13.5.3. Drugs affecting the immune response
Restrictions:
Restricted to use under specialist dermatological supervision
Prescribing Notes:
Can be used for severe atopic dermatitis or severe psoriasis when conventional therapy has failed.
Prescribe by brand name.
Restrictions:
Restricted to use under specialist dermatological supervision.
Prescribing Notes:
Near Patient Testing (NPT) arrangements for GPs may be in place for this medicine. See the relevant section in the Prescribing Resources page for current information.
Restrictions:
Restricted to specialist use for the treatment of moderate-to-severe atopic dermatitis in patients who
have had an inadequate response to an existing systemic immunosuppressant such as ciclosporin, or
in whom such treatment is considered unsuitable.
Prescribing Notes:
Following a MHRA review in April 2023, the risk of increased incidence of malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality, when compared to those treated with tumour necrosis factor (TNF)-alpha inhibitors, were are considered a class effects across JAK inhibitors used for chronic inflammatory disorders and therefore it is advised to avoid prescribing these medicines unless there are no suitable alternatives in patients with the following risk factors:
- age 65 years or older
- current or past long-time smoking
- other risk factors for cardiovascular disease or malignancy
Please see further details of the review here.
Restrictions:
Restrictions apply as per prescribing notes below.
Prescribing Notes:
Adalimumab should be prescribed by brand name. Amgevita® is the preferred biosimilar.
Formulary indications:
- Treatment of chronic plaque psoriasis is restricted to specialist use only in patients with severe disease as defined by a total Psoriasis Area Severity Index (PASI) score of >10 and a Dermatology Life Quality Index (DLQI) of >10.
- Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients with an inadequate response to conventional systemic HS therapy is restricted to specialist use only.
For use in other indications, see sections 1.5.3, 11.8 and 10.1.3.
Restrictions:
The treatment of moderate to severe chronic plaque psoriasis in adults patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) is restricted to specialist initiation.
Prescribing Notes:
- Specialist secondary care clinics continue to have responsibility for:
- providing prescription for the initiation pack
- all monitoring
- assessment of response
- GPs can obtain advice from specialist clinics (contact details provided with each patient request)
- Further information can be found in the accompanying GP Information sheet
For other indications please see chapter 10.1.3
Restrictions:
Restricted to specialist use in accordance with local guidelines for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy who have failed at least one current systemic immunosuppressant due to intolerance, contraindication or inadequate disease control.
Prescribing Notes:
Following a MHRA review in April 2023, the risk of increased incidence of malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality, when compared to those treated with tumour necrosis factor (TNF)-alpha inhibitors, were are considered a class effects across JAK inhibitors used for chronic inflammatory disorders and therefore it is advised to avoid prescribing these medicines unless there are no suitable alternatives in patients with the following risk factors:
- age 65 years or older
- current or past long-time smoking
- other risk factors for cardiovascular disease or malignancy
Please see further details of the review here.
Restrictions:
Restricted to specialist use in accordance with local guidelines in patients with the following indication.
Psoriasis
Patients with moderate to severe psoriasis who have failed to respond to standard systemic therapies, are intolerant to, or have a contra-indication to these treatments.
Restrictions:
Restricted to specialist use in accordance with local guidelines in patients with moderate to severe plaque psoriasis who have failed to repond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra-indication to these medicines.
Restrictions:
Restricted to specialist use in accordance with local guidelines in patients with moderate to severe plaque psoriasis who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra-indication to these treatments.
Prescribing Notes:
For uses in rheumatology, see section 10.1.3
Restrictions:
Restricted to specialist use only for the treatment of moderate to severe plaque psoriasis in adults who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contraindication to these treatments.
Restrictions:
Restricted to specialist use only in patients in whom other non-biologic systemic treatments (methotrexate, ciclosporin and acitretin) are not appropriate, or have failed and who are considered unsuitable for biologic therapy given they current disease state or personal preference,
Restrictions:
Atopic dermatitis:
The use in the treatment of moderate-to-severe atopic dermatitis in adults is restricted to use in accordance with local guidelines in patients who have had an inadequate response to existing systemic immunosuppressants such as ciclosporin, or in whom such treatment is considered unsuitable.
Prurigo nodularis:
Treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
Restrictions:
Restricted to specialist use only.
- Use for adults with psoriasis is restricted to initiation and supervision only by specialist physicians in accordance with NICE Technology Appraisal 103.
- Use for the treatment of chronic severe plaque psoriasis in children and adolescents is restricted to specialist use in patients where the disease:
- is severe as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10,
- has failed to respond to standard systemic therapies or the patient is intolerant to, or has a contraindication to these treatments,
- Etanercept should be discontinued in patients whose psoriasis has not responded adequately at 12 weeks.
Prescribing Notes:
Etanercept should be prescribed by brand name. Benepali® is the preferred biosimilar.
Restrictions:
Restricted to specialist use in accordance with local guidelines in patients with moderate to severe plaque psoriasis who have failed to respond to conventional systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra-indication to these treatments.
Restrictions:
Restricted to specialist use only. Treatment of severe plaque psoriasis in adults is restricted to specialist use in patients who failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapy including ciclosporin, methotrexate or psoralen ultraviolet A (PUVA) and in accordance with the local approved protocol.
Prescribing Notes:
Infliximab should be prescribed by brand name. Remsima® is the preferred biosimilar.
Restrictions:
Restricted to specialist use in patients with moderate to severe plaque psoriasis who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra-indication to these treatments
Prescribing Notes:
For use in psoriatic arthritis, see section 10.1.3
Restrictions:
Restricted to specialist use only. Restricted to use under specialist dermatological supervision.
Prescribing Notes:
Near Patient Testing (NPT) arrangements for GPs may be in place for this medicine. See the relevant section in the Prescribing Resources page for current information.
Restrictions:
Restricted to initiation by physicians experienced in the management of eczema. It is restricted to the management of moderate eczema on the face and neck of children aged between 2 years and 16 years that has not been controlled by topical steroids or where there is serious risk of important adverse effects from further topical steroid use, particularly irreversible skin atrophy.
Restrictions:
Restricted to specialist use in the treatment of:
- Moderate to severe plaque psoriasis in accordance with local guidelines in patients who have failed to respond to conventional systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have contra-indications to these treatments.
- Moderate to severely active Crohn's disease in patients 16 year of age and older, who have an inadequate response to, lost response to, or where intolerant to conventional therapy, or if such therapies are not advisable.
Restrictions:
Psoriasis:
Use for moderate to severe plaque psoriasis in adults is restricted to specialist use in patients who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to or have contraindications to these treatments.
Hidradenitis suppurativa:
Treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adults with an inadequate response to conventional systemic HS therapy. Restricted for use in adult patients with active moderate to severe HS for whom adalimumab is contraindicated or otherwise unsuitable, including those who have failed to respond or have lost response to prior adalimumab treatment.
Prescribing Notes:
For other indications please see chapter 10.1.3
Restrictions:
Topical tacrolimus is restricted to initiation and review by a dermatologist.
Restrictions:
Restricted to specialist use in the treatment of moderate to severe plaque psoriasis in accordance with local guidelines in patients who have failed to respond to conventional systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have contra-indications to these treatments.
Restrictions:
Restricted to specialist use for the treatment of moderate-to-severe atopic dermatitis in adult patients who have had an inadequate response to an existing systemic immunosuppressant such as ciclosporin, or in whom such treatment is considered unsuitable.
Restrictions:
Restricted to specialist use in accordance with the prescribing notes below.
Prescribing Notes:
Psoriasis in adults:
- The treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA) is restricted to specialist use. Continued treatment should be restricted to patients who achieve a PASI 75% response within 16 weeks.
Psoriasis in adolescents:
- The treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies is restricted to specialist use. Continued treatment should be restricted to patients who achieve at least 75% improvement in their Psoriasis Area and Severity Index (PASI 75) within 16 weeks.
For use in psoriatic arthritis see section 10.1.3 and for use in Crohn's disease see section 1.5.3
Restrictions:
Restricted to specialist use for moderate to severe atopic dermatitis in patients who have had an
inadequate response to at least one conventional systemic immunosuppressant such as ciclosporin, or
in whom such treatment is considered unsuitable.
Prescribing Notes:
Following a MHRA review in April 2023, the risk of increased incidence of malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality, when compared to those treated with tumour necrosis factor (TNF)-alpha inhibitors, were are considered a class effects across JAK inhibitors used for chronic inflammatory disorders and therefore it is advised to avoid prescribing these medicines unless there are no suitable alternatives in patients with the following risk factors:
- age 65 years or older
- current or past long-time smoking
- other risk factors for cardiovascular disease or malignancy
Please see further details of the review here.