1210 - Golimumabís Efficacy in Patients with Very Active Disease in Methotrexate-naÔve Rheumatoid Arthritis

Monday, November 7, 2011: 9:00 AM-6:00 PM
Hall F2 - Poster Hall (McCormick Place West)
Paul Emery, Chapel Allerton Hospital, Leeds, United Kingdom, R. M. Fleischmann, University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, TX, Elizabeth C. Hsia, Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development, LLC, Malvern, PA, Stephen Xu, Centocor R & D, a division of Johnson & Johnson Pharmaceutical Research & Development, LLC, Weichun Xu, Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development, LLC, Malvern and Daniel G. Baker, Centocor R & D, a division of Johnson & Johnson Pharmaceutical Research and Development, LLC, Malvern, PA
Presentation Number: 1210

Background/Purpose:† To assess golimumab (GLM) treatment effect in patients with rheumatoid arthritis (RA) naÔve to methotrexate (MTX) therapy with severe, active and progressive disease.

Methods: The GO-BEFORE trial studied GLM 50mg and 100mg + MTX in MTX-naÔve 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-naÔve 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)

 

 

 

 

 

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)

 

 

 

 

 

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)

 

 

 

 

 

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)

 

 

 

 

 

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

 


Keywords: methotrexate (MTX) and rheumatoid arthritis (RA)

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 .