PHILADELPHIA—Officials from the U.S. Food & Drug Administration discussed recent drug approvals and drug safety issues at ACR Convergence in November in a session that captured the flurry of activity in the rheumatology sphere at the agency over the past year.
Sabiha Khan, MD, clinical reviewer in the Division of Rheumatology and Transplant Medicine at the FDA, reviewed approvals for new indications, new populations and new dosing regimens for a a variety of drugs for rheumatic conditions.
New Drugs & Indications
Over the past year, the FDA approved several drugs with new indications, including the Janus kinase (JAK) inhibitor tofacitinib for ankylosing spondylitis (AS); the JAK inhibitor upadacitinib for AS, psoriatic arthritis (PsA) and non-radiographic axial spondyloarthritis (nr-axSpA); the monoclonal antibody secukinumab for enthesitis-related arthritis (ERA) in patients 4 years or older; and the monoclonal antibody risankizumab for PsA.
Officials also expanded the PsA indication for secukinumab to patients 2 years or older; the lupus nephritis (LN) indication for belimumab to patients 5 years or older; and the PsA indication for ustekinumab to patients 6 years or older.
Other approvals included the intravenous use of tocilizumab for giant cell arteritis (GCA); baricitinib for COVID-19; pegloticase plus methotrexate for gout; and approvals of biosimilars.
“This has been another busy year,” Dr. Khan said. “The last year has been an exciting year for the division.”
Safety Updates
Raj Nair, MD, clinical team leader in the Division of Rheumatology and Transplant Medicine, reviewed new safety information for several therapies.
Because of better responses seen for co-administration of pegloticase and methotrexate in trials, the FDA approved 8 mg of pegloticase intravenously co-administered with methotrexate every two weeks in adults with chronic gout who are refractory to conventional treatment. Pegloticase can be used alone in patients for whom methotrexate is contraindicated or otherwise inappropriate.
Infusion reactions are more common when pegloticase is used alone—seen in 31% of cases without methotrexate, but seen only in 4% when co-administered with methotrexate.
“There was one case of anaphylaxis in the study,” said Dr. Nair, “and that did occur in the co-administered pegloticase and methotrexate arm, so it’s still important to keep all the precautions when administering this product.”
For risinakizumab in PsA, Dr. Nair noted a slightly elevated occurrence of hepatic events and hypersentivity reactions that were not previously in the prescribing information, but said they were “not considered serious” and there was no drug-induced liver injury seen for risankizumab in the psoriatic arthritis studies.
