Guideline for the use of Biological Therapies in the Treatment of Psoriasis

Transcription

1 1 Date of Production: March1 st 2011 Date of 1 st review: July 10 th 2015 Date for next review: March1 st 2018 Local Contact Dermatology Consultant Shanti Ayob Patient group to which this applies: Patients with moderate to severe chronic plaque psoriasis This guideline has been registered with the Trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date. Peer Review The Guidelines have been reviewed by the Clinical Director, Governance Lead and Consultant Members of the Dermatology Department. Evidence Base These guidelines are based on NICE Technology Appraisal (TA) guidance for each biological therapy; Etanercept, TA Infliximab, TA Adalimumab, TA Ustekinumab, TA British Association of Dermatologists guidelines for biologic interventions for psoriasis 2009 BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-tnf-alpha treatment Dissemination: A copy of the Guidelines will be kept in all the clinical rooms. A copy of the guidelines will be circulated to all the Dermatology Consultants at the August 2015 directorate meeting.

2 Training: Training in the use of the Psoriasis Area Severity Index (PASI) was carried out initially in preparation for these guidelines in July and October Competency in PASI is now part of the revised specialty curriculum in dermatology and is adopted as part of the routine assessment of patients with psoriasis. All the nurse specialists who routinely monitor phototherapy and immunosuppressive drugs for psoriasis such as methotrexate and acitretin are competent to perform PASI. 2 Audit: There have been annual audits of the use of these guidelines against current departmental practice which have been presented to the dermatology department annually or bi-annually from A repeat audit is planned for References: 1. Biologic Interventions for Psoriasis. Smith CH et al. Br J Dermatol 2009;161(5): BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-tnf-alpha treatment. British Thoracic Society Standards of Care Committee. Thorax 2005;60(10): Etanercept for the treatment of chronic plaque psoriasis Infliximab for the treatment of chronic plaque psoriasis Adalimumab for the treatment of chronic plaque psoriasis Ustekinumab for the treatment of chronic plaque psoriasis

3 3 Biologic Therapy For the Treatment of Moderate to Severe Chronic Plaque Psoriasis. 1.0 Important Etanercept, Adalimumab and Ustekinumab and Infliximab are biological therapies currently licensed for the treatment of chronic psoriasis. They should only be initiated by clinicians experienced in the diagnosis and management of severe psoriasis. All the drugs with the exception of Infliximab are delivered subcutaneously by the patient at home after appropriate training. Infliximab is given intravenously using day care facilities shared with gastroenterology. 1.1 Patient assessment prior to the Initiation of Biological Therapies licensed for moderately severe chronic plaque psoriasis Patient Assessment 1. The patient must have chronic severe psoriasis and have failed treatment or been intolerant of at least two systemic therapies including phototherapy. 2. The burden of disease is then assessed in two ways; a clinical disease severity score (Psoriasis Area Severity Index, PASI) and a disease impact score (Dermatology Life Quality Index, DLQI). Both of these scores must be greater than 10 for a patient to qualify for treatment with a biological agent. Scoring sheets for DLQI and PASI are found in the filing cabinet in each clinic room as well as laminates to help with the PASI assessment. Starting a patient on Biological Therapies 1. The initial choice of a biological therapy is determined by disease severity and other disease co-morbidities such as psoriatic arthritis and heart failure. Patients with psoriatic arthritis and psoriasis may need a different approach to their disease and consultation with a rheumatologist is recommended. All patients will require a PEST score and review by Dr Ayob or another consultant dermatologist prior to Rheumatology referral. 2. NICE recommends the use of Etanercept, Adalimumab and Ustekinumab as appropriate first line agents. In practice Adalimumab or Etanercept tend to be used as first line therapy before Ustekinumab, largely because this is a relatively newer drug with lesser known long term side effects. Infliximab is reserved for patients with severe disease, a PASI of >20 due to the increased risk of infection associated with this drug.

4 4 3. Anti- TNF alpha drugs (Etanercept, Adalimumab and Infliximab) are contraindicated in patients who have a history of heart disease and an ejection fraction of less than 50% on cardiac echo. Anti-TNF alpha drugs are also contraindicated with a history of demyelination. Ustekinumab is not contraindicated in these two medical conditions and as such in certain patients may become a first line therapy choice. 4. A check list for each biological therapy (attached to the protocol) must be filled in prior to the initiation of therapy. This includes screening blood tests, a baseline PEST score and an assessment for risk of TB (See TB assessment algorithm). A QuantIFERON assay is requested as the standard screening test for TB in patients on immunosuppressive therapy since a Mantoux is often unreliable. HIV screening is now routine for all patients, not just patients deemed at risk, due to the increased incidence of HIV in the general population. 5. Some patients will be on methotrexate prior to commencing treatment with a biological therapy. If the patient is on methotrexate and is benefiting the patient, the dose of the methotrexate can be lowered to 10mg weekly and the patient may remain on the medication during the first 3 months of treatment with the biologic therapy. All other immunosuppressants such as Ciclosporin and Fumaderm should be discontinued. 6. The drug is delivered to the patient by Healthcare at Home for Etanercept and Adalimumab or BUPA for Ustekinumab. These companies will provide the necessary training and support to allow patients to learn how to self-inject at home. On receipt of the registration documentation, patients are usually contacted within 14 days by these companies. The registration process is usually carried out and supported by one of the clinical nurse specialists, Joanne McWilliam, Coleen Gradwell or Clive Tubb. 1.2 Personal TB Risk Assessment for each patient A risk assessment for each patient prior to commencing treatment with a biologic agent must be made. A TB assessment algorithm is included below to help with this assessment (see Appendix). In general a Tuberculin test carried out on a patient who is currently on an immunosuppressive therapy such as methotrexate or Ciclosporin may be unreliable and a QuantIFERON (Inteferon Gamma Receptor assay IGFR) blood test is suggested which is requested on a standard blood form at the treatment centre.

5 5 All tuberculin tests can be carried out by the TB nursing team at the City Hospital campus, usually within 3 weeks. Contact details from City Hospital Christine Daniel EXT The results are ed back to the referring clinician. Help with the interpretation of the chest X ray, and TB test results can be obtained by referral to the respiratory physicians at the City Hospital Campus and is suggested for any ambiguity in interpreting the TB screening test results. 1.3 The following are available in the biologic treatment trolley Check lists for Etanercept, Adalimumab, Ustekinumab British Association of Dermatology patient information sheets for all the above licensed biological therapies Laminates to help with the PASI assessment tools; erythema, scale and induration of the psoriasis plaques. The PASI and DLQI scoring sheets TB assessment algorithms Health Care at Home/ BUPA Registration forms A copy of the Biologics Register Information sheets and patient consent forms 1.4 The British Association of Dermatology Biologics Interventions Register (BADBIR) This is a national registry. Patients on biological therapies must be entered on this register. Prior to the initiation of the biological therapies, patients may attend a biological therapies education and counselling clinic coded S31JM (first Friday of the month). As part of this clinic, information about BADBIR is given together with consent documentation. Entry to the register and upkeep of the data is co-ordinated by Joanne Mc William, Biological therapy nurse specialist. All patients commenced on biologics are entered into a local database which tracks appointments, annual screening of quantiferon TB and prescriptions sent.

6 1.5 The Dosage Regimens and Time Efficacy Points for licensed biological therapies 1. It is important to assess whether the prescribed biological therapy is working for the patient. To determine this disease severity and impact are measured by PASI and DLQI prior to commencing therapy and repeated at the time efficacy point, as recommended by NICE, for each drug as listed below. Etanercept Dosage at 50 mg SC weekly or 25mg SC twice weekly Drug Efficacy assessed at week 12 Adalimumab Dosage at 80mg loading dose SC, followed at one week by 40mg SC repeated every other week Drug Efficacy assessed at week 16 Ustekinumab Dosage for body weight < 100kg: 45mg SC initially, at one month then 3-monthly For body weight > 100kg: 90mg SC initially, at one month then 3-monthly Drug Efficacy assessed at week 16 Infliximab Intravenous Dosage a 5mg/Kg at weeks 0,2 and 6 then every 8 weeks. Drug Efficacy assessed at week 10 Infliximab is not routinely given at the treatment centre. Administration of this therapy is given on the gastroenterology day ward in line with their protocols and staff support. 2. Each biological therapy can only be continued if there is a 75% improvement in the PASI score (PASI 75) or a 50% improvement in the PASI (PASI 50) together with a 5 point reduction in the DLQI. This must be recorded in the notes Failure of the Patient to Respond to a Biological Therapy Failure of the patient to respond to or tolerate therapy are defined by the criteria in section 1.5. Failure of one biological therapy does not preclude the use of a second agent but it is important to adhere to a wash out period when switching between therapies. This is calculated at 4-5 half lives of the drug. Etanercept 1-2 weeks Adalimumab 5-6 weeks Ustekinumab 12 weeks

7 1.7 Use of biologic therapy perioperatively for elective surgery 1. TNF antagonists (etanercept, adalimumab & infliximab) should be withheld 4 half-lives prior to major surgery i.e. etanercept 2 weeks, adalimumab 4-6 weeks and infliximab 4 weeks. 2. The BAD recommendation for ustekinumab is that it is discontinued 12 weeks (4 half-lives) prior to major surgery. 3. Treatment can be restarted 2 weeks postoperatively if there is no evidence of infection & wound healing is satisfactory Support for use of the biologic therapies for the treatment of psoriasis Support is offered by Dr Ayob, clinical lead for biological therapies. There are weekly consultant- and nurse-led clinics for biological therapies. Any problems can be referred to these clinics as appropriate. 1.9 Continuing treatment and monitoring Patients who fulfil NICE criteria for continuing with biological agents they are reviewed 3-monthly in consultant- or nurse-led biologic clinics. Skin lesion checks for any skin cancers and lymph node examinations are performed 6-monthly.

8 8 Appendix 1: TB assessment algorithm Questions to Help with Risk stratification for TB Ethnic origin If not white Tuberculin/IFGRassay Country of birth if not UK Tuberculin/IFGRassay Age If >55 Tuberculin/IFGRassay History of TB & treatment Resp Physician TB symptoms Resp Physician Chest X-ray Abnormal Resp Physician

9 9 Appendix 2: Checklists for starting biological therapies Patient ID Label Date... Systemic therapy Previous Biological Therapy ETANERCEPT check list Initial at sides when completing this form and receiving results Treatment with 2 or more of the following failed or contra indicated Phototherapy Methotrexate Ciclosporin Fumaderm Acitretin Hydroxyurea Check for the following contraindications History of demyelination History of Heart failure Current infection History of cancer Skin cancer within 5 years Including HIV Planned surgery Pregnancy test Negative The base line severity scores for chronic plaque Psoriasis (both >10 to meet the NICE treatment criteria) Date..Pre Treatment PASI.Weight..Girth PEST score.. Date..Pre Treatment DLQI BP.Ht Hips Date1 st Injection Time of Efficacy point.. 12 week DLQI..12 week PASI. Date Tests ordered Date received Action FBC LFT Fasting Lipids U&E Hep C B Serology ANF CXR TB Test CRP Varicella Serology HIV

10 10 Baseline Photos Lymph Node examination Skin Cancer check Contraception advice Method used.. Date last cervical smear test.. Results.. The following should be discussed Patient Information Leaflet Nurse contact details given Explain Unknown long-term risks Risk of Infection Unknown risk of Malignancy Marrow suppression Allergy local/systemic (Latex) No live vaccines BADBIR Information Leaflet new patient being considered for Biologic therapy Prescribing Complete registration for Healthcare at Home Continuing on Mtx Etanercept Dose 25mg s.c twice /weekly 50mg s.c. Weekly Photocopy Rx x 2 1 file in notes 2 pass to Biologics administrator Send forms 1 and 2 to Healthcare at Home Give Patient forms for blood test 2-3 days before 4 week appointment Ask Patient to make an appointment for 6/7weeks Gurjit to add information onto database Monitoring Weeks DLQI Document score PASI Document Score FBC Us&Es LFT CRP Measurements Girth Hips Weight BP Side effects Skin Cancer Check Lymph node check BADBIR

11 11 Patient Sticker Systemic Therapy Previous Biological Therapy Date Adalimumab check list Initial at sides when completing this form and receiving results Treatment with 2 or more of the following failed or contra indicated Phototherapy Methotrexate Ciclosporin Fumaderm Acitretin Hydroxyurea Check for the following contraindications History of demyelination History of Heart failure Current infection History of cancer Skin cancer within 5 years Including HIV Planned surgery Pregnancy test Negative The base line severity scores for chronic plaque Psoriasis (both >10 to meet the NICE treatment criteria) Date..Pre Treatment PASI.Weight..Girth PEST score. Date..Pre Treatment DLQI BP.Ht Hips Date1 st Injection Time of Efficacy point.. 16 week DLQI..16 week PASI. Date Tests ordered Date received Outcome Action FBC LFT Fasting Lipids U&E Hep C B Serology ANF CXR TB Test

12 12 CRP Varicella Serology HIV Baseline Photos Lymph Nodes Skin cancer examination Contraception advice Method used.. Last cervical smear test. Results The following should be discussed Patient Information Leaflet Nurse contact details given Explain Unknown long-term risks Risk of Infection Unknown risk of Malignancy Marrow suppression Allergy local/systemic (Latex) No live vaccines BADBIR Information Leaflet new patient being considered for Biologic therapy Prescribing Complete registration form Healthcare at Home Continuing on Mtx Complete prescription for Adalimumab Dose Week 0 80mg Loading dose Week 1, 40mgs Week 3 alternate weeks at 40mg Photocopy Rx x 2 1 file in notes 1 pass to biologics administrator Send forms 1 and 2 to Healthcare at Home Give Patient forms for blood test 2-3 days before 4 week appointment Ask Patient to make an appointment for 6/7weeks Gurjit to add information onto database Monitoring Weeks DLQI Document score PASI Document Score FBC Us&Es LFT CRP Measurements Girth Hips Weight BP Side effects Skin Cancer Check Lymph node check BADBIR

13 13 Patient ID Label Systemic therapy Previous Biological Therapy Date Ustekinumab check list Initial at sides when completing this form and receiving results Treatment with 2 or more of the following failed or contra indicated Phototherapy Methotrexate Ciclosporin Fumaderm Acitretin Hydroxyurea Check for the following contraindications Current infection History of cancer Skin cancer within 5 years including HIV Planned surgery Pregnancy test Negative The base line severity scores for chronic plaque Psoriasis (both >10 to meet the NICE treatment criteria) Date..Pre Treatment PASI.Weight..Girth..PEST score.. Date..Pre Treatment DLQI BP.Ht Hips Date1 st Injection Time of Efficacy point.. 16 week DLQI..16 week PASI. Date Tests ordered Date received Outcome Action FBC LFT Fasting Lipids U&E Hep C B Serology ANF CXR TB Test CRP

14 14 Varicella serology HIV Baseline Photos Lymph Nodes checked Skin Cancer Check Contraception advice Last cervical smear test. The following should be discussed Patient Information Leaflet Explain Unknown long-term risks Risk of Infection Allergy local/systemic (Latex) No live vaccines Method used Results Nurse contact details given Unknown risk of Malignancy BADBIR Information Leaflet new pt being considered for Biologic therapy Prescribing Complete registration for Careology Complete prescription Adults & Elderly patients 100kg 45mg at week 0 followed by 45mg dose at week 4 then ever 12 weeks Patients >100kg 90mg at week 0 followed by 90mg dose at week 4 then every 12 weeks Photocopy Rx x 2 1 file in notes 2 pass to biologics administrator Fax and Send form to Careology Give Patient forms for blood test 2-3 days before 4 week appointment Ask Patient to make an appointment for 6/7weeks Gurjit Kandola to add information onto database Monitoring Weeks DLQI Document score PASI Document Score FBC Us&Es LFT CRP Measurements Girth Hips Weight BP Side effects Skin Cancer Check Lymph node check BADBIR