Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)

Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)

Author Burmester, Gerd R. Google Scholar
Rubbert-Roth, Andrea Google Scholar
Cantagrel, Alain Google Scholar
Hall, Stephen Google Scholar
Leszczynski, Piotr Google Scholar
Feldman, Daniel Autor UNIFESP Google Scholar
Rangaraj, Madura J. Google Scholar
Roane, Georgia Google Scholar
Ludivico, Charles Google Scholar
Bao, Min Google Scholar
Rowell, Lucy Google Scholar
Davies, Claire Google Scholar
Mysler, Eduardo F. Google Scholar
Abstract Objectives To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs). Methods Patients (n=1262) were randomised 1: 1 to receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw in combination with DMARD(s). After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11: 1 to TCZ-SC (n=521) or TCZ-IV (TCZ-SCIV, n=48), and patients receiving TCZ-IV were re-randomised 2: 1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV-SC

n=186). Maintenance of clinical responses and safety through week 97 were assessed. Results The proportions of patients who achieved American College of Rheumatology (ACR) 20/50/70 responses, Disease Activity Score in 28 joints remission and improvement from baseline in Health Assessment Questionnaire Disability Index >= 0.3 were sustained through week 97 and comparable across arms. TCZ-SC had a comparable safety profile to TCZ-IV through week 97, except that injection site reactions (ISRs) were more common with TCZ-SC. Safety profiles in patients who switched were similar to those in patients who received continuous TCZ-SC or TCZ-IV treatment. The proportion of patients who developed anti-TCZ antibodies remained low across treatment arms. No association between anti-TCZ antibody development and clinical response or adverse events was observed. Conclusions The long-term efficacy and safety of TCZ-SC was maintained and comparable to that of TCZ-IV, except for ISRs. Profiles in patients who switched formulations were comparable to those in patients who received TCZ-IV or TCZ-SC. TCZ-SC provides additional treatment options for patients with RA.
Keywords Modifying Antirheumatic Drugs
Interleukin-6 Receptor Inhibition
Rheumatoid-Arthritis
Double-Blind
Biologic Agents
Placebo
Trial
Professionals
Monotherapy
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Language English
Sponsor Roche
F. Hoffmann-La Roche, Ltd.
Date 2016
Published in Annals Of The Rheumatic Diseases. London, v. 75, n. 1, p. 68-74, 2016.
ISSN 0003-4967 (Sherpa/Romeo, impact factor)
Publisher Bmj Publishing Group
Extent 68-74
Origin http://dx.doi.org/10.1136/annrheumdis-2015-207281
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000366402400049
URI http://repositorio.unifesp.br/handle/11600/49698

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