Humira is one of the best-selling drugs in history, generating over $200 billion in global sales since its approval in 2002. As one of the most widely prescribed biologics for autoimmune conditions, it remains a key treatment for managing chronic inflammation. But what is Humira used for exactly?
While its FDA approvals cover diseases like rheumatoid arthritis, Crohn’s disease, and plaque psoriasis, its impact reaches further. Some doctors use it beyond its official indications, exploring its potential for conditions that aren’t widely discussed.
This article takes a closer look at Humira’s approved treatments and off-label uses, offering insight into its broader role in managing inflammatory diseases.
How Does Humira Work in the Body?
Humira (adalimumab) is a biologic medication that targets tumor necrosis factor-alpha (TNF-alpha).
The immune system naturally produces TNF-alpha to help fight infections and heal injuries. However, in autoimmune diseases, the immune system overreacts and produces too much TNF-alpha. This leads to chronic inflammation, which can cause pain, swelling, and damage to healthy tissues. Depending on the condition, this inflammation may affect the joints, skin, or digestive system.
Humira helps by binding to TNF-alpha and blocking its activity. When TNF-alpha is neutralized, it can no longer trigger an inflammatory response. As a result, symptoms such as swelling, pain, and tissue damage decrease over time.
What is Humira Used For?
Humira first received FDA approval in 2002 for rheumatoid arthritis. Since then, it has become one of the most widely used biologic drugs for several autoimmune diseases. Below is a list of its approved uses and some off-label applications.
FDA-Approved Indications of Humira
The FDA approved Humira for the following conditions:
1. Rheumatoid Arthritis (RA)
Rheumatoid arthritis is a long-term autoimmune disease that mainly affects the joints, causing redness, swelling, and joint pain. In severe cases, it can reduce movement.
People with RA have high TNF-alpha levels. TNF-alpha activates cells in the joint lining that cause the lining to grow too much and increase inflammation. This also leads to the release of enzymes that break down cartilage and bone, worsening joint damage.
In the US, RA affects 0.6% to 1% of the adult population, and around 35% experience work-related disability. The total yearly healthcare costs for RA patients in the US are estimated at $19.3 billion.
Who can use Humira for Rheumatoid Arthritis?
Humira is approved for adults with moderate to severe RA. A long-term study examined its effectiveness and persistence in real-world RA patients over 10+ years. Among those who stayed on Humira for at least one year:
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- 67% achieved low disease activity or remission.
- Significant improvements were seen in pain, stiffness, fatigue, and joint symptoms.
These improvements remained stable for over 10 years in those who continued treatment.
2. Ankylosing Spondylitis (AS)
Ankylosing spondylitis mainly affects the spine and sacroiliac joints. It causes pain, stiffness, and limited movement and can eventually lead to spinal fusion, where the bones in the spine grow together into a single, rigid structure.
As the condition worsens, flexibility decreases, making it harder to bend or move. In severe cases, the spine may become completely stiff, causing a hunched posture.
The exact cause of AS is unclear, but genetics are closely linked to the disease. The HLA-B27 gene is strongly associated with AS, with over 90% of people with the condition carrying this genetic marker.
Who can use Humira for Ankylosing Spondylitis?
Humira is approved for adult patients with active AS. Clinical trials have shown that it reduces disease activity, improves symptoms, and is well-tolerated, particularly in patients who have not responded to treatments like NSAIDs, glucocorticoids, methotrexate, or sulfasalazine.
In one study, patients treated with Humira experienced a 53.6% reduction in spinal inflammation and a 52.9% reduction in sacroiliac joint inflammation after 12 weeks. These improvements were sustained for up to 52 weeks.
3. Crohn’s Disease (CD)
Crohn’s disease is a chronic inflammatory bowel disease (IBD) that causes inflammation in the digestive tract, often affecting the small intestine and the beginning of the large intestine. Although, inflammation can also occur in any part of the digestive system, from the mouth to the anus. The affected tissues become thick and swollen, and open sores (ulcers) may develop on the inner lining of the digestive tract.
More than half a million Americans are currently living with Crohn’s disease. For unclear reasons, its prevalence has been rising in the US and several other parts of the world.
Who can use Humira for Crohn’s Disease?
Humira is approved for adults and children (6 years and older) with moderately to severely active Crohn’s disease.
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- In adults: A study in Japanese patients found that over 70% remained in remission for up to three years, demonstrating long-term effectiveness. Additionally, 42.3% achieved mucosal healing (absence of ulcers).
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- In children: A meta-analysis showed that after 12 weeks of treatment, 59% achieved remission and 60% had improved symptoms. By 1 year, 57% remained in remission, and 63% continued responding to treatment.
These results demonstrate Humira’s ability to manage Crohn’s disease effectively in both adults and children.
4. Ulcerative Colitis (UC)
Ulcerative colitis is another form of IBD, which also causes chronic inflammation in the intestinal lining. However, unlike Crohn’s disease, which can affect any part of the digestive system, ulcerative colitis is limited to the colon.
In both Crohn’s disease and ulcerative colitis, the immune system mistakenly attacks the intestines, releasing inflammatory proteins like TNF-alpha, which leads to:
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- Scarring in the intestine
- Tissue breakdown in the gut
- Ongoing inflammation and damage, which harms the gut lining and blood vessels
This cycle of chronic inflammation and tissue damage results in pain, digestive issues, and complications commonly seen in affected patients.
Who can use Humira for Ulcerative Colitis?
Humira is approved for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients aged 5 years and older. However, its use is limited in patients who did not respond to or could not tolerate TNF blockers.
In a study of 1,613 ulcerative colitis patients, Humira was effective in 70%-83% of those with moderate to severe UC over 8 to 52 weeks. The best results were seen with a 40 mg dose over 52 weeks, leading to the highest rates of mucosal healing, remission, and symptom improvement.
A real-world study also suggests that Humira is effective in children with ulcerative colitis, even in those who could not tolerate or did not respond to infliximab (a TNF blocker). After 52 weeks, 41% achieved long-term remission without steroids, and 28% experienced mucosal healing.
5. Hidradenitis Suppurativa (HS)
Hidradenitis suppurativa (HS) is a long-term inflammatory skin condition. It causes deep, painful lumps (about 0.2 to 0.8 inches) that can last from days to months. These lumps are often mistaken for boils but tend to be deeper, recur frequently, and may rupture. Over time, they can form tunnels under the skin that drain fluid and may develop ulcers.
HS commonly appears in areas where skin rubs together, such as the armpits, groin, and under the breasts. The condition can lead to scarring and significantly impact daily life due to pain, drainage, and odor.
HS affects an estimated 1% to 4% of people, though actual cases may be higher due to misdiagnosis. Women are about three times more likely to have HS than men.
Who can use Humira for Hidradenitis Suppurativa?
Humira is approved for individuals aged 12 and up who have moderate to severe HS. It is one of only two biologics approved for HS and the only FDA-approved option for pediatric patients.
Clinical studies have shown that many patients experience a significant reduction in inflammatory nodules and abscesses within 12 weeks of treatment. Additionally, real-world data suggest that Humira remains effective for at least one year, particularly in those with moderate to severe disease.
6. Juvenile Idiopathic Arthritis (JIA)
Juvenile idiopathic arthritis is a type of arthritis that affects children. A study in the US and Canada found that JIA occurs in about 0.041 to 0.061 per 1,000 children. Unlike rheumatoid arthritis in adults, which is a lifelong condition, many children outgrow JIA. However, the disease can still impact bone growth during childhood.
JIA follows the typical pattern of inflammatory joint disease, including:
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- Joint swelling
- Fluid buildup
- Soft tissue inflammation
- Bone changes like reduced bone density, bone swelling, and erosion
Since it affects children, it can also lead to growth-related issues such as uneven limb length, early closure of growth plates, and changes in bone development.
Who can use Humira for Juvenile Idiopathic Arthritis?
There are several types of JIA, but Humira is specifically approved to reduce the signs and symptoms of polyarticular JIA in patients 2 years and older. This type of JIA affects five or more joints within the first six months of the disease. Blood tests can determine whether it is rheumatoid factor (RF)-positive or RF-negative.
Two studies evaluated Humira’s safety and effectiveness. One included patients 4 years and older, while the other focused on children 2 to 4 years. Both studies demonstrated positive outcomes.
7. Plaque Psoriasis (Ps)
Psoriasis is the most common immune-mediated inflammatory disease, with plaque psoriasis being the most prevalent form. These plaques form due to rapid skin cell growth, resulting in thick scaling. It typically appears on the scalp, trunk, and the outer parts of the elbows and knees.
Many patients experience flare-ups and relapses, which can sometimes become severe and progress to the pustular form of psoriasis. Unlike typical plaque psoriasis, which causes scaly patches, the pustular subtype develops pus-filled blisters (pustules) on the skin. Additionally, at least 15% of individuals with plaque psoriasis go on to develop psoriatic arthritis.
Although plaque psoriasis is not life-threatening, it is challenging to treat, and response to therapy varies widely among patients.
Who can use Humira for Plaque Psoriasis?
Humira is approved for adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, particularly when other systemic treatments are not medically suitable.
Real-world studies found Humira to be more effective than traditional treatments. Patients using Humira were 2.37 times more likely to achieve near-clear skin within 6 months, and they reached this improvement twice as fast as those on traditional treatments.
8. Psoriatic Arthritis (PsA)
Psoriatic arthritis affects both the skin and joints. While it can impact any joint, it most commonly affects the fingers, toes, knees, and spine, leading to pain, swelling, and stiffness. Many individuals also experience nail changes, such as pitting, thickening, or separation from the nail bed.
In most cases (68%), skin symptoms appear before joint symptoms. However, in about 15% of patients, skin and joint symptoms develop at the same time, while in 17%, arthritis appears before any skin symptoms, which can make diagnosis more challenging.
Who can use Humira for Psoriatic Arthritis?
Humira is approved for adult patients with active psoriatic arthritis. A retrospective study that followed Ps and PsA patients for up to 9 years found that Humira demonstrated consistent safety and effectiveness, comparable to results from clinical trials.
Most patients experienced rapid and lasting improvement in skin symptoms, as measured by PASI 75, PASI 90, and PASI 100 scores (which indicate 75%, 90%, or complete clearance of psoriasis symptoms).
Obese patients and those who had previously used other biologic drugs (including other anti-TNFs) also showed positive results. Additionally, elderly patients tolerated Humira well, with no unexpected safety concerns.
9. Uveitis
Uveitis is an inflammation of the uvea, the middle layer of the eye that includes the iris, ciliary body, and choroid. It can affect one or both eyes and, if left untreated, may lead to vision loss.
There are four types of uveitis based on the affected location:
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- Anterior uveitis – Inflammation in the front part of the eye, involving the iris and ciliary body.
- Intermediate uveitis – Affects the vitreous humor, the gel-like substance in the middle of the eye.
- Posterior uveitis – Involves the retina and choroid, located at the back of the eye.
- Panuveitis – Affects all parts of the eye.
The exact cause of uveitis is often unknown, but it can be linked to autoimmune diseases, infections, eye injuries, or previous eye surgeries.
Who can use Humira for Uveitis?
Humira is approved for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and children aged 2 years and older. It is not indicated for anterior uveitis or cases caused by infections, eye injuries, or surgeries.
An analysis in 2022 demonstrated that Humira is effective in controlling non-infectious uveitis, helping stabilize or improve vision, reduce the need for immunosuppressants, and lower corticosteroid use. Additionally, no new safety concerns were identified over the 12-month follow-up period.
Off-Label Uses of Humira
Off-label use refers to a doctor prescribing a medication for a purpose not officially approved by regulatory bodies like the FDA. This practice is common in medicine, as physicians rely on their clinical judgment and knowledge of a patient’s condition to determine the best course of treatment.
Humira is used off-label for various conditions, including:
1. Pyoderma Gangrenosum (PG)
Pyoderma gangrenosum is a skin disorder characterized by large, painful ulcers. In up to 50% of cases, PG is associated with underlying health conditions, including:
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- IBD such as ulcerative colitis and Crohn’s disease
- Arthritic conditions like rheumatoid arthritis
In November 2020, Japan became the first country to approve Humira for PG. This approval was based on a phase III clinical trial in Japan that demonstrated the drug’s efficacy and safety in treating PG.
Before this approval, several case reports and studies had suggested the potential effectiveness of Humira in treating PG. For example, a 2007 case study reported that a patient showed a response to Humira within two months and achieved complete healing after 5.5 months of treatment.
2. Behcet Disease
Behcet’s disease, also known as Behcet’s syndrome, is characterized by recurrent inflammation in blood vessels, leading to a variety of symptoms.
Diagnosing Behcet’s disease can be challenging due to its wide range of symptoms, which overlap with other conditions. There is no single test for the disease. Instead, diagnosis is based on clinical criteria. A confirmed diagnosis typically requires recurrent mouth ulcers along with at least two of the following symptoms:
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- Genital ulcers
- Eye inflammation
- Skin lesions
- A positive pathergy test (a skin hypersensitivity test)
Humira was approved in Japan in 2013 for the treatment of intestinal Behcet’s disease, making it the first biologic indicated for this condition in the country. However, it’s not approved in the US.
3. Sarcoidosis
Sarcoidosis is characterized by the formation of tiny clumps of inflammatory cells, known as granulomas, in various organs. These granulomas most commonly affect the lungs and lymph nodes but can also involve the eyes, skin, heart, and other organs.
Despite the lack of FDA approval for this indication, some studies and clinical experiences suggest that Humira may effectively reduce sarcoidosis symptoms. One case report documented significant improvement after five weeks of Humira treatment.
The patient experienced a reduction in nodules on the nose, while those on the eyebrows, chin, and upper lip had completely resolved. The nodules and erosions on the legs also showed marked improvement. By the tenth week, the nasal nodules had flattened further, the leg erosions were fully healed, and the remaining nodules became softer and less pronounced. Notably, the patient did not experience any adverse effects during treatment.
4. Pemphigus
Pemphigus is a rare autoimmune disease that causes painful blistering of the skin and mucous membranes, including the mouth, throat, nose, eyes, and genitals.
There are several types of pemphigus, including:
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- Pemphigus vulgaris – The most common form, affecting both the skin and mucous membranes.
- Pemphigus foliaceus – A milder form that affects only the skin.
- Paraneoplastic pemphigus – A rare variant associated with certain cancers and tumors.
The primary FDA-approved treatments for pemphigus vulgaris include Rituxan (rituximab) and prednisone (a corticosteroid).
5. Multicentric Reticulohistiocytosis (MRH)
Multicentric Reticulohistiocytosis is a rare systemic disease characterized by the accumulation of histiocytes (a type of immune cell) in the skin, joints, and sometimes internal organs. It primarily manifests as destructive polyarthritis (which resembles rheumatoid arthritis) and cutaneous nodules, often affecting the fingers, face, and other body parts.
In severe cases, MRH can lead to joint deformities and functional impairment. There is no standardized or FDA-approved treatment for Multicentric Reticulohistiocytosis (MRH) due to its rarity, but prednisone or other glucocorticoids are often the initial treatment to control inflammation and slow disease progression.
Summary
Humira is a trusted treatment for autoimmune and inflammatory diseases, backed by long-term effectiveness and safety data. However, it may not be right for everyone and should be used under a doctor’s supervision. Ongoing research and real-world studies continue to refine its role in managing complex immune-related conditions.
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