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Adalimumab in pediatrics

Gergely Iványi, Romána Zelkó
OBJECTIVE: The intention of the present study was to demonstrate the postauthorization changes of adalimumab (European trade name: Humira), evaluating the variations in its safety, efficacy, and quality profile. METHODS: Type-II, major variations of the Summary of Product Characteristics (SmPC) from September 8, 2003 to November 19, 2015, were analyzed, which, according to Commission Regulation (EC) No. 1234/2008, have to reflect changes that may have a significant impact on the safety, efficacy, or quality profile of a medicinal product...
November 30, 2016: International Journal of Clinical Pharmacology and Therapeutics
Gerd Horneff, Ariane Klein, Jens Klotsche, Kirsten Minden, Hans-Iko Huppertz, Frank Weller-Heinemann, Jasmin Kuemmerle-Deschner, Johannes-Peter Haas, Anton Hospach
BACKGROUND: Treatment response, remission rates and compliance in patients with polyarticular juvenile idiopathic arthritis (polyJIA) treated with adalimumab, etanercept, or tocilizumab were analyzed in clinical practice. METHODS: Data collected in the German BIKER registry were analyzed in patients with polyJIA who started treatment with approved biologics, adalimumab, etanercept or tocilizumab, from 2011 to 2015. Baseline patient characteristics, treatment response, safety and drug survival were compared...
November 24, 2016: Arthritis Research & Therapy
Amir B Orandi, Eric Eutsler, Cole Ferguson, Andrew J White, Maleewan Kitcharoensakkul
BACKGROUND: Sarcoidosis is a multi-system disease characterized by the presence of non-caseating epithelioid granulomas in affected tissues, including skeletal muscle. These organized collections of immune cells have important pathophysiologic action including cytokine production leading to inflammation as well as enzymatic conversion of cholecalciferol to calcitriol via 1-α hydroxylase. There are limited reports of isolated granulomatous myositis causing hypercalcemia in pediatric patients...
November 10, 2016: Pediatric Rheumatology Online Journal
Merih Oray, İlknur Tuğal-Tutkun
Pediatric uveitis may be a serious health problem because of the lifetime burden of vision loss due to severe complications if the problem is not adequately treated. Juvenile idiopathic arthritis (JIA)-associated uveitis is characterized by insidious onset and potentially blinding chronic anterior uveitis. Periodic ophthalmologic screening is of utmost importance for early diagnosis of uveitis. Early diagnosis and proper immunomodulatory treatment are essential for good visual prognosis. The goal of treatment is to achieve enduring drug-free remission...
April 2016: Turkish Journal of Ophthalmology
Athanasios Tragiannidis, Ioannis Kyriakidis, Ilse Zündorf, Andreas H Groll
Macromolecular immunosuppressive monoclonal antibodies and fusion proteins directed against molecules or cells involved in inflammation and immunity represent a recent and important addition to our therapeutic armamentarium. Tumor necrosis alpha (TNFα) is a cytokine involved in systemic inflammation and clinical utilization of its antagonists has revolutionized treatment of juvenile rheumatoid and psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. Clinical utility has also been demonstrated for use against steroid-refractory graft-vs-host disease and other immune-mediated conditions...
October 21, 2016: Mycoses
Carmelo Guerrero-Laleona, Joan Calzada-Hernández, Matilde Bustillo-Alonso, Jorge Gil-Albarova, Marta Medrano-San Ildefonso, Estibaliz Iglesias-Jiménez, Antoni Noguera-Julian
Treatment with tumor necrosis factor α inhibitors is a risk factor for tuberculosis (TB). Despite previous treatment with isoniazid for latent TB, a 9-year-old girl with juvenile idiopathic arthritis developed disseminated TB after changing therapy with etanercept to adalimumab and after new contact with a smear-positive relative. Genotyping strain matches and susceptibility to isoniazid make reinfection more likely than reactivation in our patient.
January 2017: Pediatric Infectious Disease Journal
Domenico Corica, Claudio Romano
The incidence of inflammatory bowel disease (IBD) has increased steadily worldwide, both in adult and in children; approximately 25% of IBD patients are diagnosed before the age of 18. The natural history of IBD is usually more severe in children than in adults, and can be associated with linear growth impairment, delayed puberty onset, reduced bone mass index, malnutrition, and the need for surgery. Biological therapies, especially blocking tumor necrosis factor-α (TNFα), have radically modified the treatment strategies and disease course of IBD in children...
September 15, 2016: Journal of Clinical Gastroenterology
Kenji Hosoi, Yoshikazu Ohtsuka, Tohru Fujii, Takahiro Kudo, Nobuaki Matsunaga, Takeshi Tomomasa, Hitoshi Tajiri, Reiko Kunisaki, Takashi Ishige, Hiroyuki Yamada, Katsuhiro Arai, Atsushi Yoden, Kosuke Ushijima, Tomoki Aomatsu, Satoru Nagata, Keiichi Uchida, Kazuo Takeuchi, Toshiaki Shimizu
BACKGROUND: Childhood-onset inflammatory bowel disease (IBD) is characterized by extensive intestinal involvement and rapid early progression. Infliximab (IFX), cyclosporine (CYA), and tacrolimus (FK506) are increasingly used to treat pediatric IBD; however, their long-term effects and adverse events have not been properly investigated in pediatric patients. The aim of this study was to characterize the effects of these biologics and immunomodulators on pediatric IBD patients in Japan...
July 31, 2016: Journal of Gastroenterology and Hepatology
Sami K Saikaly, Monica Mattes
Generalized pustular psoriasis (GPP) is a rare form of childhood psoriasis, often requiring systemic therapy, which is challenging as there is a paucity of randomized controlled trials and standardized guidelines. Biologic agents have been used in adults and in pediatric plaque psoriasis, but evidence regarding their efficacy in pediatric GPP has slowly become available. The objective of this study is to summarize and compare the efficacy and safety of biologic agents, such as etanercept, infliximab, and adalimumab, in the treatment of pediatric GPP...
2016: Curēus
Won Jae Song, Ben Kang, So Yoon Choi, Yon Ho Choe
PURPOSE: We aimed to investigate the efficacy and safety of adalimumab in pediatric-onset Crohn's disease patients who had failed treatment with infliximab. METHODS: In this retrospective study, patients included were those who had been diagnosed with Crohn's disease before 18 years old, and had received treatment with adalimumab after infliximab failure. The efficacy of adalimumab treatment was investigated at 1 month and 1 year, and adverse events that had occurred during treatment with adalimumab were explored...
June 2016: Pediatric Gastroenterology, Hepatology & Nutrition
Elizabeth C Maxwell, Andrew B Grossman
No abstract text is available yet for this article.
2016: Adolescent Medicine: State of the Art Reviews
Jonathan Shepherd, Keith Cooper, Petra Harris, Joanna Picot, Micah Rose
BACKGROUND: Juvenile idiopathic arthritis (JIA) is characterised by joint pain, swelling and a limitation of movement caused by inflammation. Subsequent joint damage can lead to disability and growth restriction. Treatment commonly includes disease-modifying antirheumatic drugs (DMARDs), such as methotrexate. Clinical practice now favours newer drugs termed biologic DMARDs where indicated. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of four biologic DMARDs [etanercept (Enbrel(®), Pfizer), abatacept (Orencia(®), Bristol-Myers Squibb), adalimumab (Humira(®), AbbVie) and tocilizumab (RoActemra(®), Roche) - with or without methotrexate where indicated] for the treatment of JIA (systemic or oligoarticular JIA are excluded)...
April 2016: Health Technology Assessment: HTA
Claudia Castiblanco, Halea Meese, C Stephen Foster
PURPOSE: To evaluate adalimumab therapy in children with uveitis. METHODS: The electronic health records of pediatric patients diagnosed with uveitis and treated with adalimumab therapy were reviewed retrospectively. Demographic information, site and degree of intraocular inflammation, visual acuity, underlying systemic disorders, duration of therapy, side effects, and ability to obtain steroid-free remission were recorded. RESULTS: A total of 17 patients were included, 16 patients with anterior uveitis and 1 with panuveitis; 14 patients had bilateral disease...
April 2016: Journal of AAPOS: the Official Publication of the American Association for Pediatric Ophthalmology and Strabismus
Nitin Mehrotra, Atul Bhattaram, Justin C Earp, Jeffry Florian, Kevin Krudys, Jee Eun Lee, Joo Yeon Lee, Jiang Liu, Yeruk Mulugeta, Jingyu Yu, Ping Zhao, Vikram Sinha
Dose selection is one of the key decisions made during drug development in pediatrics. There are regulatory initiatives that promote the use of model-based drug development in pediatrics. Pharmacometrics or quantitative clinical pharmacology enables development of models that can describe factors affecting pharmacokinetics and/or pharmacodynamics in pediatric patients. This manuscript describes some examples in which pharmacometric analysis was used to support approval and labeling in pediatrics. In particular, the role of pharmacokinetic (PK) comparison of pediatric PK to adults and utilization of dose/exposure-response analysis for dose selection are highlighted...
July 2016: Drug Metabolism and Disposition: the Biological Fate of Chemicals
Piotr Dziechciarz, Andrea Horvath, Jaroslaw Kierkuś
BACKGROUND AND AIM: Adalimumab is well-established therapy for adults with Crohn's disease [CD]. The aim of the study was to systematically assess the published evidence on the efficacy and safety of adalimumab for Crohn's disease in children. METHODS: MEDLINE, EMBASE, the Cochrane Library, and abstracts from the main gastroenterological meetings in the past 5 years were systematically searched up to July 2015 for randomised controlled trials and observational studies on the efficacy and safety of adalimumab for Crohn's treatment in children and adolescents...
October 2016: Journal of Crohn's & Colitis
Laura Merras-Salmio, Kaija-Leena Kolho
Anti-tumor necrosis factor-alpha (TNF-α) blockade is so far the most effective therapy for extensive pediatric Crohn disease (CD), but loss of response is frequently encountered. We describe here the use of golimumab (Simponi) in 6 pediatric CD patients with antibody formation/loss of response to infliximab and adalimumab. Most patients had undergone surgery but had poor disease control. After introduction of golimumab, the levels of inflammatory markers and fecal calprotectin declined at first, but the response was not sustained...
September 2016: Journal of Pediatric Gastroenterology and Nutrition
Marla C Dubinsky, Joel Rosh, William A Faubion, Jaroslaw Kierkus, Frank Ruemmele, Jeffrey S Hyams, Samantha Eichner, Yao Li, Bidan Huang, Nael M Mostafa, Andreas Lazar, Roopal B Thakkar
BACKGROUND: The efficacy of adalimumab in inducing and maintaining remission in children with moderately to severely active Crohn's disease was shown in the IMAgINE 1 trial (NCT00409682). As per protocol, nonresponders or patients experiencing flare(s) on every other week (EOW) maintenance dosing could escalate to weekly dosing; we aimed to determine the therapeutic benefits of weekly dose escalation in this subpopulation. METHODS: Week 52 remission and response rates were assessed in patients who escalated to weekly dosing from their previous EOW schedule, which was according to randomized treatment dose (higher dose [HD] adalimumab [≥40 kg, 40 mg EOW; <40 kg, 20 mg EOW] or lower dose [LD; ≥40 kg, 20 mg EOW; <40 kg, 10 mg EOW])...
April 2016: Inflammatory Bowel Diseases
Javier Blasco Alonso, Francisco Girón Fernández-Crehuet, Miguel A Lendínez Ramírez, Sivia Gallego Gutiérrez, Silvia Luque Pérez, Juliana Serrano Nieto, Víctor M Navas López, Carlos Sierra Salinas
INTRODUCTION AND OBJECTIVES: Metastatic Crohn's disease (MCD) is an extraintestinal manifestation of Crohn's disease, with biopsy as fundamental diagnostic tool. There are few references to MCD in children, with a 0.5-1% estimated incidence in adults. There is no consensus about its therapeutic approach. We describe our diagnostic and therapeutic experience in MCD. RESULTS: Four cases of MCD are described in our Pediatric Gastroenterology Unit in a tertiary care hospital...
September 2016: Revista Española de Enfermedades Digestivas
Casey Bishop, Hayley Simon, David Suskind, Dale Lee, Ghassan Wahbeh
OBJECTIVES: We describe the use of ustekinumab for 4 patients with pediatric Crohn disease treated at the Seattle Children's Hospital Inflammatory Bowel Disease Center. METHODS: A retrospective chart review was done to identify patients' clinical data, disease phenotype, treatment history, and laboratory and growth parameters before treatment with ustekinumab and at last follow-up. Adverse events while on ustekinumab were also recorded. RESULTS: Four adolescent patients with Crohn disease at our center received ustekinumab...
September 2016: Journal of Pediatric Gastroenterology and Nutrition
Prativa S A Jayasekera, Maeve L Walsh, Daniel Hurrell, Richard A G Parslew
A 12-year-old girl with extended oligoarthritis treated with adalimumab presented with a short history of a progressive cutaneous eruption involving the legs and scalp. Physical examination and histologic results were consistent with lichen planopilaris. The adalimumab was discontinued. She received treatment with topical clobetasol propionate and the majority of the lesions resolved. Residual lesions and the extended oligoarthritis were then treated with sulfasalazine. Adalimumab is a tumor necrosis factor α (TNF-α) inhibitor used for the treatment of a variety of immunologically mediated conditions, including lichen planus and lichen planopilaris...
March 2016: Pediatric Dermatology
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