New Axial Spondyloarthritis Guideline Recommends Against Mandatory Switching to Biosimilars

The American College of Rheumatology, the Spondylitis Association of America, and the Spondyloarthritis Research and Treatment Network, have released an updated treatment guideline for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. In the guideline, the organizations strongly recommend that patients who are stable on their therapy not be made to switch to a biosimilar of their anti—tumor necrosis factor (anti-TNF) therapies.

The guideline update, write the authors, which analyzed 26 new clinical questions since the previous guideline was issued in 2015, was primarily motivated by the availability of new treatment options, including biosimilars, and to answer questions among both patients and providers as to how these new products fit within the pharmacologic treatment strategy.

“While the efficacy of originator and biosimilar…is comparable, and although either could be chosen to initiate new courses of [anti-TNF] treatment, it was the opinion of the panel to recommend against mandated switching to a biosimilar during the course of treatment, in the absence of evidence of interchangeability,” write the guideline’s authors. They add that medication changes can increase the risk of destabilizing a patient’s condition, and that a more compelling rationale for switching medications—particularly in light of “marginal” cost savings provided by biosimilar anti-TNFs in the United States—is necessary.

In addition to its recommendation against mandatory switching, the guideline also strongly recommends against switching to a biosimilar of the first anti-TNF treatment in patients whose disease is still active despite anti-TNF treatment, as response to a biosimilar can be expected to be the same as response to an originator.

For patients who have primary nonresponse to a first anti-TNF agent, the guideline conditionally recommends treatment with secukinumab or ixekizumab rather than cycling to a different anti-TNF. However, for patients with secondary nonresponse to anti-TNF, the guideline recommends cycling to a different anti-TNF agent rather than switching to a biologic with a different mechanism of action. These recommendations diverge from the 2015 guideline, which conditionally recommended a trial of a second anti-TNF for cases of nonresponse, whether primary or secondary.

The guideline also recommends that, in patients for whom nonsteroidal anti-inflammatory drugs have not been adequate, anti-TNF agents are recommended, though no particular anti-TNF agent is the preferred choice; treatment decisions should take into account patient preferences regarding frequency and route of administration.

Anti-TNFs are recommended over secukinumab or tofacitinib, and the guideline strongly recommends against systemic glucocorticoid use.

Discontinuing or tapering biologics in stable patients is not recommended, and if tapering is being considered, patients should be counseled about their risk for increased disease activity. Treat-to-target strategies are also not recommended.

Finally, concomitant low-dose methotrexate in patients whose disease is either active or stable under anti-TNF therapy is not recommended.

Reference

Ward MM, Deodhar A, Gensler LS, et al. 2019 update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis [published online August 22, 2019]. Arthritis Care Res. doi: 10.1002/acr.24025.