ABBVIE INC. 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
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
'Ulcerative colitis is unpredictable and affects everyone, especially children, in different ways,' said
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
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.
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.
To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older.
To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.
Important Safety Information About HUMIRA (adalimumab)
What is the most important information I should know about HUMIRA
You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.
Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn't heal.
What should I tell my doctor BEFORE starting HUMIRA
Tell your doctor about all of your health conditions, including if you: Have an infection, are being treated for infection, or have symptoms of an infection
Get a lot of infections or infections that keep coming back
Have diabetes
Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
Live or have lived in an area (such as the
Have or have had hepatitis B
Are scheduled for major surgery
Have or have had cancer
Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barre syndrome
Have or had heart failure
Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA
Are allergic to rubber, latex, or any HUMIRA ingredients
Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
Have a baby and you were using HUMIRA during your pregnancy. Tell your baby's doctor before your baby receives any vaccines
Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol), or SIMPONI (golimumab). Tell your doctor if you have ever used RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (mercaptopurine, 6-MP).
What should I watch for AFTER starting HUMIRA
HUMIRA can cause serious side effects, including: Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.
Call your doctor or get medical care right away if you develop any of the above symptoms.
Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.
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.
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.
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
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