Aber Maintenance Meile is approved by the FDA for the treatment of children with moderate to severe active ulcerative colitis

CompileKe Ke

On February 24, AbbVie announced that the US FDA approved Humira (Adalimumab, trade name Humira) for the treatment of moderate to severe active ulcerative colitis (UC) in children aged 5 years and older.

According to AbbVie, this approval is based on the results of the key Phase 3 clinical study ENVISION I.

ENVISION I is a randomized, double-blind, multi-center phase 3 study designed to evaluate the efficacy, safety and pharmacokinetics of Humira in children with moderate to severe UC (age 4-17 years) (defined as FMS 6 -12, endoscopy score is 2-3 points, confirmed by central reading endoscopy), subcutaneous injection.

By week 8, patients in both dose groups took Humira 2.

The results of the study showed that at the end of the 8-week induction period, 60% of patients (28/47) who took high-dose Humira achieved clinical remission at each premenstrual syndrome, while those who took low-dose Humira , 43% of patients (13/30) achieved clinical remission.

The approved dose of Humira will be determined based on the weight of the child, as follows:

For patients over 18 years of age, and patients whose Humira treatment regimen is well controlled, it is recommended to continue to use the recommended pediatric dose.

In the ENVISION I study, no new safety signals from Humira were observed.

In 2018, Humira was the world's best-selling prescription drug, and this trend has continued for several years.

In December 2021, AbbVie announced the positive results of the phase 3 induction study U-ACHIEVE, another moderate to severe UC drug Rinvoq (upadacitinib).

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