General guidelines for use of anti-tumor necrosis factor alpha agents in ankylosing spondylitis and in peripheral and non-radiographic axial spondyloarthritis
- David T Yu, MD
David T Yu, MD
- Emeritus Professor
- University of California Los Angeles
The ability of anti-tumor necrosis factor (TNF)-alpha agents (TNF inhibitors) to reduce disease activity in patients with axial spondyloarthritis (SpA), including both ankylosing spondylitis (AS) and non-radiographic axial SpA (nr-axSpA), has been demonstrated in multiple randomized trials and several meta-analyses [1-3]. Similarly, several randomized trials have shown the efficacy of these agents in patients with peripheral SpA, including patients who have failed to respond to a traditional disease-modifying antirheumatic drug (DMARD) [4,5].
Other than recognized medical contraindications to anti-TNF therapy (eg, untreated latent tuberculosis, active infection, and moderate or severe heart failure), there are no convincing evidence-based indications to exclude any patients with AS from such treatment. However, the very high cost of these therapies is a major impediment to their more widespread use in symptomatic SpA . To control healthcare costs, government agencies and health insurance payers have imposed restrictions on the use of these agents. These policies vary by payer. In some countries, such as the US, each health payer formulates its own rules regarding patient characteristics that are required to have the cost of anti-TNF therapy covered.
The Assessment of SpondyloArthritis International Society (ASAS) working group, an international organization of more than 100 experts from a variety of countries, first published a set of guidelines for use of anti-TNF agents in axial SpA in 2003, updated them in 2006 and 2010, and published a literature review in 2012 [7-11]. The guidelines address patient selection, monitoring, and discontinuation of these drugs in patients with AS and other axial SpA, including nr-axSpA. The ASAS guidelines represent an opinion of the majority of ASAS members. Although some questions have been raised in the context of these recommendations, they provide general guidelines that are helpful in making decisions regarding individual patients [12,13]. Most other guidelines (eg, from individual countries) use a similar approach to the ASAS guidelines. Many of the existing guidelines define practice for a particular region or for the patients covered by a particular payer. Thus, clinicians in each region need to consult the regulatory or insurance guidelines of their own country, region, insurer, or other payer to determine the criteria that patients must meet to have anti-TNF therapies approved by the responsible agency or insurer .
This topic reviews the ASAS guidelines for cost-conscious use of TNF inhibitors in patients with AS and nr-axSpA, and addresses additional related issues. Detailed reviews of the overall approaches to diagnosis and management of AS and other forms of SpA, including the use of TNF inhibitors as well as other agents, are presented separately. (See "Diagnosis and differential diagnosis of ankylosing spondylitis and non-radiographic axial spondyloarthritis in adults" and "Assessment and treatment of ankylosing spondylitis in adults" and "Clinical manifestations and diagnosis of peripheral spondyloarthritis in adults".)
Patients who should receive anti-tumor necrosis factor (TNF) therapy should have the following:
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