lPRE-TREATMENT SCREENING
TuberculosisPatients should be evaluated for tuberculosis
before treatment.
lMONITORING REQUIREMENTS
▶Manufacturer advises monitor for infection before, during,
and for 4 months after treatment.
▶Manufacturer advises monitor for non-melanoma skin
cancer before and during treatment, especially in patients
with a history of PUVA treatment for psoriasis or extensive
immunosuppressant therapy.
▶For uveitis, manufacturer advises patients should be
assessed for pre-existing or developing central
demyelinating disorders before and at regular intervals
during treatment.
lPRESCRIBING AND DISPENSING INFORMATION
Adalimumab is a biological medicine. Biological medicines
must be prescribed and dispensed by brand name, see
Biological medicinesandBiosimilar medicines, under
Guidance on prescribing p. 1.
lPATIENT AND CARER ADVICEAn alert card should be
provided.
When used to treathidradenitis suppurativa, patients and
their carers should be advised to use a daily topical
antiseptic wash on lesions during treatment with
adalimumab.
Tuberculosispatients and their carers should be advised to
seek medical attention if symptoms suggestive of
tuberculosis (e.g. persistent cough, weight loss, or, and
fever) develop.
Blood disordersPatients and their carers should be advised
to seek medical attention if symptoms suggestive of blood
disorders (such as fever, sore throat, bruising, or bleeding)
develop.
lNATIONAL FUNDING/ACCESS DECISIONS
NICE decisions
▶Abatacept, adalimumab, etanercept and tocilizumab for
treating juvenile idiopathic arthritis (December 2015 )
NICE TA373
Adalimumab is recommended as an option for treating
polyarticular juvenile idiopathic arthritis (JIA), including
polyarticular‑onset, polyarticular‑course and extended
oligoarticular JIA in patients 2 years and older whose
disease has responded inadequately to 1 or more disease-
modifying antirheumatic drugs (DMARDs) and for treating
enthesitis‑related JIA in patients 6 years and older whose
disease has responded inadequately to, or who are
intolerant of, conventional therapy.
http://www.nice.org.uk/guidance/ta373
▶Adalimumab, etanercept and ustekinumab for treating plaque
psoriasis in children and young people (July 2017 )NICE TA455
Adalimumab is recommended as an option for treating
plaque psoriasis in children and young people aged 4 years
or older, only if the disease:
.is severe, as defined by a total Psoriasis Area and
Severity Index (PASI) of 10 or more and
.has not responded to standard systemic therapy, such as
ciclosporin, methotrexate or phototherapy, or these
options are contra-indicated or not tolerated.
Stop treatment at 16 weeks if the psoriasis has not
responded adequately. An adequate response is defined as
a 75 % reduction in the PASI score from the start of
treatment.
Patients currently receiving adalimumab who do not
meet the above criteria and whose treatment was started
within the NHS before this guidance was published, should
have the option to continue treatment until they and their
clinician consider it appropriate to stop.
http://www.nice.org.uk/guidance/ta455
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (April 2015 )
that adalimumab (Humira®) is accepted for restricted use
within NHS Scotland for the treatment of active enthesitis-
related arthritis in children 6 years of age and over who
have had an inadequate response to, or who are intolerant
of, conventional therapy, and is used within specialist
rheumatology services (including those working within the
network for paediatric rheumatology).
TheScottish Medicines Consortiumhas advised (June
2017 ) that adalimumab (Humira®) is accepted for use
within NHS Scotland for the treatment of active moderate-
to-severe hidradenitis suppurativa (HS) (acne inversa) in
adolescents from 12 years of age with an inadequate
response to conventional systemic HS therapy.
All Wales Medicines Strategy Group (AWMSG) Decisions
TheAll Wales Medicines Strategy Grouphas advised
(January 2017 ) that adalimumab (Humira®)is
recommended as an option for use within NHS Wales for
the treatment of moderately to severely active Crohn’s
disease in children 6 years and over, who have had an
inadequate response to conventional therapy including
primary nutrition therapy and a corticosteroid and/or an
immunomodulator, or who are intolerant to or have
contra-indications for such therapies.
TheAll Wales Medicines Strategy Grouphas advised
(August 2017 ) that adalimumab (Humira®)is
recommended as an option for use within NHS Wales for
the treatment of active moderate to severe hidradenitis
suppurativa (acne inversa) in adolescents from 12 years of
age with an inadequate response to conventional systemic
hidradenitis suppurativa therapy. This advice is contingent
upon the continuing availability of the Wales Patient
Access Scheme or a list price that is equivalent or lower.
TheAll Wales Medicines Strategy Grouphas advised
(December 2017 ) that adalimumab (Humira®)is
recommended as an option for use within NHS Wales for
the treatment of paediatric chronic non-infectious
anterior uveitis in patients from two years of age who have
had an inadequate response to or are intolerant to
conventional therapy, or in whom conventional therapy is
inappropriate.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for injection
CAUTIONARY AND ADVISORY LABELS 10
▶Humira(AbbVie Ltd)
Adalimumab 50 mg per 1 mlHumira 40 mg/ 0. 8 ml solution for
injection vials| 2 vialP£ 704. 28
Adalimumab 100 mg per 1 mlHumira 40 mg/ 0. 4 ml solution for
injection pre-filled pen| 2 pre-filled disposable injectionP
£ 704. 28 DT = £ 704. 28
Humira 20 mg/ 0. 2 ml solution for injection pre-filled syringes| 2 pre-
filled disposable injectionP£ 352. 14
Humira 40 mg/ 0. 4 ml solution for injection pre-filled syringes| 2 pre-
filled disposable injectionP£ 704. 28 DT = £ 704. 28Etanercept 14-Sep-2017
lINDICATIONS AND DOSE
BENEPALI®SOLUTION FOR INJECTION
Polyarthritis in children who have had an inadequate
response to methotrexate or who cannot tolerate it|
Extended oligoarthritis in children who have had an
inadequate response to methotrexate or who cannot
tolerate it
▶BY SUBCUTANEOUS INJECTION
▶Child 2–17 years: 800 micrograms/kg once weekly (max.
per dose 50 mg), consider discontinuation if no
response after 4 months continued→BNFC 2018 – 2019 Arthritis 643
Musculoskeletal system10