1. Biologics and the Role of the CNS Lucy Moorhead RGN, BA (Hons), MA, CNS in Medical Dermatology Guys and St Thomas’ NHS Foundation Trust With kind thanks to janssen cilag for allowing me to use their slides re immune system and actions of biologicsjanssen cilag

2. Contents What are biologics? What is a clinical nurse specialist (CNS)? Tertiary referral psoriasis clinic Role of CNS in pathway Biologic patients pathway Questions

3. Biologics Anti-TNF or interleukin agents Made from living human or animal proteins Block the action of certain immune cells that play a role in psoriasis. Targets a type of immune cell called T cells while others target the chemical messengers released by activated T cells

4. NICE guidance 2012 Who should receive Biologics? Patients with severe chronic plaque psoriasis PASI > 10 + DLQI > 10 Failed to respond to, contra-indication to, or intolerance to standard systemic therapy (e.g. methotrexate, ciclosporin, acitretin, PUVA) Consider patients with localised involvement who don’t meet above criteria

5. NICE guidance 2012 Changing to an alternative biological drug (systemic biological therapy) Consider changing to an alternative biological drug in adults if: the psoriasis does not respond adequately to a first biological drug as defined in NICE technology appraisals (at 10 weeks after starting treatment for infliximab, 12 weeks for etanercept, and 16 weeks for adalimumab and ustekinumab; primary failure) or the psoriasis initially responds adequately but subsequently loses this response, (secondary failure) or the first biological drug cannot be tolerated or becomes contraindicated.

6. Nomenclature of biologic therapies Suffix indicates class of biologic therapy 1  cept = human receptor fusion protein e.g. etanercept  ximab = chimaeric monoclonal antibody e.g. infliximab  zumab = humanized monoclonal antibody e.g. efalizumab  umab = fully human monoclonal antibody e.g. adalimumab, ustekinumab 1. Johnston SL. J Clin Pathol. 2007;60(1):8-17.

7. Biological therapies for psoriasis and psoriatic arthritis (UK) generic name brand name agentskinjoints Cytokine inhibitors ustekinumabStellara IL 12 & 23 + TNF  blockers etanerceptEnbrelTNF-R ++ infliximabRemicade anti- TNF  ++ adalimumabHumira anti- TNF  ++

8. Etanercept (Enbrel) S/C administration Pre filled syringe or a pen 25 mg twice weekly or 50 mg once weekly or 50 mg twice weekly initially PASI & DLQI 10 Decision to continue treatment at 12 weeks

9. Infliximab (Remicade) Administered via infusion Dose calculated on weight (5 mg/kg) After initial loading dose infusion (wks 0, 2 & 6) every 8 weeks PASI 20 & DLQI 18 Decision to continue treatment at 10 weeks

10. Adalimumab (Humira) S/C administration Week 0 – 80 mg, week 1 – 40 mg, week 3 – 40 mg and fortnightly thereafter PASI & DLQI 10 Decision to continue treatment at 14 weeks

11. Ustekinumab (Stellara) Fully human monoclonal binding to IL 12 and IL 23 Week 0, 4, 16 and then every 12 weeks PASI 10 DLQI 10 S/C administration NICE recommend hospital administration Decision to treat at 16 weeks Dose weight dependent but cost neutral

12. Role of the Clinical Nurse Specialist

13. The history of development 1992Scope of Professional Practice (UKCC) 1993The Working Time Directive of the European Union (Council Directive 93/104/EC) 1998Nurse Consultant HSC 1998 / 161(DH) 1999Establishing posts HSC 1999 / 217 2000Department of Health – The NHS Plan: A plan for investment, a plan for reform 2002 Department of Health - Liberating the Talents: Helping Primary Care Trusts and Nurses to Deliver the NHS Plan’

14. Clinical Nurse Specialists: Job plans are varied; often dependent on speciality Generic definition –  ‘The clinical nurse specialist (CNS) role focuses on improving patient care and developing clinical services, often within specialist areas.’ (McArthur 2008)

15. Key Functions of Clinical Nurse Specialist Role Clinical (67%) Administration (21%) Education (6%) Research (4%) Consultation (2%) RCN Rheumatology Nursing Forum Clinical nurse specialists: adding value to care. An executive summary. 2010

16. RCN 2013 – Specialist Nursing in the UK Want govt, commissioners and healthcare providers to commit to:  All patients with long term conditions or have access to CNS  To be allowed time accomplish vital aspects or their role  Increase funding combined with understanding of wider cost implications and health improvements (medium to long term)

17. Tertiary Referral Psoriasis Clinic Patients referred in mostly from London and home counties Approx 1435 patient visits a year (new and follow ups combined) Over 400 patients on biologics Adalimumab, etanercept, infliximab and ustekinumab 2 x Nurse led clinics attached to psoriasis clinic (biologics and systemics)

18. Role of the CNS in psoriasis clinic First point of contact Initiation and early monitoring of treatments IP for topicals/treatment at home plans – to be extended to include systemics and biologics

20. Biologic Initiation - Decision made and screening started within psoriasis clinic Patient for referred to NLC to complete screening and initiation Electronic prescription for all Reviewed in NLC at week 4 of treatment Reviewed in psoriasis clinic at NICE time point Review every 3 months plus after 2 years 6 monthly reviews considered

21. Decision in clinic to start patient on ustekinumab Start screening Determine washout/cross over Give appropriate patient information (BAD info sheet and pack) and contact details Book appointments Refer to research Patient attends NLC: Complete screening and Refer for discussion to MDM Refer to research If patients fails screening to follow applicable pathway  Patient discussed in MDM by referring doctor Week 0 Injection administered by BUPA team Week 4 Biologics monitoring visit (as per protocol) Confirm/ensure week 4 visit with BUPA Week 13 (or one week prior to next planned dose) Review in the psoriasis clinic NICE compliance ascertained Patient to discontinue therapy Follow applicable pathway Patient to receive week 16 dose (or appropriate dose) BUPA prescription to be completed in clinic and given to PPM for screening by pharmacy  Appt for next review in severe psoriasis service to be arranged (11 weeks)  mdCNS to check bloods next day and follow protocol for any abnormal values.  To inform patient by telephone that drug can be administered  Refer to research Week 16 BUPA nurse to email mdCNS to confirm injection administered Spreadsheet to be updated  Prescription signed by doctor  Added to database  Screened by pharmacist  Sent to BUPA

22. Patient Information Research shows that up to 50% of patients are taking drugs incorrectly! Recognise that patients prefer information to be given in different ways Recognise that it can be daunting to regularly administer/receive a sub-cutaneous injection or infusion Recognise that we often ‘overload’ patients with information in clinic settings

23. Patient Information Patients are given BAD patient information AND industry sponsored information often including a CD Patients are given card with contact details for our service Information briefly introduced in the severe psoriasis clinic and reviewed at depth in nurse led clinic

24. British Association of Dermatologists - PIS

25. Biologics Initiation and Monitoring Clinic Nurse consultant: Karina Jackson In operation for over 5 years Once weekly clinic – Tuesday morning 7 patient slots a week 30 minute appointments Often overbooked! Patients booked for initiation and for one month reviews

26. Biologics Initiation and Monitoring Clinic Scope of clinic: To ensure all patients under consideration for biologic therapies used in the treatment of psoriasis have fulfilled all recommended clinical assessments and investigations prior to treatment initiation and to ensure the patient fully understands the risks and benefits of therapy To initiate patients on biologic therapies used in the treatment of psoriasis To review the patient at one month post initiation of applicable sub cutaneous biologic therapy

27. NLC - Initiation of Biologic Check all screening Review patient information Baseline PASI/DLQI if required Crossover/washout Confirm timings Confirm appointments

28. Psoriasis MDM Prior to all psoriasis clinic Attended by all dermatology consultants, registrars, CNS’ and research nurses All patients screened for biologics Referred to MDM prior to initiation appt Presented by Dermatology Registrar Outcome documented on EPR

29. NLC - 1 month review NOT included in BAD guidelines BUT important:  Confirm correct administration & schedule  Patient motivation  Side effects  FBC, U&E’s & LFT’s  Confirm next psoriasis clinic appt (NICE)  Topicals and other concomitant medication

30. Administration related to biologics Letters to GP/Consultant Healthcare at Home/BUPA Paperwork Liaising with pharmacy/H@H/BUPA Confirm contact details Ensuring patient has correct follow up appointments

32. Recent issues occurring within biologics clinic Live vaccinations Wrong dosing schedule Low literacy level in patient on s/c mtx and etanercept Planned surgery/dental treatments Fathering of a child whilst on MTX

34. Nurse Preceptorship’s Commenced in July 2010 2 days experience in St John’s Institute of dermatology 1 nurse attends every 2 months Preceptorships aimed at dermatology nurses either working within biologics or planning to Tailored to each individual Funded by unrestricted educational grant (Abbvie)

35. ‘The specialist nurse is a key member of the multidisciplinary team delivering biological therapy, and acts to facilitate all aspects of the patient pathway’ (BAD - Guidelines for Biological Interventions for Psoriasis - 2009)

36. Thank you for listening! Lucy.moorhead@gstt.nhs.uk