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Posted by on Sep 27, 2018 in Rheumatoid Arthritis | 0 comments

In a nutshell

This study investigated if certolizumab pegol (Cimzia) in combination with methotrexate (Trexall) can reduce disease activity in patients with rheumatoid arthritis (RA). They found that this treatment combination was safe and improved RA symptoms.

Some background

Rheumatoid arthritis (RA) is a condition caused by an overactive immune system. Excessive inflammation in the joints causes pain and affects physical function. To treat RA, patients are prescribed medication to reduce inflammation.

Methotrexate (MTX) is a standard medication for RA. Some patients do not respond well to MTX. For these patients, it can be helpful to prescribe a drug that reduces a specific protein that causes inflammation. This protein is called tumor necrosis factor (TNF). Certolizumab pegol (CZP) is a medication that stops TNF from causing inflammation. It is still unclear if CZP in combination with MTX can help improve disease symptoms in patients that do not respond well to MTX alone.

Methods & findings

This study included 430 Chinese patients with RA. These patients were unresponsive to MTX alone. Patients were assigned to one of 2 groups. Patients in the combination group received 200 milligrams CZP every 2 weeks plus MTX. Patients in the MTX alone group received placebo (inactive drug) every 2 weeks and MTX. The study lasted 24 weeks. The target of the study was to achieve a 20% reduction in RA symptoms. The safety of CZP+MTX treatment was also evaluated.

54.8% of patients in the combination group achieved a 20% reduction in RA symptoms. 23.9% of patients that received MTX alone met this target. The chance of achieving a 20% reduction was 3.9 times greater in CZP + MTX patients. These patients also reported improvement in the quality of life and disease activity.

6.3% of CZP + MTX patients reported serious adverse events, compared to 2.7% of MTX patients. The most common side effects reported in the combination group were respiratory infections (1.9%) and allergic reactions (1.3%).

The bottom line

The authors concluded that certolizumab pegol in combination with methotrexate was safe and improved RA symptoms.

The fine print

This study did not test other anti-TNF drugs. The long-term safety of CZP will need further investigation.

This study was funded by UCB Pharma, the manufacturer of certolizumab pegol.

Published By :

Clinical and experimental rheumatology

Date :

Aug 29, 2018

Original Title :
Efficacy and safety of certolizumab pegol in combination with methotrexate in methotrexate-inadequate responder Chinese patients with active rheumatoid arthritis: 24-week results from a randomised, double-blind, placebo-controlled phase 3 study.
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