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Golimumab ( Simponi ), a new tumour necrosis factor-alpha ( TNF-alpha ) blocker reduces the signs and symptoms of rheumatoid arthritis in patients who have previously received any other TNF-alpha inhibitor, and might be a good option for patients who have inadequate responses to one or two other TNF-alpha inhibitors.

Rheumatoid arthritis is a chronic inflammatory disease that affects over three million people in Europe and about 1.3 million in the US. TNF-alpha inhibitors are commonly used to treat rheumatoid arthritis, but 30%-50% of patients treated with these drugs have an inadequate response or are intolerant to this therapy. These patients are often treated with more than one TNF-alpha inhibitor. However, no controlled trials have been done to establish if patients who do not respond to one TNF-alpha inhibitor might benefit from switching to another.

To resolve this uncertainty, Josef Smolen and colleagues undertook the GO-AFTER trial to assess the safety and efficacy of Golimumab in patients with active rheumatoid arthritis who had previously been treated with one or more TNF-alpha inhibitor [ Etanercept ( Enbrel ), Adalimumab ( Humira ), or Infliximab ( Remicade ) ].

In total, 461 patients were recruited from 82 sites in 10 countries and randomised to receive injections of placebo ( n=155 ), 50mg of Golimumab ( n=153 ), or 100mg of Golimumab ( n=153 ) every 4 weeks for 24 weeks. Patients were assessed at week 14 to determine whether they had achieved a 20% or higher improvement in American College of Rheumatology criteria for assessment of rheumatoid arthritis ( ACR 20 ).

Findings showed that significantly more patients on Golimumab achieved at least at a 20% improvement in arthritis symptoms ( ACR 20 ) than those on placebo. 35% of patients on 50mg of Golimumab and 38% of patients on 100mg of Golimumab achieved ACR 20 at week 14, compared to 18% of patients receiving placebo.

Importantly, among the 58% of patients who had discontinued previous TNF-alpha inhibitor treatment due to lack of effectiveness, 36% on 50mg Golimumab and 43% on 100mg Golimumab achieved ACR 20 compared to 18% of patients on placebo.

Up to 24 weeks, serious adverse events were recorded in 14 ( 5% ) of patients on 50mg Golimumab, 8 ( 4% ) on 100mg Golimumab, and 15 ( 10% ) of patients on placebo.

In conclusion, Golimumab reduces the signs and symptoms of active rheumatoid arthritis and improves physical function in patients who had previously received TNF-alpha inhibitors, which suggests that switching patients from one TNF-alpha inhibitor to Golimumab is effective and generally well tolerated.

In an accompanying comment, Yusuf Yazici from NYU Hospital for Joint Diseases in New York discusses whether these findings will affect the way rheumatoid arthritis patients are treated and concludes: For those patients who have failed or had an inadequate response to Adalimumab, Etanercept, Infliximab, or Abatacept (Orencia ), Golimumab might be a good option.

Source: TheLancet, 2009


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