Commitment
BUILT ON
HUMIRA
US-MULT-230356
US-MULT-230356
BUILT ON
HUMIRA
*A literature search strategy was designed to find adalimumab publications parsed out by study type: open-label publications, meta-analyses, observational/registry studies, and randomized controlled trials (RCTs). Four databases in the ACSSTN command language platform were used: Medline, 1946 to January 17, 2020; Embase, 1947 to January 17, 2020; Biosis, 1926 to January 17, 2020; and HCAPLUS (Chemical Abstracts Plus), 1907 to January 17, 2020.
HUMIRA innovations—including the prefilled syringe and the HUMIRA Pen for self-injection, HUMIRA Citrate-free, and HUMIRA Complete patient support—designed with the patient experience in mind
2003
Offered patients an option to self-administer HUMIRA using a prefilled device
2006
Designed for ease of use, with patient self-administration in mind
2014
Helping patients start and stay on track with their prescribed treatment plan
2018
The majority of patients on HUMIRA today are taking HUMIRA Citrate-free, an innovation proven to offer less pain immediately following injection compared to HUMIRA 40 mg/0.8 mL presentations
†HUMIRA is intended for use under the guidance and supervision of a physician. A patient may self-inject HUMIRA or a caregiver may inject HUMIRA if a physician determines that it is appropriate and with medical follow-up as necessary, after proper training in subcutaneous injection technique.
HUMIRA has over 24 years of clinical trial experience starting in rheumatoid arthritis‡
1997
Clinical Trials Begin9
2002
FDA Approval
Moderate to Severe RA in Adults5
2003
First Adult Patient Enrolled in Plaque Psoriasis Clinical Trials10
2005
FDA Approval
Psoriatic Arthritis in Adults11
2006
FDA Approval
Ankylosing Spondylitis in Adults12
2007
FDA Approval
Moderate to Severe Crohn's Disease in Adults13
2008
FDA Approval
Moderate to Severe Juvenile Idiopathic Arthritis (age 4+)14
2008
FDA Approval
Moderate to Severe Chronic Plaque Psoriasis in Adults15
2012
FDA Approval
Moderate to Severe Ulcerative Colitis in Adults16
2014
FDA Approval
Polyarticular Juvenile Idiopathic Arthritis (age 2+)17
2014
FDA Approval
Moderate to Severe Pediatric Crohn’s Disease (age 6+)18
2015
FDA Approval
Moderate to Severe Hidradenitis Suppurativa in Adults19
2016
FDA Approval
Non-Infectious Intermediate, Posterior, and Panuveitis in Adults20
2017
FDA Approval
Data for Moderate to Severe Fingernail Psoriasis in Adults21
2018
FDA Approval
Label Expansion to Include Pediatric Patients (2+) With Non-Infectious Intermediate, Posterior, and Panuveitis22
2018
FDA Approval
Label Expansion to Include Adolescents (≥12) With Moderate to Severe HS23
2021
FDA Approval
Label Expansion to Include Pediatric Patients (5+) With Moderate to Severe Ulcerative Colitis24
‡First patient dosed April 1997 in rheumatoid arthritis.9
SERIOUS INFECTIONS
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
HYPERSENSITIVITY
HEPATITIS B VIRUS REACTIVATION
NEUROLOGIC REACTIONS
HEMATOLOGIC REACTIONS
CONGESTIVE HEART FAILURE
AUTOIMMUNITY
IMMUNIZATIONS
ADVERSE REACTIONS
Please see Full Prescribing Information.
US-HUM-210183
References:
HUMIRA has >90% preferred national commercial and Medicare Part D formulary coverage under the pharmacy benefit as of January 20231*
*Preferred means HUMIRA is on a preferred tier or otherwise has preferred status on the plan’s formulary.
Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
Questions about access for your patients?
Learn more about how to help your patients access HUMIRA
1. Data on file, AbbVie Inc., January 2023.
US-HUM-220513
