14 Dec Hepatorenal Syndrome-Acute Kidney Injury: Predictors of Response to Terlipressin
As a physician treating patients with difficult conditions like HRS-1, I am committed to continuing to build on decades of research of investigational products like terlipressin that can advance our scientific understanding of potential treatment options for these very sick patients who often rapidly decline and experience significant mortality rates if left untreated.
10 Dec Engensis: Growth-Factor Inducing DNA Evaluated for Severe Diabetic Nerve Pain
In May 2018, the FDA awarded Engensis the special breakthrough designation of RMAT (Regenerative Medicine Advanced Therapy) which is the first time for a pain medication and the first time for any type of medication used to treat a disease that affects a large part of the U.S. population.
10 Dec COVID-19 Impacts Breast Cancer Study Data Acquisition
We look forward to resolution of the COVID-19 pandemic with the future widespread availability of COVID-19 vaccines so that clinical research will be unaffected in the future.
09 Dec Vector-Borne Bartonella Organisms Associated with Skin and Neuropsychiatric Symptoms
MedicalResearch.com Interview with: Ed Breitschwerdt, DVM, DACVIM The Melanie S. Steele Distinguished Professorship in Medicine Professor, Internal Medicine NC State...
01 Dec Similar Frameshift Mutations Identified in Variety of Tumors
These classes of antigens are very immunogenic, can be used potentially for the design of common “off-the-shelf” cancer vaccines and eventually for T cell therapy.
26 Nov Breast Cancer: Cost-Effectiveness of Neoadjuvant-Adjuvant Treatment Strategies
In this study we examined the cost effectiveness of different neoadjuvant followed by adjuvant treatment strategies from a healthcare payer perspective.
18 Nov Study Suggests Gut Microbes Linked to Amyloid Found in Alzheimers Dementia
Posted at 11:24h
in Alzheimer's - Dementia, Author Interviews, Lipids, Mental Health Research, Microbiome
These associations do not prove that Alzheimer’s is caused by an imbalance of microbiota products in the blood, but suggest that the interplay between gut microbes, inflammation and the brain.
![MedicalResearch.com Interview with: Jeffrey D. Kent, M.D., FACG, FACP Executive Vice President, Medical Affairs and Outcomes Research Horizon MedicalResearch.com: What is the background for this study? What is the marker for reduced immunogenicity with Pegloticase? Response: Pegloticase is a recombinant, pegylated uricase that is used for treatment of chronic gout in patients who fail oral urate lowering therapy (uncontrolled gout) and has a demonstrated impact on the serum uric acid (sUA) level. As with other biologics, in some people the body’s immune system develops anti-drug antibodies and reduces the effectiveness of the biologic therapy. Recent case series and open-label trials have suggested that using an immunomodulator with pegloticase has the potential to increase the durability of response so patients can receive a full course of therapy. Researchers in the RECIPE trial sought to examine whether the co-administration of disease-modifying antirheumatic drugs (DMARDs), specifically mycophenolate mofetil, may mitigate this loss of efficacy and increase in response rates for people living with uncontrolled gout MedicalResearch.com: Are symptoms of gout improved as well as reduced infusion reactions? Response Results from this trial indicated that short-term concomitant use of mycophenolate mofetil with pegloticase was generally well tolerated. It was also associated with a statistically significant and clinically meaningful impact on the proportion of patients achieving and maintaining an sUA ≤6 mg/dL at 24 weeks. No infusion reactions were reported in the pegloticase/mycophenolate mofetil arm (0 or 22 patients) compared to 30 percent (3 of 10) of patients reporting infusion reactions in the pegloticase/placebo arm. It’s been well established that in patients receiving pegloticase with persistent urate lowering, they experience relatively rapid resolution of tophi indicating significant reductions in their urate burden. MedicalResearch.com: What are the main findings? Response: This is the first randomized controlled trial evaluating pegloticase co-prescribed with an immunomodulator compared to pegloticase with placebo. Data showed that 86.4 percent of patients (19 of 22) receiving co-therapy of pegloticase with mycophenolate mofetil achieved an sUA ≤ 6 mg/dL through Month 3, the primary study endpoint, compared to 40.0 percent of patients (4 of 10) receiving pegloticase monotherapy. After Month 3, all patients received pegloticase only and at Month 6 a sustained response was shown in 68.2 percent (15 of 22) of patients who had received pegloticase with mycophenolate mofetil versus 30.0 percent (3 of 10) of patients who received pegloticase and placebo. This data adds to the growing body of evidence on the concomitant use of pegloticase with an immunomodulator to ultimately help more patients receive a full course of therapy and improve outcomes and may help shift the treatment paradigm in uncontrolled gout. MedicalResearch.com: What should readers take away from your report? Response: While rheumatologists are familiar with and may use DMARDs for other autoimmune conditions to minimize the development of anti-drug antibodies and increase response to therapies, data shows that the use of an immunomodulating therapy in patients with uncontrolled gout can improve response rates. MedicalResearch.com: What recommendations do you have for future research as a result of this work? Response: There is a consistent pattern demonstrating that the concomitant use of pegloticase and an immunomodulator can improve patient outcomes without introducing additional toxicities. As clinicians we understand the immense burden gout places on our patients. Future research should continue exploring options to maximize the benefit of effective treatments to improve patient outcomes. MedicalResearch.com: Is there anything else you would like to add? Response: Uncontrolled gout is a chronic, systemic inflammatory condition and we continue to see data linking it to many comorbid conditions. Horizon is evaluating the use of methotrexate to improve response rates for pegloticase. We are committed to exploring various immunotherapy co-treatment options to allow both patients and clinicians to address elevated sUA levels to minimize urate burden and avoid lasting damage to the body. RECIPE is an investigator-initiated trial led by Puja Khanna, M.D., M.P.H. and Kenneth Saag, M.D., M.Sc. Citation: Khanna P, Khanna D, Cutter G, Foster J, Melnick J, Jaafar S, Biggers S, Rahman A, Kuo H, Feese M, Saag K. Reducing Immunogenicity of Pegloticase (RECIPE) with Concomitant Use of Mycophenolate Mofetil in Patients with Refractory Gout—a Phase II Double Blind Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/reducing-immunogenicity-of-pegloticase-recipe-with-concomitant-use-of-mycophenolate-mofetil-in-patients-with-refractory-gout-a-phase-ii-double-blind-randomized-controlled-trial/. Accessed November 12, 2020. [subscribe] Last Modified: [last-modified] The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.](https://medicalresearch.com/wp-content/uploads/2020/11/Dr-Jeffrey-Kent.jpg)
12 Nov Use of Pegloticase- KRYSTEXXA® with an Immunomodulator Improves Outcomes in Refractory Gout
There is a consistent pattern demonstrating that the concomitant use of pegloticase and an immunomodulator can improve patient outcomes without introducing additional toxicities.
10 Nov Aggressive Oral Tongue Squamous Cell Carcinoma in Young, Non-Smokers and Non-Drinkers
Young patients diagnosed with oral tongue squamous cell carcinoma without habitual tobacco or alcohol use seem to have a more aggressive phenotype and worse prognosis compared to older patients.
21 Oct Psychiatric Subtypes Identified by AI-Enhanced EEGs
This study generates new evidence in support of a brain imaging biomarker that may help guide people suffering from post-traumatic stress disorder (PTSD) or major depressive disorder (MDD) towards the most effective treatment.
08 Oct TAGRISSO® (osimertinib) in Resected EGFR-Mutated Non–Small-Cell Lung Cancer
These results expand on the proven efficacy of osimertinib in treating central nervous systems metastases in the advanced setting as a result of its ability to penetrate the blood-brain barrier.
21 Sep Minorities At Increased Risk of Cancer Care Disruption During COVID-19
Compared to White patients, Black and Hispanic patients were less likely to utilize telehealth during the pandemic and were also at a disproportionately higher risk of developing COVID-19.
16 Sep Skin Reactions in Children Treated With Targeted Cancer Therapies
The study is reassuring in that no children developed skin cancers while taking these medications.
19 Aug Bisphosphonates: Fragile Broken Bones vs Atypical Fractures
The benefits of bisphosphonates and other osteoporosis treatments, including the reduction of the devastating consequences of hip and other fractures far, far outweigh the risks of atypical fractures.
12 Aug Metabolic Syndrome Can Help Identify Patients Who Benefit Most From PCSK9 Inhibition With Evolocumab – Repatha®
The future study should evaluate the cost-effectiveness of the therapeutic strategy based on presence or absence of metabolic syndrome in patients with ASCVD.
31 Jul FDA Approves Dupixent® (dupilumab) Pre-Filled Pen For All Indications in Patients Aged 12 Years and Older
Dupixent is a biologic therapy that works differently from existing therapies that treat atopic diseases.
08 Jul Age Alone Not A Reason to Withhold Statins in Older Adults
This study provides evidence that statins may prevent death and cardiovascular events in adults aged 75 and over.
24 Jun Does Lowering Uric Acid with Allopurinol Slow Progression of Chronic Kidney Disease?
Our results are complementary to the PERL and FEATHER trials. The totality of evidence suggests that urate-lowering therapy does not prevent progression of CKD.
16 Jun VENETOCLAX-AZACITIDINE FOR PREVIOUSLY-UNTREATED PATIENTS WITH AML
AML is a difficult-to-treat blood cancer and the treatment landscape has not evolved enough in the past three decades, especially for patients who cannot withstand intensive chemotherapy.
15 Jun Biologic Dupixent® Approved for Children with Severe Atopic Dermatitis – Eczema
Dupilumab is a biologic therapy that works differently from existing therapies to address type 2 inflammation – an underlying cause of atopic dermatitis. Dupilumab is the only biologic approved for this pediatric population.
12 Jun Platinum-Sensitive, Recurrent Ovarian Cancer: Trial of Surgery + Chemo With and Without Bevacizumab
These highly effective options combined with the negative impact on overall survival in women undergoing sub-optimal surgery, place a premium on patient selection if it is to be undertaken.
11 Jun Lupus: Highly Targeted Antibody Anifrolumab Reduced Flares in Phase 3 Trials
We observed a reduction in lupus flare rates in those who received anifrolumab during the studies. This is important because each time a flare occurs, the well-being of the patient is compromised.
04 Jun ASCO: Antibody-Drug Conjugate Shows Promise in HER2 Positive Advanced Colorectal Cancer
T-DXd has now been shown to be a powerful therapy for HER2+ advanced CRC after failure of standard therapies and its role in the strategy of treatment of colorectal cancer should be further investigated in earlier lines of therapy.
30 May ASCO20: Prognostic Impact of ESR1 mutations in ER+ HER2- Metastatic Breast Cancer
The key question is how and when to use fulvestrant or the many Selective Estrogen Receptor Degraders (SERDs) currently in development.
19 May CARTITUDE-1 Study Shows Promise in Patients With Refractory Myeloma
These longer-term results from the CARTITTUDE-1 study show the continued treatment benefit of JNJ-4528 in heavily pretreated myeloma patients who have few or no remaining treatment options.
14 May Coronary Calcium Score Can Lead to Cost-Effective Statin Treatment in African Americans
Posted at 15:14h
in Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, Race/Ethnic Diversity, Statins
It is important for African American patients at intermediate risk to discuss their treatment preferences with their physicians when making statin treatment decisions.
13 May KRAS Mutant Cancers: Phase I study RAF-MEK inhibitor and FAK inhibitor defactinib in an intermittent dosing schedule
The Phase 1 regimen with the combination of the two therapies may also have wider implications for other cancers.
11 May Personalized Medicine: Caris Life Sciences Offers DNA and RNA Cancer Profiling
Posted at 19:57h
in Author Interviews
There are essentially no other labs in the world that offer both whole exome (DNA) and whole transcriptome (RNA) testing for every patient and that have the same clinical reach as Caris.
09 May VITRAKVI® (larotrectinib): Outcomes by Prior Treatment & Performance Status in TRK Fusion Cancer Patients
Posted at 11:01h
in AACR, Author Interviews, Biomarkers, Cancer Research, MD Anderson, Pharmaceutical Companies
These data overall demonstrate the importance of testing our patients to identify if they have NTRK gene fusions and may benefit from treatment with larotrectinib.