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Patterns of tocilizumab use, effectiveness and safety in patients with rheumatoid arthritis: core data results from a set of multinational observational studies
B. Haraoui1, G. Casado2, L. Czirják3, A. Taylor4, C. Bernasconi5, W. Reiss6, R. Caporali7
- Institut de Rhumatologie, Montreal, Canada. haraouib@gmail.com
- Department of Rheumatology, Hospital Militar Central, Buenos Aires, Argentina.
- Rheumatology and Immunology Clinic, University of Pécs, Medical Center, Pécs, Hungary.
- Medicine and Pharmacology RPH Unit, Royal Perth Hospital, University of Western Australia, Perth, Australia.
- F. Hoffmann-La Roche, Basel, Switzerland.
- F. Hoffmann-La Roche, Basel, Switzerland.
- Department of Rheumatology, University of Pavia, IRCCS S. Matteo Foundation, Pavia, Italy.
CER10034
2017 Vol.35, N°6
PI 0899, PF 0906
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PMID: 28516886 [PubMed]
Received: 21/10/2016
Accepted : 06/03/2017
In Press: 28/04/2017
Published: 11/12/2017
Abstract
OBJECTIVES:
To observe patients with rheumatoid arthritis (RA) treated with the interleukin-6 receptor-alpha inhibitor tocilizumab (TCZ) in routine clinical practice.
METHODS:
Data on concomitant medications, effectiveness and safety were pooled from independent, multinational studies in patients with RA initiating intravenous TCZ according to local label recommendations observed in routine practice for 6 months. Patients were grouped by TCZ monotherapy or combination therapy with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). The primary endpoint was the proportion of patients receiving TCZ after 6 months.
RESULTS:
Of 1336 patients enrolled, 506 (37.9%) received TCZ monotherapy and 830 (62.1%) received combination therapy. Kaplan-Meier analysis estimated that 80% (95% CI, 76%–83%) of monotherapy and 87% (95% CI, 84%–89%) of combination therapy patients continued to receive TCZ at 6 months (log-rank p<0.001). During the observation period, TCZ was discontinued by 113 (22.3%) monotherapy patients and 116 (14.0%) patients on combination therapy. The mean prednisone-equivalent oral corticosteroid dose was 8.4 mg/day for monotherapy and combination therapy patients at baseline and 7.7 and 7.6 mg/day, respectively, at month 6. Adverse events or laboratory abnormalities requiring TCZ dose modification were reported for 66 (13.0%) monotherapy and 130 (15.7%) combination therapy patients. Effectiveness at 6 months was similar between groups; mean (SD) change from baseline in Clinical Disease Activity Index (CDAI) was -20.3 (14.18) for monotherapy and -22.3 (16.09) for combination therapy (p=0.7347).
CONCLUSIONS:
In routine clinical practice, 38% of patients received TCZ as monotherapy. Persistence on monotherapy or in combination therapy with csDMARDs was high, with a slight trend towards a higher rate with combination therapy, and effectiveness was similar between groups.