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. Disease prevalence in Canada is about 1% (0.9% in 2010), and it is expected to increase to 1.3% by 2040.
Treatment guidelines for RA emphasize the use of non-drug interventions, which include exercise therapy, electro-physical modalities, orthoses and assistive devices, and self-management interventions (including education), in addition to pharmacological therapy. Non-pharmacological care affords symptomatic relief without altering the course of disease progression. The pharmacological therapy of RA aims to achieve remission and, if that is not possible, to minimize disease activity while controlling symptoms, halting joint damage, preventing disability, and improving quality of life.
Traditional 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 the first-line DMARD treatment in patients with RA unless contraindicated or not tolerated. Nonsteroidal anti-inflammatory drugs (NSAIDs) and/or glucocorticoids (in the lowest effective dose possible) can be added to the initial treatment with DMARD as a bridge therapy while waiting for DMARD to take effect, to manage flares, or for symptom control if no other options exist.
It is recommended that patients with an inadequate response to the target dose of at least two DMARDs in mono- or combination therapy after three months be considered for biologic therapies, including currently available subcutaneous (SC) golimumab that targets specific mechanisms of inflammation. The objective of this report is to evaluate the beneficial and harmful effects of IV golimumab (Simponi IV) at recommended doses in combination with methotrexate for the treatment of adult patients with moderately to severely active RA.
This report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). In addition to CADTH staff, the review team included a clinical expert in rheumatoid arthritis 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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