Humira (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis

NORTH CHICAGO, Ill., Feb. 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Humira (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, Humira induced clinical remission at Week 8 and maintained remission at Week 52 in patients who responded at Week 8.1,2

“Ulcerative colitis can have a profound effect on children and for too long, treatment options for pediatric patients have been limited,” said Brandee Pappalardo, vice president and head of U.S. immunology medical affairs, AbbVie. “This approval provides the first and only subcutaneous biologic for pediatric patients with ulcerative colitis that can be administered at home. This new indication for Humira demonstrates AbbVie’s commitment to patients with inflammatory bowel diseases and reinforces our goal of reducing the burden of this disease for patients.”

This approval is based on results from the pivotal Phase 3 ENVISION I study, which showed that Humira achieved the co-primary endpoints of clinical remission per Partial Mayo Score (PMS) at Week 8 and, among those who responded at Week 8, clinical remission per Full Mayo Score (FMS) at one year (52 weeks).1,2 Clinical remission was defined as a PMS or as a FMS less than or equal to two and no individual sub-score greater than one.1,2

“Ulcerative colitis is unpredictable and affects everyone, especially children, in different ways,” said Marla Dubinsky, M.D., chief, Division of Pediatric Gastroenterology for the Mount Sinai Health System and co-director of the Susan and Leonard Feinstein IBD Center at Mount Sinai.* “In the ENVISION I study, Humira provided clinical response as early as Week 8, and many who achieved partial Mayo score response at Week 8 achieved clinical remission at Week 52, per FMS. As a clinician, I am excited to have a new treatment option available and am encouraged by these positive results, which have the potential to help pediatric patients and their caregivers manage their disease.”

Ulcerative colitis is characterized by inflammation of the large intestine with symptoms ranging from mild to severe bowel urgency and bowel incontinence as well as weight loss and fatigue.3,4 It remains a lifelong condition that is not adequately controlled in many patients, underscoring the need for more treatment options.3,4 Significant unmet needs remain in moderate to severe pediatric ulcerative colitis, compared to adults, as pediatric patients tend to have more extensive disease often causing significant morbidity in children.4,5

About the ENVISION I Phase 3 Study1,2,6

The ENVISION I study was a Phase 3, randomized, double-blind, multicenter study designed to evaluate the efficacy, safety and the pharmacokinetics of Humira in pediatric patients (ages 4-17) with moderate to severe ulcerative colitis (defined as a FMS of 6 to 12 with endoscopy subscore of 2 to 3 points, confirmed by centrally read endoscopy), administered subcutaneously. 

Through Week 8, patients in both dosage groups received 2.4 mg/kg (maximum of 160 mg) at Week 0, 1.2 mg/kg (maximum of 80 mg) at Week 2, and 0.6 mg/kg (maximum of 40 mg) at Weeks 4 and 6. The higher dosage group also received an additional dosage of 2.4 mg/kg (maximum of 160 mg) at Week 1. Between Week 8 and Week 52, patients received double-blind placebo, Humira 0.6 mg/kg (maximum of 40 mg) every other week, or every week. The co-primary endpoints of the study were clinical remission per PMS (defined as PMS ≤ 2 and no individual subscore > 1) at Week 8, and clinical remission per the Mayo Score (defined as Mayo Score ≤ 2 and no individual subscore > 1) at Week 52 in patients who achieved clinical response per PMS at Week 8. 

Study results demonstrated 60 percent [28/47] of patients taking the higher dosage of Humira achieved clinical remission per PMS, at the end of the 8-week induction period and 43 percent [13/30] of patients in the lower dosage group. At Week 52, among Week 8 PMS responders, 45 percent [14/31] of patients receiving the higher dosage of Humira achieved remission per FMS and 29 percent [9/31] of patients taking the lower dosage of Humira and 33 percent [4/12] of those randomized to placebo. There are limitations to the interpretability of the placebo data due to the small sample size.

Approved dosing for Humira will be determined based on the child’s weight, as follows1:


Recommended Dosage

Days 1 – 15

Starting on Day 29

20 kg (44
lbs) to < 40
kg (88 lbs)


≥ 40 kg (88


It is recommended to continue the recommended pediatric dosage in patients who turn 18 years of age and who are well-controlled on their Humira regimen.

In the ENVISION I study, no new safety signals for HUMIRA were observed.1,2 Throughout any Humira exposure in the study, 22.6 percent of patients experienced a serious adverse event.1,2 The most frequently reported (greater than or equal to 5 percent) treatment-emergent adverse events during induction and maintenance periods were headache and worsening of ulcerative colitis.6 No deaths, malignancies, active tuberculosis or demyelinating disease were observed in this study.1,2

More information on this trial can be found at (NCT02065557).

*Marla Dubinsky, M.D. is a consultant and advisor for AbbVie.

About Humira (adalimumab) in the U.S.


Humira is a prescription medicine used:

  • To reduce the signs and symptoms of:
    • Moderate to severe rheumatoid arthritis (RA) in adults. Humira can be used alone, with methotrexate, or with certain other medicines. Humira may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. Humira can be used alone or with methotrexate.
    • Psoriatic arthritis (PsA) in adults. Humira can be used alone or with certain other medicines. Humira may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Ankylosing spondylitis (AS) in adults.
    • Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.

    About AbbVie in Gastroenterology

    AbbVie has focused on improving care in gastroenterology for more than 10 years. With a robust clinical trial program in inflammatory bowel disease (IBD), we are committed to cutting-edge research to drive exciting discoveries and developments in Crohn’s disease and ulcerative colitis. By innovating, learning, and adapting, AbbVie aspires to eliminate the burden of IBD and make a long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit

    About AbbVie

    AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Forward-Looking Statements

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.


    SOURCE AbbVie

    Posted: February 2021

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    Humira (adalimumab) FDA Approval History

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