Plaque psoriasis (initiated by a specialist)
▶BY SUBCUTANEOUS INJECTION
▶Adult: Initially 80 mg, then 40 mg every 2 weeks, to be
started 1 week after initial dose, review treatment if no
response within 16 weeks—consult product literature
Rheumatoid arthritis (initiated by a specialist)
▶BY SUBCUTANEOUS INJECTION
▶Adult: 40 mg every 2 weeks, then increased if necessary
to 40 mg once weekly, alternatively 80 mg every
2 weeks, dose to be increased only in patients receiving
adalimumab alone, review treatment if no response
within 12 weeks
Psoriatic arthritis (initiated by a specialist) | Ankylosing
spondylitis (initiated by a specialist) | Axial
spondyloarthritis (initiated by a specialist)
▶BY SUBCUTANEOUS INJECTION
▶Adult: 40 mg every 2 weeks, review treatment if no
response within 12 weeks
Crohn’s disease (initiated by a specialist)
▶BY SUBCUTANEOUS INJECTION
▶Adult: Initially 80 mg, then 40 mg after 2 weeks;
maintenance 40 mg every 2 weeks, increased if
necessary to 40 mg once weekly, alternatively 80 mg
every 2 weeks, review treatment if no response within
12 weeks
Crohn’s disease (accelerated regimen) (initiated by a
specialist)
▶BY SUBCUTANEOUS INJECTION
▶Adult: Initially 160 mg, dose can alternatively be given
as divided injections over 2 days, then 80 mg after
2 weeks; maintenance 40 mg every 2 weeks, increased
if necessary to 40 mg once weekly, alternatively 80 mg
every 2 weeks, review treatment if no response within
12 weeks
Ulcerative colitis (initiated by a specialist)
▶BY SUBCUTANEOUS INJECTION
▶Adult: Initially 160 mg, dose can alternatively be given
as divided injections over 2 days, then 80 mg after
2 weeks; maintenance 40 mg every 2 weeks, increased
if necessary to 40 mg once weekly, alternatively 80 mg
every 2 weeks, review treatment if no response within
8 weeks
Hidradenitis suppurativa (initiated by a specialist)
▶BY SUBCUTANEOUS INJECTION
▶Adult: Initially 160 mg, dose can alternatively be given
as divided injections over 2 days, followed by 80 mg
after 2 weeks, then maintenance 40 mg once weekly,
after 2 weeks, alternatively 80 mg every 2 weeks, after
2 weeks, review treatment if no response within
12 weeks; if treatment interrupted—consult product
literature
Uveitis (initiated by a specialist)
▶BY SUBCUTANEOUS INJECTION
▶Adult: Initially 80 mg, then 40 mg after 1 week;
maintenance 40 mg every 2 weeks
PDF page 1192
NICE decisions
▶Adalimumab for plaque psoriasis in adults (June 2008)
NICE TA146
Adalimumab is recommended for the treatment of severe
plaque psoriasis which has failed to respond to standard
systemic treatments (including ciclosporin and
methotrexate) and photochemotherapy, or when standard
treatments cannot be used because of intolerance or
contra-indications. Adalimumab should be withdrawn if
the response is not adequate after 16 weeks.
www.nice.org.uk/guidance/ta146
▶Infliximab and adalimumab for Crohn’s disease (May 2010)
NICE TA187
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.
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 treatment, adalimumab can be restarted.
www.nice.org.uk/guidance/ta187
▶Infliximab, adalimumab and golimumab for treating
moderately to severely active ulcerative colitis after the
failure of conventional therapy (February 2015) NICE TA329
Adalimumab 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.
Adalimumab 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
▶Etanercept, infliximab, and adalimumab for the treatment of
psoriatic arthritis (August 2010) NICE TA199
Adalimumab 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).
Adalimumab should be discontinued if there is an
inadequate response at 12 weeks.
www.nice.org.uk/guidance/ta199
▶Adalimumab, etanercept, infliximab, rituximab, and
Musculoskeletal system
abatacept for the treatment of rheumatoid arthritis after the
failure of a TNF inhibitor (August 2010) NICE TA195
Adalimumab, 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. In patients
who cannot use methotrexate because of intolerance or
contra-indications, adalimumab can be given as
monotherapy. 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
▶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
Adalimumab, 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).
Adalimumab can be used as monotherapy in patients who
cannot take methotrexate because it is contra-indicated or
because of intolerance, when the criteria above are met.
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 adalimumab 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).
Adalimumab, certolizumab pegol and etanercept are
also recommended as options for treating severe non-
radiographic axial spondyloarthritis in patients whose
disease has responded inadequately to, or who are
intolerant of, NSAIDs.
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
▶Adalimumab for treating moderate-to-severe hidradenitis
suppurativa (June 2016) NICE TA392
Adalimumab is recommended, within its marketing
authorisation, as an option for treating active moderate-
to-severe hidradenitis suppurativa in adults whose disease
has not responded to conventional systemic therapy. The
drug is recommended only if the manufacturer provides it
at the price agreed in the patient access scheme. Response
should be assessed after 12 weeks of treatment, and the
drug continued only if there is clear evidence of response,
defined as a reduction of 25% or more in the total abscess
and inflammatory nodule count and no increase in
abscesses and draining fistulas.
www.nice.org.uk/guidance/ta392
▶Adalimumab and dexamethasone for treating non-infectious
uveitis (July 2017) NICE TA460
Adalimumab is recommended as an option for treating
non-infectious uveitis in the posterior segment of the eye
in adults with inadequate response to corticosteroids, only
if there is:
. active disease (that is, current inflammation in the eye),
and
. inadequate response or intolerance to
immunosuppressants, and
. systemic disease or both eyes are affected (or one eye is
affected if the second eye has poor visual acuity), and
. worsening vision with a high risk of blindness (for
example, risk of blindness that is similar to that seen in
people with macular oedema).
Stop adalimumab for non-infectious uveitis in the
posterior segment of the eye in adults with inadequate
response to corticosteroids if there is one of the following:
. new active inflammatory chorioretinal or inflammatory
retinal vascular lesions, or both, or
. a two-step increase in vitreous haze or anterior chamber
cell grade, or
. worsening of best corrected visual acuity by three or
more lines or 15 letters.
Patients currently receiving adalimumab whose disease
does not meet the above criteria should be able to
continue treatment until they and their clinician consider
it appropriate to stop.
www.nice.org.uk/guidance/ta460
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium issued similar advice for
plaque psoriasis to NICE TA146 in May 2008.
PDF pages 1193, 1194
