The effectiveness and safety of rituximab as induction therapy in ABO-compatible non-sensitized renal transplantation: a systematic review and meta-analysis of randomized controlled trials

Figures & data

Table 1. Main characteristics of the studies included in this meta-analysis.

	Van den Hoogen et al.9	Tyden et al.10	Clatworthy et al.11	Tsai et al.12
Country	Netherlands	Sweden	UK	Taiwan
Year	2015	2009	2009	2009
Patients	KTx recipients from either living or deceased ABO compatible donor; PRA <85%	KTx recipients from either living or deceased donor; PRA <50%	KTX recipients; inclusion criteria not reported	HLA-mismatched KTx recipients; PRA <20%
Total number	281	140	13	46
Outcome assessment period	6 months for most outcomes; 24 months for malignancy	6 months	3 months	6 months
Randomization	Adequate	Adequate	NR	NR
Double blinding	Yes	Yes	No	NR
RTX group	A single dose of rituximab 375 mg/m^2 IV during surgery	A single dose of rituximab 375 mg/m^2 within 24 h before revascularization	Rituximab 10 mg/kg (day 0 and day 7) and methylprednisolone 10 mg/kg (day 0 and day 7 before rituximab)	Group 1: A single dose of rituximab 375 mg/m^2 before transplant reperfusion Group 2: A single dose of rituximab 375 mg/m^2 before transplant reperfusion + mycophenolate 1000–2000 mg/d
Control group	Placebo	Placebo	Daclizumab 1 mg/kg (day 0 and day 7)	Mycophenolate 1000–2000 mg/d
Baseline immunosuppression	Prednisolone, tacrolimus, mycophenolate	Prednisolone, tacrolimus, mycophenolate	Tacrolimus, mycophenolate	Steroid tacrolimus
Prophylaxis for infection	Valganciclovir, bactrim	Valganciclovir, bactrim	NR	NR
RR for acute rejection	0.79 (0.48–1.29)	0.67 (0.29–1.53)	5.83 (0.92–37.08)	Group 1 vs control 0.80 (0.21–3.00) Group 2 vs control 0
RR for graft loss	0.51 (0.18–1.47)	1.00 (0.06–15.66)	NR	NR
RR for mortality	0.51 (0.13–2.02)	1.00 (0.06–15.66)	NR	Group 1 or 2 vs control 0
RR for infection	1.03 (0.86–1.23)	0.70 (0.28–1.73)	NR	Group 1 or 2 vs control 0
RR for malignancy	1.03 (0.40–2.66)	NR	NR	NR
RR for leukopenia	13.38 (3.24–55.29)	3.00 (0.32–28.13)	NR	NR
Quality assessment  (Jadad scale)	5	5	3	Cannot assessed because of information only from abstract

Figure 1. Forest plot of included RCTs comparing risk of biopsy-proven acute rejection in recipients with rituximab induction versus control; square data markers, RRs; horizontal lines, 95% CIs, with marker size reflecting statistical weight of study using random-effects meta-analysis. Diamond data markers, overall RRs and 95% CIs for outcomes of interest. IV, inverse variance; SE, standard error.

Figure 2. Forest plot of included RCTs comparing risk of biopsy-proven acute rejection in recipients with rituximab induction versus placebo; square data markers, RRs; horizontal lines, 95% CIs, with marker size reflecting statistical weight of study using random-effects meta-analysis. Diamond data markers, overall RRs and 95% CIs for outcomes of interest. IV, inverse variance; SE, standard error.

van den Hoogen MW, Kamburova EG, Baas MC, et al. Rituximab as induction therapy after renal transplantation: A randomized, double-blind, placebo-controlled study of efficacy and safety. Am J Transplant. 2015;15:407–416

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Tyden G, Genberg H, Tollemar J, et al. A randomized, doubleblind, placebo-controlled, study of single-dose rituximab as induction in renal transplantation. Transplantation. 2009;87:1325–1329

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Clatworthy MR, Watson CJ, Plotnek G, et al. B-cell-depleting induction therapy and acute cellular rejection. N Engl J Med. 2009;360:2683–2685

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Tsai MK, Lee CY, Yang CY, Yeh CC, Hu RH, Lee PH. Rituximab induction therapy provided additional immunosuppressive effect and functional benefit to non-sensitized renal transplant recipients. Am J Transplant. 2012;12:319

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