First Report®

American Society of Consultant Pharmacists (ASCP) Fall 2012 Annual Meeting & Exhibition

November 6-9, 2012; National Harbor, MD


Examining Safety and Efficacy of Humira in Older Adults With Arthritis

Within the past 10 years, Humira (adalimumab) has been approved by the US Food and Drug Administration to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. As adalimumab belongs to a relatively new class of drugs called biologics, its safety and efficacy have been of great interest in the research community, representing a new avenue of treatment for these and numerous other debilitating conditions. In a product theater at the ASCP meeting, Evan L. Siegel, MD, Arthritis and Rheumatism Associates, Rockville, MD, discussed Humira in the treatment of rheumatic diseases in the primary care setting. Annals of Long-Term Care® (ALTC) had the opportunity to interview Dr. Siegel about the indications of Humira and considerations before prescribing Humira to older adults.

CG: Briefly describe the mechanism of action of Humira.
Dr. Siegel: 
Adalimumab is a fully human monoclonal antibody specific to tumor necrosis factor (TNF)-alpha. TNF-alpha is a cytokine, a molecule that allows cell-to-cell communication, which is essential during the initiation, maintenance, and amplification of an inflammatory response. Humira intercepts TNF-alpha both in serum and at the cell surface. 

Which patients are candidates for receiving Humira?
Humira is indicated for the treatment of adult patients with psoriatic arthritis, ankylosing spondylitis, or moderate to severe rheumatoid arthritis. Of course, the first step is always to confirm the diagnosis. Joint and back pain can be related to many diagnoses other than those already mentioned, and each would be treated very differently. Patients with more than 6 weeks of chronic joint inflammation and swelling particularly in the hands and feet, or chronic inflammatory type back pain (worse with rest, better with activity) should be evaluated by a rheumatologist, if possible. Active disease may be manifest in many ways, depending on the disease: by ongoing peripheral joint inflammation with pain, tenderness and swelling; ongoing inflammatory back pain; erosive bone changes on radiography; or active psoriatic skin disease. Methotrexate is usually used as an initial disease-modifying antirheumatic drug in rheumatoid arthritis, but Humira may be appropriate as an initial agent in patients with ankylosing spondylitis or those with psoriatic arthritis.

What are some of the screening and monitoring considerations for prescribing Humira to older adults?
The list of potential side effects of adalimumab is long and beyond the scope of a short answer in this type of forum, but by far one of the most important adverse events to watch for is infection. TNF inhibition can allow for reactivation of latent tuberculosis, and all patients should be screened for tuberculosis before and intermittently during therapy with Humira, which is especially important in long-term care settings. Subclinical hepatitis must also be ruled out. Serious bacterial and fungal infections can occur at higher frequency and aggressive work-up of fever or other signs of infection is essential. In the elderly population, Humira should be used with caution due to a higher incidence of infections and malignancies. Additionally, congestive heart failure can be exacerbated by TNF inhibition, so these patients should be monitored carefully. There are many other potential side effects, so Humira should only be administered by a rheumatologist or other professional well-versed on the risk/benefit profile of Humira.

This product theater was sponsored by Abbott Laboratories.