Janssen announced 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 ARIA® 2 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 study’s primary endpoint, compared with 21.8 percent of patients receiving placebo (P < 0.001). SIMPONI ARIA® also 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 ARIA® is currently under review by 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 ARIA® is 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 ARIA® at 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
- Among patients receiving SIMPONI ARIA®, 43.6 percent and 24.5 percent achieved a 50 and 70 percent improvement in signs and symptoms (ACR50 and ACR70), respectively, compared with 6.3 percent and 2.1 percent of patients receiving placebo, respectively.
- A greater proportion of SIMPONI ARIA®-treated patients achieved a 75 percent improvement in psoriasis as measured by the Psoriasis Area Severity Index (PASI 75) compared with patients receiving placebo (59.2 percent versus 13.6 percent, respectively).
- Mean improvements in the health assessment questionnaire disability index (HAQ-DI) scores were significantly greater for the SIMPONI ARIA® group compared to the placebo group (0.60 vs 0.12, respectively).
- Change from baseline in the Medical Outcomes Study Short Form-36 questionnaire (SF-36) physical component summary (SF36-PCS) scores and mental component summary (SF36-MCS) scores were significant for the SIMPONI ARIA® group (8.65 and 5.33, respectively) compared to placebo (2.69 and 0.97, respectively). The SF-36 is a general health assessment that evaluates the physical and mental impact of a disease on quality of life. A clinically meaningful improvement is defined as a 5 point increase or greater.
- Among study participants with enthesitis (inflammation of the entheses, the sites where tendons or ligaments attach to bone), mean change from baseline in enthesitis scores were -1.8 for the SIMPONI ARIA® group compared to -0.8 for the placebo group.
- Among study participants with dactylitis (inflammation of the entire finger or toe), mean change from baseline in dactylitis scores were -7.8 for the SIMPONI ARIA® group compared to -2.8 for the placebo group.
At week 24
- Among patients receiving SIMPONI ARIA®, 53.5 percent achieved ACR50 compared with 6.3 percent of patients receiving placebo.
- Analyses of X-rays at week 24 showed significant inhibition of the progression of structural damage in patients receiving SIMPONI ARIA® compared with patients receiving placebo, with a mean change from baseline in total modified van der Heijde Sharp scores (vdH-S) of -0.36 vs. 1.95, respectively. The vdH-S score is an X-ray measure of joint destruction and damage, including joint erosion and joint space narrowing, with higher mean change in scores indicating greater structural damage and lower mean change in scores indicating less structural damage.
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 ARIA® vs. 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 ARIA® group. 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 ARIA® was 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 ARIA® data being presented at EULAR 2017 includes findings from the Phase 3 ankylosing spondylitis GO-ALIVE study:
- Improvements in Sleep Problems and Pain in Patients with Active Ankylosing Spondylitis Treated with Intravenous Golimumab: 28-Week Results
- Safety and Efficacy of Intravenous Golimumab in Adult Patients with Active Ankylosing Spondylitis: Results through Week 28
Filed Under: Drug Discovery