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Remicade Therapy in AS: 12-Month Study

12/19/2003

Researchers sought to evaluate the usefulness and safety of long-term infliximab (Remicade) therapy in people with severe, hard-to-treat ankylosing spondylitis (AS). Infliximab is a tumor-necrosis factor-alpha medication currently approved for use in rheumatoid arthritis and Crohn’s disease, yet some doctors prescribe it for use in people with AS.

T. I. Temekonidis and colleagues from the University of Ioannina, Greece, published results in a recent issue of the Annals of the Rheumatic Diseases.

Participant Breakdown and Study Set-Up

  • Twenty-five people (24 males; 1 female)
  • Average age -- 36-years-old
  • Average disease duration -- 13.8 years.
  • 88% tested positive for the HLA-B27 gene
  • 100% had active axial disease according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, PDF file) and C reactive protein (CRP), despite adequate treatment. BASDAI is a self-administered instrument and was developed as an approach to defining disease activity in those with AS.

    Patients received infliximab (5 mg/kg) intravenously at weeks 0, 2, 6 and every 8 weeks thereafter for 12 months. The primary end point was the reduction of patients’ global assessment of pain (GAP) by over 20%.

    Results
    GAP was reduced by more than 20% in 23 (92%) patients, by 50% in 21 (84%) patients, and by 70% in 13 (52%) patients.

    The change in BASDAI and CRP from the beginning of the study to the end was statistically significant.

    Infliximab treatment was well tolerated with minimal side effects. One patient dropped out because the medication was not helping him, and another person stopped treatment owing to an allergic reaction.

    Researchers concluded that the longer length study confirms the usefulness of infliximab and the good safety profile in people with AS.

    Learn More About Infliximab
    Visit the Spondylitis Association of America’s Medications section.

    Source: Infliximab therapy in patients with ankylosing spondylitis: an open label 12 month study.” Annals of the Rheumatic Diseases 2003; 62: 1218-1220.

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