The European League Against Rheumatism (EULAR) has recommended the use of janus kinase (JAK) protein inhibitors, such as Pfizer’s Xeljanz (tofacitinib citrate), for the management of rheumatoid arthritis (RA).
EULAR’s recommendations were published recently in the article “EULAR Recommendations For The Management Of Rheumatoid Arthritis With Synthetic And Biological Disease-Modifying Antirheumatic Drugs” in the journal Annals of the Rheumatic Diseases.
The list of recommendations includes the use of targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARDs), including Xeljanz, in patients who do not respond well to conventional therapies.
“Pfizer is pleased to see tsDMARDs recommended as second-line therapy, which is consistent with the current labeling where tofacitinib is approved,” according to a press release issued by Pfizer. “The recommendations provide additional guidance to physicians to facilitate treatment decisions for patients with RA.”
Xeljanz works by inhibiting the JAK proteins, which participate in several signaling mechanisms related to the immune response that causes pain, tenderness and inflammation.
The use of Xeljanz to treat moderate-to-severe RA is approved in more than 50 countries, in which the drug serves as a treatment option for patients in whom one or more DMARDs have failed. In the U.S., Xeljanz is approved by the U.S. Food and Drug Administration (FDA) as a once-daily treatment for RA patients who respond inadequately, or are intolerant, to methotrexate therapy.
In Europe, Xeljanz is still an investigational therapy, but the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended its approval in the EU’s 28 member countries for the treatment of adults with moderate-to-severe RA.
Xeljanz can be used alone or in combination with methotrexate or other non-biologic DMARDs. However, the combination of Xeljanz with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.
Pfizer recently announced that Xeljanz is more effective in combination with methotrexate than as a monotherapy, according to results of the Phase 3b/4 ORAL Strategy trial (NCT02187055). The trial enrolled 1,152 patients to compare the effect between 5 mg of Xeljanz twice daily as a monotherapy or in combination with methotrexate, and Humira (adalimumab) plus methotrexate in people without an adequate response to methotrexate.