COMMENTARY

10 Rheumatology Advances From 2016

Kevin D. Deane, MD, PhD

Disclosures

December 19, 2016

4: Biosimilar Approvals

Whereas several biosimilars have been approved for years for rheumatologic use in Europe and Asia, in 2016 the US Food and Drug Administration (FDA) approved three biosimilars in the United States: one for infliximab (Inflectra™, approved April 2016), one for etanercept (Erelzi™, approved August 2016), and one for adalimumab (Amjevita™, approved September 2016). Each of these has been approved for multiple indications, including RA; psoriasis and psoriatic arthritis; ankylosing spondylitis; and, for Inflectra and Amjevita, inflammatory bowel disease.

The impact and cost-effectiveness of the clinical use of these agents is being studied currently; in addition, the mechanisms by which these new agents will be used instead of the original therapies are under investigation. However, the hope is that they will improve access to biologic therapy for patients with rheumatic diseases.

5: Tocilizumab in Giant Cell Arteritis and Polymyalgia Rheumatica

In 2016, data from several small, randomized, controlled studies demonstrated that the anti-interleukin 6 therapy tocilizumab was effective in treating giant cell arteritis[4] and polymyalgia rheumatica.[5] Furthermore, although not yet fully published, the results of the large GiACTA study confirm the efficacy of tocilizumab in giant cell arteritis.[6] In particular, tocilizumab appears to rapidly improve inflammation and allow steroid reduction.

The overall cost/benefit of tocilizumab in these diseases is being evaluated further, with particular attention to expense of tocilizumab compared with steroids, and possible increased risks for adverse events, such as cytopenias and intestinal perforation. Nevertheless, the success of these studies raises the hope that the rheumatology community will finally have an effective steroid-sparing agent for this set of diseases.

6: Rituximab for Preclinical RA

Growing data support that RA has a preclinical period of development, during which there are elevations of autoantibodies, including antibodies to citrullinated proteins and rheumatoid factor, that are highly predictive of future RA. With this as a background, the Dutch PRAIRI study has reported preliminary data from a randomized, blinded study of 81 participants. When given to individuals with elevated antibodies to citrullinated proteins and rheumatoid factor but no synovitis on baseline examination, rituximab 1000 mg as a single dose delayed the onset of development of future clinically apparent RA by about 12 months.[7] Full study data have yet to be released, but this study and other prevention trials for RA that are under way in the United States[8] and Europe[9] raise the hope that RA may soon be a disease in which prevention strategies can be applied.

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