for active psoriatic arthritis — prevention of further joint damage
FDA approved a supplemental BLA expanding Tremfya's label to include prevention of further joint damage in adults with active psoriatic arthritis, based on data showing slowed structural damage progression. Cements Tremfya as the only IL-23 inhibitor with this specific labelling claim.
Psoriatic arthritis is a chronic inflammatory joint disease that affects about 30% of people with psoriasis and can progressively damage joints if left untreated. Tremfya is a lab-made antibody that blocks interleukin-23, an immune signal that drives the inflammation behind this joint damage. By interrupting that signal, the drug may calm the inflammation that erodes joints, potentially helping slow further structural damage in people with active psoriatic arthritis.
The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Source: ClinicalTrials.gov