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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Soluble Buffered Alendronate After Denosumab Discontinuation in Erosive Hand OA Patients (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3304;    
    Clinical implications of the increase of bone turnover markers in this non osteoporotic remain doubtful, since BMD values did not change over time, except at the lumbar spine in the 24 weeks alendronate group. Longer follow-up is warranted to evaluate clinical consequences on long term.
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Real-world Trends in the Use of Immunomodulation as Co-therapy to Pegloticase: Claims-based Findings Since 2016 (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3239;    
    Compelling real-world 5, 11 and clinical trial 9 efficacy/safety data has led to wide-spread awareness and adoption of IMM co-administration with pegloticase, often a last-hope therapy for patients suffering from uncontrolled gout. In the last part of 2022, over 70% of patients beginning pegloticase were co-administered IMM, with the majority of these patients receiving MTX.
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    Evaluation of Outcomes Following Discontinuation of Pegloticase Therapy (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3219;    
    An important minority of patients fail to receive any ULT after cessation of pegloticase. Additionally, many patients who were able to restart restarting pegloticase after a prolonged gap in therapy achieved had its expected resulting SU-lowering effect with therapy even after a gap in therapy, although the context for the interruption needs to be further explored.
  • ||||||||||  Prevalence and Incidence of Paradoxical Side-effects of TNF-? Inhibitors: A Cross-sectional Study (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3194;    
    Additionally, many patients who were able to restart restarting pegloticase after a prolonged gap in therapy achieved had its expected resulting SU-lowering effect with therapy even after a gap in therapy, although the context for the interruption needs to be further explored. Incidence of PSE per 1000 patient-years was 7.9 (95% CI : 4.4
  • ||||||||||  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.
  • ||||||||||  Tepezza (teprotumumab) / Roche, Amgen
    Rationale for Targeting Insulin-like Growth Factor Signalling in Systemic Sclerosis (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3062;    
    Attenuation of hallmark profibrotic gene and protein signature in explant dermal SSc fibroblasts by teprotumumab is consistent with autocrine or paracrine activation of SSc fibroblasts by IGF1 or IGF2 via IGF1-R.Our findings are consistent with an antifibrotic effect and support clinical evaluation of teprotumumab as a possible therapy in SSc. Figure 1 IGF ligand and receptor levels in SSc or control serum Figure 2 Effect of teprotumumab on protein and mRNA expression in SSc and HC fibroblasts
  • ||||||||||  Tavneos (avacopan) / Kissei, Amgen, Otsuka
    Efficacy and Safety Experience with Avacopan Beyond 52 Weeks in the Early Access Program (EAP) (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2790;    
    These results suggest that continuation of avacopan beyond 52 weeks is generally well-tolerated in patients with GPA and MPA and may be effective in terms of disease control. Limitations of this program include low patient number, potential underreporting, and incomplete data.
  • ||||||||||  Tavneos (avacopan) / Kissei, Amgen, Otsuka
    Avacopan for the Treatment of ANCA-associated Vasculitis. Real World Experience in Spain (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2789;    
    Limitations of this program include low patient number, potential underreporting, and incomplete data. Avacopan, a selective antagonist of C5a receptor, has been approved for the treatment of adult patients with severe and active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in combination with rituximab (RTX) or cyclophosphamide (CF)...eGFR increased 6.1
  • ||||||||||  Tavneos (avacopan) / Kissei, Amgen, Otsuka
    Safety and Efficacy of Avacopan in Patients 65 Years and Older with ANCA-Associated Vasculitis (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2788;    
    D. Jayne: AstraZeneca, 2, Aurinia, 4, Boehringer Ingelheim, 2, Chinook, 2, CSL Vifor, 2, Roche, 2; D. Geetha: Amgen, 2, Aurinia, 2, calliditas, 2, chemocentryx, 2, GlaxoSmithKlein(GSK), 2; C. Pagnoux: AstraZeneca, 1, 2, 6, GlaxoSmithKlein(GSK), 1, 6, Otsuka, 1, 2, 5, 6, Pfizer, 5, Roche, 2; S. Sattui: AstraZeneca, 5, Bristol Myers Squibb Foundation, 5, Rheumatology Research Foundation, 5, Sanofi, 2, 5; P. Merkel: AbbVie/Abbott, 5, Amgen, 2, 5, ArGenx, 2, AstraZeneca, 2, 5, Boehringer-Ingelheim, 2, 5, Bristol-Myers Squibb(BMS), 2, 5, Cabaletta, 2, CSL Behring, 2, Eicos, 5, Electra, 5, Genentech, 5, GlaxoSmithKlein(GSK), 2, 5, HiBio, 2, InflaRx, 2, 5, Janssen, 2, Jubilant, 2, Kyverna, 2, 11, MiroBio, 2, Neutrolis, 5, Novartis, 2, NS Pharma, 2, Q32, 2, Regeneron, 2, Sanofi, 2, Sparrow, 2, Takeda, 2, 5, UpToDate, 9, Visterra, 2.
  • ||||||||||  Tavneos (avacopan) / Kissei, Amgen, Otsuka
    Remission, Glucocorticoid Toxicity, Health-Related Quality of Life, and Safety Outcomes in Patients with Renal Involvement in the Phase 3 Trial of Avacopan for the Treatment of ANCA-Associated Vasculitis (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2787;    
    D. Geetha: Amgen, 2, Aurinia, 2, calliditas, 2, chemocentryx, 2, GlaxoSmithKlein(GSK), 2; F. Cortazar: Amgen, 2, 6, Aurinia, 2, 6, Calliditas, 6, Travere, 2, Valenza Bio, 2; A. Bruchfeld: Amgen, 2, AstraZeneca, 2, 12, Investigator fees, Bayer, 2, ChemoCentryx, 1, 12, Investigator fees, CSL Vifor, 2, 12, Investigator fees, Fresenius, 2, 12, Investigator fees, Merck/MSD, 2, 12, Investigator fees; a. Karras: AstraZeneca, 6, GlaxoSmithKlein(GSK), 4, Novartis, 2, Pfizer, 6; P. Merkel: AbbVie/Abbott, 5, Amgen, 2, 5, ArGenx, 2, AstraZeneca, 2, 5, Boehringer-Ingelheim, 2, 5, Bristol-Myers Squibb(BMS), 2, 5, Cabaletta, 2, CSL Behring, 2, Eicos, 5, Electra, 5, Genentech, 5, GlaxoSmithKlein(GSK), 2, 5, HiBio, 2, InflaRx, 2, 5, Janssen, 2, Jubilant, 2, Kyverna, 2, 11, MiroBio, 2, Neutrolis, 5, Novartis, 2, NS Pharma, 2, Q32, 2, Regeneron, 2, Sanofi, 2, Sparrow, 2, Takeda, 2, 5, UpToDate, 9, Visterra, 2; D. Jayne: AstraZeneca, 2, Aurinia, 4, Boehringer Ingelheim, 2, Chinook, 2, CSL Vifor, 2, Roche, 2.
  • ||||||||||  Tavneos (avacopan) / Kissei, Amgen, Otsuka, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
    Efficacy and Safety of Avacopan in Patients with ANCA-Associated Vasculitis Receiving Rituximab in a Phase 3 Trial (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2785;    
    Compared to the prednisone group, patients in the avacopan group had numerical improvements in remission at week 26, relapse rate, eGFR, albuminuria, and less GC toxicity. There was no increase in serious TEAEs in patients treated with avacopan.
  • ||||||||||  Tavneos (avacopan) / Kissei, Amgen, Otsuka, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
    Avacopan in ANCA-associated Vasculitis Received Intensified Induction Therapy with Cyclophosphamide Plus Rituximab  (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2783;    
    Avacopan appears to favor steroid tapering in severe courses of AAV on combined therapy with cyclophosphamide plus rituximab. However, due to the small number of cases and the retrospective evaluation, the results have to be confirmed by studies with larger number of cases.
  • ||||||||||  Orencia (abatacept) / BMS, Enbrel (etanercept) / Pfizer, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
    Drug Switching Due to Inefficacy in Rheumatoid Arthritis Patients Treated with Biological and Targeted Therapies. Daily Clinical Experience (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2577;    
    We have found higher switching rates of ts/bDMARDs due to inefficacy in the female sex, younger patients, subsequent courses of treatment, concomitant use of corticoids as well as with some ts/bDMARDs in specific (Abatacept and anti-IL6). Patients receiving the third or posterior course of treatment had a higher risk of switching due to inefficacy meanwhile the male sex acted as a protective factor; treatment with abatacept seemed to have a higher risk to switching due to inefficacy but it did not reach statistical significance.
  • ||||||||||  Erelzi (etanercept-szzs) / Sandoz, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / AbbVie
    Outcomes in Patients with Rheumatoid Arthritis Initiating Therapy with Etanercept, Adalimumab, or Janus Kinase Inhibitors (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2560;    
    In this real-world study in patients initiating first-line b/tsDMARD therapy with ETN, ADA, or JAKis, we did not observe differences in clinical effectiveness/patient-reported outcomes and treatment persistency at 6M and 12M after treatment initiation. Patient Description at Time of Initiation and Unadjusted Disease Activity Results Adjusted Mean Differences in Change in Effectiveness and Patient-Reported Outcomes Relative to Etanercept Initiators D. Pappas: AbbVie, 2, 6, CorEvitas, LLC, 3, 8, 11, Corrona Research Foundation, 4, Novartis, 6, Roche Hellas, 2, 6, Sanofi, 1, 6; J. O'Brien: CorEvitas, LLC, 3; L. Guo: CorEvitas, LLC, 3; Y. Shan: CorEvitas, LLC, 3; J. Baker: Bristol-Myers Squibb(BMS), 2, Burns-White, LLC, 2, CorEvitas, LLC, 2, Pfizer, 2; G. Kricorian: Amgen, 3, 11; S. Stryker: Amgen, 3, 11; D. Collier: Amgen, 3, 11.
  • ||||||||||  Olumiant (baricitinib) / Incyte, Eli Lilly, Enbrel (etanercept) / Pfizer, Amgen, Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi
    Molecular Characterization of Biologic and Targeted Synthetic DMARDs Effects Through Ex- vivo Studies in Rheumatoid Arthritis Immune Cells (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2546;    
    The distinctive cellular and molecular changes promoted by TNFi, IL6Ri, and JAKinibs in ex vivo assays of RA immune cells, were consistent with specific altered serum profiles observed in subgroups of active RA patients. Such observations provide compelling evidence regarding the therapeutic potential of each therapy, as it aligns with the specific molecular profile alterations exhibited by individual patients at baseline.
  • ||||||||||  Enbrel (etanercept) / Pfizer, Amgen
    Differential Responses to Initial Treatment Strategies for Rheumatoid Arthritis Among Those with Lower Body Mass and Adiposity (Ballroom 20B-C; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2045;    
    This is the first study, to our knowledge, to identify a meaningful difference between two active strategies based on weight and body habitus and may reflect phenotypic differences or pharmacodynamic effects. The results support earlier escalation to TNFi among thin patients that do not respond to methotrexate and have implications for future clinical trial design.
  • ||||||||||  Actimmune (interferon gamma-1 b) / Clinigen, Amgen
    Development of Engineered Smith-Specific Regulatory T Cells to Treat Lupus Nephritis (Room 26A-B; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1976;    
    HLDA-DR15+Sm+ SLE patient PBMC induced a model of LN, in which Sm-Tregs were therapeutic. Autologous Sm-Treg cell therapy is a promising treatment for LN, and other antigen-specific autoimmune diseases could be similarly targeted.
  • ||||||||||  dazodalibep (HZN-4920) / Amgen
    Dazodalibep, a CD40L Antagonist, in Subjects with Sj (Room 5A-B; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1830;    
    P2
    DAZ-mediated CD40-CD40L blockade in subjects with Sj The results during Stage II provide further evidence of DAZ clinical efficacy in Sj
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Cardiovascular Risk and Fracture Risk Among Women Initiating Treatment with Romosozumab or Denosumab (Room 33A-C; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1790;    
    In this cohort of older women with claims data linked to EHR data, patients with high CV risk were less likely to be given romo compared with dmab. These data suggest that the boxed warning regarding CV risk for romo appropriately influences clinical decision making of physicians when prescribing anabolic medications for osteoporosis patients.
  • ||||||||||  Tavneos (avacopan) / Kissei, Amgen, Otsuka
    Change in Albuminuria in Patients with ANCA-Associated Vasculitis Treated with Avacopan (Ballroom 20D; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1759;    
    The rapid reduction in UACR seen in patients with AAV receiving avacopan suggests more rapid control of glomerular inflammation which may have contributed to the observed subsequent improvement in eGFR. D.