Johnson & Johnson (JNJ) said Friday Tremfya met the primary and major secondary endpoints in a phase 4 study, showing significant improvements in axial symptoms and a reduction in MRI-confirmed inflammation in biologic-naive adults with active psoriatic arthritis and axial involvement.
The primary endpoint assessed improvement in the Bath Ankylosing Spondylitis Disease Activity Index at Week 24 compared with placebo.
Major secondary endpoints included significant improvements in axial symptoms measured by the Ankylosing Spondylitis Disease Activity Score using C-reactive protein and a significant reduction in MRI-confirmed inflammation of the sacroiliac joints.
The safety profile was consistent with previous Tremfya data in PsA, with no new safety signals reported, the company said.