Josef S. Smolen, MD, PhD, Medical University of Vienna, Vienna, Austria, presented data from the GO-AFTER Study (NCT00264550), the first prospective, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of a TNF inhibitor (golimumab) in patients with active rheumatoid arthritis (RA) who were previously exposed to another TNF inhibitor.

In this study, patients with a diagnosis of active RA (ACR criteria, duration ≥3 months; ≥4 tender joints and 4 swollen joints) who had received at least one dose of a biologic TNF-blocker but discontinued treatment for any reason were randomly assigned to receive placebo (n=155) or golimumab 50 mg (n=153) or 100 mg (n=153) subcutaneously every 4 weeks. Patients could continue to receive stable doses of methotrexate, sulfasalazine, and/or hydroxychloroquine if they were receiving them at baseline. The primary study endpoint was the proportion of patients who achieved ACR20 at Week 14.

Patients were predominately women who had a median age of 55 years and median disease duration of 8.65 to 9.80 years. Two-thirds (66%) of patients had received one anti-TNF agent, 25% had received 2, and 9% had received 3. Prior anti-TNF therapy had been discontinued due to lack of efficacy in 58% of patients.

At Week 14, significantly (p<0.001) more patients who were treated with golimumab achieved ACR20 versus placebo-treated patients. These results essentially were maintained at Week 24. Golimumab also was significantly more effective than placebo in the subgroup of patients whose prior anti-TNF-alpha therapy had been discontinued due to lack of efficacy (36% golimumab 50 mg and 43% golimumab 100 mg vs 18% placebo; p=0.006 and p<0.001, respectively).

The percentage of patients who achieved ACR50 and ACR70 at Week 24 was significantly higher (p≤0.01) with golimumab versus placebo (18.3% and 20.3% vs 5.2% and 11.8% and 10.5% vs 3.2%; ACR50 and ACR70, golimumab 50 mg and 100 mg vs placebo, respectively). These results are similar to those that were seen in trials that included other biologics and methotrexate [Genovese MC et al. New Engl J Med 2005; Cohen SB et al. Arthritis Rheum 2006].

Golimumab was generally well tolerated (Table 1) and demonstrated a safety profile that was similar to other anti-TNF agents. Antibodies to golimumab were detected in 3.0% of golimumab-treated patients.

“Our findings show that golimumab holds great promise in various RA patient populations, including those patients who have previously discontinued other TNF inhibitors,” said Prof. Smolen.