A systematic review of the effectiveness of adalimumab

TABLE 14 Key outcomes for the BeSt study
a research nurse who was blinded to treatment
allocation. Patients had a mean age of between 54
and 55 years, 68% were women, all met ARA
disease classification criteria despite a median
time from diagnosis of 2 weeks, and 65% had a
positive rheumatoid factor blood test.
Key outcomes of this study are shown in the
Table 14. Patients in groups 3 and 4 improved
more rapidly than those in groups 1 and 2
(p < 0.001), but at 1 year differences were less
marked (p < 0.009). No statistically significant
differences were found on comparing group 1 with
group 2, or on comparing group 3 with group 4.
Similarly, significantly less radiographic
progression (p < 0.007 or less) was seen in groups
3 and 4 than in groups 1 and 2, at 1 year.
Radiographic joint damage did not progress in
67%, 73%, 87% and 93% of patients in groups 1 to
4, respectively. Minor gastrointestinal and skin
reactions were the most frequently reported
adverse events. Ten patients (8%) in group 4 had
an infusion reaction to infliximab necessitating
drug cessation. SAEs occurred in 6%, 7%, 13% and
5% in groups 1–4, respectively; no clear pattern of
adverse reactions was noted.
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Health Technology Assessment 2006; Vol. 10: No. 42
Treatment sequence
Outcome Group 1 Group 2 Group 3 Group 4
Sequential Step-up Initial Initial
monotherapy combination combination combination
with prednisolone with infliximab
HAQ (mean ± SD)
Baseline 1.4 ± 0.7 1.4 ± 0.6 1.4 ± 0.7 1.4 ± 0.7
3 months 1.0 ± 0.7 1.0 ± 0.6 0.6 ± 0.6 0.6 ± 0.6
12 months
DAS44 (mean ± SD)
0.7 ± 0.7 0.7 ± 0.6 0.5 ± 0.5 0.5 ± 0.5
Baseline 4.5 ± 0.9 4.5 ± 0.8 4.4 ± 0.9 4.3 ± 0.9
3 months 3.5 ± 1.1 3.5 ± 1.2 2.4 ± 1.0 2.6 ± 1.1
12 months
ACR20
2.3 ± 1.1 2.2 ± 1.0 2.0 ± 0.9 2.0 ± 1.0
3 months 30% 37% 71% 60%
12 months
ACR50
64% 63% 78% 79%
3 months 7% 9% 48% 39%
12 months
ACR70
43% 46% 62% 62%
3 months 2% 3% 21% 19%
12 months 19% 22% 30% 40%
Increase in total 2.0 (0.0–7.4) 2.5 (0.0–6.0) 1.0 (0.0–2.5) 0.5 (0.0–2.3)
van der Heijde–Sharp score:
Median (IQR)
Of the 128 patients allocated to group 4, which
included infliximab at inception, two patients
(1.6%), who had latent tuberculosis, declined
prophylactic antituberculosis therapy. The
percentages of patients receiving infliximab in
groups 1, 2 and 3 after 12 months or more were
20%, 3% and 6%, respectively; recall that patients
in this trial had therapies withdrawn because of a
sustained DAS of