Session Information
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Tocilizumab (TCZ) is approved for the treatment of adults with rheumatoid arthritis (RA) either as monotherapy or in combination with disease-modifying antirheumatic drugs (DMARDs). However, to date, data on its real-world utilization and durability are limited. The aim of this analysis was to describe its real life use over 6 months and assess its safety in Canada.
Methods: ACT-UP CARE (ACT-UP Canadian Physician Observance of RA Patients on TCZ [CARE]) is an ongoing, multi-national, observational study with TCZ. As of January 2015, 1,432 patients have been enrolled from 18 countries. In this analysis, data from the 200 Canadian patients participating in ACT-UP are presented. The Framingham Cardiovascular (CV) Risk Score (FCRS) was measured at baseline (BL) as an exploratory assessment. Within-group changes in disease parameters were evaluated with the paired-samples t-test. Safety was described with the incidence of adverse events (AEs).
Results: The mean (SD) RA disease duration was 12.6 (10.4) years, and 79% of patients were on a previous biologic. Low, moderate and high FCRS category was reported for 52.6%, 36.8%, and 10.5%, respectively, of patients with available data. The most frequent CV risk factors were hypertension (36.7%), hyperlipidemia (21.6%), and current smoking (18.6%). Concomitant methotrexate (MTX) use was reported for 51.5% of patients at BL (mean dose: 19.5 mg/week) and 57.7% of patients over 6 months of treatment (mean dose: 18.7 mg/week). Corticosteroid use was reported for 40.5% of patients at BL (mean prednisone dose: 10.8 mg/day). Among patients on prednisone at BL, stable dose was reported for 50.6%, decreased dose for 22.8%, increased dose for 10.1%, and steroid discontinuation for 16.5% over 6 months. Mean (SD) disease and lipid parameters at BL and 6 months are shown in Table 1.
There were 20 (10.0%) discontinuations due to: AEs (n=6), lack of efficacy (n=5), withdrawal of consent (n=5), other (n=3), and death (n=1), without any significant differences based on prior use of a biologic (10.8% for bio-experienced vs. 7.1% for bio-naïve; P=0.772) and presence of comorbidities (8.7% for presence vs. 17.9% for no presence; P=0.168). A total of 351 AEs were reported by 144 (72.7%) patients (353.0 events /100 PYs), the majority of which (93.4%) were non-serious. Most frequently reported AEs included upper respiratory tract infection (n=14, 7.1%), headache (n=9, 4.5%), and fatigue (n=8, 4.0%). Serious infections were reported by 5 (2.5%) patients. One death due to pneumonia was reported which was judged by the treating physician as not related to TCZ.
Conclusion: The results of this real-world Canadian study show that TCZ is well tolerated and effective in significantly improving clinical parameters and patient reported outcomes as early as 6 months of treatment.
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To cite this abstract in AMA style:
Haraoui B, Jamal S, Ahluwalia V, Manchanda T, Khraishi MM. Real-World Use of Tocilizumab in Rheumatoid Arthritis Patients: Cardiovascular Risk, Concomitant Treatment, and Outcomes over 6 Months of Follow-up [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/real-world-use-of-tocilizumab-in-rheumatoid-arthritis-patients-cardiovascular-risk-concomitant-treatment-and-outcomes-over-6-months-of-follow-up/. Accessed .« Back to ACR/ARHP Annual Meeting 2015
ACR Meeting Abstracts - https://acrabstracts.org/abstract/real-world-use-of-tocilizumab-in-rheumatoid-arthritis-patients-cardiovascular-risk-concomitant-treatment-and-outcomes-over-6-months-of-follow-up/