The initial approval of Simponi was based on a 259 patient, comparative clinical trial that demonstrated patients treated with subcutaneous Simponi experienced a significant response to treatment.
Psoriatic arthritis is a condition that stems from psoriasis, an autoimmune disease in which the body’s immune system attacks the skin, resulting in scaly, red patches on the skin. In some psoriasis patients, the immune system attacks the joints as well, leading to inflammation and the condition known as psoriatic arthritis, or PsA. Symptoms of PsA are highly variable among patients, coming and going over time and affecting one or many joints of the body.
Now the results of the GO-VIBRANT study evaluating intravenous Simponi Aria have recently been presented at the EULAR 2017 meeting and published in Arthritis & Rheumatology.
In this clinical trial, 480 PsA patients were treated with either placebo or intravenous Simponi Aria 2 mg/kg (n=241) at weeks 0, 4, 12, and 20. The primary endpoint was a 20% improvement in signs and symptoms of PsA at week 14.
High-level responses were seen at the week 14 evaluations. The ACR20 was 75.1% for Simponi Aria treated patients compared to only 21.8% in the placebo group. A 50% improvement in signs and symptoms (43.6% vs 6.3%), and a 70% improvement in signs and symptoms (24.5% vs 2.1%) were also significantly better. In addition, significant radiographic improvement was also evident in Simponi Aria treated patients.
While these intravenous results appear superior to those obtained with subcutaneously administered Simponi, this was not a head to head clinical trial directly comparing the intravenous and subcutaneous formulations.
Reference: Kavanaugh, A., Husni, M. E., Harrison, D. D., Kim, L., Lo, K. H., Leu, J. H. and Hsia, E. C. (), Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: Results through week 24 of the GO-VIBRANT study. Arthritis Rheumatol. Accepted Author Manuscript. doi:10.1002/art.40226