ASPIRE Study

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ASPIRE Study Overview

The approval for REMICADE in early rheumatoid arthritis (RA) was based on the results of the landmark ASPIRE study. ASPIRE stands for Active-Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset. ASPIRE was the largest controlled RA study in patients with early RA (disease duration of 3 years or less).

Who were the study participants?  

The study included 1004 patients at 122 research centers in North America, Europe, and Israel. All patients had moderately-to-severely active RA that had been diagnosed within the previous 3 years. To enter the study, patients had to have at least 10 swollen joints (out of 66), and 12 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. Even though many participants had been diagnosed only months before, x-rays showed that more than 80% already had damage to their joints.

The majority of patients in the study had not previously taken MTX, but many were taking other medications, such as nonsteroidal anti-inflammatory drugs (e.g., ibuprofen) or steroids.

*Rheumatoid factor is an antibody that is present in 80% of patients with RA.
^†C-reactive protein is a sign of inflammation used in the diagnosis of RA.

Which medications were given to study participants?

The study participants were divided into 3 groups and given treatments for 1 year. One group (Group 1) received REMICADE at a dose of 3 mg/kg plus MTX. REMICADE was infused at the start of the study, 2 and 6 weeks later, and then every 8 weeks until the end of the study. Another group (Group 2) received a higher dose of REMICADE (6 mg/kg) plus MTX at the start of the study, 2 and 6 weeks later, and then every 8 weeks until the end of the study. The third group (Group 3) received MTX only.

The ASPIRE study demonstrated that REMICADE + MTX was superior to MTX alone in all 3 of these measurements:

1. 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 ASPIRE 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, ACR 70, and ACR 90 scores, which represent 50%, 70%, and 90% reductions, respectively. 

More patients treated with the REMICADE + MTX than MTX alone had ACR 20, ACR 50, ACR 70, and ACR 90 scores at the end of the study. In other words, these patients had less pain, joint swelling, and tenderness after 1 year of treatment with REMICADE + MTX.

2. 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 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 ASPIRE 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.

3. REMICADE improved physical function
At the beginning of the ASPIRE 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 significantly more patients treated with REMICADE + MTX had meaningful improvement in their HAQ scores. In other words, they were able to perform their tasks more easily after REMICADE + MTX than they were before starting the treatment.

Safety information from the ASPIRE study

During the ASPIRE 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, nausea, headache, and sinusitis. 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.

Infusion reactions were the most common reason that patients stopped taking REMICADE + MTX. Infusion reactions were more common in patients treated with REMICADE + MTX than in patients taking MTX alone. Only your doctor can determine if REMICADE is right for you.

The safety information from the ASPIRE study needs to be reviewed with the 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.

ASPIRE is not the only extensive study conducted on the effectiveness of REMICADE + MTX. Also see ATTRACT.