A systematic review of the effectiveness of adalimumab

TABLE 13 Quality of included RCTs: infliximab (cont’d)
Study Sample size Truly random Adequate Blinding Important Important Use of ITT
allocation/ allocation differences in differences in analysis
Remain on concealment Participants Investigators Assessors baseline completion rates
randomised characteristics between groups
treatment between (% randomised
groups (item) patients completed)
Taylor, 2004140 Placebo: 12 Unclear Yes Yes Yes Yes No No (one patient No
Infliximab: 12 withdrew, but did not
state which arm)
Durez, 2004 139 Methylprednisolone: 15 Unclear Unclear No Unclear Yes No Unclear Unclear
Infliximab: 12
Quinn, 2005141 Placebo: 10 Yes Unclear Yes Yes Yes No No Yes
Infliximab: 10 Placebo: 10/10
Infliximab: 9/10
a Only 28 (32%) of the those allocated MTX in year 1 continued compared with 231 (68%) of those on infliximab plus MTX. For ethical reasons the study was unblinded at week
54. Unblinding occurred in 12% of patients before completion of all HAQ evaluations. Ninety-four of the 259 patients had a gap of more than 8 weeks between treatments
because of the timing of the protocol amendment. The mean length of time for which infliximab was suspended was 19.4 weeks.
b –1 Before unblinding, 45 patients at two study sites were excluded from the efficacy analysis (16 in the MTX–placebo group, 14 in the MTX–3 mg kg infliximab group and 15 in the
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MTX–6 mg kg –1 infliximab group) because their study data could not be verified with source documents.
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