Mycophenolate mofetil versus methotrexate for prevention of graft‐versus‐host disease in people receiving allogeneic hematopoietic stem cell transplantation

Mohamed Kharfan‐Dabaja; Rahul Mhaskar; Tea Reljic; Joseph Pidala; Janelle B Perkins; Benjamin Djulbegovic; Ambuj Kumar

doi:10.1002/14651858.CD010280.pub2

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Figure 1

Study flow diagram.

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Figure 2

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

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Figure 3

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

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Analysis 1.1

Comparison 1 Mycophenolate mofetil versus methotrexate, Outcome 1 Prevention of acute GVHD grade II to IV.

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Analysis 1.2

Comparison 1 Mycophenolate mofetil versus methotrexate, Outcome 2 Overall survival.

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Analysis 1.3

Comparison 1 Mycophenolate mofetil versus methotrexate, Outcome 3 Time to neutrophil engraftment.

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Analysis 1.4

Comparison 1 Mycophenolate mofetil versus methotrexate, Outcome 4 Time to platelet engraftment.

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Analysis 1.5

Comparison 1 Mycophenolate mofetil versus methotrexate, Outcome 5 Incidence of relapse.

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Analysis 1.6

Comparison 1 Mycophenolate mofetil versus methotrexate, Outcome 6 Nonrelapse mortality.

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Analysis 1.7

Comparison 1 Mycophenolate mofetil versus methotrexate, Outcome 7 Prevention of chronic GVHD.

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Analysis 1.8

Comparison 1 Mycophenolate mofetil versus methotrexate, Outcome 8 Incidence of severe mucositis.

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Analysis 1.9

Comparison 1 Mycophenolate mofetil versus methotrexate, Outcome 9 Use of total parenteral nutrition.

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Analysis 1.10

Comparison 1 Mycophenolate mofetil versus methotrexate, Outcome 10 Incidence of narcotic use for pain control.

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Summary of findings for the main comparison. Mycophenolate mofetil versus methotrexate for prevention of graft‐versus‐host disease in people receiving allogeneic hematopoietic stem cell transplantation

Mycophenolate mofetil versus methotrexate for prevention of graft‐versus‐host disease in people receiving allogeneic hematopoietic stem cell transplantation
Patient or population: people receiving allogeneic hematopoietic stem cell transplantation Settings: inpatients/hospital Intervention: mycophenolate mofetil versus methotrexate
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Methotrexate	Mycophenolate mofetil
Overall survival			HR 0.73 (0.45 to 1.17)	129 (2 studies)	⊕⊕⊝⊝ low^1,3
Prevention of acute GVHD grade II to IV	Study population		RR 1.25 (0.75 to 2.09)	174 (3 studies)	⊕⊝⊝⊝ very low^1,2,3
	595 per 1000	744 per 1000 (446 to 1000)
	Moderate⁵
	368 per 1000	460 per 1000 (276 to 769)
Incidence of relapse	Study population		RR 0.84 (0.52 to 1.38)	129 (2 studies)	⊕⊕⊝⊝ low^1,3
	348 per 1000	293 per 1000 (181 to 481)
	Moderate⁵
	386 per 1000	324 per 1000 (201 to 533)
Nonrelapse mortality	Study population		RR 1.21 (0.62 to 2.36)	89 (1 study)	⊕⊕⊝⊝ low^1,4
	255 per 1000	309 per 1000 (158 to 603)
	Moderate⁵
	255 per 1000	309 per 1000 (158 to 602)
Prevention of chronic GVHD	Study population		RR 0.92 (0.65 to 1.3)	129 (2 studies)	⊕⊕⊝⊝ low^1,3
	500 per 1000	460 per 1000 (325 to 650)
	Moderate⁵
	539 per 1000	496 per 1000 (350 to 701)
Incidence of severe mucositis	Study population		RR 0.48 (0.32 to 0.73)	174 (3 studies)	⊕⊕⊝⊝ low^1,3
	557 per 1000	267 per 1000 (178 to 407)
	Moderate⁵
	579 per 1000	278 per 1000 (185 to 423)
Use of total parenteral nutrition	Study population		RR 0.48 (0.26 to 0.91)	129 (2 studies)	⊕⊕⊝⊝ low^1,3
	606 per 1000	291 per 1000 (158 to 552)
	Moderate⁵
	614 per 1000	295 per 1000 (160 to 559)
Incidence of narcotic use for pain control	Study population		RR 0.76 (0.63 to 0.91)	129 (2 studies)	⊕⊕⊝⊝ low^1,3
	909 per 1000	691 per 1000 (573 to 827)
	Moderate⁵
	921 per 1000	700 per 1000 (580 to 838)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. 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; GVHD: graft‐versus‐host disease; HR: hazard ratio; RR: risk ratio.
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 Only one of the included articles described an adequate method of generation of randomization sequence and reported an adequate concealment of the sequence of allocation (Perkins 2010). The trials conducted by Kiehl et al. and Perkins et al. were open‐label trials. ² The pooled estimate has wide confidence intervals, which reflects lower precision of the estimate. ³ Only three RCTs are published comparing mycophenolate mofetil versus methotrexate which reflects potential publication bias. ⁴ Data were reported in only one RCT. ⁵ Generated by GRADEpro software based on event rate in the control arm of included studies.

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Comparison 1. Mycophenolate mofetil versus methotrexate

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prevention of acute GVHD grade II to IV Show forest plot	3	174	Risk Ratio (M‐H, Random, 95% CI)	1.25 [0.75, 2.09]

2 Overall survival Show forest plot	2	129	Hazard Ratio (Random, 95% CI)	0.73 [0.45, 1.17]

3 Time to neutrophil engraftment Show forest plot	2	129	Hazard Ratio (Random, 95% CI)	0.77 [0.51, 1.17]

4 Time to platelet engraftment Show forest plot	2	129	Hazard Ratio (Random, 95% CI)	0.87 [0.81, 0.93]

5 Incidence of relapse Show forest plot	2	129	Risk Ratio (IV, Random, 95% CI)	0.84 [0.52, 1.38]

6 Nonrelapse mortality Show forest plot	1	89	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.62, 2.36]

7 Prevention of chronic GVHD Show forest plot	2	129	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.65, 1.30]

8 Incidence of severe mucositis Show forest plot	3	174	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.32, 0.73]

9 Use of total parenteral nutrition Show forest plot	2	129	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.26, 0.91]

10 Incidence of narcotic use for pain control Show forest plot	2	129	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.63, 0.91]

Comparison 1. Mycophenolate mofetil versus methotrexate

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