Table 4

Overall safety of placebo and rituximab 2×500 mg and 2×1000 mg (all with a stable dose of methotrexate (MTX) 10−25 mg/week) over 48 weeks (safety population)

Baseline to week 24Baseline to week 48
Placebo + MTX (n=172)Rituximab 2×500 mg + MTX (n=167)Rituximab 2×1000 mg + MTX (n=170)Rituximab 2×500 mg + MTX (n=167)Rituximab 2×1000 mg + MTX (n=170)
Treated (n)172167170152154
Total patient-years of follow-up79.2479.6381.36152.43153.36
Patients with AEs, n (%)
 Any AE128 (74)128 (77)130 (76)143 (86)138 (81)
 Deaths0002 (1)0
 Deaths after withdrawal1 (<1)001 (<1)1 (<1)
 Serious AE15 (9)6 (4)15 (9)13 (8)17 (10)
 AE leading to withdrawal (excluding RA flare)2 (1)2 (1)3 (2)3 (2)7 (4)
IRR (any)*
 Day 1 infusion24 (14)31 (19)42 (25)19 (13)17 (11)
 Day 15 infusion14 (8)12 (7)10 (6)6 (4)8 (5)
 IRR leading to withdrawal0 (0)0 (0)1 (1)0 (0)2 (1)
Infection
 Any74 (43)69 (41)61 (36)96 (57)85 (50)
 Serious4 (2)1 (<1)2 (1)3 (2)3 (2)
Lower gastrointestinal events
 Any20 (12)16 (10)16 (9)21 (13)24 (14)
 Serious3 (2)1 (1)1 (<1)2 (1)1 (<1)
Cardiac disorder events
 Any4 (2)5 (3)7 (4)8 (5)8 (5)
 Serious2 (1)2 (1)1 (<1)2 (1)1 (<1)
Vascular disorder events
 Any4 (2)6 (4)7 (4)11 (7)8 (5)
 Serious00000
 Malignancy1 (<1)1 (<1)2 (1)1 (<1)2 (1)
AE rates per 100 patient-years (95% CI)
 Overall infection rate159.00 (133.53 to 189.34)138.13 (114.59 to 166.52)120.45 (98.81 to 146.82)133.83 (116.67 to 153.52)106.94 (91.76 to 124.63)
 Serious infection rate8.83 (4.21 to 18.53)1.26 (0.18 to 8.92)2.46 (0.61 to 9.83)2.62 (0.98 to 6.99)1.96 (0.63 to 6.07)
  • * AEs occurring during or within 24 h of an infusion and considered by the investigator to have at least a possible relation to treatment.

  • Week 24 to week 48, based on number of patients receiving the infusion/day.

  • Reported as serious and/or treated with intravenous antibiotics.

  • AE, adverse event; IRR, infusion-related reaction; RA, rheumatoid arthritis; SAE, serious adverse event.