Topical pimecrolimus for eczema

Darren M Ashcroft; Li‐Chia Chen; Ruth Garside; Ken Stein; Hywel C Williams

doi:10.1002/14651858.CD005500.pub2

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Figure 1

Flow diagram outlining the inclusion of studies

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Analysis 1.1

Comparison 1 Pimecrolimus 1.0% BID vs. vehicle BID, Outcome 1 Clear or almost clear eczema (IGA 0 or 1).

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Analysis 1.2

Comparison 1 Pimecrolimus 1.0% BID vs. vehicle BID, Outcome 2 Complete or well controlled eczema (PGA).

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Analysis 1.3

Comparison 1 Pimecrolimus 1.0% BID vs. vehicle BID, Outcome 3 Mild or absent pruritus (pruritus score 0 or 1).

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Analysis 1.4

Comparison 1 Pimecrolimus 1.0% BID vs. vehicle BID, Outcome 4 Withdrawals.

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Analysis 1.5

Comparison 1 Pimecrolimus 1.0% BID vs. vehicle BID, Outcome 5 Adverse events.

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Analysis 2.1

Comparison 2 Pimecrolimus 1.0% BID vs. vehicle BID, participants with facial AD, Outcome 1 Clear or almost clear of facial eczema (facial IGA 0 or 1).

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Analysis 2.2

Comparison 2 Pimecrolimus 1.0% BID vs. vehicle BID, participants with facial AD, Outcome 2 Mild or absent pruritus (pruritus score 0 or 1).

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Analysis 2.3

Comparison 2 Pimecrolimus 1.0% BID vs. vehicle BID, participants with facial AD, Outcome 3 Withdrawals.

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Analysis 3.1

Comparison 3 Pimecrolimus 1.0% BID vs. vehicle BID, participants responded to topical steroids, Outcome 1 Withdrawals.

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Analysis 3.2

Comparison 3 Pimecrolimus 1.0% BID vs. vehicle BID, participants responded to topical steroids, Outcome 2 Adverse events.

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Analysis 4.1

Comparison 4 Pimecrolimus 1.0% BID vs. vehicle BID, participants did not respond to topical steroids, Outcome 1 Clear or almost clear eczema (IGA 0 or 1).

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Analysis 4.2

Comparison 4 Pimecrolimus 1.0% BID vs. vehicle BID, participants did not respond to topical steroids, Outcome 2 Complete or well controlled eczema (PGA).

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Analysis 4.3

Comparison 4 Pimecrolimus 1.0% BID vs. vehicle BID, participants did not respond to topical steroids, Outcome 3 Mild or absent pruritus (pruritus score 0 or 1).

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Analysis 4.4

Comparison 4 Pimecrolimus 1.0% BID vs. vehicle BID, participants did not respond to topical steroids, Outcome 4 Withdrawals.

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Analysis 4.5

Comparison 4 Pimecrolimus 1.0% BID vs. vehicle BID, participants did not respond to topical steroids, Outcome 5 Adverse events.

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Analysis 5.1

Comparison 5 Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares, Outcome 1 Clear or almost clear eczema (IGA 0 or 1).

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Analysis 5.2

Comparison 5 Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares, Outcome 2 Complete or well controlled eczema (PGA).

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Analysis 5.3

Comparison 5 Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares, Outcome 3 Mild or absent pruritus (pruritus score 0 or 1).

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Analysis 5.4

Comparison 5 Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares, Outcome 4 No flare of eczema.

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Analysis 5.5

Comparison 5 Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares, Outcome 5 No use of rescue medication.

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Analysis 5.6

Comparison 5 Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares, Outcome 6 Withdrawals.

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Analysis 5.7

Comparison 5 Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares, Outcome 7 Adverse events.

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Analysis 6.1

Comparison 6 Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares, participants responded to steroids, Outcome 1 Withdrawals.

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Analysis 7.1

Comparison 7 Pimecrolimus 1.0% BID vs. triamcinolone acetonide 0.1% BID, Outcome 1 Clear or almost clear eczema (IGA 0 or 1).

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Analysis 7.2

Comparison 7 Pimecrolimus 1.0% BID vs. triamcinolone acetonide 0.1% BID, Outcome 2 Mild or absent pruritus (pruritus score 0 or 1).

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Analysis 7.3

Comparison 7 Pimecrolimus 1.0% BID vs. triamcinolone acetonide 0.1% BID, Outcome 3 Withdrawals.

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Analysis 7.4

Comparison 7 Pimecrolimus 1.0% BID vs. triamcinolone acetonide 0.1% BID, Outcome 4 Adverse events.

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Analysis 8.1

Comparison 8 Pimecrolimus 1.0% BID vs. betamethasone valerate 0.1% BID, Outcome 1 Moderately clear or better eczema (PGA more than 50% improvement).

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Analysis 8.2

Comparison 8 Pimecrolimus 1.0% BID vs. betamethasone valerate 0.1% BID, Outcome 2 Mild or absent pruritus (pruritus score 0 or 1).

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Analysis 8.3

Comparison 8 Pimecrolimus 1.0% BID vs. betamethasone valerate 0.1% BID, Outcome 3 Withdrawals.

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Analysis 8.4

Comparison 8 Pimecrolimus 1.0% BID vs. betamethasone valerate 0.1% BID, Outcome 4 Adverse events.

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Analysis 9.1

Comparison 9 Pimecrolimus 1.0% BID vs. tacrolimus 0.03% BID, Outcome 1 Clear or almost clear eczema (IGA 0 or 1).

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Analysis 9.2

Comparison 9 Pimecrolimus 1.0% BID vs. tacrolimus 0.03% BID, Outcome 2 Mild or absent pruritus (pruritus score 0 or 1).

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Analysis 9.3

Comparison 9 Pimecrolimus 1.0% BID vs. tacrolimus 0.03% BID, Outcome 3 Withdrawals.

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Analysis 9.4

Comparison 9 Pimecrolimus 1.0% BID vs. tacrolimus 0.03% BID, Outcome 4 Adverse events.

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Analysis 10.1

Comparison 10 Pimecrolimus 1.0% BID vs. tacrolimus 0.1% BID, Outcome 1 Clear or almost clear eczema (IGA 0 or 1).

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Analysis 10.2

Comparison 10 Pimecrolimus 1.0% BID vs. tacrolimus 0.1% BID, Outcome 2 Withdrawals.

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Analysis 10.3

Comparison 10 Pimecrolimus 1.0% BID vs. tacrolimus 0.1% BID, Outcome 3 Adverse events.

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Analysis 11.1

Comparison 11 Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QID, Outcome 1 Clear or almost clear eczema (IGA 0 or 1).

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Analysis 11.2

Comparison 11 Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QID, Outcome 2 Complete or well controlled eczema (PGA).

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Analysis 11.3

Comparison 11 Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QID, Outcome 3 Mild or absent pruritus (pruritus score 0 or 1).

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Analysis 11.4

Comparison 11 Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QID, Outcome 4 Withdrawals.

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Analysis 11.5

Comparison 11 Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QID, Outcome 5 Adverse events.

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Analysis 12.1

Comparison 12 Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QD, participants responding to pimecrolimus, Outcome 1 Clear or almost clear eczema (IGA 0 or 1).

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Analysis 12.2

Comparison 12 Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QD, participants responding to pimecrolimus, Outcome 2 No flare of eczema.

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Analysis 12.3

Comparison 12 Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QD, participants responding to pimecrolimus, Outcome 3 Withdrawals.

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Analysis 12.4

Comparison 12 Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QD, participants responding to pimecrolimus, Outcome 4 Adverse events.

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Table 1. Summary of methodological quality

Name of study	Allocat'n generation	Allocat'n concealed	Blinding	Loss to follow up	Attrition rate	Certainty of AD	Comparable severity
ASM981C2315 2005	Unclear	Unclear	Adequate	Adequate	15.36%	Unclear	Adequate
ASM981C2316 2005	Unclear	Unclear	Adequate	Adequate	18.42%	Unclear	Unclear
ASM981C2322 2005	Unclear	Unclear	Adequate	Adequate	10.12%	Unclear	Unclear
ASM981C2402 2005	Unclear	Unclear	Adequate	Inadequate	23.29%	Unclear	Unclear
Barba 2003	Unclear	Unclear	Adequate	Adequate	7.55%	Unclear	Unclear
CASM981C1301 2005	Unclear	Unclear	Adequate	Adequate	13.75%	Adequate	Unclear
CASM981C1303 2005	Unclear	Unclear	Adequate	Adequate	15.61%	Unclear	Unclear
CASM981C2413 2006	Unclear	Unclear	Adequate	Inadequate	27.24%	Unclear	Unclear
CASM981C2436 2006	Unclear	Unclear	Adequate	Inadequate	16.87%	Adequate	Unclear
CASM981C2442 2006	Unclear	Unclear	Adequate	Inadequate	43.5%	Adequate	Unclear
CASM981CDE10 2005	Unclear	Unclear	Adequate	Adequate	15.76%	Adequate	Unclear
CASM981CUS03 2005	Unclear	Unclear	Adequate	Adequate	26.89%	Unclear	Unclear
Eichenfield (a) 2002	Unclear	Unclear	Adequate	Adequate	18.18%	Adequate	Adequate
Eichenfield (b) 2002	Unclear	Unclear	Adequate	Adequate	13.66%	Adequate	Adequate
Ho 2003	Unclear	Unclear	Adequate	Inadequate	23.66%	Adequate	Adequate
Kapp 2002	Unclear	Unclear	Adequate	Inadequate	27.09%	Adequate	Adequate
Kaufmann 2006	Adequate	Unclear	Adequate	Adequate	5.56%	Unclear	Adequate
Kempers 2004	Adequate	Adequate	Adequate	Adequate	11.35%	Unclear	Adequate
Leo 2004	Unclear	Unclear	Adequate	Adequate	0.00%	Adequate	Unclear
Ling 2005	Unclear	Unclear	Adequate	Adequate	16.33%	Adequate	Unclear
Luger 2001	Unclear	Unclear	Adequate	Inadequate	22.31%	Adequate	Adequate
Luger 2004	Adequate	Unclear	Adequate	Inadequate	41.19%	Adequate	Adequate
Meurer 2002	Unclear	Unclear	Adequate	Inadequate	30.21%	Adequate	Adequate
Paller (a) 2005	Adequate	Adequate	Adequate	Adequate	24.18%	Adequate	Adequate
Paller (b) 2005	Adequate	Adequate	Adequate	Inadequate	34.96%	Adequate	Adequate
Paller (c) 2005	Adequate	Adequate	Adequate	Inadequate	21.79%	Adequate	Adequate
Staab 2005	Unclear	Unclear	Adequate	Adequate	19.39%	Adequate	Adequate
Seigfried 2006	Unclear	Unclear	Adequate	Inadequate	21.45%	Adequate	Unclear
Thaci 2003	Unclear	Unclear	Adequate	Inadequate	28.72%	Unclear	Adequate
Wahn 2002	Adequate	Unclear	Adequate	Inadequate	38.26%	Adequate	Adequate
Whalley 2002	Unclear	Unclear	Adequate	Inadequate	36.10%	Adequate	Unclear

Table 1. Summary of methodological quality

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Table 2. Quality of life measures

Population	QoL measure	Scale of measure	Study
Adults	Dermatology Life Quality Index (DLQI)	10 items, maximum score: 30 (score 0 to 3 for each item)	Meurer 2002,
	Quality of Life Index‐ Atopic Dermatitis (QoLI‐AD)	25 items, maximum score: 25 (yes, no scored 1, 0)	Meurer 2002,
Children	Children's Dermatology Life Quality Index (CDLQI)	10 items, maximum score: 30 (score 0 to 3 for each item)	Leo 2004, Wahan 2002
Carers	Parent's Index of Quality of Life‐ Atopic Dermatitis (PIQoL‐AD)	28 items, maximum score: 28 (yes, no scored 1, 0)	Whalley 2002, Kappa 2002, Wahn 2002
	Parents' Quality of Life Index‐ Atopic Dermatitis (PQoL‐AD)	26 items in 5 sub‐scales (each items scored 1 to 5 in 5‐point Likert Scale)	Staab 2005

Table 2. Quality of life measures

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Comparison 1. Pimecrolimus 1.0% BID vs. vehicle BID

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clear or almost clear eczema (IGA 0 or 1) Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 1 week	1	336	Risk Ratio (M‐H, Random, 95% CI)	2.0 [1.06, 3.76]
1.2 2 weeks	1	336	Risk Ratio (M‐H, Random, 95% CI)	1.58 [1.00, 2.52]
1.3 3 weeks	5	783	Risk Ratio (M‐H, Random, 95% CI)	2.72 [1.84, 4.03]
1.4 4 weeks	1	336	Risk Ratio (M‐H, Random, 95% CI)	1.42 [1.00, 2.03]
1.5 6 weeks	3	589	Risk Ratio (M‐H, Random, 95% CI)	2.03 [1.50, 2.74]
2 Complete or well controlled eczema (PGA) Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 3 weeks	1	106	Risk Ratio (M‐H, Random, 95% CI)	1.88 [1.33, 2.67]
2.2 6 weeks	1	186	Risk Ratio (M‐H, Random, 95% CI)	2.65 [1.74, 4.04]
3 Mild or absent pruritus (pruritus score 0 or 1) Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 1 week	3	472	Risk Ratio (M‐H, Random, 95% CI)	1.89 [1.51, 2.35]
3.2 3 weeks	5	783	Risk Ratio (M‐H, Random, 95% CI)	2.02 [1.69, 2.42]
3.3 6 weeks	3	589	Risk Ratio (M‐H, Random, 95% CI)	1.82 [1.48, 2.25]
4 Withdrawals Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 For any reason	9	1753	Risk Ratio (M‐H, Random, 95% CI)	0.40 [0.27, 0.58]
4.2 For lack of efficacy	8	1657	Risk Ratio (M‐H, Random, 95% CI)	0.21 [0.11, 0.41]
4.3 For adverse events	5	1025	Risk Ratio (M‐H, Random, 95% CI)	0.43 [0.19, 0.97]
5 Adverse events Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 Any adverse events	4	827	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.82, 1.02]
5.2 Bacterial skin infections	1	186	Risk Ratio (M‐H, Random, 95% CI)	0.13 [0.01, 1.12]
5.3 Application site skin burning	5	914	Risk Ratio (M‐H, Random, 95% CI)	1.40 [0.90, 2.18]

Comparison 1. Pimecrolimus 1.0% BID vs. vehicle BID

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Comparison 2. Pimecrolimus 1.0% BID vs. vehicle BID, participants with facial AD

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clear or almost clear of facial eczema (facial IGA 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 1 week	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 3 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.3 6 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Mild or absent pruritus (pruritus score 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 1 week	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 3 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 6 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Withdrawals Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 For any reason	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 For lack of efficacy	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 For adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 2. Pimecrolimus 1.0% BID vs. vehicle BID, participants with facial AD

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Comparison 3. Pimecrolimus 1.0% BID vs. vehicle BID, participants responded to topical steroids

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Withdrawals Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 For any reason	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 For lack of efficacy	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.3 For adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Adverse events Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Any adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Pimecrolimus 1.0% BID vs. vehicle BID, participants responded to topical steroids

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Comparison 4. Pimecrolimus 1.0% BID vs. vehicle BID, participants did not respond to topical steroids

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clear or almost clear eczema (IGA 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 6 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Complete or well controlled eczema (PGA) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 6 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Mild or absent pruritus (pruritus score 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 6 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4 Withdrawals Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4.1 For any reason	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.2 For lack of efficacy	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.3 For adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5 Adverse events Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

5.1 Any adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.2 Skin infections	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.3 Viral skin infections	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.4 Application site skin burning	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. Pimecrolimus 1.0% BID vs. vehicle BID, participants did not respond to topical steroids

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Comparison 5. Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clear or almost clear eczema (IGA 0 or 1) Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 1 week	2	526	Risk Ratio (M‐H, Random, 95% CI)	3.45 [1.66, 7.14]
1.2 3 weeks	1	251	Risk Ratio (M‐H, Random, 95% CI)	1.43 [0.98, 2.10]
1.3 6 months	1	251	Risk Ratio (M‐H, Random, 95% CI)	1.46 [0.98, 2.19]
1.4 12 months	1	251	Risk Ratio (M‐H, Random, 95% CI)	1.15 [0.83, 1.60]
2 Complete or well controlled eczema (PGA) Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 6 weeks	1	251	Risk Ratio (M‐H, Random, 95% CI)	1.40 [1.06, 1.85]
2.2 6 months	2	443	Risk Ratio (M‐H, Random, 95% CI)	1.62 [1.29, 2.04]
2.3 9 months	1	251	Risk Ratio (M‐H, Random, 95% CI)	1.33 [1.01, 1.74]
2.4 12 months	1	251	Risk Ratio (M‐H, Random, 95% CI)	1.15 [0.90, 1.47]
3 Mild or absent pruritus (pruritus score 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 6 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 6 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 9 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.4 12 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4 No flare of eczema Show forest plot	9		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 6 months	9	3091	Risk Ratio (M‐H, Random, 95% CI)	1.47 [1.32, 1.64]
4.2 12 months	2	962	Risk Ratio (M‐H, Random, 95% CI)	1.69 [1.45, 1.96]
5 No use of rescue medication Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 6 months	1	192	Risk Ratio (M‐H, Random, 95% CI)	2.24 [1.46, 3.44]
5.2 12 months	2	962	Risk Ratio (M‐H, Random, 95% CI)	1.76 [1.50, 2.08]
6 Withdrawals Show forest plot	9		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 For any reason	9	3091	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.54, 0.76]
6.2 For lack of efficacy	9	3091	Risk Ratio (M‐H, Random, 95% CI)	0.42 [0.34, 0.51]
6.3 For adverse events	8	2380	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.28, 1.27]
7 Adverse events Show forest plot	8		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 Any adverse events	4	1398	Risk Ratio (M‐H, Random, 95% CI)	1.07 [1.00, 1.16]
7.2 Skin infections	3	718	Risk Ratio (M‐H, Random, 95% CI)	1.14 [0.75, 1.72]
7.3 Viral skin infections	3	718	Risk Ratio (M‐H, Random, 95% CI)	1.79 [0.89, 3.61]
7.4 Bacterial skin infections	4	982	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.51, 1.39]
7.5 Application site skin burning	3	999	Risk Ratio (M‐H, Random, 95% CI)	4.36 [1.75, 10.85]

Comparison 5. Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares

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Comparison 6. Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares, participants responded to steroids

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Withdrawals Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 For any reason	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 For lack of efficacy	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.3 For adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 6. Pimecrolimus 1.0% BID vs. vehicle BID, topical steroids for flares, participants responded to steroids

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Comparison 7. Pimecrolimus 1.0% BID vs. triamcinolone acetonide 0.1% BID

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clear or almost clear eczema (IGA 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 1 week	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 3 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.3 6 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.4 12 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Mild or absent pruritus (pruritus score 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 12 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Withdrawals Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 For any reason	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 For lack of efficacy	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 For adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4 Adverse events Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4.1 Any adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.2 Skin infections	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.3 Viral skin infections	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.4 Bacterial skin infections	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.5 Application site skin burning	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 7. Pimecrolimus 1.0% BID vs. triamcinolone acetonide 0.1% BID

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Comparison 8. Pimecrolimus 1.0% BID vs. betamethasone valerate 0.1% BID

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Moderately clear or better eczema (PGA more than 50% improvement) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 3 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Mild or absent pruritus (pruritus score 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 1 week	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 3 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Withdrawals Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 For any reason	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 For lack of efficacy	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 For adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4 Adverse events Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4.1 Any adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.2 Application site skin burning	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 8. Pimecrolimus 1.0% BID vs. betamethasone valerate 0.1% BID

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Comparison 9. Pimecrolimus 1.0% BID vs. tacrolimus 0.03% BID

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clear or almost clear eczema (IGA 0 or 1) Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 1 week	2	567	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.63, 1.31]
1.2 3 weeks	2	567	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.58, 1.15]
1.3 6 weeks	2	567	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.69, 1.02]
2 Mild or absent pruritus (pruritus score 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 1 week	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 3 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 6 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Withdrawals Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 For any reason	2	567	Risk Ratio (M‐H, Random, 95% CI)	1.94 [0.54, 6.98]
3.2 For lack of efficacy	2	567	Risk Ratio (M‐H, Random, 95% CI)	3.45 [1.23, 9.71]
3.3 For adverse events	2	567	Risk Ratio (M‐H, Random, 95% CI)	8.19 [1.50, 44.73]
4 Adverse events Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 Any adverse events	2	567	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.90, 1.17]
4.2 Skin infections	2	567	Risk Ratio (M‐H, Random, 95% CI)	1.65 [0.12, 22.75]
4.3 Bacterial skin infections	1	141	Risk Ratio (M‐H, Random, 95% CI)	6.90 [0.36, 131.23]
4.4 Viral skin infections	2	567	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.15, 6.96]
4.5 Application site skin burning	2	567	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.55, 2.49]

Comparison 9. Pimecrolimus 1.0% BID vs. tacrolimus 0.03% BID

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Comparison 10. Pimecrolimus 1.0% BID vs. tacrolimus 0.1% BID

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clear or almost clear eczema (IGA 0 or 1) Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 1 week	2	639	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.53, 1.34]
1.2 3 weeks	2	639	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.41, 0.77]
1.3 6 weeks	2	639	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.46, 0.74]
2 Withdrawals Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 For any reason	2	639	Risk Ratio (M‐H, Random, 95% CI)	1.18 [0.91, 1.52]
2.2 For lack of efficacy	2	639	Risk Ratio (M‐H, Random, 95% CI)	2.37 [1.10, 5.08]
2.3 For adverse events	2	639	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.43, 2.41]
3 Adverse events Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 Any adverse events	2	639	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.47, 2.26]
3.2 Skin infections	2	639	Risk Ratio (M‐H, Random, 95% CI)	1.60 [0.37, 6.99]
3.3 Viral skin infections	1	413	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.07, 16.43]
3.4 Application site skin burning	2	639	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.36, 1.62]

Comparison 10. Pimecrolimus 1.0% BID vs. tacrolimus 0.1% BID

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Comparison 11. Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QID

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clear or almost clear eczema (IGA 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 3 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Complete or well controlled eczema (PGA) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 3 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Mild or absent pruritus (pruritus score 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 3 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4 Withdrawals Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4.1 For any reason	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.2 For lack of efficacy	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.3 For adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5 Adverse events Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

5.1 Any adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.2 Application site skin burning	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 11. Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QID

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Comparison 12. Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QD, participants responding to pimecrolimus

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clear or almost clear eczema (IGA 0 or 1) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 8 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 16 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 No flare of eczema Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 16 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Withdrawals Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 For any reason	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 For lack of efficacy	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 For adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4 Adverse events Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4.1 Any adverse events	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.2 Skin infections	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 12. Pimecrolimus 1.0% BID vs. pimecrolimus 1.0% QD, participants responding to pimecrolimus

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