Background: Adalimumab (ADA) is a fully human monoclonal
antibody which binds with a high affinity and specificity to
tumor necrosis factor (TNFa). Controlled clinical trials have
demonstrated its efficacy and safety in the treatment of
moderate-to-severe Crohn's disease (CD). However, long term
experience with ADA in real-life clinical practice has rarely
been reported.
Objective: to assess the long term effectiveness and the safety
of ADA in a multicenter cohort of patients with moderate-tosevere
CD.
Methods: Fifty-five patients (21 men, 34 women), mean
age 37.5 years (±11.4 years), median disease duration
12.7 years (range 1 41 years) were treated with ADA and
followed up over a period of 52 weeks (range 12 96 weeks,
median 50 weeks). Thirty-eight patients had previously been
treated with infliximab (IFX). The ADA induction regimen was
160/80 mg in 31 patients and 80/40 mg in 24 patients. The
clinical evolution during treatment was evaluated with the
Harvey Bradshaw Index (HBI) at week (W) 4 6, 12, 24 and 52.
Patients were classified in three categories: remission (HBI < 4
pts), response (reduction HBI >3 pts) and non response.
Results: On week 4 6, a response was demonstrated in 83.6 %
patients and remission was obtained in 52.7%. The remission
was maintained in 89.6% and 72.4% of the patients at W12
and W24, respectively. In per protocol analysis at W52, half
of patients were still in response and half had stopped ADA:
5/19 because of adverse events and 14/19 because of no
response or loss of response. Thirteen patients (23.6%) needed
a dose escalation after a mean interval of 7 months (range
1 24 month). The response rate at W4 6 was not influenced
by gender, smoking status, disease duration, localisation of
disease, previous surgery, previous IFX treatment, the first
month total ADA dose, or the first month ADA dose divided
by body weight. Interestingly, however, the remission rate at
W4 6 was significantly higher in patients intolerant (78.9%) to
IFX, as compared to those who had lost response to IFX (42.1%;
p = 0.02). Overall ADA was well tolerated, 54.5% patients didn't
report any side effects. The most common side effect was pain
at the injection site (10.9%), followed by asthenia (9%) and
infections (7.2%).
Conclusion: ADA was effective and safe in clinical practice as
induction and maintenance therapy for patients with moderateto-
severe CD.