Simponi ARIA saw a 20 percent improvement in their joint and skin symptoms 14 weeks into a recent Phase 3 study. By contrast, 21.8 percent of those receiving placebo saw the same result.
The drug “also showed significant improvement across all secondary endpoints evaluating improvements in skin symptoms, joint damage and health-related quality of life measures,” notes Janssen in a press release. The study data was presented for the first time at the 2017 Annual European Congress of Rheumatology in Madrid.
The U.S. Food and Drug Administration is currently reviewing Simponi, an intravenous TNF-inhibitor, for psoriatic arthritis and ankylosing spondylitis patients, per the release. It has already been approved with methotrexate for treatment of patients with moderate to severe rheumatoid arthritis.
The study shows that “treatment with intravenous golimumab improved joint and skin symptoms in patients with active psoriatic arthritis, and inhibited the progression of structural damage, which are important treatment goals in the management of this progressive, inflammatory disease,” said Arthur Kavanaugh, chair of the study steering committee and professor of clinical medicine at UC San Diego School of Medicine, in the release.
“Intravenously administered golimumab could represent an important new anti-TNF-alpha therapy for rheumatologists to consider in the treatment of active psoriatic arthritis in the future,” he added.
By week 14, the group (240 patients) receiving golimumab achieved 50 percent improvement at a rate of 43.6 percent, and 70 percent improvement at a 24.5 percent rate. The placebo group (also 240 patients) showed much less improvement: 6.3 percent achieved ACR50, and 2.1 percent ACR70. Where 59.2 percent percent of the golimumab group achieved a 75 percent psoriasis improvement under the Psoriasis Area Severity Index (PASI), compared to 13.6 percent of placebo-takers.
At 24 weeks, the percentage of the golimumab group achieving ACR50 rose to 53.5, while it remained at 6.3 percent for the placebo group.
[Read more about psoriatic arthritis symptoms.]
