Cimzia (certolizumab pegol) / Astellas, UCB 
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 50 Diseases   29 Trials   29 Trials   3299 News 


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  • ||||||||||  Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  BIOTAPE: Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis (clinicaltrials.gov) -  Jan 17, 2024   
    P4,  N=15, Active, not recruiting, 
    These findings suggest that post-marketing surveillance of biologics should be prioritized for those patients. Recruiting --> Active, not recruiting | N=156 --> 15 | Trial completion date: Mar 2024 --> Aug 2024 | Trial primary completion date: Dec 2023 --> Jul 2024
  • ||||||||||  Journal:  Therapeutic TNF Inhibitors Exhibit Differential Levels of Efficacy in Accelerating Cutaneous Wound Healing. (Pubmed Central) -  Jan 16, 2024   
    In line with histologic assessments, proteomics analyses from healing wounds exposed to various TNF inhibitors revealed distinct and differential wound-healing signatures that may underlie the differential efficacy of these inhibitors in accelerating cutaneous wound healing. Taken together, these data revealed that TNF inhibitors exhibited differential levels of efficacy in accelerating cutaneous wound healing in the impaired wound-healing model in
  • ||||||||||  Bimzelx (bimekizumab) / UCB
    Journal:  Bimekizumab (Bimzelx) for psoriasis. (Pubmed Central) -  Jan 11, 2024   
    Taken together, these data revealed that TNF inhibitors exhibited differential levels of efficacy in accelerating cutaneous wound healing in the impaired wound-healing model in No abstract available
  • ||||||||||  Trial completion date, Trial primary completion date:  Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response (clinicaltrials.gov) -  Jan 3, 2024   
    P3,  N=400, Recruiting, 
    In addition, secondary non-response was more frequent in patients with high RF levels treated with IFX and ADL. Trial completion date: Mar 2027 --> Mar 2028 | Trial primary completion date: Mar 2025 --> Mar 2026
  • ||||||||||  Stelara (ustekinumab) / J&J, Entyvio (vedolizumab) / Takeda, Humira (adalimumab) / AbbVie
    SAFETY OF ANTI-TUMOR NECROSIS FACTOR AGENTS COMPARED TO USTEKINUMAB AND VEDOLIZUMAB IN ELDERLY PATIENTS WITH ULCERATIVE COLITIS (Bellagio Ballroom - Bellagio Las Vegas) -  Dec 24, 2023 - Abstract #CCCongress2024CCCongress_361;    
    While these medications have all demonstrated general efficacy and safety in UC, this study aims to examine the long-term comparative safety of anti-TNF agents with vedolizumab and ustekinumab in elderly patients with UC.The Research Network on TriNetX database was accessed on September 26, 2023, to identify patients at least 65 old who were diagnosed with UC: the first cohort included patients prescribed anti-TNF agents (included adalimumab, certolizumab pegol, golimumab, and infliximab) and the second cohort included patients prescribed either vedolizumab or ustekinumab. In elderly patients with UC, ustekinumab or vedolizumab are safer treatment options compared to anti-TNF therapy.
  • ||||||||||  Humira (adalimumab) / AbbVie
    LOWER MORTALITY RISK WITH COMBINATION THERAPY WITH ANTI-TNF THERAPY AND THRIOPURINE COMPARED TO THIOPURINE ALONE IN ELDERLY PATIENTS WITH UC (Bellagio Ballroom - Bellagio Las Vegas) -  Dec 24, 2023 - Abstract #CCCongress2024CCCongress_359;    
    The study findings highlight the risks of thiopurine use in patients over the age of 65 given the significantly higher 10-year mortality risk in thiopurine monotherapy-treated patients. The results also suggest that combination therapy with thiopurine and anti-TNF therapies - despite utilization in patients with more active disease indicators - is not associated with an additive risk in terms of infection and mortality in elderly patients.
  • ||||||||||  BIOLOGICS AND SMALL MOLECULES USED IN IBD MIMICS: HIGHLIGHTING THE IMPORTANCE OF DIAGNOSIS CONFIRMATION (Bellagio Ballroom - Bellagio Las Vegas) -  Dec 24, 2023 - Abstract #CCCongress2024CCCongress_342;    
    14 were treated with one biologic, 5 with two biologics, and 6 with three or more biologics.The biologics used in the management of these IBD mimics included infliximab (n=21), vedolizumab (n=12), adalimumab (n=11), ustekinumab (n=6), and certolizumab (n=1).Of the 25 cases of biologic usage without definitive confirmation of IBD, 6 ended up with a diagnosis where biologics were an appropriate treatment for the mimic. These mimics included drug-induced colitis (n=3), Behcet
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, Cimzia (certolizumab pegol) / Astellas, UCB
    Identification of IL36RN missense mutations in Crohn (Poster exhibition) -  Dec 21, 2023 - Abstract #ECCOIBD2024ECCO_IBD_704;    
    Spesolimab was made available on the basis of an out of scope request. Boehringer Ingelheim was given the opportunity to review this abstract as a courtesy.
  • ||||||||||  Journal:  Overview and therapy update Crohn's disease (Pubmed Central) -  Dec 18, 2023   
    Moreover, the Janus kinase-1 inhibitor upadacitinib has been available for the treatment of CD in the EU since 2023...Nevertheless, CD remains an incurable disease and so far, for all existing treatments only a fraction of patients responds to the therapy. Therefore, the development of new therapies should continue.
  • ||||||||||  Journal:  Long-term retention rates of (Pubmed Central) -  Dec 16, 2023   
    The main reason for discontinuation was secondary inefficacy. Regarding adalimumab, secondary inefficacy was linked to the extent of arthritis upon treatment initiation.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Enrollment open, Trial initiation date:  CERTIFY: Certolizumab in Recurrent Implantation Failure (RIF) (clinicaltrials.gov) -  Dec 11, 2023   
    P3,  N=161, Recruiting, 
    In bDMARD-na Not yet recruiting --> Recruiting | Initiation date: Sep 2023 --> Nov 2023
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Trial primary completion date:  Pediatric Arthritis Study of Certolizumab Pegol (clinicaltrials.gov) -  Dec 7, 2023   
    P3,  N=193, Active, not recruiting, 
    Not yet recruiting --> Recruiting | Initiation date: Sep 2023 --> Nov 2023 Trial primary completion date: Dec 2023 --> Mar 2024
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Journal:  Clinical problems in Medical Mycology: Problem number 56 (Pubmed Central) -  Dec 4, 2023   
    We present the case of a twenty six year-old woman with rheumatoid arthritis, treated with certolizumab...Histoplasma capsulatum PCR test and urinary antigen were positive, so an antifungal treatment with voriconazole was started...With this measure the patient progressed favorably. The test of urinary Histoplasma capsulatum antigen and PCR amplification were key to make a diagnosis and also for a follow-up.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Trial completion date, Trial primary completion date:  Zr-89 Cimzia PET Imaging Rheumatoid Arthritis (clinicaltrials.gov) -  Dec 4, 2023   
    P1,  N=10, Suspended, 
    This study provided the most recent epidemiological characteristics from the prospective TReasure database, one of the comprehensive registries in rheumatology practice. Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Journal:  Characterization of anti-drug antibody dynamics using a bivariate mixed hidden-markov model by nonlinear-mixed effects approach. (Pubmed Central) -  Nov 9, 2023   
    A mixed hidden-Markov model (MHMM) was developed to characterize the underlying (hidden) formation of ADA against the biologic, using certolizumab pegol (CZP), as a test drug...Individual state sequences obtained using a Viterbi algorithm suggested that the model was able to determine the start of ADA production for each individual, being a more assay-independent methodology than traditional population PK. The model serves as a basis for identification of covariates influencing the ADA formation, and thus has the potential to identify aspects that minimize its impact on PK and/or efficacy.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Trial completion date:  Pediatric Arthritis Study of Certolizumab Pegol (clinicaltrials.gov) -  Nov 8, 2023   
    P3,  N=193, Active, not recruiting, 
    The model serves as a basis for identification of covariates influencing the ADA formation, and thus has the potential to identify aspects that minimize its impact on PK and/or efficacy. Trial completion date: Dec 2023 --> Mar 2024
  • ||||||||||  Trial completion date, Trial primary completion date, Immunomodulating:  COVER: COVID-19 VaccinE Response in Rheumatology Patients (clinicaltrials.gov) -  Nov 8, 2023   
    P4,  N=1000, Recruiting, 
    Trial completion date: Dec 2023 --> Mar 2024 Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: May 2023 --> Feb 2024
  • ||||||||||  A Translational Approach to Identifying and Targeting TNF Signaling in Idiopathic Multicentric Castleman Disease (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_5336;    
    We utilized a translational research approach including experimental and unbiased machine learning approaches to identify TNF as a novel therapeutic target that we inhibited to treat a highly refractory iMCD patient. Together, our data suggest that over-production of TNF, in part by activated T cells, promotes iMCD pathogenesis and highlight that further research is needed into TNF inhibition as a potential treatment strategy for iMCD.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Journal:  A quantitative systems pharmacology model for certolizumab pegol treatment in moderate-to-severe psoriasis. (Pubmed Central) -  Nov 1, 2023   
    Our study provided patient specific QSP models that reproduced clinical and molecular efficacy features, supporting the use of computational methods as modelling strategy to explore drug response variability. This might shed light on the differences in drug efficacy in diverse subpopulations, especially useful in complex diseases such as psoriasis, through the generation of mechanistically based hypotheses.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Trial completion date, Trial primary completion date:  IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy (clinicaltrials.gov) -  Oct 18, 2023   
    P2,  N=55, Recruiting, 
    Differences in TNFi structure profoundly impact the clearance of TNF, while it is unlikely that TNF itself significantly contributes to target-mediated drug disposition of TNFi. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
  • ||||||||||  Persistence to Therapy Among Patients with Psoriatic Arthritis Treated with IL-17A or TNF? Inhibitors (IL-17Ai or TNFi) (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_4213;    
    Persistence to therapy can be especially important in chronic, progressive diseases like PsA where patients will likely have to change treatment regimens over the course of disease. Results from this study indicate that IL-17Ai biologics can represent a viable, long-lived treatment choice even among patients with prior biologic experience and high comorbidity burden.
  • ||||||||||  Humira (adalimumab) / AbbVie
    De Novo Manifestations During Adalimumab Treatment in Beh (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3622;    
    Majority of these (75%) were major organ involvement, mainly vascular involement. of the patients developed posterior uveitis, the 2 patients with uveitis developing during ADA had anterior uveitis that was controlled with topical agents.
  • ||||||||||  Paternal Effects of Anti-TNFs in Inflammatory Arthritis (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3436;    
    Among the male patients taking anti-TNF treatment, infertility due to paternal origin does not seem to be a major issue according to our limited data. Anti-TNF treatment thus seems to be safe with regards to fertility in male patients.
  • ||||||||||  Exploring the Risk of Demyelination Associated with TNF Alpha Inhibitors: Analysis of the FDA Adverse Event Reporting System (FAERS) (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3183;    
    While a temporal relationship between anti-TNF-a treatment and demyelinating events is suggested, the overall number of published cases is small compared to the total number of treated patients. In most cases, demyelination either progressed slowly or resolved after discontinuing anti-TNF-a therapy, indicating a potential protective effect or short-lasting harmful impact in patients already suffering from latent MS.