Asthma Control: Setting Goals - World Allergy Organization Control - Setting Goals... · Goals of asthma management Overall Asthma Control Current Control achieving Symptoms ... Asthma

Asthma Control: Setting Asthma Control: Setting GoalsGoals

Session: SY 1Session: SY 1

WAO – WISC2010Dubai December 2010

Eric D. BatemanEric D. BatemanProfessor of Respiratory Medicine, University of Cape TownProfessor of Respiratory Medicine, University of Cape TownDirector of University of Cape Town Lung InstituteDirector of University of Cape Town Lung Institute

Presenter DisclosuresPresenter DisclosuresEric D Bateman

Lecture Fees: AstraZeneca, Alk Abello, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Nycomed, Pfizer, TEVA

Consultancy or Advisory Boards: Almirall, AlkAbello, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Forest, Hoffmann la Roche, GlaxoSmithKline, Merck, Morria Biopharmaceuticals, Novartis, Nycomed, Pfizer, ScheringPlough

Industry-sponsored grants (Institution): Aeras, Almirall, Altana, AstraZeneca, Boehringer Ingelheim, Chiesi, Hoffmann la Roche, GlaxoSmithKline, Merck, Morria Biopharmaceuticals, Novartis, Nycomed, Pfizer.

Learning objectivesLearning objectives

Asthma Control: Setting GoalsAsthma Control: Setting Goals

� To review current thinking on what defines acceptable asthma control

� To review tools that are available to evaluate control

� To review how to set goals to achieve asthma control

Not well controlled

GINA 2006 treatment approach

Control-driven management“to achieve and maintain control”

“Treating to target”

Partly controlled

Controlled

What do you view as What do you view as

Asthma Control: Setting GoalsAsthma Control: Setting Goals

� Acceptable control of asthma?

� Optimal control?

� Ideal control?

� Are they different?

Why ?

Why ?

Baseline characteristics in two studiesChuchalin et al STUDY A

TreatmentMean PEF (FEV1) % pred.

% symptom-free days

Reliever use (inh/day)

Salm-FP qd 87 (97) 41 0.7

FP bid 87 (96) 41 0.7

Placebo 88 (98) 39 0.7

Mean age = 34years

Papi et al STUDY B

BDP-Alb prn 89 56 0.4

Alb prn 89 52 0.5

BDP bid 89 49 0.4

BDP-Alb bid 87 47 0.5

Mean age = 37 yearsChuchalin A et al. 2008

Papi A, Canonica GW, Maestrelli P. et al. N EJM 2007 ;356:2040-52

0

10

20

30

40

50

60

70

80

90

100

Combinationprn

Albuterol prn BDP bid Combinationbid

% D

ays

Baseline Wks 23-24

P=0.04

Papi A, Canonica GW, Maestrelli P. et al. N EJM 2007;356:2040-52

Papi et al: % days without symptoms

No placebo !No placebo !

Once-daily low-dose Salm-FP in Mild Asthma:Symptom-free days

P=0.001

Chuchalin A et al. 2008

0

10

20

30

40

50

60

70

80

90

100

Salm-FP 50/100 qd

P=0.001 P=0.001

FP 100 bid Placebo

% s

ympt

om-f

ree

days

Baseline Treatment period

ATS/ERS Task Force Report, ATS/ERS Task Force Report, ATS/ERS Task Force Report, ATS/ERS Task Force Report, AJRCCM, AJRCCM, AJRCCM, AJRCCM, 2009; 180:592009; 180:592009; 180:592009; 180:59----99999999....

ATS/ERS Statement: Asthma Control and Exacerbations

Asthma goals are based on:Asthma goals are based on:

� What is possible to achieve with treatment

� Benefit – the immediate and long-term benefits of treatment

� Cost – financial / short and long-term side-effects of treatment

Percentage of patients achieved “total control” and “well-controlled” asthma with Salm-FP and FP

Bateman ED et al. Am J Respir Crit Care Med 2004; 170: 836–844

Salm-FP FP

41

71

28

59

0

20

40

60

80

Total control at 1 year Well controlled asthma at 1 year

Pat

ient

s (%

)

All strata (8-week assessment at end of phase 2)

ACT score and GINA categories in outpatients with a sthma in five European countries and the USA

Thomas M, et al, Prim Care Resp J 2009; 18:41-9.

Study date: Q1 2007France, Italy, UK, Spain, Germany and USAN = 2949 patients: 10 consecutive from each doctorGP 50, Pulmonologists 50 and Allergists 20 in each country

Fre

quen

cy

(num

ber

of p

atie

nts)

ACT Score

400

300

200

100

0

5 10 15 20 25

Uncontrolled20% (576)

Controlled49% (1433)

= Median

Partly controlled32% (940)

Disease Specific Programmes IV Survey

GOAL: Who is less likely to achieve Well-Controlled asthma?

� Smokers < ex-smokers

� Men

� Longer duration of asthma

� Lower lung function

� Lack of control on ICS

Pedersen SE et al, JACI 2007

Measures of Clinical Control of Chronic Diseases

Overall ControlOverall Control

Current ControlCurrent Control

achieve and maintain

Future RiskFuture Risk

reduce

Bateman ED et al, JACI 2010

Glycaemic controlGlycaemic controlMicrovascularMicrovascularcomplicationscomplications

Blood PressureBlood PressureCardiovascularCardiovascularcomplicationscomplications

Goals of asthma management

Overall Asthma Control

Current Control

achieving

Symptoms

Activity

Reliever use

Lung function

defined by

Future Risk

Instability/ Worsening

Loss of lung function

Exacerbations

Adverse effectsof Medication

reducing

defined by

Bateman ED et al, JACI 2010

Measures of Asthma Control: categorical versus continuous measures?

“Control should preferably be described using continuous variables”Examples –ACQ, ACT, ACSS, ATAQ

“… if categorical descriptors are used, they should be based on clinically meaningful cut points”Examples –controlled, partly controlled, uncontrolled (GINA 2006)

Taylor DR Taylor DR Taylor DR Taylor DR et al, ERJ et al, ERJ et al, ERJ et al, ERJ 2008; 32:5452008; 32:5452008; 32:5452008; 32:545----554554554554

The Asthma Control Questionnaire (ACQ) is the most widely used assessment tool in clinical practice

6 = All thetime

5 = Most ofthe time

4 = A lot of the time

3 = A moderateamount ofthe time

2 = A little of the time

1 = Hardly any ofthe time

0 = Not at allQ5. In general, during the past week, how much of the time did you wheeze

6 = A verygreat deal

5 = A greatdeal

4 = Quite alot

3 = Amoderateamount

2 = A little1 = Very little0 = NoneQ4. In general, during the past week, how much shortness of breath did you experience because of your asthma?

6 = Totallylimited

5 =Extremelylimited

4 = Verylimited

3 = Moderatelylimited

2 = Slightly limited

1 = Very slightlylimited

0 = Not limited at all

Q3. In general, during the past week, how limited were you in your activities because of your asthma?

6 = Veryseveresymptoms

5= Severesymptoms

4 = Quite severesymptoms

3 =Moderatesymptoms

2 = Mild symptoms

1 = Very mild symptoms

0 = No symptoms

Q2. On average, during the past week, how bad were your asthma symptoms when you woke up in the morning?

6 = Unableto sleepbecause ofasthma

5 = A greatmany times

4 = Manytimes

3 = Several times

2 = A few times

1 = Hardly ever

0 = NeverQ1. On average, during the past week, how often were you woken by your asthma during the night?

1. Juniper EF, et al. AJRCCM 2000;162:1330-1334;2. Juniper EF, et al. Eur Res J 1999;14:902-907.Questions taken from ACQ-5 a shortened version of the ACQ-7

How often woken during night

How bad symptoms in morning

How limited were activities

How much shortness of breath

How much time with wheeze

Levels of Asthma Control

Characteristic Controlled Controlled (All of (All of the following)the following)

Partly controlledPartly controlled(Any present in any week)(Any present in any week)

Uncontrolled Uncontrolled

Daytime symptomsNone (2 or less / week)

More than twice / week

3 or more features of partly controlled asthma present in any week

Limitations of activities

None Any

Nocturnal symptoms / awakening

None Any

Need for rescue / “reliever” treatment

None (2 or less / week)

More than twice / week

Lung function (PEF or FEV1)

Normal< 80% predicted or

personal best (if known) on any day

GINA GINA UU

0

6

2

1

3

4

5

PP CC

GINA: U = Uncontrolled, P = Partly Controlled, C = Controlled

ACQ = Asthma Control Questionnaire

OOOO’’’’Byrne P Byrne P Byrne P Byrne P et al, ERJ et al, ERJ et al, ERJ et al, ERJ 2010201020102010

ACQ-5 score at study end by control stateas defined by GINA criteria

> 1 <

AC

QA

CQ

-- 55sc

ore

What do ourWhat do ourpatients want?patients want?

No fear ofNo fear ofExacerbationsExacerbations

(attacks)(attacks)

More stability/More stability/predictabilitypredictability

No symptomsNo symptoms(Normal life)(Normal life)

Less medicinesLess medicinesLess costLess cost

Less side effectsLess side effects

Asthma Therapy Assessment Questionnaire (ATAQ) in relation to “asthma events” over subsequent 12 months

Future risk … in relation to current controlNatural History of Asthma: Outcomes and Treatment R egimens (TENOR)

Unscheduled contacts

Oral steroid “bursts”

ER visits

Nights in hospital

1 3 5 7 9 11 13 15 25Odds ratio

ATAQ score (vs 0 )

123

(compared to ATAQ score 0)

Outcome

Chen H et al, JACI 2007; 120: 376-402(n = 987)

Historical = 0.40

Historical = 0.70

0.28

0.090.01

0.42

0.170.07

0.130.05 0.02

0.23 0.19 0.130

0.2

0.4

0.6

0.8

Stratum 1: ICS-naive Stratum 3: Moderate ICS

*Requiring either oral steroids or hospitalisation / emergency visitGOAL Study

Exacerbation rate in maintenance phase(according to control status achieved in phase I)

Not TC or WC

Well controlled Total control

Not TC or WC

Well controlled Total control

Mean exacerbation rate per patient per year

Fluticasone

Salm-FP

Predicting asthma exacerbations from current level of Asthma Control

PartlyPartlyControlledControlled

UncontrolledUncontrolled ExacerbationExacerbation

ControlledControlled

* Markov Model: Transitional probability independen t of time (homogeneous) SMART Studies: Bateman ED SMART Studies: Bateman ED SMART Studies: Bateman ED SMART Studies: Bateman ED et al, JACI 2010et al, JACI 2010et al, JACI 2010et al, JACI 2010

GOAL Study: Bateman et al. Allergy 2008; 63: 932-8.

75%

20%

5% 0.05%


UncontrolledUncontrolled





ExacerbationExacerbation

75%

5%

20%

0.1%


UncontrolledUncontrolled





ExacerbationExacerbation

2%5%

>90%

0.35%

SummarySummaryAsthma Control: Setting GoalsAsthma Control: Setting Goals

� What is acceptable asthma control? - Partly controlled or better

� How to measure control? – Composite measure (e.g. ACT) or categorical method (e.g. GINA)

� How to set goals? Individualize but understand risks and benefits, and differential effects of drugs

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Asthma Control: Setting Goals - World Allergy Organization Control - Setting Goals... · Goals of asthma management Overall Asthma Control Current Control achieving Symptoms ... Asthma