A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study)
| Autor: | Gerd R Burmester, Piotr Leszczyński, Charles Ludivico, Georgia Roane, Min Bao, Madura J. Rangaraj, Alain Cantagrel, Andrea Rubbert-Roth, Eduardo Mysler, Lucy Rowell, Peng Lu, Stephen B. Hall, Daniel Feldman |
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| Přispěvatelé: | Charite, Free Univ Berlin, Humboldt Univ, Klinikum Univ Koln, Ctr Hosp Univ Toulouse, Cabrini Med Ctr, Poznan Univ Med Sci, Universidade Federal de São Paulo (UNIFESP), Arthrit & Diabet Clin Inc, Rheumatol Associates PA, East Penn Rheumatol Associates PC, Hoffmann La Roche Inc, Roche Prod Ltd, Genentech Inc, Org Med Invest |
| Rok vydání: | 2013 |
| Předmět: |
Adult
Male musculoskeletal diseases medicine.medical_specialty Injections Subcutaneous Immunology Rheumatoid Arthritis DMARDs (biologic) Antibodies Monoclonal Humanized Severity of Illness Index General Biochemistry Genetics and Molecular Biology Arthritis Rheumatoid chemistry.chemical_compound Tocilizumab Double-Blind Method Rheumatology Internal medicine Severity of illness medicine Humans Immunology and Allergy Disease Activity skin and connective tissue diseases Adverse effect Aged business.industry Incidence (epidemiology) Middle Aged Clinical and Epidemiological Research medicine.disease Connective tissue disease Surgery Antirheumatic Agents Treatment Outcome chemistry Rheumatoid arthritis Injections Intravenous Drug Therapy Combination Female business Immunosuppressive Agents |
| Zdroj: | Repositório Institucional da UNIFESP Universidade Federal de São Paulo (UNIFESP) instacron:UNIFESP Annals of the Rheumatic Diseases |
| ISSN: | 1468-2060 0003-4967 |
| DOI: | 10.1136/annrheumdis-2013-203523 |
| Popis: | Roche. F. Hoffmann-La Roche, Ltd (Roche) Objectives This study compared the efficacy and safety of subcutaneous (SC) versus intravenous (IV) formulations of tocilizumab in patients with rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs (DMARD).Methods Patients (n=1262) were randomly assigned to receive tocilizumab-SC 162mg weekly+placebo-IV every 4weeks or tocilizumab-IV 8mg/kg every 4weeks+placebo-SC weekly in combination with traditional DMARD. the primary outcome was to demonstrate the non-inferiority of tocilizumab-SC to tocilizumab-IV with regard to the proportion of patients in each group achieving an American College of Rheumatology (ACR) 20 response at week 24 using a 12% non-inferiority margin (NIM). Secondary outcomes were disease activity score using 28 joints (DAS28), ACR responses, health assessment questionnaire scores and safety assessments.Results At week 24, 69.4% (95% CI 65.5 to 73.2) of tocilizumab-SC-treated patients versus 73.4% (95% CI 69.6 to 77.1) of tocilizumab-IV-treated patients achieved an ACR20 response (weighted difference between groups -4.0%, 95% CI -9.2 to 1.2); the 12% NIM was met. ACR50/70 responses, DAS28 and physical function improvements were comparable between the tocilizumab-SC and tocilizumab-IV groups. the safety profiles of tocilizumab-SC and tocilizumab-IV were similar, and the most common adverse event was infection. Injection-site reactions (ISR) occurred more frequently in the tocilizumab-SC group than in the tocilizumab-IV (placebo-SC) group. No anaphylaxis was reported over the 24weeks.Conclusions Tocilizumab-SC 162mg weekly demonstrated comparable efficacy to tocilizumab-IV 8mg/kg. the safety profile of tocilizumab-SC is consistent with the known and well-established safety profile of tocilizumab-IV, with the exception of a higher incidence of ISR, which were more common with tocilizumab-SC administration. Charite, D-10117 Berlin, Germany Free Univ Berlin, Berlin, Germany Humboldt Univ, D-10099 Berlin, Germany Klinikum Univ Koln, Cologne, Germany Ctr Hosp Univ Toulouse, Toulouse, France Cabrini Med Ctr, Malvern, Australia Poznan Univ Med Sci, J Strus Poznan Municipal Hosp, Poznan, Poland Universidade Federal de São Paulo, São Paulo, Brazil Arthrit & Diabet Clin Inc, Monroe, LA USA Rheumatol Associates PA, Charleston, SC USA East Penn Rheumatol Associates PC, Bethlehem, PA USA Hoffmann La Roche Inc, Nutley, NJ 07110 USA Roche Prod Ltd, Welwyn Garden City AL7 3AY, Herts, England Genentech Inc, San Francisco, CA 94080 USA Org Med Invest, Buenos Aires, DF, Argentina Universidade Federal de São Paulo, EPM, São Paulo, Brazil Web of Science |
| Databáze: | OpenAIRE |
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