Drug Companies

In current clinical practice, approximately one-third of patients with axial spondyloarthritis experience adequate pain control with non-steroidal anti-inflammatory drugs (NSAIDs). However, at least 50% of patients continue to progress because local spinal inflammation is not fully controlled. More potent anti-inflammatory therapies, such as tumor necrosis factor inhibitors (TNFi), are available and can control pain and inflammation, as measured by existing techniques, and slow disease progression in many cases. In some patients, these agents act primarily as analgesics, masking pain rather than fully suppressing underlying inflammation. TNFi therapies are associated with high cost and potential toxicity, leading payors to impose stringent criteria for their use. At present, patients are typically required to demonstrate persistent low back pain despite NSAID therapy before TNFi treatment is considered. 

Furthermore, different TNFi agents may be variably effective across patients, but determining individual responsiveness requires prolonged, sequential trials of different therapies. Approximately one-third of patients do not respond to the first TNFi and may or may not respond to subsequent agents. This trial-and-error process often spans many months, resulting in substantial healthcare costs and extended exposure to ineffective treatments.

KeyIn-1 is designed to address these challenges by providing objective, biologically grounded insight into inflammatory activity. By quantifying inflammation and repair from a simple blood test, KeyIn-1 enables more informed treatment selection, supports earlier assessment of treatment efficacy, and reduces prolonged trial-and-error therapy. This approach has the potential to improve clinical outcomes while lowering unnecessary cost and risk across drug development and clinical use.