Table 3

Adverse events and RA disease activity

MTX continue (n=156)MTX hold (n=160)P values
Any AE (%)34 (21.8)45 (28.1)0.194
SAE (%)0 (0)0 (0)1.000
AE occurring in >1% of patients (%)
 Upper respiratory infection12 (7.7)9 (5.6)0.461
 Myalgia5 (3.2)10 (6.3)0.203
 Injection site reaction4 (2.6)6 (3.8)0.750
 Abdominal pain3 (1.9)1 (0.6)0.366
 Rash2 (1.3)2 (1.3)1.000
 Fatigue0 (0)2 (1.3)0.498
 Sore throat0 (0)2 (1.3)0.498
 Dizziness2 (1.3)0 (0)0.243
DAS28 at visit 1 (0–100)2.2 (0.9)2.3 (1.1)0.517
DAS28 at visit 2 (1–100)2.3 (0.9)2.4 (1.1)0.220
Rescue medication (%)7 (4.5)10 (6.3)0.487
RA flare at visit 2 (%)8 (5.1)17 (10.6)0.070
  • The data are expressed as mean (SD) or number (%). RA flare was defined as an increase in DAS28 of >1.2 (or >0.6 if the DAS28 was ≥3.2).

  • AE, adverse event; DAS28, Disease Activity Score in 28 joints; MTX, methotrexate; RA, rheumatoid arthritis; SAE, serious adverse event.