FDA Update for Rheumatic Disease Drugs Presented at ACR Conference

FDA officials discuss safety data and drug approvals at the American College of Rheumatology Annual Meeting.

A safety update on FDA-approved rheumatic disease therapies was recently presented at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals

Annual Meeting. Since safety data can impact the risk profile and accepted use of therapies, this was a very anticipated session, according to a press release.

During the session, the speakers discussed the latest safety data for drugs approved to treat rheumatologic conditions, in addition to other information that could impact patients and their physicians.

“We have been providing a safety update to the ACR for a number of years,” said Rachel Glaser, MD, a medical officer in the FDA’s Division of Pulmonary, Allergy & Rheumatology Products. “There are usually a number of noteworthy safety issues from the past year, and 2017 is no different.”


Since 2016, multiple new drugs have been approved for rheumatologic conditions. Perhaps the most notable was tocilizumab (Actemra), the first approved drug to treat giant cell arteritis, according to the panelists.

Additionally, abatacept (Orencia) was approved to treat pediatric patients as young as age 2 with polyarticular juvenile idiopathic arthritis.

“We also had 2 additional biosimilars approved since the last ACR meeting,” said Juwaria Waheed, MD, a medical officer in the FDA’s Division of Pulmonary, Allergy & Rheumatology Products. “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.” 


The speakers said that over the last year, an advisory committee examined a proposed indication for tofacitinib in psoriatic arthritis, while also discussing the assessment of radiographic progression. These meetings highlight drug development considerations for rheumatology, according to the session.

External groups also held a number of drug development meetings that centered around patients.

“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 actions that may affect patients with rheumatologic conditions, including the contraindication of codeine for pain in pediatric patients younger than 12, according to the session. This rule may affect pain management for older pediatric patients.

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


Another area of interest is medication safety during pregnancy. The speakers noted that the FDA has been removing category classification of A, B, and C for drugs used during pregnancy and has taken a more standardized approach, according to the session.

“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 speakers concluded that it is crucial for physicians to stay up-to-date on new drug approvals and safety information.

“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,” Dr Glasser concluded. “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.”