EULAR 2021 : les nouvelles donnees du portefeuille de rhumatologie d'UCB demontrent une valeur reelle pour les patients atteints de spondyloarthrite axiale, de rhumatisme psoriasique et les femmes en age de procreer
- Une analyse post-hoc de l'etude C-OPTIMISE confirme le benefice d'un traitement continu par CIMZIA((R) )(certolizumab pegol), avec une dose d'entretien complete ou reduite, chez les patients atteints de spondyloarthrite axiale (axSpA) qui obtiennent une remission prolongee.
- De plus amples informations, issues de l'une des plus importantes cohortes de grossesses suivies de maniere prospective, avec des devenirs connus, chez des patientes atteintes de spondyloarthrite axiale, de la maladie de Crohn, de rhumatisme psoriasique, de psoriasis et de polyarthrite rhumatoide, destinees aux professionnels de sante envisageant un traitement par le certolizumab pegol, si cela est cliniquement necessaire, pour leurs patientes qui sont des femmes en age de procreer, seront presentees.
- La tolerance a long terme, l'efficacite, les resultats rapportes par les patients (PRO) et les donnees sur la qualite de vie du bimekizumab, inhibiteur de l'IL-17A et de l'IL-17F, montrent le potentiel de la molecule experimentale d'UCB a faire une difference significative chez les patients atteints de rhumatisme psoriasique (PsA) et de spondylarthrite ankylosante (SA).
PARIS, 3 juin 2021 /PRNewswire/ -- UCB, entreprise biopharmaceutique mondiale, a annonce aujourd'hui la presentation de nouvelles donnees pour son anti-TNF sans fragment Fc, le certolizumab pegol (CIMZIA((R))), et son inhibiteur de l'IL-17A et de l'IL-17F, le bimekizumab, au Congres Europeen de Rhumatologie (EULAR) 2021 du 2 au 5 juin 2021. Au total, sept resumes ont ete acceptes pour le congres virtuel de cette annee, qui soulignent tous l'engagement d'UCB dans l'innovation en rhumatologie pour repondre aux besoins non satisfaits des patients. Trois des sept resumes seront presentes sous forme de posters avec des presentations guidees et des questions-reponses en direct.
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" Les donnees que nous presentons a l'EULAR refletent notre recherche innovante en rhumatologie et nous preparent a un avenir prometteur. Ce rendez-vous important nous donne l'opportunite de connecter notre science et notre innovation aux lacunes et aux obstacles qui existent dans le parcours des patients en rhumatologie ", a declare Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
Donnees portant sur le certolizumab pegol
Les donnees portant sur le certolizumab pegol incluent une analyse post-hoc de l'etude de phase 3b C-OPTIMISE dans l'axSpA. L'analyse a evalue l'activite de la maladie et les marqueurs cliniques de l'inflammation chez les patients qui n'ont pas presente de poussee de la maladie apres la randomisation avec une dose d'entretien complete du certolizumab pegol (200 mg toutes les deux semaines [Q2W]), la dose d'entretien reduite du certolizumab pegol (200 mg toutes les quatre semaines [Q4W]) ou un placebo de la semaine 48 a la semaine 96 de C-OPTIMISE.(1) L'analyse a identifie une activite de la maladie constamment plus elevee et des augmentations des biomarqueurs serologiques et inflammatoires chez les patients randomises avec placebo qui n'ont pas presente de poussee de la semaine 48 a la semaine 96 de C-OPTIMISE par rapport a ceux qui sont restes sous le certolizumab pegol.(1 )Les resultats confirment le benefice d'un traitement continu par le certolizumab pegol, avec la dose d'entretien complete ou reduite en cas de remission prolongee de la spondyloarthrite axiale, par rapport a l'arret du traitement.(1)
Les donnees supplementaires portant sur le certolizumab pegol comprennent les resultats a deux ans de l'etude de phase 4 en ouvert C-VIEW evaluant l'impact du traitement par le certolizumab pegol sur les poussees d'uveite anterieure aigue (UAA),(2) chez les patients atteints d'axSpA et les resultats d'une analyse post-hoc d'une etude interventionnelle controlee par placebo de 52 semaines dans la nr-axSpA (C-axSpAnd) pour identifier si un IRM des articulations sacro-iliaques positif a l'inclusion ou la presence de l'antigene-B27 des leucocytes humains- (HLAB27) sont des facteurs predictifs de la reponse au certolizumab pegol a 52 semaines.(3)
UCB partagera une analyse qui comprend plus de 1000 grossesses suivies de maniere prospective avec exposition au certolizumab pegol au moins au cours du premier trimestre, ce qui represente l'une des plus importantes cohortes de grossesses avec des devenirs connus chez les patientes atteintes de spondyloarthrite axiale, de la maladie de Crohn, de rhumatisme psoriasique, de psoriasis et de polyarthrite rhumatoide.(4)
Aucune augmentation des issues indesirables de grossesse ou de malformations congenitales specifiques n'a ete observee chez les grossesses exposees au certolizumab pegol par rapport a la population generale.(4,5,6)
Nos donnees ont en outre confirme l'influence de facteurs de confusion, tels que des rhumatismes inflammatoires chroniques specifiques, des medicaments concomitants ou des comorbidites, sur l'issue de la grossesse. Prises ensemble, ces donnees apportent davantage d'information aux professionnels de sante qui envisagent un traitement par le certolizumab pegol, s'il existe un besoin clinique, pour leurs patientes qui sont en age de procreer.
Donnees portant sur le Bimekizumab
Les nouvelles donnees issues des extensions en ouvert des etudes de phase 2b BE AGILE et BE ACTIVE evaluant la tolerance et l'efficacite a long terme du traitement par bimekizumab (160 mg toutes les 4 semaines) chez les patients atteints de spondylarthrite ankylosante et de rhumatisme psoriasique, respectivement, demontrent que le profil de tolerance du bimekizumab etait similaire aux etudes anterieures.(7,8) Aucun nouveau signal de tolerance n'a ete observe et le taux d'incidence des evenements a diminue avec la duree de l'exposition.(7,9) Dans les deux etudes, les resultats d'efficacite clinique observes a la semaine 48 se sont maintenus jusqu'a trois ans de traitement.(7)(,)(8)
Des donnees supplementaires issues de l'extension en ouvert de l'etude BE AGILE chez des patients atteints de SA active traites par bimekizumab pendant trois ans demontrent une efficacite soutenue et coherente dans les resultats rapportes par les patients (PRO), concernant l'activite de la maladie, la fonction physique, la douleur rachidienne, la fatigue, la raideur matinale et la qualite de vie avec la spondylarthrite ankylosante (ASQoL).(10) Dans toutes les mesures rapportees, l'efficacite a ete maintenue de la semaine 48 a la semaine 144 ou 156.(10)
L'efficacite et la tolerance du bimekizumab n'ont pas encore ete etablies, ni validees a ce jour par aucune autorite reglementaire dans le monde.
Presentation des donnees d'UCB a l'EULAR 2021 :
e-Posters CIMZIA((R)) avec presentation guidee :
-- Activite de la maladie et inflammation apres l'arret du traitement par
le certolizumab pegol chez les patients atteints de spondyloarthrite
axiale qui n'ont pas presente de poussees pendant l'etude C-OPTIMISE, L.
Gensler, X. Baraliakos, L. Bauer, B. Hoepken, T. Kumke, M. Kim, R.
Landewe (abstract #POS0229)
-- Donnees de pharmacovigilance sur la grossesse dans une large population
de patientes atteintes de maladie inflammatoire chronique exposes au
certolizumab pegol : resultats de la grossesse et facteurs de confusion,
M. Clowse, R. Fischer-Betz, C. Nelson-Piercy, A. Scheuerle, T. Kumke, B.
Lauwerys, R. Kasliwal, F. Forger, Landewe (abstract #POS0022)
e-Posters CIMZIA((R)) :
-- Reduction des poussees d'uveite anterieure chez les patients atteints de
spondyloarthrite axiale pendant le traitement par le certolizumab pegol
: resultats a 96 semaines de l'etude C-VIEW, I. Van der Horst-Bruinsma,
R. Van Bentum, F. Verbraak, T. Rath, B. Hoepken, O. Irvin-Sellers, T.
Kumke, L. Bauer, M. Rudwaleit (abstract #POS0897)
-- Predicteurs de reponse chez les patients atteints de spondyloarthrite
axiale non-radiographique recevant du certolizumab pegol dans l'etude
C-axSpAnd, W. Maksymowych, T. Kumke, S. Auteri, B. Hoepken, L. Bauer, M.
Rudwaleit (abstract #POS0896)
e-Poster Bimekizumab avec presentation guidee :
-- Tolerance et efficacite a long terme du bimekizumab chez les patients
atteints de spondylarthrite ankylosante : resultats a 3 ans d'une etude
de phase 2b, D. van der Heijde, A. Deodhar, L. S. Gensler, D. Poddubnyy,
A. Kivitz, M. Dougados, N. de Peyrecave, M.Oortgiesen, T. Vaux,
C.Fleurinck, X.Baraliakos (abstract #POS0226)
e-Posters Bimekizumab:
-- Le bimekizumab montre des ameliorations durables a long terme dans les
resultats rapportes par les patients (PRO) et sur la qualite de vie dans
la spondylarthrite ankylosante : resultats a 3 ans d'une etude de phase
2b, X. Baraliakos, M. Dougados, K. Gaffney, R. Sengupta, M. Magrey, N.
de Peyrecave, M. Oortgiesen, T. Vaux, C. Fleurinck, V. Ciaravino, A.
Deodhar (abstract #POS0919)
-- Tolerance et efficacite du bimekizumab chez les patients atteints de
rhumatisme psoriasique : resultats a 3 ans de l'extension en ouvert
d'une etude de phase 2b, L. Coates, R. Warren, C. Ritchlin, L. Gossec,
J. Merola, D. Assudani, J. Coarse, J. Eells, B. Ink, I. Mcinnes
(abstract #POS1022)
About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively and directly inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.(11) IL-17F has overlapping biology with IL-17A and drives inflammation independently of IL-17A.(12,13,14,15,16) Selective inhibition of IL-17F in addition to IL-17A suppresses inflammation to a greater extent than IL-17A inhibition alone.(15,16) The safety and efficacy of bimekizumab are being evaluated across multiple disease states as part of a robust clinical program.
About CIMZIA((R)) in the EU/EEA
In the EU, CIMZIA((R)) 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 is also indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Cimzia((R)) (certolizumab pegol) EU/EEA* Important Safety Information
Date of revision March 2021
Cimzia((R)) 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((R) )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% of patients discontinued taking Cimzia((R)) due to adverse events vs. 2.7% 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((R)) 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((R)) was consistent with the safety profile in RA and previous experience with Cimzia((R)).
Cimzia((R)) 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((R) )400 mg every 2 weeks and Cimzia((R)) 200 mg every 2 weeks was generally similar and consistent with previous experience with Cimzia.
*EU/EEA means European Union/European Economic Area
Cimzia((R)) 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((R)). Some of these events have been fatal. Before initiation of therapy with Cimzia((R)), all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, Cimzia((R)) 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((R)).
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia((R) )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((R)). Carriers of HBV who require treatment with Cimzia((R)) should be closely monitored and in the case of HBV reactivation Cimzia((R)) should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
TNF antagonists including Cimzia((R)) 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((R)) 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((R)).
Adverse reactions of the haematologic system, including medically significant cytopenia, have been reported with Cimzia((R)). 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((R)). Consider discontinuation of Cimzia((R)) therapy in patients with confirmed significant haematological abnormalities.
The use of Cimzia((R)) in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, Cimzia((R)) should not be administered concurrently with live vaccines. The 14-day half-life of Cimzia((R)) should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on Cimzia((R)) 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 March 2021.
https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-product-information_en.pdf [https://c212.net/c/link/?t=0&l=fr&o=3180863-1&h=2929577533&u=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fproduct-information%2Fcimzia-epar-product-information_en.pdf&a=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fproduct-information%2Fcimzia-epar-product-information_en.pdf]
Last accessed: April 2021.
About UCB
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 of the immune system or of the central nervous system. With more than 7,600 people in approximately 40 countries, the company generated revenue of EUR 5.3 billion in 2020. UCB is listed on Euronext Brussels
Forward looking statements UCB
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References :
(1)Gensler L, Baraliakos X, Bauer L, et al. Disease Activity and Inflammation Following Withdrawal of Certolizumab Pegol Treatment in Axial Spondyloarthritis Patients Who Did Not Experience Flares during the C-OPTIMISE Study. Abstract to be presented at EULAR 2021, June 2-5.
(2)Van der Horst-Bruinsma I, Van Bentum R, Verbraak F, 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 EULAR 2021, June 2-5.
(3)Maksymowych W, Kumke T, Auteri S, et al. Predictors of Response in Patients with Non-Radiographic Axial Spondyloarthritis Receiving Certolizumab Pegol in the C-axSpAnd Study. Abstract to be presented at EULAR 2021, June 2-5.
(4)Clowse M, Fischer-Betz R, Nelson-Piercy C, et al. Pharmacovigilance Pregnancy Data in a Large Population of Patients with Chronic Inflammatory Disease Exposed to Certolizumab Pegol: Pregnancy Outcomes and Confounders. Abstract to be presented at EULAR 2021, June 2-5.
(5)Ventura SJ, Curtin SC, Abma JC, et al. Estimated pregnancy rates and rates of pregnancy outcomes for the United States, 1990-2008. Natl Vital Stat Rep. 2012;60(7):1-21.
(6)Lee H, Okunev I, Tranby E, et al. Different levels of associations between medical co-morbidities and preterm birth outcomes among racial/ethnic women enrolled in Medicaid 2014-2015: retrospective analysis. BMC Pregnancy Childbirth. 2020;20:33.
(7)Van der Heijde D, Deodhar A, Gensler L.S., et al. Bimekizumab Long-Term Safety and Efficacy in Patients with Ankylosing Spondylitis: 3-Year Results from a Phase 2b Study. Abstract to be presented at EULAR 2021, June 2-5.
(8)Coates L, Warren R, Ritchlin C, et al. Bimekizumab Safety and Efficacy in Patients with Psoriatic Arthritis: 3-Year Results from a Phase 2b Open-Label Extension Study. Abstract to be presented at EULAR 2021, June 2-5.
(9)Mcinnes I, Merola JF, Mease PJ, et al. SAT0403 EFFICACY AND SAFETY OF 108 WEEKS' BIMEKIZUMAB TREATMENT IN PATIENTS WITH PSORIATIC ARTHRITIS: INTERIM RESULTS FROM A PHASE 2 OPEN-LABEL EXTENSION STUDY. Annals of the Rheumatic Diseases. 2020;79:1153-1154.
(10)Baraliakos X, Dougados M, Gaffney K, et al. Bimekizumab Shows Sustained Long-Term Improvements in Patient-Reported Outcomes and Quality of Life in Ankylosing Spondylitis: 3-Year Results from a Phase 2b Study. Abstract to be presented at EULAR 2021, June 2-5.
(11)Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1001.
(12)Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses by IL-17F. J Exp Med. 2008;205(5):1063-1075.
(13)Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot fold: structure and activity of a novel cytokine, IL-17F, and implications for receptor binding. EMBO J. 2001;20(19):5332-5341.
(14)van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous expression pattern of interleukin 17A (IL-17A), IL-17F and their receptors in synovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: possible explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther. 2014;16(4):426.
(15)Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-17A and IL-17F provides evidence of IL-17F contribution to chronic inflammation in disease-relevant cells. Ann Rheum Dis. 2017;76(2):213.
(16)Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.
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