Regional Availability of and Reimbursement Models for Biologic Therapies to Treat RA Patients with Moderate to Severe Disease

Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the musculoskeletal system with typical symptoms including swollen and painful joints, joint
stiffness and loss of function, ultimately leading to disability if untreated. RA also has significant systemic featureRA Patientss in many patients that appreciably impact upon their quality of life, including fatigue and depression. Prevalence varies between 0.3 – 1.0% and is more common in women and in developed countries.1

Modern RA treatment paradigms (i.e. “treat to target”) focus on achieving remission/low disease activity to minimize joint damage and disability. Biologic agents targeting key inflammatory mediators (TNF-alpha, IL-1, IL-6), key cells and activation pathways of the adaptive immune system such as B cells and T cell co-stimulation pathways, have revolutionized the treatment of RA and many other immune-mediated inflammatory diseases (IMIDs), and have rapidly been introduced into accepted treatment paradigms2,3 when earlier disease modifying anti rheumatic disease (DMARD) agents such as methotrexate (and others) are insufficient to reach these target goals. Continue reading

Adjudicating Cardiovascular Endpoints in Diabetic Kidney Disease Studies

Diabetic kidney disease (DKD) patients have an increased cardiovascular (CV) risk in Diabetic Kidney Disease Covance Blogaddition to their increased risk of progression to end-stage renal disease. Recognizing that the FDA and other regulatory agencies have great interest in both the CV and renal safety and efficacy of compounds under development, pharmaceutical companies should consider inclusion of an appropriate approach to adjudication of potential CV events early in the course of planning for development of drugs to treat DKD.

Adapting current regulatory perspectives

From the regulatory perspective, there is a lot of emphasis focused on looking at both CV and renal risks during the development of type 2 diabetes treatments.1  However, no specific guidance exists for clinically-evident endpoints in DKD. Continue reading

New Mechanisms of Action for Disease Modification in RA

Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the musculoskeletal system with typical symptoms including swollen and painful joints, joint stiffness and loss of function, ultimately leading to disability if untreated. RA also produces significant systemic affects such as fatigue and depression that may appreciably impact quality of life for many patients. Prevalence varies between 0.3 – 1.0% and is more common in women and in developed countries.1

Rheumatoid arthritis
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TDAR Assays for In Vivo Assessment and Testing

The immune system is the body’s main defense against foreign materials and biologic agents such as bacteria, viruses, chemicals, and foreign cells and tissues. The immune response includes specific action of lymphocytes (one type of white blood cell) and is facilitated by other white blood cells, including neutrophils, monocytes, macrophages, eosinophils and basophils. The immune system can be viewed as a system controlled by negative feedback, meaning that normally it must reduce the effects of disturbance or invaders through self-regulation.Immune Covance Blog Continue reading

Applying Preclinical Biomarkers to Identify Renal Injuries

Identification of new medicines for kidney disease remains an ongoing challenge in drug Male Kidney Image Covance Blogdevelopment. This challenge includes establishing new biochemical measurements (biomarkers) which can sensitively and accurately reflect the status of renal health and any associated changes in renal function. Sponsors are exploring many options to improve the application of biomarkers in preclinical use in order to better inform early phase safety studies and downstream clinical trials.

Katherine Landschulz, PhD, associate director of the translational biomarker solutions laboratory, and veterinarian pathologist Laura Boone, DVM, PhD, recently shared their experiences working on renal disease studies at Covance. They discussed their insights on how biomarkers are being used in preclinical studies to predict safety and advance translational medicine in drug development.

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The Current Status of Clinical Biomarkers for Diabetic Kidney Disease Progression

Of the 422 million people in the world with type 1 and 2 diabetes, 20-30% will develop diabetic nephropathy, also called diabetic kidney disease (DKD) – the leading cause of renal failure in the western world1.

From the perspective of drug developers, testing new therapies to prevent, treat or reverse this serious complication relies on biomarkers for timely and accurate patient identification and efficacy or safety monitoring.

Jennifer Ennis, MD, medical director at LabCorp and D. Walt Chandler, PhD, executive director at LabCorp, recently shared their thoughts on today’s biomarkers to detect and monitor DKD.

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Charting a Regulatory Course for Diabetic Kidney Disease Treatment

As the diabetic epidemic grows, so does the prevalence of diabetic kidney disease (DKD), a frequent complication of both type 1 and 2 diabetes. Diabetic nephropathy is the leading cause of end-stage renal disease, and despite its global health burden and increased prevalence, no specific regulatory guidelines exist for developing drugs for diabetic renal disease.

Diabetic Kidney Disease Treatment Continue reading

Can You Enhance Your Management and Tracking of Clinical Trial Risks?

Despite expert design and thoughtful planning, all studies will encounter risks and issues. How well these risks and issues are managed directly correlates to how well a Covance Clinial Trial Technologystudy is run. But tracking issues and their mitigating actions can be a cumbersome and inefficient process.

To gather insights about how to solve this ongoing problem, we met with study teams, representatives from multiple functional areas, oversight teams and clients. See how these critical insights were used to design a flexible system centered on operational and quality excellence. Continue reading

Leveraging Real-World Patient Data to Support Recruitment in Diabetic Kidney Disease Studies

Practicing physicians frequently obtain laboratory assessments of kidney function in their routine management of patients with diabetes. Two tests that are commonly performed are the estimated glomerular filtration rate (eGFR) and the urinary albumin toDiabetic Kidney Disease Studies creatinine ratio (ACR). Results of these tests are often used to determine patient eligibility for clinical trials of drugs to treat patients with diabetic kidney disease (DKD).

One challenge that drug developers and clinical trialists face is in choosing eGFR and ACR criteria that support the aims of the clinical study—without hindering recruitment.

To address this issue, researchers at Covance and LabCorp queried a LabCorp database of 329,841 diabetic patients to analyze real-world data. They wanted to understand the distribution of eGFR and ACR values among diabetic patients in the United States and assess how these laboratory parameters predicted renal disease progression.

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Maximizing Real-World Data: Impact of Cardiovascular Disease on Clinical Outcomes in Rheumatoid Arthritis

Current guidance on rheumatoid arthritis (RA) stresses the importance of considering Clinical Outcomes in RAcomorbidity when assessing disease activity and making clinical decisions.1 Comorbidities commonly associated with RA include cardiovascular disease (CVD), lung disease and malignancy.2

The complex relationship between RA and CVD comorbidities

The presence of CVD itself has been shown to increase the risk of death in RA patients by approximately 50%,3 and there is an emerging relationship between RA, CVD and the therapies used to treat them. Continue reading