dmard monitoring guidelines
(= > 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). Revised BSR guidance was published in early 2008 and was intended to be modified according to local practice. 1.3 PICO table For full details see the review protocol in appendix A. However, some guidelines suggest that monitoring is required every 3 months [ RCN, 2015 ]. Thereafter, at least every 12 weeks. This can occur in primary care when supported by the national Directed Enhanced Service or a local Enhanced Service. PAGE 26 PAGE 2 $ . In June 2017 the Regional Group on Specialist Medicines approved updated shared care guidelines for a number of DMARD type amber drugs. Clinical effect usually in 2 – 4 months. ABATACEPT 5 / 3 / 2009 This is a fusion protein directed at preventing full T cell activation. Check for drug interactions with the Pharmacy Department. The final new agent to be covered in this edition is tocilizumab. Paracetamol is as effective as non-steroidal anti-inflammatory drugs (NSAIDs) in many patients with osteoarthritis. 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. Mean cell volume more than 105 fL. This is requested by patients and is felt to improve compliance. The British Society of Rheumatology advises the following: “Clinicians may need to be flexible about blood testing for patients on stable DMARDs. Table 1: PICO characteristics of review question Population Adults with RA who are DMARD naïve. Routine blood / urine monitoring tests are not necessary other than those below. Pneumococcal vaccine should preferably be given before starting therapy, but if not it should be repeated at 5 yearly intervals (rather than 10). They largely reflect the BSR core guidelines for DMARD monitoring, except that these have no information on biologic agents. The monitoring parameters cited are derived from a range of guideline sources, other reference sources and expert opinion and must therefore be considered suggestions only. h CJ Baseline Clinical examination including blood pressure Urinalysis FBC / U+E / LFT / Urate / Lipids Repeat creatinine x2 >1 week apart 24 hour urine CrCl or PCI and GFR suggested Routine Blood pressure (with each blood test) U+E / LFT’s (especially if on NSAID eg diclofenac) 2 weekly until stable dosage reached Then monthly for 4 months Then 3 monthly Check Lipids / Urate at 2 - 3 months (optional) IF BP > 160 / 95 or risen >20mm/Hg Creatinine > 30% baseline HALF dose Potassium > 5.5mmol/l (esp with ACE) AST or ALT > 3 times normal range Ankle swelling / Headache (check BP) / Hirsutism Confusion / Tremor / Gingival hyperplasia If unsure Stop Medication and contact local rheumatology service (telephone or fax) CORTICOSTEROIDS (4 / 3 / 2009) When commencing treatment the following will be considered Generally considered safe in conception & pregnancy (see below) Potential drug interactions: Increases ciclosporin levels Diuretics (antagonise / hypokalaemia) AVOID live vaccines if high doses used Used in various rheumatic and other diseases. 4) AVOID live vaccines. he*¦ CJ 2) Considered teratogenic. Where MTX used a dose of approximately 15mg per week is thought appropriate by any route. If injection site reaction try topical (or oral) anti-histamine / corticosteroids. Where possible a hospital based rheumatology specialist nurse will be available for advice for patients or medical staff regarding problems with the use of these drugs. It is also being used in … The results of the audit have been with the local hospitals. A Regional protocol is currently being established for day case administration of IV pulse therapy. Where TLCO less - Penicillin’s may potentiate than 70% or clinical concern levels of MTX an HRCT chest is advisable - Avoid Live vaccines Treatment may begin at a dose of 10- 15mg WEEKLY in 2.5mg tabs and increased to 20mg after 2 – 4 weeks. hàxH CJ 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. DMARD MONITORING GUIDELINES – FOR GP INFORMATION 10.10.08 D-Penicillamine A. 1,2 Spontaneous remission is uncommon (<5%) and most affected individuals require long term disease modifying anti-rheumatic drug (DMARD) therapy to control symptoms and prevent joint damage. Patients with uncertain alcohol intake or other hepatotoxic drugs may warrant increased vigilance. Where this is in place and a patient is stable, monitoring may then be accepted by primary care. No specific laboratory monitoring is required during TNF inhibitor therapy as haematological and liver test abnormalities are rarely caused by these agents. 1) Absolute contraindications Pregnancy / Breastfeeding (though early data is reassuring) Active infection Open leg ulcers Previously infected prosthetic joint (unless completely removed) Septic arthritis in last year HIV or Hepatitis B carriers Previous malignancy within 10 years (except BCC) NYHA Grade 3 or more heart failure Any history of demyelinating disease 2) Relative contraindications Uncontrolled diabetes Pulmonary fibrosis Bronchiectasis (assess severity) PUVA therapy of >1000 Joules Hepatitis C (absolute if RNA +ve) History of TB or positive PPD test (isoniazid and pyridoxine one month before starting and for further 6 months) NYHA heart failure grade 1 or 2 3) Potential Problems Atypical or unusual infections Neutropenia / aplasia Pneumonitis / lung fibrosis Infusion / injection site reactions ANA or DNA positivity (especially infliximab) Induction of autoimmunity Interaction with anikinra AVOID Live Vaccines ( SEE VACCINES SECTION) ADALIMUMAB (see anti-TNF) (5 / 3 / 2009) This is a human monoclonal antibody given as a 40mg sub cut injection every 2 weeks. These tests should be repeated and checked at the time of each injection, and results reviewed prior to the administration of the next one (ie 1 week in arrears). Indications: (Licensed) RA, dermatomyositis and polymyositis, autoimmune and chronic active hepatitis, pemphigus vulgaris. A certificate saying Yellow Fever vaccine cannot be given on medical grounds may be acceptable to some immigration authorities in special circumstances. Clinical response should be carefully assessed, including DAS 28 score, at 3 and 6 months. Most guidelines have similar recommendations for the monitoring of azathioprine and methotrexate, in terms … Clinicians should consider . If injection site reaction try topical (or oral) anti-histamine / corticosteroids. If unsure or progressive abnormal trend telephone/fax VACCINATIONS (5 / 3 / 2009) General information Live vaccinations should not be given to patients receiving Azathioprine, Methotrexate, Leflunomide, Ciclosporin, Cyclophosphamide and Biologics (Anti-TNF, Abatacept, Anakinra, Rituximab and Tocilizumab). Formal opthalmological screening is also suggested when : 1) A cumulative dose of 500grams, which is equivalent to 3.4 years of 200mg bd or 6.8 years of 200mg daily 2) If doses of > 6.5mg/kg/day are used. WCC < 3.5 Neutrophils < 2.0 AST / ALT > 3 times normal Pruritis / Rash Contact local Rheumatology service ANTI-TNF THERAPY (5 / 3 / 2009) Treatment for patients with active RA, PsA, Psoriasis or AS where NICE approval exists. 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). 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. 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. Folic acid 5mg daily or weekly, except on the day of the MTX, should be used to reduce toxicity. Posted on 21st September 2017 21st September 2017 by Richard Lennon. Avoid live vaccines Patients advised to use contraception during use 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 when indicated - Hep B & C - Pregnancy test when indicated Repeat - Usual tests for MTX or other DMARD - If monotherapy FBC / LFT at 1, 3 and 6 months and 3 monthly - ANA 3 monthly IF any evidence of infection or demyelination or SLE-like syndrome stop treatment. Tablets should be taken as a single dose in the morning with or after food. ; Scenario: Azathioprine: covers the monitoring of azathioprine in adults in primary care. CYCLOPHOSPHAMIDE (4 / 3 / 2009) When commencing treatment the following will be considered : 1) Age/Sex of patient & fertility 4)Potential drug interactions Teratogenic – until 3/12 off Rx - Allopurinol (increases levels) 2) Renal / hepatic impairment - Oral hypoglycaemics 3) Avoid in porphyria - AVOID live vaccines Usually reserved for vasculitis / serious connective tissue disease, and given in IV pulses. h10_ CJ h�)T h10_ 5�CJ$ hÈUá 5�CJ( aJ( h10_ 5�CJ( aJ( h*0¦ h10_ 5�CJ( aJ( h*0¦ hØ"É 5�CJ( aJ( hØ"É 5�CJ( aJ( h e 5�CJ$ h10_ 5�CJ$ hØ"É 5�CJ$ hG4Q 5�CJ$ hG4Q h¯( hØ"É h10_ hàxH + w x • – — ˜ ™ š ¨ © ª ½ ¿ Ş ß ú ú ú ú ò å İ Û Û Û Û Ö İ Û Û İ Î § Û &. This article provides an overview of the main recommendations of the new guideline. Pneumococcal vaccine should be given 2-4 weeks before starting a biologic as response after starting treatment is thought to be poor. 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 There is no contra-indication for the administration of live vaccines to relatives or friends of patients on immunosuppressant drugs. The guideline addresses the use of vaccines in patients starting/receiving DMARDs or biologic agents, screening for tuberculosis in patients starting/receiving biologic agents or tofacitinib, and laboratory monitoring for traditional DMARDs. Dose increased to maximum of 1g bd over a 2 to 8 week period. SLE and Wegners are two important examples but there are many others. In contrast to conventional systemic DMARDs (csDMARDs) traditionally used to treat inflammatory disease, these agents offer a targeted approach, and their widespread use has resulted in disease remission becoming an increasingly achievable goal. Following any dose changes repeat FBC one month after dose increase then revert to usual monitoring regime if stable. Leeds has had more experience of this agent in clinical practice than anywhere else in the UK. It was first trialled in juvenile Stills disease, where it has proved to be very effective. It is licensed and approved by NICE for the treatment of RA with MTX where patients have failed to respond or are intolerant of DMARDS including at least one anti-TNF (see website). B. Creatinine has increased more than 30% over 12 months and/or calculated GFR is less than 60 mL/min. Monitoring The guideline recommends a standard schedule for monitoring patients newly prescribed a DMARD or when a second DMARD is initiated (see Table 3) but again there are many exceptions. Indications: (Licensed) RA, dermatomyositis and polymyositis, autoimmune and chronic active hepatitis, pemphigus vulgaris. In some patients response can be late but significant and maintained. The three main agents (infliximab, etanercept and adalimumab) have proved to be safe and well tolerated by the great majority of patients. The recommendations in the guidelines are in line with the new 2016 BSR guideline. Under most circumstances drug monitoring and prescribing is best undertaken in General Practice. rheumatoid arthritis; DMARDs (biologic) DMARDs (synthetic) treatment; economic evaluations; The European League Against Rheumatism (EULAR) developed its first recommendations for the management of rheumatoid arthritis (RA) with synthetic and biological disease-modifying antirheumatic drugs (DMARDs) in 2010.1 They summarised the state of the art and provided rheumatologists, … Reliable contraception essential until drug elimination completed (In both men and women - see SPC – though risk small) 3) Renal or Hepatic impairment (contraindicated in hepatitis B/C carriers) 4) Potential drug interactions : - Cholestyramine / Rifampicin / Warfarin / Tolbutamide - AVOID Live vaccines Do not use loading dose of 100mg daily for three days. those at high risk of TB) should be reviewed every 3 months (grade 2C, SOA 94%). CKS recommends following the recommendations of local guidelines. Where a live vaccine is indicated it should be given 4 weeks prior to commencing therapy. Patient information leaflets, giving clear instructions on monitoring, have been produced for each DMARD. Treatment response at three months should be carefully assessed including 28 DAS score. No routine monitoring is necessary with apremilast, hydroxychloroquine, mepa-crine or minocycline. An example is: dose reducing to paracetamol oral 500mg four times daily. 1.3 PICO table For full details see the review protocol in appendix A. It is licenced and approved by NICE for uncontrolled active RA and PsA, but not for AS (see website). Oral prednisolone 30 - 60mg between infusions should be given for CTD patients, especially Sjorgrens and those with high globulins. These Yorkshire Guidelines are felt … * More frequent monitoring is appropriate in patients at higher risk of toxicity; After 12 months, monitoring may be discontinued. For people on any disease-modifying anti-rheumatic drug (DMARD), consider stopping treatment and referring urgently to rheumatology if monitoring results show any of the following: White cell count less than 3.5 x 10 9 /L. Background Shared care guidelines are used by hospitals and primary care for drug toxicity monitoring in the UK. For review on or before July 2021. appropriate monitoring as described in the shared care agreement. If significant rash or any evidence of infection stop treatment. 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. This is felt to reduce toxicity, particularly to the bladder. 20mg (or 10mg) tablets daily as a single tablet should be started. Version 1 … Immunosuppressed patients may be given non-live vaccines (refer to table 2). 1. The guideline includes 74 recommendations: 23% are strong and 77% are conditional. Full clinical reassessment of response at weeks 12 and 24, with treatment withdrawal if response inadequate (reduction in DAS 28 < 1.2 or overall DAS 28 >3.2). Combined Adsorbed diphtheria (low dose), tetanus and inactivated poliomyelitis preparation given. Dose Typical dose 7.5mg-25mg once weekly. Avoid Live Vaccines during and 3/12 after treatment Adequate contraception essential and for 3/12 after use Avoid in pregnancy and when breast feeding ROUTINE TESTING when treatment commences Baseline - Full clinical / infection screen - Urinalysis and BP - FBC / U&E / LFT - CXR (for evidence of old TB) - TB spot or quantiferon test when indicated - Pregnancy test when indicated - Hepatitis serology Repeat - Usual tests for MTX or other DMARD - If monotherapy FBC / LFT at 1, 3 and 6 months and 3 monthly If any evidence of infection withhold treatment. Side effects are usually GI, mild and self limiting. 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). Initial assessment of patients and the decision to start treatment will continue to be carefully made by Consultants and GPs where appropriate. (BSR) produced its second edition of DMARD monitoring guidelines for rheumatologists but this was considered by the committee for evaluation of guidelines of the Royal College of Physicians to be more appropriate as a ‘practical tool’ than guideline. (Unlicensed) Vasculitides, such as polyarteritis and giant cell arteritis  and systemic lupus Where MTX is used a dose of approximately 15mg per week is thought appropriate by any route. FBC and urine should then be checked after 6 days prior to giving the next full dose of 50mg IM. endstream endobj startxref SHARED CARE GUIDELINE FOR THE USE OF DISEASE MODIFYING ANTI-RHEUMATIC DRUGS (DMARDS) Adapted with kind permission from NHS Worcestershire Guidelines for the use of Disease Modifying Drugs (DMARDs). Go to algorithm. 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 … If no response in 3 months consider an increase in dose to 750 mg/day. MTX dose may be split on day of treatment or taken twice weekly if side effects occur. Table for full details see the review protocol in appendix a advice when needed significant. Of this agent in clinical practice than anywhere else in the morning with or after food Licensed ) RA Wilson... Prescribing is best undertaken in General practice after initiation and on stable.. And self limiting effective in combination with alternative appropriate DMARD ’ s.. Full blood Count ( FBC ) every 2 weeks until dose is stable for 6 weeks to. 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