prezalumab (AMG 557) / Amgen, AstraZeneca 
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 22 Diseases   0 Trials   0 Trials   31 News 
  • ||||||||||  Orencia (abatacept) / BMS, Actemra IV (tocilizumab) / Roche, JW Pharma
    Review, Journal:  Sjögren's syndrome: Old and new therapeutic targets. (Pubmed Central) -  Aug 7, 2021   
    Abatacept and belimumab, already licensed for the treatment of RA and lupus respectively, as well combination regimens of both rituximab and belimumab hold some promise in alleviation of SS-specific complaints, but data from large controlled trials are awaited...While targeting of cathepsin-S (Petesicatib), inducible costimulator of T cells ligand (prezalumab), and lymphotoxin beta receptor (baminercept) failed to fulfil the primary outcome measures, preliminary results from two randomized placebo controlled trials on CD40 blockade (Iscalimab) and B-cell activating factor receptor (Ianalumab) inhibition resulted in significant reduction of SS disease activity, with a favorable so far safety profile. Results from administration of other kinase inhibitors, a transmembrane activator and calcium-modulator and cytophilin ligand interactor TACI fusion protein (RC18), as well as low dose recombinant interleukin-2 to expand T-regulatory cells are currently awaited.
  • ||||||||||  Orencia (abatacept) / BMS
    Biomarker, Clinical, Journal, IO Biomarker:  Blocking T cell co-stimulation in primary Sjögren's syndrome: rationale, clinical efficacy and modulation of peripheral and salivary gland biomarkers. (Pubmed Central) -  Nov 1, 2020   
    Despite a clear biological effect on downstream B cell activation has been observed in patients treated with CTLA-4-Ig (abatacept) and with monoclonal antibodies targeting CD40 and ICOSL, the clinical efficacy of this approach has so far yielded mixed results; while the anti-CD40 monoclonal antibody iscalimab showed significant improvement in systemic disease activity compared to placebo, two large RCTs with abatacept and a phase IIa RCT with an anti-ICOSL monoclonal antibody (prezalumab) failed to reach their primary endpoints. Although the discrepancies between biological and clinical efficacy of targeting T cell co-stimulation on pSS remain unresolved, several factors including drug bioavailability and receptor occupancy, patient stratification based on T-cell related biomarkers and the choice of study outcome are likely to play an important role and form the basis for further work towards the quest for a disease-modifying biologic therapy in pSS.
  • ||||||||||  prezalumab (AMG 557) / Amgen, AstraZeneca
    A Phase 2a Study of MEDI5872 (AMG557), a Fully Human Anti-ICOS Ligand Monoclonal Antibody in Patients with Primary Sjögren’s Syndrome (Hall B5) -  Oct 7, 2019 - Abstract #ACRARHP2019ACR_3471;    
    P2a
    Although the discrepancies between biological and clinical efficacy of targeting T cell co-stimulation on pSS remain unresolved, several factors including drug bioavailability and receptor occupancy, patient stratification based on T-cell related biomarkers and the choice of study outcome are likely to play an important role and form the basis for further work towards the quest for a disease-modifying biologic therapy in pSS. In patients with active pSS, despite decreasing the level of RF, MEDI5872 210 mg did not achieve consistent improvement of clinical or other biomarker measures of disease activity.
  • ||||||||||  Orencia (abatacept) / BMS, ALPN-101 / Alpine
    ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Underlying Rheumatoid and Psoriatic Arthritis (Hall B5) -  Oct 7, 2019 - Abstract #ACRARHP2019ACR_2612;    
    The data suggest that ALPN-101 may significantly improve upon the clinical efficacy of currently approved therapeutics like abatacept for treatment of inflammatory diseases, including rheumatoid, psoriatic, and juvenile idiopathic arthritis. A Phase 1 clinical trial with ALPN-101 in healthy volunteers is underway, and trials in inflammatory arthritis and other inflammatory diseases are targeted to begin soon.
  • ||||||||||  prezalumab (AMG 557) / Amgen, AstraZeneca
    Trial completion:  Safety Study of AMG 557 in Subjects With Lupus Arthritis (clinicaltrials.gov) -  Apr 21, 2016   
    P1,  N=20, Completed, 
    Phase classification: P2 --> P2a | Trial primary completion date: Feb 2017 --> Jul 2017 Active, not recruiting --> Completed
  • ||||||||||  prezalumab (AMG 557) / Amgen, AstraZeneca
    Enrollment closed, Enrollment change:  Safety Study of AMG 557 in Subjects With Lupus Arthritis (clinicaltrials.gov) -  Jul 21, 2015   
    P1,  N=20, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=40 --> 20