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How can Simponi® help patients like N.E?

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in combination with MTX has shown a good short-term efficacy profile in patients with RA and insufficient response to methotrexate.(efficacy according to DAS28 response).1
In GO-FORWARD, clinically meaningful and statistically significant responses in Disease Activity Scale(DAS) 28 were observed at each prespecified time point, at week 14 and at week 24 (p ≤ 0.001). Among patients who remained on the Simponi treatment to which they were randomised at study start, DAS28 responses were maintained through week 104. Among patients remaining in the study and treated with Simponi, DAS28 responses were similar from week 104 through week 256.2
42.7%
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GO-Forward Study Details4

Objective: The phase III GO-FORWARD study examined the efficacyand safety of golimumab in patients with active rheumatoid arthritis (RA) despite methotrexate therapy.4

Study Design:This was a phase III, multicentre, randomised, double-blind, placebo controlled trial.The study included a double-blind controlled phase to week 52 and an open-label extension up to 5 years.4
Patients who still met the study criteria (n=444) were randomly assigned in a 3 : 3 : 2 : 2 ratio to receive: placebo injections plus methotrexate (group 1), golimumab 100 mg injections plus placebo capsules (group 2), golimumab 50 mg injections plus methotrexate (group 3), or golimumab 100 mg injections plus methotrexate (group 4).4
There were two co-primary endpoints: the proportion of patients achieving an ACR20 response at week 14 (p=0.001) and the improvement from baseline in HAQ-DI score at week 24 (p<0.001).4

Simponi+MTX Reduce the signs and symptoms of RA Slow down the damage to bones and joints Improve physical function.5

RF, Rheumatoid Factor. RA, Rheumatoid Arthritis. MTX, Methotrexate. AE, Adverse Events. TB, Tuberculosis. ACR, American College of Rheumatology response criteria

References:

1- Keystone EC, Genovese MC, Klareskog L, et al; GO-FORWARD Study. Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GOFORWARD Study. Ann Rheum Dis. 2009 Jun; 68 (6) :789-96.
2- Simponi Summary of Product Characteristics. Available on https://www.medicines.org.uk/emc/product/5707/smpc#gref Last Accessed on 24.2.2021.

3- Keystone EC, Genovese MC, Hall S, Bae SC, 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.

4- 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.
5- Ministry of Health Simponi approved insert Leaflet 6-12-2020.

CP-226096