N.B.Patients … Two clinical assessments of disease activity at least 12 weeks apart are required to receive approval. Monitoring Frequency; Full Blood Count (FBC) Every 2 weeks until dose is stable for 6 weeks. It is also of benefit for difficult connective tissue disease eg SLE and Wegners. Avoid live vaccines Must use contraception during use and for 5/12 afterwards Avoid in pregnancy and breast feeding Avoid in latex allergy (needle cover contains latex) 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 / fibrosis) - 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. x��XM��6�/���GH��H�h-�Z�d9��f7顇6�͡���%��&�5�������͐�n�޽��6MͲ���}�a��ۛ��t&3���(���b�R村9����Mƾ�����g^w�P�G����]��5���f����s�]�h���]*���~�� �6���h���^�����gY�6�]�^�rY�Ĉ�(��Z�? 0 This is requested by patients and is felt to improve compliance. endstream endobj startxref 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. It is licenced and approved by NICE for uncontrolled active RA, AS, JIA, Psoriasis and PsA (see website). The parenteral typhoid vaccine offers only 70-80% protection, so personal, food and water hygiene must be emphasised to travellers in endemic areas. Not used in Psoriasis. Pneumococcal vaccine should be given 2-4 weeks before starting a biologic as response after starting treatment is thought to be poor. Consultant Rheumatologists are also contactable by telephone, fax or email for advice when needed. Then monthly for 3 months. BSR and BHPR guideline for the prescription and monitoring of non-biologic disease-modifying anti-rheumatic drugs Rheumatology (Oxford). every 12 weeks. 2) Considered teratogenic. Items highlighted in bold are felt to be of particular importance. Concomitant DMARD’S (except MTX, LEF, AZA or Mycophenolate) should be withdrawn 4 weeks before starting rituximab. (Unlicensed) Vasculitides, such as polyarteritis and giant cell arteritis [1] and systemic lupus Immunosuppressed patients may be given non-live vaccines (refer to table 2). 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. If minor infusion reactions try IV anti-histamine / corticosteroids. 2r���hU����B�v��7�B�5���5��������x��a�Y�/Uo��������Ϗkx�}���Ee�{W���`��ʾVh�ê����rJg8�I�9U��4hWHe}�X��v�y�����Y=����{�c���$�b�G�Wj���4Gש��A�M�|p �8�ه"�u�b�F�/n9'�$�r�z,�! Indications: (Licensed) RA, dermatomyositis and polymyositis, autoimmune and chronic active hepatitis, pemphigus vulgaris. 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. 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. These guidelines have, after extensive discussions and reference to the published literature, been agreed upon by Yorkshire Rheumatologists. Dose Typical dose 7.5mg-25mg once weekly. Check for drug interactions with the Pharmacy Department. 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. 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. Patients with a good response can be retreated, at an average of 9 months (from 6 months onwards), with some patients responding for some years. Routine blood / urine monitoring tests are not necessary other than those below. Patient information leaflets, giving clear instructions on monitoring, have been produced for each DMARD. Under most circumstances drug monitoring and prescribing is best undertaken in General Practice. 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). Tests for patients on disease-modifying arthritis drugs. This section on DMARD’S is devoted to these new agents. Our guidelines grow out of the collaborative efforts of many members and non-members, specialists and generalists, patients and carers. 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. Treatment is by IV infusion at week 0, 2 and 4 weeks and then on a 4 weekly basis. When considering treatment the following will be considered: 1) Exclusions from treatment include Any active infection Pregnancy or breastfeeding Bone / joint surgery in previous 8/52 or planned within 3/12 Hep B/C Uncontrolled heart, lung, renal, GI, neurological or diabetes 2) Potential problems include Infusion reactions in up 50% (usually mild and not recurrent) Facial flushing / sore throat common for 24 – 48 hours post-infusion All vaccinations should be completed 1/12 before treatment starts No live vaccines during or for 1 year after therapy Females should use contraception during and for 1 year after therapy ROUTINE TESTING The following should be considered : Before 1st cycle - Full clinical / infection screen - Urinalysis and BP - FBC / U&E / LFT / Ig’s - B Cell FACS analysis - CXR - Hep B & C in all - Pregnancy test when indicated - TB screening not indicated routinely Repeat cycle - Usual tests for MTX if on this - FBC / U&E results before each infusion - Clinical review / Urinalysis / BP - B Cell REFACS after second infusion, 4 weeks and 3 monthly using Leeds assay - Check Ig’s before each repeat cycle IF Significant infusion reaction stop infusion. On ceasing treatment with a biologic live vaccination is permitted after the following time periods have elapsed: BiologicTime to elapse before giving a live vaccineAbatacept3 monthsAdalimumab3 monthsEtanercept4 weeksInfliximab6 monthsRituximab12 monthsTocilizumab12 weeks Mantoux or tuberculin testing may be performed on patients receiving the above listed medications, but the response may be reduced by the immunosuppressant therapy. Dose Typical dose 7.5mg-25mg once weekly. > E l n v w x ” ˜ ™ š Ÿ § ¨ © ª ¼ ½ ¾ İ Ş ß à ÷ S ] ± endstream endobj 1087 0 obj <>stream In June 2017 the Regional Group on Specialist Medicines approved updated shared care guidelines for a number of DMARD type amber drugs. Tablets should be taken as a single dose in the morning with or after food. (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. Adherence to them will not ensure a successful outcome in every case. 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, … Contraindicated in pregnancy and breast- feeding. It is licenced and approved by NICE for uncontrolled active RA, PsA, AS and in JIA (see website). With considerable increase in DMARD prescriptions following early diagnosis and … For review on or before July 2021. appropriate monitoring as described in the shared care agreement. In other specialties usage is increasing, notably for inflammatory bowel disease and uveitis. It may be expected to enter into more widespread use soon. In particular Chickenpox may be fatal. This should be prescribed in combination with methotrexate, or an alternative appropriate DMARD (although this is unlicensed). In AS where two or more NSAID’S have failed, etanercept and adalimumab have NICE approval. 1090 0 obj <>/Filter/FlateDecode/ID[<11C4673FC283284093061D3E238E7F14><0B74B0954AF4954CAE03AE9DED152259>]/Index[1083 15]/Info 1082 0 R/Length 62/Prev 295826/Root 1084 0 R/Size 1098/Type/XRef/W[1 3 1]>>stream An example is: dose reducing to paracetamol oral 500mg four times daily. hår� CJ 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 These guidelines are not intended to be a comprehensive review of DMARD therapy. Mean cell volume more than 105 fL. Indications: (Licensed) RA, dermatomyositis and polymyositis, autoimmune and chronic active hepatitis, pemphigus vulgaris. Dose: Grade of evidence: C Typical dose is: RA: 10–20 mg once a day [1–3] when monotherapy is used. Evidence for combination with alternative appropriate DMARD’s is weak. These Yorkshire Guidelines are felt … The only exceptions are acrolimus, ciclosporin and t methotrexate/leflunomide combinations – where extended monthly monitoring longer term is advocated. The patients who are receiving DMARDs for non-rheumatological conditions do not have access to a nurse-led, hospital-based blood monitoring service. Subsequently if no problems occur the dose is usually increased weekly to 100mg daily and then 150mg daily taken at the same time or in divided doses with meals. In some patients response can be late but significant and maintained. Patients taking hydroxychloroquine should not take chloroquine as part of their malaria prophylaxis regime. Also prescribed for Psoriatic Arthritis, Crohns disease, connective tissue disease (SLE, myositis and vasculitis), Felty’s syndrome. June 2017. %PDF-1.5 %���� 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. 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). Usual regime is 1gram IV two weeks apart given after 100mg methyl-prednisolone with pre-treatment with antihistamine and paracetamol. Patients with uncertain alcohol intake or other hepatotoxic drugs may warrant increased vigilance. There is evidence for use both as monotherapy or in combination with MTX. Thresholds for action remain unchanged. Existing guidance prior to the pandemic is that patients should be up-to-date with vaccinations before rituximab treatment, as vaccination may not be as effective if given after. Baseline Urinalysis FBC / U&E Routine Two weekly for the first 2 months (0-2 months) Monthly for 4 months (2-6 months) Thereafter 3 monthly (unless dose changes) IF WCC < 3.5 Neutrophils < 2.0 Platelets < 150 Proteinuria / Blood > 1+ Rash / Unusual Bruising / Mouth ulceration / loss of taste If Proteinuria and negative MSU, suggest PCI and GFR or 24 hour urine for CrCl and protein Stop medication and contact local Rheumatology service. The three main agents (infliximab, etanercept and adalimumab) have proved to be safe and well tolerated by the great majority of patients. This is requested by patients and is felt to improve compliance. 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. Indications: (Unlicensed) RA, systemic lupus erythematosus and lupus nephritis and inflammatory myopathy such as dermatomyositis and polymyositis. Oral prednisolone 30 - 60mg between infusions should be given for CTD patients, especially Sjorgrens and those with high globulins. Tick-borne encephalitisTicoVac®Typhoid (Polysaccharide injection for vaccination)Typherix®, Typhim Vi® Travel Advice All non-live vaccines should be given as appropriate. This is another monoclonal antibody which in this case blocks IL6 receptor function, one of the key pro-inflammatory cytokines. 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. Version 1 approved by DMAG July 2019. 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. Immunisation with the oral cholera vaccine (Dukoral®) does not provide complete protection. For more detailed information on immunisation and contra-indications refer to the Department of Health Green Book Website: HYPERLINK "http://www.dh.gov.uk/en/publichealth/healthprotection/immunisation/greenbook/DH_4097254" www.dh.gov.uk/en/publichealth/healthprotection/immunisation/greenbook/DH_4097254 Table 2, Non-live vaccines VaccineBrand NameCholera Vaccine (Oral preparation only)Dukural®DiptheriaGiven as combined adsorbed diphtheria (low dose), tetanus and inactivated poliomyelitis preparation.Hepatitis AAvaxim®, Epaxal®, Havrix Monodose®, Vaqta Paediatric®Hepatitis BEngerix®, Fendrix®, HBvaxPRO®Hepatitis A and B CombinedAmbirix®, Twinrix®InfluenzaAggrippal®, Begrivac®, Enzira®, Fluarix®, Fluvirin®, Imuvac®, Influvac® Sub-unit, Mastaflu®, Optaflu® and Viroflu®Pneumococcal Pneumovax II® (Adults and Children over 5 years), Prevenar® (Primary childhood immunisation) Poliomyeltis (Injection)Inactivated Poliomyelitis Vaccine (non-proprietary) IPVMeningococcal Group CMeningitec®, Menjugate Kit®, NeisVac-C®Meningococcal polysaccharide A,C, W135 and Y vaccineACWY Vax®RabiesRabipur®Tetanus*Single preparation no longer available. Biologics Live vaccines should not be given to patients receiving treatment with biologics (refer to table 1). There is a wide variability amongst hospitals within a region on shared care arrangements. 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). 1.3 PICO table For full details see the review protocol in appendix A. These guidelines have now been revised five times and will continue to require modification. - Antacids (decrease levels) 2) Avoid if previous Hep B / C - Cholestyramine (likewise) 3) Avoid if recurrent Herpes - Probenecid or Shingles - Rifampicin 4) Care if marked renal failure - AVOID live vaccines (GFR below 25ml/min) Usually considered in active SLE (especially if nephritis or pneumonitis) or other serious connective tissue disease, often following induction with cyclophosphamide pulses, though it may soon become first line in some situations (eg Renal lupus). If no response in 3 months consider an increase in dose to 750 mg/day. Repeat Renal function every 6 months in those over 60 or at risk of renal impairment Optician Screening : Recommend pre treatment assessment and annual visual acuity / fundoscopy and Amsler charting. Monitor for the 1st3 months, then 6 monthly or as clinically indicated Monthly for the first 3 months, then 3 monthly thereafter if stable. 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Cell depletion, and personal hygiene is essential when travelling to areas where cholera exists adapted therapeutic guidelines COVID-19... % are conditional, JIA, Psoriasis and PsA ( see website ) prescribed as monotherapy but more in..., autoimmune and chronic active hepatitis, pemphigus vulgaris it may be discontinued weeks. Table 2 ) September 2017 by Richard Lennon, recommending that all blood tests performed by hospital... Methotrexate ( eg RA ) the General principles of managing an adult who is on a.... Be withdrawn 4 weeks before starting rituximab in other specialties usage is,... Grounds may be increased up to 30mg weekly consider Sub Cut use Travel endemic! The recommendations in the UK patients have severe disease and more toxic drug regimes, hospital may. If they have any infection / require antibiotics such as dermatomyositis and,! Once stabilised, i.e clinical assessments of disease activity Sub Cut use, mild and self limiting transformed! 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Try topical ( or oral ) anti-histamine / corticosteroids or auto antibodies, play an important role in.. At 3 and 6 months newly diagnosed rheumatoid arthritis and ( with the new BSR!