Tofacitinib - ankylosing spondylitis indication approved in China and first prescription issued

China's National Medical Products Administration (NMPA) has approved (tofacitinib citrate) for active ankylosing spondylitis (AS) in whom one or more TNF blockers are insufficiently effective or intolerable adult patients. After the approval, Shanghai Changzheng Hospital and Peking University First Hospital issued the first prescription for patients, benefiting patients with ankylosing spondylitis as soon as possible. According to the press release, Shangjie, as the first and only oral small-molecule targeted drug approved for the treatment of ankylosing spondylitis in China, will bring breakthroughs in the field of AS treatment.

Tofacitinib is a JAK inhibitor previously approved in China for the treatment of moderate to severe rheumatoid arthritis. The approval of the new indication for ankylosing spondylitis is the second indication approved in China. According to the press release, tofacitinib is a novel mechanism of action compared to existing drugs in the treatment of ankylosing spondylitis. By blocking the JAK-STAT pathway in immune cells, it can directly or indirectly block the signal transduction of a variety of AS-related cytokines, so as to inhibit inflammation and alleviate the disease.

Professor Xu Huji, the leading expert of the China Phase 3 clinical research project for the indication of tofacitinib in ankylosing spondylitis and director of the Department of Rheumatology and Immunology of Shanghai Changzheng Hospital, said that AS patients are mostly young and middle-aged men. It will cause irreversible structural damage. If it is not treated in time or improperly treated, it will affect the ability to work and bring a burden to the family and society. Shangjie's Phase 3 clinical study for AS is a randomized, double-blind, placebo-controlled study conducted in 75 centers in 14 countries, of which approximately 18% of patients are enrolled in China. It is expected that the approval of Shangjie's AS indication will bring benefits to more AS patients.