These have been standardised where possible to allow consistency and reduce errors. Dose increased to maximum of 1g bd over a 2 to 8 week period. The British Society of Rheumatology advises the following: “Clinicians may need to be flexible about blood testing for patients on stable DMARDs. ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿì¥Á %` ø¿ S¢ bjbj"x"x 7Z @ @ *š ( ÿÿ ÿÿ ÿÿ ¤ ¸ ¸ ¸ ¸ ¸ ¸ ¸ Ì �m �m �m 8 Èm ô ¼n ä Ì º« h ¬p ( Ôp ( üp üp üp ×q ×q ×q D¥ F¥ F¥ F¥ - s¥ ä W¨ ä ;« $ "­ h Š¯ ô _« ¸ òx ×q ×q òx òx _« ¸ ¸ üp üp Û t« ‚ ‚ ‚ òx ” ¸ üp ¸ üp D¥ ‚ òx D¥ ‚ ‚ Äœ Ì ¸ ¸ ,Ÿ üp  p @ÿ(ûóÍ �m †y 4 �� 0¢ Š« 0 º« ª� ‚ ~° º ä ~° 4 ,Ÿ ~° ¸ ,Ÿ ×q Æ �s D ‚ át åu ×q ×q ×q _« _« �� | ×q ×q ×q º« òx òx òx òx Ì Ì Ì Äg �m Ì Ì Ì �m Ì Ì Ì ¸ ¸ ¸ ¸ ¸ ¸ ÿÿÿÿ YORKSHIRE REGIONAL GUIDELINES FOR THE MONITORING OF ADULT PATIENTS ON DISEASE MODIFYING DRUGS (DMARDS) INCLUDING BIOLOGIC THERAPIES Fifth Edition Revised March 2009 YORKSHIRE DMARD MONITORING These guidelines have, after extensive discussions and reference to the published literature, been agreed upon by Yorkshire Rheumatologists. This section on DMARD’S is devoted to these new agents. It was first trialled in juvenile Stills disease, where it has proved to be very effective. Quick Reference Guide – Ongoing Monitoring Requirements for Disease Modifying Anti-rheumatic Drugs (DMARDs) Rachael Pugh, Prescribing Adviser & Abigail Cowan, Prescribing Advisers, Medicines Management Team, MLCSU Written: March 2016 Approved: MCGT June 2016 Review date: June 2019 DMARD FBC U&Es/serum creatinine LFTs Other BP They largely reflect the BSR core guidelines for DMARD monitoring, except that these have no information on biologic agents. Neutrophils less than 1.6 x 10 9 /L. Scenario: General principles of managing DMARDs: covers the general principles of managing an adult who is on a DMARD. In cases of combination therapy with another potentially hepatotoxic DMARD … Conclusion It is licensed in combination with MTX for the treatment of active RA in adult patients who have had insufficient response to (or intolerance of) other DMARDS, including at least one anti-TNF. Recommended DMARD Blood Monitoring Schedule when Starting or Adding a New DMARD Check FBC, creatinine/calculated GFR, ALT and/or AST and albumin every 2 weeks until on stable dose for 6 weeks; then once on stable dose, monthly FBC, creatinine/calculated GFR, ALT and/or AST and albumin for 3 months; thereafter, FBC, creatinine/calculated GFR, ALT and/or AST and albumin at least … (01423 883389 / Fax 01423 553468 / HYPERLINK "mailto:Andrew.Gough@hdft.nhs.uk" Andrew.Gough@hdft.nhs.uk) or Tina Hawkins, Lead Rheumatology Pharmacist, Chapel Allerton Hospital (0113 392 4589 / Tina.Hawkins@leedsth.nhs.uk) or Professor Paul Emery, Academic Unit of Musculoskeletal Disease, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA (0113 392 4883 / Fax 0113 392 4991) CONTENTS Page 4) AZATHIOPRINE 5) BIOLOGIC THERAPY 6) ABATACEPT 7) ANTI-TNF THERAPY 8) ADALIMUMAB 9) ETANERCEPT 10) INFLIXIMAB 11) RITUXIMAB 13) TOCILIZUMAB 14) CICLOSPORIN 15) CORTICOSTEROIDS 16) CYCLOPHOSPHAMIDE 17) GOLD 18) HYDROXYCHLOROQUINE 19) LEFLUNOMIDE 20) METHOTREXATE 21) MYCOPHENOLATE 22) PENICILLAMINE 23) SULFASALAZINE 24) VACCINATIONS IN RHEUMATOLOGY AZATHIOPRINE (4 / 3 / 2009) When commencing treatment the following will be considered : 1) Age / Sex of patient and fertility 4) Serious interaction (considered relatively safe in - ALLOPURINOL pregnancy, where benefit may 5) Potential interactions outweigh the risks eg SLE) - Sulfasalazine + related drug 2) Known renal or hepatic impairment - Cotrimoxazole (both parts) 3) TPMT assay or genotype check - Captopril (?other ACE) pre-treatment is now suggested - Warfarin (reduces coag) - Avoid Live Vaccines Treatment is usually started at one 50mg tablet daily with or after breakfast for the first week. There is a wide variability amongst hospitals within a region on shared care arrangements. The final new agent to be covered in this edition is tocilizumab. Avoid live vaccines Must use contraception during use and for 5/12 afterwards Avoid in pregnancy and breast feeding ROUTINE TESTING when treatment commences Baseline - Full clinical / infection screen - Urinalysis and BP - FBC / U&E / LFT / ANA / DNA - CXR (for evidence of old TB) - TB spot or quantiferon test - Hep B & C - Pregnancy test when indicated Repeat - Usual tests for MTX or other DMARD monitoring - FBC / U&E / Urinalysis results before each infusion - ANA / LFT 3-4 monthly STOP TREATMENT IF significant infusion reaction, any evidence of infection, demyelination or SLE-like syndrome IF WCC < 3.5 Neutrophils < 2.0 AST / ALT > 3 times normal Pruritis / Rash (very rarely including Stevens Johnsons) Contact local Rheumatology service RITUXIMAB (5 / 3 / 2009) This is a human/mouse monoclonal antibody directed against B cells. Passive immunisation with immunoglobulin should be given to patients who are in contact with cases of chickenpox or herpes zoster. No routine monitoring is necessary with apremilast, hydroxychloroquine, mepa-crine or minocycline. DMARD MONITORING GUIDELINES – FOR GP INFORMATION 10.10.08 Mycophenolate mofetil A. ROUTINE TESTING when treatment commences Baseline BP FBC / U&E and LFT Repeat Week 2 = BP and FBC / LFT Then 2 weekly for 2 months (0-2) Monthly for 4 months (2-6) Then 3 monthly (stable dose) IF WCC < 3.5 Neutrophils < 2.0 Platelets < 150 AST or ALT > 3 times normal range Significant BP rise or > 160/95 Abdominal pain / Nausea / Diarrhoea / Weight loss Pruritis / Rash / Breathlessness Stop medication and contact local Rheumatology service If unsure or progressive abnormal trend telephone/fax IF needed washout = cholestyramine 8gr tds 11 days METHOTREXATE (4 / 3 / 2009) When commencing treatment the following should be considered : 1) Age/Sex & alcohol intake 5) All should stop 3/12 before 2) Contraindicated in pregnancy considering conception and when breastfeeding 6) Potential drug interactions : 3) Renal or Hepatic impairment - NSAIDS eg diclofenac, salicylate 4) Underlying chest disease/smoker - Other anti-folates (eg phenytoin - All patients with RA should trimethoprim, cotrimoxazole) have a pre-treatment CXR - Uricosurics and PFT. With considerable increase in DMARD prescriptions following early diagnosis and … Rituximab, a monoclonal antibody which depletes B cells, has NICE approval for RA where anti-TNF agents have failed, and may be used for patients where they are contraindicated. Indications: (Licensed) RA, dermatomyositis and polymyositis, autoimmune and chronic active hepatitis, pemphigus vulgaris. endstream endobj 1084 0 obj <>/Metadata 81 0 R/Pages 1081 0 R/StructTreeRoot 95 0 R/Type/Catalog>> endobj 1085 0 obj <>/MediaBox[0 0 595.32 841.92]/Parent 1081 0 R/Resources<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 1086 0 obj <>stream Side effects are usually mild and self-limiting. The major ones include : Osteoporosis (Always consider DXA / prophylaxis) Weight gain Thin skin / purpura / bruising / acne Hypertension Diabetes (regular urine checks) Cataracts Myopathy Mental disturbance Rapid dose reduction or discontinuation of chronic therapy can lead to life threatening Addisonian crisis and should always be medically supervised. ; Scenario: Apremilast: covers the monitoring of apremilast in adults in primary care. It is licenced and approved by NICE for uncontrolled active RA, PsA, AS and in JIA (see website). Although influenza and pneumococcal vaccines do not offer complete protection (70-80% influenza & 50-70% pneumococcal) they should be offered to all patients receiving immunosuppressant therapy. (= > 400mg/day for 60kg patient) IF Photophobia / Haloes Field Defects / Reduced Acuity Stop medication and contact local rheumatology service LEFLUNOMIDE (4 / 3 / 2009) When commencing treatment the following should be considered : 1) Usually considered for patients with active RA/ PsA who have failed methotrexate and sulphasalazine (licensed for both). Table 1 lists the current live vaccines available in the UK: Table 1, Live vaccines VaccineBrand NameBCGBacillus Calmette-Guerin VaccineMeasles, Mumps and Rubella Combined Vaccine (MMR)MMRvaxPRO®, Priorix®Poliomyeltis (Live oral vaccine)Poliomyeltis Vaccine, live (oral) GSK OPVRotavirus (Live oral vaccine)Rotarix®Typhoid (Live oral vaccine)Vivotif®Varicella-Zoster VaccineVarilrix®, Varivax®Yellow Fever Arilvax®, Stamaril® If vaccination is required with a live preparation it should not be given until 3 months after the above listed drugs have been stopped or 2 to 4 weeks prior to commencing the medication (see below). Table 1: PICO characteristics of review question Population Adults with RA who are DMARD naïve. Previous. There is no contra-indication for the administration of live vaccines to relatives or friends of patients on immunosuppressant drugs. Initial assessment of patients and the decision to start treatment will continue to be carefully made by Consultants and GPs where appropriate. ROUTINE TESTING when treatment commences Baseline FBC / U&E / LFT Opthalmological screening recommended if pre- existing ocular pathology or visual disturbance, impaired renal function or over the age of 60. The only exceptions are acrolimus, ciclosporin and t methotrexate/leflunomide combinations – where extended monthly monitoring longer term is advocated. Dose Typical dose 7.5mg-25mg once weekly. The anti-TNF agents have been in regular use for a decade for patients with RA and have transformed the lives of many. For RA this is when two or more DMARD’S have failed (including methotrexate), and 2 BSR assessments for activity of RA have been done more than 4 weeks apart to establish eligibility. The BAD guideline recommends that monitoring of people on biologic DMARDs can be carried out every 6 months [ BAD, 2017 ]. This should be prescribed in combination with methotrexate, or an alternative appropriate DMARD (although this is unlicensed). It too has proved to be very effective and well tolerated. Immunisation with the oral cholera vaccine (Dukoral®) does not provide complete protection. Usual regime is 1gram IV two weeks apart given after 100mg methyl-prednisolone with pre-treatment with antihistamine and paracetamol. Patients should avoid taking ciclosporin with grapefruit or its juice. Items highlighted in bold are felt to be of particular importance. 2017 Jun 1;56(6):865-868. doi: 10.1093/rheumatology/kew479. If unsure or progressive abnormal trend telephone/fax HYDROXYCHLOROQUINE (4 / 3 / 2009) When commencing treatment the following will be considered: 1) Generally thought safe in 4) Potential drug interactions: pregnancy (but crosses placenta) - Amiodarone 2) Renal and Hepatic impairment - Moxifloxacin 3) Known ocular disease - Ciclosporin - Digoxin - Antacids avoid within 4hrs - Anti-epileptics Usually started at a dose of 200mg bd for the first 3 months and then reduced to 200mg daily as a maintenance dose if effective (aim for 3-5mg/Kg/day LEAN body weight). For each drug a single reference sheet outlining recommended drug monitoring tests, which should be done in order to minimise the risk of toxicity, is enclosed. Treatment is given as an IV infusion at 8mg/kg, initially 2 weekly and then at 4 weekly intervals. Clinical response should be carefully assessed, including DAS 28 score, at 3 and 6 months. BCG is a live vaccine and must not be given to patients on immunosuppressant therapy. Prophylaxis is not absolute and personal protection against being bitten is very important. It has also been used in psoriasis, atopic dermatitis and autoimmune bullous dermatoses such as pemphigus. Check for drug interactions with the Pharmacy Department. Revised BSR guidance was published in early 2008 and was intended to be modified according to local practice. Treatment is by IV infusion at week 0, 2 and 4 weeks and then on a 4 weekly basis. Castlemans and adult stills are other possible indications. Paracetamol oral 1g 4–6 hourly (maximum 4g in 24 hours) 1. Use - Aciclovir / Ganciclovir contraception for 6/52 after - Azathioprine discontinuation. The results of the audit have been with the local hospitals. DMARD Quick Reference Guide Approval date: February 2019 Version 5.0 Review Date: February 2022 North Central London Joint Formulary Committee Quick Reference Guide for Primary Care Prescribers Monitoring Disease Modifying Anti-Rheumatic Drugs (DMARDs) Azathioprine, Mercaptopurine, Sulfasalazine, Hydroxychloroquine, Ciclosporin, Penicillamine, Leflunomide and Mycophenolate mofetil … every 12 weeks. 2) Known hypertension / renal / hepatic impairment /malignancy 3) There are many potential drug interactions: always check with pharmacy / BNF. ROUTINE TESTING when treatment commences Blood - Baseline FBC / U+E / LFT - Repeat FBC and LFT 2 weekly for 2 months (0-2 months) Monthly for 4 months (2-6 months) Then 3 monthly twice, 6 monthly twice and may then be discontinued IF WCC < 3.5 Neutrophils < 2.0 Platelets < 150 AST or ALT > 3 times normal range Sore throat / Oral Ulceration / Fever or Rash Stop medication and contact local Rheumatology service. :��%�g�\�T� }r �$k˜P'�Y����~�]z]�o躂�o Zej� The administration of yellow fever vaccine is contra-indicated making travel to endemic areas, including tropical Africa and South America inadvisable. Usual b.d. Oral prednisolone 30 - 60mg between infusions should be given for CTD patients, especially Sjorgrens and those with high globulins. Full clinical reassessment of response at week 12 and 24, with treatment withdrawal if response inadequate (reduction in DAS 28 < 1.2 or overall DAS 28 >3.2). Abatacept is a fully human fusion protein which interferes with T cell signalling and has been shown to have good efficacy in RA. DMARD - disease modifying anti-rheumatic drug MCV - mean corpuscular volume WCC - white cell count eGFR - estimated glomerular filtration rate WCC <3.5 or Neutrophils <1.6 x 109/L URGENT ACTION MAJOR/COMMON Risk of infection Neutrophils <1.0: Same day discussion Febrile and/or neutrophils <0.5: Urgent clinical assessment OTHER CONSIDERATIONS Take account of … Firmly embedded in clinical practice – users lead the proposal, selection and development of all guideline topics – we choose new areas, areas where there is clinical uncertainty, where mortality or morbidity can be reduced. hàxH CJ ; Scenario: Azathioprine: covers the monitoring of azathioprine in adults in primary care. Where MTX used a dose of approximately 15mg per week is thought appropriate by any route. Biologic therapies are not without potential risk, and hence it is important that clinicians are aware of these risks and ensure that appropriate precautions are taken to minimize t… These Yorkshire Guidelines are felt … These Yorkshire Guidelines are felt to represent a safe level of clinical care for patients requiring DMARD treatment, while keeping monitoring time and expenditure to an acceptable level. Side effects are usually GI, mild and self limiting. Tablets should be taken as a single dose in the morning with or after food. Biologics Live vaccines should not be given to patients receiving treatment with biologics (refer to table 1). Patients receiving steroid therapy equivalent to 20mg of oral prednisolone or more should also not be given live vaccines. endstream endobj startxref No specific laboratory monitoring is required during TNF inhibitor therapy as haematological and liver test abnormalities are rarely caused by these agents. Thresholds for action remain unchanged. Shared Care Guidelines are local policies to enable GPs to pick up the prescribing and monitoring of medicines/treatments in primary care in agreement with the initiating specialist. (Nb During pregnancy doses of prednisolone 20mg daily or greater can lead to neonatal addisonian crisis) Immuno-suppression can lead to serious consequences with infections and live vaccines. In particular Chickenpox may be fatal. ROUTINE TESTING when treatment commences Baseline FBC / U&E / LFT Urinalysis Repeat FBC on day 7 to 10 after each pulse Urinalysis Results checked prior to giving next pulse. 0 MTX dose may be split on day of treatment or taken twice weekly if side effects occur. ; Scenario: Baricitinib : covers the monitoring of baricitinib in adults in primary care. Not used in Psoriasis. One regimen is : 10 to 15 mg/kg IV Cyclo + 5 to 10mg/kg IV Methylpred 3 pulses given 2 weekly then 3 given 3 weekly Assess for remission / reduce pulses or maintenance Rx Pulses can be given with oral mesna cover, although most haematology units do not feel this is necessary, with or without anti-emetics. If unsure or progressive abnormal trend telephone/fax BIOLOGIC THERAPY (5 / 3 / 2009) Immunotherapy of autoimmune disease in rheumatology and other specialties has changed enormously in the last decade. Timing of dose is not important. Evidence for combination with alternative appropriate DMARD’s is poor. Treatment response at three months should be carefully assessed including 28 DAS score. It may be prescribed as monotherapy but is usually more effective in combination with methotrexate (eg RA). ROUTINE TESTING Baseline : FBC / U + E / LFT Consider Hep B & C Repeat FBC/LFT : 2 weekly for 2 months (0-2 months) : monthly for 4 months (2-6 months) : Then 3 monthly (assuming dose stable) IF WCC < 3.5 Neutrophils < 2.0 Platelets < 150 AST or ALT > 3 times normal range Mouth or Throat Ulceration Unexplained bruising or bleeding Fever / Nausea / Vomiting / Diarrhoea Diffuse alopecia Stop medication and contact local Rheumatology service. BSR has published guidelines stressing the importance of monitoring for early detection of toxicity. If nausea or ineffective at up to 30mg weekly consider Sub Cut use. Steps have been taken to ensure that all blood tests performed by the hospital are copied to the practice. Seropositive patents respond better. Immunosuppressed patients may be given non-live vaccines (refer to table 2). 1.3 PICO table For full details see the review protocol in appendix A. If injection site reaction try topical (or oral) anti-histamine / corticosteroids. Version 1 … Thereafter, at least every 12 weeks. 2. gH��W�H*�l���r���m'�Sr�sq�̻�p:�q��T7�eٺ��م�d��;a����n4Z��_���M��7�ͪ6�#J����UO���W�ɇq�j����z5ϛw}F�����a�X�Bɯ�K)M���[T)o~m����m�M���}٨f0�7�u�����c�0� �s�Bn�Ŀ Ǒ���y�;N�ÛpHrh:G�/!��"����⬁ �m4��Ԃ���:���!e$��t̽S'�+놸B��e[lqn�MIX A certificate saying Yellow Fever vaccine cannot be given on medical grounds may be acceptable to some immigration authorities in special circumstances. B. 20mg (or 10mg) tablets daily as a single tablet should be started. Systemic antivirals are recommended where infection is suspected. ABATACEPT 5 / 3 / 2009 This is a fusion protein directed at preventing full T cell activation. Here too it has proved to be effective and phase 3 studies have been completed. Go to algorithm. Variations exist in practice for DMARD monitoring, therefore we advise clinicians working in primary care to work with their specialist centres for patient-specific advice and guidance. Following any dose changes repeat FBC one month after dose increase then revert to usual monitoring regime if stable. DMARD MONITORING GUIDELINES – FOR GP INFORMATION 10.10.08 D-Penicillamine A. DMARDs (rheumatology) shared care guidelines (West Devon) Coronavirus (COVID-19) pandemic: In order to minimise the need for patients to attend NHS facilities for face-to-face contact, reduced frequency of drug safety monitoring has been temporarily introduced for some groups of patients. DMARD MONITORING GUIDELINES – FOR GP INFORMATION 10.10.08 Leflunomide A. ROUTINE TESTING Baseline BP and Creatinine Clearance FBC / U&E / LFT / Lipids Repeat FBC / U&E / LFT and BP At week one 2 weekly for 2 months (0-2 months) Monthly for 4 months (2 to 6 months) Then 3 monthly +/- Lipids IF WCC < 3.5 Neutrophils < 2.0 Platelets < 150 AST or ALT > 3 times normal range Abdominal pain / Diarrhoea / Rash / Bruising / Bleeding Stop medication and contact local Rheumatology service If unsure or progressive abnormal trend telephone/fax D PENICILLAMINE (4 / 3 / 2009) When commencing treatment the following will be considered 1) Avoid in pregnancy and breastfeeding 2) Known renal or hepatic impairment 3) Caution if ANA positive (check) 4) Caution if previous reaction to chrysotherapy 5) Potential drug interactions : - renal toxicity with NSAIDS - zinc and iron may reduce absorption so avoid either within 2 hours of dosing Treatment is usually started at 125mg daily taken at least half an hour before food/milk or last thing at night. Under most circumstances, csDMARD drug monitoring and prescribing is best undertaken in General Practice after initiation and on stable therapy. poor absorption), regular or dispersible forms should be tried. Table 1: PICO characteristics of review question Population Adults with RA who are DMARD naïve. This is felt to reduce toxicity, particularly to the bladder. And lupus nephritis and inflammatory myopathy such as dermatomyositis and polymyositis as an IV at! Two clinical assessments of disease activity at least every 6 months protection against being is. Hydroxychloroquine, mepa-crine or minocycline be modified according to local practice dermatoses such as.. Conditions do not use this drug in DMARD prescriptions following early diagnosis and … monitoring... They have any infection / require antibiotics oral ) anti-histamine / corticosteroids warrant especially careful monitoring of Baricitinib in in! 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