What is Xeljanz used for and is it a biologic?

Xeljanz is an oral medication used to treat:

• moderate to severe rheumatoid arthritis in adults
• active psoriatic arthritis in adults
• moderate to severe ulcerative colitis in adults
• ankylosing spondylitis in adults
• polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

Xeljanz and Xeljanz XR (generic name: tofacitinib) are classified as a Janus kinase (JAK) inhibitor and Disease-Modifying Anti-Rheumatic Drug (DMARD). Xeljanz is not considered a true biologic, as it is made with traditional drug manufacturing techniques, but has side effects similar to the biologics. JAK inhibitors, which also includes baricitinib (Olumiant) and upadacitinib (Rinvoq), are not listed in the FDA's Purple Book of Licensed Biologic Agents.

JAK inhibitors work by blocking activity of JAK enzymes (JAK1, JAK2, JAK3, TYK2) inside the cell to help block release of chemicals that lead to inflammation (which causes swelling and pain).

Xeljanz and Xeljanz XR, from Pfizer, are given as an oral tablet. It is also available as an oral solution for use in children 2 years and older with polyarticular juvenile idiopathic arthritis.

View Xeljanz dosing here.

Limitation of use: Use of Xeljanz and Xeljanz XR in combination with biologic disease-modifying anti-rheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. Do not use non-TNF (tumor necrosis factor) biologics in combination with TNF blocking agents or other powerful immunosuppressants due to the possibility of an increased risk of infection.

Learn more: What are the new drugs for the treatment of rheumatoid arthritis (RA)?

Rheumatoid arthritis

Rheumatoid arthritis (RA) is an inflammatory disease of joints in areas like the hands, feet or wrist. The joints become painful, stiff, and tender. They may feel warm or look red. In an autoimmune disease like rheumatoid arthritis, healthy tissues are attacked. RA cannot be cured but there are treatments that help control the pain, inflammation and joint destruction. RA is different from osteoarthritis, which is due to the wear-and tear on the joints and cartilage over time.

In RA, Xeljanz can reduce joint pain, joint swelling, and help to stop further joint damage. Effects on pain and swelling can begin as early as 2 weeks in some patients.

Xeljanz and Xeljanz XR are used in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to or cannot tolerate methotrexate. It can be used alone or with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Active psoriatic arthritis

Roughly 30% of people with psoriasis may also develop psoriatic arthritis, a type of rheumatoid arthritis that tends to affect the joints of the hands and feet. Symptoms can include swelling of the ankles, toe joints, hands, and knees. Psoriasis of the nail may occur.

Most people first develop psoriasis and then later develop psoriatic arthritis. In both psoriasis and psoriatic arthritis, flare ups of symptoms may come and go with periods of remission (when symptoms subside).

Xeljanz can reduce joint pain, joint swelling, and help to improve your physical functioning in psoriatic arthritis. Effects on pain and swelling can begin as early as 2 weeks in some patients.

For the treatment of psoriatic arthritis, Xeljanz or Xeljanz XR are also used in those who have tried methotrexate or other medicines without success.

Ulcerative colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease and a chronic autoimmune disease. In UC, ulcers and swelling occur on the lining of the colon (also called the large intestine) and the rectum

• Common symptoms of UC include stomach pain or cramping, diarrhea (that may be bloody or contain pus), rectal pain or bleeding, blood in the stool, an urgent need to defecate, weight loss, and fatigue, among others.
• In studies of Xeljanz in patients with ulcerative colitis, Xeljanz has been shown to reduce rectal bleeding and stool frequency in 2 weeks in some patients, and can lead to remission without the use of corticosteroids.
• Xeljanz and Xeljanz XR are approved to treat adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.

Ankylosing spondylitis

Ankylosing spondylitis is an ongoing inflammatory disease that includes chronic pain and stiffness in the back and hips. It usually occurs between the ages of 30 and 45 in both males and females. Over time, some patients may experience fusion of the bones in the spinal column.

• In 16-week studies that evaluated Xeljanz for use in ankylosing spondylitis, the number of patients that achieved an ASAS20 (Assessment in SpondyloArthritis international Society 20) was greater with Xeljanz (56.4%, n= 75) versus placebo (29.4%, n=40) and was statistically significant.
• ASAS20 is used to determine improvement or response to treatment. Safety for this use was similar to that seen in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients.

Polyarticular juvenile idiopathic arthritis (patients 2 years of age and older)

Polyarticular juvenile idiopathic arthritis is a form of Juvenile Idiopathic Arthritis (JIA), also called juvenile rheumatoid arthritis. It is a long-term inflammatory disease that affects multiple joints and usually begins in children before the age of 16 years.

• Polyarticular JIA affects at least five joints and can occur in the hands, feet, knees, hips and ankles. The joint lining (synovial membrane) becomes inflamed and enlarged, and leads to pain, tenderness and limited movement.
• In studies, disease flares of JIA were shown to be significantly less in patients receiving Xeljanz than those receiving a placebo. Patients can use an oral tablet or oral solution for their dose, which is based upon weight.

Learn more: Review Xeljanz side effects and Boxed Warnings (in detail). Xeljanz boxed warning includes information on serious infections, mortality (death), malignancy (cancer), major adverse cardiovascular events (cardiovascular death, heart attack, and stroke) and thrombosis (blood clots).

This is not all the information you need to know about Xeljanz or Xeljanz XR for safe and effective use. Review the full Xeljanz or Xeljanz XR information, and discuss any questions you have with your doctor or other health care provider.

Related Questions

• What are the new drugs for rheumatoid arthritis (RA)?
• What are JAK inhibitors and how do they work?
• What happens when you stop taking Xeljanz?