Asthma Guidelines and Pharmacological Treatment. Dr James Wilkinson

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2 Asthma Guidelines and Pharmacological Treatment Dr James Wilkinson

3 Asthma is a common disease in the UK 5.4 million people in the UK are currently receiving treatment for asthma: 4.3 million adults (1 in 12). 1.1 million children (1 in 11) Asthma prevalence stable since the late 1990s UK still has some of the highest rates in Europe The NHS spends around 1 billion a year treating it

4 Asthma still kills In 2014 (most recent data) 1216 people died from asthma. RCP Review of asthma deaths 2015: Issues with health professionals' use of asthma guidelines that could have helped to avoid death in 46% 57% no specialist medical care in previous year 43% had not had a local surgery asthma review in previous year Only 22.5% had personalised action plans 21% had attended a hospital A&E at least once in the previous year 10% died within 28 days of discharge from hospital after treatment for asthma

5 Asthma deaths in England & Wales

6 UK Asthma Guidelines First British Thoracic Society guideline in 1993 Second guideline published in 1997 Updated annually from 2004 to 2012 Updates biennially from 2012 NICE quality standards (2014) based on BTS/SIGN Latest BTS / SIGN Guidelines updated Sept 2016

7 What do they cover? Diagnosis of asthma in adults and children Treatment of stable asthma in adults, children and adolescents Treatment of acute asthma in adults and children Inhaled treatment Asthma in pregnancy Occupational asthma Delivery of asthma care

8 Diagnosis of Asthma

9 Diagnosing Asthma Structured Clinical Assessment to stratify whether high, low or intermediate likelihood of asthma Variable symptoms - wheeze - persistent cough - sleep disturbance - recurrent bronchitis Documented wheezing or low airflow measurements (Peak Flow or FEV 1 ) History or family history of atopy Other causes of symptoms appear less likely

10 Likelihood of asthma after structured clinical assessment Low investigate for other causes of symptoms High Record as probably asthma Trial of treatment, as for asthma, with relief inhaler + low dose ICS Follow with stepwise management approach Intermediate requires more investigation

11 Intermediate probability of asthma This group may need more detailed investigation Serial Peak Flow Readings (>20% of mean PEFR on readings TDS over 2 weeks) Reversibility Testing (>15% rise in PEFR or 12% in FEV 1 after bronchodilator) Exhaled Nitric Oxide A marker of eosinophilic airways information (ie asthma) Levels <15 negative. Levels >50 positive

12 Treating asthma

13 Asthma treatment goals No daytime symptoms No waking due to asthma No need for relief bronchodilator medication No asthma attacks No limitations on activity, including exercise Normal lung function (in practical terms FEV 1 and/or PEF 80% predicted or best) Minimal side effects from medication

14 Drug Treatments for Asthma Bronchodilators Anti-Inflammatories β-agonists short acting long acting Anticholinergics short acting long acting Theophyllines Steroids inhaled oral parenteral Leukotriene antagonists (Theophyllines) Cromones Biologics (Immunotherapy)

15 Biologics Anti IgE Omalizumab Binds to IgE preventing it from attaching to its receptor to activate mast cells etc Given as weekly injection Anti-IL5 Mepolizumab Binds to IL-5 receptors on eosinophils, downregulating inflammatory response Given as weekly injection

16 The mainstay of treatment is inhalers Relievers Steroids LABAs LAMAs ICS/LABA LAMA/LABA

17 No inhaler is perfect That s why there are so many different types!

18 Guideline comments on inhalers Prescribe inhalers only after patients have received training in their use and have satisfactory technique. Assessment of technique by a competent healthcare professional If the patient is unable to use a device satisfactorily, an alternative should be found. A pmdi ± spacer is as effective as any other hand-held inhaler, but patients may prefer some types of DPI. Avoid generic prescribing Encourage use of similar/same device for different drugs

19 Asthma - suspected Diagnosis & Assessment Stepwise management of asthma Adult asthma - diagnosed Evaluation: - assess symptoms, measure lung function, check inhaler technique and adherence - adjust dose update management plan move up and down as appropriate Consider monitored initiation of treatment with low dose ICS Infrequent, short-lived wheeze Regular preventer Low dose ICS Initial add-on therapy Add inhaled LABA to low dose ICS (normally as a combination inhaler) Additional addon therapies No response to LABA stop LABA and consider increased ICS If benefit from LABA nut control still inadequate continue LABA and increase ICS to medium dose If benefit from LABA but vcontrol still inadequate continue LABA and ICS and consider trial of other therapy LTRA, S-R theophylline, LAMA High dose therapies Consider trials of: Increasing ICS to high dose Additionof a fourth drug, eg LRTA, SR theophylline, beta agonist tablet, LAMA Refer patient for specialist care Continuous or frequent use of oral steroids Use daily steroid tablet in the lowest dose providing adequate control Maintain high dose ICS Consider other treatments to minimise use of steroid tablets Refer patient for specialist care Short acting ß 2 agonist as required. Consider moving up if using 3 doses a week or more

20 Confirmed asthma Mild Intermittent asthma Includes exercise-induced asthma Use short acting β 2 -agonist (SABA) as necessary Consider whether to start on low dose ICS

21 Regular Preventer Start patients at a dose of inhaled steroids appropriate to the severity of their disease Titrate to the lowest dose at which effective control of asthma is maintained Reduce dose by 25-50% at 3 month intervals if symptoms well controlled

22 Percent of maximum Why start inhaled steroids? Symptoms and lung function improve with low doses of ICS Daily dose of budesonide (mcg) Symptoms FEV 1 Exercise FEV 1 NO FEF 25%-75% Barnes PJ, et al. Am J Respir Crit Care Med. 1998;157:S1-S53.

23 Rate ratio of asthma-related deaths Why start inhaled steroids? Risk of death from asthma decreases with use of ICS ICS MDIs used per year (N) Adapted from Suissa S, et al. N Engl J Med. 2000;343:332.

24 When should we start inhaled steroids? Exacerbation of asthma in the last two years Using β-agonist three times a week or more Symptomatic three times a week or more Waking one night a week or more

25 Inhaled Steroids Dose depends on drug and inhaler device Steroid Low dose Medium dose High dose Beclometasone MDI (BDP) 100mcg 2 Puffs bd 200 mcg 2 Puffs bd 200 mcg 4 puffs bd Clenil Modulite (BDP) 100mcg 2 Puffs bd 200 mcg / 250mcg 2 Puffs bd Qvar 50 mcg 2 Puffs bd 100mcg 2 Puffs bd 100mcg 4 Puffs bd Pulmicort Turbohaler mcg 1 Puff bd mcg 1 Puff bd 400mcg 1 Puff bd Flixotide Accuhaler 100mcg 1Puff bd 250mcg 1 Puff bd 500 mcg 1 Puff bd Asmanex 100mcg 1 Puff bd 200 mcg 1 Puff bd

26 Initial add-on therapy A long-acting β 2 -agonist (LABA) should be added to the initial dose of inhaled corticosteroid before the dose of inhaled corticosteroid is increased

27 Estimated yearly exacerbation rate (number/patient/year) Why add LABA? FACET study Effect of addition of formoterol on severe exacerbations 1.0 p = 0.01 p = (-26%) 0.67 (-49%) 0.46 (-63%) BUD 100mcg b.d. + placebo BUD 100mcg b.d. + formoterol 12mcg b.d. BUD 400mcg b.d. + placebo BUD 400mcg b.d. + formoterol 12mcg b.d. Adapted from Pauwels et al. N Engl J Med 1997

28 Percentage of patients remaining free of exacerbation Improvements in asthma control vs components Time (weeks) Placebo Salmeterol 50 μg Accuhaler 1 b.d. Seretide 100 Accuhaler 1 b.d. Fluticasone 100 μg Accuhaler 1 b.d. * Salmeterol is not recommended as monotherapy in the UK *p<0.007 vs all other treatments McCarthy et al. Thorax 2001

29 How should we add in LABAs? In efficacy studies.. there is no difference in efficacy in giving inhaled corticosteroid and a longacting β2 agonist in combination or in separate inhalers. In clinical practice combination inhalers aid adherence and also have the advantage of guaranteeing that the long-acting β2 agonist is not taken without the inhaled corticosteroid.

30 Combination LABA/ICS Inhalers Symbicort Turbohaler twice daily DPI - Budesonide + formoterol Seretide Accuhaler twice daily DPI - Fluticasone propionate + salmeterol Fostair twice daily MDI - Beclometasone + formoterol Flutiform twice daily MDI - fluticasone + formoterol Relvar Ellipta once daily DPI - Fluticasone furoate + vilanterol

31 Additional add on therapies If symptoms are no better on additional LABA, stop it. Consider increasing to medium dose ICS If symptoms are improved but inadequately controlled on medium strength steroid + LABA, consider increase to medium dose ICS and/or add in one of : LAMA LTRA (montelukast, zafirlukast) Theophylline (uniphyllin, phyllocontin) Cromone (cromoglycate, nedocromil)

32 Consider trials of: High dose therapies Increasing to high dose ICS Adding in fourth drug from: LAMA LTRA (montelukast, zafirlukast) Theophylline (uniphyllin, phyllocontin) Cromone (cromoglycate, nedocromil) Refer to specialist clinic

33 Continuous or frequent use of oral steroid Long term oral steroid required in addition to other agents Continue with high dose ICS Refer to specialist clinic Consider other treatments to minimise use of steroid tablets Anti IgE Anti IL-5

34 Pregnancy, labour and breastfeeding Maintaining good control is paramount SABA, LABA, ICS, Theophyllines can all be used LTRAs should not be withheld if needed for asthma control Short courses off oral steroid should be used if needed Women receiving oral prednisolone >7.5 mg for >2 weeks prior to delivery should receive parenteral hydrocortisone 100 mg 6-8 hourly during labour. Acute severe asthma is an emergency and should be treated in hospital. Asthma attacks during labour are rare.

35 Asthma with COPD or COPD with asthma Asthma and COPD are both common in adults Asthma / COPD overlap is not unusual. Treat primarily as asthma. Severity stratification of COPD should be based on best spirometry, when asthma component is fully controlled. More likely to benefit from early use of LAMA than pure asthma. Avoid LABA, LAMA or LABA/LAMA combinations without also using ICS if there is co-existing asthma.

36 Acute asthma exacerbations Moderate Severe increasing symptoms PEF 50 75% of best or predicted no features of acute severe asthma Any one of: PEF 33-50% best or predicted respiratory rate >25/min heart rate 110/min inability to complete sentences in one breath

37 Life-threatening asthma In a patient with severe asthma any one of: PEFR <33% best or predicted SpO 2 <92% or PaO 2 <8 kpa normal PaCO 2 ( kpa) silent chest cyanosis poor respiratory effort arrhythmia exhaustion altered conscious level hypotension

38 Treatment of acute severe asthma Nebulised salbutamol + ipratropium Oxygen to maintain SaO 2 >93% Fluids (i-v) may be necessary Oral prednisolone 30-40mg daily If poor response consider i-v Magnesium sulphate infusion

39 Asthma Management Plans All patients should have personal asthma management plans The single most effective non therapeutic intervention in asthma management A comprehensive personalised plan can be downloaded for free from the Asthma UK website:

40 A simple asthma management plan Best PEFR if PEFR is: < 80% of best - double dose of steroid inhaler < 60% of best - start emergency course of steroids and inform GP/nurse < 40% of best - attend A&E urgently (ambulance)

41 Why do patients fail on any given level of treatment? Asthma severity increasing (environmental factors) Medical carers underestimate severity Poor concordance / compliance

42 % of patients experiencing We aren t very good at gauging severity GPs Nurses Patients 10 0 SOB Waking Cough can't talk

43 Number of patients at each step Patients asthma symptoms are often worse than they admit 10,000 8,000 % Patients not well controlled 6, % 4, % 2, % BTS guidelines steps 5 (n=15,649) Neville et al. Eur Respir J 1999

44 Many UK Patients Are Non-adherent 25% of patients have asthma adherence rates < 30% 1 Non-adherence problems typically involve the under-use of preventer medications 2 Non-adherence is thought to contribute to 18-48% of asthma deaths 3 Lack of adherence may be related to - Limited patient knowledge of condition or medication - Lack of motivation to take medication - Issues with medication 1. Dasgupta R, et al. Pharmacoeconomics. 2003;21: Farber HJ, et al. J Asthma. 2003;40: National Asthma Campaign. Asthma J. 2001;6(suppl 3).

45 Adherence better with bronchodilators than with steroids Steroid ß-agonist Reported adherence Actual adherence Right dose, right time Days without treatment

46 Adherence Difficulty in using inhalers Inconvenient dosing regime Too many different medications Too many different devices Failure to understand treatment Fear of side effects ( esp. steroids) Refusal to accept chronic disease

47 Increasing Compliance Education (theory and practice!) Choose the right inhaler The right inhaler for the patient is the one they can use properly Minimise number of different inhalers Simplify dosing regimes Minimise side effects Ownership Asthma management plans

48 Keys to asthma treatment success Right Inhaler Right Drug(s) Right amount Patient understanding Patient ownership

49 What can we do to help patients? Evidence for pharmacist-led interventions is lacking and further high quality randomised trials testing pharmacist-led interventions to improve asthma outcomes are needed. However, there are areas in which there is potential for helpful pharmacy intervention!

50 What can we do to help patients? Medication reviews Inhaler technique feedback to local surgery Rationalising medication Flagging up overuse of medication Exploring whether patients have management plans Opportunistic lifestyle advice

51 Lifestyle advice Opportunistic lifestyle advice: Avoiding precipitants Smoking cessation Influenza vaccination Weight loss Breastfeeding (for mother s and baby s benefit) Ineffectiveness of ionisers, air filters, and other measures to control house dust mite

52 Reducing House Dust Mite Allergen Many studies have looked at methods of reducing HDM Removing soft furnishings, Frequent vacuuming Hot wash cycles (>60 degrees) Freezing cuddly toys Mite proof mattress covers Fungicides (kill food supply) Pesticides (kill mites) Ionisers Filters No consistent significant effect on symptoms or IgE

53 Many studies have looked at methods of reducing HDM Removing soft furnishings, Frequent vacuuming Hot wash cycles (>60 degrees) Freezing cuddly toys Mite proof mattress covers Fungicides (kill food supply) Pesticides (kill mites) Ionisers Filters No consistent significant effect on symptoms or IgE

54 Reducing Cat allergen load

55 Children & Cats 1/3 prefer cat to brother or sister 1/3 think mother prefers cat to father 1/6 prefer cat to granny

56 THE END

57 Smoking Smoking in pregnancy impairs lung development Environmental Tobacco Smoke in pre-school children increases risk of developing asthma by 30% Starting smoking as a teenager doubles risk of developing asthma

58 Immunotherapy Very strong evidence of benefit 67 papers All show medication requirements bronchial responsiveness symptom scores no effect on spirometry 1 comparative study with budesonide - steroid more effective than immunotherapy NOT AVAIABLE IN UK

59