Refs. | ABMR definition | Trial design and intervention (N) | Patients with hemodialysis dependency or graft loss (intervention vs. control) |
---|---|---|---|
Böhmig et al (123) | Banff 1997 | Stratified RCT; 9–14 sessions of immunoadsorption (protein A) | Treatment benefit observed: |
0 vs. 4 at 3 weeks | |||
ARR = 0.8 (95% CI, 0.2–0.9) | |||
Blake et al (124) | Vascular | Stratified RCT; 5 PP treatments | No treatment benefit: |
4 vs. 6 at 6 months; RRR = 0.3 (95% CI, 0.001–0.8) | |||
10 vs. 13 at 5 years; RRR = 0.2 (95% CI, 0.001–0.5) | |||
Bonomini et al (125) | Vascular, MP-resistant | RCT; 3–7 PP treatments | Treatment benefit observed: |
7 vs. 17 at 2 weeks; RRR = 0.6 (95% CI, 0.3–0.8) | |||
Kirubakaran et al (126) | Vascular | RCT; 8 PP treatments | Trend to harm: |
6 vs. 3 at 1 month; RRI = 0.5 (95% CI, 0.001–0.8) | |||
Allen et al (127) | Vascular, MP-resistant | RCT; 6 PP treatments | No treatment benefit (trend to harm at 220 days): |
3 vs. 4 at 6 days; RRR = 0.2 (95% CI, 0.001–0.8) | |||
11 vs. 9 at 220 days; RRI = 0.2 (95% CI, 0.001–0.5) | |||
Franco et al (128) | Vascular, MP-resistant | Historical control; 6 PP treatments | Treatment benefit observed: |
6 vs. 13 at 3 months; OR = 0.4 (95% CI, 0.1–1.3) | |||
Lefaucheur et al (129) | Banff 1997 | Historical control; 4 PP treatments; 2 rituximab doses | Treatment benefit observed: |
1 vs. 6 at 3 years; OR = 0.1 (95% CI, 0.008–0.9) | |||
Kaposztas et al (130) | ALG-resistant | Historical control; rituximab | Treatment benefit observed: |
2 vs. 8 at 2 years; OR = 0.2 (95% CI, 0.04–1.09) | |||
Vangelista et al (131) | Vascular, anti-HLA | Nonrandomized case-controlled; 4–5 PP treatments | Treatment benefit observed: |
1 vs. 3 | |||
Macaluso et al (132) | ABMR (no other details) | Nonrandomized, case-controlled; 4 doses of bortezomib, 1 dose of rituximab, 5 PP treatments | Treatment benefit observed: |
1 vs. 10 at 3 months; OR = 0.1 (95% CI, 0.01–0.9) | |||
Loupy et al (45) | Vascular with DSA | Nonrandomized, case-controlled; OKT3 vs. IVIG vs. PP and rituximab | Treatment benefit observed for PP and rituximab: |
HR = 0.19 (vs. OKT3) | |||
HR = 0.11 (vs. IVIG) | |||
Lubetzky (133) | With DSA | Nonrandomized, case-controlled; rituximab vs. bortezomib | Treatment benefit observed for bortezomib: |
3 vs. 1 at 6 months; OR = 5.3 (95% CI, 0.5–59.3) | |||
Waiser et al (134) | With DSA | Historical cohort; 4 bortezomib doses vs. 1 rituximab dose, 6 PP treatments and 30 g IVIG | No treatment benefit: |
2 vs. 3 (at 6 months); OR = 0.5 (95% CI, 0.06–4.0) |
ABMR, antibody-mediated rejection; ALG, antilymphocyte globulin; ARR, absolute risk reduction; CI, confidence interval; DSA, donor-specific antibodies; HR, hazard ratio; IVIG, intravenous immunoglobulin; MP, methylprednisolone; OR, odds ratio; PP, plasmapheresis; RCT, randomized controlled trial; RRI, relative risk increase; RRR, relative risk reduction; RRI, relative risk increase.
Table 1Adapted with permission from Roberts et al 122.