FDA approves biologic treatment for pediatric ulcerative colitis

The FDA approved AbbVie’s biologic therapy Humira to treat moderate to severe active ulcerative colitis in pediatric patients, the company announced Feb. 24.

Advertisement

In clinical trials, pediatric patients that achieved clinical remission at week eight maintained remission at week 52, according to the company’s phase 3 Envision I study.

Researchers studied how Humira interacted with pediatric patients with either moderate to severe ulcerative colitis. Patients treated with 2.4 mg/kg at week zero, 2.4 mg/kg at week one, 1.2 mg/kg at week two and 0.6 mg/kg at weeks four and six were more likely to achieve remission. Physicians will determine what dose to give patients based on their weight.

Approximately 22.6 percent of patients experienced a serious adverse event when taking Humira. Those events included headaches and worsening of ulcerative colitis symptoms.

More articles on physicians:
Physician pay under Stark Law’s final rule: 4 takeaways on fair market value
Physician practices are a hot target: 45 sales in January
Dr. Michael Ast: 3 ways orthopedics, ASCs will change in the next 3 years

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in GI & Endoscopy

  • OSF HealthCare Saint Anthony Medical Center in Rockford, Ill., has added Tarik Firozi, MD, according to an April 6 report…

  • Miami-based Gastro Health has finalized a partnership with Digestive Disease Physicians, an Alexandria, Va.-based gastroenterology practice, according to an April…

  • Birmingham (Ala.) Gastroenterology has opened a clinic in Jasper, Ala., expanding access to digestive health services in the region, the…

Advertisement

Comments are closed.