StemCell Therapy

Janssenannounced results from the pivotal Phase 3 GO-VIBRANT study that showed the significant efficacy of the intravenously administered anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI ARIA(golimumab) in the treatment of active psoriatic arthritis. In GO-VIBRANT, 75.1 percent of patients with active psoriatic arthritis receiving SIMPONI ARIA2 mg/kg achieved at least a 20 percent improvement in arthritis signs and symptoms as measured by the American College of Rheumatology (ACR20) at week 14, the studys primary endpoint, compared with 21.8 percent of patients receiving placebo (P< 0.001). SIMPONI ARIAalso showed significant improvement across all secondary endpoints evaluating improvements in skin symptoms, joint damage and health-related quality of life measures. Data from GO-VIBRANT are being presented for the first time at the Annual European Congress of Rheumatology (EULAR) 2017. SIMPONI ARIAis currentlyunder reviewby the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis and the treatment of adults with ankylosing spondylitis. SIMPONI ARIAis approved in the U.S. for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.

Results from the GO-VIBRANT study showed 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, MD, Professor of Medicine, University of California San Diego, and Chair of the GO-VIBRANT steering committee. 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. Treatment with SIMPONI ARIAat weeks 0 and 4 and every eight weeks thereafter resulted in statistically significant improvements in all secondary endpoints presented below (P< 0.001 for all measures).

At week 14

At week 24

Through week 24, 46.3 percent of SIMPONI ARIA-treated patients and 40.6 percent of placebo-treated patients reported at least one adverse event (AE). Serious AEs were reported by 2.9 percent of patients receiving SIMPONI ARIAvs. 3.3 percent for placebo. Two deaths and two malignancies were reported, all in the placebo group, and one demyelinating event occurred in the SIMPONI ARIAgroup. The most common treatment-emergent type of AE was infection, identified in 20.0 percent of SIMPONI ARIA-treated patients compared to 13.8 percent of placebo-treated patients. There was no opportunistic infection or tuberculosis through week 24. The rate of infusion reactions with SIMPONI ARIAwas less than 2 percent and none were serious or severe.

At Janssen, our commitment to rheumatology began more than two decades ago with discovery, development and approval of the first anti-TNF-alpha therapy, and since then, we have continued to build upon our portfolio of medicines for patients with immune-mediated diseases, said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. Data from the GO-VIBRANT study demonstrated how SIMPONI ARIA, a product already helping people living with moderately to severely active rheumatoid arthritis, may also help those living with psoriatic arthritis, pending its approval in the U.S.

Additional SIMPONI ARIAdata being presented at EULAR 2017 includes findings from the Phase 3 ankylosing spondylitis GO-ALIVE study:

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New Phase 3 Data Shows Golimumab Significantly Improved Arthritis and Skin Manifestations in Patients with Active RA - Drug Discovery &...

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