Treating Autoimmune Conditions: Methotrexate vs. Humira

On June 24, 2022, a historic decision was made by the U.S. Supreme Court to overturn Roe v. Wade, profoundly affecting our healthcare system, which is still recovering in the aftermath of the COVID-19 pandemic.

With this ruling, the legal status of abortion is now entirely up to individual states, meaning each state has the authority to allow or prohibit pregnancy terminations.

There are numerous blogs, articles, and statements published by accredited institutions and experts regarding how this decision will affect women’s reproductive health for years to come. However, that is not the topic of this article. This article aims to bring awareness to a rising issue affecting other patient communities—those with rheumatological disorders and autoimmune diseases.

In many states where abortion has been banned or severely restricted, patients with rheumatoid arthritis (RA) or other autoimmune conditions have reported challenges in getting methotrexate prescribed and filled. This patient population has been on methotrexate for years as maintenance therapy, either as a monotherapy or with other prescription drugs, for rheumatoid arthritis and other autoimmune diseases.

The reason behind this is many states, as a result of the ruling, classify certain medications as “abortion-inducing drugs,” and methotrexate is considered to be one of them because it is also indicated to treat ectopic pregnancy.

Continue reading to learn more about the impact that restricting these medications may have on the health and well-being of millions of people who deal with chronic illnesses daily, especially women of child-bearing age.

What is rheumatoid arthritis?

For a healthy person, or specifically speaking, one without an autoimmune disease, their immune system recognizes bacteria and viruses for what they are—invaders. In response, the immune system releases the appropriate chemicals to fight these so-called intruders. In a nutshell, that is how you get over an infection.

Rheumatoid arthritis is one of several autoimmune diseases. In patients with autoimmune diseases such as rheumatoid arthritis or severe psoriasis, their immune systems mistakenly target their own cells or organs as foreign objects, and then inflammatory chemicals are released to attack these cells and organs.

Specifically, with rheumatoid arthritis, the immune system attacks the synovium, a protective layer covering the joints, providing the joints with essential fluid to reduce friction, thus, ensuring smooth movement. As the synovium is attacked, joint pain and swelling occur.

What is methotrexate (MTX)? How does it treat rheumatoid arthritis?

Methotrexate belongs to a drug class called disease-modifying antirheumatic drug (DMARD), which was first developed in the 1940s as part of cancer treatment. By 1988, the FDA approved this medication to treat rheumatoid arthritis, as RA patients showed positive clinical responses such as a reduction in joint pain and swelling.

There is no doubt that methotrexate is a well-known drug with extensive clinical studies. Methotrexate has been the mainstay, first-line systemic therapy for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and juvenile idiopathic arthritis (JIA), among other autoimmune conditions.

According to John Hopkins Arthritis Center, approximately 60% of rheumatoid arthritis patients currently take or have used methotrexate to treat moderate to severe rheumatoid arthritis.

As mentioned above, methotrexate has shown effectiveness in reducing pain, swelling, and other hallmark symptoms of rheumatoid arthritis. Not only that, but methotrexate also slows down joint damage and delays the disease progression long-term. For those who do not experience superior efficacy with methotrexate, combining this medication with other systemic therapies will usually improve treatment outcomes, along with symptom relief.

What are other health conditions treated with methotrexate?

In addition to its indication to treat severe rheumatoid arthritis, methotrexate, as monotherapy or with other medications, has also proven to be effective in treating other health conditions listed below:

At much higher dosages, methotrexate is indicated to treat leukemia and other cancers such as skin, neck, breast, uterus, and lung.
Ankylosing spondylitism (inflammatory arthritis affecting the spine and large joints)
Axial spondyloarthritis (inflammatory arthritis primarily affecting the lower back)
Lupus
Psoriatic arthritis
Severe Crohn’s disease
Severe ulcerative colitis
Severe hidradenitis suppurativa (a condition that causes small, painful lumps to form underneath the skin due to infected sweat glands)
Moderate to severe psoriasis; severe plaque psoriasis; severe chronic plaque psoriasis
- Psoriasis is often referred to as a “skin rash” or considered a “cosmetic issue.” However, psoriasis can be both a medical problem and cosmetic dermatology. Psoriasis patients have to deal with the embarrassment and discomfort caused by plaque psoriasis.
- A clinical study was conducted to determine the safety and effectiveness of adalimumab compared to methotrexate and a placebo (Humira is the brand name of adalimumab). Data from this clinical trial has shown that adalimumab (Humira) has shown better improvement in psoriasis area and severity index among these psoriasis patients.

So, with recent political developments leading to restricted access to methotrexate in some states, a question arises: Is Humira the answer for patients with severe psoriasis, rheumatoid arthritis, and other inflammatory diseases?

Starting Humira - Is that the solution?

Whether you have rheumatoid arthritis, chronic plaque psoriasis, or other immune system-related health conditions causing inflammation, the question of whether or not Humira is the answer will be thoroughly evaluated by your healthcare provider. They will consider your medical history, other medications you take, insurance coverage, and last but not least, your personal preference. Read more below to educate yourself on Humira before your next doctor’s visit.

What is Humira?

Adalimumab is the active ingredient of Humira. Humira belongs to a drug class called tumor necrosis factor blockers, commonly called TNF blockers. Humira is a biologic drug—this type of drug is made from living organisms or contains components of living organisms using biotechnology.

Humira is available as an injectable solution that is administered subcutaneously (injected under the skin). Your healthcare provider will teach you the proper administration technique if starting Humira.

As mentioned earlier, methotrexate is a disease-modifying antirheumatic drug (DMARD) and is considered a conventional DMARD. Typically, your healthcare provider will decide to start Humira or another biologic drug only when treatment fails with conventional DMARDs, such as methotrexate. Without a doubt, Humira, among other biologic treatments, is a powerful medication that has shown effectiveness in patients with moderate to severe rheumatoid arthritis, psoriatic arthritis, severe plaque psoriasis, ankylosing spondylitis, Crohn’s disease, severe hidradenitis suppurativa, and numerous other autoimmune or inflammatory health conditions.

What are Humira’s side effects?

Keep in mind that this is a summary of the most commonly reported side effects of Humira; this does not contain all possible side effects of Humira. You should inform your healthcare provider if you experience any serious side effects or any that are not listed here or in the Humira medication guide. More details about Humira’s side effects are listed in the medication guide.

Commonly reported mild side effects from Humira

Inform your healthcare provider if these side effects do not go away or worsen:

Injection site reactions causing skin rash, pain, redness, itching, or bruising
Upper respiratory infections such as sinus infections or common cold
Headache

Serious side effects from Humira

Allergic reaction—this type of reaction can happen with any medication. If you experience an anaphylactic allergic reaction causing shortness of breath, hives, swelling of your face, throat, lips, or tongue, immediately seek emergency medical care as this is a life-threatening situation.

Apart from an anaphylactic allergic reaction, Humira can cause other serious side effects. Though uncommon, these serious side effects can occur. If you experience any of these serious adverse events, inform your healthcare provider right away. In case of a medical emergency, please call 911 and get urgent medical care at your local hospital. Below are the serious side effects of Humira:

Liver problems
Reactivation of serious infections such as tuberculosis and hepatitis B
Lupus-like syndrome, including chest discomfort or rash on your cheeks or arms that worsens in the sun
Heart problems, including heart failure
Seizures
Multiple sclerosis
Blood disorders such as anemia

Other than the above possible side effects, Humira also has boxed warnings. Boxed warnings, formerly known as black box warnings, are required by the FDA for certain medications that carry serious safety risks. Boxed warnings communicate the risk of these rare but potentially dangerous side effects. Boxed warnings can also contain information regarding the safe use and handling of the medication.

Below are Humira’s boxed warnings:

Increased risk of serious infections: Humira treatment can cause an increased risk of serious infections, including tuberculosis and infections caused by viruses, fungi, and other rare types of infection. Bacterial infection leading to sepsis is another risk of Humira treatment.
Risk of cancer:
- Lymphoma - a type of cancer of the lymphatic system has occurred in some pediatric and adolescent patients on Humira treatment.
  - Hepatosplenic T-cell lymphoma is a rare type of lymphoma. Some pediatric and adolescent patients with inflammatory bowel disease, such as Crohn's disease, developed hepatosplenic T-cell lymphoma while on Humira treatment.
- Other cancers leading to death have also been reported.

How much does Humira cost?

Humira is a complex medication that is made using DNA technology. The complexity of this drug makes it extremely costly. A one-month supply of Humira typically requires two subcutaneous Humira kits. The cash price for one month's supply of Humira is approximately $6,300 without insurance coverage. The exact cost of Humira will depend on the strength, product, and type of insurance. There are also different ways to save on Humira, whether you have insurance or not. If starting Humira is a decision you and your healthcare provider make, ask your local pharmacist about different ways you can save on Humira.

Humira will require prior authorization to ensure the medical necessity and appropriateness of the treatment.

Summary and next steps

This article aims to bring awareness to the effects of the latest historic decision made by the U.S. Supreme Court on the millions of patients who live with chronic autoimmune conditions, not to mention their families and loved ones.

Per the Arthritis Foundation, this decision significantly impacts the arthritis community and “is likely to disproportionately affect the uninsured, under-insured, and communities of color.”

Biologic products such as Humira are evidence of the wonders that today’s modern science can achieve. Without a doubt, Humira is an incredible drug product with the ability to treat numerous autoimmune diseases and inflammatory conditions effectively. However, on the other hand, methotrexate is a well-established medication used for decades to treat the same type of conditions. Also, biologic drugs like Humira are typically prescribed for patients who experience treatment failure with a conventional DMARD like methotrexate.

Living with chronic conditions like rheumatoid arthritis and lupus is a challenge on its own; these communities of patients must continue to have access to methotrexate. Though this issue has just recently arisen in certain states, the American College of Rheumatology is aware and following closely to see if accessing methotrexate is going to be a widespread issue.

If you or your loved ones are having difficulties getting methotrexate, below are a few resources that you can reach out to for help and guidance:

The American College of Rheumatology: advocacy@rheumatology.org
The Arthritis Foundation:
- Helpline: 1-800-283-7800 (Spanish-speaking expert available)
- Email: advocacy@arthritis.org
- Twitter: @AFAdvocacy
Crohn's & Colitis Foundation: advocacy@crohnscolitisfoundation.org