REVIEW
Adherence to NICE criteria for initiation and continuation of treatment with a biologic in atopic dermatitis
Here we report on a retrospective study undertaken in a UK hospital to investigate adherence to National Institute for Health and Care Excellence ( NICE ) criteria and guidance in treatment of atopic dermatitis with a biologic therapy
Michael Wilcock BSc ( Hons ) MPhil Leanne Roberson MAPharmT Pharmacy Department
Alison McInnes DIP ( HE ) Nursing / NIP Dermatology Department Royal Cornwall Hospitals NHS Trust , Truro , UK
GETTY
Atopic dermatitis ( AD ) is a chronic , recurrently flaring , generalised skin condition that can be life-limiting , debilitating and isolating . It can affect all aspects of life ( physical , psychological , social and financial ). Severe disease is associated with intolerable itch that disrupts sleep , and there is a higher risk of depression and suicide . 1 It affects 2 %– 10 % of adults worldwide and can be associated with other systemic disorders such as asthma . 2
The severity of atopic dermatitis and its effect on quality of life is assessed by a variety of scoring systems that include both subjective and objective measurements . 3 A typical treatment pathway involves emollients and topical corticosteroids ( first line ), topical calcineurin inhibitors ( i . e ., tacrolimus , pimecrolimus ) as second line , phototherapy ( third line ) and systemic immunosuppressant therapies ( fourth line ) including oral corticosteroids , ciclosporin ( the only licensed drug ), methotrexate , azathioprine and mycophenolate mofetil . Long term use of systemic agents is not recommended due to the risk of adverse side effects . 4
Dupilumab was the first therapy to be approved for moderate-to-severe AD that does not respond to topical therapies based on large , randomised , double-blind placebocontrolled clinical trials . 5 – 7 Dupilumab ( Dupixent , Sanofi Genzyme ) is a human monoclonal antibody that targets the signalling mechanisms of cytokines interleukin ( IL ) -4 and IL-13 . It is indicated for the ‘ treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy ’. It is given by subcutaneous injection and the recommended dose is 300mg every two weeks after an initial loading dose of 600 mg ( two 300mg injections at different sites ). Various national guidelines position dupilumab either after other systemic therapies 6 or as another systemic therapy option in the pathway for uncontrolled atopic dermatitis . 7 – 9
Across England and Wales , guidance from the National Institute for Health and Care Excellence ( NICE ) assesses the clinical and cost effectiveness of health technologies , including pharmaceuticals . The National Health Service ( NHS ) is legally obliged to fund and resource medicines and treatments recommended by NICE ’ s technology appraisals ( TA ). Furthermore , the NHS Constitution , which sets out rights to which patients , public and staff are entitled , and pledges which the NHS is committed to achieve , states that patients have the right to drugs and treatments that have been recommended by NICE for use in the NHS , if their doctor believes they are clinically appropriate . 8
Within the NICE TA , dupilumab is recommended as an option for treating moderate to severe AD in adults , only if : the disease has not responded to at least one other systemic therapy , such as ciclosporin , methotrexate , azathioprine and mycophenolate mofetil , or these are contraindicated or not tolerated ; and the company provides dupilumab according to the commercial arrangement . Dupilumab should be stopped at 16 weeks if the AD has not responded adequately . An adequate response is : at least a 50 % reduction in the Eczema Area and Severity Index ( EASI ) score from when treatment started ; and at least a 4-point reduction in the Dermatology Life Quality Index ( DLQI ) from when treatment started . 1
EASI assesses both lesional intensity and extent . Four
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