OARSI white paper on burden of OA submitted to FDA drives home seriousness of disease

Leadership of Osteoarthritis Research Society International recently submitted a white paper entitled, “Osteoarthritis: A serious disease,” to the FDA to garner greater attention of the FDA, policy makers and other regulatory agencies to the work that remains to be done to identify effective therapies for osteoarthritis.

The main argument of the Osteoarthritis Research Society International (OARSI) paper, which was developed by the Pre-competitive Consortium for Osteoarthritis (PCCOA) of OARSI, is that osteoarthritis (OA) is a serious condition, according to the OARSI website. The 103-page paper includes a discussion on the burden of OA from the patient perspective and reviews the epidemiology, symptoms and related disability of OA, its association with increased morbidity and comorbidity risks, and other topics. It also mentions interventions or therapies available to halt OA disease progression or manage pain and loss of mobility.

The submission was not in response to a call for information from the FDA, but resulted from a decision OARSI leaders made to advocate for patients with OA “with the hope of encouraging ongoing drug development to move toward finding a disease-modifying drug therapy for one of America’s most common disabling conditions,” Lyn March, MD BS, MSc, PhD, co-chair of the PCCOA writing group, told Healio Rheumatology.

OA is a common disease, but, she said, a high bar has been set for it in terms of a treatment that does not increase the risk of serious side effects, that can modify the course of the disease, relieve symptoms and possibly reduce the need for joint replacement surgery.

“Companies are shying away from development of drugs for OA and the OA clinicians, researchers and people living with arthritis were concerned that no further development would occur,” March, who is professor of medicine and public health in the Institute of Bone and Joint Research at Sydney Medical School in Sydney, Australia, said.

With the identification of some early markers in blood, bone, joint fluid and tissue, and cartilage that may predict which patients will need joint replacement in the future, OARSI also hopes the acceptance of such predictors of OA “might shorten the pathway and enable the clinical trial program for new drugs to be more practical and less costly,” according to March. – by Susan M. Rapp

Reference:

www.oarsi.org/sites/default/files/docs/2016/oarsi_white_paper_oa_serious_disease_121416_1.pdf

Disclosures: March reports that she received no personal remuneration for completion of the report. In the past 5 years, she received speaker’s fees and consultancy payments from Servier, Pfizer and Regeneus. Her department received funding from OARSI for contribution to a post-doctoral fellow’s salary to help write the report.