Severe active Crohn’s disease
▶BY INTRAVENOUS INFUSION
▶Adult: Initially 5 mg/kg, then 5 mg/kg after 2 weeks,
then 5 mg/kg after 4 weeks, if condition has responded,
then maintenance 5 mg/kg every 8 weeks
Fistulating Crohn’s disease
▶BY INTRAVENOUS INFUSION
▶Adult: Initially 5 mg/kg, then 5 mg/kg after 2 weeks,
followed by 5 mg/kg after 4 weeks, if condition has
responded consult product literature for guidance on
further doses
Severe active ulcerative colitis
▶BY INTRAVENOUS INFUSION
▶Adult: Initially 5 mg/kg, then 5 mg/kg after 2 weeks,
followed by 5 mg/kg after 4 weeks, then 5 mg/kg every
8 weeks, discontinue if no response 14 weeks after
initial dose
Rheumatoid arthritis (in combination with methotrexate)
▶BY INTRAVENOUS INFUSION
▶Adult: Initially 3 mg/kg, then 3 mg/kg after 2 weeks,
followed by 3 mg/kg after 4 weeks, then 3 mg/kg every
8 weeks, dose to be increased only if response is
inadequate after 12 weeks of initial treatment;
increased in steps of 1.5 mg/kg every 8 weeks,
increased if necessary up to 7.5 mg/kg every 8 weeks,
alternatively increased if necessary to 3 mg/kg every
4 weeks, discontinue if no response by 12 weeks of
initial infusion or after dose adjustment
Ankylosing spondylitis
▶BY INTRAVENOUS INFUSION
▶Adult: 5 mg/kg, then 5 mg/kg after 2 weeks, followed by
5 mg/kg after 4 weeks, then 5 mg/kg every 6–8 weeks,
discontinue if no response by 6 weeks of initial
infusion
Psoriatic arthritis (in combination with methotrexate)
▶BY INTRAVENOUS INFUSION
▶Adult: 5 mg/kg, then 5 mg/kg after 2 weeks, followed by
5 mg/kg after 4 weeks, followed by 5 mg/kg every
8 weeks
Plaque psoriasis
▶BY INTRAVENOUS INFUSION
▶Adult: 5 mg/kg, then 5 mg/kg after 2 weeks, followed by
5 mg/kg after 4 weeks, then 5 mg/kg every 8 weeks,
discontinue if no response within 14 weeks of initial
infusion
PDF page 1201
Moderate or severe heart failure.
severe infections
PDF page 1201
Demyelinating disorders (risk of exacerbation).
dermatomyositis. development of malignancy. hepatitis B
virus—monitor for active infection. history of colon
carcinoma (in inflammatory bowel disease). history of
dysplasia (in inflammatory bowel disease). history of
malignancy. history of prolonged immunosuppressant or
PUVA treatment in patients with psoriasis. mild heart
failure (discontinue if symptoms develop or worsen).
predisposition to infection (discontinue if new serious
infection develops). risk of delayed hypersensitivity
reactions if drug-free interval exceeds 16 weeks (re-
administration after interval exceeding 16 weeks not
recommended)
CAUTIONS, FURTHER INFORMATION
▶Infection Manufacturer advises patients should be up-to-
date with current immunisation schedule before initiating
treatment.
Musculoskeletal system
▶Tuberculosis Manufacturer advises to evaluate patients for
active and latent tuberculosis before treatment. Active
tuberculosis should be treated with standard treatment for
at least 2 months before starting infliximab. If latent
tuberculosis is diagnosed, treatment should be started
before commencing treatment with infliximab. Patients
who have previously received adequate treatment for
tuberculosis can start infliximab but should be monitored
every 3 months for possible recurrence. In patients
without active tuberculosis but who were previously not
treated adequately, chemoprophylaxis should ideally be
completed before starting infliximab. In patients at high
risk of tuberculosis who cannot be assessed by tuberculin
skin test, chemoprophylaxis can be given concurrently
with infliximab. Patients should be advised to seek medical
attention if symptoms suggestive of tuberculosis develop
(e.g. persistent cough, weight loss and fever).
▶Hypersensitivity reactions Hypersensitivity reactions
(including fever, chest pain, hypotension, hypertension,
dyspnoea, transient visual loss, pruritus, urticaria, serum
sickness-like reactions, angioedema, anaphylaxis)
reported during or within 1–2 hours after infusion (risk
greatest during first or second infusion or in patients who
discontinue other immunosuppressants). Manufacturer
advises prophylactic antipyretics, antihistamines, or
hydrocortisone may be administered.
PDF page 1201
Tuberculosis Manufacturer advises patients should be
evaluated for tuberculosis before treatment.
PDF page 1202
Infliximab is
a biological medicine. Biological medicines must be
prescribed and dispensed by brand name, see Biological
medicines and Biosimilar medicines, under Guidance on
prescribing p. 1.
PDF page 1202
NICE decisions
▶Infliximab for plaque psoriasis in adults (January 2008)
NICE TA134
Infliximab is recommended for the treatment of very
severe plaque psoriasis which has failed to respond to
standard systemic treatments (including ciclosporin and
methotrexate) or to photochemotherapy, or when
standard treatments cannot be used because of intolerance
or contra-indications. Infliximab should be withdrawn if
the response is not adequate after 10 weeks.
www.nice.org.uk/guidance/ta134
▶Infliximab for acute exacerbations of ulcerative colitis
(December 2008) NICE TA163
Infliximab is recommended as an option for the treatment
of acute exacerbations of severe ulcerative colitis when
treatment with ciclosporin is contra-indicated or
inappropriate.
www.nice.org.uk/guidance/ta163
▶Infliximab and adalimumab for Crohn’s disease (May 2010)
NICE TA187
Infliximab 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 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 treatment, infliximab can be restarted.
www.nice.org.uk/TA187
▶Adalimumab, etanercept, infliximab, rituximab, and
abatacept for the treatment of rheumatoid arthritis after the
failure of a TNF inhibitor (August 2010) NICE TA195
Infliximab, in combination with methotrexate, is an option
for the treatment of severe active rheumatoid arthritis in
adults who have had an inadequate response to, or have an
intolerance of, other DMARDs including at least 1 TNF
inhibitor, and who cannot use rituximab because of
contra-indications or intolerance. Treatment should be
continued only if there is adequate response. Patients
should be monitored at least every 6 months.
www.nice.org.uk/guidance/ta195
▶Etanercept, infliximab, and adalimumab for the treatment of
psoriatic arthritis (August 2010) NICE TA199
Infliximab is recommended for the treatment of active and
progressive psoriatic arthritis in adults who have
peripheral arthritis with at least 3 tender joints and at least
3 swollen joints, and who have not responded adequately
to at least 2 standard disease-modifying antirheumatic
drugs (used alone or in combination).
Infliximab should be discontinued if there is an
inadequate response at 12 weeks.
www.nice.org.uk/guidance/ta199
▶Infliximab, adalimumab and golimumab for treating
moderately to severely active ulcerative colitis after the
failure of conventional therapy (February 2015) NICE TA329
Infliximab is an option for treating moderately to severely
active ulcerative colitis in adults whose disease has
responded inadequately to conventional therapy including
corticosteroids and mercaptopurine or azathioprine, or in
adults who are intolerant to or have contra-indications for
conventional therapies.
The choice of treatment should be made on an
individual basis and if more than one treatment is suitable,
the least expensive should be chosen.
Infliximab should be given as a planned course of
treatment until treatment fails (including the need for
surgery) or until 12 months after starting treatment,
whichever is shorter. Treatment should be continued only
if there is clear evidence of a response. Patients who
continue treatment should be reassessed at least every
12 months to determine whether ongoing treatment is still
clinically appropriate.
www.nice.org.uk/guidance/ta329
▶Adalimumab, etanercept, infliximab, certolizumab pegol,
golimumab, tocilizumab and abatacept for rheumatoid
arthritis not previously treated with DMARDs or after
conventional DMARDs only have failed (January 2016)
NICE TA375
Infliximab, in combination with methotrexate, is
recommended as an option for treating rheumatoid
arthritis, only if the following criteria are met:
. disease is severe, that is, a disease activity score (DAS28)
greater than 5.1, and,
. disease has not responded to intensive therapy with a
combination of conventional disease-modifying
antirheumatic drugs (DMARDs).
Continue treatment only if there is a moderate response
measured using European League Against Rheumatism
(EULAR) criteria at 6 months after starting therapy. After
initial response within 6 months, withdraw treatment if a
moderate EULAR response is not maintained.
Patients currently receiving infliximab whose disease
does not meet the above criteria should have the option to
continue their treatment until they and their clinician
consider it appropriate to stop.
www.nice.org.uk/guidance/ta375
▶TNF-alpha inhibitors for ankylosing spondylitis and non-
radiographic axial spondyloarthritis (February 2016)
NICE TA383
Adalimumab, certolizumab pegol, etanercept, golimumab
and infliximab are recommended as options for treating
severe active ankylosing spondylitis in patients whose
disease has responded inadequately to, or who are
intolerant of, non-steroidal anti-inflammatory drugs
(NSAIDs). Infliximab is recommended only if treatment is
started with the least expensive infliximab product.
Patients currently receiving infliximab should continue
treatment with the same infliximab product until they and
their clinician considers it appropriate to stop.
The response to treatment should be assessed 12 weeks
after the start of treatment and should only be continued if
there is clear evidence of response.
Treatment with another tumour necrosis factor (TNF) -
alpha inhibitor is recommended in those who cannot
tolerate, or whose disease has not responded to, treatment
with the first TNF-alpha inhibitor, or in those whose
disease has stopped responding after an initial response.
www.nice.org.uk/guidance/ta383
PDF pages 1202, 1203
