Tailored interventions based on sputum eosinophils versus clinical symptoms for asthma in children and adults

Helen L Petsky; Albert Li; Anne B Chang

doi:10.1002/14651858.CD005603.pub3

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Figure 1

In the control group 82 people out of 100 had people with one or more exacerbations over 16 months, compared to 62 (95% CI 49 to 74) out of 100 for the active treatment group.

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Figure 2

In the control group 24 people out of 100 had people with one or more hospitalisations over 16 months, compared to 8 (95% CI 3 to 21) out of 100 for the active treatment group.

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Figure 3

Study flow diagram for 2008‐2017 literature searches.

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Figure 4

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Analysis 1.1

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 1 Occurrence of any exacerbation.

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Analysis 1.2

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 2 Number of participants who had one or more exacerbations over the study period.

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Analysis 1.3

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 3 Number of participants with exacerbations regarding hospitalisations over the study period.

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Analysis 1.4

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 4 Number of severe exacerbations requiring oral corticosteroids.

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Analysis 1.5

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 5 MIld exacerbations over study period.

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Analysis 1.6

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 6 Eosinophilic v Noneosinophilic exacerbations.

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Analysis 1.7

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 7 Exacerbations subgrouped by asthma severity: Mild vs Severe.

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Analysis 1.8

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 8 Exacerbations subgrouped by asthma severity: Use of LABA.

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Analysis 1.9

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 9 Mean dose of inhaled corticosteroids per person per day (Bud equiv).

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Analysis 1.10

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 10 Mean dose of oral corticosteroids per person per day.

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Analysis 1.11

Comparison 1 Asthma treatment tailored on sputum esoinophils versus symptoms, Outcome 11 Yearly cost per person (USD).

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Summary of findings for the main comparison. Tailored interventions based on sputum eosinophils compared to tailored interventions based on clinical symptoms for asthma in adults and children

Tailored interventions based on sputum eosinophils compared to tailored interventions based on clinical symptoms for asthma in adults and children
Patient or population: adults and children with asthma Settings: hospital outpatients Intervention: based on sputum eosinophils count Comparison: based on clinical symptoms
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk at one year	Corresponding risk
	Tailored interventions based on clinical symptoms	Tailored interventions based on sputum eosinophils
Number of participants who had one or more exacerbations over the study period Follow‐up: 12 to 24 months	82 per 100	62 per 100 (49 to 74)	OR 0.36 (0.21 to 0.62)	228 (3 studies)	⊕⊕⊕⊝ moderate¹	see Figure 1
Hospitalisations Follow‐up: 12 to 24 months	24 per 100	8 per 100 (3 to 21)	OR 0.28 (0.09 to 0.84)	269 (4 studies)	⊕⊕⊕⊝ moderate²	see Figure 2
Mean dose of inhaled corticosteroids per person per day (BUD equivalent mcg/day) Follow‐up: 12 to 24 months		The mean dose of inhaled corticosteroids per person per day in the intervention groups was 13 mcg/day higher (128 lower to 153 higher)		316 (4 studies)	⊕⊕⊝⊝ low³
Mean daily use of oral corticosteroids per person per day Follow‐up: 12 months	See comment	See comment	Not estimable	68 (1 study)		Not estimable
Yearly cost per person (USD) Follow‐up: 12 months	See comment	See comment	Not estimable	68 (1 study)		Not estimable
The basis for the assumed risk* is the mean of the two studies with a duration of one year. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of effect. Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different. Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect. Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
¹ One paper (Chlumsky 2006) was open labelled , but results were similar without this study. Our confidence in these results was downgraded by one point because of inconsistency in defining exacerbations ² One paper (Chlumsky 2006) was open labelled, but did not contribute to this outcome. Our confidence in these results was downgraded by one point because of the small number of hospitalisations ³The dose of inhaled steroids varied considerably within and between studies and results are compatible with both important reduction or decrease in dose of inhaled corticosteroids using sputum eosinophils.

Summary of findings for the main comparison. Tailored interventions based on sputum eosinophils compared to tailored interventions based on clinical symptoms for asthma in adults and children

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Table 1. Included studies definitions

Study	Exacerbation definition	Sputum eosinophil cut‐off (%)	Control arm	Study duration (months)
Cao 2007	Unknown	Decrease ICS < 1 Keep same 1 to 3 Increase ICS > 3	"Standard clinical guidelines"	6
Chlumsky 2006	Doubling of the frequency of symptoms and/or number of puffs of rescue salbutamol and/or reduction in morning PEF by 30% or more on at least 2 consecutive days. A decrease in FEV₁ by > 30% at any study visit	Decrease ICS ≤ 3 Keep same 4 to 8 Increase ICS ≥ 8	GINA guidelines	18
Fleming 2012	Minor exacerbation: use of bronchodilators > 5 times/week (excl. routine or pre‐exercise) Major exacerbation: deterioration requiring high‐dose OCS (≥ 20 mg/day) for at least 2 days	Decrease ICS < 0.1 (or FeNO < 22 ppb) Keep same 0.1 to 2.5 (or FeNO 22 to 30 ppb) Increase ICS > 2.5 (or FeNO > 30 ppb)	Based on number of major exacerbations in preceding 3 months and SABA use in preceding 2 weeks	12
Green 2002	Severe exacerbations: decrease in morning PEF > 30% on 2 or more consecutive days, or deterioration in symptoms needing OCS.	Decrease ICS < 1 Keep same 1 to 3 Increase ICS > 3	BTS guidelines	12
Jayaram 2006	Worsening of symptoms requiring increased use of SABA by ≥ 4 puffs/day for a minimum of 48 hours, or early morning wakening due to respiratory symptoms > 2 times/week, with or without reduction in FEV₁ of at least 20%. Severe exacerbation: course of OCS as determined by study investigator.	Decrease ICS ≤ 2 Increase ICS ≥ 2	Canadian Asthma Consensus Group Guidelines	24
Malerba 2015	Moderate exacerbation: requiring an unscheduled visit with a course of OCS. Severe exacerbation: hospital admission and requiring > 3 days OCS.	Sputum eosinophil (%) & FeNO (ppb) Decrease ICS < 2% & ≤ 10 pbb Keep same 2% to 3% & 11 to 20 ppb Increase ICS > 3% & ≥ 20 ppb	Symptom scores, use of SABA and night time symptoms	24
FeNO: exhaled nitric oxide; FEV₁: forced expiratory volume in one second; ICS: inhaled corticosteroids; OCS: oral corticosteroids; PEF: peak expiratory flow; ppb: parts per billion

Table 1. Included studies definitions

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Comparison 1. Asthma treatment tailored on sputum esoinophils versus symptoms

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Occurrence of any exacerbation Show forest plot	4	269	Rate Ratio (Random, 95% CI)	0.57 [0.38, 0.86]

1.1 Adults	3	215	Rate Ratio (Random, 95% CI)	0.45 [0.24, 0.86]
1.2 Children	1	54	Rate Ratio (Random, 95% CI)	0.75 [0.54, 1.04]
2 Number of participants who had one or more exacerbations over the study period Show forest plot	4	269	Odds Ratio (M‐H, Fixed, 95% CI)	0.36 [0.21, 0.62]

2.1 Adult	3	215	Odds Ratio (M‐H, Fixed, 95% CI)	0.36 [0.20, 0.64]
2.2 Children	1	54	Odds Ratio (M‐H, Fixed, 95% CI)	0.39 [0.09, 1.71]
3 Number of participants with exacerbations regarding hospitalisations over the study period Show forest plot	4	269	Odds Ratio (M‐H, Fixed, 95% CI)	0.28 [0.09, 0.84]

3.1 Adult	3	215	Odds Ratio (M‐H, Fixed, 95% CI)	0.14 [0.02, 1.25]
3.2 Children	1	54	Odds Ratio (M‐H, Fixed, 95% CI)	0.38 [0.10, 1.45]
4 Number of severe exacerbations requiring oral corticosteroids Show forest plot	1		Rate Ratio (Fixed, 95% CI)	Totals not selected

5 MIld exacerbations over study period Show forest plot	2	150	Rate Ratio (Fixed, 95% CI)	0.82 [0.67, 1.00]

6 Eosinophilic v Noneosinophilic exacerbations Show forest plot	1		Risk Ratio (Fixed, 95% CI)	Subtotals only

6.1 Eosinophilic Exacerbations	1	2	Risk Ratio (Fixed, 95% CI)	0.28 [0.10, 0.76]
6.2 Noneosinophilic Exacerbations	1	2	Risk Ratio (Fixed, 95% CI)	1.07 [0.62, 1.85]
7 Exacerbations subgrouped by asthma severity: Mild vs Severe Show forest plot	1		Rate Ratio (Fixed, 95% CI)	Subtotals only

7.1 Very mild to mild asthma	1	2	Rate Ratio (Fixed, 95% CI)	1.34 [0.52, 3.43]
7.2 Moderate to severe asthma	1	2	Rate Ratio (Fixed, 95% CI)	0.63 [0.38, 1.04]
8 Exacerbations subgrouped by asthma severity: Use of LABA Show forest plot	1		Rate Ratio (Fixed, 95% CI)	Subtotals only

8.1 On LABA	1	2	Rate Ratio (Fixed, 95% CI)	0.53 [0.25, 1.14]
8.2 Not on LABA	1	2	Rate Ratio (Fixed, 95% CI)	1.05 [0.62, 1.78]
9 Mean dose of inhaled corticosteroids per person per day (Bud equiv) Show forest plot	5	316	Mean Difference (Fixed, 95% CI)	12.56 [‐127.92, 153.04]

9.1 Adults	4	262	Mean Difference (Fixed, 95% CI)	0.67 [‐154.39, 155.73]
9.2 Children	1	54	Mean Difference (Fixed, 95% CI)	67.0 [‐264.81, 398.81]
10 Mean dose of oral corticosteroids per person per day Show forest plot	1		Mean Difference (Fixed, 95% CI)	Totals not selected

11 Yearly cost per person (USD) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 1. Asthma treatment tailored on sputum esoinophils versus symptoms

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