Table 1.

Summary of clinical and radiographic response through Week 104. Data shown are change from baseline or number (%) of patients with response unless noted otherwise. Data are summarized by randomized treatment group.

Group 1
Placebo + MTX1
Group 2
Golimumab 100 mg + Placebo2
Group 3
Golimumab 50 mg + MTX3
Group 4
Golimumab 100 mg + MTX
Combined
Golimumab + MTX
Randomized patients1331338989178
  ACR20 response68/104 (65.4%)74/106 (69.8%)62/83 (74.7%)48/67 (71.6%)110/150 (73.3%)
    At Wk 52 and Wk 10457/73 (78.1%)59/69 (85.5%)52/63 (82.5%)40/46 (87.0%)92/109 (84.4%)
  ACR50 response38/104 (36.5%)49/106 (46.2%)50/83 (60.2%)34/67 (50.7%)84/150 (56.0%)
    At Wk 52 and Wk 10428/47 (59.6%)32/41 (78.0%)32/41 (78.0%)27/35 (77.1%)59/76 (77.6%)
  ACR70 response24/104 (23.1%)33/106 (31.1%)26/83 (31.3%)24/67 (35.8%)50/150 (33.3%)
    At Wk 52 and Wk 10416/25 (64.0%)16/23 (69.6%)17/21 (81.0%)20/28 (71.4%)37/49 (75.5%)
  Swollen joint count
    Median (IQR) joint count2.0 (0.0, 5.0)2.0 (0.0, 6.0)2.0 (0.0, 6.0)1.0 (0.0, 4.0)1.5 (0.0, 4.0)
    Median (IQR) change−8.5 (−13.0, −5.5)−8.0 (−14.0, −5.0)−9.0 (−19.0, −5.0)−10.0 (−15.0, −5.0)−10.0 (−15.0, −5.0)
  Tender joint count
    Median joint count3.0 (1.0, 9.5)3.0 (1.0, 9.0)3.0 (0.0, 12.0)2.0 (0.0, 9.0)3.0 (0.0, 9.0)
    Median (IQR) change−15.0 (−23.0, −7.5)−17.0 (−26.0, −7.0)−17.0 (−30.0, −8.0)−16.0 (−27.0, −10.0)−16.5 (−28.0, −8.0)
  DAS28-CRP
    Median (IQR) score3.0 (1.9, 3.9)3.0 (2.1, 3.9)2.7 (1.9, 4.1)2.5 (1.8, 3.8)2.7 (1.9, 3.9)
    Median (IQR) change−2.1 (−3.1, −1.3)−2.1 (−3.2, −1.6)−2.5 (−3.4, −1.5)−2.6 (−3.3, −1.9)−2.6 (−3.4, −1.7)
    Responder (Good + Moderate)89/102 (87.3%)91/105 (86.7%)73/83 (88.0%)61/67 (91.0%)134/150 (89.3%)
    At Wk 52 and 10477/82 (93.9%)80/90 (88.9%)68/75 (90.7%)56/59 (94.9%)124/134 (92.5%)
    Remission (< 2.6)42/102 (41.2%)43/105 (41.0%)39/83 (47.0%)35/67 (52.2%)74/150 (49.3%)
    At Wk 52 and Wk 10422/31 (71.0%)22/32 (68.8%)24/34 (70.6%)25/33 (75.8%)49/67 (73.1%)
  HAQ-DI score
    Median (IQR) score0.9 (0.3, 1.4)0.5 (0.1, 1.1)0.5 (0.3, 1.4)0.6 (0.3, 1.3)0.6 (0.3, 1.4)
    Median (IQR) change0.4 (0.0, 0.7)0.5 (0.1, 1.0)0.6 (0.1, 1.0)0.4 (0.1, 0.9)0.5 (0.1, 0.9)
    ≥ 0.25–unit improvement64/104 (61.5%)75/106 (70.8%)60/83 (72.3%)49/67 (73.1%)109/150 (72.7%)
      At Wk 24 and Wk 10443/47 (91.5%)50/57 (87.7%)52/60 (86.7%)53/60 (88.3%)105/120 (87.5%)
      At Wk 52 and Wk 10456/68 (82.4%)60/64 (93.8%)57/63 (90.5%)46/50 (92.0%)103/113 (91.2%)
  SHS-Total4,5
    Mean (SD) change to Wk 1041.15 (4.41)1.87 (5.77)0.51 (3.32)0.54 (3.49)0.52 (3.39)
    No radiographic progression* at Wk 5260/105 (57.1%)60/106 (56.6%)51/81 (63.0%)44/66 (66.7%)95/147 (64.6%)
    No radiographic progression at Wk 104*54/106 (50.9%)56/108 (51.9%)56/83 (67.5%)46/69 (66.7%)102/152 (67.1%)
  • 1 Includes patients who escaped early at Week 16 or crossed over at Week 24 to receive golimumab 50 mg + MTX or whose doses were escalated after Week 52 to receive golimumab 100 mg + MTX.

  • 2 Includes patients who escaped early at Week 16 to receive golimumab 100 mg + MTX or added MTX after Week 52.

  • 3 Includes patients who escaped early at Week 16 or whose doses were escalated after Week 52 to receive golimumab 100 mg + MTX.

  • 4 Includes patients with baseline SHS and ≥ 1 SHS after Week 52.

  • 5 Missing imputation rules were applied. Within type (erosion, joint space narrowing) and region (hand, foot), if ≥ 50% of joint scores were imputed with worst-case scores because of procedure or injection, then change from baseline of this subscore was imputed with worst change score of type-by-region subscores among all other patients.

  • * Change in SHS ≤ 0. ACR: American College of Rheumatology; CRP: C-reactive protein; DAS28: Disease Activity Score using 28-joint count; HAQ-DI: Health Assessment Questionnaire (Disability Index); IQR: interquartile range; MTX: methotrexate; SHS: Sharp/van der Heijde Score.