Is golimumab safe and effective in rheumatoid arthritis patients who have previously taken anti-TNF therapy?

This study examined whether golimumab (Simponi) is safe and effective in rheumatoid arthritis patients who have previously used anti-tumor necrosis factor therapy.

Anti-tumor necrosis factor (TNF) therapy (Humira, Enbrel, Remicade and Cimzia) is used to treat patients who have a severe form of rheumatoid arthritis (RA). Patients taking anti-TNF therapy continuously may achieve remission (no signs or symptoms of disease). In patients who stop taking anti-TNF, it is possible that they will relapse (return of signs and symptoms).

Golimumab (Simponi) is a drug which also belongs to the class of anti-TNF. Its long-term effectiveness and safety in patients who have previously taken anti-TNF is currently unknown.

This study involved 461 RA patients who received a placebo (a substance with no therapeutic effect) or golimumab. Participants received golimumab injections every 4 weeks. 66% of participants were also receiving treatment with methotrexate (Trexall). Patients were followed over a 5 year period.

42.3% of patients receiving golimumab saw a 20% improvement in RA symptoms over 5 years. 29.9% of patients saw a 50% improvement. 8.5% of patients achieved remission after 5 years. Patients receiving golimumab in combination with methotrexate were more likely to respond to treatment.

Side effects included infections of the respiratory (breathing) tract, nausea, headache and cough. After 5 years, the safety profile of golimumab was similar to the safety profile at 24 weeks and 160 weeks of use. The safety profile of golimumab was similar the safety profile of other anti-TNF therapies. 

This study concluded that golimumab is safe and effective for long-term use in rheumatoid arthritis patients who have discontinued previous use of anti-TNF alpha inhibitors.

This study was limited by the small size of the placebo group (2 patients). After 16 weeks, patients in the placebo group could switch to one of the two groups receiving golimumab. There was no placebo group present after 24 weeks. 

Consult your physician regarding the risks and benefits of golimumab.