Table 3.
Study results.
| Author and Year | Average (SD) # IC infusions in interventional group vs comparison group | Average IEQ/kg (SD) with infusion interventional vs comparison group |
Difference in IEQ/kg or # of infusions | II | HbA1c (%) | Infection |
|---|---|---|---|---|---|---|
| Allotransplant | ||||||
|
ETA |
|
|
|
|
|
|
| Hering 200511 | 1 (0) | 7271 (1035) | - | 12mo: 100% (8/8); >12mo: 62.5% (5/8) | Pre-txp range 6.6 ± 1.1 to 8.3 ± 1.1 vs post-txp range 5.3 ± 0.5 to 6.0 ± 0.5 | 0/8 |
| Bellin 200812 | 1.9 (0.4) | 6476 (2203.7) | - | 12mo: 83% (5/6); 24mo: 66.7% (4/6) | 24mo: 6.0 ± 0.7; those achieved II: 5.6 ± 0.2 | 0/6 |
| Faradji 200810 | - | SI: 5613 (485) vs 8713 (2123) | - | 18mo: ETA group 100% (4/4) vs non-ETA group 20% (1/5) (p = 0.04); II duration over the 18mo: ETA group >non-ETA group per survival curve comparison (p = 0.025) | 18mo: ETA 6.2 ± 0.08 vs non-ETA 7.05 ± 0.55 | - |
| Froud 200813 | 1.7 (0.6) vs 1.8 (0.4) | 7352.6 (4303.8) vs 7204.9 (1953.1) | Cumulative IEQ/kg: ETA 12,554.3 ± 7173 vs non-ETA 13,058.8 ± 3540 (p = 0.92) | 3mo: ETA 66.7% (2/3) vs non-ETA 87.5% (14/16) | 24mo: ETA 5.1 ± 0.15 vs non-ETA 6.3 ± 0.12 pmol/mL (p < 0.01) | 0/3 |
| Gangemi 20088 | 1.3 (0.5) vs 2.5 (0.6) | 8612.1 (2605.3) vs 9754.1 (4023.2) | Total IEQ to achieve II: ETA 537,495 ± 190,968 with 1 infusion vs non-ETA 1,460,080 ± 418 330 in 2 (n = 2) or 3 (n = 2) infusions (p = 0.028) | 15mo: ETA 66.7% (4/6) vs non-ETA 100% (4/4) | Lower in both groups from baseline (p = 0.001), ETA 7.8 ± 1.0 to 6.1 ± 0.3 (after 1 infusion) vs non-ETA 6.5 ± 0.6 to 5.6 ± 0.2 (after ≥2 infusions) | ETA 1/6 vs non-ETA 0/4 |
| Koh 201014 | 1.1 (0.2) | 6076 (492) vs 9071 (796) | - | ATG + ETA 82.6% (11/13) vs DAC 100% (4/4) (p = 1.) | Pre-SI 7.0 ± 0.2 vs post-SI 6.1 ± 0.2% (p = 0.005) | - |
|
Rickels 20139 |
1.4 (0.5) vs 1.8 (0.4) |
6952.0 (517.7) vs 7951.7 (1242.8) |
Proportion of group with 2 infusions: ETA 36.4% (4/11) vs non-ETA 80% (4/5) (p < 0.05); Total IEQ/kg: ETA 9480 ± 706 vs non-ETA 14313 ± 2237 (p < 0.05) |
12mo: ETA 100% (9/9) vs non-ETA 20% (1/5) |
- |
- |
|
INF |
|
|
|
|
|
|
|
Froud 200515 |
1.9 (0.4) vs 1.8 (0.5) |
6702.4 (2040) vs 7683.8 (1861.2) |
- |
14/14 (100%), 2 did not complete study protocol; II without SI at 12mo: 79% (11/14); II without SI at 18mo: 43% (6/14) |
Normalized in 8 patients with sustained II over 3y |
2/16 including parvovirus anemia, aspiration pneumonia |
|
ETA + ANA |
|
|
|
|
|
|
| Matsumoto 201116 | 1 (0) vs 2 (0) | 11811.8 (1833.2) vs 8119.7 (1018.1) | Total IEQ/infusion: ANA 720522 ± 111826 vs non-ANA 552138 ± 69233 (p = 0.22) | SUITO index at 1mo: ANA 49.6 ± 8.3 vs non-ANA 19.3 ± 6.3 (p < 0.05) | Insulin free: ANA 5.9 ± 0.1 vs non-ANA 5.7 ± 0.3 (p = 0.68) | - |
|
Takita 201217 |
1.25 (0.5) vs 2 (0) |
10953 (1015) vs 8158 (2091) |
ETA+ANA 10953 ± 1015 vs ETA 1st infusion 7881 ± 1753, 2nd infusion 8435 ± 2429 (p = 0.48) |
- |
- |
0/8 opportunistic infection; 2/8 upper respiratory |
|
ETA Long-term Follow-up |
|
|
|
|
|
|
| Bellin 201219 | 1.3 (0.5) vs 2.1 (0.8) | 7298.7 (546.8) vs 6688.9 (343.2) | Cumulative IEQ: Group 1 (intervention group) <Group 2, 3, and 4 (historical CITR groups) (p < 0.01) | II significantly lower at every time point in ATG group without TNF blocker vs ATG with TNF blocker; II and significantly associated variables per adjusted analysis: TNF blocker (p = 0.03) | - | - |
|
Qi 201420 |
1.8 (1.0) vs 2.5 (0.6) |
8237 (2308.1) vs 9754.1 (4023.2) |
Total IEQ/kg: ETA 16414 ± 9423 vs non-ETA 24385 ± 14209 (p = 0.85) |
100% (10/10), ETA needed 1 SI vs non-ETA ≥2 SI to achieve II; 83.3% (5/6) maintained II in ETA vs 25% (1/4) in non-ETA |
<6% within 6mo: 90% (9/10) |
- |
| Autotransplant | ||||||
|
ETA or ETA + ANA |
|
|
|
|||
| Naziruddin 201818 | 1 (0) vs 1 (0) | ETA – 5384 (3104); ANA + ETA – 5352 (3145) vs CTL 5424 (3592) | ETA 5384 ± 3104 vs ANA + ETA 5352 ± 3145 vs CTL 5424 ± 3592 (p = 0.99) | SUITO at 6mo: ANA + ETA>ETA (p = 0.035), ANA + ETA no difference from CTL (p = 0.103) | 6mo: ETA<CTL (p < 0.05), ANA + ETA<CTL (p < 0.05), no difference at other time points | - |
Abbreviations: ANA, anakinra; ATG, antithymocyte globulin; CITR, Collaborative Islet Transplant Registry; CTL, control; DAC, daclizumab; ETA, etanercept; HbA1c, hemoglobin A1c; IC, islet cells; II, insulin independence; mo, months; SD, standard deviation; SI, supplemental infusion; SUITO, secretory unit of islet transplant objects; txp, transplant; y, year