13.5.3 Drugs affecting the immune response

Drugs which affect the immune response in skin conditions, listed elsewhere in the formulary:

Topical calcineurin inhibitors (TCIs) should only be used if the eczema has not shown a satisfactory clinical response to adequate use of the maximum strength and potency of topical steroid that is appropriate for the patient's age and the area being treated, and/or if there is risk of important adverse effects from topical corticosteroid treatment.

Consider TCI therapy particularly for eczema of the face (especially eyelids) or flexures in children or adults requiring long term or frequent use of mild or moderate potency topical corticosteroids.

Skin irritation (itching and burning sensation) is very common during the first 1-2 weeks of TCI therapy and usually improves with time.

Irritant side effects may be minimised by introducing TCIs after a 5-7 day burst of topical steroid therapy (e.g. moderate potency topical steroid for face and flexures and potent for body and limbs).

Treatment with TCIs should only be initiated by prescribers with appropriate experience in treating atopic eczema.

Until more is known about the photocarcinogenic potential of topical calcineurin inhibitors, patients should be advised to take sensible sun precautions and avoid excessive exposure to sunlight when using these products.

Do not use topical tacrolimus or pimecrolimus:

  • for mild atopic eczema
  • as first-line treatment for atopic eczema of any severity
  • under bandages or dressings without specialist dermatological advice
Pimecrolimus
  • Cream 1% (£19.69 = 30g)

Indications

  • Short-term treatment of mild to moderate atopic eczema (including flares) when topical corticosteroids cannot be used

Dose

  • Short-term treatment: Apply twice daily until symptoms resolve (stop if eczema worsens or no response after 6 weeks). Reduce to once daily if symptoms allow

Notes

  1. NICE TA82: Tacrolimus and pimecrolimus for atopic eczema (August 2004):
    1. Topical pimecrolimus (Elidel) is not recommended for the treatment of mild atopic eczema or as first-line treatments for atopic eczema of any severity
    2. Topical pimecrolimus (Elidel) is recommended as an option for the second-line treatment of moderate atopic eczema on the face and neck in children aged 2 to 16 years that has not been controlled by topical corticosteroids, where there is a serious risk of important adverse effects from further topical corticosteroid use, particularly irreversible skin atrophy
Tacrolimus
  • Ointment 0.1% (adults and child over 16 years) (£19.95 = 30g)
  • Ointment 0.03% (child aged 2 to 16 years) (£23.33 = 30g)

Indications

Dose

  • Short-term treatment: Apply twice daily until lesions clear (stop if eczema worsens or no response after 2 weeks). Reduce to once daily if symptoms allow. In children, only the 0.03% strength of topical tacrolimus should be used
  • Prevention of flares: Apply twice weekly (see BNF). Use short-term treatment regimen during an acute flare

Notes

  1. NICE TA82: Tacrolimus and pimecrolimus for atopic eczema (August 2004):
    1. Topical tacrolimus (Protopic) is not recommended for the treatment of mild atopic eczema or as first-line treatments for atopic eczema of any severity
    2. Topical tacrolimus (Protopic) is recommended as an option for the second-line treatment of moderate atopic eczema on the face and neck in children aged 2 to 16 years that has not been controlled by topical corticosteroids, where there is a serious risk of important adverse effects from further topical corticosteroid use, particularly irreversible skin atrophy

Cytokine modulators

Bimekizumab
  • Solution for injection in pre-filled pens 160mg

Notes

  1. NICE TA723: Bimekizumab (Bimzelx) is recommended as an option for treating plaque psoriasis in adults (September 2021), only if:
    1. the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and
    2. the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and
    3. the company provides the drug according to the commercial arrangement
    4. refer to TA723 for stopping criteria and other considerations
Brodalumab
  • Solution for injection in pre-filled syringe 210mg in 1.5ml

Notes

  1. NICE TA511: Brodalumab (Kyntheum) isrecommended as an option for treating plaque psoriasis in adults, only when the criteria of the NICE TA are met (March 2018)
Dupilumab
  • Solution for injection 150mg in 1ml

Notes

  1. NICE TA534: Dupilumab (Dupixent) is recommended as an option for treating moderate to severe atopic dermatitis in adults, only when the criteria of the NICE TA are met (August 2018)
Guselkumab
  • Solution for injection 100mg in 1ml

Notes

  1. NICE TA521: Guselkumab (Tremfya) is recommended as an option for treating plaque psoriasis in adults, only when the criteria of the NICE TA are met (June 2018)
  2. NICE TA711: Guselkumab (Tremfya), alone or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them (June 2021), only if they have:
    1. peripheral arthritis with 3 or more tender joints and 3 or more swollen joints
    2. moderate to severe psoriasis (a body surface area of at least 3% affected by plaque psoriasis and a Psoriasis Area and Severity Index [PASI] score greater than 10)
    3. had 2 conventional DMARDs and at least 1 biological DMARD
    4. Guselkumab is recommended only if the company provides it according to the commercial arrangement
    5. refer to TA711 for stopping criteria and other considerations
Ixekizumab
  • Solution for injection prefilled pen or prefilled syringes 80mg in 1ml

Notes

  1. NICE TA442: Ixekizumab (Taltz) is recommended as an option for treating plaque psoriasis in adults, only when the criteria of the NICE TA are met (April 2017)
  2. NICE TA537: Ixekizumab (Taltz) alone, or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults, only when the criteria of the NICE TA are met (August 2018)
  3. NICE TA718: Ixekizumab (Taltz) is recommended as an option for treating active ankylosing spondylitis that is not controlled well enough with conventional therapy, or active non-radiographic axial spondyloarthritis with objective signs of inflammation (shown by elevated C-reactive protein or MRI) that is not controlled well enough with non-steroidal anti-inflammatory drugs (NSAIDs), in adults (July 2021). It is recommended only if:
    1. tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and
    2. the company provides ixekizumab according to the commercial arrangement.
    3. Refer to TA718 for continuation criteria and other considerations
Risankizumab
  • Solution for injection pre-filled syringes 150mg in 1ml

Notes

  1. NICE TA596: Risankizumab (Skyrizi) is recommended as an option for treating plaque psoriasis in adults only when the criteria of the NICE TA are met (August 2019)
Tildrakizumab
  • Solution for injection pre-filled syringes 100mg in 1ml

Notes

  1. NICE TA575: Tildrakizumab (Ilumetri) is recommended as an option for treating plaque psoriasis in adults, only when the criteria of the NICE TA are met (April 2019)

 

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