In GO-FORWARD clinically meaningful and statistically significant improvements were demonstrated in health-related quality of life as measured by the physical component score of the SF-36 in patients treated with Simponi versus placebo at week 24.1
Among patients who remained on the Simponi treatment to which they were randomised at study start, improvement of the SF-36 physical component was maintained through week 24.1
Among patients remaining in the study and treated with Simponi, improvement of the SF-36 physical component was similar from week 104 through week 256.1
In GO-FORWARD clinically meaningful and statistically significant responses in Disease Activity Score (DAS)28 were observed at each prespecified time point, at week 14 and at week 24 (p ≤ 0.001).1 Among patients who remained on the Simponi treatment to which they were randomised at study start, DAS28 responses were maintained through week 104.1
Among patients remaining in the study and treated with Simponi, DAS28 responses were similar from week 104 through week 256.1
Simponi+MTX Reduce the signs and symptoms of RA Slow down the damage to bones and joints Improve physical function.4
*DAS28-CRP Remission defined as score < 2.6.1
RA, Rheumatoid Arthritis. MTX, Methotrexate. DAS, Disease Activity Score. CRP, C-Reactive Protein . HAQ-DI, Health
Assessment Questionnaire-Disability Index.
1- Simponi 50mg Summary of Product Characteristics. Available on Last Accessed on 5.4.2021.
2- Keystone EC, Genovese MC, Hall S, et al. Safety and Efficacy of Subcutaneous Golimumab in Patients with Active Rheumatoid Arthritis despite Methotrexate Therapy: Final 5-year Results of the GO-FORWARD Trial. J Rheumatol. 2016 Feb; 43 (2) :298-306.
3- Kay J, Fleischmann R, Keystone E, et al. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol. 2016 Dec; 43 (12) :2120-2130.
4- Ministry of Health Simponi approved insert Leaflet 6-12-2020.