What is Humira (Adalimumab)?

From the Guidelines

Humira (adalimumab) is recommended as a first-line biologic treatment option for adult patients with moderate-to-severe plaque psoriasis, with a recommended starting dose of 80 mg taken as 2 self-administered subcutaneous 40-mg injections of the initial dose, followed by a 40-mg self-administered subcutaneous injection 1 week later, and then 40 mg self-administered every 2 weeks thereafter 1.

Key Points

• Adalimumab is a human anti-TNF-a monoclonal antibody that binds to soluble and membrane-bound TNF-a, inhibiting its interaction with TNF 1.
• The efficacy of adalimumab in patients with moderate-to-severe psoriasis has been established in multiple RCTs, with a PASI 75 response rate of 71% and a PASI 90 response rate of 45% at week 16 1.
• Adalimumab can be used as monotherapy or in combination with other treatments, such as topicals, acitretin, methotrexate, apremilast, or cyclosporine, to augment efficacy for the treatment of moderate-to-severe plaque psoriasis in adults 1.
• Common side effects of adalimumab include injection site reactions, upper respiratory infections, headache, and rash, and patients should be screened for tuberculosis before starting treatment and monitored regularly for potential complications such as liver problems or blood disorders 1.

Treatment Considerations

• The decision to continue treatment with adalimumab should be based on the patient's response to treatment, with a recommended assessment of PASI response at week 16 1.
• Patients with severe psoriasis, defined as a PASI score of 10 or higher, and a DLQI score of 10 or higher, may be eligible for treatment with adalimumab, according to the British Association of Dermatologists' guidelines 1.
• Adalimumab may be combined with other biologics or systemic therapies, such as methotrexate or cyclosporine, to treat patients with moderate-to-severe psoriasis who have failed to respond to or have a contraindication to other treatments 1.

From the FDA Drug Label

The effectiveness of HUMIRA has not been established in patients who have lost response or were intolerant to TNF blockers. Adalimumab is a tumor necrosis factor blocker Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. The Humera drug is adalimumab (SQ), a tumor necrosis factor blocker that binds to TNF-alpha. It is used to treat various conditions, but its effectiveness has not been established in patients who have lost response or were intolerant to TNF blockers 2.

• Key points:
  • Mechanism of action: binds to TNF-alpha and blocks its interaction with cell surface receptors
  • Indications: various conditions, but not established in patients with lost response or intolerance to TNF blockers
  • Warning: closely monitor patients 65 years of age and older for infection or malignancy 2

From the Research

Humera Drug Overview

• Humera, also known as Adalimumab, is a fully human TNF-alpha monoclonal antibody used for the treatment of rheumatoid arthritis and other conditions such as psoriasis and psoriatic arthritis 3.
• It has been shown to be effective in reducing symptoms and signs of rheumatoid arthritis, improving physical function, and slowing radiographic changes in joints 4, 5.

Efficacy and Safety

• Adalimumab has been compared to other TNF inhibitors, such as etanercept and infliximab, in terms of efficacy and safety 4, 5.
• Studies have shown that adalimumab is effective in achieving American College of Rheumatology (ACR) 20%, 50%, and 70% improvement criteria, with varying degrees of efficacy compared to other TNF inhibitors 5.
• The safety of adalimumab has been evaluated, with no statistically significant differences noted compared to placebo, although infliximab had higher rates of withdrawal due to lack of efficacy and adverse events 5.

Real-World Use and Cost-Effectiveness

• The use of adalimumab in real-world settings has been evaluated, with studies showing that dosing patterns may vary from label regimens, resulting in cost reductions 6.
• Cost-effectiveness analyses have been performed, with results suggesting that adalimumab may be a cost-effective option for the treatment of rheumatoid arthritis, particularly when used as a third-line therapy 4.

Therapeutic Drug Monitoring

• Proactive therapeutic drug monitoring of adalimumab has been shown to be associated with better long-term outcomes compared to standard of care in patients with inflammatory bowel disease 7.
• This approach may help optimize treatment and reduce the risk of treatment failure, although further studies are needed to confirm these findings.