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Author Details
Written By
Pallavi
Reviewed By
Shital Pawar

Last updated : 25 oct 2025 | 06:18 AM (IST)

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ADALIMUMAB

History of Adalimumab

Adalimumab (Humira) is the first fully human monoclonal antibody, developed in the 1990s using phage display technology and approved by the FDA in 2002. Originally created as D2E7, it was later developed and marketed by Abbott, and then AbbVie. As the third TNF inhibitor and the only fully human one it is approved for many inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriasis, and juvenile idiopathic arthritis.


Approved Uses of Adalimumab

    Adalimumab is used to treat various autoimmune and inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. It also helps manage moderate to severe psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, and non-infectious uveitis by reducing inflammation and symptoms.


Mechanism of Action Adalimumab

    Adalimumab works by blocking TNF-?, a protein that causes inflammation. By preventing TNF-? activity, it reduces inflammation and helps control symptoms of autoimmune diseases.


Administration of Adalimumab

    Adalimumab is given as a subcutaneous injection, usually in the thigh or abdomen, with rotation of injection sites to prevent irritation. It comes in pre-filled pens or syringes for self-use, and the dosing schedule varies by the condition being treated.


Side Effects of Adalimumab

    Adalimumab can cause injection site reactions, headache, nausea, rash, and mild infections. It may also increase the risk of serious infections like TB due to immune suppression. Rarely, it can affect the liver, blood cells, nervous system, or heart. Regular monitoring is important, and any signs of infection or unusual symptoms should be reported to a doctor.


Contraindications and Precautions

    Adalimumab should not be used in patients allergic to it or those with severe active infections like TB or sepsis. Screening for latent infections is required before treatment. Caution is needed in people with chronic infections, heart failure, or demyelinating diseases. Live vaccines should be avoided, and regular monitoring of liver function, blood counts, and infection signs is recommended. Use in pregnancy or breastfeeding should be based on medical advice.


Final word

    Adalimumab is a highly effective biologic that targets TNF-? to manage autoimmune and inflammatory diseases. It has greatly improved outcomes in conditions like rheumatoid arthritis, Crohn’s disease, and psoriasis. Although monitoring is important due to infection risks, it remains a valuable and widely used treatment when guided by proper medical care.


Frequently Asked Questions (FAQs) about Adalimumab

Q1. How does Adalimumab differ from other TNF-? inhibitors?

Adalimumab is a fully human monoclonal antibody, unlike infliximab (a chimeric antibody) and etanercept (a fusion protein). This fully human structure reduces the risk of immunogenicity and allergic reactions compared to chimeric or partially humanized antibodies.

Q2. Can Adalimumab be used in combination with other immunosuppressants?

Yes, Adalimumab is often used in combination with methotrexate, especially in rheumatoid arthritis, to enhance therapeutic efficacy and reduce the development of anti-drug antibodies. However, combining multiple immunosuppressants increases the risk of infections and requires close monitoring.

Q3. What is the impact of anti-drug antibodies (ADAs) on Adalimumab efficacy?

The development of anti-Adalimumab antibodies can reduce the drug's efficacy and increase the risk of adverse reactions. Concurrent use of immunomodulators like methotrexate may help reduce the formation of these antibodies.

Q4. How should patients be screened before initiating Adalimumab?

Patients must be screened for latent or active tuberculosis using a tuberculin skin test or IGRA. Screening for hepatitis B, hepatitis C, and HIV may also be considered based on risk factors. Baseline CBC, liver function tests, and chest X-ray are often recommended.

Q5. What are the long-term safety concerns with Adalimumab therapy?

Long-term use may increase the risk of serious infections, malignancies (such as lymphoma or skin cancers), autoimmune phenomena, and demyelinating disorders. Regular follow-up and patient education are essential for early detection of these risks.

Q6. Can Adalimumab be used during pregnancy or breastfeeding?

Adalimumab is classified as pregnancy category B. It may be used during pregnancy when the benefits outweigh the risks, especially during the first two trimesters. The drug can cross the placenta in the third trimester, so infant vaccination schedules (especially live vaccines) may need adjustment. Caution is also advised during breastfeeding.

Q7. How is Adalimumab stored and handled?

Adalimumab must be stored refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light. It should not be frozen.

Q8. What is the mechanism behind Adalimumab-associated reactivation of tuberculosis?

By neutralizing TNF-?, Adalimumab disrupts granuloma formation and maintenance, which are crucial for containing latent TB. This suppression can lead to reactivation of latent tuberculosis infections, hence the need for screening and possible prophylactic treatment prior to starting therapy.

Q9. Is dose adjustment necessary in renal or hepatic impairment?

No dose adjustment is generally required for patients with renal or hepatic impairment, but such patients should be monitored closely as safety data is limited.

Q10. How is loss of response to Adalimumab managed in clinical practice?

Loss of response can be due to immunogenicity, disease progression, or pharmacokinetic changes. Management strategies include dose escalation, shortening the dosing interval, switching to another TNF inhibitor, or changing to a biologic with a different mechanism of action, such as IL-6 or IL-17 inhibitors.


Medical Advisory

    Information provided is for educational purposes only and should not replace professional medical advice. Always consult your doctor before use.

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