RAPID™-PsA study highlights burden of psoriatic arthritis and showed that patients treated with certolizumab pegol reported improvements in pain and fatigue, and increased productivity at work and within the home
Brussels (Belgium), June 13th 2013, 1800 CEST – UCB announced today new data from the RAPIDTM-PsA study on certolizumab pegol in the treatment of moderate to severe psoriatic arthritis (PsA) at the European League Against Rheumatism (EULAR) 2013 Congress in Madrid, Spain. Results showed that certolizumab pegol improved multiple patient reported outcomes including pain, fatigue and health-related quality of life.1 Patients reported that PsA placed a high burden of disease on workplace and household productivity. Compared with the placebo group, patients treated with certolizumab pegol reported improvements in productivity at the workplace through reduced absenteeism, presenteeism and PsA interference with work, as well as improvements in household productivity and increased participation in social and daily activities.2,3
“PsA places a high burden of disease on paid work and household activity that in turn could lead to a financial burden for both patients and society,” said Professor Dafna Gladman, Toronto Western Research Institute, Canada. “To date, there are few data on work and household productivity among patients with PsA. The RAPID™-PsA study offers additional insight on the burden of PsA. In this study, patients treated with certolizumab pegol reported improved work and household productivity as well as improvements in outcomes such as fatigue and pain, which can help patients cope with everyday activities.”
PsA is a chronic inflammatory condition which affects both the skin and joints.4 The RAPIDTM-PsA study is an ongoing Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of certolizumab pegol in patients with adult onset active and progressive PsA. Patients (n=409) were randomized 1:1:1 to placebo, or 400 mg certolizumab pegol at week 0, 2 and 4 loading dose followed by either 200 mg certolizumab pegol every two weeks or 400 mg certolizumab pegol every four weeks.5 The clinical primary endpoint of the RAPID™-PsA study was the ACR20 response at week 12. The ACR20 response at week 12 was significantly higher in both the certolizumab pegol arms of the study vs. placebo (p<0.001). Adverse events occurred in 62% vs. 68% and serious adverse events in 7% vs. 4% in certolizumab pegol (combined dose) vs. placebo, respectively.6
Abstract title: Effect of certolizumab pegol on the multiple facets of psoriatic arthritis as reported by patients with and without prior anti-TNF exposure: 24-week patient-reported outcome results of RAPIDTM-PsA study1
Patient-reported outcome measures evaluated fatigue assessment scale (FAS), patient assessment of pain (VAS), health assessment questionnaire-disability index (HAQ-DI), health-related quality of life (HRQoL) measured by the SF-36 (physical component summary (PCS), mental component summary (MCS) scores and domain scores), Psoriatic Arthritis Quality of Life (PsAQoL) measure, and Dermatology Life Quality Index (DLQI).
Significant differences in pain, fatigue, HAQ-DI, HRQoL (SF-36 PCS, MCS and all domain scores), PsAQoL, and DLQI were observed in certolizumab pegol 200 mg every 2 weeks and 400 mg every 4 weeks vs. placebo (p<0.001). Pain was significantly improved from week one, and fatigue and HAQ-DI from week two. More patients on certolizumab pegol reached SF-36 general population norms than placebo patients. Post-hoc analyses showed similar improvements in patient reported outcomes for patients with and without prior anti-TNF exposure.
Abstract title: High economic burden of moderate to severe psoriatic arthritis on paid work and household productivity: Baseline results from the RAPIDTM-PsA study2
At baseline, 59.4% of PsA patients were employed outside the home and 13.9% were work-disabled due to the disease. PsA was shown to have a high burden on workplace productivity in employed patients with on average more than one week of paid work affected. Employed patients with manual jobs reported higher productivity losses at work and within household activities vs. employed patients with non-manual jobs.
The burden of PsA on home productivity and social activities was greater with on average more than two weeks of household duties or social activities affected per month, at study baseline. The PsA impact on household duties was, on average, up to 2 to 3 times higher in non-employed or work-disabled patients vs. employed patients. Overall 41.8% of patients required regular assistance from relatives, friends or paid caregivers in their usual activities because of PsA. These patients reported on average 2 to 4 times higher workplace and household productivity losses vs. patients who did not require regular assistance.
Abstract title: Improvements in productivity at paid work and within household, and increased participation in daily activities after 24 weeks of certolizumab pegol in patients with psoriatic arthritis: Results of RAPID-PsATM study3
Compared to placebo, employed patients treated with certolizumab pegol reported less work days lost per month with improvements reported as early as week 4 and maintained to week 24 (mean 2.0 days at baseline (BL) and 0.2 at week 24 for 200 mg certolizumab pegol every 2 weeks, 1.6 days at BL and 0.6 at week 24 for 400 mg certolizumab pegol every 4 weeks vs. 2.6 days at BL and 1.6 at week 24 for placebo). Patients in both certolizumab pegol arms also reported less work days with reduced productivity per month from week 4 to week 24.
Compared to placebo, patients treated with certolizumab pegol reported fewer days missed of household work per month with improvements reported as early as week 4 and maintained to week 24 (mean 5.9 days at BL and 2.4 at week 24 for 200 mg certolizumab pegol every 2 weeks, 5.5 days at BL and 2.5 at week 24 for 400 mg certolizumab pegol every 4 weeks vs 5.7 days at BL and 4.7 at week 24 for placebo). Patients also reported less household work days with reduced productivity per month from week 4 to week 24 and fewer days missed of family/social/leisure activities per month (mean 4.1 days missed at BL and 1.1 at week 24 for 200 mg certolizumab pegol every 2 weeks, 3.3 days missed at BL and 1.0 at week 24 for 400 mg certolizumab pegol every 4 weeks vs 3.7 days missed at BL and 2.8 at week 24 for placebo).
In the EU, certolizumab pegol in combination with methotrexate (MTX) is approved for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs including MTX. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.7
Certolizumab pegol is not approved for the treatment of PsA. In February 2013, UCB filed with the EU regulatory authorities to extend the marketing authorization for certolizumab pegol to the treatment of active PsA.
Note to editors
Cimzia® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. Cimzia® in combination with MTX is approved in the EU for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX. Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. UCB is also developing Cimzia® in other autoimmune disease indications. Cimzia® is a registered trademark of UCB PHARMA S.A.
Cimzia® (certolizumab pegol) EU/EEA Important Safety Information
Cimzia® was studied in 4,049 patients with RA in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with Cimzia® and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking Cimzia® due to adverse events vs. 2.7% for placebo.
Cimzia® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections or moderate to severe heart failure.
Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving Cimzia.® Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia®. Treatment with Cimzia® must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop Cimzia® if infection becomes serious. Before initiation of therapy with Cimzia®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, Cimzia® therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia®. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with Cimzia®
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Cimzia®. Carriers of HBV who require treatment with Cimzia® should be closely monitored and in the case of HBV reactivation Cimzia® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
TNF antagonists including Cimzia® may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, Cimzia® should be discontinued and appropriate therapy instituted.
With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia®
Adverse reactions of the hematologic system, including medically significant cytopaenia, have been infrequently reported with Cimzia®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia®. Consider discontinuation of Cimzia® therapy in patients with confirmed significant haematological abnormalities.
The use of Cimzia® in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, Cimzia® should not be administered concurrently with live vaccines. The 14-day half-life of Cimzia® should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on Cimzia® should be closely monitored for infections.
Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision 25th April 2013.
1. Gladman D., Fleischmann R., Coteur G. et al. Effect of certolizumab pegol on the multiple facets of psoriatic arthritis as reported by patients with and without prior anti-TNF exposure: 24-week patient reported outcome results of RAPID-PsA study. Presented at the European League Against Rheumatism (EULAR) 2013 Congress. Abstract # SAT0260
2. Kavanaugh A., Mease J.P., Purcaru O. et al. High economic burden of moderate to severe psoriatic arthritis on paid work and household productivity: Baseline results from the RAPID-PsA study. Presented at the European League Against Rheumatism (EULAR) 2013 Congress. Abstract # SAT0275
3. Kavanaugh A., Gladman D., Van der Heijde D., Braun J. et al. Improvements in productivity at paid work and within household and increased participation in daily activities after 24 weeks of certolizumab pegol in patients with psoriatic arthritis: Results of RAPID-PsA study. Presented at the European League Against Rheumatism (EULAR) 2013 Congress. Abstract # SAT0276
4. Psoriatic Arthritis, Genetics Home Reference. Accessed 10th June, 2013 from http://ghr.nlm.nih.gov/condition/psoriatic-arthritis
5. ClinTrials.gov. Certolizumab pegol in subjects with adult onset active and progressive psoriatic arthritis. Accessed 10th June, 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01087788?term=certolizumab+pegol+and+psoriatic+arthritis&rank=1
6. Mease P.J., Fleischmann R., Wollenhaupt J. et al. Effect if certolizumab pegol on signs and symptoms in patients with psoriatic arthritis from the RAPID-PsA study: Impact of baseline skin involvement and prior anti-TNF therapy. Presented at the European League Against Rheumatism (EULAR) 2013 Congress. Abstract # SAT0298
7. Cimzia® Summary of Product Characteristics Accessed 10th June, 2013 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
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