Table 1 Characteristics of the 12 randomised controlled trials of biotherapies in RA included in these meta-analyses for serious infections
Sources (reference)No. of randomised patients (no. of patients treated*)No. who completed the follow-upRA characteristicsStudy protocol with doses (no. of patients treated*in each group)Duration of follow-up (weeks)
Rituximab
    Edwards et al, 2004 10161 (161)130Active RA despite MTX⩾10 mg per week of MTX+placebo (40) 1000 mg on days 1 and 15 of rituximab (40) 1000 mg on days 1 and 15 of rituximab+750 mg on days 3 and 17 of cyclophosphamide (41) 1000 mg on days 1 and 15 of rituximab+ ⩾10 mg per week of MTX (40)48
    Emery et al, 2006 22465 (465)375Active RA resistant to DMARDs, including biological agents10–25 mg per week of MTX+placebo (149) 1000 mg on days 1 and 15 of rituximab+ 10–25 mg per week of MTX (192) 500 mg on days 1 and 15 of rituximab+ 10–25 mg per week of MTX (124)24
    Cohen et al, 2006 23520 (517)366Active RA despite TNF-α blockers10–25 mg per week of MTX+placebo (209) 10–25 mg per week of MTX+1000 mg on days 1 and 15 of rituximab (308)24
Abatacept
    Moreland et al, 2002 9122 (122)90Refractory RA despite DMARDs or etanerceptPlacebo (32) 0.5 mg/kg of abatacept on days 1, 15, 29 and 57 (26) 2 mg/kg of abatacept on days 1, 15, 29 and 57 (32) 10 mg/kg of abatacept on days 1, 15, 29 and 57 (32)12
    Kremer et al, 2003 and 2005 24 25339 (339)235Active RA despite MTX10–30 mg per week of MTX+placebo (119) 10–30 mg per week of MTX+abatacept 2 mg/kg on days 1, 15 and 30 and every 30 days thereafter (105) 10–30 mg per week of MTX+abatacept 10 mg/kg on days 1, 15 and 30 and every 30 days (115)48
    Genovese et al, 2005 26393 (391)322Active RA despite at least 3 months of TNF-α blockerDMARDs+placebo (133) DMARDs+10 mg/kg of abatacept on days 1, 15, 29 and every 28 days (258)24
    Kremer et al, 2006 27656 (652)547Active RA despite MTX⩾15 mg per week of MTX+placebo (219) ⩾15 mg per week of MTX+10 mg/kg of abatacept on days 1, 15 and 29, and every 28 days (433)48
    Weinblatt et al, 2006 281456 (1441)1231Active RA despite biological or non-biological DMARDsAt least 1 non-biological DMARD+placebo (418) 1 biological DMARD+placebo (64) At least 1 non-biological DMARD+10 mg/kg of abatacept on days 1, 15 and 29 and every 4 weeks thereafter for a total of 14 infusions (856) 1 biological DMARD+10 mg/kg of abatacept on days 1, 15 and 29 and every 4 weeks thereafter for a total of 14 infusions (103)48
Anakinra
    Bresnihan et al, 1998 8472 (472)468Active and severe RAPlacebo (121) 30 mg daily of anakinra (119) 75 mg daily of anakinra (116) 150 mg daily of anakinra (116)24
    Cohen et al, 2002 29419 (419)331Moderate to severe active RA despite MTXMTX (15–25 mg/wk)+placebo (74) MTX (15–25 mg/wk)+daily 0.04 or 0.01 or 0.4 or 1 or 2 mg/kg of anakinra (345)24
    Cohen et al, 2004 30506 (501)492Active RA despite MTXMTX (10–25 mg/wk)+placebo (251) MTX (10–25 mg/wk)+100 mg per day of anakinra (250)24
    Schiff et al, 2004† 311414 (1399)1105Active RA with and without comorbidity factorDMARDS+placebo (283) DMARD+100 mg per day of anakinra (1116)24
  • RA, rheumatoid arthritis; MTX, methotrexate; DMARDs, disease-modifying antirheumatic drugs; wk, week.

  • *Number of patients who received at least one dose of study medication in this arm of randomisation and were analysed.

  • †Including 951 patients with comorbidity factors (775 in the anakinra group and 196 in the placebo group).