IBD Treatment News: Changes to Xeljanz Boxed Warning & New Humira Biosimilar Approved

In July, the U.S. Food & Drug Administration (FDA) made two announcements regarding IBD treatments:

New HUMIRA® biosimilar approved for ulcerative colitis and adult Crohn’s disease patients

The FDA announced the approval of HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA (adalimumab) for the treatment of for the treatment of ulcerative colitis and adult Crohn’s disease. As with other HUMIRA biosimilars, HADLIMA will not be available in the market until 2023.

Similar to other biologic therapies, biosimilars are made from natural proteins to target part of your immune system. Biosimilars are designed to be near-identical copies of approved biologic therapies and have the same effectiveness and safety as the originally approved biologic. They are also taken in the same form, such as by injection or intravenous infusion.

Click here to read the announcement from Samsung Bioepis Co., Ltd.

Changes to Xeljanz® Boxed Warning

The FDA approved new boxed warning about the increased risk of blood clots and death with the 10-milligram, twice-daily dose of Xeljanz (tofacitinib), which is used in patients with ulcerative colitis. Because of the risk of blood clots, use of Xeljanz will be limited to patients who are not treated effectively or who experience severe side effects with other medications known as tumor necrosis factor (TNF) blockers (such as adalimumab, golimumab, and infliximab).

It is important to note that IBD patients have a 1.5 to 3-fold increased risk of developing blood clots. The blood clots experienced by patients on Xeljanz were found in older rheumatoid arthritis patients and have not yet been reported in all the clinical trials or real-world data of ulcerative colitis. Make sure to talk to your healthcare provider about your history of blood clots or heart problems when taking or considering Xeljanz.

Additionally, the FDA recommends calling your doctor if you have unusual symptoms such as:

  • Sudden shortness of breath
  • Chest pain that worsens with breathing
  • Swelling of a leg or arm
  • Leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm

If you have questions about either of these announcements, please contact the IBD Help Center at [email protected] or 1-888-MY-GUT-PAIN (888-694-8872, extension 8)

Posted by: Clinical Trials Community

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