A systematic review of the effectiveness of adalimumab

54
Effectiveness
TABLE 11 Summary of 2-year results from TEMPO study: combination of etanercept (25 mg s.c. twice weekly) plus MTX versus MTX
alone in MTX-naïve patients/responders
Comparison or outcome N included Statistical method Effect size (95% CI)
in analysis
ACR20 responder 459 RR (fixed) 1.49 (1.25 to 1.77)*
ACR50 responder 459 RR (fixed) 1.92 (1.52 to 2.41)*
ACR70 responder 459 RR (fixed) 2.53 (1.82 to 3.54)*
RD ACR20 responder 459 RD (fixed) 0.22 (0.13 to 0.30)*
RD ACR50 responder 459 RD (fixed) 0.27 (0.19 to 0.36)*
RD ACR70 responder 459 RD (fixed) 0.25 (0.17 to 0.33)*
SJC, end of study result 459 WMD (fixed) –3.70 (–5.71 to –1.69)*
Patients’ global assessment, end of
study result
459 WMD (fixed) –1.20 (–1.51 to –0.89)*
HAQ, end of study result 459 WMD (fixed) –0.40 (–0.52 to –0.28)*
DAS, end of study result
Modified van de Heijde–Sharp score,
459 WMD (fixed) –0.80 (–1.02 to –0.58)*
mean change from baseline (1-year result) 430 WMD (fixed) –3.34 (–5.12 to –1.56)*
Withdrawal for any reasons 459 RR (fixed) 0.61 (0.48 to 0.77)*
Withdrawal due to lack of efficacy 459 RR (fixed) 0.27 (0.13 to 0.55)*
Withdrawal due to adverse events 459 RR (fixed) 0.80 (0.55 to 1.17)
Death 459 RR (fixed) 0.99 (0.06 to 15.68)
SAEs 459 RR (fixed) 1.25 (0.87 to 1.81)
Malignancy: all 459 RR (fixed) 2.47 (0.48 to 12.59)
Malignancy: skin cancer excluding melanoma
Malignancy: all cancer excluding
459 RR (fixed) 1.97 (0.18 to 21.62)
non-melanoma skin cancer 459 RR (fixed) 2.96 (0.31 to 28.26)
Serious infection 459 RR (fixed) 0.86 (0.42 to 1.76)
Any infection 459 RR (fixed) 1.00 (0.91 to 1.11)
* Statistically significant result at (p < 0.05)
least six swollen joints and six tender joints were
recruited and followed for 14 weeks. The primary
end-point was not stated, although various disease
activity measures and serum matrix
metalloproteinase-3 (MMP-3) were evaluated.
Methods of randomisation, allocation
concealment, patient withdrawals and use of ITT
analysis were not clearly described.
START: Westhovens and colleagues, 2006 105,111
This double-blind, multicentre safety trial
compared infliximab, at two doses (3 or
10 mg kg –1 , i.v., at week 0, 2 and 6, then every
8 weeks thereafter), and placebo in patients
receiving concurrent methotrexate. Patients were
treated for 46 weeks, but patients in the placebo
group were switched to receive infliximab
3mgkg –1 every 8 weeks at week 22. Thus results
beyond week 22 are excluded from this review and
the 22-week results are referred to as the end of
trial results.
Patients who were receiving methotrexate for at
least 3 months and at a stable dose (≤ 25 mg per
week) for at least 4 weeks, with a minimum of six
swollen joints and six tender joints were recruited.
Concomitant stable doses of other DMARDs were
allowed. Twenty-five per cent of the patients were
receiving one or more DMARDs in addition to
methotrexate. The primary end-point was any
occurrence of a serious infection within the first
22 weeks after initiating therapy.
Quinn and colleagues, 2005 141
This small, double-blind, single-centre RCT
compared methotrexate alone (started at 7.5 mg