StemCell Therapy

June 16, 2017

The studys primary endpoint was an improvement in arthritis signs and symptoms

Janssenannounced results from the Phase 3 study, GO-VIBRANT, evaluatingSimponi Aria(golimumab) for the treatment of active psoriatic arthritis. The results were presented at the 2017 Annual European Congress of Rheumatology (EULAR) in Madrid, Spain.

GO-VIBRANT, a multicenter, double-blind, placebo-controlled trial, evaluated the safety and efficacy of intravenous Simponi Aria in biologic-nave adult patients withactive psoriatic arthritis. Patients (n=480) were randomized to receive Simponi Aria 2mg/kg at Weeks 0, 4, and every 8 weeks thereafter, or placebo at Weeks 0, 4, 12 and 20 with crossover to Simponi Aria at Week 24. The study's primary endpoint was an improvement in arthritis signs and symptoms as measured by the American College of Rheumatology ACR20 response at Week 14. Other endpoints of the trial included ACR50, ACR75, Psoriasis Area Severity Index (PASI 75) and mean change in HAQ-DI scores.

At Week 14, 75.1% of the treatment group achieved ACR20 vs. 21.8% of the placebo group, demonstrating a statistically significant benefit with Simponi Aria (P<0.001). A greater percentage of patients in the treatment arm compared with placebo achieved ACR50 (43.6% vs. 6.3%, respectively), ACR70 (24.5% vs. 2.1%) and PASI 75 (59.2% vs. 13.6%). The Simponi Aria group also experienced greater improvements in HAQ-DI scores from baseline to Week 14 (0.60) than placebo (0.12). All improvements in secondary endpoints with Simponi Aria were statistically significant withP<0.001.

Additionally, at Week 24, treatment with Simponi Aria showed significant inhibition of joint destruction and damage, joint erosion, and joint space narrowing compared to placebo.

Regarding adverse events, 46.3% of patients receiving Simponi Aria and 40.6% of patients receiving placebo reported at least one adverse event. The most common event was infection, which was seen in 20% of Simponi Aria-treated patients. No events of opportunistic infection or tuberculosis were reported throughout Week 24

Simponi Aria is a fully human anti-TNF-alpha monoclonal antibody that selectively targets TNF-alpha, a protein that causes inflammation and damages cartilage, tissue and bones. By inhibiting both soluble and transmembrane TNF-alpha, Simponi Aria helps control inflammation.

Simponi Aria is currently approved for the treatment of adults with moderately to severely active rheumatoid arthritis in combination with methotrexate. It is available as single-use vials containing 50mg golimumab per 4mL of solution.

For more information visit SimponiAria.com.

Read the original here:
Golimumab Significantly Improves Psoriatic Arthritis Symptoms - Monthly Prescribing Reference (registration)

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