Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.


Golimumab and Radiographic Progression in Rheumatoid Arthritis: Results of GO-BEFORE and GO-FORWARD Studies

Emery1,  P., Fleischmann2,  R., van der Heijde3,  Désirée M.F.M., Keystone4,  Edward C., Genovese5,  M. C., Conaghan6,  P. G., Hsia7,  E. C.

Univ Leeds, Leeds, United Kingdom
U of Texas Southwest Med Center, Dallas, TX
Leiden University Medical Center, Leiden, Netherlands
Professor of Medicine/University of Toronto, Toronto, ON
Stanford University, Palo Alto, CA
U of Leeds, Leeds, United Kingdom
Centocor R&D, Inc/U of Penn School of Med, Malvern, PA
Centocor R&D, Inc, Malvern, PA
Centocor, Malvern, PA

Purpose:

To evaluate the effect of golimumab (GLM) on radiographic progression in pts with RA.

Methods:

In both GO-BEFORE (MTX-naïve pts; n=637) and GO-FORWARD (MTX-inadequately responding (IR) pts; n=444) pts were randomized to PBO+MTX, GLM 100mg+PBO, GLM 50mg+MTX, or GLM 100mg+MTX. Subcutaneous injections were administered q4 wks. The GO-BEFORE had a control period of 52 wks with early escape [EE] at wk 28 and GO-FORWARD had a control period of 24 wks with EE at wk 16. Pts. in control grps meeting EE criteria start receiving GLM 50 mg + MTX. Radiographs of hands and feet at baseline, wk 24 (wk 16 for EE pts) and wk 52 in GO-FORWARD, and baseline, wk 28, and wk 52 in GO-BEFORE were scored by 2 independent readers and an adjudicator using the van der Heijde -Sharp score (vdHS). Different readers were used for the two trials. Linear extrapolation was used for radiographs taken at EE visits.

Results:

In the MTX-naïve population, vdHS changes from baseline to wk 52 (co-primary endpoint) in both the 50mg and 100mg GLM+MTX grps were significantly lower compared with those in the PBO+MTX grp (Table). In the MTX-IR population, vdHS changes from baseline to wk 24 (primary analysis) were minimal in all grps, preventing any significant effect of GLM to be detected. The proportion of pts with change in vdHS above the smallest detectable change (SDC=2.58 for the study) was 4 % in the PBO+MTX grp. The lack of progression in the PBO grp may have been due to the short placebo-control period (in PBO+MTX gr 32% EE at wk 16 and remaining pts crossed over at wk 24 to receive GLM) and relatively less active pt population (median CRP of 0.9, lower joint counts, lower baseline vdHS scores) than in previously reported trials in similar populations.

Table. Total vdHS for pts in GO-BEFORE and GO-FORWARD

 PBO + MTXGLM 100 mg + PBO50 mgGLM + MTX 100 mgCombined
MTX-naïve (GO-BEFORE)     
Pts randomized160159159159318
Total vdHS     
Baseline     
  Mean ± SD19.71 ± 35.4420.42 ± 30.9018.69 ± 32.3918.22 ± 35.4718.45 ± 33.92
  Median (IQR)5.25 (2.00–18.10)6.00 (2.50–26.50)5.50 (2.00–19.50)6.00 (2.50–18.00)6.00 (2.00–18.00)
Change from baseline to wk 28     
  Mean ± SD1.11 ± 3.880.61 ± 3.550.71 ± 3.770.01 ± 1.470.36 ± 2.88
  Median (IQR)0.0 (0.00–1.00)0.00 (0.00–0.50)0.00 (0.00–0.50)0.00 (0.00–0.50)0.00 (0.00–0.50)
  p value 0.0540.0650.0030.005
Change from baseline to wk 52     
  Mean ± SD1.37 ± 4.561.25 ± 6.160.74 ± 5.230.07 ± 1.830.41 ± 3.93
  Median (IQR)0.00 (0.00–1.50)0.00 (0.00–1.00)0.00 (-0.50–0.50)0.00 (0.00–0.50)0.00 (0.00–0.50)
  p value 0.2660.0150.0250.006
MTX-IR (GO-FORWARD)     
Pts randomized1331338989175
Total vdHS     
Baseline     
  Mean ± SD36.70 ± 52.0637.42 ± 52.4529.67 ± 39.2939.57 ± 56.0934.59 ± 48.49
  Median (IQR)17.50 (1.50–49.50)15.25 (2.50–49.00)9.50 (2.00–49.64)17.00 (3.00–47.00)14.00 (2.50–49.28)
Change from baseline to wk 24     
  Mean ± SD0.55 ± 2.350.27 ± 1.600.6 ± 2.740.23 ± 1.340.41 ± 2.16
  Median (IQR)0.00 (0.00–0.50)0.00 (0.00–0.50)0.00 (0.00–0.50)0.00 (0.00–0.50)0.00 (0.00–0.50)
  p value 0.3610.9530.2930.551
Change from baseline to wk 52     
  Mean ± SD1.10 ± 4.680.89 ± 3.370.93 ± 4.860.15 ± 1.640.54 ± 3.64
  Median (IQR)0.00 (0.00–1.10)0.00 (0.00–1.00)0.00 (0.00–0.50)0.00 (0.00–0.85)0.00 (0.00–0.50)
  p value 0.9670.8550.2210.390
P values for comparisons between GLM and PBO+MTX grps. using an analysis of variance on the van der Waerden normal scores.

Conclusion:

Both GLM 50 + MTX & 100 mg + MTX demonstrated statistically significant and comparable inhibition of radiographic progression in MTX-naïve population compared with MTX alone. In the MTX-IR population the minimal radiographic progression in the MTX alone grp prevented any effect of GLM to be detected.

To cite this abstract, please use the following information:
Emery, P., Fleischmann, R., van der Heijde, Désirée M.F.M., Keystone, Edward C., Genovese, M. C., Conaghan, P. G., et al; Golimumab and Radiographic Progression in Rheumatoid Arthritis: Results of GO-BEFORE and GO-FORWARD Studies [abstract]. Arthritis Rheum 2009;60 Suppl 10 :640
DOI: 10.1002/art.25720

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