Table 3

SIE reported before and after another biological DMARD therapy following rituximab treatment

SIE*Subsequent RA biological DMARD post-rituximabTime from last rituximab dose to subsequent biological DMARD (days)Day of onset after biological DMARD†Last CD19+ cell count before biological DMARDLast CD19+ cell count before SIE‡ (days from CD19+ cell count to SIE)
Before other biological agent
    DiarrhoeaABA392NA57 (59)
    GastroenteritisADA459NA361 (38)
    DiverticulitisADA211NA434 (65)
    Pneumonia**ADA181NA30 (15)
    Pneumonia§ANK171NA11 (21)
    DiverticulitisANK515NA100 (11)
    Bronchitis¶‡‡ETN521NA166116 (44)
    Infection of right hipINF262NA01 (12)
    UTI¶‡‡ETN521NA166359 (51)
    GastroenteritisPost-CYC, pre-ETN239NA110 (21)
    Shigella infectionINF358NA84 (52)
    Cellulitis‡‡INF114NA00 (42)
    UTI‡‡INF366NA406 (12)
After other biological agent
    ErysipelasETN1481822 (39)
    CellulitisETN4351359 (8)
    Arthritis, bacterial**ETN and INF156417 days after starting INF, 77 days after starting ETN1 (INF), 53 (ETN)53(83)
    PneumoniaABA1482014122 (6)
    Pneumonia§ANK171511 (28)
    Meningitis (viral)ADA38241167 (37)
    UTI**ADA18117332 (73)
    UTI††ETN230713028 (62)
    CellulitisETN16651222 (82)
    Wound infectionETN3899485312 (45)
  • *Patients with multiple serious adverse events are indicated. †In the case of serious infection before receipt of another biological disease-modifying antirheumatic drug (DMARD), this is not available (NA). In the case of a serious infection after another biological DMARD, this refers to the duration following receipt of the biological DMARD to serious infection events (SIE). ‡The lower limit of normal of peripheral CD19+ B-cell counts is ⩽80 cells/μl. Note that CD19+ cell counts were often taken at various time intervals before the SIE (range 6–83 days; median 39 days). §The same patient experienced SIE before and after the receipt of anakinra (ANK). ¶Patient experienced bronchitis followed by urinary tract infection (UTI) 4 months later. **Patient experienced pneumonia before receipt of adalimumab (ADA) and experienced UTI after receipt of ADA. ††Patient took blinded natalizumab before etanercept (ETN). ‡‡Four events were not categorised as serious adverse events per protocol, but required intravenous antibiotics.

  • ABA, abatacept; CYC, cyclophosphamide; INF, infliximab; RA, rheumatoid arthritis; TNF, tumour necrosis factor.