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Purpose: Golimumab (GLM), a new human monoclonal anti-TNFα antibody demonstrated efficacy in improving articular and dermatologic manifestation, functional status, and quality of life in pts with psoriatic arthritis (PsA). The effect of GLM on the progression of structural damage in PsA pts is being reported now.
Methods: Adult PsA pts with ³ 3 swollen & ³ 3 tender joints were randomized to receive SC placebo (PBO) or GLM (50 or 100 mg) q4 wks. At wk16, pts with <10% improvement in swollen and tender joint counts entered early escape (EE) in a double-blinded manner to GLM 50 mg (PBO pts) or GLM 100 mg (GLM 50 mg pts). All pts randomized to PBO received GLM 50 mg from wk24 through wk52. Radiographs of the hands and feet were obtained at wk0, wk24, and wk52. Erosions (ERO) and joint space narrowing (JSN) were evaluated by two independent readers unaware of treatment and image time sequence using the van der Heijde-Sharp (vdH-S) method modified for PsA. Changes from baseline in the modified vdH-S scores were compared at wk 24 using ANOVA with pts' baseline MTX usage (Y/N) as a factor in the model based on the van der Waerden normal score (primary endpoint). Wk24 comparisons were between GLM grps and the PBO grp, based on the original randomized grps even for pts who entered EE at wk16. Missing data was imputed using median change from baseline in total vdH-S scores of all pts within the same MTX stratum or by linear extrapolation. Due to lack of adequate control arm, no statistical comparisons were performed at Wk52.
Results: 405 pts were enrolled. Mean age was 46-48 yrs, median swollen/tender joint counts were 12-14/22-24, HAQ scores were 1.0-1.1, CRP levels were 0.6 mg/dL, and total vdH-S scores were 9.00-10.50. At wk24, the GLM 50 mg treatment grp had significantly less radiographic damage than PBO, as measured by the mean change from baseline in total vdH-S score (Table). Significantly more GLM -treated pts (50 mg and 100 mg) had no progression defined as change in total vdH-S score < 0 compared with PBO-treated pts. In a subset of pts without ERO or JSN at baseline, significantly more GLM 50 mg and 100 mg pts maintained an ERO and JSN free state. GLM 50 mg and 100 mg randomized pts had less progression at wk52 (mean change from baseline in total vdH-S score [±SD]: -0.22±1.64 and -0.14±1.53 , respectively)as compared with pts randomized to PBO (0.22±1.38 ) who began treatment with GLM at wk16/24.
Table: Summary of radiographic findings at baseline and wk24
| PBO† | GLM† 50 mg | GLM† 100 mg | |
Baseline total vdH-S score | ||||
N | 111 | 143 | 143 | |
Mean ± SD | 18.15±27. 76 | 23.85±35.41 | 23.37±35.38 | |
Median (IQR) | 9.50(3.00, 20.50) | 10.50(3.50, 28.00) | 9.00(3.00, 26.50) | |
Wk 24 | ||||
Change from baseline in total vdH-S score | ||||
N | 113 | 146 | 146 | |
Mean ± SD | 0.27±1.26 | -0.16±1.31 | -0.02±1.32 | |
Median (IQR) | 0.00(0.00, 0.50) | 0.00(0.00, 0.00) | 0.00(0.00, 0.00) | |
|
| p=0.011 | p=0.086 | |
Pts with change ≤0 in total vdH-S score from baseline | ||||
N | 102 | 132 | 137 | |
| 64 (62.7%) | 104 (78.8%) p=0.007 | 105 (76.6%) p=0.020 | |
Pts with progression based on total vdH-s score >SDC†† | ||||
N | 102 | 132 | 137 | |
| 8(7.8%) | 2(1.5%) | 4(2.9%) | |
|
| p=0.016 | p=0.074 | |
Pts maintaining ERO free state | ||||
N | 102 | 132 | 138 | |
| 73 (71.6%) | 115 (87.1%) p=0.003 | 123 (89.1%) p<0.001 | |
Pts maintaining JSN free state state | ||||
N | 102 | 132 | 138 | |
90 (88.2%) | 128 (97.0%) p=0.008 | 133 (96.4%) p=0.013 | ||
†Includes pts who qualified for EE
†† SDC-smallest detectable change (=2.21)
Conclusions: GLM 50 mg and 100 mg demonstrated inhibition of structural damage in pts with active PsA through wk24 with the maintenance of this benefit through wk52.
Disclosure: A. Kavanaugh, Centocor Research and Development, Inc, 9 ; D. van der Heijde, Centocor Research and Development, Inc, 9 ; D. Gladman, Centocor Research and Development, 9 ; P. Mease, Centocor Research and Development, Inc, 9 ; I. McInnes, Centocor Research and Development, Inc, 9 ; G. G. Krueger, Centocor Research and Development, Inc, 9 ; W. Xu, Centocor Research and Development, Inc., 3 ; M. U. Rahman, Centocor Research and Development, Inc, 3 ; J. Zrubek, Centocor Research and Development, Inc, 3 ; A. Baratelle, Centocor Research and Development, Inc, 3 ; A. Beutler, Centocor Research and Development, Inc., 3 .