Table 2

Summary of AEs* reported over 52 weeks (safety population)

Placebo+MTX (n=207)Ocrelizumab (200 mg×2)+MTX (n=196)Ocrelizumab (500 mg×2)+MTX (n=202)
Patient-years of observation201.1190.7196.7
AEs, n (%)167 (80.7)171 (87.2)167 (82.7)
Serious AEs, n (%)21 (10.1)18 (9.2)28 (13.9)
 Musculoskeletal3 (1.4)2 (1.0)2 (1.0)
 Cardiac3 (1.4)3 (1.5)2 (1.0)
 Injury2 (1.0)1 (0.5)3 (1.5)
 Gastrointestinal disorders2 (1.0)1 (0.5)2 (1.0)
 Neoplasms1 (0.5)02 (1.0)
 Blood/lymphatic02 (1.0)2 (1.0)
AEs leading to withdrawal,(%)2 (1.0)3 (1.5)12 (5.9)
Infections, n (%)106 (51.2)101 (51.5)105 (52.0)
Serious infections, n (%)6 (2.9)5 (2.6)10 (5.0)
 Pneumonia2 (1.0)02 (1.0)
 Cellulitis1 (0.5)01 (0.5)
 Urinary tract infection01 (0.5)3 (1.5)
 Others3 (1.4)4 (2.0)6 (3.0)
Infusion-related reactions, n (%)18 (8.7)52 (26.5)54 (26.7)
 Course 1, 1st infusion7 (3.4)43 (21.9)46 (22.8)
 Course 1, 2nd infusion6 (2.9)6 (3.1)8 (4.1)
 Course 2, 1st infusion7 (3.6)11 (6.0)4 (2.2)
 Course 2, 2nd infusion5 (2.7)3 (1.7)4 (2.2)
Serious infusion-related reactions, n (%)001 (0.5)
Malignancies, n (%)2 (1.0)01 (0.5)
Deaths, n (%)2 (1.0)2 (1.0)1 (0.5)
  • * Data are reported as n (%) unless stated. Multiple occurrences of the same AE in one individual counted only once.

  • Week 52 completers with AEs that led to withdrawal at week 52 were included.

  • n Values for placebo, ocrelizumab 200 mg×2, ocrelizumab 500 mg×2: course 1, 1st infusion: n=207, 196, 202; course 1, 2nd infusion: n=205, 193, 194; course 2, 1st infusion: n=193, 183, 186; course 2, 2nd infusion: n=188, 179, 181.

  • AE, adverse event; MTX, methotrexate.