Brussels, Belgium – 3 April, 7:00 CEST – UCB announced today that 4-year data on Cimzia® (certolizumab pegol) in the treatment of psoriatic arthritis (PsA), in patients both with and without prior anti-tumor necrosis factor (TNF) exposure, from the phase 3 double-blind randomized placebo-controlled RAPIDTM-PsA trial, have been published online in RMD Open.1
“PsA takes a significant toll on patients, causing joint pain and stiffness, skin plaques, swollen toes and fingers, and persistent inflammation of the sites where tendons or ligaments insert into the bone. Maintaining long-term control of PsA and sustained improvements in symptoms is critical for improving patient outcomes. The four-year results of the RAPID-PsA study demonstrate the value of Cimzia, highlighting efficacy across skin, joint, and other PsA disease domains, and supporting the use of Cimzia for the long-term therapeutic management of PsA,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB.
The study showed that the efficacy of Cimzia® in improving the spectrum of PsA symptoms was maintained over 4 years, and that a substantial proportion of patients completing 4 years of Cimzia® treatment achieved stringent disease inactivity targets: 76% achieved at least DAPSA Low Disease Activity with 44% also achieving DAPSA Remission, and 58% achieved Minimal Disease Activity (MDA; ≥5/7 MDA criteria), with 29% also achieving Very Low Disease Activity (7/7 MDA criteria).1
Improvements in psoriasis were also maintained over 4 years. Amongst patients who had at least 3% of their body surface area affected by psoriasis at baseline, 79% achieved at least a 75% improvement in the Psoriasis Area and Severity Index (PASI75) after 48 weeks of Cimzia® treatment, and 80% showed this level of improvement after 4 years of treatment. At least a 90% improvement in psoriasis (PASI90) was seen in 56% of patients after 48 weeks of treatment (in 62% after 4 years).1
Importantly, Cimzia® also demonstrated efficacy in resolving enthesitis, dactylitis and nail psoriasis in patients with PsA; of those remaining in the study at 4 years, 77%, 92%, and 71% of patients with enthesitis, dactylitis, and nail psoriasis, respectively, achieved total resolution of their symptoms.1
X-ray assessments showed minimal progression of structural damage to patients’ joints over the 4 years of the RAPID™-PsA study. Of the 186 Cimzia®-treated patients who had X-rays at baseline and at 4 years, 121 (65%) had no radiographic progression (defined as a change in modified total Sharp Score [mTSS] ≤0), and 145 (78%) had a change in mTSS ≤0.5.
For all measured patient-reported outcomes – Health Assessment Questionnaire Disability Index, pain, fatigue, PsA Quality of Life Index, and the Short-form 36-item Health Survey – the early improvements observed at Week 24 were maintained or further improved at 4 years.1
The safety profile of Cimzia® was as expected for this therapeutic class, with the most frequent serious TEAEs being infections, and was in line with that previously reported from the RAPID-PsA trial; no new safety signals were reported between Week 96 and the end of the 4-year study.1
Cimzia®, in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. In the EU, Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
About Psoriatic Arthritis (PsA)
PsA is a serious, highly heterogenous, chronic systemic inflammatory condition affecting both the joints and skin, with a prevalence of 0.05% to 0.25% of the population and 6% to 41% of patients with psoriasis.4 Symptoms include joint pain and stiffness, skin plaques, swollen toes and fingers, and persistent inflammation of the sites where tendons or ligaments insert into the bone (enthesitis). Up to 40% of people with PsA can suffer from joint destruction and permanent physical deformity.
RAPID™-PsA (n=409) was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study (NCT01087788) designed to evaluate the efficacy and safety of certolizumab pegol in patients with active PsA. Patients were randomized 1:1:1 to placebo, 400 mg loading dose certolizumab pegol at Week 0, 2 and 4 followed by either 200 mg certolizumab pegol every two weeks or 400 mg certolizumab pegol every four weeks. RAPID™-PsA was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label to Week 216.1
Cimzia® is the only Fc-free, PEGylated anti-TNF (Tumour 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.
In the EU, CIMZIA® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.
CIMZIA® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA® in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.
CIMZIA® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.
CIMZIA®, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. CIMZIA® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
CIMZIA® is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:
- Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
- Axial spondyloarthritis (axSpA) without radiographic evidence of AS - adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs
Cimzia® (certolizumab pegol) EU/EEA Important Safety Information5
CIMZIA® was studied in 4,049 patients with rheumatoid arthritis (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 haematologic 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.
CIMZIA® was studied in 325 patients with active axial spondyloarthritis (axSpA) in a placebo-controlled clinical trial for up to 30 months and in 409 patients with psoriatic arthritis (PsA) in a placebo-controlled clinical trial for up to 30 months. The safety profile for axSpA and PsA patients treated with CIMZIA® was consistent with the safety profile in RA and previous experience with CIMZIA®.
Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision December 2017.
For further information:
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- van der Heijde, D., Deodhar, A., FitzGerald, O., et al 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis RMD Open 2018;4:e000582.
- Mease, P.J., Fleischmann, R., Deodhar A. et al. Effect of Certolizumab Pegol on Signs and Symptoms in Patients with Psoriatic Arthritis: 24-Week Results of a Phase 3 Double-Blind Randomised Placebo-Controlled Study (RAPID-PsA). Ann Rheum Dis 2014;73(1): 48-55.
- Mease, P. J, Deodhar, A., Fleischmann, R et al. Effect of certolizumab pegol over 96 weeks in patients with psoriatic arthritis with and without prior antitumour necrosis factor exposure. RMD Open 2015;1(1): e000119.
- Ogdie, A., Weiss, P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015 November; 41(4): 545–568. doi:10.1016/j.rdc.2015.07.001.
- Cimzia® EU Summary of Product Characteristics, European Medicines Agency. Accessed 21st February 2018 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases in immunology and neurology. With approximately 7,500 people operating in 40 countries, the company generated revenue of € 4.5 billion in 2017. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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