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Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis.
- Source :
- Rheumatology; Jun2019, Vol. 58 Issue 6, p1056-1064, 9p, 2 Charts, 3 Graphs
- Publication Year :
- 2019
-
Abstract
- Objectives This post hoc analysis of the TOZURA study programme evaluated the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) as monotherapy or with concomitant conventional synthetic DMARDs (csDMARDs) in patients with RA categorized by baseline glucocorticoid (GC) use. Methods TOZURA was a multinational, open-label, single-arm, common-framework study programme (11 protocols, 22 countries) in patients with moderate to severe RA in whom csDMARDs or biologic therapies had failed or who were MTX naïve. Patients received once-weekly TCZ-SC 162 mg for ⩾24 weeks as monotherapy or in combination with csDMARDs and/or oral GC use (⩽10 mg/day prednisone or equivalent), which was to be continued unchanged for 24 weeks. Treatment subgroups were defined by baseline GC use and analysed for efficacy and safety. Results Of 1804 patients who received TCZ-SC, 145 received monotherapy + GC, 208 received monotherapy without GC, 730 received combination therapy + GC and 721 received combination therapy without GC. The median GC dose in both GC subgroups was 5 mg/day. The proportion of patients who achieved clinical remission, defined as DAS in 28 joints using ESR <2.6, increased similarly from baseline to week 24 in all subgroups. Improvements in patient-reported outcomes were similar in all subgroups. Overall adverse event profiles were generally similar between subgroups, with some slight numerical differences between GC and non-GC subgroups. Conclusion The incremental efficacy benefits of TCZ-SC as monotherapy and in combination with csDMARDs were similar between patients with and without previous and continued oral GC treatment, with generally similar safety profiles. Trial Registration ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01941940, NCT01941095, NCT01951170, NCT01987479, NCT01988012, NCT01995201, NCT02001987, NCT02011334, NCT02031471, NCT02046603, NCT02046616. [ABSTRACT FROM AUTHOR]
- Subjects :
- THERAPEUTIC use of glucocorticoids
ANTIRHEUMATIC agents
SUBCUTANEOUS injections
BIOTHERAPY
COMBINATION drug therapy
COMBINED modality therapy
HEALTH outcome assessment
RHEUMATOID arthritis
STATISTICS
DATA analysis
TREATMENT effectiveness
EVALUATION of human services programs
TOCILIZUMAB
THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 14620324
- Volume :
- 58
- Issue :
- 6
- Database :
- Complementary Index
- Journal :
- Rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 136673219
- Full Text :
- https://doi.org/10.1093/rheumatology/key393