Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis : results of a multicentre, double-blind, randomised-withdrawal trial
| Autor: | Zhenhua Xu, Nicolino Ruperto, Andreas Reiff, Violeta Panaviene, W. Emminger, Maria Del Rocio Maldonado Velázquez, Kirsten Minden, Marcia Bandeira, Hermine I. Brunner, Rik Joos, Elżbieta Smolewska, L. Kim, Carlos Abud-Mendoza, Daniel J. Kingsbury, Nadina Rubio-Pérez, Bernard Lauwerys, Ekaterina Alexeeva, Jocelyn H. Leu, Alberto Martini, Keith Gilmer, Irina Nikishina, Matthew J. Loza, S. Lamberth, Vyacheslav Chasnyk, Nikolay Tzaribachev, Annet van Royen-Kerkhof, Ivan Foeldvari, Vladimir Keltsev, Flavio Sztajnbok, Gerd Horneff, Earl D. Silverman, Daniel J. Lovell |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
Juvenile Arthritis Biochemistry anti-tumour necrosis factor biologics golimumab juvenile idiopathic arthritis Adolescent Antibodies Monoclonal Antirheumatic Agents Arthritis Juvenile Child Child Preschool Double-Blind Method Drug Therapy Combination Female Humans Injections Subcutaneous Methotrexate Remission Induction Symptom Flare Up Treatment Outcome Etanercept 0302 clinical medicine Monoclonal Clinical endpoint Immunology and Allergy 030212 general & internal medicine Body surface area Subcutaneous Combination medicine.drug medicine.medical_specialty Immunology Placebo Antibodies General Biochemistry Genetics and Molecular Biology Injections 03 medical and health sciences Drug Therapy Rheumatology Internal medicine medicine Preschool Adverse effect 030203 arthritis & rheumatology business.industry Biochemistry Genetics and Molecular Biology(all) Clinical and Epidemiological Research medicine.disease Golimumab Surgery Clinical trial business Genetics and Molecular Biology(all) |
| Zdroj: | Annals of the Rheumatic Diseases, 77(1), 21. BMJ Publishing Group Annals of the Rheumatic Diseases |
| ISSN: | 0003-4967 |
| Popis: | ObjectiveThis report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA).MethodsIn this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m2 of body surface area; maximum: 50 mg/dose) every 4 weeks together with weekly methotrexate during Part 1 (weeks 0–16). Patients with at least 30% improvement per American College of Rheumatology Criteria for JIA (JIA ACR30) in Part 1 entered the double-blinded Part 2 (weeks 16–48) after 1:1 randomisation to continue golimumab or start placebo. In Part 3, golimumab was continued or could be restarted as in Part 1. The primary outcome was JIA flares in Part 2; secondary outcomes included JIA ACR50/70/90 responses, clinical remission, PK and safety.ResultsAmong 173 patients with polyJIA enrolled, 89.0% (154/173) had a JIA ACR30 response and 79.2%/65.9%/36.4% demonstrated JIA ACR50/70/90 responses in Part 1. At week 48, the primary endpoint was not met as treatment groups had comparable JIA flare rates (golimumab vs placebo: 32/78=41% vs 36/76=47%; p=0.41), and rates of clinical remission were comparable (golimumab vs placebo: 10/78=12.8% vs 9/76=11.8%). Adverse event and serious adverse event rates were similar in the treatment groups during Part 2. Injection site reactions occurred with ConclusionAlthough the primary endpoint was not met, golimumab resulted in rapid, clinically meaningful, improvement in children with active polyJIA. Golimumab was well tolerated, and no unexpected safety events occurred.Clinical Trial RegistrationNCT01230827; Results. |
| Databáze: | OpenAIRE |
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