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Certolizumab Plus Methotrexate Improves Patient-Reported RA Outcomes CME
News Author: Will Boggs, MD
CME Author: Penny Murata, MD
CME Released: 12/07/2009; Valid for credit through 12/07/2010
December 7, 2009 — Adding certolizumab pegol to methotrexate improves health-related quality of life, fatigue, and other patient-reported outcomes in rheumatoid arthritis (RA), according to results of a randomized, placebo-controlled trial.
"(Patient-related outcomes) correlate so well with work productivity data, x-ray, and clinical responses, but most importantly these are the most robust 'patient centric' data and include productivity within as well as outside the home and family, social, and leisure activities," Dr. Vibeke Strand from Stanford University School of Medicine, Palo Alto, California, told Reuters Health in an email.
In the open-access online journal Arthritis Research and Therapy, Dr. Strand and colleagues present the patient-reported outcomes from the RAPID 1 trial of the pegylated anti-tumor necrosis factor certolizumab, and they also examine the correlations between patients' self-reports and their American College of Rheumatology (ACR)20 and Disease Activity Score (DAS) responses.
RAPID 1 involved 982 patients, including 393 randomized to certolizumab 200 mg plus methotrexate, 390 to certolizumab 400 mg plus methotrexate, and 199 to placebo plus methotrexate.
Patients in the certolizumab arms reported significantly improved health-related quality of life compared with the placebo group, beginning at week 12 and continuing through week 52 of the study.
These improvements consistently exceeded minimal clinically important differences, as did reductions in fatigue (nearly 49% in each certolizumab plus methotrexate arm versus 12.6% for placebo plus methotrexate), physical function, and pain.
Patient-reported outcomes agreed with clinical responses as determined by either ACR20 response rates or DAS, the investigators report.
"These results demonstrate that the benefits of certolizumab extend beyond clinical efficacy endpoints into areas that are more relevant and meaningful for patients on a daily basis," the authors conclude.
"We need to data mine this large database to show correlations between patient reported measures and what we rheumatologists typically assess, e.g., disease responses and prevention of structural damage," Dr. Strand said.
"We hope to look at it in early rheumatoid arthritis and psoriatic arthritis," Dr. Strand added. "(There are) already a lot of confirmatory data in rheumatoid arthritis by four phase 3 randomized controlled trials."
Arthritis Res Ther. 2009;11:R170.
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