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Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis

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Emery P1, Rondon J2, Parrino J3, Lin Y4, Pena-Rossi C4, van Hoogstraten H4, Graham NMH3, Liu N4, Paccaly A3, Wu R3, Spindler A5. Rheumatology (Oxford). 2018 Dec 19. doi: 10.1093/rheumatology/key361. [Epub ahead of print]

Abstract

Author information 1 Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. 2 Arthritis and Rheumatic Diseases of South Florida, Pembroke Pines, FL, USA. 3 Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA. 4 Sanofi Genzyme, Bridgewater, NJ, USA. 5 Rheumatology, Universidad Nacional de Tucumán, Tucumán, Argentina.

Abstract

OBJECTIVES: 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 <1.0 giga/l was similar between sarilumab and tocilizumab, and occurred more frequently in the higher dose groups. No association between decrease in absolute neutrophil count and increased incidence of infection was observed in either study.

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).