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Ann Rheum Dis 72:381-389 doi:10.1136/annrheumdis-2012-201411
  • Clinical and epidemiological research

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

Table 3

Summary of adverse events among treated patients through week 16 (placebo-controlled period) and week 24

Week 16
Placebo+MTX Golimumab 2 mg/kg+MTX
Number of treated patients 197 395
Average duration of follow-up (weeks) 15.9 15.9
Average exposure (number of administrations) 2.9 2.9
Patients with ≥1 adverse event 86 (43.7%) 187 (47.3%)
System-organ class/preferred term occurring in ≥2% of patients in any treatment group
Infections and infestations 41 (20.8%) 96 (24.3%)
 Upper respiratory tract infection 11 (5.6%) 20 (5.1%)
 Urinary tract infection 5 (2.5%) 10 (2.5%)
 Nasopharyngitis 4 (2.0%) 8 (2.0%)
 Pharyngitis 1 (0.5%) 8 (2.0%)
 Influenza 4 (2.0%) 3 (0.8%)
Musculoskeletal and connective tissue disorders 29 (14.7%) 27 (6.8%)
 Arthralgia 7 (3.6%) 6 (1.5%)
 Rheumatoid arthritis 11 (5.6%) 6 (1.5%)
 Back pain 4 (2.0%) 4 (1.0%)
Nervous system disorders 8 (4.1%) 27 (6.8%)
 Headache 5 (2.5%) 17 (4.3%)
Gastrointestinal disorders 11 (5.6%) 26 (6.6%)
Skin and subcutaneous tissue disorders 7 (3.6%) 26 (6.6%)
Respiratory, thoracic and mediastinal disorders 5 (2.5%) 19 (4.8%)
Investigations 8 (4.1%) 15 (3.8%)
Vascular disorders 5 (2.5%) 15 (3.8%)
 Hypertension 3 (1.5%) 11 (2.8%)
General disorders and administration site disorders 5 (2.5%) 11 (2.8%)
 Pyrexia 0 (0.0%) 8 (2.0%)
Metabolism and nutrition disorders 0 (0.0%) 9 (2.3%)
Injury, poisoning and procedural complications 6 (3.0%) 7 (1.8%)
Week 24
Placebo+MTX Placebo + MTX→ Golimumab 2 mg/kg + MTX* Golimumab 2 mg/kg+MTX Combined Golimumab
Number of treated patients 197 68 395 463
Average duration of follow-up (weeks) 20.9 8.2 23.7 21.4
Average exposure (number of administrations) 4.2 2.0 3.9 3.6
Patients with ≥1 adverse event 97 (49.2%) 19 (27.9%) 226 (57.2%) 245 (52.9%)
Patients with ≥1 serious adverse event 4 (2.0%) 0 (0.0%) 19 (4.8%) 19 (4.1%)
Patients with ≥1 serious infection 0 (0.0%) 0 (0.0%) 4 (1.0%) 4 (0.9%)
System-organ class/preferred term
Infections and infestations 0 (0.0%) 0 (0.0%) 3 (0.8%) 3 (0.6%)
 Appendicitis 0 (0.0%) 0 (0.0%) 1 (0.3%) 1 (0.2%)
 Bacteraemia 0 (0.0%) 0 (0.0%) 1 (0.3%) 1 (0.2%)
 Upper respiratory tract infection 0 (0.0%) 0 (0.0%) 1 (0.3%) 1 (0.2%)
Respiratory, thoracic and mediastinal disorders 0 (0.0%) 0 (0.0%) 1 (0.3%) 1 (0.2%)
 Interstitial lung disease 0 (0.0%) 0 (0.0%) 1 (0.3%) 1 (0.2%)
Infusion reactions
 Patients with reactions 1 (0.5%) 3 (4.4%) 13 (3.3%) 16 (3.5%)
 Infusions with reactions 2/828 (0.2%) 3/136 (2.2%) 15/1528 (1.0%) 18/1664 (1.1%)
ALT abnormalities by TB prophylaxis
Patients with baseline ALT ≤ULN and receiving TB prophylaxis 34 16 48 64
 Patients with ALT abnormalities 7 (20.6%) 1 (6.3%) 19 (39.6%) 20 (31.3%)
Patients with baseline ALT ≤ULN and not receiving TB prophylaxis 148 47 309 356
 Patients with ALT abnormalities 32 (21.6%) 12 (25.5%) 88 (28.5%) 100 (28.1%)
  • Data presented are number (%) of patients.

  • * Patients who early escaped at week 16 and started receiving golimumab at week 16.

  • ALT, alanine aminotransferase; MTX, methotrexate; TB, tuberculosis; ULN, upper limit of the normal range.

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