Belatacept in renal transplantation in comparison to tacrolimus and molecular understanding of resistance pattern: Meta-analysis and systematic review

Table 2 Characteristics of included studies

Ref.	Study design	Donor type	Belatacept based (group 1)	Tacrolimus based (group 2)	Belatacept based (group 3)
Ferguson et al[33], 2011	Multicentre, prospective, randomized (93 patients, 1 yr)	Living and deceased	Belatacept 10 mg/kg on day 1 and 5, then once every 2 wk through 3 mo, every 4 wk through 6 mo and 5 mg/kg from 7 mo onwards; MMF: 1 mg twice daily; Induction: Thymoglobulin + Corticosterids	Tac 0.2 mg/kg divided into two doses; Tac 0.2 mg/kg divided into two doses; Induction: Thymoglobulin + Corticosterids	Belatacept 10 mg/kg on day 1 and 5, then once every 2 wk through 3 mo, every 4 wk through 6 mo and 5 mg/kg from 7 mo onwards; SRL initiated on day 1 and dose level 7-12 ng/mL. Induction: Thymoglobulin + Corticosterids
de Graav et al[34], 2017	Single centre, prospective, randomized (40 patients, 1 yr)	Living	Belatacept 10 mg/kg on day 0, 4, 15, 30, 60, 90 d of transplant, following that 5 mg/kg till 12 mo	Tac 0.2 mg/kg divided into two doses. Target concentration 10 to 15 ng/mL (week 1-2); 8 to 12 ng/mL (week 3-4); 5-10 ng/mL (week > 5)	NA
Newell et al[35], 2017	Multicentre, prospective, randomized (19 patients, 1 yr)	Living and deceased	Belatacept 10 mg/kg on day 0 (day of transplant) and then on days 4, 14, 28, 56, and 84. After day 84, participants received a maintenance dose of 5 mg/kg every 4 wk until completion of the trial; MMF: 1 mg twice daily; Induction: Thymoglobulin, rapid methylprednisolone taper	Tac 0.1 mg/kg divided into two doses; Target concentration8 to 12 ng/mL (week 24), then 5 to 8 ng/mL (week > 24); MMF: 1 mg twice daily; Induction: Thymoglobulin, rapid methylprednisolone taper	Belatacept 10 mg/kg on day 0 (day of transplant) and then on days 4, 14, 28, 56, and 84. After day 84, participants received a maintenance dose of 5 mg/kg every 4 wk. Tac 0.1 mg/kg divided into two doses then adjusted to target trough levels: 8-12 ng/mL by Day 29, 5-8 ng/mL by Day 57, 3-5 ng/mL by Day 85 then stopped. MMF: 1 mg twice daily; Tac: 5 to 8 ng/mL (till 24 wk); Induction: Basiliximab + Corticosteroids
Trial 1856257[36], 2017	Multicentre, prospective, randomized (69 patients, 1 yr)	Living and deceased	Belatacept 10 mg/kg on day 1 (24 h of transplant) and then on days 5, 14, 28, 56, and 84. MMF: 1 mg twice daily; Induction: Thymoglobulin + Corticosteroids	Tac started on day 0/1; Target concentration 8 to 12 ng/mL (week 24), then 5 to 8 ng/mL (week > 24); MMF: 1 mg twice daily; Induction: Thymoglobulin + Corticosteroids	Belatacept 10 mg/kg on day 1 (24 h of transplant) and then on days 5, 14, 28, 56, and 84. Tac started on day 0/1; Target concentration 8 to 12 ng/mL (day 1-84) and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/mL at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. MMF: 1 mg twice daily; Induction: Basiliximab + Corticosteroids + Tac

MMF: Mycofenolate mofetil; NA: Not applicable; SRL: Sirolimus; Tac: Tacrolimus.