Steroid avoidance or withdrawal for kidney transplant recipients

Maria C Haller; Ana Royuela; Evi V Nagler; Julio Pascual; Angela C Webster

doi:10.1002/14651858.CD005632.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

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Figure 4

Funnel plot of comparisons that included at least 10 studies in the meta‐analysis

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Analysis 1.1

Comparison 1 Steroid withdrawal versus steroid maintenance, Outcome 1 Death and graft loss.

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Analysis 1.2

Comparison 1 Steroid withdrawal versus steroid maintenance, Outcome 2 Rejection.

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Analysis 1.3

Comparison 1 Steroid withdrawal versus steroid maintenance, Outcome 3 New‐onset diabetes after transplantation and cardiovascular events.

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Analysis 1.4

Comparison 1 Steroid withdrawal versus steroid maintenance, Outcome 4 Infection and malignancy.

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Analysis 1.5

Comparison 1 Steroid withdrawal versus steroid maintenance, Outcome 5 Kidney function.

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Analysis 2.1

Comparison 2 Steroid avoidance versus steroid maintenance, Outcome 1 Death and graft loss.

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Analysis 2.2

Comparison 2 Steroid avoidance versus steroid maintenance, Outcome 2 Rejection.

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Analysis 2.3

Comparison 2 Steroid avoidance versus steroid maintenance, Outcome 3 New‐onset diabetes after transplantation and cardiovascular events.

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Analysis 2.4

Comparison 2 Steroid avoidance versus steroid maintenance, Outcome 4 Infection and malignancy.

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Analysis 2.5

Comparison 2 Steroid avoidance versus steroid maintenance, Outcome 5 Kidney function.

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Analysis 3.1

Comparison 3 Steroid avoidance versus steroid withdrawal, Outcome 1 Death and graft loss.

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Analysis 3.2

Comparison 3 Steroid avoidance versus steroid withdrawal, Outcome 2 Rejection.

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Analysis 3.3

Comparison 3 Steroid avoidance versus steroid withdrawal, Outcome 3 New‐onset diabetes after transplantation, infection, malignancy.

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Analysis 3.4

Comparison 3 Steroid avoidance versus steroid withdrawal, Outcome 4 Kidney function.

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Analysis 4.1

Comparison 4 Steroid withdrawal versus maintenance in children, Outcome 1 Death and graft loss.

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Analysis 4.2

Comparison 4 Steroid withdrawal versus maintenance in children, Outcome 2 Rejection, malignancy.

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Analysis 4.3

Comparison 4 Steroid withdrawal versus maintenance in children, Outcome 3 Kidney function.

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Analysis 5.1

Comparison 5 Publication bias, Outcome 1 Funnel plots.

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Summary of findings for the main comparison. Steroid withdrawal versus steroid maintenance for kidney transplant recipients

Steroid withdrawal versus steroid maintenance for kidney transplant recipients
Patient or population: kidney transplant recipients Intervention: steroid withdrawal Comparison: steroid maintenance
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Steroid maintenance	Steroid withdrawal
Mortality Follow‐up: 1 year	22 per 1000	15 per 1000 (8 to 29)	RR 0.68 (0.36 to 1.3)	1913 (10)	⊕⊕⊝⊝ low^1,2
Graft loss (excluding death) Follow‐up: 1 year	32 per 1000	38 per 1000 (23 to 62)	RR 1.17 (0.72 to 1.92)	1817 (8)	⊕⊕⊝⊝ low^2,3
Acute rejection Follow‐up: 1 year	152 per 1000	268 per 1000 (182 to 396)	RR 1.77 (1.2 to 2.61)	1913 (10)	⊕⊕⊕⊝ moderate¹
NODAT Follow‐up: 5 years	57 per 1000	44 per 1000 (28 to 69)	RR 0.77 (0.49 to 1.21)	1439 (6)	⊕⊕⊝⊝ low^2,4
CMV infection Follow‐up: 5 years	100 per 1000	104 per 1000 (80 to 137)	RR 1.04 (0.8 to 1.36)	1758 (5)	⊕⊕⊝⊝ low^2,5
The assumed risk* is the baseline risk in the control group treated with steroid maintenance. 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; RR: Risk ratio; NODAT: new‐onset diabetes after transplantation; CMV ‐ cytomegalovirus
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Most studies were unblinded (9 studies) and did not report details about random sequence generation or allocation concealment or both (8 studies). One study had inappropriate random sequence generation. Four studies were industry sponsored. ITT analysis was unclear in four. ² Total number of events were fewer than 300. ³ Most studies were unblinded (7 studies) and did not report details about random sequence generation or allocation concealment or both (6 studies). One study had inappropriate random sequence generation. Four studies were industry sponsored. ITT analysis was unclear in two. ⁴ Most studies were unblinded (5 studies) and did not report details about random sequence generation or allocation concealment or both (5 studies). Three studies were industry sponsored. ITT analysis was unclear in three studies. One study had selective outcome reporting. ⁵ Most studies were unblinded (4 studies) and did not report details about random sequence generation or allocation concealment or both (4 studies). Three studies were industry sponsored. ITT analysis was unclear in two studies. One study had selective outcome reporting.

Summary of findings for the main comparison. Steroid withdrawal versus steroid maintenance for kidney transplant recipients

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Summary of findings 2. Steroid avoidance versus steroid maintenance for kidney transplant recipients

Steroid avoidance versus steroid maintenance for kidney transplant recipients
Patient or population: kidney transplant recipients Intervention: steroid avoidance Comparison: steroid maintenance
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Steroid avoidance versus steroid maintenance
Mortality Follow‐up: 1 year	31 per 1000	30 per 1000 (16 to 56)	RR 0.96 (0.52 to 1.8)	1462 (10)	⊕⊕⊝⊝ low^1,2
Graft loss (excluding death) Follow‐up: 1 year	42 per 1000	46 per 1000 (27 to 79)	RR 1.09 (0.64 to 1.86)	1211 (7)	⊕⊕⊝⊝ low^2,3
Acute rejection Follow‐up: 1 year	204 per 1000	323 per 1000 (221 to 470)	RR 1.58 (1.08 to 2.3)	835 (7)	⊕⊕⊕⊝ moderate⁴
NODAT Follow‐up: 5 years	107 per 1000	80 per 1000 (54 to 117)	RR 0.75 (0.51 to 1.1)	1618 (9)	⊕⊕⊝⊝ low^2,5
CMV Infection Follow‐up: 5 years	106 per 1000	101 per 1000 (74 to 138)	RR 0.96 (0.7 to 1.31)	1454 (6)	⊕⊕⊝⊝ low^2,6
The assumed risk* is the baseline risk in the control group treated with steroid maintenance. 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; RR: Risk ratio; NODAT: new‐onset diabetes after transplantation; CMV ‐ cytomegalovirus
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate
¹ All studies were unblinded. Six studies were industry sponsored. In six studies random sequence generation or allocation concealment or both was unclear. In two studies ITT was either not performed or unclear. One study had selective outcome reporting ² Total number of events was fewer than 300 ³ All studies were unblinded. Five studies were industry sponsored. In four studies random sequence generation or allocation concealment or both was unclear. ITT was unclear in one study. One study had selective outcome reporting ⁴ All studies were unblinded. Five studies were industry sponsored. In four studies random sequence generation or allocation concealment or both was unclear. In three studies ITT was either not performed or unclear. One study had selective outcome reporting ⁵ Most studies were unblinded (8 studies). Five studies were industry sponsored. In four studies random sequence generation or allocation concealment or both was unclear. One study had selective outcome reporting ⁶ Most studies were unblinded (5 studies). Four studies were industry sponsored. One study had unclear ITT

Summary of findings 2. Steroid avoidance versus steroid maintenance for kidney transplant recipients

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Table 1. Steroid withdrawal versus steroid maintenance ‐ stratified subgroup and sensitivity analysis for death, graft loss and acute rejection up to one year after transplantation

	Death			Graft loss			Acute rejection			Biopsy‐proven acute rejection
	Studies	RR	95% CI	Studies	RR	95% CI	Studies	RR	95% CI	Studies	RR	95% CI
*Publication status*
Peer reviewed journal	8	0.60	0.31 to 1.17	7	1.25	0.73 to 2.13	8	2.02	1.23 to 3.23	4	1.32	0.66 to 2.66
Abstract only	2	3.04	0.33 to 28.29	1	0.82	0.23 to 2.94	2	1.25	0.67 to 2.32	1	1.37	0.70 to 2.69
*ITT analysis*
ITT analysis used	6	0.69	0.30 to 1.61	6	1.31	0.69 to 2.46	6	2.07	1.10 to 3.91	3	1.37	0.64 to 2.94
ITT analysis not used/unclear	4	0.67	0.25 to 1.81	2	1.00	0.46 to 2.17	4	1.65	0.81 to 3.36	2	1.04	0.24 to 4.59
*Calcineurin inhibitor*
CsA	9	0.75	0.36 to 1.54	7	0.90	0.50 to 5.14	9	2.08	1.29 to 3.35	4	1.60	0.87 to 2.92
TAC	1	0.50	0.13 to 1.97	1	2.13	0.88 to 5.14	1	1.11	0.82 to 1.51	1	0.89	0.61 to 1.30
*Antimetabolite*
MMF or EC‐MPS	6	0.67	0.31 to 1.47	5	1.25	0.75 to 2.08	6	1.41	1.02 to 1.94	3	1.27	0.81 to 2.00
AZA	2	0.93	0.26 to 3.40	2	0.25	0.03 to 2.18	2	2.61	0.62 to 10.91	1	0.33	0.04 to 2.56
MMF or EC‐MPS or AZA	8	0.73	0.38 to 1.43	7	1.15	0.70 to 1.89	8	1.46	1.07 to 1.98	4	1.19	0.75 to 1.90
none	2	0.31	0.03 to 2.95	1	3.00	0.13 to 71.61	2	5.80	2.16 to 15.57	1	9.00	1.19 to 67.93
*Induction treatment*
Induction (yes)	2	3.00	0.32 to 27.87	1	0.33	0.01 to 8.02	2	0.80	0.22 to 2.91	NA	‐‐	‐‐
Induction (no)	8	0.60	0.31 to 1.17	7	1.21	0.74 to 1.99	8	1.93	1.26 to 2.94	NA	‐‐	‐‐
AZA ‐ azathioprine; CI ‐ confidence interval; CsA ‐ cyclosporin A; EC‐MPS ‐ enteric‐coated mycophenolate sodium; ITT ‐ intention to treat; MMF ‐ mycophenolate mofetil; NA ‐ not available; RR ‐ risk ratio; TAC ‐ tacrolimus

Table 1. Steroid withdrawal versus steroid maintenance ‐ stratified subgroup and sensitivity analysis for death, graft loss and acute rejection up to one year after transplantation

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Table 2. Steroid avoidance versus steroid maintenance ‐ stratified subgroup and sensitivity analysis for death, graft loss and acute rejection up to one year after transplantation

	Death			Graft loss			Acute rejection			Biopsy‐proven acute rejection
	Studies	RR	95% CI	Studies	RR	95% CI	Studies	RR	95% CI	Studies	RR	95% CI
*ITT analysis*
ITT analysis used	7	1.16	0.48 to 2.83	5	1.09	0.56 to 2.11	4	1.92	1.18 to 3.14	4	2.31	1.47 to 3.63
ITT analysis not used/unclear	3	0.51	0.07 to 3.83	2	1.11	0.46 to 2.67	3	1.24	0.97 to 1.59	2	1.05	0.49 to 2.23
*Calcineurin inhibitor*
CsA	8	0.88	0.47 to 1.66	5	1.08	0.59 to 1.99	5	1.31	1.05 to 1.63	3	1.89	1.29 to 2.79
TAC	2	6.82	0.36 to 130.81	2	1.14	0.39 to 3.3	2	2.40	1.05 to 5.49	3	1.81	0.66 to 4.99
*Antimetabolite*
MMF or EC‐MPS	6	1.15	0.36 to 3.69	6	1.09	0.56 to 2.11	5	1.87	1.20 to 2.91	6	1.94	1.26 to 2.98
AZA	1	1.64	0.29 to 9.2	NA	‐‐	‐‐	NA	‐‐	‐‐	NA	‐‐	‐‐
MMF or EC‐MPS or AZA	8	1.16	0.48 to 2.83	NA	‐‐	‐‐	NA	‐‐	‐‐	NA	‐‐	‐‐
None	2	0.51	0.07 to 3.83	1	1.11	0.46 to 2.67	2	1.26	0.95 to 1.65	NA	‐‐	‐‐
*Induction treatment*
Induction (yes)	7	0.97	0.38 to 2.48	5	1.06	0.45 to 2.46	4	1.50	0.97 to 2.32	5	1.67	1.19 to 2.36
Induction (no)	3	0.92	0.17 to 5.01	2	1.12	0.57 to 2.2	3	1.72	0.89 to 3.32	1	3.89	2.16 to 7.03
AZA ‐ azathioprine; CI ‐ confidence interval; CsA ‐ cyclosporin A; EC‐MPS ‐ enteric‐coated mycophenolate sodium; ITT ‐ intention to treat; MMF ‐ mycophenolate mofetil; NA ‐ not available; RR ‐ risk ratio; TAC ‐ tacrolimus

Table 2. Steroid avoidance versus steroid maintenance ‐ stratified subgroup and sensitivity analysis for death, graft loss and acute rejection up to one year after transplantation

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Comparison 1. Steroid withdrawal versus steroid maintenance

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Death and graft loss Show forest plot	15		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Death up to one year	10	1913	Risk Ratio (M‐H, Random, 95% CI)	0.68 [0.36, 1.30]
1.2 Death one to five years	7	1118	Risk Ratio (M‐H, Random, 95% CI)	1.26 [0.73, 2.17]
1.3 Graft loss including death up to one year	8	1817	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.64, 1.49]
1.4 Graft loss including death one to five years	7	1092	Risk Ratio (M‐H, Random, 95% CI)	1.41 [1.00, 2.01]
1.5 Graft loss excluding death up to one year	8	1817	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.72, 1.92]
1.6 Graft loss excluding death one to five years	7	1092	Risk Ratio (M‐H, Random, 95% CI)	1.61 [0.98, 2.64]
2 Rejection Show forest plot	11		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Acute rejection up to one year	10	1913	Risk Ratio (M‐H, Random, 95% CI)	1.77 [1.20, 2.61]
2.2 Biopsy‐proven acute rejection up to one year	5	1292	Risk Ratio (M‐H, Random, 95% CI)	1.32 [0.78, 2.22]
3 New‐onset diabetes after transplantation and cardiovascular events Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 New onset diabetes after transplantation up to five years	6	1439	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.49, 1.21]
3.2 Cardiovascular events up to five years	2	607	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.42, 2.33]
4 Infection and malignancy Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 Infection (all) up to five years	5	1819	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.84, 1.22]
4.2 CMV infection up to five years	5	1758	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.80, 1.36]
4.3 Malignancy up to five years	3	756	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.41, 1.46]
5 Kidney function Show forest plot	8		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

5.1 Serum creatinine (mg/dL) up to one year	4	644	Std. Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.21, 0.13]
5.2 Serum creatinine (mg/dL) one to five years	5	762	Std. Mean Difference (IV, Random, 95% CI)	0.08 [‐0.06, 0.23]
5.3 Creatinine clearance (mL/min) up to one year	2	215	Std. Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.35, 0.21]
5.4 Creatinine clearance (mL/min) one to five years	3	669	Std. Mean Difference (IV, Random, 95% CI)	‐0.21 [‐0.56, 0.13]

Comparison 1. Steroid withdrawal versus steroid maintenance

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Comparison 2. Steroid avoidance versus steroid maintenance

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Death and graft loss Show forest plot	13		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Death up to one year	10	1462	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.52, 1.80]
1.2 Death one to five years	7	1201	Risk Ratio (M‐H, Random, 95% CI)	0.57 [0.32, 1.01]
1.3 Graft loss including death up to one year	7	1211	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.72, 1.62]
1.4 Graft loss including death one to five years	7	1245	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.53, 1.18]
1.5 Graft loss excluding death up to one year	7	1211	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.64, 1.86]
1.6 Graft loss excluding death one to five years	7	1245	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.66, 1.45]
2 Rejection Show forest plot	9		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Acute rejection up to one year	7	835	Risk Ratio (M‐H, Random, 95% CI)	1.58 [1.08, 2.30]
2.2 Biopsy‐proven acute rejection up to one year	6	1073	Risk Ratio (M‐H, Random, 95% CI)	1.94 [1.26, 2.98]
3 New‐onset diabetes after transplantation and cardiovascular events Show forest plot	9		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 New onset diabetes after transplantation up to five years	9	1618	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.51, 1.10]
3.2 Cardiovascular events up to five years	4	1013	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.30, 1.05]
4 Infection and malignancy Show forest plot	11		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 Infection (all) up to five years	9	1833	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.84, 1.03]
4.2 CMV Infection up to five years	6	1454	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.70, 1.31]
4.3 Malignancy up to five years	7	1635	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.61, 1.52]
5 Kidney function Show forest plot	10		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

5.1 Serum creatinine (mg/dL) up to one year	5	735	Std. Mean Difference (IV, Random, 95% CI)	0.02 [‐0.12, 0.17]
5.2 Serum creatinine (mg/dL) one to five years	3	688	Std. Mean Difference (IV, Random, 95% CI)	‐0.01 [‐0.16, 0.14]
5.3 Creatinine clearance (mL/min) up to one year	6	1104	Std. Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.23, 0.08]
5.4 Creatinine clearance (mL/min) one to five years	3	563	Std. Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.25, 0.08]

Comparison 2. Steroid avoidance versus steroid maintenance

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Comparison 3. Steroid avoidance versus steroid withdrawal

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Death and graft loss Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Death up to one year	1	222	Risk Ratio (M‐H, Random, 95% CI)	0.39 [0.08, 1.98]
1.2 Death one to five years	2	152	Risk Ratio (M‐H, Random, 95% CI)	2.67 [0.63, 11.32]
1.3 Graft loss including death up to one year	1	222	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.32, 2.29]
1.4 Graft loss including death one to five years	2	152	Risk Ratio (M‐H, Random, 95% CI)	2.44 [0.89, 6.70]
1.5 Graft loss excluding death up to one year	1	222	Risk Ratio (M‐H, Random, 95% CI)	1.64 [0.40, 6.68]
1.6 Graft loss excluding death one to five years	2	152	Risk Ratio (M‐H, Random, 95% CI)	1.91 [0.48, 7.67]
2 Rejection Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Acute rejection up to one year	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Biopsy‐proven acute rejection up to one year	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 New‐onset diabetes after transplantation, infection, malignancy Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 New onset diabetes after transplantation up to five years	3	351	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.36, 1.09]
3.2 Infection (all) up to five years	3	374	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.76, 1.50]
3.3 CMV Infection up to five years	2	284	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.30, 0.92]
3.4 Malignancy up to five years	1	90	Risk Ratio (M‐H, Random, 95% CI)	1.57 [0.28, 8.94]
4 Kidney function Show forest plot	2		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

4.1 Serum creatinine (mg/dL) up to one year	2	88	Std. Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.47, 0.37]
4.2 Creatinine clearance (mL/min) up to one year	2	206	Std. Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.41, 0.14]

Comparison 3. Steroid avoidance versus steroid withdrawal

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Comparison 4. Steroid withdrawal versus maintenance in children

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Death and graft loss Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Death up to five years	2	174	Risk Ratio (M‐H, Random, 95% CI)	0.16 [0.02, 1.35]
1.2 Graft loss including death up to five years	2	174	Risk Ratio (M‐H, Random, 95% CI)	0.09 [0.01, 0.69]
1.3 Graft loss excluding death up to five years	2	174	Risk Ratio (M‐H, Random, 95% CI)	0.09 [0.00, 1.64]
2 Rejection, malignancy Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Acute rejection up to one year	2	174	Risk Ratio (M‐H, Random, 95% CI)	0.37 [0.13, 1.02]
2.2 Biopsy‐proven acute rejection up to one year	1	42	Risk Ratio (M‐H, Random, 95% CI)	0.17 [0.01, 3.27]
2.3 Malignancy (PTLD) up to five years	1	132	Risk Ratio (M‐H, Random, 95% CI)	1.89 [0.51, 6.98]
3 Kidney function Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

3.1 Creatinine clearance (mL/min) up to five years	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. Steroid withdrawal versus maintenance in children

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Comparison 5. Publication bias

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Funnel plots Show forest plot	20	5288	Risk Ratio (M‐H, Fixed, 95% CI)	1.36 [1.15, 1.62]

1.1 Death, steroid withdrawal versus maintenance	10	1913	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.39, 1.29]
1.2 Acute rejection steroid withdrawal versus maintenance	10	1913	Risk Ratio (M‐H, Fixed, 95% CI)	1.55 [1.28, 1.87]
1.3 Death, steroid avoidance versus maintenance	10	1462	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.52, 1.63]

Comparison 5. Publication bias

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