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Background/Purpose: To assess golimumab (GLM) treatment effect in patients with rheumatoid arthritis (RA) naïve to methotrexate (MTX) therapy with severe, active and progressive disease.
Methods: The GO-BEFORE trial studied GLM 50mg and 100mg + MTX in MTX-naïve patients. In the overall GO-BEFORE study population, patients exhibited lower disease activity (baseline ACR components and DAS28) than was observed in previous studies of biologic agents in MTX-naive patients1. This is a retrospective analysis of GO-BEFORE wk 52 data which compares efficacy outcomes in subsets of RA patients with severe, active disease to the overall study population. 637 MTX-naïve pts were randomized to PBO+MTX (Grp 1), GLM 100mg+PBO (Grp 2), GLM 50mg+MTX (Grp 3), or GLM 100mg+MTX (Grp 4). GLM/PBO received injections q4wks. Pts with <20% improvement in TJC/SJC at wk28 in Grps 1, 2, and 3 entered early escape to GLM 50mg+MTX, GLM 100mg+MTX, and GLM 100mg+MTX, respectively.(Grp4 had no change). The following baseline disease characteristics were used to define subsets of patients with severe, active, and progressive disease: SJC≥20 and TJC ≥12, EULAR DAS28 CRP >5.1, and CRP ≥3 mg/dL. Treatment effect for each subset and the overall population was defined as the differences between GLM 50mg or 100mg +MTX and MTX-alone in ACR50, DAS28 (CRP) remission, change in HAQ ≥ 0.25 and total vdHS score ≤0. Differences in the treatment effect between each subset of severe, active and progressive RA and the overall population was examined.
Results: Greater proportions of patients achieved the efficacy endpoints in the GLM+MTX groups versus MTX-alone and the difference between the treatment groups (tx effect) was generally larger in the severe, active and progressive subsets compared with the overall population (Table).
Conclusion: Overall, treatment effect in the efficacy parameters between GLM 50mg +MTX and GLM 100mg +MTX versus MTX-alone was greater for the severe, active and progressive subsets versus the overall population.
Table: Treatment effect between golimumab + MTX and MTX-alone at Wk 52 | |||||
| Grp 1* MTX Alone N=160 | Grp 3** GLM 50mg+MTX N=159 | Tx effect Grp 3 vs Grp 1 | Grp 4 GLM 100mg+MTX N=159 | Tx effect Grp 4 vs Grp 1 |
ACR50 %(n/N) |
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All pts | 35.6 (57/160) | 42.1 (67/159) | 6.5 | 48.4 (77/159) | 12.8 |
CRP≥3 | 29.3 (12/41) | 52.4 (22/42) | 23.1 | 48.8 (21/43) | 19.5 |
SJC≥20 and TJC ≥12 | 31.4 (11/35) | 47.7 (21/44) | 16.3 | 44.2 (19/43) | 12.8 |
DAS28 CRP>5.1 | 33.9 (37/109) | 45.6 (52/114) | 11.7 | 43.6 (48/110) | 9.7 |
EULAR DAS28 CRP remission %(n/N) |
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All pts | 26.3 (42/160) | 35.8 (57/159) | 9.5 | 39.6 (63/159) | 13.3 |
CRP≥3 | 14.6 (6/41) | 35.7 (15/42) | 21.1 | 30.2 (13/43) | 15.6 |
SJC≥20 and TJC ≥12 | 11.4 (4/35) | 27.3 (12/44) | 15.9 | 34.9 (15/43) | 23.5 |
DAS28 CRP >5.1 | 18.3 (20/109) | 33.3 (38/114) | 15.0 | 30.9 (34/110) | 12.6 |
HAQ ≥0.25 %(n/N) |
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All pts | 62.5 (100/160) | 65.4 (104/159) | 2.9 | 70.4 (112/159) | 7.9 |
CRP≥3 | 78.0 (32/41) | 85.7 (36/42) | 7.7 | 86.0 (37/43) | 8.0 |
SJC≥20 and TJC ≥12 | 68.6 (24/35) | 75.0 (33/44) | 6.4 | 88.4 (38/43) | 19.8 |
DAS28 CRP >5.1 | 71. 6 (78/109) | 78.1 (89/114) | 6.5 | 82.7 (91/110) | 11.1 |
X-ray vdHS ≤ 0 %(n/N) |
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All pts | 53.9 (76/141) | 71.4(100/140) | 17.5 | 61.2 (85/139) | 7.3 |
CRP≥3 | 34.1 (14/41) | 64.3 (27/42) | 30.2 | 51.2 (22/43) | 17.1 |
SJC≥20 and TJC ≥12 | 34.3 (12/35) | 68.2 (30/44) | 33.9 | 65.1 (28/43) | 30.8 |
DAS28 CRP >5.1 | 52.3 (57/109) | 72.8 (83/114) | 20.5 | 60.0 (66/110) | 7.7 |
*Includes pts who early escape at wk28 to GLM 50 mg +MTX;**Includes pts who early escape at wk28 to GLM 100 mg + MTX; For early escape pts, wk28 value carried forward to wk 52; Last observation carried forward for missing data, and treatment failure rules applied. | |||||
References
1Emery et al. Arthritis&Rheumatism. 2009; 60(8); 2272-2283
Disclosure: P. Emery, Centocor, R and D, a division of Johnson and Johnson Pharmaceutical Research Development, LLC, 2 ; R. M. Fleischmann, Centocor Research and Development, a division of Johnson and Johnson Pharmaceutical Research and Development, L.L.C, 2 ; E. C. Hsia, Centocor Research and Development, a division of Johnson and Johnson Pharmaceutical Research and Development, L.L.C, 3 ; S. Xu, Centocor Research and Development, a division of Johnson and Johnson Pharmaceutical Research and Development, L.L.C, 3 ; W. Xu, Johnson & Johnson, 3 ; D. G. Baker, Centocor Research and Development, a division of Johnson and Johnson Pharmaceutical Research and Development, L.L.C, 3 .