page80
responded adequately to treatment with a corticosteroid
and a
conventional
drug
that
affects
the
immune
response,
or who are intolerant of them.
NICE guidance
Infliximab and adalimumab for Crohn’s
disease (May 2010)
Infliximab or adalimumab is recommended for the
treatment of severe active Crohn’s disease that has
not
responded to conventional
therapy (including
corticosteroids
and
other
drugs
affecting
the
immune response)
or
when conventional
therapy
cannot
be used because of
intolerance or
contra-
indications;
infliximab can also be used in a similar
way in children over 6 years of age. In adults over 18
years
of
age,
infliximab is recommended for
the
treatment
of
fistulating Crohn’s
disease that
has
not
responded to conventional
therapy (including
antibacterials,
drainage,
and other
drugs affecting
the immune response) or when conventional therapy
cannot
be used because of
intolerance or
contra-
indications.
Infliximab or
adalimumab should be given as
a
planned course of treatment for 12 months or until
treatment
failure,
whichever
is shorter.
Treatment
should be continued beyond 12 months only if there
is evidence of
active disease—in these cases the
need for
treatment
should be reviewed at
least
annually. If the disease relapses after stopping treat-
ment,
adalimumab or
infliximab can be restarted
(but
see Hypersensitivity Reactions under
Inflixi-
mab,
p.
66).
NICE guidance
Infliximab for subacute manifestations of
ulcerative colitis (April 2008)
Infliximab is not recommended for the treatment of
subacute
manifestations
of
moderate
to
severe
active ulcerative colitis that would normally be man-
aged in an outpatient setting.
NICE guidance
Infliximab for acute exacerbations of
ulcerative colitis (December 2008)
Infliximab is recommended as an option for
the
treatment
of
acute exacerbations of
severe ulcer-
ative colitis when treatment with ciclosporin is con-
tra-indicated or inappropriate.
Adalimumab (section 1.5.3)
is licensed for the treat-
ment of severe active Crohn’s disease in patients whose
condition has not
responded adequately to treatment
with a corticosteroid and a conventional
drug that
affects the immune response,
or who are intolerant of
them.
For inducing remission,
adalimumab should be
used in combination with a corticosteroid, but it may be
given alone if a corticosteroid is inappropriate or is not
tolerated.
Adalimumab may also be used for Crohn’s
disease in patients
who have relapsed while taking
infliximab or
who cannot
tolerate infliximab because
of hypersensitivity reactions.
Maintenance of
remission of
acute ulcerative
colitis and Crohn’s disease
Smoking cessation
(section 4.10.2)
reduces the risk of
relapse in Crohn’s
disease and should be encouraged.
Aminosalicylates
are efficacious in the maintenance of remission of ulcer-
ative colitis,
but there is no evidence of efficacy in the
maintenance of remission of Crohn’s disease.
Corticos-
teroids
are not
suitable for
maintenance treatment
because of
their side-effects.
In resistant or frequently
relapsing cases either azathioprine (section 1.5.3) [unli-
censed indication]
or
mercaptopurine (section 1.5.3)
[unlicensed indication],
given under close supervision
may be helpful.
Methotrexate (section 1.5.3) is tried in
Crohn’s disease if azathioprine or mercaptopurine can-
not be used [unlicensed indication].
Maintenance ther-
apy with infliximab should be considered for patients
with Crohn’s disease or ulcerative colitis who respond to
the initial
induction course of infliximab;
fixed-interval
dosing is superior to intermittent dosing.
Adalimumab
is licensed for maintenance therapy in Crohn’s disease.
Fistulating Crohn’s disease
Treatment may not be
necessary for
simple,
asymptomatic perianal
fistulas.
Metronidazole (section 5.1.11)
or ciprofloxacin (sec-
tion
5.1.12)
can
improve
symptoms
of
fistulating
Crohn’s
disease but
complete healing occurs
rarely
[unlicensed indication].
Metronidazole
by
mouth is
used at a dose of
10–20 mg/kg daily in divided doses
(usual dose 400–500 mg 3 times daily); it is usually given
for 1 month but
no longer than 3 months because of
concerns about peripheral neuropathy. Ciprofloxacin by
mouth is given at a dose of
500 mg twice daily.
Other
antibacterials should be given if
specifically indicated
(e.g. sepsis associated with fistulas and perianal disease)
and for
managing bacterial
overgrowth in the small
bowel.
Fistulas may also require surgical
exploration
and local drainage.
Either azathioprine or
mercaptopurine is used as a
second-line treatment for fistulating Crohn’s disease and
continued
for
maintenance
[unlicensed
indication].
Infliximab is used for fistulating Crohn’s disease refrac-
tory to conventional treatments; fixed-interval dosing is
superior
to intermittent
dosing.
Maintenance therapy
with infliximab should be considered for patients who
respond to the initial
induction course of
infliximab.
Adalimumab can be used if
there is intolerance to
infliximab [unlicensed indication]
Adjunctive treatment of inflammatory bowel dis-
ease
Due attention should be paid to diet; high-fibre or
low-residue diets should be used as appropriate.
Antimotility drugs such as codeine and loperamide, and
antispasmodic drugs may precipitate paralytic ileus and
megacolon in active ulcerative colitis;
treatment of the
inflammation is more logical. Laxatives may be required
in proctitis. Diarrhoea resulting from the loss of bile-salt
absorption (e.g. in terminal ileal disease or bowel resec-
tion) may improve with colestyramine (section 1.9.2),
which binds bile salts.
Clostridium difficile infection
Clostridium difficile
infection is caused by colonisation
of the colon with
Clostridium difficile
and production of
toxin. It often follows antibiotic therapy and is usually of
acute onset,
but may become chronic.
It is a particular
hazard of ampicillin, amoxicillin, co-amoxiclav, second-
and third-generation cephalosporins,
clindamycin,
and
quinolones,
but
few antibiotics are free of
this side-
effect.
Oral
metronidazole (see section 5.1.11) or oral
vancomycin (see section 5.1.7)
are used as specific
treatment;
vancomycin may be preferred for very sick
patients.
Metronidazole can be given by intravenous
infusion if oral treatment is inappropriate.
60
1.5 Chronic bowel disorders
BNF 61
1
Gastro-intestinal system