Literature DB >> 34397604

Safety updates in novel therapeutics for pediatric rheumatic disease.

Rachel L Randell1, Mara L Becker1,2.   

Abstract

PURPOSE OF REVIEW: Biologics and novel targeted therapeutics have transformed the management of pediatric rheumatic diseases over the past two decades; however, questions about short-term and long-term safety remain. Safety data gathered from recent clinical trials, long-term extensions of prior trials, registries, and other real-world evidence are summarized here for biologics and novel therapeutics commonly prescribed for pediatric rheumatic diseases. RECENT
FINDINGS: With nearly 20 years of therapeutic experience, tumor necrosis inhibitors (TNFi) are generally well tolerated, although infections, malignancy, and development of new autoimmunity remain a concern. Risk of infections may be higher in IL-1 and IL-6 inhibitors, and lower in abatacept, compared with TNFi. Safety data for B-cell-targeted therapeutics and janus kinase inhibitors are emerging, but remain limited, especially in children.
SUMMARY: Biologic and novel targeted therapeutics offer a promising future for children with pediatric rheumatic disease. However, long-term safety data in children remain limited for several agents. With any therapeutic option, both short-term and long-term safety concerns must be weighed against individual clinical needs when choosing the optimal treatment for each child.
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

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Year:  2021        PMID: 34397604      PMCID: PMC8826486          DOI: 10.1097/BOR.0000000000000811

Source DB:  PubMed          Journal:  Curr Opin Rheumatol        ISSN: 1040-8711            Impact factor:   4.941


  39 in total

1.  Update on malignancies in children with juvenile idiopathic arthritis in the German BIKER Registry.

Authors:  Gerd Horneff; Ariane Klein; Prasad T Oommen; Anton Hospach; Ivan Foeldvari; Isa Feddersen; Kirsten Minden
Journal:  Clin Exp Rheumatol       Date:  2016-09-08       Impact factor: 4.473

2.  Adalimumab versus adalimumab and methotrexate for the treatment of juvenile idiopathic arthritis: long-term data from the German BIKER registry.

Authors:  A Klein; I Becker; K Minden; I Foeldvari; J P Haas; G Horneff
Journal:  Scand J Rheumatol       Date:  2018-11-09       Impact factor: 3.641

3.  Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: a RCT.

Authors:  Athimalaipet V Ramanan; Andrew D Dick; Ashley P Jones; Dyfrig A Hughes; Andrew McKay; Anna Rosala-Hallas; Paula R Williamson; Ben Hardwick; Helen Hickey; Naomi Rainford; Graeme Hickey; Ruwanthi Kolamunnage-Dona; Giovanna Culeddu; Catrin Plumpton; Eifiona Wood; Sandrine Compeyrot-Lacassagne; Patricia Woo; Clive Edelsten; Michael W Beresford
Journal:  Health Technol Assess       Date:  2019-04       Impact factor: 4.014

4.  Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial.

Authors:  Sandra V Navarra; Renato M Guzmán; Alberto E Gallacher; Stephen Hall; Roger A Levy; Renato E Jimenez; Edmund K-M Li; Mathew Thomas; Ho-Youn Kim; Manuel G León; Coman Tanasescu; Eugeny Nasonov; Joung-Liang Lan; Lilia Pineda; Z John Zhong; William Freimuth; Michelle A Petri
Journal:  Lancet       Date:  2011-02-04       Impact factor: 79.321

5.  Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis.

Authors:  Athimalaipet V Ramanan; Andrew D Dick; Ashley P Jones; Andrew McKay; Paula R Williamson; Sandrine Compeyrot-Lacassagne; Ben Hardwick; Helen Hickey; Dyfrig Hughes; Patricia Woo; Diana Benton; Clive Edelsten; Michael W Beresford
Journal:  N Engl J Med       Date:  2017-04-27       Impact factor: 91.245

6.  Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials.

Authors:  Nicolino Ruperto; Hermine I Brunner; Pierre Quartier; Tamàs Constantin; Nico M Wulffraat; Gerd Horneff; Ozgur Kasapcopur; Rayfel Schneider; Jordi Anton; Judith Barash; Reinhard Berner; Fabrizia Corona; Ruben Cuttica; Marine Fouillet-Desjonqueres; Michel Fischbach; Helen E Foster; Dirk Foell; Sebastião C Radominski; Athimalaipet V Ramanan; Ralf Trauzeddel; Erbil Unsal; Jérémy Levy; Eleni Vritzali; Alberto Martini; Daniel J Lovell
Journal:  Ann Rheum Dis       Date:  2018-09-29       Impact factor: 19.103

7.  Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial.

Authors:  Ivan Foeldvari; Tamàs Constantin; Jelena Vojinović; Gerd Horneff; Vyacheslav Chasnyk; Joke Dehoorne; Violeta Panaviene; Gordana Sušić; Valda Stanevicha; Katarzyna Kobusinska; Zbigniew Zuber; Bogna Dobrzyniecka; Irina Nikishina; Brigitte Bader-Meunier; Luciana Breda; Pavla Doležalová; Chantal Job-Deslandre; Ingrida Rumba-Rozenfelde; Nico Wulffraat; Ronald D Pedersen; Jack F Bukowski; Bonnie Vlahos; Alberto Martini; Nicolino Ruperto
Journal:  Arthritis Res Ther       Date:  2019-05-23       Impact factor: 5.156

8.  Safety and Efficacy of Belimumab Plus Standard Therapy for Up to Thirteen Years in Patients With Systemic Lupus Erythematosus.

Authors:  Daniel J Wallace; Ellen M Ginzler; Joan T Merrill; Richard A Furie; William Stohl; W Winn Chatham; Arthur Weinstein; James D McKay; W Joseph McCune; Michelle Petri; James Fettiplace; David A Roth; Beulah Ji; Amy Heath
Journal:  Arthritis Rheumatol       Date:  2019-06-05       Impact factor: 10.995

9.  Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial.

Authors:  Hermine I Brunner; Nicolino Ruperto; Zbigniew Zuber; Caroline Keane; Olivier Harari; Andrew Kenwright; Peng Lu; Ruben Cuttica; Vladimir Keltsev; Ricardo M Xavier; Inmaculada Calvo; Irina Nikishina; Nadina Rubio-Pérez; Ekaterina Alexeeva; Vyacheslav Chasnyk; Gerd Horneff; Violetta Opoka-Winiarska; Pierre Quartier; Clovis A Silva; Earl Silverman; Alberto Spindler; Eileen Baildam; M Luz Gámir; Alan Martin; Christoph Rietschel; Daniel Siri; Elzbieta Smolewska; Daniel Lovell; Alberto Martini; Fabrizio De Benedetti
Journal:  Ann Rheum Dis       Date:  2014-05-16       Impact factor: 19.103

10.  Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis.

Authors:  Nicolino Ruperto; Hermine I Brunner; César Pacheco-Tena; Ingrid Louw; Gabriel Vega-Cornejo; Alberto J Spindler; Daniel J Kingsbury; Heinrike Schmeling; Arturo Borzutzky; Rubén Cuttica; C J Inman; Victor Malievskiy; Christiaan Scott; Vladimir Keltsev; Maria Teresa Terreri; Diego Oscar Viola; Ricardo M Xavier; Taciana A Pedrosa Fernandes; María Del Rocío Maldonado Velázquez; Michael Henrickson; Michael B Clark; Karen A Bensley; Xiaoming Li; Kim Hung Lo; Jocelyn H Leu; Chyi-Hung Hsu; Elizabeth C Hsia; Zhenhua Xu; Alberto Martini; Daniel J Lovell
Journal:  Rheumatology (Oxford)       Date:  2021-10-02       Impact factor: 7.580

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