Humira: One Drug, Many Uses, Billions of Dollars
Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Jan 24, 2021.
Humira is Adalimumab
Humira is a biologic -- an injectable protein known as a monoclonal antibody which has been developed through genetic engineering. It's is classified as a Tumor Necrosis Factor (TNF) alpha inhibitor, and binds to and blocks the action of TNF in our body.
What does TNF do? TNF can attack healthy tissue and cause inflammation in the body that can lead to:
- destruction in joints and other organs.
One Drug, Multiple Uses
Humira is one of the world's best selling drugs. In fact, overall global revenue for Humira in 2019 reached close to $20 billion, with roughly $15 billion coming from the US market.
However, looming biosimilar competition is taking a bite, especially in the European Union. In fact, AbbVie is expecting Humira biosimilars to erode European sales by about 40%, as reported by FiercePharma in 2019.
Because Humira blocks the inflammatory process, it has a place in many autoimmune conditions with inflammation as a central mechanism, including:
What Is An Autoimmune Disease?
So you've been told a TNF inhibitor like Humira treats autoimmune diseases, but what exactly does that mean?
An autoimmune disease, which may run in families, causes your body's immune system to attack your own healthy cells by mistake.
Antibodies, normally used by your immune system to attack foreign substances like viruses and bacteria, instead attack your cells and lead to inflammation.
Any part of your body can be mistakenly attacked, including:
- digestive tract
This mistaken attack can result in autoimmune diseases like lupus, Crohn's disease, and rheumatoid arthritis.
Humira: Patent Loss and Biosimilars
In late 2016, Humira's original patent expired and opened doors for biosimilar development. But not so fast - due to other pending patents, it's biosimilar products will not reach the US market until 2023. Currently, there are 6 biosimilars awaiting U.S. commercialization.
- The FDA approved the first biosimilar for Humira in September 2016, Amjevita (adalimumab-atto) from Amgen.
- In August 2017, the second Humira biosimilar was cleared for marketing by the name of Cyltezo (adalimumab-adbm) from Boehringer Ingelheim.
- In October 2018, the biosimilar Hyrimoz (adalimumab-adaz) from Sandoz was cleared.
- In 2019, two more biosimilars for Humira were approved: these include: Hadlima (adalimumab-bwwd) from Samsung Bioepis, and Abrilada (adalimumab-afzb) from Pfizer.
- In 2020, Hulio (adalimumab-fkjp) was cleared as the 6th biosimilar to Humira. Mylan plans to launch Hulio in the U.S. in July 2023.
Once available, the new biosimilars can't be directly substituted for Humira by a pharmacist; a doctor must specifically prescribe the biosimilar for their patient, as noted in the FDA's Purple Book.
Humira biosimilars could be one way to save dollars for both the patient and the US health care system, but it's still not quite here yet. Biosimilars available in the EU are now starting to affect overall global sales for Humira.
Place in Therapy: Rheumatoid Arthritis
If you have rheumatoid arthritis, do you have trouble doing normal activities, like cooking, bathing or exercise, even though you've been on older medications? Do joint pain, stiffness, and swelling still persist? Talk to your doc, because it may be time to think about other options to more fully help protect your joints.
Humira is used for reducing signs and symptoms, slowing the progression of joint damage, and improving physical function in adult patients with moderate to severe active rheumatoid arthritis. Humira can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
Studies have shown that combining methotrexate with a TNF blocker like Humira is more effective than using either agent alone and may slow disease progression and structural joint damage.
Other Options: Non-TNF Biologics for RA
- Orencia (abatacept)
- Olumiant (baricitinib)
- Rituxan (rituximab) and biosimilars Truxima (rituximab-abbs), Riabni (rituximab-arrx), and Ruxience (rituximab-pvvr)
- Kineret (anakinra)
- Kevzara (sarilumab)
- Actemra (tocilizumab)
- Xeljanz (tofacitinib)
are all non-TNF biologics and target other immune system molecules; they may be used if a TNF blocker plus methotrexate is not adequate in rheumatoid arthritis.
- In general, non-TNF biologics are not used together with TNF inhibitor biologics due to an increased risk of immunosuppression and serious infection.
- However, most biologics are given by injection and can be added to non-biologic DMARDs, NSAIDs or corticosteriods.
Xeljanz is an oral agent approved for moderate to severe active rheumatoid arthritis in patients without an adequate response to methotrexate. It also comes in an extended-release formulation, Xeljanz XR.
Place in Therapy: Juvenile Idiopathic Arthritis
Humira has an important use in children. Humira, and the biosimilars Amjevita, Cyltezo, Hadlima and Abrilada are FDA-approved for Juvenile Idiopathic Arthritis (JIA), also known as Juvenile Rheumatoid Arthritis, the most common form of arthritis in kids under 17.
Juvenile Idiopathic Arthritis usually affects 5 or more joints on both sides of the body, including the neck, jaw, hands or feet. Like all arthritis, symptoms can flare up and come and go.
- If regular pain and inflammatory medications aren't effective, Humira (and biosimlars when available) can be used in children and the dose is based on weight.
- Other agents, such as NSAIDs and disease modifying agents (DMARDs) can be used with biologics, too, if needed.
TNF Blocker Precautions
Knowing the Boxed Safety Warnings with biologics like Humira is important. Review the Boxed Warnings for Humira with your doctor.
- TNF blockers not only block TNF, they can lower the infection-fighting ability of your immune system.
- Some people using Humira have developed a rare, fast-growing type of lymphoma (cancer), including in adolescents and children. Some cases have resulted in death. Hepatosplenic T-cell lymphoma (HSTCL) has been reported, as well as other cancers. Discuss this risk of cancer with your doctor.
- If an infection (bacterial, viral, or fungal), fever, night sweats or weight loss occur, report these immediately to your doctor.
Before you start any biologic treatment, be sure to review your vaccine history with your doctor. If you need any vaccines, it may be better to have them before Humira treatment starts.
Tell your doctor if you have a history of congestive heart failure (CHF), cancer or hepatitis. You will also be tested for tuberculosis (TB) before starting a biologic agent.
Humira: Common Side Effects
Most people tolerate Humira treatment well. The most common side effects with Humira occurring in greater than 1 out of every 10 patients include:
- infections, like upper respiratory tract infections or sinusitis
- injection site reactions
Injections site reactions such as pain, redness, itching, or swelling were the most common side effects in clinical trials occurring in about 2 out of every 10 patients (20%). However, even the placebo caused injection site reactions in about 1.4 out of every 10 patients, so it may not always be due to the drug.
Are you concerned about Humira side effects? Chat with your doctor and see more side effect information here.
Humira Use in Ankylosing Spondylitis
Low back pain and stiffness, usually worse in the morning and at night, are common symptoms in adults with ankylosing spondylitis (AS).
- But other parts of the body can be affected as AS progresses; it's important to see a rheumatologist for a proper diagnosis as back pain is a common symptom in many people.
- Sometimes regular pain relievers like NSAIDs aren't strong enough, and narcotic painkillers can be addicting.
- Humira works in severe ankylosing spondylitis by blocking the source of inflammation that leads to the pain, as with other uses. The dose of Humira for AS is usually 40 mg injected every other week.
- Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued with Humira treatment.
- The biosimilars to Humira are also approved for use in ankylosing spondylitis.
Place in Therapy: Plaque Psoriasis
Psoriasis is a lifelong autoimmune disease. Skin cells turn over a quick rate, and the extra skin cells can cause raised plaques on the skin that can turn flaky, red, and itchy.
- There is no cure for psoriasis, but advanced treatments and medications allow roughly 80 to 90 percent of patients to have successful treatment.
- Humira may be used after unsuccessful topical and methotrexate therapy.
- To learn more about psoriasis and its treatments, view our Drugs.com Psoriasis Slideshow.
Place in Therapy: Psoriatic Arthritis
Psoriatic arthritis can affect those who have also had psoriasis. The goal in psoriatic arthritis is to control symptoms and prevent joint damage.
- Like other types of arthritis, joint pain, stiffness and swelling are the main symptoms in psoriatic arthritis. Psoriatic arthritis can affect any area of the body, and symptoms may flare up and calm down intermittently.
- Humira is usually dosed at 40 mg injected every other week in psoriatic arthritis. Studies have shown Humira can reduce symptoms of psoriatic arthritis within 3 months, and clear 75% of associated skin psoriasis symptoms within 6 months for the majority of patients.
- The biosimilars to Humira are also approved for psoriatic arthritis.
Place in Therapy: Crohn's Disease
Humira is one treatment approved for moderate to severe Crohn's disease in both adults and children 6 years of age and older when certain other treatments fail. The biosimilar agents have also been cleared by the FDA for use in Crohn's disease.
- Crohn's disease is an autoimmune condition in which the body attacks the lining of the digestive tract leading to diarrhea, stomach pain, weight loss, and fever.
- The goal of treatment is to reduce the inflammation that triggers the disease symptoms; there is no cure for Crohn's disease.
- Humira may be used immediately upon diagnosis of severe Crohn's or when other drugs fail. In clinical studies, Humira led to clinical remission in up to 36 percent of patients at one year.
TNF Inhibitors and Biosimilars
Humira is not the only TNF inhibitor on the market with biosimilars. Others products include:
- Enbrel (etanerept), plus its biosimilars Erelzi (etanercept-szzs) and Eticovo (etanercept-ykro) - biosimilars to Enbrel
- Remicade (infliximab), plus the biosimilars Inflectra (infliximab-dyyb), Renflexis (infliximab-abda), Ixifi (infliximab-qbtx), and Avsola (infliximab-axxq)
- Simponi (golimumab)
- Cimzia (certolizumab pegol)
Prices may range in the thousands of dollars per month if you are paying cash, although the approval of biosimilars should bring prices down. Biosimilars for Humira are expected to launch in 2023.
In the U.S. you will most likely get these drugs from a Specialty Pharmacy that deals with complicated and expensive drugs. They will guide you with ordering your drug and refills, administration, safety, storage, co-pay assistance cards, and other matters related to your treatment.
Learn more about how a Specialty Pharmacy can serve you.
Place in Therapy: Ulcerative Colitis
Humira and the biosimilars are also approved to treat ulcerative colitis in adults.
Ulcerative colitis, like Crohn's disease, is an inflammatory autoimmune condition. Symptoms usually develop over time in the colon and rectum and may include diarrhea, often with blood or pus, stomach cramping, rectal pain or bleeding, stool urgency, weight loss, fatigue, and fever.
Humira dosing for ulcerative colitis is similar to that used in adult Crohn's disease.
- After a higher initial loading dose in the first month, a maintenance dose of 40 mg injected every other week is started.
- Aminosalicylates and/or corticosteroids may be continued during treatment.
- If full improvement is not seen in 8 weeks, contact your doctor, as Humira therapy may need to be re-evaluated.
Latest Uses: Hidradenitis Suppurativa or Uveitis
Most people don't know what hidradenitis suppurativa (HS) is unless they have fallen victim to this condition. In fact, when Humira was FDA-approved in September 2015 for HS, it was the first approved therapy for this condition on the market.
- Hidradenitis suppurativa is a chronic skin disease with symptoms of painful, swollen, and sometimes pus-filled, foul smelling lesions found around the armpits, groin, buttocks and under the breasts.
- Treatment involves higher initial doses of Humira followed by maintenance injections every other week. Humira is also approved for this condition in adolescent patients 12 years of age and older weighing at least 30 kg. Doses are based on weight.
- Antibiotics, corticosteroids, or surgery may be needed, as well.
In 2016 Humira was the first FDA-approved non-corticosteroid treatment option for certain types of uveitis (non-infectious intermediate, posterior and panuveitis).
- Uveitis is an inflammation of the uveal tract in the eye which includes the iris, ciliary body, and choroid. Humira helps to control the inflammation that can have a role in uveitis.
- In studies, patients treated with Humira had a significantly lower risk for treatment failure, defined as a combination of uveitic flare and decrease in visual acuity, compared to placebo.
The approved biosimilars for Humira did not receive approval for the hidradenitis suppurativa or uveitis uses.
Is Humira Difficult to Inject?
Humira comes preloaded in either a single-use syringe or as a single-use auto-injector pen. Humira is injected under the skin (subcutaneous injection) of your stomach or thigh. It sounds difficult and painful, but it's not, and before long you'll be giving the shots to yourself.
- Your doctor or nurse will train you on how to do this. You can inject Humira in the morning or at bedtime, just be consistent.
- Humira's usually injected once every two weeks for most, but not all, conditions.
- Your doctor will determine your best dose.
Humira Injection Facts
If you and your doctor should decide that Humira is the right medication for you, you'll need to learn how to inject it.
Humira is given subcutaneously (SQ), which means injected under the skin. You'll have training sessions at the doctor's office, and extra ones with a nurse if needed.
- Be sure to store Humira in the refrigerator.
- When traveling, you can store Humira at room temperature up to 77° F for 14-days with protection from light in the original carton. Humira should then be discarded if not used within that 14-day period.
- Instructional videos on Humira administration can be accessed here. Complete instructions are found in the Humira box. Be sure to check with your doctor or pharmacist for any questions, too.
Drugs.com Humira Support Groups
Maybe you have more questions about Humira or your condition?
Consider joining the Drugs.com Support Groups where you can ask and answer questions, talk about therapy success and concerns, and keep up with the latest news and research.
Our most popular Humira Support Groups can be found here:
Finished: Humira: One Drug, Many Uses, Billions of Dollars
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- Humira biosimilars catch fire in Europe and could take half the market in a year: report. Fierce Pharma. Accessed Jan. 24, 2020 at https://www.fiercepharma.com/pharma/humira-biosimilars-catch-fire-europe-and-could-take-half-market-a-year-report
- AbbVie, Amgen Reach Settlement in Humira Patent Dispute. WSL. Accessed Jan. 24, 2021 at https://www.wsj.com/articles/abbvie-amgen-reach-settlement-in-humira-patent-dispute-1506635070
- Singh JA, Saag KG, Bridges SL, et al. American College of Rheumatology. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Accessed Jan 24, 2021 at http://www.rheumatology.org/Portals/0/Files/ACR%202015%20RA%20Guideline.pdf
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- Maxwell LJ, Zochling J, Boonen A, et al. TNF-alpha inhibitors for ankylosing spondylitis. Cochrane Database Syst Rev. 2015 April 18;4:CD005468. Accessed Accessed Jan 23, 2020 at PMID: 25887212
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