Pfizer’s Oral JAK Inhibitor XELJANZ (Tofacitinib) Receives FDA Approval for Fifth Indication in Active Ankylosing Spondylitis

December 14, 2021 /BioValleyBIOON/ --Pfizer(Pfizer) recently announced that the U.S. Food and Drug Administration (FDA) has approved anti-inflammatory drugsXeljanz (tofacitinib, tofacitinib)A new indication: for the treatment of patients who are resistant to one or moreTumorActive Insufficiency or Intolerance to Tumor Necrosis Factor (TNF) BlockersAnkylosing Spondylitis (AS)Adult patients. In the EU, Xeljanz was approved in November 2021 for the treatment of adult patients with active AS who have had an inadequate response to conventional therapy.

Ankylosing Spondylitis (AS) is a type of arthritis that can cause inflammation in certain parts of the spine, affecting more than 350,000 people in the United States. The disease often occurs in early adulthood and can cause pain, swelling, and may limit mobility. This approval provides clinicians and patients with an additional oral treatment option.

This regulatory approval also affirms the clinical value and versatility of Xeljanz.Xeljanz is the first and only oral JAK inhibitor approved for five indications in the U.S. and EU, the most among all JAK inhibitors., The four previously approved indications include: (1) Moderate to severe active rheumatoidRheumatoid Arthritis(1) Adult patients with RA; (2) Adult patients with active psoriatic arthritis (PsA); (3) Adult patients with moderate to severe active ulcerative colitis (UC); (4) Patients aged 2 years and above with active polyarticular juvenile idiopathic arthritis (pcJIA) and juvenile PsA.

This approval of the AS indication is based on the positive results of a Phase 3 clinical study (A3921120). The data showed that, according to the Assessment of SpondyloArthritis international Society (ASAS) criteria, at week 16 of treatment, compared with placebo, Xeljanz achieved the primary endpoint (ASAS20 response) and key secondary endpoint (ASAS40 response).

A3921120 is a multicenter, double-blind, placebo-controlled Phase 3 study conducted in 270 adult patients with active AS who met the modified New York criteria for AS (MNY) and had an inadequate response to or were intolerant of two or more non-steroidal anti-inflammatory drugs (NSAIDs). In the study, patients were randomly assigned to receive either 5 mg of Xeljanz or placebo twice daily for 16 weeks, with a total of 269 patients receiving treatment. Qualified patients who completed the 16-week double-blind treatment period were assigned to receive open-label 5 mg of Xeljanz twice daily for an additional 32 weeks, followed by a 4-week follow-up period.

The results showed that the study met the primary endpoint:At week 16 of treatment, the proportion of patients in the Xeljanz group achieving an ASAS20 response was significantly higher compared to the placebo group (56.4% vs 29.4%; p＜0.0001).. In addition, compared with the placebo group, the Xeljanz treatment groupThe proportion of patients achieving ASAS40 response significantly increased (40.6% vs 12.5%; p＜0.0001)., a key secondary endpoint of the study. ASAS20/40 is used to determine improvement or treatment response. In this study, the safety profile observed in AS patients treated with Xeljanz was consistent with that seen in the classRheumatoid ArthritisThe safety profile observed in patients with RA and PsA was consistent, and the most common adverse events occurring in >5% of patients in any treatment group included: upper respiratory tract infections, nasopharyngitis, diarrhea, elevated alanine aminotransferase (ALT), arthralgia, and headache.

Ankylosing Spondylitis (AS) is a chronic inflammatory disease that affects both men and women in early adulthood. The first symptoms usually occur before the age of 30, rarely appearing after 45. Symptoms of AS include back and buttock pain and stiffness. Over time, some patients may experience fusion of the vertebrae in the spine. AS can cause severe chronic pain for patients and negatively impact health-related quality of life.

The active pharmaceutical ingredient in Xeljanz is tofacitinib, which is aOral JAK inhibitors can selectively inhibit JAK kinase and block the JAK/STAT pathway., This signaling pathway is a signal transduction pathway stimulated by cytokines, and it participates in many important biological processes such as cell proliferation, differentiation, apoptosis, and immune regulation.

In the Chinese market, Xeljanz was approved for marketing in March 2017 for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to or intolerance to MTX therapy. Xeljanz can be used in combination with MTX or other non-biologic DMARDs. The recommended dose is 5mg, taken orally twice daily with or without food. This approval makes Xeljanz a treatment option in the Chinese market forRheumatoid ArthritisThe first JAK inhibitor for RA. (Bioon.com)

Source of Original Text:U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Ankylosing Spondylitis