Rheumatology diseases affect the musculoskeletal system (i.e., the joints, muscles, bones, tendons, and ligaments). Included in this group are diseases like osteoarthritis, gout, tendonitis, and autoimmune diseases like rheumatoid arthritis (RA) and lupus. Rheumatic disorders are often quite painful and may result in swelling, stiffness, structural deformity, and a significant deterioration in functional mobility and quality of life.
Due to the autoimmune nature of diseases like RA, the field of rheumatology has become an important testing ground for the development of medications designed to interfere with the immune system. As such, a large number of rheumatology drugs approved by the FDA in recent years have been monoclonal antibodies. This class of pharmaceuticals can be difficult to develop in part due to complicated pharmacokinetics and the potential for patients to develop anti-drug antibodies.
Even drugs designed to treat non-autoimmune rheumatic conditions like gout or osteoarthritis can be difficult to characterize due to the compartmentalized nature of the joints. Many of these conditions require drugs to penetrate into the synovial fluid of the joints. In order to properly characterize the drug at the site of action, pharmacokinetic (PK) assessments must be made not only in the plasma but also in the synovial fluid. In addition to these challenges, drug developers often face significant hurdles including heterogeneity in the underlying disease and sometimes wide variability in therapeutic responses.
Because of the many complexities associated with these diseases and the therapies used to treat them, developing rheumatology drugs requires specialized knowledge in the field. Careful planning and conscientious study design are critical. Expertise and experience in clinical pharmacology, pharmacokinetics, PK/PD modeling, and regulatory strategy are also key aspects of a successful rheumatology drug approval.
Nuventra’s Rheumatology Experience
Nuventra can perform any of our wide range of services for drugs to treat Rheumatology indications.
Visit our services page to see our full range of services and to learn more about what our drug development consultants can offer your program.