Humira Ulcerative Colitis Indication Expanded to Include Children

February 24, 2021 – The U.S. FDA has approved an expanded indication for Humira® (adalimumab), manufactured by AbbVie. Humira is now indicated to treat moderately to severely active ulcerative colitis (UC) in patients who are at least five years old. Previously, Humira’s UC indication was restricted to adults.

UC is a chronic autoimmune condition that causes inflammation of the large intestine and the rectum. This can cause the development of ulcers, as well as urgent and unpredictable need to void the bowels. Patients who have UC may lose weight, feel fatigued, and experience abdominal pain and cramping. In children, the condition can also inhibit growth. Pediatric UC patients tend to have more extensive disease than adults, with fewer treatment options available.

In a clinical study, up to 60% of pediatric patients treated with Humira achieved clinical remission of moderate-to-severe UC at the end of an eight-week period. Recommended dosing is based on the patient’s weight. The dosing schedule allows for either once weekly or twice-monthly administration. Humira is given as a subcutaneous injection and can be administered at home by a patient or caregiver who has been instructed in proper injection technique by a healthcare professional.

A black box warning cautions that TNF blockers like Humira are associated with serious infections. There is also a black box warning advising that malignancies, sometimes fatal, have been reported in children and adolescents treated with TNF blockers.

First FDA approved in 2002, Humira is also indicated to treat ankylosing spondylitis, Crohn’s disease, hidradenitis suppurativa, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and uveitis.