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Abstract
Introduction
The objective of this study was to observe the patterns of usage, efficacy, and safety of tocilizumab (TCZ) in clinical practice in patients with rheumatoid arthritis.
Methods
Data on the real-world usage, efficacy, and safety of TCZ were collected from patients during routine follow-up visits conducted over a 6-month period. Patients were grouped by previous exposure to biologic therapies (biologic exposed vs. biologic naive).
Results
Of 1912 patients enrolled from 16 countries, 639 (33.4%) received TCZ monotherapy and 1273 (66.6%) received TCZ combination therapy. At baseline, 1073 patients (56.1%) were biologic naive and 839 (43.9%) were biologic exposed. At 6 months, 1504 patients (78.7%) continued to receive TCZ treatment, with no descriptive differences in retention rates between biologic-exposed and biologic-naive patients and between patients receiving TCZ monotherapy or combination therapy. Dose and use of methotrexate and prednisone were reduced at 6 months. Efficacy at 6 months, including patient-reported outcomes, was demonstrated in both biologic-naive and biologic-exposed groups. Adverse events (AEs) occurred in 817 patients [42.7%; incidence rate: 179 events per 100 patient-years (PY)], and serious AEs (SAEs) occurred in 118 patients (6.2%; 17 events per 100 PY), with comparable rates of AEs and SAEs between subgroups.
Conclusion
In routine clinical practice, TCZ discontinuation rates were low and unaffected by prior use of biologics. Effectiveness was similar between groups, and no new safety signals were identified.
Funding
F. Hoffmann-La Roche.
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Details
1 Institut de Rhumatologie de Montréal, Montreal, Canada
2 Hospital Militar Central, Department of Rheumatology, Buenos Aires, Argentina
3 University of Pécs, Rheumatology and Immunology Clinic, Medical Center, Pécs, Hungary (GRID:grid.9679.1) (ISNI:0000 0001 0663 9479)
4 University of Western Australia, Medicine and Pharmacology RPH Unit, Royal Perth Hospital, Perth, Australia (GRID:grid.1012.2) (ISNI:0000 0004 1936 7910)
5 Huazhong University of Science and Technology, Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical College, Wuhan, China (GRID:grid.33199.31) (ISNI:0000 0004 0368 7223)
6 OzBiostat Pty Ltd, Manly, Australia (GRID:grid.33199.31)
7 F. Hoffmann-La Roche, Ltd, Basel, Switzerland (GRID:grid.417570.0) (ISNI:0000 0004 0374 1269)
8 University of Pavia, IRCCS S. Matteo Foundation, Department of Rheumatology, Pavia, Italy (GRID:grid.8982.b) (ISNI:0000 0004 1762 5736)