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Pharmaceutical industry

HUMIRA Offers Safety and Efficacy in Treating Rheumatoid Arthritis

Strategic Insights

— 1 min read

The U.S. Food and Drug Administration (FDA) has approved HUMIRA (adalimumab), a human monoclonal antibody, for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs). The approval was based on the efficacy and safety data obtained in four controlled clinical trials in more than 2,000 RA patients.

Key Takeaways:

  • HUMIRA is the first human monoclonal antibody approved for treating RA, providing a new treatment option for patients who have had insufficient response to traditional DMARDs.
  • The approval was based on the efficacy and safety data obtained in four controlled clinical trials in more than 2,000 RA patients.
  • HUMIRA is approved for use alone or in combination with traditional DMARDs, and the recommended dose is 40mg every other week by subcutaneous injection.
  • The pre-filled syringe of HUMIRA was specially designed for patients with limited hand use, making it easy for them to self-administer the medication at home.
  • HUMIRA has been shown to slow the progression of joint destruction caused by RA and to improve symptoms in some patients as early as one week.
  • The most frequent adverse events seen in the placebo-controlled clinical trials were upper respiratory infection, injection site pain, headache, rash, and sinusitis.

Statistics:

  • 22% (14/63 patients) of patients experienced an improvement in RA signs and symptoms as early as one week.
  • ACR responses have been seen in some patients out to three years.
  • 7% of patients discontinued due to adverse events in the placebo-controlled clinical trials.
  • More than 5 million people suffer from RA worldwide.

Sources:

  • The U.S. Food and Drug Administration (FDA)
  • Abbott Laboratories
  • American College of Rheumatology (ACR)
  • Denver Arthritis Clinic
  • University of Colorado School of Medicine
  • European Agency for the Evaluation of Medicinal Products (EMEA)
  • Cambridge Antibody Technology (CAT)
  • Arthritis Foundation
  • Abbott's Investor Relations Web site
  • Abbott's Web site
  • PR Newswire

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