Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis
| Autor: | Yong Lin, Janie Parrino, Neil M.H. Graham, Juan Rondon, Nancy Liu, Anne Paccaly, Claudia Pena-Rossi, Alberto Spindler, Richard Wu, Hubert van Hoogstraten, Paul Emery |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Nausea Injections Subcutaneous sarilumab Neutropenia Antibodies Monoclonal Humanized Gastroenterology Arthritis Rheumatoid 03 medical and health sciences chemistry.chemical_compound tocilizumab 0302 clinical medicine Tocilizumab Rheumatology Double-Blind Method Internal medicine Medicine Humans Pharmacology (medical) 030212 general & internal medicine Adverse effect skin and connective tissue diseases Aged 030203 arthritis & rheumatology business.industry Clinical Science Middle Aged medicine.disease Sarilumab Treatment Outcome Tolerability chemistry Rheumatoid arthritis Antirheumatic Agents intravenous Absolute neutrophil count subcutaneous Administration Intravenous Female medicine.symptom business RA |
| Zdroj: | Rheumatology (Oxford, England) |
| ISSN: | 1462-0324 |
| Popis: | Objective Safety and efficacy of mAbs blocking the IL-6 receptor have been established in RA. This is the first analysis examining safety and tolerability of sarilumab and tocilizumab administered as single or multiple doses in patients with RA within the same study. Methods In ASCERTAIN, patients were randomized 1: 1: 2 to 24 weeks’ double-blind sarilumab 150 or 200 mg every 2 weeks s.c. or tocilizumab 4 mg/kg every 4 weeks i.v., increased to 8 mg/kg if clinically indicated. In Study 1309, patients were randomized 1: 1: 1: 1 to single-dose open-label sarilumab 150 or 200 mg s.c. or tocilizumab 4 or 8 mg/kg i.v. Results In ASCERTAIN, incidence of treatment-emergent adverse events was similar between sarilumab and tocilizumab. The most common treatment-emergent adverse events were the following: sarilumab: neutropenia [6 patients (12.2%) in the 150 mg group and 8 (15.7%) in the 200 mg group], nasopharyngitis [6 (12.2%) and 3 (5.9%)], and injection-site erythema [4 (8.2%) and 4 (7.8%)]; tocilizumab: accidental overdose [9 (8.8%)], upper respiratory tract infection [7 (6.9%)] and nausea [7 (6.9%)]. Laboratory changes in both studies included decreased neutrophils and platelets and increased transaminases and lipids. In Study 1309, incidence of absolute neutrophil count Conclusion No clinically meaningful differences in treatment-emergent adverse events were observed between sarilumab and tocilizumab. Laboratory changes with sarilumab were within the same range as those with tocilizumab. Trial registration numbers ASCERTAIN (NCT01768572); Study 1309 (NCT02097524). |
| Databáze: | OpenAIRE |
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