Treatment: Biologics
Adalimumab

FDA approved to treat:

• Adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy (circulates throughout the body because taken as a pill, injection, or infusion) or phototherapy, and when other systemic therapies are medically less appropriate.

• Adults with active psoriatic arthritis. Studies show that adalimumab can prevent further joint damage and improve one’s ability to perform everyday tasks from getting dressed in the morning to climbing stairs.

What’s involved in taking adalimumab:

• Patients give themselves an injection. A maintenance dose is usually injected every other week.

• Adalimumab is meant for long-term continuous treatment.

• Adalimumab may be taken while taking some other medications for psoriatic arthritis, such as methotrexate.

• Screenings tests for the hepatitis B virus and latent (not causing symptoms) tuberculosis (TB) are conducted before adalimumab is prescribed.

• Patients on adalimumab therapy are closely monitored and receive regular follow-up exams.

How adalimumab works: People who have psoriasis and/orpsoriatic arthritis have too much TNF-alpha, a chemical found in the immune system. This excess TNF-alpha causes the immune system to overreact. Adalimumab blocks TNF-alpha and helps lower the amount of TNF-alpha in the person’s body, which helps reduce the inflammation that causes psoriasis and psoriatic arthritis.

Effectiveness: Studies conducted to obtain approval from the U.S. Food and Drug Administration (FDA) have found:

• Skin clearing. In a study conducted with people who had psoriasis and psoriatic arthritis, 3 out of 5 patients had a 75% or greater skin clearing, and 2 out of 5 had a 90% skin clearing. In a 52-week clinical trial of patients living with chronic moderate to severe plaque psoriasis, 71% of the patients who received 40 mg. of adalimumab achieved a 75% reduction in signs and symptoms at week 16. During the course of this trial, 50% of the patients treated with adalimumab achieved a 90% improvement. One in four of these patients showed full clearance on their skin.

• Results maintained. A 48-week study of patients with psoriatic arthritis showed that if patients’ joint symptoms improved, the improvements lasted for the full 48 weeks. In the 52-week clinical trial of patients with moderate to severe plaque psoriasis, few who continued receiving adalimumab lost their response.

• Sometimes rapid improvement. Patients with psoriatic arthritis have experienced improvements as early as 14 days after beginning adalimumab.

• Fewer tender and swollen joints. After taking adalimumab for 24 weeks, nearly 60% of patients with psoriatic arthritis who had tender and swollen joints reported significant improvement in their joints.

• Can prevent further joint damage. A study that measured joint damage with before and after x-rays found that the patients in the study who did not receive adalimumab had 10 times greater joint damage.

• Physical improvements. Patients given adalimumab also had significant improvement in their ability to perform everyday tasks that included getting dressed, walking, and climbing stairs. With continued use of adalimumab, these results were maintained.

Safety and side effects: Studies show that adalimumab is generally well-tolerated. Since adalimumab suppresses the immune system, patients have some increased risk of developing an infection. Taking adalimumab can make an existing infection worse.

In clinical studies, the most common side effects were mild and consisted of developing an infection or mild injection-site reaction, such as redness or swelling.

Side effects that are more serious have been reported. Serious infections, such as a TB infection, can occur. In clinical trials, more cancers were seen in patients receiving a medication that blocks TNF, including adalimumab, than in patients who did not receive a TNF blocker. The most commonly occurring cancers were lymphoma and nonmelanoma skin cancers.

References:
Gottlieb AB. “Biologics Workshop.” Presented as a workshop (WRK 404) at the 65th Annual Meeting of the American Academy of Dermatology. February 2007; Washington, DC.

Menter A, Tyring SK, Gordon K et al. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. Journal of the American Academy of Dermatology 2008; 58: 106-15.

Ogbru, O. “Adalimumab.” MedcineNet.com. Last accessed March 20, 2007.
 

For an overview, visit the AAD pamphlet Psoriasis and Psoriatic Arthritis.