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Patients treated with certolizumab pegol who experienced clinically meaningful improvements in physical function, fatigue and pain, reported increased productivity at work, both within and outside the home, and reduced interference of the disease in daily life after three months of treatment
UCB today announced data which showed that Cimzia®, the only approved PEGylated anti-TNF for the treatment of moderate-to-severe rheumatoid arthritis (RA), plus methotrexate (MTX), versus placebo plus MTX provided a significant improvement in patient physical function, fatigue and pain. A clear association between clinically meaningful improvements in these outcomes and increased work productivity were observed both within and outside the home.
The data (taken from two large multinational Phase III, multi-centre, double-blind, placebo-controlled studies [RAPID 1 and 2]) published in Rheumatology, showed that a clinically meaningful reduction in RA symptoms was associated with improved productivity at work outside and within the home, as achieved in patients treated with certolizumab pegol plus MTX. Five times as many patients treated with certolizumab pegol plus MTX versus placebo plus MTX reported clinically meaningful improvements in RA-associated pain, and two-to-three times as many patients recorded improvements in physical function and fatigue.
“The pain, fatigue and functional impairment caused by rheumatoid arthritis significantly impact patients’ lives, it decreases their productivity as well as participation in family, social and leisure activities,” said Dr. Johanna M. Hazes, Erasmus MC, University Medical Center, The Netherlands, and lead author.
“Importantly these data showed that reducing pain, fatigue and improving function was strongly associated with increased productivity at work, both within and outside the home.”
Patients treated with certolizumab pegol plus MTX reported a decrease in the number of full household work days missed, versus placebo plus MTX, by Week 12 which was associated with clinically meaningful relief of pain (mean decreases of -5.1 vs -2.1 days in non-responders) and fatigue (mean decreases of -4.9 vs -2.5 days), and clinically meaningful improvement in physical function (mean decreases of -5.1 vs. -2.4 days).
Improvements were seen in productivity at paid work, with reductions in presenteeism (days with productivity at paid work reduced by ≥50%) by Week 12 being associated with clinically meaningful relief of pain (mean decreases of -6.0 vs. -2.1 days) and fatigue (mean decreases of -6.0 vs -2.7 days), and clinically meaningful improvement in physical function (mean decreases of -6.4 vs -1.9 days). Similar associations were seen between reduced interference of RA with work within and outside home, household productivity and participation in family, social and leisure activities, and improvements in physical function, pain and fatigue.
Reported serious adverse reactions included infections (including tuberculosis) and malignancies (including lymphoma). The most common adverse reactions belonged to the system organ classes Infections and Infestations, reported in 15.5% of patients on certolizumab pegol and 7.6% of patients on placebo, and General disorders and administration site conditions, reported in 10.0% of patients on certolizumab pegol and 9.7% of patients on placebo. A pooled analysis of the safety data showed there was a low incidence of injection site pain (1.5%) and a low level of discontinuations due to adverse events (5%). Certolizumab pegol demonstrated a favorable risk-benefit profile in patients with at least up to two years of drug exposure.
It is estimated that, in the seven major markets, five million people suffer from rheumatoid arthritis. Prevalence is not split evenly between genders, since women are three times more likely to be affected than men. Although RA can affect people of all ages, the onset of the disease usually occurs between 30-60 years of age. RA symptoms often lead to restricted mobility, and permanently damage and disfigure the joints and bones. Limitations in physical function, mobility and increased levels of pain and fatigue in patients with RA affect their ability to perform work and household activities, and impair their ability to engage in family, social and leisure activities.
This analysis evaluated data from two large multinational Phase III, multi-centre, double-blind, placebo-controlled studies (RAPID 1 and 2) comparing the efficacy and safety of certolizumab pegol plus MTX versus placebo plus MTX. These findings demonstrated that RA patients treated with certolizumab pegol plus MTX who experienced clinically meaningful improvements in physical function, fatigue and pain also reported increased productivity within and outside the home, and less interference of RA with their work, household activities and participation in family, social and leisure activities.