BENEPALI ® SOLUTION FOR INJECTION
Moderate-to-severe active rheumatoid arthritis (alone or
in combination with methotrexate) when the response to
other disease-modifying antirheumatic drugs is
inadequate | Severe, active and progressive rheumatoid
arthritis not previously treated with methotrexate |
Active and progressive psoriatic arthritis when the
response to other disease-modifying antirheumatic
drugs is inadequate | Severe active ankylosing
spondylitis when the response to conventional therapy is
inadequate | Severe, non-radiographic axial
spondyloarthritis when the response to non-steroidal
anti-inflammatory drugs is inadequate
▶BY SUBCUTANEOUS INJECTION
▶Adult: 50 mg once weekly, review treatment if no
response within 12 weeks of initial dose
Moderate-to-severe plaque psoriasis when the response
to other systemic therapies or psoralen and ultraviolet-A
light (PUVA) is inadequate, or when these therapies
cannot be used because of intolerance or contra-
indications
▶BY SUBCUTANEOUS INJECTION
▶Adult: 50 mg once weekly, alternatively 50 mg twice
weekly for up to 12 weeks, followed by 50 mg once
weekly if required continue treatment for up to
24 weeks—continuous therapy beyond 24 weeks may be
appropriate in some patients (consult product
literature), discontinue if no response after 12 weeks
ENBREL ® POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
Moderate-to-severe active rheumatoid arthritis (alone or
in combination with methotrexate) when the response to
other disease-modifying antirheumatic drugs is
inadequate | Severe, active and progressive rheumatoid
arthritis not previously treated with methotrexate|
Active and progressive psoriatic arthritis when the
response to other disease-modifying antirheumatic
drugs is inadequate | Severe active ankylosing
spondylitis when the response to conventional therapy is
inadequate | Severe, non-radiographic axial
spondyloarthritis when the response to non-steroidal
anti-inflammatory drugs is inadequate
▶BY SUBCUTANEOUS INJECTION
Musculoskeletal system
▶Adult: 25 mg twice weekly, alternatively 50 mg once
weekly, review treatment if no response within
12 weeks of initial dose
Moderate-to-severe plaque psoriasis when the response
to other systemic therapies or psoralen and ultraviolet-A
light (PUVA) is inadequate, or when these therapies
cannot be used because of intolerance or contra-
indications
▶BY SUBCUTANEOUS INJECTION
▶Adult: 25 mg twice weekly, alternatively 50 mg once
weekly, alternatively 50 mg twice weekly for up to
12 weeks, followed by 25 mg twice weekly, alternatively
50 mg once weekly if required continue treatment for
up to 24 weeks—continuous therapy beyond 24 weeks
may be appropriate in some patients (consult product
literature), discontinue if no response after 12 weeks
ENBREL ® SOLUTION FOR INJECTION
Moderate-to-severe active rheumatoid arthritis (alone or
in combination with methotrexate) when the response to
other disease-modifying antirheumatic drugs is
inadequate | Severe, active and progressive rheumatoid
arthritis not previously treated with methotrexate|
Active and progressive psoriatic arthritis when the
response to other disease-modifying antirheumatic
drugs is inadequate | Severe active ankylosing
spondylitis when the response to conventional therapy is
inadequate | Severe, non-radiographic axial
spondyloarthritis when the response to non-steroidal
anti-inflammatory drugs is inadequate
▶BY SUBCUTANEOUS INJECTION
▶Adult: 25 mg twice weekly, alternatively 50 mg once
weekly, review treatment if no response within
12 weeks of initial dose
Moderate-to-severe plaque psoriasis when the response
to other systemic therapies or psoralen and ultraviolet-A
light (PUVA) is inadequate, or when these therapies
cannot be used because of intolerance or contra-
indications
▶BY SUBCUTANEOUS INJECTION
▶Adult: 25 mg twice weekly, alternatively 50 mg once
weekly, alternatively 50 mg twice weekly for up to
12 weeks, followed by 25 mg twice weekly, alternatively
50 mg once weekly if required continue treatment for
up to 24 weeks—continuous therapy beyond 24 weeks
may be appropriate in some patients (consult product
literature), discontinue if no response after 12 weeks
PDF page 1197
Active infection
PDF page 1197
Development of malignancy. diabetes mellitus
. heart failure (risk of exacerbation). hepatitis B virus—
monitor for active infection. hepatitis C infection
(monitor for worsening infection). history of blood
disorders. history of malignancy. history or increased risk
of demyelinating disorders. predisposition to infection
(avoid if predisposition to septicaemia). significant
exposure to herpes zoster virus—interrupt treatment and
consider varicella–zoster immunoglobulin
CAUTIONS, FURTHER INFORMATION
▶Tuberculosis Active tuberculosis should be treated with
standard treatment for at least 2 months before starting
etanercept. Patients who have previously received
adequate treatment for tuberculosis can start etanercept
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 etanercept. In patients at high risk of tuberculosis
who cannot be assessed by tuberculin skin test,
chemoprophylaxis can be given concurrently with
etanercept.
Musculoskeletal system
PDF pages 1197, 1198
Tuberculosis Patients should be evaluated for tuberculosis
before treatment.
PDF page 1198
Etanercept
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 1198
NICE decisions
▶Etanercept and efalizumab for plaque psoriasis (July 2006)
NICE TA103
Etanercept is recommended for severe plaque psoriasis
which has failed to respond to standard systemic
treatments (including ciclosporin and methotrexate) and
to photochemotherapy, or when standard treatments
cannot be used because of intolerance or contra-
indications. Etanercept should be withdrawn if the
response is not adequate after 12 weeks.
www.nice.org.uk/guidance/ta103
▶Adalimumab, etanercept, infliximab, rituximab, and
abatacept for the treatment of rheumatoid arthritis after the
failure of a TNF inhibitor (August 2010) NICE TA195
Etanercept, 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, etanercept 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
▶Etanercept, infliximab, and adalimumab for the treatment of
psoriatic arthritis (August 2010) NICE TA199
Etanercept 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).
Etanercept should be discontinued if there is an
inadequate response at 12 weeks.
www.nice.org.uk/guidance/ta199
▶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
Etanercept, 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)
Etanercept 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 etanercept 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
Etanercept is recommended as an option 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).
Etanercept is also recommended as an option 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
PDF pages 1198, 1199
