August 9, 2016

Long-Term Safety of Humira® Reported in Analyses of over 15,000 Patients

By cancerconnect

A review of the long-term outcomes and safety issues associated with the TNF inhibitor, Humira® (adalimumab) was recently published.

Humira works by blocking the inflammatory effects of a protein called tumor necrosis factor alpha (TNF alpha) in rheumatoid arthritis (RA) and other conditions associated with inflammation. The body produces TNF when there is inflammation and untreated inflammation can lead to tissue damage.

Humira is approved to treat adults with moderate to severe RA, alone or with methotrexate or with certain other medicines. Humira is also approved to treat psoriatic arthritis (alone or with certain other medicines), ankylosing spondylitis, and moderate to severe Crohn’s disease (CD) in adults who have not responded well to other treatments.

Doctors conducted analyses to evaluate the safety of Humira in 15,132 patients with a total of 24,810 patient-years of follow-up who were exposed to Humira in RA clinical trials. The analyses confirm the known safety profile associated with Humira, and provide more safety data on laboratory abnormalities, hepatitis B reactivation, and pregnancy outcomes.

  • Overall serious infections occurred in 4.7% of individuals with the most common being pneumonia, cellulitis, bacterial arthritis, and sepsis.
  • Tuberculosis (TB): During screening, 13.5% of patients were diagnosed with latent TB by a positive tuberculin skin test. However with long-term follow-up, only 18 patients converted from a negative PPD to positive TB status. A total of 63 active TB events occurred in 59 patients. This was 0.3 events per 100 patient-years.
  • Only 2 cases of hepatitis B virus (HBV) reactivation were reported.

Pregnancies were reported in 154 women: 74 were exposed to Humira and 80 were not. Of 74 pregnant women exposed to adalimumab, approximately 40% were exposed in the first trimester and 44% used Humira throughout the pregnancy. The risk for spontaneous abortion in the Humira exposed patients was not increased significantly. Major birth defects were not different between Humira and non- Humira treated women, and no specific patterns of birth defects were evident.

Reference: Burmester G, Landewé R,Genovese M, et al. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Annals of the Rheumatic Diseases. Ann Rheum Dis doi:10.1136/annrheumdis-2016-209322. Available at:

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