No Safety Surprises from Humira

Humira safety profile in patients with rheumatic and Crohns disease remains consistent

/ Author:  / Reviewed by: Robert Carlson, M.D

(RxWiki News) Humira (adalimumab) is a medication used to treat a variety of diseases. As the medication is being prescribed to more and more patients, researchers wanted to see if there were any side effects they didn't know about before.

Because the medication is used to treat so many diseases, there is a possibility that patients with different diseases will have different reactions to the medication.

Through a review of past studies, researchers found that infection was the most commonly reported harmful side effect of adalimumab, with highest rates of infection in patients with rheumatoid arthritis or Crohn's disease.

Overall, results showed that rates of harmful side effects differed between patients with different diseases. However, the researchers found no new side effects.

In fact, it seemed the safety of the medication was in line with what is already known about all medications like adalimumab.

"Tell your pharmacists about any Rx side effects."

Gerd R. Burmester, MD, of the Department of Rheumatology and Clinical Immunology at Charité University Hospital in Berlin, Germany, and colleagues set out to analyze the long-term safety of adalimumab treatment. 

Adalimumab is part of a class of medications known as anti-tumor necrosis factor (anti-TNF) drugs. Treatment with anti-TNF medications has become accepted practice for a number of inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis and the inflammatory bowel condition, Crohn's disease.

For their research, Dr. Burmester and colleagues studied 71 clinical trials that included 23,458 patients who had taken adalimumab. The clinical trials involved patients with rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis or Crohn's disease - all of which are commonly treated with adalimumab.

Results showed that infection was the most frequently reported serious adverse event (harmful side effect) of adalimumab. The most common serious infections were:

  • Cellulitis (a bacterial skin infection) and pneumonia in patients with rheumatoid arthritis, at rates of 0.3 events per 100 person-years and 0.7 events per 100 person-years, respectively
  • Appendicitis (swelling of the appendix) and herpes zoster (shingles) in patients with juvenile arthritis, at rates of 0.5 events per 100 person-years and 0.3 events per 100 person-years, respectively
  • Urinary tract infection in patients with psoriatic arthritis, at a rate of 0.4 events per 100 person-years
  • Cellulitis in patients with psoriasis, at a rate of 0.3 events per 100 person-years
  • Gastrointestinal tract abscess (bacteria in the gastrointestinal tract), gastroenteritis (inflammation of the gastrointestinal tract) and pneumonia in patients with Crohn's disease, at rates of 1.6, 0.3 and 0.4 events per 100 person-years, respectively

The majority of patients with serious infections (70 percent) continued taking adalimumab. However, 32 percent of rheumatoid arthritis patients and 28 percent Crohn's patients with serious infections permanently stopped taking the medication. Of the patients with the other four conditions, 18 to 24 percent stopped taking the medication after serious infection.

The researchers also looked at the possible ties between cancer and adalimumab treatment. 

Cancer rates among patients in each disease population were similar to those in the general population.

Rates of lymphoma (a type of blood cancer) increased in patients with rheumatoid arthritis. But these rates were within the range expected for rheumatoid arthritis patients not treated with drugs like adalimumab.

Rates of non-melanoma skin cancer increased in adalimumab-treated patients with rheumatoid arthritis, psoriasis and Crohn's disease.

Other serious harmful events - such as active tuberculosis, opportunistic infections, congestive heart failure, lupus-like syndrome and worsening of psoriasis - were not so common.

The authors concluded that these findings provide further support for the long-term safety of adalimumab in patients with any of these six different inflammatory diseases. In addition, these results highlight important differences between patient populations and did not reveal any new safety concerns.

The study was first published May 5, 2012 in the Annals of the Rheumatic Diseases. The research was funded by Abbott Laboratories - the manufacturer of Humira.

The authors reported financial ties to Abbott and other pharmaceutical companies. Two of the study's authors are employees of Abbott.

Reviewed by: 
Review Date: 
February 27, 2013
Last Updated:
March 3, 2013