Efficacy and Safety of Tocilizumab for Polyarticular‐Course Juvenile Idiopathic Arthritis in the Open‐Label Two‐Year Extension of a Phase III Trial
| العنوان: | Efficacy and Safety of Tocilizumab for Polyarticular‐Course Juvenile Idiopathic Arthritis in the Open‐Label Two‐Year Extension of a Phase III Trial |
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| المؤلفون: | Ruben Cuttica, Rik Joos, Hermine I. Brunner, Yukiko Kimura, Zbigniew Zuber, Manuel Ferrandiz Zavaler, Nicolino Ruperto, Kamal N. Bharucha, Fabrizio De Benedetti, Sunethra Wimalasundera, Ruben Burgos-Vargas, Inmaculada Calvo Penades, Graciela Espada, Wendy Douglass, Alberto Martini, Vladimir Keltsev, Chris Wells, Earl D. Silverman, Ricardo Machado Xavier, Chantal Job-Deslandre, Daniel J. Lovell, Carolina Duarte |
| المصدر: | Arthritis & Rheumatology (Hoboken, N.j.) |
| بيانات النشر: | John Wiley and Sons Inc., 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | musculoskeletal diseases, Male, medicine.medical_specialty, Adolescent, Immunology, Population, Full Length, Arthritis, Placebo, Antibodies, Monoclonal, Humanized, Infections, 03 medical and health sciences, Juvenile Arthritis Disease Activity Score, chemistry.chemical_compound, 0302 clinical medicine, Tocilizumab, Chickenpox, Rheumatology, 030225 pediatrics, Internal medicine, medicine, Immunology and Allergy, Humans, Patient Reported Outcome Measures, Adverse effect, education, skin and connective tissue diseases, Bronchitis, Child, Glucocorticoids, 030203 arthritis & rheumatology, education.field_of_study, business.industry, Cellulitis, Pneumonia, medicine.disease, Pediatric Rheumatology, Arthritis, Juvenile, Clinical trial, Methotrexate, Treatment Outcome, chemistry, Antirheumatic Agents, Child, Preschool, Female, Chemical and Drug Induced Liver Injury, business, medicine.drug |
| الوصف: | Objective To report the 2‐year efficacy and safety of tocilizumab (TCZ) in patients with polyarticular‐course juvenile idiopathic arthritis (JIA). Methods Patients ages 2–17 years with active polyarticular‐course JIA, in whom treatment with methotrexate was unsuccessful, received 16 weeks of open‐label intravenous TCZ in part 1 (once every 4 weeks: 8 mg/kg or 10 mg/kg for body weight [BW] 1 of the remaining JIA CRVs by >30%) at week 16 were randomly assigned (1:1) to receive TCZ or placebo in part 2. Patients remained in part 2 until either week 40 or the occurrence of JIA flare. Upon starting part 3, all patients received open‐label TCZ. At week 104 of the study, efficacy was assessed using JIA‐ACR50/70/90 response rates (defined as 50%, 70%, or 90% improvement, respectively), achievement of inactive disease, and the Juvenile Arthritis Disease Activity Score in 71 joints (JADAS‐71). Safety was assessed in the all‐exposure population per 100 patient‐years of exposure. Results Overall, 188 patients entered part 1, 166 patients entered part 2, and 160 patients entered part 3. By week 104, among the 188 patients in the modified intent‐to‐treat group who received TCZ, JIA‐ACR50/70/90 response rates were 80.3%/77.1%/59.6%, respectively, the median JADAS‐71 score decreased from 3.6 at week 40 to 0.7 at week 104, 51.1% of patients had achieved inactive disease, and 31 of 66 patients who had been receiving glucocorticoids discontinued them. Adverse event (AE) and serious AE rates were 406.5 per 100 patient‐years and 11.1 per 100 patient‐years, respectively. The infection rate was 151.4 per 100 patient‐years, and the serious infection rate was 5.2 per 100 patient‐years. Conclusion Patients treated with TCZ for polyarticular‐course JIA showed high‐level disease control for up to 2 years. The TCZ safety profile was consistent with that previously reported. |
| اللغة: | English |
| تدمد: | 2326-5205 2326-5191 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b134ea905446bbdd96810445ac41b0d6 http://europepmc.org/articles/PMC7986602 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....b134ea905446bbdd96810445ac41b0d6 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 23265205 23265191 |
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