The British Association of Dermatologists (BAD) has released a rapid update to their guidelines on the use of biologic therapies targeting TNF, IL12/23p40, IL17A, IL17RA and IL23p19 for the treatment of psoriasis, with consideration given to the specific needs of patients with psoriasis and psoriatic arthritis. The guideline update was published in the British Journal of Dermatology.
In this update, a panel of experts from the BAD Clinical Standards Unit, which includes the Therapy & Guidelines subcommittee, convened to review the latest evidence for biologic treatments evaluated in the 2017 publication of the guidelines, as well as newer treatments that have been licensed or will soon be licensed in the United Kingdom (UK). The guideline recommendations were developed for implementation in the National Health Service in the UK.
Using biologic therapy
Initiation, management, and follow-up of psoriatic biologic therapy for patients should be undertaken by specialist physicians experienced in the diagnosis and treatment of psoriasis. The criteria for biologic agent therapy include presence of extensive psoriasis (BSA >10% or Psoriasis Area and Severity Index (PSAI) ≥ 10) or when it psoriasis is severe at localized sites and associated with significant functional impairment and/or increased levels of distress. For those who meet these requirements and may also have active psoriatic arthritis, biologic therapy is recommended earlier in the treatment pathway.
When prescribing biologic therapy, physicians should be aware of benefits, contraindications, and adverse effects and provide detailed, high-quality, evidenced-based explanations to patients receiving these therapies. It is suggested that patients be given adequate time to consider the information. When reviewing biologic therapy in patients with psoriasis, it is recommended to assess initial response and then on a regular basis, at appropriate time points for the treatment in question, to monitor response to the biologic therapy. Other evaluations that should be considered include the impact on the physical, psychological, and social functioning, whether the minimal response criteria have been met and changing to an alternative therapy if required. Switching to an alternative therapy should made if there is primary failure, secondary failure, the therapy cannot be tolerated, or becomes contraindicated.
Choice of biologic therapy: general considerations
General considerations for the choice of biologic agent therapy should take into account both psoriasis and psoriatic arthritis and management in consultation with a rheumatologist. It is advised that the choice of biologic agent should be tailored based on the needs of the individual patient and consider psoriasis factors, patient factors, and drug costs.
In adults, any of the currently licensed biologic therapies can be offered as first-line therapy, tumor necrosis factor (TNF) antagonist can be offered to those who have both psoriasis and psoriatic arthritis. Infliximab should be reserved for patients with very severe disease when other biologic agents have failed. In situations of an inadequate primary response due to insufficient drug exposure, escalating the dose of/reducing the interval for biologic therapy is advised. During a second or subsequent biologic therapy failure, advice should be sought from a dermatologist with expertise in biologic therapy. In children and young people, the guidelines suggest offering adalimumab (age ≥ 4 years), etanercept (≥6 years) or utsekinumab (≥12 years) to those who meet the criteria for biologic therapy. During a second or subsequent biologic therapy failure, a dermatologist with expertise in biologic therapy should be consulted.
Transitioning to or between biologic therapies
When transitioning to or between therapies, the pharmacology of the drugs, the patient’s clinical circumstances and their views on the risks and benefits of transitioning options should be considered. In addition, when shifting from standard systemic therapy or previous biologic therapy to a new biologic therapy, considerations should include a 1-month washout period in stable disease. In patients taking methotrexate, a biologic therapy with no drug washout period should be selected.
Conception and pregnancy
Women with childbearing potential should be advised to use effective contraception and to discuss conception plans with the consultant supervising their care. Although there are no known interactions between biologic therapies and contraceptive methods, it is recommended to provide information about known effects of biologic therapy as well as the risks and benefits. Advice should be offered on an individual basis.
Certolizumab pegol should be considered as a first-line choice; biologic therapy should be considered stopped in the second/third trimester. Ciclosporin or certoloizumab pegol should be first-line options if systematic therapy needs to be initiated during the second or third trimester. Moreover, consultation and information should be shared across specialties, including with an obstetrician with expertise in caring for pregnant women with medical issues.
Biologic therapy and cancer risk
Patients with psoriasis should be assessed prior to, and during, treatment with biologic therapy with respect to the patient’s cancer status and future risk for cancer. Caution should be exercised, and discussion should take place with the relevant cancer specialist, when prescribing biologic agents in patients with psoriasis with a history of cancer and /or where the baseline risk for skin cancer is increased. Advice should be offered on an individual basis taking into account the guidance from the treating oncologist, multidrug therapy discussion and patient considerations.
Biologic therapy and infections
Assess patients with psoriasis prior to, and during, treatment with biologic therapy for risk factors for infection, known infections, and signs or symptoms suggestive of infection. Patients should be tested for hepatitis B, hepatitis C, and HIV before starting biologic therapy. The guidance recommends that ongoing screening be conducted annually for hepatitis B, C, and HIV, especially in those who are at increased risk for infection. It is also recommended to test for varicella zoster virus antibody in patients with a negative or uncertain history for chickenpox before starting biologic therapy. Patients should also be screened for tuberculosis and if positive, a consultation with a tuberculosis specialist is recommended.
Biologics and vaccination
It is recommended that live vaccines not be given to patients on biologic therapy or to infants (<6 months) whose mothers have received biologic therapy beyond 16 weeks’ gestation. Biologic therapy should be stopped for 6 to 12 months before giving live vaccines and can be restarted 4 weeks after administration of a live vaccine. Information should be provided on safe use of vaccinations including which can be tolerated and which should be avoided. Lastly, when possible, all required vaccinations should be completed before initiation of biologic therapy.
Contraindications to biologic therapies
TNF antagonists should not be used in patients with demyelinating diseases or severe cardiac failure; in these populations alternative interventions are recommended. Caution should be exercised when biologic therapy in patients with inflammatory bowel disease and those who are undergoing elective surgery.
Limitations and Conclusions
The update is based on the current best available data and acknowledges that recommendations changed as a result of future studies. Also, certain disorders may require deviation from the recommendations. Lastly, with the inclusion of only English-language literature reviews it is recognized that important information published in other languages may have been excluded.
The BAD intends to perform an annual literature review as part of their guideline development methodology for this rapid-moving topic with recommendations updated when necessary.
Disclosure: Several study authors declared conflicts of interest. Please see the original reference for a full list of authors’ disclosures.
Smith CH, Yiu ZZ, Bale T, Burden AD, Coates LC, Edwards W. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020ꟷa rapid update. Br J Dermatol. (published online March 18, 2020) doi:10.1111/bjd.19039