Humira: One Drug, Nine Uses, Billions of Dollars
Humira is Adalimumab
No doubt you've seen the Humira ads on prime time TV. Humira's generic name is adalimumab, and it's a mouthful - it's pronounced "AY da LIM ue mab". Humira is a biologic, an injectable protein known as a monoclonal antibody which has been developed through genetic engineering. Humira 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, one of the world's best selling drugs, has many uses. 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 skin, digestive tract, joints and tendons, resulting in autoimmune diseases like lupus, Crohn's disease, and rheumatoid arthritis.
Humira: Patent Loss in 2016
In 2016, Humira posted close to $10.5 million in net revenues for AbbVie and was it's top-selling product. However, in late 2016 Humira's patent expired opening doors for competition. The FDA approved the first biosimilar for Humira in September 2016 -- Amjevita (adalimumab-atto). In August 2017, the second Humira biosimilar was cleared for marketing: it's name is Cyltezo (adalimumab-adbm).
Of note, Humira makes up over half of all profits for AbbVie. The new biosimilars can't be directly substituted for Humira by a pharmacist; a doctor must specifically prescribe Amjevita for their patient. Biosimilars may be one way to save dollars for both the patient and the health care system.
Place in Therapy: Rheumatoid Arthritis
If you have RA, 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? The use of TNF blockers like Humira, with or without methotrexate, is recommended for patients with moderate to severe rheumatoid arthritis (RA) or who fail non-biologic disease-modifying agents like methotrexate.
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.
Non-TNF Biologics for Rheumatoid Arthritis
Orencia (abatacept), Rituxan (rituximab), Kineret (anakinra), Actemra (tocilizumab) and Xeljanz (tofacitinib) are 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.
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 severely active rheumatoid arthritis in patients without an adequate response to methotrexate.
Place in Therapy: Juvenile Rheumatoid Arthritis
Humira has an important use in children. Humira, and the biosimilars Amjevita and Cyltezo are FDA-approved for Juvenile Idiopathic Arthritis (JIA), also known as Juvenile Rheumatoid Arthritis, the most common form of arthritis in kids under 17.
JIA 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, these biologics 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 safety warnings with biologics is important.
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), too. What should you watch out for? Infection, fever, night sweats or weight loss should be reported to your doctor. Before you start any biologic treatment, be sure to review your vaccine history with your provider. If you are lacking in any vaccines, it may be better to have them before Humira treatment.
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, headache, and rash.
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. 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.
Place In Therapy: 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. As with rheumatoid arthritis, Humira works in severe ankylosing spondylitis by blocking the source of inflammation that leads to the pain. The dose of Humira for AS is usually 40 mg injected every other week.
Both biosimilars to Humira -- Amjevita and Cyltezo -- are also approved for use in AS.
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 Amjevita and Cyltezo 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 Amjevita and Cyltezo 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.
Specialty Pharmacy Benefits
Humira is not the only TNF inhibitor on the market. Others include:
- Amjevita (adalimumab-atto) and Cyltezo (adalimumab-adbm) - biosimilars to Humira
- Enbrel (etanerept)
- Erelzi (etanercept-szzs) - a biosimilar to Enbrel
- Remicade (infliximab)
- Inflectra (infliximab-dyyb) - a biosimilar to Remicade
- Simponi (golimumab)
- Cimzia (certolizumab pegol)
However, 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 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. If clinical remission is not seen by 8 weeks, see your doctor, as Humira therapy may need to be re-evaluated.
Place In Therapy: Hidradenitis Suppurativa
Don't feel bad if you don't know what Hidradenitis Suppurativa (HS) is; most people don't 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. HS 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. Antibiotics, corticosteroids, or surgery may be needed, as well.
Humira is a Self-Administered Injection. Is It Difficult?
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. The biosimilar Amjevita is also self-injected.
How To Inject Humira
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 at your home 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, too.
Join the Drugs.com Support Groups
Maybe you have more questions about Humira or your condition? Check with your doctor, and then consider joining the Drugs.com Support Groups where you can ask and answer questions, express therapy success and concerns, and keep up with the latest research. Our most popular Humira Support Groups can be found here:
Finished: Humira: One Drug, Nine Uses, Billions of Dollars
- FDA Approves Cyltezo. Drugs.com. August 29, 2017. Accessed September 19, 2017 at https://www.drugs.com/newdrugs/fda-approves-cyltezo-adalimumab-adbm-biosimilar-humira-4583.html
- FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira. Drugs.com. Accessed 2/20/2017 at https://www.drugs.com/newdrugs/fda-approves-amjevita-adalimumab-atto-biosimilar-humira-4434.html
- 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 2/20/2017 at http://www.rheumatology.org/Portals/0/Files/ACR%202015%20RA%20Guideline.pdf
- Scheinfeld N. Adalimumab: a review of side effects. Expert Opin Drug Saf. 2005 Jul;4(4):637-41. Accessed 2/20/2017 at http://www.ncbi.nlm.nih.gov/pubmed/16011443
- Maxwell LJ, Zochling J, Boonen A, et al. TNF-alpha inhibitors for ankylosing spondylitis. Cochrane Database Syst Rev. 2015 April 18;4:CD005468. Accessed 2/20/2017 at http://www.ncbi.nlm.nih.gov/pubmed/25887212
- Humira Professional Labeling. AbbVie. 2013. Accessed 2/20/2017 at https://www.humira.com/
- The Motley Fool. Can AbbVie Inc. Overcome Humira's Looming Patent Expiration? Accessed 2/20/2017 at http://www.fool.com/investing/general/2015/01/20/can-abbvie-inc-overcome-humiras-looming-patent-exp.aspx