Simponi Aria(golimumab)

Simponi Aria (golimumab) is an injectable drug approved for use. Efficacy results from clinical trials showed varying ACR 20, 50, and 70 response rates. For instance, ACR 20 response rates ranged from 25% to 63%, ACR 50 response rates from 13% to 35%, and ACR 70 response rates from 3% to 18%. The drug is administered as a 2 mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter.

Notable safety findings include a discontinuation rate due to adverse reactions ranging from 0.5% to 3.5%. The incidence of malignancies (other than lymphoma and NMSC) in the Simponi Aria group was 0.56 per 100-patient-years, with a 95% CI of 0.01 to 3.11. In the placebo group, this incidence was 0 per 100-patient-years (95% CI: 0.00, 3.79). The median time to malignancy in pediatric patients treated with TNF-blockers was 30 months, with a range of 1 to 84 months. The most common adverse reactions had an incidence greater than 3%.

Simponi Aria received approval with BLA Number 125433, Supplement 0014, following a submission date of October 6, 2014, and an original BLA approval date of July 2013. The dosage form is an injection, 50 mg/4 mL (12.5 mg/mL), in each single-use vial.