The Food and Drug Administration (FDA) has approved new labeling for Simponi Aria® (golimumab injection; Janssen) to include language related to fatigue improvement in patients with active psoriatic arthritis and those with moderately to severely active rheumatoid arthritis.
The efficacy and safety of Simponi Aria in patients with psoriatic arthritis were established in a randomized, double-blind, placebo-controlled trial that included 480 adult patients who had active disease despite nonsteroidal anti-inflammatory drug (NSAID) or disease modifying antirheumatic drug (DMARD) therapy.
Simponi Aria was approved for moderately to severely active rheumatoid arthritis based on results from a randomized, double-blind, controlled trial in 592 adult patients who had been receiving methotrexate but had not been treated with a biologic tumor necrosis factor (TNF)-blocker.
In both studies, fatigue was assessed by the Functional Assessment of Chronic Illness Therapy Fatigue score (FACIT-F), which measures self-reported fatigue based on its impact on daily activities and function. Results showed that treatment with Simponi Aria resulted in improvement in fatigue as measured by FACIT-F.
The prescribing information for the product has been updated to include this health related outcome.
Simponi Aria® [prescribing information]. Horsham, PA; Janssen Biotech, Inc. 2021.