Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling, joint tenderness, and destruction of synovial joints, leading to severe disability and premature mortality. The prevalence of RA in Canada is about 1%.
The pharmacological therapy of RA aims to achieve remission and, if remission is not possible, to minimize disease activity while controlling symptoms, halting damage, preventing disability, and improving quality of life. Non-biologic synthetic disease-modifying antirheumatic drugs (DMARDs) have been shown to alter the clinical course of RA and slow or halt radiographic progression when used early and aggressively in the treatment of RA. Methotrexate is the preferred DMARD with respect to efficacy and safety and is recommended as first-line DMARD treatment in patients with RA unless contraindicated or not tolerated. Based on Canadian Rheumatology Association guidelines, if patients do not attain the desired target within three to six months of non-biologic DMARD therapy, treatment with a biologic therapy should be initiated.
Tocilizumab (TCZ) is a recombinant humanized anti-human interleukin (IL)-6 receptor monoclonal antibody. It blocks the pleiotropic cytokine IL-6, which is found at high levels in the joints affected by RA. In Canada, TCZ is available as 162 mg/0.9 mL solution in single-use pre-filled syringes for subcutaneous (SC) injection, and in single-use vials containing 80 mg/4 mL, 200 mg/10 mL, or 400 mg/20 mL for intravenous (IV) infusion. The IV formulation of TCZ was previously reviewed by the Canadian Drug Expert Committee for the treatment of RA and received a recommendation to be listed for adults with moderate to severely active RA who have failed to respond to an adequate trial of both DMARDs and a tumour necrosis factor (TNF) alpha inhibitor.
The objective of this review was to evaluate the beneficial and harmful effects of the SC formulation of TCZ at recommended doses alone or in combination with methotrexate (MTX) or other DMARDs in adult patients with moderately to severely active RA with an inadequate response to one or more DMARDs and/or TNF alpha inhibitor therapies.
This review report was prepared by CADTH. In addition to CADTH staff, the review team included a clinical expert in rheumatology who provided input on the conduct of the review and the interpretation of findings.
Through the CADTH Common Drug Review (CDR) process, CADTH undertakes reviews of drug submissions, resubmissions, and requests for advice, and provides formulary listing recommendations to all Canadian publicly funded federal, provincial, and territorial drug plans, with the exception of Quebec.
The report contains an evidence-based clinical and/or pharmacoeconomic drug review, based on published and unpublished material, including manufacturer submissions; studies identified through independent, systematic literature searches; and patient-group submissions. In accordance with CDR Update — Issue 87, manufacturers may request that confidential information be redacted from the CDR Clinical and Pharmacoeconomic Review Reports.
The information in this report is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment with respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this document to ensure that its contents are accurate, complete, and up-to-date as of the date of publication, CADTH does not make any guarantee to that effect. CADTH is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in the source documentation. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the information in this document or in any of the source documentation.
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