Rheumatol Ther. 2018 Dec;5(2):551-565. doi: 10.1007/s40744-018-0130-6. Epub 2018 Oct 28.
Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results From an Observational, Noninterventional Study.
Rheumatology and therapy
Boulos Haraoui, Shahin Jamal, Vandana Ahluwalia, Diana Fung, Tarang Manchanda, Majed Khraishi
Affiliations
Affiliations
- Department of Medicine, Université de Montréal, Montreal, QC, Canada. [email protected].
- Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
- Rheumatology Division, William Osler Health System, Brampton, ON, Canada.
- Hoffmann-La Roche Canada, Mississauga, ON, Canada.
- Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, Canada.
PMID: 30370468
PMCID: PMC6251854 DOI: 10.1007/s40744-018-0130-6
Abstract
INTRODUCTION: This study was conducted to observe patterns of use of the interleukin-6 receptor-alpha inhibitor tocilizumab in routine clinical practice in patients with rheumatoid arthritis (RA).
METHODS: This was a 12-month noninterventional, observational study in adult patients with RA who initiated tocilizumab in routine practice in Canada according to the local product monograph. The primary end point was the proportion of patients receiving tocilizumab at 6 months. Secondary end points were treatment patterns, effectiveness, and safety of tocilizumab over 12 months.
RESULTS: Of 200 patients who initiated tocilizumab (91.0% at 8 mg/kg), 67 (33.5%) received tocilizumab monotherapy and 133 (66.5%) received tocilizumab combined with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Kaplan-Meier analysis estimated that 85% (95% CI 74-92%) of monotherapy and 89% (95% CI 82-93%) of combination therapy patients continued to receive tocilizumab at 6 months (log-rank p = 0.0888). During the observation period, 12 (17.9%) monotherapy and 27 (20.3%) combination therapy patients withdrew from the study. At month 12, 58.5% in the monotherapy group and 59.3% in the combination therapy group achieved Disease Activity Score at 28 joints remission (≤ 2.6), 25.6% and 24.7% achieved Simplified Disease Activity Index remission (≤ 3.3), and 18.2% and 22.3% achieved Clinical Disease Activity Index remission (≤ 2.8), respectively. Rates of serious adverse events and serious infections were found in 29.6/100 patient-years (PY) and 3.1/100 PY, respectively, for monotherapy and 19.2/100 PY and 4.8/100 PY, respectively, for combination therapy.
CONCLUSIONS: Patients initiating tocilizumab in routine practice had comparable effectiveness and safety outcomes regardless of whether they received tocilizumab as monotherapy or as combination therapy with csDMARDs.
TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01613378 FUNDING: F. Hoffmann-La Roche (Roche) Canada.
Keywords: Antirheumatic agents; Biological agents; Inflammation; Interleukin-6 receptor; Primary care; Rheumatoid arthritis; Tocilizumab
References
- Arthritis Rheum. 2008 Oct;58(10):2968-80 - PubMed
- Int Immunopharmacol. 2005 Nov;5(12):1731-40 - PubMed
- Ann Rheum Dis. 2012 Dec;71(12):1950-4 - PubMed
- Ann Rheum Dis. 2016 Jun;75(6):1081-91 - PubMed
- Lancet. 2008 Mar 22;371(9617):987-97 - PubMed
- J Rheumatol. 2012 Aug;39(8):1559-82 - PubMed
- Blood. 2008 Nov 15;112(10):3959-64 - PubMed
- Clin Exp Rheumatol. 2017 Nov-Dec;35(6):899-906 - PubMed
- Expert Opin Biol Ther. 2010 Sep;10(9):1367-78 - PubMed
- Lancet. 2013 May 4;381(9877):1541-50 - PubMed
- Ann Rheum Dis. 2014 Mar;73(3):492-509 - PubMed
- Arthritis Care Res (Hoboken). 2012 May;64(5):625-39 - PubMed
- Ann Rheum Dis. 2016 Jan;75(1):3-15 - PubMed
- Clin Rheumatol. 2015 Mar;34(3):563-71 - PubMed
- Ann Rheum Dis. 2013 Jan;72(1):43-50 - PubMed
- Ann Rheum Dis. 2008 Nov;67(11):1516-23 - PubMed
- Ann Rheum Dis. 2010 Jan;69(1):88-96 - PubMed
- Arthritis Care Res (Hoboken). 2013 Mar;65(3):362-71 - PubMed
- Ann Rheum Dis. 2011 Apr;70(4):583-9 - PubMed
- Arthritis Rheum. 2011 Mar;63(3):609-21 - PubMed
- J Rheumatol. 2013 Jun;40(6):768-80 - PubMed
- J Rheumatol. 2009 Aug;36(8):1611-7 - PubMed
- Bull NYU Hosp Jt Dis. 2008;66(2):77-85 - PubMed
Publication Types