ATTRACT Study Reveals Treatment with REMICADE Is Effective in Stopping the Progression of RA Joint Damage
ATTRACT Study Overview
The approval for REMICADE in patients not doing well on MTX alone was based on the results of the landmark ATTRACT study. ATTRACT stands for Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy.
Who were the study participants?
The study included 428 patients at 34 research centers in the United States, Canada, and Europe. All patients had moderately-to-severely active RA despite taking MTX. To enter the study, patients had to have at least 6 swollen joints (out of 66), and 6 tender joints (out of 68). Also, patients had x-rays of their hands and feet to look for evidence of joint damage. Blood samples were taken to look for a protein called rheumatoid factor (RF), or for high levels of another protein called C-reactive protein (CRP), which is a sign of inflammation. Many were taking other medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen) or steroids.
Which medications were given to study participants?
The study participants were divided into 5 groups and given treatments for 2 years. Two groups received REMICADE at a dose of 3 mg/kg plus MTX, while two other groups received REMICADE at a dose of 10 mg/kg plus MTX. REMICADE was infused at the start of the study, 2 and 6 weeks later, and then either every 4 or 8 weeks until the end of the study. A fifth group received MTX only.
The ATTRACT study demonstrated that REMICADE + MTX was superior to MTX alone in all 3 of these measurements:
- REMICADE improved signs and symptoms of rheumatoid arthritis
Signs and symptoms of RA are measured by the American College of Rheumatology (ACR) score. The score includes the number of tender and swollen joints; the patient’s and doctor’s assessment of how well the patient is doing; the amount of pain present; ability to perform physical activities; and results of blood tests that monitor inflammation (e.g., CRP).
At the beginning of the ATTRACT study, all patients were examined by a doctor and given an ACR score. At the end of the study, patients were examined again.
Higher ACR scores represent worse signs and symptoms of rheumatoid arthritis, like joint pain and tenderness. At the end of the study, patients who had a 20% decrease in the original ACR score were classified as having an ACR 20 score. In other words, a patient’s signs and symptoms improved by 20%. Some patients had ACR 50 and ACR 70, which represent 50% and 70% reductions, respectively. More patients treated with REMICADE + MTX than MTX alone had ACR 20, ACR 50, and ACR 70 scores at the end of the study. In other words, these patients had less pain, joint swelling, and tenderness after 2 years of treatment with REMICADE + MTX.
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REMICADE helped stop the progression of joint damage
Joint damage in RA is evaluated by examining x-rays of the hands and feet. By looking at x-rays, the doctor can evaluate how much damage exists in each joint and calculate something called a Sharp score. The Sharp score takes into account how much the joints have eroded and how much the spaces inside the joints have narrowed. Higher Sharp scores represent greater joint damage. At the end of the ATTRACT study, patients treated with REMICADE + MTX had a very small change in their Sharp score, meaning there was very little detectable progression of joint damage. Patients treated with MTX alone, however, showed significant progression of joint damage.
- REMICADE improved physical function
At the beginning of the ATTRACT study, patients answered a survey known as the Health Assessment Questionnaire (HAQ), which is designed to determine how difficult it is to perform everyday tasks like dressing, reaching, gripping, and getting up from a bed or chair. They answered the same survey or questionnaire at the end of the study. Higher HAQ scores represent greater disability in performing daily activities. Their responses showed that patients receiving REMICADE + MTX had significantly better HAQ scores than patients treated with MTX alone. In other words, they were able to perform their tasks more easily after treatment with REMICADE + MTX than they were before starting the treatment.
Safety information from the ATTRACT study
During the ATTRACT study the incidence of side effects was similar for patients treated with REMICADE + MTX and with MTX alone. The most frequently reported side effects were: upper respiratory tract infection, headache, nausea, sinusitis, and rash. The incidence of serious side effects was low and was similar in patients treated with REMICADE + MTX and with MTX alone. The most frequent serious adverse event that occurred in patients treated with REMICADE + MTX was pneumonia. The safety information from ATTRACT needs to be reviewed with the other safety information from other clinical studies and experience.
Please read the Important Safety Information and the Medication Guide for REMICADE and discuss it with your doctor. | 
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