Background/Purpose: There is a paucity of data on the use of anti-TNF therapy in patients >65 years. In this sub-analysis of GO-FURTHER, we compare the safety, efficacy, prednisone use, and discontinuation rates in patients age ≤65 years vs those >65 years through 2 years of treatment with intravenous (IV) golimumab (GLM) plus methotrexate (MTX) in an open-label extension of a Phase III trial of pts with active rheumatoid arthritis (RA) despite MTX therapy.

Methods: In this Phase III, double-blind, randomized, placebo-controlled GO-FURTHER trial, 592 patients with active RA were randomized (2:1) to IV GLM 2 mg/kg plus MTX (Group 1) or placebo (PBO) plus MTX (Group 2) at weeks 0 and 4, then every 8 weeks thereafter. PBO patients crossed over to GLM at week 16 (early escape) or week 24 (crossover by design). The final GLM infusion was at week 100. Assessments included ACR 20/50/70 response criteria. Safety was monitored through week 112.

Results: In total randomized patients, 523 patients aged ≤65 years and 69 patients >65 years were analyzed in the intention-to-treat population with last observation carried forward through week 100. Clinical response by ACR 20/50/70, respectively, was observed in 62%, 34.2%, and 17.5% of those ≤65 years at week 24 (primary endpoint) and was similar (67.9%, 39.6%, and 17%) in those >65 years of age. The ACR response rates were significantly higher (p<0.001) in GLM+MTX group compared with the PBO + MTX group in both age groups. At week 52 and week 100, ACR 20/50/70 values for patients ≤65 years and patients >65 years remained similar to those at week 24 (Table). Mean baseline prednisone dose (mg) was higher in the ≤65 (7.04±2.47) vs the >65 years age group (6.76±2.69). Discontinuation rates were similar among patients aged ≤65 years who received PBO + MTX and GLM + MTX, respectively, at week 24 (2.8% vs 2.9%). Among patients >65 years, discontinuation rates were higher in the GLM + MTX group vs PBO + MTX, respectively, at week 24 (11.3% vs 6.3%). The 2 most common reasons for discontinuation in both age groups for PBO + MTX and GLM + MTX were adverse events and withdrawal of consent.       Serious adverse events (SAEs) were numerically higher in patients aged >65 years (26.4%) vs those ≤65 years (18.7%) with infections, gastrointestinal disorders, and fractures being the most commonly reported events in the >65 years age group.

Conclusion: Clinical response to IV GLM + MTX were significantly higher than PBO + MTX in both age groups and the response was maintained through week 100 in those patients who were ≤65 years and those >65 years. Mean prednisone dose was slightly higher in patients ≤65 years, but prednisone use based on percentage was similar in both groups. SAEs were higher in patients >65 years vs ≤65 years, but no increase in unexpected events was observed in those >65 years. These data suggest IV GLM + MTX treatment in patients >65 years is not associated with loss of clinical response or an increase in unexpected adverse events vs patients ≤65 years.