The treatment of axial spondyloarthritis has been transformed in the last decade by the approval of biologics to treat the disease and the recognition that patients without evidence of radiographic damage can be treated, along with the patients who have definitive ankylosing spondylitis. The result has been a billion-dollar market in the seven major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan). A new wave of change is slated to come to the market, as drugs with new mechanisms of action are approved and as regulatory authorities clear the way for biologics to treat nr-AxSpA in the major markets.
In addition to the newly launched Cosentyx for ankylosing spondylitis, another IL-17 inhibitor—Eli Lilly’s Taltz—and an IL-12/23 inhibitor—Janssen’s Stelara—are in Phase III trials for both ankylosing spondylitis and nr-AxSpA. In the , Cimzia’s trials in nr-AxSpA patients may make it the first biologic approved by the FDA to treat the indication. Additionally, an IL-23-specific monoclonal antibody, Boehringer Ingelheim/AbbVie’s risankizumab, recently completed Phase II trials and could launch during the 2015-2025 forecast period. In this content, we analyze the likely uses of these new agents, their place in the treatment algorithm, the impact of new therapies on the size of the axial spondyloarthritis market, recent and future regulatory decisions regarding nr-AxSpA, and the launch of biosimilar versions of the market-leading TNF-α inhibitors.