BAD Guidelines for use of Biological Interventions in Psoriasis
BAD Guidelines for use of Biological Interventions in Psoriasis
Psoriasis is a common, persistent, relapsing inflammatory skin disease that can be associated with significant morbidity. Quality of life studies in psoriasis reveal a negative impact on patients comparable with that seen in cancer, arthritis and heart disease. Patients with severe disease constitute approximately 20-30% of all patients with psoriasis, often require systemic treatment, and represent a major economic burden to the Health Service.
All standard systemic therapies for severe disease are associated with the potential for major long-term toxicity, many are expensive, and a proportion of patients has treatment-resistant disease. Biological therapies or 'biologics' describe agents designed to block specific molecular steps important in the pathogenesis of psoriasis and have emerged over the last 3-5 years as potentially valuable alternative therapeutic options.
Currently, biological therapies for psoriasis comprise two main groups: (i) agents targeting the cytokine tumour necrosis factor (TNF)-α (e.g. etanercept, infliximab, adalimumab) and (ii) agents targeting T cells or antigen-presenting cells (e.g. efalizumab, alefacept). Two of these, etanercept (Enbrel) and efalizumab (Raptiva) were licensed in 2004 in the U.K. for patients with moderate to severe psoriasis.
These new treatments are relatively expensive and, given the widespread patient dissatisfaction with standard treatments, demand is likely to be high. Clinical experience of biological therapies in dermatology is relatively limited and their role in the context of existing standard systemic therapies, particularly with respect to efficacy and long-term toxicity, is uncertain. These guidelines have been developed to ensure that this new class of therapy is introduced in a systematic and planned way to achieve the greatest possible benefit to people with psoriasis, to facilitate safe and effective prescribing and to endorse the use of the British Association of Dermatologists (BAD) Biological Therapy Register as a mechanism for collecting long-term safety and efficacy data. The guideline group has sought to provide useful, evidence-based guidance based on systematic review of available literature, but acknowledges that additional funding may be required to implement guideline recommendations fully.
These guidelines were developed in accordance with a predetermined scope, agreed by the guideline working group, and are as detailed below. For practical reasons, guidance is given only on those treatments that are currently licensed for use in psoriasis in the U.K. (etanercept, efalizumab) and infliximab. Although infliximab is currently unlicensed for use in psoriasis, a licence is anticipated in the near future, it is widely available, and it is currently the most extensively used biological therapy in dermatology clinical practice.
Inclusions. Specific, evidence-based, recommendations cover the following clinical areas:
Exclusions
This guideline has been developed using BAD recommended methodology and the AGREE (Appraisal of Guidelines for Research and Evaluation) instrument. The guideline working group represents all relevant stakeholders including nurses, rheumatologists and patients. Draft guidance was made available for consultation and review by patients and the BAD membership prior to publication.
A literature review was performed by searching EMBASE and Medline databases (1990 to April 2005) for clinical trials involving efalizumab, etanercept and infliximab using an agreed protocol. Two reviewers screened all titles and abstracts independently, and full papers of relevant material were obtained wherever possible. Papers included as evidence were scored for strength of evidence using the instruments currently recommended by the Scottish Intercollegiate Guidelines Network and the National Institute for Clinical Excellence (Appendix 1). Additional ad hoc searches were done to address clinical questions that arose during the development of the guideline, and evidence was appraised in the same manner.
These guidelines have been prepared for dermatologists on behalf of the BAD and reflect the best data available at the time the report was prepared. Caution should be exercised in interpreting the data; the results of future studies may require alteration of the conclusions or recommendations in this report. It may be necessary or even desirable to depart from the guidelines in the interests of specific patients and special circumstances. Just as adherence to guidelines may not constitute defence against a claim of negligence, so deviation from them should not necessarily be deemed negligent.
This field of therapeutics is in a rapid phase of development, and revision of the scope and content of these guidelines will therefore occur on an annual basis.
Psoriasis is a common, persistent, relapsing inflammatory skin disease that can be associated with significant morbidity. Quality of life studies in psoriasis reveal a negative impact on patients comparable with that seen in cancer, arthritis and heart disease. Patients with severe disease constitute approximately 20-30% of all patients with psoriasis, often require systemic treatment, and represent a major economic burden to the Health Service.
All standard systemic therapies for severe disease are associated with the potential for major long-term toxicity, many are expensive, and a proportion of patients has treatment-resistant disease. Biological therapies or 'biologics' describe agents designed to block specific molecular steps important in the pathogenesis of psoriasis and have emerged over the last 3-5 years as potentially valuable alternative therapeutic options.
Currently, biological therapies for psoriasis comprise two main groups: (i) agents targeting the cytokine tumour necrosis factor (TNF)-α (e.g. etanercept, infliximab, adalimumab) and (ii) agents targeting T cells or antigen-presenting cells (e.g. efalizumab, alefacept). Two of these, etanercept (Enbrel) and efalizumab (Raptiva) were licensed in 2004 in the U.K. for patients with moderate to severe psoriasis.
These new treatments are relatively expensive and, given the widespread patient dissatisfaction with standard treatments, demand is likely to be high. Clinical experience of biological therapies in dermatology is relatively limited and their role in the context of existing standard systemic therapies, particularly with respect to efficacy and long-term toxicity, is uncertain. These guidelines have been developed to ensure that this new class of therapy is introduced in a systematic and planned way to achieve the greatest possible benefit to people with psoriasis, to facilitate safe and effective prescribing and to endorse the use of the British Association of Dermatologists (BAD) Biological Therapy Register as a mechanism for collecting long-term safety and efficacy data. The guideline group has sought to provide useful, evidence-based guidance based on systematic review of available literature, but acknowledges that additional funding may be required to implement guideline recommendations fully.
These guidelines were developed in accordance with a predetermined scope, agreed by the guideline working group, and are as detailed below. For practical reasons, guidance is given only on those treatments that are currently licensed for use in psoriasis in the U.K. (etanercept, efalizumab) and infliximab. Although infliximab is currently unlicensed for use in psoriasis, a licence is anticipated in the near future, it is widely available, and it is currently the most extensively used biological therapy in dermatology clinical practice.
Inclusions. Specific, evidence-based, recommendations cover the following clinical areas:
Use of infliximab, etanercept and efalizumab in adult patients with psoriasis and, when relevant, psoriatic arthritis
Which patients should be considered eligible for treatment
Who should prescribe therapy and how to do so
Definition of disease response and indications for stopping therapy
Exclusions
Agents licensed for use outside the U.K. (e.g. alefacept) or in clinical development for psoriasis (e.g. adalimumab)
Use of biological therapies in children
Use of biological therapies for indications other than psoriasis
This guideline has been developed using BAD recommended methodology and the AGREE (Appraisal of Guidelines for Research and Evaluation) instrument. The guideline working group represents all relevant stakeholders including nurses, rheumatologists and patients. Draft guidance was made available for consultation and review by patients and the BAD membership prior to publication.
A literature review was performed by searching EMBASE and Medline databases (1990 to April 2005) for clinical trials involving efalizumab, etanercept and infliximab using an agreed protocol. Two reviewers screened all titles and abstracts independently, and full papers of relevant material were obtained wherever possible. Papers included as evidence were scored for strength of evidence using the instruments currently recommended by the Scottish Intercollegiate Guidelines Network and the National Institute for Clinical Excellence (Appendix 1). Additional ad hoc searches were done to address clinical questions that arose during the development of the guideline, and evidence was appraised in the same manner.
These guidelines have been prepared for dermatologists on behalf of the BAD and reflect the best data available at the time the report was prepared. Caution should be exercised in interpreting the data; the results of future studies may require alteration of the conclusions or recommendations in this report. It may be necessary or even desirable to depart from the guidelines in the interests of specific patients and special circumstances. Just as adherence to guidelines may not constitute defence against a claim of negligence, so deviation from them should not necessarily be deemed negligent.
This field of therapeutics is in a rapid phase of development, and revision of the scope and content of these guidelines will therefore occur on an annual basis.
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