Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease

Horneff, Gerd; Seyger, M.M.B.; Arikan, Dilek; Kalabic, Jasmina; Anderson, J.; Lazar, Andreas; Williams, David A.; Wang, Chen; Tarzynski-Potempa, R.; Hyams, Jeffrey S.

doi:10.1016/j.jpeds.2018.05.042

Cited by 39 publications

(26 citation statements)

References 34 publications

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“…The long‐term safety profile of ADA from this study is also supported by the safety profiles from other trials of long‐term ADA treatment of adults and children with psoriasis and other indications (rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and Crohn disease). The adverse events observed in these trials and analyses are similar to those experienced by the current paediatric population . The rates of events per 100 PYs were similar across these trials and analyses.…”

Section: Discussionsupporting

confidence: 62%

“…The adverse events observed in these trials and analyses are similar to those experienced by the current paediatric population. [35][36][37]44,45 The rates of events per 100 PYs were similar across these trials and analyses. The adverse event rate for IT MTX responders who received ADA 0Á8 mg kg À1 in the LTE was similar to the rates for patients receiving ADA in the other study periods.…”

Section: Discussionmentioning

confidence: 76%

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Sustained long‐term efficacy and safety of adalimumab in paediatric patients with severe chronic plaque psoriasis from a randomized, double‐blind, phase III study

et al. 2019

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SummaryBackgroundAdalimumab (ADA) (Humira®, AbbVie Inc., U.S.A.) is approved by the European Medicines Agency for children aged ≥ 4 years with severe plaque psoriasis.ObjectivesTo evaluate the long‐term efficacy and safety of ADA in children with severe plaque psoriasis.MethodsResults are presented from the 52‐week long‐term extension (LTE) of the randomized, double‐blind, double‐dummy, phase III trial, in children with severe plaque psoriasis (results from prior periods have been published). Patients aged ≥ 4 and < 18 years were randomized 1 : 1 : 1 to ADA 0·8 mg kg−1 (40 mg maximum) or 0·4 mg kg−1 (20 mg maximum) every other week or to methotrexate (MTX) 0·1–0·4 mg kg−1 (25 mg maximum) weekly. The 16‐week initial treatment (IT) period was followed by a 36‐week withdrawal period and a 16‐week retreatment period. Patients could enter the LTE at prespecified time points to receive ADA 0·8 mg kg−1 (blinded or open label) or ADA 0·4 mg kg−1 (blinded), or to remain off treatment. Efficacy is reported for patient groups according to doses received in the IT and LTE periods.ResultsOf the 114 patients randomized in the IT period, 108 entered the LTE (n = 36 in each group); 93 received ADA 0·8 mg kg−1. Efficacy (≥ 75% improvement from baseline in Psoriasis Area and Severity Index) was maintained or improved from entry to the end of the LTE: MTX(IT)/ADA 0·8(LTE) 31–86% of patients; ADA 0·4(IT)/0·4 or 0·8(LTE) 28–47%; ADA 0·8(IT)/0·8(LTE) 50–72%. No serious infections occurred in the LTE.ConclusionsAfter 52 weeks of long‐term ADA treatment in children aged 4–18 years with severe plaque psoriasis, disease severity was reduced and maintained or further improved, as demonstrated by efficacy outcomes. No new safety risks were identified. What's already known about this topic? The results from the first three periods of this phase III trial in children aged 4–18 years with severe plaque psoriasis suggest that adalimumab is a safe and efficacious treatment option in this population. What does this study add? This is the first study to evaluate long‐term treatment of adalimumab in children with severe psoriasis, and the first to evaluate switching from methotrexate to adalimumab in this population.

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Section: Discussionsupporting

confidence: 62%

Section: Discussionmentioning

confidence: 76%

Sustained long‐term efficacy and safety of adalimumab in paediatric patients with severe chronic plaque psoriasis from a randomized, double‐blind, phase III study

et al. 2019

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“…Adalimumab postmarketing surveillance data were not included in this analysis because of limitations associated with voluntary reporting. Of note, this analysis did not include pediatric patients; a separate analysis on pediatric safety was recently published [80].…”

Section: Clinical Trialsmentioning

confidence: 99%

Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis

et al. 2019

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Introduction: The safety profile of adalimumab was previously reported in 23,458 patients across multiple indications. Here we report the long-term safety of adalimumab in adults with plaque psoriasis (Ps), hidradenitis suppurativa (HS), rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, non-radiographic axial spondyloarthritis, peripheral spondyloarthritis, Crohn's disease (CD), ulcerative colitis (UC), and non-infectious uveitis (UV). Methods: Safety data from 77 clinical trials were pooled. Safety assessments included adverse events (AEs) and serious AEs (SAEs) that occurred after the first study dose and within 70 days (5 half-lives) after the last study dose. Results: A total of 29,967 patients were included, representing 56,916 patient-years (PY) of exposure. The most frequently reported SAE of interest was infection (3.7/100 PY) with highest incidences in CD, RA, UV, and UC (3.5/ 100 PY-6.9/100 PY); serious infections in Ps (1.8/100 PY) and HS (2.8/100 PY) were lower. The observed number of deaths was below what would be expected in an age-and sex-adjusted population for most adalimumab-treated patients (including Ps). Lack of real-life data and limited long-term data ([ 5 years) for most patients are limitations of this analysis. Conclusion: The safety profile of adalimumab was consistent with previous findings and no new safety signals were observed.

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“…Anwendungsgebiete finden sich in der Kinderrheumatologie, der Kindergastroenterologie und der Dermatologie. Umfangreiche Sicherheitsuntersuchungen stehen zur Verfügung . Adalimumab ist zur Behandlung der schweren chronischen Plaque‐Psoriasis bei Kindern und Jugendlichen ab einem Alter von vier Jahren zugelassen, die nur unzureichend auf eine topische Therapie und Phototherapien angesprochen haben oder für die diese Therapien nicht geeignet sind.…”

Section: Therapieunclassified

S2k‐Leitlinie zur Therapie der Psoriasis bei Kindern und Jugendlichen – Kurzfassung Teil 2

Eisert

Augustin

Bach

et al. 2019

J Deutsche Derma Gesell

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Zusammenfassung Diese Leitlinie richtet sich an Assistenz‐ und Fachärzte der Dermatologie, Pädiatrie, Kinderdermatologie und Kinderrheumatologie sowie an Kostenträger und politische Entscheidungsgremien. Die Leitlinie wurde im formellen Konsensusverfahren (S2k) von Dermatologen und Kinderdermatologen unter Einbindung von Kinderrheumatologen erstellt. Die Leitlinie stellt einen Überblick über Schweregrad, Lebensqualität und Therapieziele mit Erläuterung der Off‐Label‐Problematik im Kindesalter dar. Es werden Diagnosestellung und Triggerfaktoren erläutert. Der Schwerpunkt der Leitlinie liegt auf der Darstellung der verschiedenen topischen Therapien, UV‐Therapien und systemischen Therapieoptionen mit Abbildung der Empfehlungen zur Anwendung der Therapien sowie Therapiealgorithmen. Darüber hinaus wird im Kontext auf Impfungen bei Psoriasis im Kindesalter sowie auf verschiedene Sonderformen wie Psoriasis guttata, Windelpsoriasis, Psoriasis pustulosa und Psoriasisarthritis eingegangen. Auch werden Empfehlungen zu Tuberkulosediagnostik und Röntgenuntersuchung vor Systemtherapie gegeben.

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Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease

Abstract: Clinicaltrials.gov: NCT00048542, NCT00775437, NCT00690573, NCT01166282, NCT01251614, NCT00409682, and NCT00686374.

Cited by 39 publications

References 34 publications

Sustained long‐term efficacy and safety of adalimumab in paediatric patients with severe chronic plaque psoriasis from a randomized, double‐blind, phase III study

Sustained long‐term efficacy and safety of adalimumab in paediatric patients with severe chronic plaque psoriasis from a randomized, double‐blind, phase III study

Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis

S2k‐Leitlinie zur Therapie der Psoriasis bei Kindern und Jugendlichen – Kurzfassung Teil 2

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