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Background/Purpose: Previous analyses have shown that treatment with golimumab (GLM) for 6 months resulted in significant improvements in hemoglobin (Hgb) levels among patients with anemia at baseline, particularly for patients with anemia of inflammation. The purpose of this analysis was to determine the long-term effects of GLM on anemia of inflammation in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).
Method: Data through 3 yrs
were pooled from 5 studies in the GLM rheumatology clinical program including: 3 RA studies (GO-BEFORE, GO-FORWARD,
GO-AFTER), 1 PsA study (GO-REVEAL), and 1 AS study (GO-RAISE). Subcutaneous (SC) placebo (PBO) or GLM (50mg or 100mg) was
administered q4wks in the randomized portions of the ongoing Phase3 trials. At
6 months/1 yr, pts remaining in the studies entered long term extensions (LTE)
and received GLM 50mg or 100mg q4wks in an unblinded
fashion. Dose escalation from 50mg to 100mg was allowed; no dose reduction was
permitted. Primary endpoints for the studies compared
patients treated with GLM±MTX with patients receiving placebo (PBO±MTX).
Patients were defined as anemic if their Hgb were below the age- and
sex-specific normal range of the central laboratory (Quintiles Laboratories, Smyrna, GA, United States).
The normal Hgb range for the central laboratory was 11.6 to 16.2 g/dL for women
aged ≤65 yrs, 11.0 to 16.1 g/dL for women aged ≥66 yrs,
13.0 to 17.5 g/dL for men aged ≤65 yrs, and 12.6 to 17.7 g/dL for men
aged ≥66 yrs. A
subset of patients with anemia of inflammation (anemic and ferritin
≥ 60 ng/mL), at
baseline (BL) was analyzed for normalization and improvement of Hgb levels at 6 months; the long-term maintenance of these
improvements were also analyzed at yrs 1, 2, and 3.
Result: At 6 months, among patients
who had anemia of inflammation at baseline, patients treated with GLM±MTX
showed greater Hgb improvements than patients treated with PBO±MTX
(median improvement: 1.45 g/dL vs. 0.55
g/dL, p < 0.001) at 6 months. More GLM±MTX-treated patients achieved normal Hgb
(67.9% vs. 42.3%, p = 0.020). Table 1 shows that 93.0% to 96.7% of these
patients maintained normal Hgb at 1-, 2- and 3 years.
Table 1: Pooled Analysis of Data From GLM Rheumatology Clinical Trials-Maintenance of Normalized Hgb /Improvement From 6 Months to Years 1, 2, and 3 Among Pts With Anemia of Inflammation at BL
| Anemia of Inflammation at BL | Anemia of Inflammation at BL; Median Hgb improvement (g/dL) |
Normalized Hgb at 6 months
| ||
PBO
| 11/27 (40.7%) | 0.55 |
GLM±MTX
| 55/84 (65.5%) | 1.45 |
Maintenance of normalized Hgb*
| ||
Year 1
| 58/62 (93.6%) | 1.9 |
Year 2
| 59/61 (96.7%) | 1.8 |
Year 3
| 53/57 (93.0%) | 2.0 |
At 6 months all patients were receiving GLM (except in GO-BEFORE where all patients were receiving GLM at 1 year) *Of all patients (including PBO- and GLM-treated patients) who had anemia of inflammation at BL and improved at 6 months
| ||
Conclusion: Among patients with RA, PsA and AS with anemia of inflammation at BL, patients treated with GLM±MTX achieved greater median improvements in Hgb and greater proportions had normalized Hgb levels at 6 months. Patients who achieved normal levels at 6 months and continued treatment with GLM, maintained the normal Hgb levels through 3 yrs. These improvements in anemia of inflammation support the hypothesis that anemia of inflammation responds to suppression of inflammation with GLM.
Disclosure: D. E. Furst, Johnson & Johnson, 2 ; T. Gathany, Johnson and Johnson, 3 ; J. Kay, Johnson & Johnson, 2 ; M. C. Wasko, Johnson & Johnson, 2 ; E. Keystone, Johnson & Johnson, 2 ; A. Kavanaugh, Johnson & Johnson, 2 ; A. Deodhar, Johnson & Johnson, 2 ; F. T. Murphy, Johnson & Johnson, 2 ; C. Han, Johnson & Johnson, 3 ; M. K. Doyle, Johnson & Johnson, 3 .