UCB Showcases Key Rheumatology Data at American College of Rheumatology Convergence 2020
BRUSSELS, Nov. 5, 2020 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced new data on its TNF inhibitor, CIMZIA® (certolizumab pegol), and investigational IL-17A and IL-17F inhibitor, bimekizumab. Data are being presented at the American College of Rheumatology (ACR) Convergence 2020 virtual congress on November 5-9, 2020.
"The important data we are sharing at ACR Convergence 2020 further highlight UCB's impressive rheumatology research and our unwavering commitment to addressing the unmet needs of patients living with rheumatic diseases. The data demonstrate the real-world difference that CIMZIA can make for axSpA and PsA patients by providing major improvements in disease activity. Our bimekizumab data further support the selective inhibition of IL-17F in addition to IL-17A in AS and PsA, showing that bimekizumab has the potential to provide durable clinical responses impacting overall quality of life," said Emmanuel Caeymaex, Executive Vice President Immunology Solutions and Head of US, UCB.
UCB is sharing two-year data from the Phase 4 C-VIEW study addressing a significant unmet need for axSpA patients with a history of acute anterior uveitis (AAU). AAU is the most common extra-articular manifestation in axSpA, affecting up to 40 percent of patients and causing significant pain and risk of irreversible visual impairment.1
The C-VIEW open-label study investigated the impact of CIMZIA treatment on AAU flares in patients with axSpA and a recent history of AAU over a two-year period.1 The primary efficacy variable was the incidence of AAU flares rate during 96 weeks of CIMZIA treatment versus pre-baseline period.1 Findings revealed an 82 percent reduction in the incidence of AAU flares during CIMZIA treatment compared to pre-baseline (rate ratio [95 percent CI]: 0.18 [0.12, 0.28], p< 0.001).1 Improvements in axSpA signs and symptoms were observed by week 96 with 75.6 percent of patients achieving Assessment of SpondyloArthritis international Society 20 (ASAS20) and 58.5 percent achieving ASAS40 responses.1 No new safety signals were identified, compared to previous reports.1
Additionally, UCB is presenting findings from a post hoc analysis of Phase 3 C-axSpAnd study evaluating CIMZIA treatment in patients with non-radiographic axial spondyloarthritis (nr-axSpA).2 The study identified that patients with nr-axSpA and either evidence at baseline of sacroiliitis on MRI [MRI+] and/or C-reactive protein at least 10mg/ml [CRP+] have clinically relevant responses when treated with CIMZIA over a 52-week period. Relevant responses were measured by percentage of patients achieving major improvement in ASDAS (ASDAS-MI) and ASAS40.2 Across all three subgroups (MRI+/CRP+, MRI-/CRP+, and MRI+/CRP-), response rates were higher compared to placebo for both ASDAS-MI and ASAS40 at Week 12 and Week 52.2
Data presentations from two Phase 2b studies on UCB's investigational IL-17A and IL-17F inhibitor, bimekizumab, highlight rapid clinical improvements in joint and skin outcomes; as well as quality of life measures (QoL) in PsA; and long-term tolerability and consistently durable clinical responses in AS and PsA patients treated with bimekizumab.
The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.
Following is a guide to the UCB-sponsored data presentations:
Bimekizumab Long-Term Efficacy and Safety Over 96 Weeks in Patients with Ankylosing Spondylitis: Interim Results from a Phase 2B Open-Label Extension Study
Bimekizumab Treatment is Associated with Improvements in Back Pain and Fatigue in Patients with Active Psoriatic Arthritis: 48-Week Results from a Phase 2B Study
Bimekizumab Improves Patient-Reported Outcomes in Psoriatic Arthritis: 48-Week Results from a Phase 2B Study and Association Between Patient-Reported Outcomes and Disease Activity
Bimekizumab Maintenance of Response in Patients with Psoriatic Arthritis: 2-Year Results from a Phase 2B Dose-Ranging Study and its Open-Label Extension
Certolizumab Pegol Efficacy in Patients with Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status
Predictors of Response in Patients with Non-Radiographic Axial Spondyloarthritis Receiving Certolizumab Pegol in the C-axSpAnd Study
Reduction of Anterior Uveitis Flares in Patients with Axial Spondyloarthritis During Certolizumab Pegol Treatment: 96-Week Results from the C-VIEW Study
Network Meta-Analysis of Long-Term Efficacy (ASAS40) of Biologic Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) in bDMARD-Naïve Patients with Non-Radiographic Axial Spondyloarthritis
Achievement of Remission is Associated with Improvement in Functionality in Certolizumab Pegol-Treated Patients with Psoriatic Arthritis, Irrespective of Pre-Existing Radiographic Structural Damage
About CIMZIA® in the US
CIMZIA is indicated for reducing signs and symptoms of Crohn's disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
CIMZIA is also indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), adults with active ankylosing spondylitis (AS), and adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
In addition, CIMZIA is indicated for the treatment of moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.
IMPORTANT SAFETY INFORMATION about CIMZIA in the U.S.
CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.
Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue CIMZIA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.
HEPATITIS B VIRUS REACTIVATION
For full prescribing information, please visit
About CIMZIA® in the EU/EEA
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:
CIMZIA is also indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Cimzia® (certolizumab pegol) EU/EEA* Important Safety Information
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 percent) in clinical trials with Cimzia® and post-marketing were viral infections (includes herpes zoster, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthenia, leukopenia (including lymphopenia, neutropenia), 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 (including miliary, disseminated and extrapulmonary), herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopenia, 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 percent of patients discontinued taking Cimzia® due to adverse events vs. 2.7 percent for placebo.
Cimzia® was initially studied in 325 patients with active axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis) in the AS001 clinical study for up to 4 years, which includes a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 156-week open-label treatment period. Cimzia® was subsequently studied in 317 patients with non-radiographic axial spondyloarthritis in a placebo-controlled study for 52 weeks (AS0006). Cimzia® was also studied in patients with axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis) in a clinical study for up to 96 weeks, which included a 48-week open-label run-in phase (N=736) followed by a 48-week placebo-controlled phase (N=313) for patients in sustained remission (C-OPTIMISE). In all 3 studies, the safety profile for these patients was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia®.
Cimzia® was studied in 409 patients with psoriatic arthritis (PsA) in a clinical study for up to 4 years which included a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 168-week open-label treatment period.
The safety profile for axSpA and PsA patients treated with Cimzia® was consistent with the safety profile in RA and previous experience with Cimzia®.
Cimzia® was studied in 1112 patients with psoriasis in controlled and open-label studies for up to 3 years. In the Phase III program, the initial and maintenance periods were followed by a 96-week open-label treatment period. The long-term safety profile of Cimzia® 400 mg every 2 weeks and Cimzia® 200 mg every 2 weeks was generally similar and consistent with previous experience with Cimzia.
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, and moderate to severe heart failure.
Serious infections including sepsis, tuberculosis and opportunistic infections (e.g. histoplasmosis, nocardia, candidiasis) have been reported in patients receiving Cimzia®. Some of these events have been fatal. 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®.
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 including multiple sclerosis; 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 cytopenia, have been 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 July 2020.
CIMZIA® is a registered trademark of the UCB Group of Companies.
Forward looking statements UCB
Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.
UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.
Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.
For further information, UCB:
1 van der Horst-Bruinsma I, van Bentum RE, Verbraak FD, et al. Reduction of anterior uveitis flares in patients with axial spondyloarthritis during certolizumab pegol treatment: 96-week results from the c-view study. Abstract to be presented at ACR 2020, 5-9 November.
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SOURCE UCB, Inc.
Company Codes: EuronextBrussels:UCB, OTC-PINK:UCBJY