With 10 approved uses and the potential for more on the way, Humira (adalimumab) has emerged as the best-selling drug in the world. But it’s not without a price. The medication can cost more than $50,000 a year per patient. For some 4,200 patients, it may have cost them their lives.
Humira is made by joining together DNA molecules. It is what’s known as a biologic. Typically, patients must have an inadequate response to conventional medications to be considered for biologics.
More specifically Humira is a tumor necrosis factor-α blocker, or TNF blocker. The drug suppresses the immune system by blocking the activity of TNF.
TNF is a protein produced naturally by the body’s immune system. Some people with certain autoimmune diseases produce too much TNF.
The body’s overproduction of TNF and other proteins can cause inflammation and lead to autoimmune diseases such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
Humira binds to TNF molecules and blocks the molecules from attaching to healthy cells and attacking them. The medication does not stop the body from making too much TNF, but it is designed to reduce the damaging effects of excess TNF.
Other TNF blockers include Remicade (infliximab), Enbrel (etanercept), Cimzia (certolizumab pegol) and Simponi (golimumab). Another competitor drug, Actemra, works by blocking the protein interleukin 6 (IL-6) from connecting to cells.
10 Approved Uses
The U.S. Food and Drug Administration first approved Humira on Dec. 31, 2002, to treat rheumatoid arthritis. Between October 2005 and June 2016, the agency added nine more indications to the anti-inflammatory drug’s label.
A Chicago Tribune article dubbed the medication “the Swiss army knife of pharmaceutical drugs” because it is indicated to treat a slew of conditions affecting the skin, joints, spine and gastrointestinal tract. Even though the medication has 10 approved uses in the United States and 14 approved uses abroad, the drug’s manufacturer, AbbVie, continues to look for ways to extend the drug’s reach and find new patients.
In the meantime, pharmacies have filled more than 2.4 million Humira prescriptions in a single year. The drug is marketed to people with symptoms including itchy, painful red patches on the scalp; inflamed lesions around the armpits, groin, buttocks and breasts; stiffness of the spine or inflammation of the gastrointestinal tract.
- Rheumatoid Arthritis
- When Humira hit the market in 2002, its sole approved use was treatment in adult patients with moderately to severely active rheumatoid arthritis (RA). The drug is designed to reduce signs and symptoms, induce major clinical response, inhibit the progression of structural damage and improve physical function in these patients. The medication can be used alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs), such as methotrexate.
- Juvenile Idiopathic Arthritis
- Humira is also indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. It can be used alone or in combination with methotrexate. The drug’s label warns that some children, adolescents and young adults developed cancers — some fatal — after receiving treatment with TNF-blockers.
- Psoriatic Arthritis
- In October 2005, the FDA expanded Humira’s approved uses to include treatment in adults with active psoriatic arthritis (PsA). As with RA patients, PsA patients use the medication to reduce signs and symptoms of their disease, inhibit the progression of structural damage and improve physical function. Doctors can prescribe adalimumab on its own or in combination with non-biologic DMARDs.
- Ankylosing Spondylitis
- Humira’s label was updated in August 2006, after the FDA approved yet another indication: reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). AS is a type of progressive arthritis that mainly affects the spine.
- Adult Crohn’s Disease
- Adults who have moderately to severely active Crohn’s disease and who have had an inadequate response to conventional therapy were added to the list of candidates for Humira in 2007. The drug can reduce signs and symptoms and bring on remission in these patients as well as in patients who have also lost response to or are intolerant to Remicade.
- Pediatric Crohn’s Disease
- Humira is also indicated for reducing signs and symptoms, and inducing and maintaining remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine (6-MP) or methotrexate. Most Humira patients who developed a rare and deadly type of cancer called hepatosplenic T-cell lymphoma were male teenagers or young men with inflammatory bowel disease who were also being treated with Imuran (azathioprine) or Purinethol (6‐mercaptopurine, 6‐MP).
- Ulcerative Colitis
- The FDA expanded the list of approved Humira uses to include another gastrointestinal disorder, Ulcerative Colitis (UC), in September 2012. The medication is indicated for bringing on and sustaining remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). Scientists have not established whether adalimumab is effective in patients who have lost response or were intolerant to other TNF blockers.
- Plaque Psoriasis
- In January 2008, AbbVie gained approval to market Humira for the treatment of adults with moderate to severe chronic plaque psoriasis (Ps) who are candidates for systemic therapy or phototherapy. The drug is approved for these patients when other systemic therapies are medically less appropriate and only under the condition that they will be closely monitored and have regular follow-up visits with a physician.
- Hidradenitis Suppurativa
- The FDA approved Humira for treatment in adults with moderate to severe hidradenitis suppurativa (HS) in 2015. Also known as acne inversa, this painful, chronic inflammatory skin disease causes lesions around the armpit, groin, buttocks and breast. Before adalimumab, adults with HS had no approved treatment.
- Humira became the first and only FDA-approved non-corticosteroid therapy available for adults with non-infectious intermediate, posterior and panuveitis, a rare inflammation of the middle pigmented layer of the eye. The FDA approved this use in June 2016.
Who Should Not Use Adalimumab?
Anyone with an allergy to Humira or to any of its ingredients, including sodium phosphate, sodium citrate, citric acid, mannitol and polysorbate 80, should not use the drug. Also, patients should tell their doctors of any allergies to rubber or latex. The needle cover on the prefilled syringe contains dry natural rubber.
The drug’s manufacturer also warns against using Humira at the same time as other TNF blockers or biologics because of a possible increased risk for serious infections. The label specifically mentions Orencia (abatacept), Kineret (anakinra), Remicade (infliximab), Enbrel (etanercept), Cimzia (certolizumab pegol) or Simponi (golimuma).
Some patients who were treated with rituximab (Rituxan) followed by a TNF blocker also showed a higher rate of serious infections. Others who were treated with Humira and Imuran (azathioprine) or Purinethol (mercaptopurine, 6-MP) developed hepatosplenic T-cell lymphoma, a rare, often deadly cancer.
Another interaction to consider is Humira and live vaccines. The FDA advises children get vaccines as recommended by the Centers for Disease Control and Prevention before starting the medication. While it may be OK for patients taking adalimumab to get certain vaccinations, they should avoid all live vaccines.
Humira should only be used during pregnancy if needed. The medicine can pass through the placenta during the third trimester of pregnancy and may affect immune response in the fetus.
While there have been no adverse event reports concerning the effects of Humira on breastfed infants, adalimumab can be passed from mother to child through breast milk. Women should discuss with their doctor the potential risks and benefits of breastfeeding while taking the medication.
Injecting the Drug
Some TNF blockers are administered intravenously at infusion centers or are injected at the dermatologist’s office. Most patients on Humira can inject the drug at home, though some people will need to visit their doctor’s office for injections.
A patient may self-inject the medication or a caregiver may inject the drug using the Humira Pen or prefilled syringe. The pen is designed so the patient does not see the needle.
The medication must be stored in a refrigerator but may be brought to room temperature for about 15 minutes to 30 minutes before it is injected into the abdomen or front thigh. Aside from the needle prick, patients have reported feeling “a sting” after the injection caused by the medicine itself.
It’s important to rotate injection sites to reduce sensitivity and avoid increasingly painful injections. Patients and caregivers should not inject the medication into areas where the skin is tender, bruised, red or hard.
Following complaints of stinging associated with Humira injections, AbbVie introduced a new “citrate-free” version of the drug that causes less pain. The syringes have a thinner needle and hold half the liquid (0.4 mL as opposed to 0.8 mL) they used to, but they contain the same amount (40 mg) of Humira.
There are other obvious differences with the citrate-free formula: the numbers on the cap of the prefilled syringe are in white, the viewing window where patients can see the medication is larger and the syringes come in a blue box rather than a maroon one.
Patients who’ve used the citrate-free injections describe them as hurting less than a flu shot. Some people feel nothing at all.
The needle cover of the citrate-free version does not contain natural rubber latex.
A patient who wishes to switch to the citrate-free version must request a new prescription from their doctor. Their health insurance provider might also require a new prior authorization.
Side Effects and Warnings
Injection site reactions such as redness, itching, bleeding and swelling are the most common side effects of the medication. While one in five patients will develop a localized reaction at the site of the shot, these effects are usually mild and don’t require the patient to stop using the drug.
Other common Humira side effects include upper respiratory infections, sinusitis, headaches and rash.
Because the medication suppresses the immune system, it can put users at a greater risk of serious or even deadly infections and illnesses. These include tuberculosis (TB) and invasive fungal infections, and cancers of the immune system known as lymphomas.
The FDA requires the drug’s label carry a black box warning for serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens. The boxed warning also includes cancer, notably lymphoma and hepatosplenic T-cell lymphoma.
- Serious infections
- Injection site reactions
- Severe allergic reactions
- Hepatitis B reactivation
- Neurological reactions
- Blood reactions
- Worsening congestive heart failure
- Lupus-like syndrome
Reported Deaths and Adverse Events
Humira was linked to more than 209,000 adverse event reports between 2013 and 2017, including more than 4,200 deaths. In 2014 and 2015, more people submitted adverse event reports directly to the FDA for Humira than for any other drug.
The drug also ranked first in 2014 in the number of total reports reaching the FDA, and it ranked No. 2 for reports of serious injuries occurring in the United States.
In 2014, the FDA received 46,937 reports of adverse events associated with adalimumab, including 1,125 cases deaths and 12,270 serious injuries. Approximately three-quarters of those reports came from consumers. The rest came from doctors and others.
The serious and fatal injuries reported in 2014 included:
- 3,298 infections
- 1,410 cases of cancers, including 197 deaths
- 1,438 hypersensitivity reactions
The medication accounted for 1,581 direct reports to the FDA in 2015.
According to the Institute for Safe Medication Practices, this category of complaints is important because it represents concerns that healthcare professionals and consumers take directly to the FDA, as opposed to those that come to light via reports from drug manufacturers.
Drug Costs and Revenues
AbbVie’s former owner, Abbott Laboratories, paid nearly $7 billion to acquire Knoll Pharmaceuticals and Humira back in 2001. A decade and a half after the acquisition, Humira has become one of the top-selling prescription drugs in the world — and one of the most costly.
United States prescriptions for the medication ballooned from 1.5 million in 2011 to 2.4 million in 2015. The drug was the most widely prescribed TNF blocker in 2015, with 634,000 dispensed outpatient prescriptions in the fourth quarter of that year.
Meanwhile, between 2012 and 2018, the price of the medication more than doubled from about $19,000 a year to more than $38,000 annually (after discounts and rebates, according to the research firm SSR Health. Before discounts and rebates, the box with two prefilled pens costs about $4,800. AbbVie tends to increase the price of the drug twice each year.
While employers and their health insurers bear most of those costs, some patients have extremely high out-of-pocket costs, or co-pays. One patient told The New York Times that she spends about $2,400 out of pocket each year on the drug, and that she’s considered going on a liquid diet and foregoing the Crohn’s treatment to avoid the expense.
In 2017, AbbVie spent $341 million on advertisements for the drug, topping all other drug advertising.
The $300-plus million for advertisements is still just a fraction of the $18.4 billion in revenues the medication generated in 2017. The drug is forecast to bring in $21 billion in sales, or $57 million a day, in 2020.
The medicine generated $12.5 billion in sales in 2014, $14 billion in 2015 and $16 billion in 2016. It is AbbVie’s single largest product and accounted for more than 60 percent of the company’s revenue in each of those years.
In 2016, the FDA approved a biosimilar, or near-copy, of Humira called Amjevita/Amgevita. Developed by Amgen Inc., Amjevita is approved for nearly all of the conditions listed on Humira’s label. While Amgevita was launched in Europe in 2018, the drug won’t be available for sale in the United States until 2023. Biosimilars are usually 15 to 30 percent cheaper than the original biologics.
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