Predicting the effectiveness of certolizumab pegol in rheumatoid arthritis by serum tumor necrosis factor alpha levels after 24 hours.

This study investigated the relationship between tumor necrosis factor-alpha (TNFα), interleukin (IL)-6, and serum certolizumab pegol (CZP; Cimzia) levels in patients with rheumatoid arthritis (RA) treated with CZP. The authors concluded that CZP was highly effective in patients with low serum TNFα levels at 24 hours after the first dose.

RA is an autoimmune and inflammatory disease. RA results in painful swelling and progressive joint and bone destruction. TNFα is a small protein involved in the development process of RA. TNFα inhibitors like CZP block arthritis and bone destruction. CZP is a biological disease-modifying anti-rheumatic drug (bDMARD). It is a monoclonal antibody that targets TNFα and is administered every 2 weeks by an injection under the skin (subcutaneous).

Preliminary evidence suggests that CZP is able to achieve high blood concentrations and is fast-acting. However, whether CZP levels in the blood and reductions in inflammatory markers such as TNFα and IL-6 after 24 hours predict response to CZP treatment in patients with RA remains under investigation.

The study involved 100 patients with RA and tender joints. Patients had received methotrexate on its own or in combination with another anti-rheumatic drug. CZP was administered at 400 mg at weeks 0, 2, and 4, followed by 200 mg every 2 weeks.

Changes in disease activity were monitored using the disease activity score in 28 joints (DAS28)-erythrocyte sedimentation rate (ESR). TNFα, IL-6, and CPZ blood levels were also evaluated at the beginning of the study and after 24 hours, 48 hours, then at 12 weeks.

DAS28-ESR had significantly improved after 24 hours and was maintained at 12 weeks. Serum TNFα and IL-6 levels were significantly lower at 24 and 48 hours after the first CZP injection. High levels of CZP at 24 hours were related to a decrease in TNFα levels at 24 hours. Serum levels of TNFα at week 12 were related to a DAS28-ESR of less than 2.6 (decreased disease activity).

The study showed that CZP was highly effective in patients with RA who had low serum TNFα levels at 24 hours after administration of the first dose of CZP.

The study did not analyze the combined effect of genetics in CZP response. This study was funded by UCB Pharma, the manufacturer of CZP.