3-Year Analysis of Patients Treated with Golimumab

Chicago—In patients with anemia of inflammation due to chronic rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PSA), treatment with golimumab was associated with greater improvements in hemoglobin at 6 months compared with placebo. In addition, a greater proportion of golimumab-treated patients achieved normal hemoglobin at 6 months, and patients who continued golimumab treatment maintained normal hemoglobin levels through 3 years. The results were presented at the ACR meeting in a poster titled Improvement & Maintenance of Hemoglobin Levels Among Rheumatoid Arthritis, Psoriatic Arthritis & Ankylosing Spondylitis Patients with Anemia of Inflammation after Treatment with Golimumab: 3 Year Pooled Analysis. In the study, Daniel E. Furst, MD, professor in the department of rheumatology at the University of California, Los Angeles, and colleagues pooled data from 5 studies in the golimumab rheumatology clinical program to determine the long-term effects of golimumab on anemia of inflammation in patients with RA, AS, and PSA. Previous studies have shown significant improvements in hemoglobin levels among patients with anemia at baseline, particularly those with anemia of inflammation, treated with golimumab for 6 months. The 5 studies included 3 studies for patients with RA and 1 study each for patients with PSA and AS. All 5 studies were phase 3 trials that randomized patients to subcutaneous placebo or golimumab (50 or 100 mg) administered every 4 weeks. Except for 1 trial, all placebo patients crossed over to golimumab (50 mg) at 6 months. After 6 months, 1 year, or 2 years, depending on the trial, patients remaining in the studies entered long-term extension and received golimumab (50 or 100 mg) every 4 weeks. All patients included in the trials were anemic, defined as a hemoglobin level below the age- and sex-specific normal range of the central laboratory (Quintiles Laboratories, Smyrna, GA). These ranges were 11.6 to 16.2 g/dL for women <65 years of age, 11.0 to 16.1 g/dL for women >66 years, 13.0 to 17.5 g/dL for men <65 years, and 12.6 to 17.7 g/dL for men >66 years. Of the 2303 patients pooled from these 5 studies, the majority were female (65.8%), Caucasian (80.8%), had RA (67%), and had disease duration of <3 years (39.1%). Overall, 571 (24.8%) patients also received methotrexate and 1000 (43.3%) received corticosteroids. Pooling the data from these trials, the current study compared hemoglobin levels at 6 months in a subgroup of patients with anemia of inflammation at baseline (defined as anemic and ferritin >60 ng/mL) randomized to placebo with or without methotrexate (n=27) or golimumab with or without methotrexate (n=84). The study found a significantly greater number of patients treated with golimumab achieved normalized hemoglobin at 6 months compared with patients given placebo (65.5% vs 40.7%; P=.023). In addition, golimumab was associated with a significantly greater median hemoglobin improvement compared with placebo (1.45 g/dL vs 0.50 g/dL; P<.001) at 6 months. Examining the long-term maintenance of these improvements, the study found that 58 (93.6%) patients maintained normal hemoglobin at year 1, 59 (96.7%) at year 2, and 53 (93.0%) at year 3. Median hemoglobin levels ranged from 1.8 to 2.0 g/dL. Based on these results, the authors concluded that patients with anemia of inflammation treated with golimumab with or without methotrexate achieved greater improvements in hemoglobin in 6 months that were maintained up to 3 years.