Table 2

Adverse events

Group 1
(n=54)
Group 2
(n=44)
Group 3
(n=49)
Group 4
(n=52)
Any AE30 (55.6)27 (61.4)26 (53.1)17 (32.7)
SAE
 Lung cancer0 (0)1 (2.3)0 (0)0 (0)
 Fracture01 (2.3)1 (2.0)0 (0)
AE occurring in >5% of patients
 Upper respiratory infection26 (48.1)18 (40.9)20 (40.8)16 (30.8)
 Dizziness1 (1.9)3 (6.8)0 (0)1 (1.9)
 Injection site reaction3 (5.6)1 (2.3)2 (4.1)0 (0)
 Headache3 (5.6)1 (2.3)1 (2.0)0 (0)
RA flare at any visit13 (24.1)15 (34.1)19 (38.8)11 (21.2)
RA flare at visit 44 (7.5)6 (14.0)9 (19.1)6 (12.0)
RA flare at last visit0 (0)0 (0)0 (0)1 (1.9)
  • The data are expressed as num ber (%). 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; RA, rheumatoid arthritis; SAE, serious adverse event.