However, these evaluations ought to be interpreted with extreme care because of the fairly little inhabitants sizes within the older age ranges. The use of anti-TNF therapy has been associated with an increased risk of infection [21] and an increased risk of some malignancies?compared with the general population [22]. and patients or ?75?years. Results In GO-FURTHER, 592 patients were randomized to receive placebo (values (chi-square test) were generated for comparisons between treatment groups in each age group separately without adjustment for multiplicity. Nonresponder imputation was used for patients who met the treatment failure or early escape criteria. For patients with missing data, last observation carried forward was used for ACR components. Physical function was evaluated using the Health GSK 0660 Assessment Questionnaire-Disability Index (HAQ-DI) [19] and general health-related quality of life (HRQoL) and 36-item Short-Form Health Survey Physical and Mental Component Summary (SF-36 PCS/MCS) scores [20]. ACR response and change in HAQ-DI were determined for weeks 14, 24, 52, and 100; change in SF-36 PCS and MCS scores was determined for weeks 12, 24, 52, and 112. Efficacy analyses were not performed for the higher age cutoffs (70?year and 75?years) due to the small numbers of patients in these groups. Safety events through 2?years were summarized for patients ?65?years or ?65?years, patients ?70?years or ?70?years, and patients ?75 or ?75?years. Results Baseline demographic and disease characteristics The GO-FURTHER study was conducted at 92 sites in 13 countries (Argentina, Australia, Columbia, Hungary, Korea, Lithuania, Malaysia, Mexico, New Zealand, Poland, Russia, Ukraine, and the USA). Patients were randomized to receive placebo plus MTX ((%) or mean??standard deviation, unless otherwise noted American College of Rheumatology, body mass index, cyclic citrullinated peptide, C-reactive protein, disease-modifying anti-rheumatic drugs, health assessment questionnaire-disability index, methotrexate, nonsteroidal anti-inflammatory drugs, rheumatoid arthritis, 36-item Short Form Health Survey Physical/Mental Component Summary, visual analog scale *DMARDs other than MTX were discontinued ?4?weeks prior to the first study agent administration Rabbit Polyclonal to IL15RA Efficacy At weeks 14 and 24, greater proportions of golimumab-treated patients achieved an ACR20 and ACR50 response compared with placebo among patients aged ?65?years and those ?65?years. In addition, greater proportions of golimumab-treated patients achieved an ACR70 response compared with placebo in both age groups; however, the difference between treatment groups did not reach statistical significance among patients ?65?years (Fig.?1). At weeks 52 and 100, when all patients had GSK 0660 been receiving golimumab plus MTX since week 24, GSK 0660 the proportions of patients achieving ACR20, ACR50, and ACR70 responses were similar for patients ?65?years and those ?65?years within each treatment group (Fig.?1). Open in a separate window Fig. 1 Proportions of patients ?65?years and ?65?years achieving ACR20, ACR50, and ACR70 responses at weeks 14 (a, b), 24 (c, d), 52 (e, f), and 100 (g, h). Patients in the placebo group could receive golimumab at week 16 if they met the early escape criteria; all other patients in the placebo group crossed over to golimumab at week 24. Treatment group comparisons were not performed after week 24. ?20%/50%/70% improvement in American College of Rheumatology criteria Mean improvements in HAQ-DI scores were also greater in the golimumab group compared with placebo in patients ?65?years and patients ?65?years at weeks 14 and 24 (Table?2). Mean improvements in SF-36 PCS and MCS scores were greater in the golimumab-treated patients compared with placebo at weeks 12 and 24; however, differences between the treatment groups did not always reach significance among patients ?65?years (Table?2). Among patients ?65?years, mean improvements in HAQ-DI and SF-36 PCS and MCS scores were sustained in the golimumab group through weeks 52 and 100/112, and improvements in the placebo crossover group approached those of the golimumab group at weeks 52 and 100/112. Among patients ?65?years, improvements in HAQ-DI and SF-36 PCS and MCS scores were maintained through week 100/112 in the golimumab group. Patients who crossed over from placebo to golimumab also demonstrated improvements at weeks 52 and 100/112, although these improvements were smaller than those.