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

• Methotrexate, see section 8.4.3 Antifolates 
• Azathioprine, see section 8.2.1 Immunosuppressive agents
• Ciclosporin, see section 8.2.1 Immunosuppressive agents
• Secukinumab, see section 8.2.1 Immunosuppressive agents
• Adalimumab, Apremilast, Etanercept, Infliximab, and Ustekinumab, see section 10.1.3 Drugs that suppress the rheumatic disease process

Cytokine modulators

Bimekizumab

• Solution for injection pre-filled syringes 160mg/1ml
• Solution for injection pre-filled disposable devices 160mg/1ml

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.
2. NICE TA916: Bimekizumab (​Bimzelx​), alone or with methotrexate, ​is recommended​ as an option for treating active psoriatic arthritis (defined as peripheral arthritis with 3 or more tender joints and 3 or more swollen joints) in adults whose condition has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them (October 2023). It is recommended only if they have had 2 conventional DMARDs ​and​:
   1. at least 1 biological DMARD ​or
   2. tumour necrosis factor (TNF)-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE TA199), and
   3. the company provides it according to the commercial arrangement.
   4. Refer to TA916 for stopping criteria and other considerations
3. NICE TA918: Bimekizumab (​Bimzelx​) ​is recommended​ as an option in adults for treating active ankylosing spondylitis (AS) when conventional therapy has not worked well enough or is not tolerated, or active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation (shown by elevated C-reactive protein or MRI) when non-steroidal anti-inflammatory drugs (NSAIDs), have not worked well enough or are not tolerated (October 2023), 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 it according to the commercial arrangement.
   3. Refer to TA918 for stopping criteria and other considerations.

Brodalumab

• Solution for injection in pre-filled syringe 210mg in 1.5ml

Notes

1. NICE TA511: Brodalumab (Kyntheum) is recommended 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 (August 2018), only if:
   1. the disease has not responded to at least 1 other systemic therapy, such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil, or these are contraindicated or not tolerated, and
   2. the company provides dupilumab according to the commercial arrangement
   3. Refer to TA534 for continuation criteria and other considerations
2. NICE TA751: Dupilumab (Dupixent) as add-on maintenance therapy is recommended as an option for treating severe asthma with type 2 inflammation that is inadequately controlled in people 12 years and over, despite maintenance therapy with high-dose inhaled corticosteroids and another maintenance treatment (December 2021), only if:
   1. the dosage used is 400 mg initially and then 200 mg subcutaneously every other week
   2. the person has agreed to and follows an optimised standard treatment plan the person has a blood eosinophil count of 150 cells per microlitre or more and fractional exhaled nitric oxide of 25 parts per billion or more, and has had at least 4 or more exacerbations in the previous 12 months
   3. the person is not eligible for mepolizumab, reslizumab or benralizumab, or has asthma that has not responded adequately to these biological therapies
   4. the company provides dupilumab according to the commercial arrangement.
   5. Stop dupilumab if the rate of severe asthma exacerbations has not been reduced by at least 50% after 12 months
3. NICE TA955: Dupilumab (Dupixent) is not recommended, within its marketing authorisation, for treating moderate to severe prurigo nodularis in adults when systemic treatment is suitable (March 2024).
4. MHRA Drug Safety Update (November 2022): Dupilumab (Dupixent): risk of ocular adverse reactions and need for prompt management
   1. Dupilumab is commonly associated with cases of conjunctivitis and allergic conjunctivitis, eye pruritus, blepharitis, and dry eye and with infrequent cases of keratitis and ulcerative keratitis, especially in patients with atopic dermatitis
   2. Be alert to the risks of ocular reactions and promptly review new onset or worsening ocular symptoms, referring patients for ophthalmological examination as appropriate
   3. Sudden changes in vision or significant eye pain that does not settle warrant urgent review
   4. See the Drug Safety Update for advice to give to patients

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 TA815: Guselkumab, 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 (August 2022). It is recommended only if they have had two conventional DMARDs and:
   1. have had at least 1 biological DMARD, or
   2. tumour necrosis factor (TNF)-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis).
   3. Guselkumab is recommended only if the company provides it according to the commercial arrangement.
   4. Refer to TA815 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

• Concentrate for solution for infusion vials 600mg/10ml
• Solution for injection cartridges 180mg/1.2ml, 360mg/2.4ml
• Solution for injection pre-filled pens 150mg/1ml
• Solution for injection pre-filled syringes 150mg/1ml

Notes

1. NICE TA596: Risankizumab (Skyrizi) is recommended as an option for treating plaque psoriasis in adults (August 2019) 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 TA596 for continuation criteria and other considerations
2. NICE TA803: Risankizumab (Skyrizi), 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 (July 2022). It is recommended 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. Risankizumab is recommended only if the company provides it according to the commercial arrangement
   5. Refer to TA803 for continuation criteria and other considerations
3. NICE TA888: Risankizumab (​Skyrizi​) ​is recommended​ as an option for treating moderately to severely active Crohn's disease in people 16 years and over (May 2023), only if:
   1. the disease has not responded well enough or lost response to a previous biological treatment ​OR​
   2. a previous biological treatment was not tolerated ​OR​
   3. tumour necrosis factor (TNF)-alpha inhibitors are not suitable, ​AND​
   4. the company provides it according to the commercial arrangement.
4. NICE TA998: Rizankizumab (Skyrizi) is recommended as an option for treating moderately to severely active ulcerative colitis in adults when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or has lost response to treatment (August 2024), only if:
   1. a tumour necrosis factor (TNF)-alpha inhibitor:
      1. has not worked (that is the condition has not responded well enough or has lost response to treatment), or
      2. cannot be tolerated or is not suitable, and
   2. the provides it according to the commercial arrangement.
5. If patients and their clinicians consider risankizumab to be 1 of a range of suitable treatments, choose the least expensive treatment. Take account of administration costs, dosage, price per dose and commercial arrangements

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)

Tralokinumab

• Solution for injection in prefilled syringes 150mg/1ml

Notes

1. NICE TA814: Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis (August 2022):
   1. Tralokinumab (Adtralza) is recommended as an option for treating moderate to severe atopic dermatitis that is suitable for systemic treatment in adults, only if:
      • the disease has not responded to at least 1 systemic immunosuppressant, or these are not suitable
      • the company provides tralokinumab according to the commercial arrangement
   2. Refer to TA814 for continuation criteria and other considerations
2. MHRA Drug Safety Update (November 2022): risk of ocular adverse reactions and need for prompt management.
   1. Tralokinumab (Adtralza), an interleukin-13 inhibitor licenced for use in atopic dermatitis, is associated with common cases of conjunctivitis and allergic conjunctivitis as well as uncommon cases of keratitis, and that patients treated with tralokinumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination

Other preparations

Fumaderm

(Fumaric acid esters)

• Tablets 105mg, 215mg (unlicensed preparations)

In hospital use with ultraviolet therapy

5-methoxy-psoralen

• Tablets 20mg (unlicensed preparation)

8-methoxy-psoralen

• Tablets 10mg (unlicensed preparation)
• Bath lotion 1.2% (unlicensed preparation)
• Emulsion 0.15% (unlicensed preparation)