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.

References:

1- Simponi 50mg Summary of Product Characteristics. Available on https://www.medicines.org.uk/emc/product/5707/smpc#gref 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.

CP-226105