Certolizumab pegol for adults with rheumatoid arthritis

Ruiz Garcia V, Jobanputra P, Burls A, Cabello JB, Gálvez Muñoz JG, Saiz Cuenca ESC, Fry-Smith A

Published Online:

February 16, 2011

This summary of a Cochrane review presents what we know from research about the effect of certolizumab pegol on adult people with rheumatoid arthritis:

The review shows that in people with rheumatoid arthritis who did not respond well to conventional treatments such as methotrexate (MTX):

- certolizumab pegol probably improves pain, function and other symptoms of rheumatoid arthritis;

- certolizumab pegol probably reduces disease activity;

- certolizumab pegol probably reduces joint damage as seen on the x-ray;

- side effects probably were more frequent in patients treated with certolizumab pegol.

What is rheumatoid arthritis and what is certolizumab?

When you have rheumatoid arthritis, your immune system, which normally fights infection, attacks the lining of your joints. This makes your joints swollen, stiff and painful. There is no cure for rheumatoid arthritis at present, so the treatments aim to relieve pain and stiffness, and improve your ability to move.

A new group of biologics has increased the number of treatment options. Certolizumab pegol belongs to this group. It is prescribed as self injection.

Best estimate of what happens to people with rheumatoid arthritis who take certolizumab pegol:

ACR 50 (number of tender or swollen joints, and other outcomes such as pain and disability)

- 29 more people out of 100 experienced improvement in the symptoms of their rheumatoid arthritis after 6 months with certolizumab pegol 200 mg sc (29% absolute improvement)
- 35 people out of 100 experienced improvement in the symptoms of their rheumatoid arthritis
- 6 people out of 100 who took a placebo experienced improvement

Remission (absence of clinical signs of inflammation)

- 9 more people out of 100 experienced remission in the symptoms of their rheumatoid arthritis after 6 months with certolizumab pegol 200 mg sc (12% absolute improvement)
- 11 people out of 100 experienced remission of their rheumatoid arthritis
- 1 person out of 100 who took a placebo experienced improvement

Serious adverse events (can include a serious infections or tuberculosis)

-5 more people out of 100 experienced serious adverse events related and not related to their rheumatoid arthritis after 6 months with certolizumab pegol 200 mg sc (5% absolute improvement)
-10 people out of 100 experienced serious adverse events related and not related to their rheumatoid arthritis
- 5 people out of 100 who took a placebo experienced serious adverse events

Limited data regarding safety of certolizumab pegol use, especially in the long term, is available.

Abstract (click to read)

Background:

TNF-alpha inhibitors have been shown to reduce the risk of joint damage and improve physical function and quality of life in people with rheumatoid arthritis (RA). This is the first Cochrane review of certolizumab pegol, a new TNF-alpha inhibitor.

Objectives:

To assess the effectiveness and safety of certolizumab pegol (CDP870) in patients with RA who have not responded well to conventional disease modifying anti-rheumatic drugs (DMARDs).

Search strategy:

We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2009, Issue 3), MEDLINE (1966 to November 2009), EMBASE (1966 to November 2009), Scopus (January 2004 to November 2009), TOXLINE (until November 2009), Web of Knowledge (until November 2009); websites of the US Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA) (until November 2009), and reference lists of articles.

Selection criteria:

Randomised controlled trials that compared certolizumab pegol with any other agent including placebo or methotrexate (MTX) in adult RA patients with active rheumatoid arthritis despite current or prior treatment with conventional DMARDs, such as methotrexate (MTX).

Data collection and analysis:

Two authors independently assessed search results, trial quality and extracted data.

Main results:

Five trials were included. We included in the analysis 2394 people for effectiveness and 2094 people for safety. The duration of follow-up was from 12 to 52 weeks, and the range of doses of certolizumab pegol were from 50 to 400 mg subcutaneously (sc). In three trials the control was placebo plus methotrexate (MTX) and in two trials it was just placebo. Significant improvements were observed at 24 weeks with the approved dose of 200 mg certolizumab pegol: American College of Rheumatology (ACR) 50% improvement: risk ratio (RR) 6.01 (95% CI 3.84 to 9.40) with an absolute benefit of 29% (95% CI 25% to 34%), number needed to treat to benefit (NNTB) of 4 (3 to 5) and the Health Assessment Questionnaire (HAQ) mean difference (MD) - 0.39 (95% CI -0.45 to -0.32) (scale 0 to 3). At 52 weeks the results were quite similar: ACR 50% improvement RR 5.27 (95% CI 3.19 to 8.71), HAQ mean difference (MD) - 0.42 (95% CI -0.52 to -0.32). Serious adverse events were more frequent for certolizumab pegol 200 mg, Peto OR 2.02 (95% CI 1.24 to 3.30). The most common adverse events with certolizumab pegol 200 mg were: upper respiratory tract infections, Peto OR 2.21 (95% CI 1.15 to 4.25); hypertension, Peto OR 2.81 (95% CI 1.38 to 5.75); and nasopharyngitis, Peto OR 2.71 (95% CI 1.30 to 5.66).

Authors' conclusions:

With an overall high grade of evidence this review revealed an improvement of clinical results (ACR50, 28 joint disease activity score (DAS-28) remission and HAQ scores) with certolizumab pegol. Adverse events were more frequent with certolizumab; there was a statistically significant increase in the number of serious adverse events, infections and hypertension.

This record should be cited as:

Ruiz Garcia V, Jobanputra P, Burls A, Cabello JB, Gálvez Muñoz JG, Saiz Cuenca ESC, Fry-Smith A. Certolizumab pegol (CDP870) for rheumatoid arthritis in adults. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No.: CD007649. DOI: 10.1002/14651858.CD007649.pub2

Assessed as up to date:

January 1, 2010

Find the research

Get full text at The Cochrane Library

Primary Review Group:

Musculoskeletal Group

Arthritis topics:

Rheumatoid Arthritis > Biologics

Health topics:

Rheumatology > Rheumatoid arthritis > Biologics

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Certolizumab pegol for adults with rheumatoid arthritis

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