ASSERT Study Shows REMICADE Improves Signs and Symptoms in Patients with Active AS

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ASSERT Clinical Study Overview

The approval for REMICADE in ankylosing spondylitis was based on the results of the landmark ASSERT study. ASSERT stands for Ankylosing Spondylitis Study For the Evaluation of Recombinant Infliximab Therapy study.

Who was studied in the ASSERT study?

The study included 279 patients at 33 research centers in North America and Europe. All patients had active ankylosing spondylitis that had been diagnosed for at least 3 months. To enter the study, patients had to have active AS as determined by the presence of symptoms such as fatigue, morning stiffness, back and joint pain. The majority of patients in the study were also taking nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen).

Which medications were given to study participants?

The study participants were divided into 2 groups and given treatments for 24 weeks. One group (Group 1) received REMICADE at a dose of 5 mg/kg. REMICADE was infused at the start of the study, 2 and 6 weeks later, and then every 6 weeks until the end of the study. Another group (Group 2) received a “placebo” or drug-free infusion at the start of the study, 2 and 6 weeks later, and then every 6 weeks until the end of the study.

The ASSERT study demonstrated that:

REMICADE improved signs and symptoms of ankylosing spondylitis
Signs and symptoms of AS are measured by the Ankylosing Spondylitis Assessment (ASAS) score. The score includes the doctor’s assessment of how well the patient is doing; the amount of back pain present; ability to perform physical activities; and the amount of morning stiffness. At the beginning of the ASSERT study, all patients were examined by a doctor and given a score. At the end of the study, patients were examined again. At the end of the study, patients who had a 20% decrease in the original ASAS score were classified as having an ASAS 20 score. In other words, a patient’s signs and symptoms improved by 20%. Some patients had ASAS 50 and ASAS 70 scores, which represent 50 and 70% reductions, respectively. More patients treated with REMICADE had ASAS 20, 50 and 70 scores at the end of the study. In other words, these patients had less back pain and morning stiffness, and could perform daily activities more easily.

REMICADE improved patient’s ability to perform daily activities
How well patients can perform routine daily activities can be assessed through a questionnaire called the Bath Ankylosing Functional Index or “BASFI”. The questionnaire asks questions related to the ability to perform physical activities. At the beginning of the ASSERT study, all patients were examined by a doctor and given a BASFI score. At the end of the study, patients were examined again. Patients treated with REMICADE had significant improvement in their BASFI score. In other words, patients treated with REMICADE could perform daily activities more easily.

Safety information from the ASSERT study

Please read Important Safety Information and the Medication Guide for REMICADE and discuss with your doctor.