Simponi: new addition to TNF inhibitor class

PHARMACOLOGY

Simponi (golimumab) is a monoclonal antibody against tumour necrosis factor (TNF).1 It is administered monthly by subcutaneous injection.

CLINICAL STUDIES

Simponi is licensed for three indications:

• In combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis when the response to DMARDs (including methotrexate) has been inadequate.

Two studies examined the efficacy of golimumab in this setting. GO-FORWARD² enrolled 444 patients who had failed to respond adequately to methotrexate; GO-AFTER³ recruited 461 patients previously treated with another TNF inhibitor. In both studies, participants continued their DMARD treatment (oral methotrexate in GO-FORWARD).

In GO-FORWARD, 55% of the patients treated with 50mg golimumab achieved a 20% or higher American College of Rheumatology criteria for assessment of rheumatoid arthritis (ACR20) response by 14 weeks, compared with 33% of those who received placebo (p=0.001). The corresponding response rates in GO-AFTER were 35% and 18%, respectively (p=0.0006).

• Active and progressive psoriatic arthritis when the response to DMARDs has been inadequate

GO-REVEAL⁴ tested golimumab in 405 patients fitting this description. At week 14, 51% of the patients receiving 50mg dose of the antibody and 9% of patients receiving placebo had achieved an ACR20 response (p<0.001).

• Severe active ankylosing spondylitis when the response to conventional therapy has been inadequate

GO-RAISE⁵ enrolled 356 patients meeting this criterion. After 14 weeks, 59% of patients in the golimumab 50mg group had achieved at least 20% improvement in the Assessment in AS International Working Group Criteria (ASAS20) response compared with 22% of patients in the placebo group (p<0.001).

View Simponi drug record

REFERENCES

1. Simponi Summary of Product Characteristics, July 2010.
2. Keystone E et al. Ann Rheum Dis 2009; 68: 789-96.
3. Smolen JS et al. Lancet 2009; 374: 210-21.
4. Kavanaugh A et al. Arthritis Rheum 2009; 60: 976-86.
5. Inman RD et al. Arthritis Rheum 2008; 58: 3402-12.