- |||||||||| bicalutamide / Generic mfg.
CARDIOVASCULAR IMPLICATIONS OF BICALUTAMIDE THERAPY FOR PROSTATE CANCER (Moderated Poster Theater 11) - Jan 26, 2024 - Abstract #ACC2024ACC_6439;
Individualized assessment of cardiovascular risk before initiating Bicalutamide is crucial. This case highlights the potential reversibility of adverse cardiac effects through discontinuation of Bicalutamide and the implementation of GDMT.
- |||||||||| Trial completion date: Hormonal Mechanisms of Sleep Restriction - Axis Study (clinicaltrials.gov) - Jan 25, 2024
P1, N=80, Active, not recruiting,
This case highlights the potential reversibility of adverse cardiac effects through discontinuation of Bicalutamide and the implementation of GDMT. Trial completion date: Dec 2023 --> Dec 2024
- |||||||||| Risk of Clostridioides difficile infection in patients with inflammatory bowel disease (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_2005;
For RHEUMA-Bio, the biologics included were infliximab, adalimumab, golimumab, certolizumab, ustekinumab, secukinumab, etanercept, abatacept, tocilizumab, rituximab, guselkumab and ixekizumab...Biologic therapy was not associated with a higher risk of CDI. In IBD patients on biologic therapy, the number of biologics received increased the risk of CDI.
- |||||||||| Immunomodulator and advanced therapies for prevention of clinical relapse and loss of response during maintenance phase in Crohn (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1936;
Tofacitinib was not effective and there was no data available for immunomodulators and combination therapies for this outcome...Conclusion On network meta-analysis immunomodulators and advanced therapies for maintenance phase, combination of anti-TNFs and immunomodulators followed by anti-TNF monotherapy had large effect size with moderate certainty for prevention of clinical relapse. There was moderate to high certainty evidence to suggest newer advanced therapies are effective in prevention of loss of clinical response.
- |||||||||| Eligard (leuprolide acetate) / Tolmar, Sanofi, Firmagon (degarelix) / Astellas, Ferring
Enrollment closed, Enrollment change: Real-life Evaluation of the Effect of ADT in Prostate Cancer Patients in Asia (READT Asia Study) (clinicaltrials.gov) - Jan 23, 2024
P=N/A, N=300, Active, not recruiting,
Elobixibat may have therapeutic benefits in PD patients suffering from chronic constipation. Recruiting --> Active, not recruiting | N=600 --> 300
- |||||||||| Cervidil (dinoprostone) / Ferring
Trial completion date, Trial primary completion date: Gemeprost Versus Dinoprostone in First Trimester Miscarriages (clinicaltrials.gov) - Jan 23, 2024
P2, N=174, Recruiting,
Active, not recruiting --> Completed Trial completion date: Nov 2023 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2025
- |||||||||| Euflexxa (hyaluronic acid) / Ferring
Review, Journal, HEOR: Health Economic Assessments of Hyaluronic Acid Treatments for Knee Osteoarthritis: A Systematic Review. (Pubmed Central) - Jan 19, 2024
The available efficacy and safety data as well as health economic analyses on the use of HA for knee OA management suggest that there are economic benefits of this treatment option. From a healthcare system perspective, the body of HA literature summarizes favorable costs profile, decreased opioid and corticosteroid use as rescue medication, and a delay to the need for TKA in patients who have HA included in their treatment regimen.
- |||||||||| Rebyota (fecal microbiota, live-jslm) / Ferring
Clinical, Retrospective data, Journal, HEOR: Efficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection. (Pubmed Central) - Jan 18, 2024
P3
From a healthcare system perspective, the body of HA literature summarizes favorable costs profile, decreased opioid and corticosteroid use as rescue medication, and a delay to the need for TKA in patients who have HA included in their treatment regimen. Compared to placebo, RBL demonstrated a significantly higher treatment success in preventing further rCDI and enhanced HRQL among patients at first recurrence, establishing RBL as an effective treatment to prevent further recurrences in these patients.
- |||||||||| 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,
Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Nov 2023 --> Mar 2024 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
- |||||||||| Cervidil (dinoprostone) / Ferring
Journal: Comparison of labor duration of induced labor with dinoprostone insert vs spontaneous labor. (Pubmed Central) - Jan 15, 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 Pre-induction with dinoprostone insert and additional foley catheter, if indicated, does not make labor longer in comparison with spontaneous labor.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
Journal: Nadofaragene: a new era of precision medicine for bladder cancer. (Pubmed Central) - Jan 15, 2024
Pre-induction with dinoprostone insert and additional foley catheter, if indicated, does not make labor longer in comparison with spontaneous labor. No abstract available
- |||||||||| Cervidil (dinoprostone) / Ferring
Biomarker, Journal: Predictive Factors for Successful Cervical Ripening among Women with Gestational Diabetes Mellitus at Term: A Prospective Study. (Pubmed Central) - Jan 11, 2024
The purpose of this prospective cohort study is to identify the predictive factors for vaginal delivery among women (n = 146) who underwent cervical ripening using a dinoprostone insert (PG) alone (13.7%), cervical ripening balloon (CRB) alone (52.7%), oral misoprostol (M) alone (4.1%), or repeated methods (R, 29.5%) for gestational diabetes mellitus (GDM) at term, and to analyze maternal and neonatal morbidity outcomes according to the method for cervical ripening...The rates of maternal and neonatal morbidity outcomes were 10.9% (n = 16) and 19.9% (n = 29), respectively, and did not differ according to the mode of delivery and to the method used for cervical ripening. Identifying these specific high-risk women (previous cesarean delivery and internal cervical os being closed before cervical ripening) for cesarean delivery among women who underwent cervical ripening for GDM at term is important and practical for all physicians to make a decision in partnership with women.
- |||||||||| Kepivance (palifermin) / SOBI, Amgen, Firmagon (degarelix) / Astellas, Ferring
Trial completion date, Trial primary completion date: Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - Jan 4, 2024
P2, N=82, Active, not recruiting,
In addition, secondary non-response was more frequent in patients with high RF levels treated with IFX and ADL. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| 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,
However, in cases of extremely immature cervical-ripening, it was feasible to use PGE2 vaginal inserts before mechanical cervical dilatation. Trial completion date: Mar 2027 --> Mar 2028 | Trial primary completion date: Mar 2025 --> Mar 2026
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Novel immunotherapeutic options for BCG-unresponsive high-risk non-muscle-invasive bladder cancer. (Pubmed Central) - Jan 2, 2024
Despite the challenges faced in finding effective therapies, many potential treatments are currently under investigation. Addressing the landscape of biomarkers, mechanisms of progression, BCG resistance, and trial design challenges in HR-NMIBC is essential for the discovery of new targets and the development of effective treatments.
- |||||||||| olamkicept (FE999301) / Ferring, Actemra IV (tocilizumab) / Roche, JW Pharma
Journal: Differential Roles of Interleukin-6 in Severe Acute Respiratory Syndrome-Coronavirus-2 Infection and Cardiometabolic Diseases. (Pubmed Central) - Dec 28, 2023
However, the efficacy of inhibition of IL-6 signaling in metabolic diseases, such as obesity and diabetes, may depend in part on cell type-dependent actions of IL-6 in controlling lipid metabolism, glucose uptake, and insulin sensitivity owing to complexities that remain to be elucidated. The present review sought to summarize and discuss the current understanding of how and whether targeting IL-6 signaling ameliorates outcomes following SARS-CoV-2 infection and associated clinical complications, focusing predominantly on metabolic and cardiovascular diseases.
- |||||||||| 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
- |||||||||| BMS-986253 / BMS, Opdivo (nivolumab) / Ono Pharma, BMS
Phase classification, Trial completion date, Trial primary completion date: Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8) (clinicaltrials.gov) - Dec 22, 2023
P1/2, N=60, Active, not recruiting,
These mimics included drug-induced colitis (n=3), Behcet Phase classification: P1b/2 --> P1/2 | Trial completion date: Dec 2023 --> Jan 2025 | Trial primary completion date: Oct 2023 --> May 2024
- |||||||||| 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.
- |||||||||| MVI-118 / Madison Vaccines
Enrollment change, Trial completion date, Trial primary completion date, Checkpoint inhibition: Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer (clinicaltrials.gov) - Dec 21, 2023
P1/2, N=60, Recruiting,
Boehringer Ingelheim was given the opportunity to review this abstract as a courtesy. N=39 --> 60 | Trial completion date: Apr 2025 --> Dec 2028 | Trial primary completion date: Apr 2025 --> Dec 2026
- |||||||||| 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.
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