A systematic review of the effectiveness of adalimumab

doses or dosing schedules other than that in
the licence. Sensitivity analyses which include
patients from these trials are summarised in
Table 75 (licensed dose and above) and Table 76
(all doses including sublicensed dose) (Appendix
4). Results are generally consistent with the
primary analyses. However, when doses above
the licensed doses are included, infliximab was
associated with a slight [Commercial-inconfidence
information removed] in any infection
(RR [Commercial-in-confidence information
removed]).
Contrary to the observations from TEMPO, data
from ATTRACT indicated that there was an
inverse relationship between absolute HAQ
© Queen’s Printer and Controller of HMSO 2006. All rights reserved.
Health Technology Assessment 2006; Vol. 10: No. 42
TABLE 15 Meta-analyses: infliximab i.v. licensed dose (3 mg kg –1 every 8 weeks) versus placebo with ongoing MTX in MTX partial
responders/non-responders, end of trial
Comparison or outcome Studies N included Statistical method Effect size (95% CI)
in analysis
ACR20 responder 2111,133 858 RR (fixed) 2.30 (1.90 to 2.78)*
ACR50 responder 2111,133 858 RR (fixed) 3.20 (2.30 to 4.44)*
ACR70 responder 2111,133 858 RR (fixed) 3.16 (1.89 to 5.27)*
RD ACR20 responder 2111,133 858 RD (fixed) 0.31 (0.25 to 0.37)*
RD ACR50 responder 2111,133 858 RD (fixed) 0.20 (0.15 to 0.26)*
RD ACR70 responder 2111,133 858 RD (fixed) 0.09 (0.05 to 0.13)*
SJC, mean change from baseline 2111,133 830 WMD (fixed) –5.08 (–6.23 to –3.94)*
Patient’s global assessment, mean change 2111,133 from baseline
829 WMD (fixed) –1.52 (–1.89 to –1.15)*
HAQ, mean change from baseline 2 111,133
818 WMD (fixed) –0.27 (–0.35 to –0.19)*
DAS28, end of study result 0 0 Not estimable No data available
Modified van de Heijde–Sharp score, 1133 mean change from baseline
135 WMD (fixed) –5.70 (–8.58 to –2.82)*
Withdrawal for any reasons 2 111,133 895 RR (random) 0.76 (0.36 to 1.60)
Withdrawal due to lack of efficacy 1133 174 RR (fixed) 0.54 (0.33 to 0.90)*
Withdrawal due to adverse events 2111,133 895 RR (fixed) 1.55 (0.82 to 2.93)
Death 2111,133 895 RR (fixed) 0.33 (0.05 to 2.06)
SAEs 2111,133 895 RR (fixed) 0.84 (0.56 to 1.26)
Malignancy: all 2111,133 895 RR (fixed) 2.48 (0.49 to 12.70)
Malignancy: skin cancer excluding melanoma 2111,133 895 RR (fixed) 1.49 (0.25 to 8.80)
Malignancy: all cancer excluding 2111,133 non-melanoma skin cancer
895 RR (fixed) 2.32 (0.34 to 15.62)
Serious infection 2 111,133
895 RR (fixed) 0.61 (0.26 to 1.46)
Any infection 2111,133 896 RR (fixed) [Commercial-inconfidence
information
removed]
* Statistically significant result (p < 0.05).
improvement and disease duration in infliximabtreated
patients.
Infliximab plus methotrexate versus
methotrexate (newly initiated methotrexate)
ASPIRE 135 and the study by Quinn and
colleagues 141 compared the combination of
infliximab and methotrexate with methotrexate
alone in methotrexate-naïve, early RA patients.
The results of primary analyses (at licensed dose)
are summarised in Table 16 and are also shown in
the lower parts of Figures 35–45.
Efficacy Infliximab combined with methotrexate is
more effective than methotrexate alone. The
differences between the combination and
63