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SIMPONI ARIA®

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SIMPONI ARIA® (golimumab)

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SIMPONI ARIA - Treatment of Rheumatoid Arthritis

Last Updated: 01/28/2025

Summary

  • Please refer to the US Prescribing Information for SIMPONI ARIA regarding the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
  • The efficacy and safety of SIMPONI ARIA for the treatment of patients with active RA despite methotrexate (MTX) therapy were evaluated in 2 phase 3, randomized, double-blind, multicenter, placebo-controlled studies (GO-LIVE and GO-FURTHER).1,2
  • In the GO-LIVE study, a 50% improvement according to the American College of Rheumatology criteria (ACR50) was achieved in 21.4% of patients in the combined SIMPONI ARIA + MTX group at week 14 compared to 13.2% of patients in the placebo + MTX group (primary endpoint; P=0.051). Through week 48, adverse events (AEs) were reported in 81.6% of all SIMPONI ARIA-treated patients and 72.1% of placebo-treated patients. Infections were the most commonly reported AEs (47.9% of SIMPONI ARIA-treated patients vs 41.1% of placebo-treated patients).1
  • In the GO-FURTHER study, a 20% improvement according to the American College of Rheumatology criteria (ACR20) was achieved in 58.5% of patients in the SIMPONI ARIA + MTX group at week 14 compared to 24.9% of patients in the placebo + MTX group (primary endpoint; P<0.001). At week 24, the proportion of patients who developed AEs was similar between the combined SIMPONI ARIA + MTX (52.9%) and the placebo + MTX groups (49.2%).2

CLINICAL DATA

Phase 3 - GO-LIVE

Kremer et al (2010)1,3 assessed the efficacy and safety of SIMPONI ARIA in patients with active RA (≥4 tender and swollen joints, plus at least 2 of the following: 1) C-reactive protein [CRP] ≥1.5 mg/dL or erythrocyte sedimentation rate [ESR] ≥28 mm/hour, 2) morning stiffness ≥30 minutes, 3) bone erosions, or 4) rheumatoid factor [RF] or anti-cyclic citrullinated peptide [CCP] positivity) despite treatment with MTX in a phase 3, randomized, double-blind, multicenter, placebo-controlled study. Further, patients had to be treated with MTX for ≥3 months before screening, including treatment at a stable dose (15-25 mg/week) for ≥4 weeks.

Study Design/Methods

  • A total of 643 adult RA patients were randomized to intravenous (IV) infusions of placebo + MTX (n=129), SIMPONI ARIA 2 mg/kg (n=128), SIMPONI ARIA 4 mg/kg (n=129), SIMPONI ARIA 2 mg/kg + MTX (n=129), or SIMPONI ARIA 4 mg/kg + MTX (n=128) every 12 weeks through week 48. IV infusions were administered at weeks 0, 12, 24, 36, and 48.
  • Patients were permitted to continue stable doses of oral corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDs). Previous but not current anti-tumor necrosis factor (TNF) therapy was also permitted with appropriate washout (infliximab washout period ≥3 months; etanercept or adalimumab washout period ≥2 months).
  • Patients who had <20% improvement from baseline in both swollen and tender joint counts were eligible to enter early escape at week 16 or have a dose regimen adjustment at week 24 in a blinded manner.
  • Patients who completed the week 48 infusion were eligible to continue in an open-label long-term extension (LTE) with golimumab 50 mg subcutaneously every 4 weeks for an additional 24 weeks (LTE weeks 0-24) beginning 12 weeks after the last IV infusion. Patients were followed for an additional 16 weeks for safety evaluations (LTE weeks 24-40).
  • The primary endpoint included the proportion of patients achieving ACR50 at week 14.

Results

Patient Characteristics
  • The mean ages ranged from 48.4-50.2 years with disease duration ranging from
    7.4-9.4 years.
  • Prior to study participation, approximately 5% of patients had received infliximab (n=36), etanercept (n=29), and/or adalimumab (n=36).
  • A total of 565 patients completed the primary study. Of these, 508 entered the LTE.
Efficacy

Summary of Efficacy Results at Weeks 14, 24, and 481,4
 
PBO + MTX
SIMPONI ARIA
SIMPONI ARIA + MTX
2 mg/kg
4 mg/kg
Combineda
2 mg/kg
4 mg/kg
Combinedb
Patients randomized
129
128
129
257
129
128
257
Week 14
   ACR50 (primary endpoint)
      n (%)
P-value
17 (13.2%)
16 (12.5%)
P=0.872
25 (19.4%)
P=0.175
41 (16.0%)
P=0.465
28 (21.7%)
P=0.073
27 (21.1%)
P=0.093
55 (21.4%)
P=0.051
   ACR20
      n (%)
P-value
36 (27.9%)
51 (39.8%)
P=0.043
62 (48.1%)
P<0.001
113 (44.0%)
P=0.002
71 (55.0%)
P<0.001
66 (51.6%)
P<0.001
137 (53.3%)
P<0.001
   ACR70
      n (%)
P-value
6 (4.7%)
5 (3.9%)
P=0.769
6 (4.7%)
P=0.987
11 (4.3%)
P=0.875
9 (7.0%)
P=0.420
7 (5.5%)
P=0.763
16 (6.2%)
P=0.524
   DAS28 (CRP) response, moderate/good
      n (%)
P-value
56 (43.4%)
78 (60.9%)
P=0.005
86 (66.7%)
P<0.001
164 (63.8%)
P<0.001
88 (68.2%)
P<0.001
94 (73.4%)
P<0.001
182 (70.8%)
P<0.001
   SF-36 PCS
      Mean (median) change
      P-value
4.3 (3.4)
4.0 (2.8)
P=0.738
5.1 (3.3)
P=0.788
4.6 (3.0)
P=0.996
6.9 (6.0)
P=0.014
6.8 (6.3)
P=0.014
6.8 (6.1)
P=0.005
Week 24
   ACR20
      n (%)
P-value
32 (24.8%)
29 (22.7%)
P=0.687
38 (29.5%)
P=0.406
67 (26.1%)
P=0.787
48 (37.2%)
P=0.032
64 (50.0%)
P<0.001
112 (43.6%)
P<0.001
   ACR50
      n (%)
P-value
12 (9.3%)
11 (8.6%)
P=0.844
15 (11.6%)
P=0.540
26 (10.1%)
P=0.795
24 (18.6%)
P=0.032
32 (25.0%)
P<0.001
56 (21.8%)
P=0.002
   ACR70
      n (%)
P-value
4 (3.1%)
4 (3.1%)
P=0.990
8 (6.2%)
P=0.236
12 (4.7%)
P=0.463
8 (6.2%)
P=0.240
10 (7.8%)
P=0.097
18 (7.0%)
P=0.120
   DAS28 (CRP) response, moderate/good
      n (%)
P-value
47 (36.4%)
41 (32.0%)
P=0.458
61 (47.3%)
P=0.080
102 (39.7%)
P=0.535
70 (54.3%)
P=0.004
82 (64.1%)
P<0.001
152 (59.1%)
P<0.001
Week 48
   ACR20
      No EE/DRAc
      % (n/Total)

71.4% (5/7)

50.0% (31/62)

51.4% (37/72)

50.7% (68/134)

67.0% (59/88)

70.4% (69/98)

68.8% (128/186)
      EE and/or DRAd
      % (n/Total)

56.5% (61/108)

40.9% (18/44)

52.3% (23/44)

46.6% (41/88)

25.9% (7/27)

31.3% (5/16)

27.9% (12/43)
   ACR50
      No EE/DRAc
      % (n/Total)

71.4% (5/7)

24.2% (15/62)

2.2% (16/72)

23.1% (31/134)

36.4% (32/88)

48.0% (47/98)

42.5% (79/186)
      EE and/or DRAd
      % (n/Total)

28.7% (31/108)

11.4% (5/44)

22.7% (10/44)

17.0% (15/88)

14.8% (4/27)

6.3% (1/16)

11.6% (5/43)
   ACR70
      No EE/DRAc
      % (n/Total)

28.6% (2/7)

12.9% (8/62)

11.1% (8/72)

11.9% (16/134)

11.4% (10/88)

17.3% (17/98)

14.5% (27/186)
      EE and/or DRAd
      % (n/Total)

6.5% (7/108)

4.5% (2/44)

6.8% (3/44)

5.7% (5/88)

3.7% (1/27)

6.3% (1/16)

4.7% (2/43)
   DAS28 (CRP) response, moderate/good
      No EE/DRAc
      % (n/Total)

100.0% (7/7)

67.7% (42/62)

73.5% (50/68)

70.8% (92/130)

82.8% (72/87)

86.7% (85/98)

84.9% (157/185)
   SF-36 PCS
      No EE/DRAc
      Mean (median) change

9.3 (7.2)

6.8 (9.2)

5.4 (3.0)

6.0 (5.6)

8.7 (8.4)

9.5 (8.8)

9.1 (8.5)
All P-values are vs PBO + MTX.
Abbreviations: ACR20, 20% improvement according to the American College of Rheumatology criteria; ACR50, 50% improvement according to the American College of Rheumatology criteria; ACR70, 70% improvement according to the American College of Rheumatology criteria; CRP, C-reactive protein; DAS28, Disease Activity Score in 28 joints; DRA, dose regimen adjustment; EE, early escape; MTX, methotrexate; PBO, placebo; SF-36 PCS, Short Form-36 Physical Component Summary.
aCombined includes patients receiving SIMPONI ARIA 2 mg/kg or 4 mg/kg.
bCombined includes patients receiving SIMPONI ARIA 2 mg/kg or 4 mg/kg + MTX.
cIncludes patients who did not enter EE at week 16 and did not have a DRA at week 24.
dIncludes patients who entered EE at week 16 and/or had a DRA at week 24.
Safety
  • A total of 3 patients died through week 48: 1 each in the SIMPONI ARIA 2 mg/kg group, SIMPONI ARIA 4 mg/kg group, and the SIMPONI ARIA 4 mg/kg + MTX group. Two additional deaths (1 in the SIMPONI ARIA 2 mg/kg group and 1 in the SIMPONI ARIA 2 mg/kg + MTX group) were reported after week 48.
  • Eight malignancies were reported in patients receiving SIMPONI ARIA, 1 in the SIMPONI ARIA 2 mg/kg group, 2 in the 4 mg/kg group, 1 in the 2 mg/kg + MTX group, and 4 in the 4 mg/kg + MTX group.
  • Antibodies to golimumab were detected in 7% (43/613) of patients with evaluable samples through week 48. Of note, through week 48, concomitant use of MTX was associated with a lower incidence of antibodies to golimumab.

Summary of Safety Results through Week 16 (Placebo-Controlled Phase) and Week 48 (Including Early Escape and Dose Regimen Adjustments)1
Outcome
PBO + MTX
IV GLM
IV GLM + MTX
All IV GLMc
2 mg/kg
4 mg/kg
Combineda
2 mg/kg
4 mg/kg
Combinedb
Week 16 (placebo-controlled phase)
Patients treated
129
129
130
259
128
126
254
513
Patients
   with ≥1
   AE, n (%)
87
(67.4%)
83
(64.3%)
80
(61.5%)
163
(62.9%)
87
(68.0%)
89
(70.6%)
176
(69.3%)
339
(66.1%)
   Patients
   with ≥1
   SAE, n (%)
2
(1.6%)
8
(6.2%)
2
(1.5%)
10
(3.9%)
5
(3.9%)
5
(4.0%)
10
(3.9%)
20
(3.9%)
Patients
   with ≥1
   infection,
   n (%)
43
(33.3%)
38
(29.5%)
40
(30.8%)
78
(30.1%)
39
(30.5%)
51
(40.5%)
90
(35.4%)
168
(32.7%)
   Patients
   with ≥1
   serious
   infection,
   n (%)
1
(0.8%)
6
(4.7%)
0
(0.0%)
6
(2.3%)
2
(1.6%)
2
(1.6%)
4
(1.6%)
10
(1.9%)
   Patients
   with ≥1
   IR, n (%)
7
(5.4%)
8
(6.2%)
3
(2.3%)
11
(4.2%)
6
(4.7%)
3
(2.4%)
9
(3.5%)
20
(3.9%)
   Infusions
   with ≥1
   IR,
   n/Total (%)
7/252
(2.8%)
9/252
(3.6%)
3/257
(1.2%)
12/509
(2.4%)
7/254
(2.8%)
3/251
(1.2%)
10/505
(2.0%)
22/1014
(2.2%)
Week 48 (including early escape and dose regimen adjustments)
   Patients
   treated
129
128
127
254
182
334
468
626
   Patients
   with ≥1
   AE, n (%)
93
(72.1%)
99
(77.3%)
99
(78.0%)
198
(78.0%)
135
(74.2%)
245
(73.4%)
358
(76.5%)
511
(81.6%)
   Patients
   with ≥1
   SAE, n (%)
7
(5.4%)
12
(9.4%)
6
(4.7%)
18
(7.1%)
18
(9.9%)
27
(8.1%)
45
(9.6%)
63
(10.1%)
   Patients
   with ≥1
   infection,
   n (%)
53
(41.1%)
56
(43.8%)
53
(41.7%)
109
(42.9%)
66
(36.3%)
139
(41.6%)
199
(42.5%)
300
(47.9%)
   Patients
   with ≥1
   serious
   infection,
   n (%)
2
(1.6%)
7
(5.5%)
1
(0.8%)
8
(3.1%)
4
(2.2%)
11
(3.3%)
15
(3.2%)
23
(3.7%)
   Patients
   with ≥1
   IR, n (%)
7
(5.4%)
8
(6.3%)
5
(3.9%)
13
(5.1%)
8
(4.4%)
5
(1.5%)
13
(2.8%)
26
(4.2%)
   Infusions
   with ≥1
   IR,
   n/Total (%)
7/357
(2.0%)
10/519
(1.9%)
6/540
(1.1%)
16/1059
(1.5%)
11/606
(1.8%)
6/1045
(0.6%)
17/1651
(1.0%)
33/2710
(1.2%)
Data through week 48 are presented by actual treatment received, with AEs being attributed to the treatment received at the time of the event. Therefore, some patients are included in more than 1 column.
Abbreviations: AE, adverse event; GLM, golimumab; IR, infusion reaction; IV, intravenous; MTX, methotrexate; PBO, placebo; SAE, serious adverse event.
aCombined includes patients receiving SIMPONI ARIA 2 mg/kg or 4 mg/kg.
bCombined includes patients receiving SIMPONI ARIA 2 mg/kg or 4 mg/kg + MTX.
cIncludes patients receiving SIMPONI ARIA with or without MTX.

Phase 3 - GO-FURTHER

Weinblatt et al (2012)2,5-7 conducted a phase 3, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of SIMPONI ARIA in patients with active RA (≥6/66 swollen joints, ≥6/68 tender joints, CRP ≥1.0 mg/dL, RF and/or anti-CCP antibody positivity) despite stable MTX treatment (≥4 weeks at 15-25 mg/week) for at least 3 months.

Study Design/Methods

  • A total of 592 patients were randomized to 1 of 2 treatment groups: SIMPONI ARIA 2 mg/kg + MTX (n=395) or placebo + MTX (n=197). Infusions were administered at weeks 0, 4, and every 8 weeks thereafter through week 100.
  • At week 16, nonresponders (<10% improvement from baseline in both tender and swollen joint counts) in the placebo group entered early escape to receive SIMPONI ARIA 2 mg/kg (weeks 16, 20, and every 8 weeks thereafter).
  • At week 24, all remaining patients in the placebo group began receiving SIMPONI ARIA 2 mg/kg.
  • The primary endpoint was the proportion of patients achieving an ACR20 response at week 14.

Results

Patient Characteristics
  • A majority of patients were Caucasian (80.4%) and female (81.6%) with a median age of 52 years.
  • A majority of patients (96.3%; 570/592) completed the study through week 24. At week 16, 34.5% of patients in the placebo + MTX group entered early escape and received SIMPONI ARIA.
  • Through week 112, a majority of patients (82% [486/592]) continued the study. Of the patients that withdrew from the study (n=106), 44 discontinued due to AEs and 12 discontinued due to lack of efficacy.
Efficacy

Summary of Efficacy Results through Week 1002,5,7,8
 
Placebo + MTX
(n=197)
SIMPONI ARIA 2 mg/kg + MTX
(n=395)
Week 2a
   ACR20
      n (%)
      P-value
23 (11.7%)
131 (33.2%)
P<0.001
Week 14
ACR20b
      n (%)
      P-value
49 (24.9%)
231 (58.5%)
P<0.001
   ACR50
      n (%)
P-value
17 (8.6%)
118 (29.9%)
P<0.001
   ACR70
      n (%)
      P-value
6 (3.0%)
49 (12.4%)
P<0.001
   EULAR (DAS28-CRP moderate or good response)c
      n (%)
      P-value
79 (40.1%)
321 (81.3%)
P<0.001
   DAS28 improvement from baseline
      Mean±SD/median (IQR)
-0.7±1.35/-0.5 (-1.6, 0.2)
-2.0±1.23/-1.9 (-2.7, 1.2)
   HAQ score improvement from baselinec
      Mean±SD/median (IQR)
      P-value
0.19±0.56/0.13 (-0.13, 0.50)
0.50±0.58/0.50 (0.13, 0.88)
P<0.001
Week 24
ACR20
      n (%)
P-value
62 (31.5%)
248 (62.8%)
P<0.001
   ACR50c
      n (%)
P-value
26 (13.2%)
138 (34.9%)
P<0.001
   ACR70
      n (%)
P-value
8 (4.1%)
69 (17.7%)
P<0.001
DAS28 improvement from baseline
      Mean±SD/median (IQR)
P-value
-0.8±1.43/-0.5 (-1.7, 0.2)
-2.0±1.40/-2.0 (-3.0, -1.1)
P<0.001
EULAR (DAS28-CRP moderate or good response)
      n (%)
P-value
88 (44.7%)
331 (83.8%)
P<0.001
Placebo → SIMPONI ARIA
2 mg/kg + MTX
(n=197)
SIMPONI ARIA
2 mg/kg + MTX
(n=395)
Week 52
   ACR20
      n (%)
121 (61.4%)
260 (65.8%)
   ACR50
      n (%)
62 (31.5%)
153 (38.7%)
   ACR70
      n (%)
29 (14.7%)
72 (18.2%)
   EULAR (DAS28-CRP moderate or good response)
      n (%)
149 (75.6%)
321 (81.3%)
   HAQ improvement ≥0.25
      n (%)
123 (62.4%)
253 (64.1%)
Week 100
   ACR20
      n (%)
130 (66.0%)
273 (69.1%)
   ACR50
      n (%)
81 (41.1%)
178 (45.1%)
   ACR70
      n (%)
47 (23.9%)
92 (23.3%)
   EULAR (DAS28-CRP moderate or good response)
      n (%)
153 (77.7%)
332 (84.1%)
   HAQ score improvement from baseline
      Mean±SD/(IQR)
0.47±0.62/(-1.5, 2.1)
0.53±0.66/(-1.3, 2.5)
Abbreviations: ACR20, 20% improvement according to the American College of Rheumatology criteria; ACR50, 50% improvement according to the American College of Rheumatology criteria; ACR70, 70% improvement according to the American College of Rheumatology criteria; DAS28, Disease Activity Score in 28 joints; DAS28-CRP, DAS28 using C-reactive protein; EULAR, European League Against Rheumatism; HAQ, Health Assessment Questionnaire; IQR, interquartile range; MTX, methotrexate; SD, standard deviation.
aWeek 2 assessments not corrected for multiplicity.
bPrimary endpoint.
cMajor secondary endpoint.

Summary of Radiographic Results through Week 1006,7,a

Placebo + MTX→ SIMPONI ARIA
2 mg/kg + MTX
(n=197)
SIMPONI ARIA
2 mg/kg + MTX
(n=395)
SIMPONI ARIA
2 mg/kg + MTX Combined
(n=592)
Baseline total vdHS, mean±SD
50.26±59.85
47.59±54.63
-
Total vdHS score change from baseline at week 24, mean±SD; P-value
1.09±3.19
0.03±1.90
P<0.001
-
Total vdHS score change from baseline at week 52, mean±SD; P-value
1.22±3.98
0.13±3.11
P<0.01
0.49±3.46
Total vdHS score change from baseline at week 100, mean±SD; P-value
2.10±7.42
0.74±6.32
P=0.005
1.19±6.73
Total vdHS score change from week 52 to week 100, mean±SD
0.80±3.03
0.56±3.07
0.64±3.06
Abbreviations: MTX, methotrexate; SD, standard deviation; vdHS, van der Heijde-Sharp.
aPatients with missing total vdHS score at week 52 were excluded.
Safety
  • Through week 24, serious AEs were reported in 4.1% of patients in the combined SIMPONI ARIA + MTX group compared to 2.0% of patients receiving MTX alone. Serious infections were reported in 0.9% (4/463) and 0.0% (0/197) of patients in these groups, respectively.
  • Through week 112, 3 patients developed tuberculosis and 2 patients developed a serious opportunistic infection.
  • Antibodies to golimumab were detected in 6.7% (37/553) of patients receiving SIMPONI ARIA through week 100.

AEs through Week 1127
 
 
Placebo + MTX -> SIMPONI ARIA 2 mg/kg + MTX
Placebo + MTX
SIMPONI ARIA 2 mg/kg at Week 16 (Early Escape)
SIMPONI ARIA 2 mg/kg at Week 24 (Crossover)
SIMPONI ARIA 2 mg/kg + MTX
Combined SIMPONI ARIA 2 mg/kg + MTX
Patients treated, n
197
68
121
395
584
Mean duration of follow-up, weeks
21.0
88.5
81.7
101.5
95.9
Mean number of infusions
4.2
11.0
10.2
12.6
11.9
Patients with ≥1 AE, n (%)
98 (49.7)
54 (79.4)
88 (72.7)
320 (81.0)
462 (79.1)
URTI, n (%)
15 (7.6)
5 (7.4)
8 (6.6)
54 (13.7)
67 (11.5)
Bronchitis, n (%)
2 (1.0)
6 (8.8)
9 (7.4)
37 (9.4)
52 (8.9)
RA, n (%)
12 (6.1)
9 (13.2)
3 (2.5)
39 (9.9)
51 (8.7)
Hypertension, n (%)
5 (2.5)
8 (11.8)
4 (3.3)
27 (6.8)
39 (6.7)
Nasopharyngitis, n (%)
5 (2.5)
3 (4.4)
8 (6.6)
28 (7.1)
39 (6.7)
Patients with ≥1 IR, n (%)
1 (0.5)
5 (7.4)
0
18 (4.6)
23 (3.9)
Number of infusions, n
829
748
1235
4972
6955
Infusions with IRs, n (%)
2 (0.2)
8 (1.1)
0
22 (0.4)
30 (0.4)
Patients with ≥1 SAE, n (%)
6 (3.0)
11 (16.2)
17 (14.0)
78 (19.7)
106 (18.2)
Patients with ≥1 serious infection, n (%)
1 (0.5)
3 (4.4)
5 (4.1)
28 (7.1)
36 (6.2)
Deaths, n (%)
1 (0.5)
0
2 (1.7)
3 (0.8)
5 (0.9)
Data are presented as n (%) unless otherwise noted.
Abbreviations: AE, adverse event; IR, infusion reaction; MTX, methotrexate; RA, rheumatoid arthritis; SAE, serious adverse event; URTI, upper respiratory tract infection.

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 28 January 2025.

Summarized in this response are relevant data from the pivotal phase 3 controlled clinical trials.

 

References

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1 Kremer J, Ritchlin C, Mendelsohn A, et al. Golimumab, a new human anti-tumor necrosis factor alpha antibody, administered intravenously in patients with active rheumatoid arthritis: forty-eight-week efficacy and safety results of a phase III randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2010;62(4):917-928.  
2 Weinblatt ME, Bingham CO, Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis. 2013;72(3):381-389.  
3 Taylor PC, Ritchlin C, Mendelsohn A, et al. Maintenance of efficacy and safety with subcutaneous golimumab among patients with active rheumatoid arthritis who previously received intravenous golimumab. J Rheumatol. 2011;38(12):2572-2580.  
4 Data on File. Clinical Study Report C0524T12. Janssen Research & Development, LLC. EDMS-ERI-81013586; 2014.  
5 Weinblatt ME, Bingham CO 3rd, Mendelsohn AM, et al. Intravenous golimumab inhibits radiographic progression and maintains clinical efficacy and safety in patients with active rheumatoid arthritis despite methotrexate therapy: 1-year results of a phase 3 trial. Poster presented at: American College of Rheumatology 76th Annual Scientific Meeting; November 10-14, 2012; Washington, DC.  
6 Weinblatt ME, Bingham CO 3rd, Mendelsohn AM, et al. Intravenous golimumab inhibits radiographic progression and maintains clinical efficacy and safety in patients with active rheumatoid arthritis despite methotrexate therapy: 2-year results of a phase 3 trial of intravenous golimumab. Abstract presented at: American College of Rheumatology 77th Annual Scientific Meeting; October 26-30, 2013; San Diego, CA.  
7 Bingham CO 3rd, Mendelsohn AM, Kim L, et al. Maintenance of clinical and radiographic benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: week-112 efficacy and safety results of the open-label long-term extension of a phase III, double-blind, randomized, placebo-controlled trial. Arthritis Care Res. 2015;67(12):1627-1636.  
8 Weinblatt ME, Westhovens R, Mendelsohn AM, et al. Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial. Ann Rheum Dis. 2014;73(12):2152-2159.