FDA expands Simponi Aria labeling to include fatigue in RA, PsA
The FDA has approved a label update for Janssen’s golimumab to include language that treatment alongside methotrexate improves fatigue in patients with active psoriatic arthritis and moderately to severely active rheumatoid arthritis.
This label expansion makes golimumab (Simponi Aria) the first TNF inhibitor approved to include fatigue improvement in its labeling, and only the second biologic overall, following the approval of guselkumab (Tremfya, Janssen), an IL-23 inhibitor, in July 2020.
“We were happy to learn that the FDA approved an update to the Simponi Aria label that states improvement in fatigue, as measured by FACIT-F, for adult patients with active PsA and with moderately to severely active RA in combination with methotrexate,” Andrew Greenspan, MD, vice president of United States medical affairs at Janssen Immunology, told Healio Rheumatology. “Simponi Aria is also the only biologic to show improvement in both physical and emotional well-being as measured by physical and mental component summary scores across PsA, RA and [ankylosing spondylitis] based on the 36-item short form health survey (SF-36).”
Often identified as one of the more common symptoms among patients with rheumatic diseases, fatigue also stands out as one of the most important patient-reported outcome measures alongside pain and physical function.
“Many studies confirm what our own members with psoriatic and rheumatoid arthritis tell us — fatigue is incredibly common and impacts a person’s quality of life and their ability to manage their daily activities,” Seth D. Ginsberg, president and co-founder of CreakyJoints and the Global Healthy Living Foundation, told Healio Rheumatology. “A person living with PsA doesn’t know upon waking if fatigue will impact their ability to make or keep plans, attend to their work, or even complete simple household chores. Possibly, it’s the unpredictability of fatigue — feeling great one day and then poorly the next — that makes it one of the more challenging aspects of inflammatory arthritis to manage.”
According to the FDA, the common adverse events reported by patients with RA and PsA treated with Simponi Aria include upper respiratory infection, abnormal liver tests, decreased white blood cells, viral infections, bronchitis, high blood pressure and rash.
“For too long, patients living with conditions like PsA and RA have struggled to not only manage the visible symptoms of their disease, but also the invisible ones like fatigue and mental health,” Greenspan said. “In the case of fatigue, research suggests that it’s one of the most complained-about symptoms among PsA and RA patients, yet there are very few approved treatment options that also address this symptom. We are very pleased by the update to the Simponi Aria product label, as it reinforces Janssen’s 20-year legacy and commitment to patients.”