Effect of certolizumab pegol in rheumatoid arthritis

The authors evaluated the safety and effectiveness of certolizumab pegol (Cimzia) in patients with low to moderate rheumatoid arthritis (RA). 

In RA, high levels of immune system proteins are generated. This causes inflammation, leading to chronic pain. Disease-modifying antirheumatic drugs (DMARDs) are safe and effective treatments used in RA patients. The progression of RA is monitored using a disease activity score (DAS) 28. This is an assessment used to measure the progress and improvement of RA by examining 28 joints. The majority of patients achieve improvement from DMARD treatments but continue to experience low (DAS28 less than 3.2) to moderate (DAS28 between 3.2 and 5.1) disease activity. This greatly affects the general well being of patients and increases the risk of joint damage progression. Certolizumab pegol (CZP), a biological DMARD, has shown effectiveness in RA patients with moderate to high disease activity (DAS score above 5.1).

Further research is needed to assess the effectiveness of CZP as an additional treatment to existing DMARDs in RA patients. 

The aim of this study was to assess the safety and effectiveness of CZP as an additional treatment to non-biologic DMARDs in RA patients with low to moderate disease activity.

194 patients were included in this study. In group 1, 96 patients were randomly assigned to receive CZP plus the existing DMARDs. In group 2, 98 patients were randomly assigned to receive placebo (harmless pill in the place of the active pill) plus the existing DMARDs. Patients who achieved remission (reduction of RA signs and symptoms) at the end of both week 20 and week 24 stopped their treatment but continued to take part in the study until week 52. In addition to DAS28, patient remission was also measured by clinical disease activity index (CDAI).This is a combination of different scoring systems used to assess joint function. A score of 2.8 or less is considered remission. A score between 2.8 and 10 is considered low disease activity.

At the start of the study, more than 90% of patients had moderate disease activity. Based on CDAI, 18.8% of patients in group 1 achieved remission. This was compared to 6.1% of patients in group 2. At week 24, 63% of patients in group 1 and 29.7% of patients in group 2 had low disease activity based on CDAI.

Based on DAS28, 19.8% of patients in group 1 achieved remission. This was compared to 3.1% of patients in group 2. A DAS28 of less than 2.6 is considered remission.

68.8% of patients in group 1 and 67.3% of patients in group 2 experienced side effects. The most common side effects were infections and stomach and intestinal complications. 

The authors concluded that the majority of patients with moderate RA reached remission or low disease activity following treatment with CZP.