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Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries.
- Source :
- Rheumatology; Mar2018, Vol. 57 Issue 3, p499-507, 9p, 1 Diagram, 2 Charts, 3 Graphs
- Publication Year :
- 2018
-
Abstract
- Objectives. The aim of this pooled analysis of the TOZURA study programme was to evaluate the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) as monotherapy or in combination with conventional synthetic DMARDs (csDMARDs) in patients with moderate to severe RA who had an inadequate response to csDMARD or anti-TNF agent therapy or who were MTX naive. Methods. TOZURA is a multinational, open-label, single-arm, common-framework, phase 4 study programme (11 protocols, 22 countries). Patients received TCZ-SC 162 mg each week for ≥24 weeks, administered at the investigator's discretion, as monotherapy or in combination with a csDMARD. Efficacy, safety and immuno-genicity were evaluated; propensity score-based matching was used for between-group comparisons. Results. Of 1804 patients, 353 (19.6%) received monotherapy and 1451 (80.4%) received combination therapy. The 28-joint DAS using ESR (DAS28-ESR) in both groups decreased significantly from baseline to week 24 (mean change: monotherapy -3.40, combination therapy -3.46), with no significant difference between groups (P = 0.46). The proportion of patients who achieved DAS28-ESR or Clinical Disease Activity Index remission or ACR 20/50/70/90 responses was similar between groups. Overall, 13.9% of patients withdrew--6.2% for safety reasons and 1.6% for insufficient therapeutic response; 5.8% of patients experienced one or more serious adverse events [14.6/100 patient-years (PY)]; six deaths occurred (0.64/100 PY). Conclusion. In a common framework of 11 studies in 22 countries, this phase 4 study programme confirmed TCZ-SC's known efficacy and safety profile with comparable effects as monotherapy and in combination with csDMARDs. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 14620324
- Volume :
- 57
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 128179907
- Full Text :
- https://doi.org/10.1093/rheumatology/kex443