THE OFFICIAL NEWS SOURCE OF ACR CONVERGENCE 2022 • NOVEMBER 10-14



FDA to provide update about latest treatment approvals

Safety is a constant concern in treating rheumatologic diseases, and new data can impact the risk profile and use of accepted treatments from year to year.


Monday’s FDA Update on Safety Issues in the Treatment of Rheumatic Diseasesession will provide the latest in safety of approved therapeutics used in rheumatology as well as other important developments that could affect rheumatologists and their patients.


“We have been providing a safety update to the ACR for a number of years,” said Rachel Glaser, MD, a Medical Officer in the Food and Drug Administration (FDA) Division of Pulmonary, Allergy & Rheumatology Products. “There are usually a number of noteworthy safety issues from the past year, and 2017 is no different.”


Dr. Glaser will join colleagues from 7:30 – 8:30 am in Room 31 C to present the latest about safety for approved therapeutics used in rheumatology as well as other important developments that could affect rheumatologists and their patients.


Several new agents have received approval for rheumatologic indications in the last year, noted Juwaria Waheed, MD, a Medical Officer in the Division of Pulmonary, Allergy & Rheumatology Products. One of the most notable was the approval of tocilizumab for giant cell arteritis, the first drug specifically approved for this type of vasculitis. Another noteworthy approval is that of abatacept to treat polyarticular juvenile idiopathic arthritis in patients as young as two years of age. 


“We also had two additional biosimilars approved since the last ACR meeting,” Dr. Waheed said. “We also have a number of approvals that we will be touching on. This annual session is a valuable opportunity to make ourselves available to the rheumatology community. This session is a way for us to help the community understand what we do and how we work to improve the safety of rheumatology treatment on a continuing basis.” 


An advisory committee meeting examined the proposed use of tofacitinib for psoriatic arthritis and included discussions of the assessment of radiographic progression. These meetings provide insight into considerations related to drug development in rheumatology. 


External groups led a new series of patient-focused drug development meetings, with the FDA as one of several stakeholder participants.


“These externally led meetings are incredibly useful in giving FDA additional perspective in terms of benefits and risks that matter to patients with specific diseases, including rheumatic diseases,” Dr. Waheed said. “The patient perspective helps give us a better sense of the framework in which we are making regulatory decisions and how we assess endpoints and the things that really matter to patients. That’s really why we do our jobs, to approve products that provide benefits that are important to patients.”


The FDA has also taken other safety steps that could affect rheumatology patients. One of the biggest changes is the recent contraindication of codeine for pain in children younger than 12. The use of codeine has also been limited in older children.


“It is important that practitioners are aware of these changes,” Dr. Glaser said. “It is a very strong safety message from the agency.”


A second broad area of interest is safety during pregnancy. The agency has been removing the familiar letter category classification of A, B, and C for agents used during pregnancy. More recent labeling has reorganized the pregnancy information to a standardized format.


“I will be discussing available pregnancy outcome data for TNF inhibitors,” Dr. Glaser said. “Pregnancy outcomes are something the community is very interested in.


“The reality is that drug approvals and labeling are critical to day-to-day practice for rheumatologists, and the latest information is not always easy to disseminate or communicate. This session is an easy way for practitioners to spend an hour and pick up the safety information that we believe is most important to their practices.”