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1 For Use in: By: For: Guidelines for the Management of Interruption of Biologic Therapies for Division responsible for document: Key words: Name and job title of document author: Name and job title of document author s Line Manager: Supported by: Assessed and approved by the: Organisation-wide elective Surgery preparation in Biologics Patients All clinicians and surgical pre-assessment staff involved in preparing patients for elective surgery Adults and Children with Rheumatological conditions requiring Biologic Therapy, who are undergoing elective surgical procedures Medical Biologics, Anti-TNF, Biosimilars, Rheumatoid Arthritis, arthritis, delayed healing, immunosuppression, infection, JIA, juvenile, risk Nicola Kerrigan, Specialist Nurse in Rheumatology Karen Mills, Lead Specialist Nurse in Rheumatology Dr Chetan Mukhtyar, Consultant Rheumatologist and Clinical Director (NNUH), Karl Gaffney, Consultant Rheumatologist, (NNUH), Joegi Thomas, Consultant Rheumatologist, (JPUH), Anna Lipp, Consultant Anaesthetist, (NNUH), Samantha Sparrow, Orthopaedic Pharmacist, (NNUH) Clinical Guidelines Assessment Panel (CGAP) Chair s Action; tick here Date of approval: 12/06/2017 Ratified by or reported as Clinical Standards Group and Effectiveness Sub-Board approved to (if applicable): To be reviewed before: This document remains current after 12/06/2020 this date but will be under review To be reviewed by: Nicola Kerrigan Reference and / or Trust Docs ID JCG No: Version No: 3 Minor changes to wording of headings in the quick reference guide and Description of changes: instead of using a range of timescales for stopping some drugs (e.g. 6 8 weeks) absolute figures given (e.g. 7 weeks) Compliance links: (is there any No NICE related to guidance) If Yes - does the strategy/policy deviate from the N/A recommendations of NICE? If so why? This guideline has been approved by the Trust's Clinical Guidelines Assessment Panel as an aid to the diagnosis and management of relevant patients and clinical circumstances. Not every patient or situation fits neatly into a standard guideline scenario and the guideline must be interpreted and applied in practice in the light of prevailing clinical circumstances, the diagnostic and treatment options available and the professional judgement, knowledge and expertise of relevant clinicians. It is advised that the rationale for any departure from relevant guidance should be documented in the patient's case notes. The Trust's guidelines are made publicly available as part of the collective endeavour to continuously improve the quality of healthcare through sharing medical experience and knowledge. The Trust accepts no responsibility for any misunderstanding or misapplication of this document. Review date: 15/06/2020 Trust Docs ID: JCG Version: 3 Page 1 of 9

2 Therapies discussed in this guideline Etanercept/ Biosimilar Adalimumab (Humira ) Infliximab/ Biosimilar Rituximab (Mabthera ) Tocilizumab (RoActemra ) Cimzia (Certolizumab) Abatacept (Orencia ) Golimumab (Symponi ) Ustekinumab (Stelara ) Secukinumab (Cosentyx ) Objective To enhance patient safety peri-operatively in terms of reducing risk of infection and promoting optimal wound healing Review date: 15/06/2020 Trust Docs ID: JCG Version: 3 Page 2 of 9

3 Quick reference Drug Dosing Regime Low infective risk High infective risk Etanercept/Biosimilar 50mg s/c once weekly 1 week 2 weeks Humira/Adalimumab 40mg s/c fortnightly 6 weeks 11 weeks Infliximab/Biosimilar 3-5mg/kg IV 8 weekly 4 weeks 7 weeks Rituximab/Mabthera 1g x2 IV 6-12 monthly 9 weeks 15 weeks Tocilizumab/Roactemra 8mg/kg IV 4 weekly or 162mg s/c weekly 4 weeks 6 weeks Certolizumab/Cimzia 200mg s/c fortnightly 6 weeks 10 weeks Abatacept/Orencia 500mg-1000mg IV 4 wkly or 125mg s/c weekly 6 weeks 9 weeks Golimumab/Symponi 50mg s/c once monthly 5 weeks 9 weeks Ustekinumab/Stelara 45mg/90mg s/c every 12 weeks 10 weeks 15 weeks Secukinumab/Cosentyx 150mg s/c once monthly 12 weeks 20 weeks Recommence Biologics once Surgeon is happy with the wound and no other signs of infection, e.g. on antibiotics Rationale Biologic Therapies are now widely used for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, and other associated rheumatological conditions such as ankylosing spondylitis. Patients with rheumatological diseases have unique surgical risk factors, such as the exposure to disease modifying anti-rheumatic drugs (DMARDS) and corticosteroids that, in addition to their underlying disease, could predispose them to infections. Tumour Necrosis Factor (TNF) mediates inflammation and modulates cellular immune responses. TNF inhibitors may therefore affect host defences against infection. This is thought to pose a risk for the development of postoperative infections and healing complications in patients with rheumatological diseases undergoing surgery. Review date: 15/06/2020 Trust Docs ID: JCG Version: 3 Page 3 of 9

4 The British Society of Rheumatology s statement on the safety of biologic therapies encourages consideration of the risks and benefits of pausing biologics peri-operatively. (2) Staff involved in preparing patients for elective surgery need to be aware of the rationale for pausing biologic therapy for rheumatology patients and the specific time scales involved for each therapy. For concerns regarding individual cases, please contact the patient s rheumatology consultant for advice. New patients starting on biologic therapies in the Rheumatology Department are given in depth counselling about the risks of infection generally and how to manage their therapy in the event of elective surgery. Broad recommendations If biologic therapy is to be stopped prior to surgery, consideration should be given to stopping 3-5 x half-life for the relevant drug before surgery. Biologic therapy should not be restarted after surgery until there is good wound healing and no evidence of infection, however subtle (2), and the surgeon is happy with the wound. For clean surgical procedures, (i.e. arthroscopy) washout = 3 x half life For high infection risk procedures, (i.e. GI tract surgery) washout = 5 x half life For bloodless procedures (such as cataract surgery) we would not advise routinely stopping biologics. Note: Patients may flare when their biologic drug is stopped, and surgical outcomes may be adversely affected in a patient with systemic disease. If steroids are used to suppress flares whilst withholding the biologic drug, they may have an even greater adverse effect on surgical outcomes. Please contact the patient s rheumatology consultant or the Biologics Specialist Nurses (x3786) for advice. Advice regarding stopping DMARDS (ie Methotrexate) prior to Elective Surgery We do not advocate stopping DMARDS peri-operatively. However if you have specific concerns about individual cases, please contact the patient s rheumatology consultant. Scope The advice given in this guideline extends to the use of biosimilar biologic products Review date: 15/06/2020 Trust Docs ID: JCG Version: 3 Page 4 of 9

5 Processes to be followed Please refer to the guidance laid out on the quick reference page. If there are concerns about a specific case, please contact the patient s rheumatology consultant. Specific Guidance for Individual Therapies: Etanercept / Biosimilar Normal adult dosing regimen: 50mg once weekly by sub-cutaneous injection 3 x half-life = 1 week (8.75 days) 5 x half-life = 2 weeks (14.58 days) Adalimumab / Humira Normal adult dosing regimen: 40 mg fortnightly by sub-cutaneous injection 3 x half-life = 6 weeks (45 days) 5 x half-life = 11 weeks (75 days) Infliximab / Biosimilar Normal adult dosing regimen: 3mg/kg at 6-8 weekly intervals 3 x half-life = 4 weeks (30 days) 5 x half-life = 7 weeks (50 days) Rituximab / Mabthera Normal adult dosing regimen: A course of Rituximab consists of two 1000mg intravenous infusions, two weeks apart. A course of treatment is repeated 6 12 monthly 3 x half-life = 9 weeks (62.4 days) 5 x half-life = 15 weeks/4 months (104 days) Review date: 15/06/2020 Trust Docs ID: JCG Version: 3 Page 5 of 9

6 Tocilizumab / RoActemra Normal adult dosing regimen: 8mg/kg intravenous infusion every 4 weeks or 162mg s/c once weekly 3 x half-life = 3-6 weeks (24-42 days) 5 x half-life = 6-7 weeks (40-70 days) Abatacept / Orencia Normal adult dosing regimen: 125mg s/c once weekly, or To be administered as a 30-minute intravenous infusion every 4 weeks at the dose specified below Table 1: Dose of ORENCIA Body Weight of Patient Dose Number of Vials < 60 kg 500 mg 2 60 kg to 100 kg 750 mg 3 > 100 kg 1,000 mg 4 3 x half-life = 6 weeks (39 days) 5 x half-life = 9 weeks (65 days) Review date: 15/06/2020 Trust Docs ID: JCG Version: 3 Page 6 of 9

7 Certolizumab / Cimzia Normal adult dosing regimen: 200mg subcutaneous injection given every 2 weeks 3 x half-life = 6 weeks (42 days) 5 x half-life = 10 weeks (70 days) Golimumab / Symponi Normal adult dosing regimen: 50mg once monthly by subcutaneous injection 3 x half-life = 4-6 weeks (30-45 days) 5 x half-life = 7-11 weeks (50-75 days) Ustekinumab / Stelara Normal adult dosing regimen: 45mg s/c every 12 weeks 3 x half-life = 6-14 weeks (45-96 days) 5 x half-life = weeks ( days) Secukinumab / Cosentyx Normal adult dosing regimen: 150mg s/c once monthly 3 x half-life = 12 weeks/3 months (81 days) 5 x half-life = 20 weeks/5 months (135 days) Review date: 15/06/2020 Trust Docs ID: JCG Version: 3 Page 7 of 9

8 Clinical audit standards To ensure that this document is compliant with the above standards, the following monitoring processes will be undertaken: Clinical audit will be carried out at a regular interval. The aim of the audit is to ensure that; - All patients currently treated on biologics have appropriate interruption in treatment when undergoing surgery The audit will require information to be collected on; Which biologic treatment patient is taking Details of type of surgery Outcomes of the surgery, i.e. any post-operative infection Details of interruption in biologic treatment, i.e. stop and start dates This audit may require use of patient electronic letters and medical notes. Results of audits will be shared with the Clinical Director and presented and discussed at Clinical Governance meetings. Summary of development and consultation process undertaken before registration and dissemination The authors listed above drafted this guideline on behalf of the MDT in the Rheumatology Department who have agreed the final content. During its development it was has been circulated for comment to: Rheumatology Consultants Rheumatology Registrars Rheumatology Specialist Nurses Colin Green Pharmacist Comments included the need for a quick reference guide, which has been included in this guideline. Review date: 15/06/2020 Trust Docs ID: JCG Version: 3 Page 8 of 9

9 References 1 den Broeder AA, Creemers MC, Fransen J et al. Risk factors for surgical site infections and other complications in elective surgery in patients with rheumatoid arthritis with special attention for anti-tumor necrosis factor: a large retrospective study. J Rheumatol 2007;34:689_95. 2 Ding T, et al BSR and BHPR rheumatoid arthritis guidelines on the Safety of anti- TNF therapies _on_safety_of_antitnf_therapies_sept_2010.pdf 3 Giles JT, Bartlett SJ, Gelber AC et al. Tumor necrosis factor inhibitor therapy and risk of serious postoperative orthopedic infection in rheumatoid arthritis. Arthritis Rheum 2006;55:333_7. 4 The manufacturer of each of the Biologic drugs was contacted via their Medical Information departments and provided a statement regarding the half life of their specific drug, and the timing of surgical procedures. This information forms the predominant basis of this guideline Associated Documentation British Society for Rheumatology (BSR) and British Health Professionals in Rheumatology (BHPR) Guidelines on Safety of anti-tnf Therapies is available on the BSR website. Author: Tina Ding 2010 Review date: 15/06/2020 Trust Docs ID: JCG Version: 3 Page 9 of 9