Xeljanz (tofacitinib) First Oral Therapy Approved for Ankylosing spondylitis (AS)
by Dr. David Borenstein, Medically Reviewed by Dr. C.H. Weaver M.D. 1/2022
Janus kinase (JAK) inhibitors are new class of small molecules that are taken orally that are regulators of the immune response. As opposed to biologic therapies that inhibit one cell signal (cytokine), JAK inhibitors blockade a variety of intracellular cell signaling pathways. This family of cytokines including JAK1, JAK2, JAK3, and Tyrosine Kinase 2 can form a variety of combinations that transmit signals from the cell surface to the cell nucleus. These signals result in the production of a range of factors that are important in the development of an inflammatory response.
AS inhibitors like Xeljanz (tofacitinib) are already successfully used for the treatment of inflammatory conditions and have demonstrated long term effectiveness.
Xeljanz is a Type 1/3 JAK inhibitor and the first orally administered JAK inhibitor approved for the treatment of AS. Xeljanz is also approved for the treatment of rheumatoid and psoriatic arthritis. The Food and Drug Administration (FDA) approval was based on a phase 3, multicenter, randomized double-blind, placebo-controlled study that evaluated the efficacy and safety of Xeljanz 5 mg twice daily versus placebo in 269 adult patients living with active AS. At week 16 following treatment with Xeljanz or placebo 56% of the Xeljanz treated patients achieved 20% improvement of AS symptoms compared with only 29% of individuals receiving a placebo and 41% had 40% improvement of AS parameters compared to 12% with placebo.
Xeljanz is approved for those AS patients who have failed one or more tumor necrosis factors. The dose is 5mg twice a day by an oral route. Xeljanz is the first biologic oral therapy approved for the treatment of AS which represents a significant advance for patients
The agent is approved for those AS patients who have failed one or more tumor necrosis factors. The dose is 5mg twice a day by an oral route.
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The agent is associated with significant side effects along with black box warnings. An increase in events is noted with cardiovascular events including myocardial infarction and stroke. Also noted is an increase in malignancies including lymphomas and solid tumors. Thrombosis is also increased including pulmonary embolism, deep venous thrombosis, and arterial clots. As noted with other biologic therapies, an increase of infections include tuberculosis, invasive fungal infections, pneumonia, and herpes zoster.
Xeljanzis the first biologic oral therapy approved for the treatment of AS which represents a significant advance for patients.
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References:
- https://old.firstwordpharma.com/node/1887681?al=393932-c99e80aa071c196525ae50c127cee33c&tsid=28>
