rheumatologycontrasting

confidence: 52%

Longterm Safety and Efficacy of Adalimumab and Infliximab for Uveitis Associated with Juvenile Idiopathic Arthritis

Cecchin

Zannin²,

Ferrari³

et al. 2018

J Rheumatol

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“…There is, however, ample data from original studies and long term outcome studies to enable a historical comparison to the efficacy of high doses of biologics to standard doses or those on traditional DMARDs alone. None of the adverse events we report are inconsistent with the findings noted in prior published experience with these agents, and the nearly 70% response rate is convergent with prior reports as well [17][18][19][20][21]. Notably, Lovell et al demonstrated rates of SAEs to be 0.13 per patient-year, and rates of serious infections were 0.04 per patient-year, in a total etanercept exposure of 225 patientyears.…”

Section: Discussionsupporting

confidence: 75%

“…In regard to the safety of biologics, there have been increasing data on long-term outcomes, with reassuring findings reported in several studies [5,[10][11][12][13]. However, the safety and efficacy of higher dose biologics for pediatric patients with a diversity of diseases have not been reported.…”

Section: Introductionmentioning

confidence: 99%

Safety and Efficacy of High-dose Tumor Necrosis Factor (TNF) Inhibitors in the Management of Pediatric Inflammatory Diseases

Sarkissian¹,

Birmingham²

2015

Rheumatology (Sunnyvale)

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Objectives: To review a cohort of patients receiving higher than standard or FDA approved dosing of TNF inhibitors to assess the safety and efficacy of these agents in the management of inflammatory joint and eye disease in a clinical pediatric rheumatology setting. Methods:A retrospective review was performed of patients 1-17 years of age with inflammatory diseases requiring TNF inhibitor therapy treated with at least six weeks of treatment of a higher than the standard FDA approved dose of TNF inhibitors, from 12/1/11-4/8/14. Entanercept (Enbrel) was given at doses greater than 0.8 mg/kg, Infliximab (Remicade) was infused in doses greater than 5 mg/kg or more frequently than every eight weeks, and Adalimumab (Humira) was given at either 20 mg/kg weekly for patients weighing less than 30 kg or 40 mg/kg weekly for patients weighing greater than 30 kg. Serious adverse events (SAE), infections, and infusion reactions were all documented. We also noted clinical improvement based on parent/patient's report of decreased symptoms and provider assessment, including exam findings and laboratory parameters. Results:Thirty-five patients were included (average 11.3 years). Of these, 24 (68%) were noted to have improvement of either symptoms or exam. There was one SAE noted in the group and one infusion reaction, and 10 patients with illnesses that may have been exacerbated by immune suppression. Conclusion:Higher than standard-dose or FDA approved dosing of TNF inhibitors appear safe and efficacious in the management of pediatric inflammatory diseases, however, caution must be taken with interpretation of the results due to the retrospective chart review study design. Larger, prospective, controlled studies will be necessary to more fully evaluate safety and efficacy of this treatment approach.

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“…Written informed consent was obtained from all parents and eligible patients, and data were collected in pseudonymized form as approved by the ethics committee. Since the year 2000, patients newly starting on-label treatment with ETA, and since 2008 with ADA, were included in the registry (16)(17)(18). Patients without exposure to a biologic agent but starting with MTX were recruited as a control cohort from 2005 to 2011, until the target of 1,500 patients was reached.…”

Section: Methodsmentioning

confidence: 99%

Uveitis Events During Adalimumab, Etanercept, and Methotrexate Therapy in Juvenile Idiopathic Arthritis: Data From the Biologics in Pediatric Rheumatology Registry

Foeldvari

Becker

Horneff

2015

Arthritis Care & Research

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ObjectiveUveitis is a major extraarticular quality of life–restricting manifestation of juvenile idiopathic arthritis (JIA). The aim of the study is to describe the occurrence of uveitis in JIA patients receiving tumor necrosis factor inhibitors or methotrexate (MTX).MethodsPatients’ characteristics, treatment, and the reported first occurrence of uveitis as an adverse event were searched in the Biologics in Pediatric Rheumatology Registry. The rates per exposed patients, exposure time, and time until event were calculated.ResultsUveitis was reported as an adverse event in 75 of 3,467 patients; 51 of 2,844 patients were receiving MTX, 37 of 1,700 patients were receiving etanercept, and 13 of 364 patients were receiving adalimumab. Patients with uveitis were younger (mean ± SD age 4.6 ± 4.2 versus 7.4 ± 4.5 years; P < 0.0001), more likely to be antinuclear antibody positive (69% versus 43%; odds ratio [OR] 2.7, P < 0.0001), and had extended oligoarticular JIA (OR 2.2, P = 0.0005). Patients with a uveitis diagnosis before starting treatment more often had a uveitis event (n = 28, 8.4%; OR 8.5, P < 0.0001), and more often received adalimumab (OR 2.15 [95% confidence interval 1.58–2.94], P < 0.0001). In 16 patients, a new uveitis event occurred: 11 while taking MTX (3.2 per 1,000 patient‐years), 2 while taking etanercept monotherapy (1.9 per 1,000 patient‐years), and 3 while taking etanercept and MTX combination (0.9 per 1,000 patient‐years). A new uveitis event occurred early in the disease course after a median disease duration of 1.5 years (interquartile range [IQR] 1.3–3.8) while taking etanercept and 1.8 years (IQR 1.8–2.1) for the MTX cohort. A recurrent uveitis event was reported after a disease duration of 7.6 years (IQR 4.3–10.0) in the etanercept cohort and 4.8 years (IQR 1.0–5.8) in the MTX cohort. Univariate analysis showed that MTX, but not etanercept or adalimumab, led to a lower rate of uveitis.ConclusionPatients with a history of uveitis had higher risks for uveitis events while taking both etanercept and adalimumab. Methotrexate turned out to be protective. Few patients developed a first uveitis event while taking etanercept, while the rate is comparable to that with MTX. Uveitis may not be attributed to be an adverse drug reaction to etanercept.

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Efficacy and Safety of Adalimumab as the First and Second Biologic Agent in Juvenile Idiopathic Arthritis: The German Biologics JIA Registry

Cited by 74 publications

References 36 publications

Longterm Safety and Efficacy of Adalimumab and Infliximab for Uveitis Associated with Juvenile Idiopathic Arthritis

Longterm Safety and Efficacy of Adalimumab and Infliximab for Uveitis Associated with Juvenile Idiopathic Arthritis

Safety and Efficacy of High-dose Tumor Necrosis Factor (TNF) Inhibitors in the Management of Pediatric Inflammatory Diseases

Uveitis Events During Adalimumab, Etanercept, and Methotrexate Therapy in Juvenile Idiopathic Arthritis: Data From the Biologics in Pediatric Rheumatology Registry

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