In recent years, Pfizer has come under fire due to the adverse reactions of Xeljanz. In early 2019, the U.S. Food and Drug Administration (FDA) released the findings of its interim analysis, which uncovered an increased risk of blood clots and death. Pfizer did not tell the FDA about these reactions, claiming that they were unaware of them.
However, after the FDA placed its black box warning on Xeljanz, it still approved it for use as a treatment for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis in low doses. Even with the FDA’s recent discovery, Pfizer is still looking to get Xeljanz approved for other conditions.
In September 2020, Pfizer announced that the FDA had approved Xeljanz as a treatment for active polyarticular course juvenile idiopathic arthritis (pcJIA) in children and adolescents two years old and younger. This approval makes tofacitinib the first (and only) JAK inhibitor approved in the U.S. for this use.
This announcement comes just under two years after the release of the FDA’s finding. We can expect the FDA and other healthcare experts to keep a close eye on Xeljanz’s use in pcJIA patients. Wormington & Bollinger will continue to keep an eye on any news regarding Xeljanz and its adverse reactions.
If you or a loved one experienced adverse reactions while taking Xeljanz, contact our dangerous drug law firm and let us help.
What is Juvenile Idiopathic Arthritis?
When people think about arthritis, they often imagine older adults suffering from this condition. However, they are not the only ones who can suffer from it. In rare cases, young children can also develop arthritis. Juvenile idiopathic arthritis (JIA) is the most common type of arthritis found in teens and children.
Formally referred to as juvenile rheumatoid arthritis (JRA), JIA is a chronic inflammatory disease that affects around 300,000 children under the age of 16 every year. There are several types of JIA, including:
- Systemic
- Oligoarticular
- Polyarticular
- Enthesitis-related
- Psoriatic
- Undifferentiated
Patients with polyarticular course juvenile idiopathic arthritis (pcJIA) experience arthritis in five or more joints, either in small joints in the hands and feet or larger joints in the knees, hips, and ankles. It affects around 25% of children suffering from JIA.
As is the case with other forms of arthritis, juvenile idiopathic arthritis is an autoimmune or autoinflammatory disease. The immune system, which is supposed to fight off foreign substances like viruses and bacteria, starts attacking the body’s cells and tissues, particularly those in joints. The body then releases an inflammatory chemical that attacks the synovium (the tissue lining the joints).
The synovium produces fluids that help joints move smoothly and cushions them. When the synovium is inflamed, the individual might experience joint pain or tenderness, swelling, or difficulty moving.
Researchers are unsure why children develop JIA. One theory suggests these children have specific genes that activate when the body comes in contact with certain bacteria or external forces. However, there is no proof that foods, toxins, allergies, or vitamin deficiencies cause this condition.
Symptoms of Juvenile Idiopathic Arthritis
JIA shares many symptoms with adult arthritis, but you should still keep an eye out for these signs and symptoms:
- Joint pain (may worsen when waking up or after staying in one position for too long)
- Stiff joints
- Reduced range of motion
- Tender joints
- Swelling
- Redness
- Blurred vision
- Rash
- Loss of appetite
- Fever
In regard to this article and Xeljanz’s use, pcJIA affects five or more joints on both sides of the body. Individuals may experience symptoms in either large or small joints.
The FDA’s Approval
The FDA just recently approved Xeljanz as a treatment for active polyarticular course juvenile idiopathic arthritis (pcJIA) in September 2020. They based their approval on the results of a Phase 3 clinical trial comprised of two phases: an 18-week open-label, run-in phase that included all 225 participants (184 of which had pcJIA). It was then followed by a 26-week, double-blind placebo-controlled trial with only 173 participants (the patients that showed no response to Xeljanz discontinued the study). The entire process took 44 weeks.
The purpose of the study was to evaluate the efficacy and safety of tofacitinib in either a 5mg tablet or a 1mg/ml oral solution twice daily based on the patient’s body weight or preference. Patients under 40 kg received the oral solution.
The trial met its goal in showing that pcJIA patients receiving tofacitinib who achieved a JIA American College of Rheumatology (ACR) 30 response at the end of the run-in phase showed a statistically significantly lower occurrence of disease flare than those taking the placebo at the end of week 44.
The study defined a disease flare as “a 30 percent or more worsening in at least three of the six variables of the JIA ACR core set, with no more than one of the remaining JIA core response variables improving by 30 percent or more.”
The FDA approved Xeljanz in two formulations: a tablet and an oral solution. The 5mg tablet is available immediately, while the oral solution is expected to be ready by the end of Q1 2021.
In general, the adverse drug reactions of pcJIA patients were similar to those seen in adult patients with rheumatoid arthritis. Pfizer has listed all side effects and safety information on their website.
Takeaway
This most recent approval will be the fourth indication for Xeljanz, following its approval for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Xeljanz’s approval for juvenile idiopathic arthritis treatment marks the first use of a JAK inhibitor for this use.
While the FDA has approved Xeljanz for juvenile idiopathic arthritis use, it also confirmed that the adverse drug reactions for pcJIA patients were consistent with those in adult rheumatoid arthritis patients. Many of these reactions (such as increased risks of blood clots) have led to a host of Xeljanz lawsuits. Wormington & Bollinger will continue to monitor the use of Xeljanz in pcJIA patients.
If you or someone you love suffered from the adverse reactions of Xeljanz, contact our dangerous drug law firm today and let us fight for the compensation you deserve.