The U.S. Food and Drug Administration (FDA) first approved Xeljanz for rheumatoid arthritis (RA) in 2012. Eventually, the FDA approved Xeljanz for other conditions, first for psoriatic arthritis (PA) in 2017 and then again for ulcerative colitis (UC) in 2018.

In September 2020, Pfizer announced that the FDA had officially approved Xeljanz for active polyarticular course juvenile idiopathic arthritis (pcJIA) in children and adolescents two years old and younger. Even after the FDA released the results of its interim analysis on Xeljanz, revealing an increased risk of blood clots and death, Pfizer continues to push for the drug’s approval for other conditions.

Recently, Pfizer announced the results of a Phase 3 study for Xeljanz in ankylosing spondylitis (AS). The FDA has not approved tofacitinib (the active ingredient in Xeljanz) for the treatment of AS in the U.S., but the positive results of this Phase 3 study are a sign that it may soon be.

Xeljanz has come under fire due to the adverse reactions of taking the drug. These reactions are life-threatening, often resulting in long-term complications. If you suffered injuries while taking Xeljanz, you deserve justice. Give Wormington & Bollinger a call today, and let us fight for the compensation you deserve.

What is Ankylosing Spondylitis (AS)? 

Much like RA, PA, and UC, ankylosing spondylitis is an inflammatory disease. AS (also known as Bechterew disease) is a rare form of arthritis that causes pain and stiffness in the spine. Over time, this condition causes the vertebrae (the small bones in your spine) to fuse together. As you can assume, as these bones fuse, your flexibility is significantly reduced, often resulting in a hunched-over posture.

It is a lifelong condition. While it usually starts in your lower back, it can quickly spread throughout your upper back and into your neck. It can also affect other damaged joints in your body. Inflammation can occur in your eyes, as well. Unfortunately, there is no cure for AS. However, there are treatments that can relieve pain and slow its progression, which is why Pfizer wants FDA approval for Xeljanz in ankylosing spondylitis.

Signs and Symptoms of AS

Signs and symptoms typically begin in early adulthood. Typically, the earliest signs are pain and stiffness in your lower back and hips. This stiffness most often occurs in the morning or after periods of inactivity. Fatigue is also quite common. This condition causes you to hunch over. As you hunch, it affects your ribs, which in turn affects your breathing.

Some commonly affected areas include:

  • The joint between the base of your spine and your pelvis
  • Lower back
  • Hip and shoulder joints
  • Places where tendons and ligaments attach to bones, such as your spine and your heels
  • The cartilage that connects your breastbone and ribs
  • Buttocks
  • Pelvis
  • Neck
  • Ribs
  • Hands
  • Feet

Those living with AS might also experience:

  • Pain and stiffness that is worse in the morning
  • A rigid spine that bends forward, giving you a hunch
  • Fatigue
  • Swelling joints
  • Difficulty breathing

Further Complications of AS 

There are many complications that often occur with ankylosing spondylitis. Each case varies from person to person, but everyone should be aware of these complications:

  • Spine: While rare, the vertebrae in your spine may weaken, making them more susceptible to breaks or fractures. Damaged vertebrae can put pressure on nerves in your spine, causing pain throughout your body.
  • Eyes: Roughly 40% of those living with AS develop an eye inflammation (known as uveitis). This condition causes blurry vision and light sensitivity, as well as pain.
  • Heart: In rare cases, AS can enlarge the largest artery in your body, the aorta. If this artery were enlarged, it would alter the shape of your aortic valve, allowing blood to leak back into your heart, which would affect how well your heart pumps.

Causes of AS 

Healthcare experts have not identified one specific cause of ankylosing spondylitis. However, they suspect that your genetics play a part in its development. For instance, people with the HLA-B27 gene are at a higher risk of developing AS than those without it. Experts believe this gene tells your immune system to attack certain bacteria, which sparks AS symptoms.

Men are also more likely to develop AS than women. Typically, AS starts developing in late adolescence or early adulthood. Around 80% of cases begin before people turn 30 and 95% before the age of 45.

Pfizer’s Positive Phase 3 Study 

In early November 2020, Pfizer announced the results of a Phase 3 investigational study. This study evaluated the safety and efficacy of tofacitinib in treating ankylosing spondylitis. This Phase 3 study was a multicenter, randomized, double-blind, placebo-controlled study. It involved 270 adult participants with active AS who showed an inadequate response or intolerance to two or more nonsteroidal anti-inflammatory drug (NSAID) therapies. The patients were randomized, receiving a twice-daily 5 mg dose of tofacitinib or matching placebo over 16 weeks.

The study met its primary and key secondary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 20 and 40 responses. By the end of week 16, the percentage of patients that achieved an ASAS 20 response was significantly higher while taking tofacitinib (56.4%) as opposed to placebo (29.4%). Additionally, the percentage of ASAS 40 response was also higher, with tofacitinib at 40.6% vs. placebo at 12.5%.

Meeting the ASAS 20 response was the primary endpoint while meeting the ASAS 40 response was the key secondary endpoint.

There were common adverse reactions during the study, occurring in over 5% of any treatment group. These reactions included:

  • Upper respiratory tract infection
  • Nasopharyngitis
  • Diarrhea
  • Alanine aminotransferase (ALT) increased
  • Arthralgia
  • Headaches

The FDA accepted Pfizer’s application for the AS indication. The positive results of this study may lead to the FDA’s approval of Xeljanz in ankylosing spondylitis. Their goal date is Q2 2021.

Contact Wormington & Bollinger

Xeljanz already has FDA approval to treat a handful of conditions. However, Pfizer continues to push for FDA approval for Xeljanz in ankylosing spondylitis. In recent years, Pfizer has faced many dangerous drug lawsuits because of the adverse reactions of Xeljanz. Blood clots are at the center of many of these lawsuits.

These reactions can be life-threatening, often leading to long-term complications. If you or someone you love suffered injuries while taking Xeljanz, contact Wormington & Bollinger today and let us fight for the compensation you deserve.