No abstract

Complement inhibitors have not been thoroughly evaluated in the treatment of acute antibody‐mediated rejection (ABMR). We performed a prospective, single‐arm pilot study to investigate the potential effects and safety of C1 inhibitor (C1‐INH) Berinert added to high‐dose intravenous immunoglobulin (IVIG) for the treatment of acute ABMR that is nonresponsive to conventional therapy. Kidney recipients with nonresponsive active ABMR and acute allograft dysfunction were enrolled between April 2013 and July 2014 and received C1‐INH and IVIG for 6 months (six patients). The primary end point was the change in eGFR at 6 months after inclusion (M+6). Secondary end points included the changes in histology and DSA characteristics and adverse events as evaluated at M+6. All patients showed an improvement in eGFR between inclusion and M+6: from 38.7 ± 17.9 to 45.2 ± 21.3 mL/min/1.73 m2 (p = 0.0277). There was no change in histological features, except a decrease in the C4d deposition rate from 5/6 to 1/6 (p = 0.0455). There was a change in DSA C1q status from 6/6 to 1/6 positive (p = 0.0253). One deep venous thrombosis was observed. In a secondary analysis, C1‐INH patients were compared with a similar historical control group (21 patients). C1‐INH added to IVIG is safe and may improve allograft function in kidney recipients with nonresponsive acute ABMR.

BACKGROUND. In patients with lymphoma who had a poor prognosis, pretransplantation 18‐fluorodeoxyglucose (FDG)‐positron‐emission tomography (PET) was important for the evaluation of response and outcome. However, little is known about the correlation of FDG‐PET with post‐transplantation PET. The current study was designed to ascertain whether positive pretransplantation PET images are modified by the conditioning regimen. METHODS. Sixty consecutive patients who had achieved remission and underwent consolidation by autologous stem cell transplantation (ASCT) had PET images obtained before ASCT (after 3 or 4 chemotherapy cycles) and 100 days after ASCT. The correlation was explored between the presence of abnormal 18‐FDG uptake (PET positive) or its absence (PET negative) and patient outcomes. RESULTS. Before ASCT, 31 patients achieved complete remission (CR), and 23 patients achieved uncertain CR. Before ASCT, 44 patients (75%) were had negative PET images; and, after ASCT, 48 patients (80%) had negative PET images. One year after ASCT, the estimated event‐free survival (EFS) rate was 80% in patients who had negative pre‐ASCT PET images compared with 43% in patients who had positive pre‐ASCT PET images (P = .0002). The EFS rate was 81% in patients who had negative post‐ASCT PET images compared with 25% in patients who had negative post‐ASCT PET images (P < .0001). In multivariate analysis, only the results for pre‐ and post‐ASCT PET images retained prognostic value, with relative risks of failure estimated at 4.9 and 11.9, respectively. CONCLUSIONS. A positive pre‐ASCT PET image indicated a high risk of ASCT failure, which was increased by a positive post‐ASCT PET image. For patients with lymphoma who have positive pre‐ASCT PET images, more investigations using new treatment approaches will be required. For patients who have negative pre‐ASCT PET images, obtaining post‐ASCT PET images does not seem to be mandatory. Cancer 2007. © 2007 American Cancer Society.

The large proportion of nonspecific AEs reported in active-drug recipients of RPCCTs, including serious and drug-related AEs, highlights the limitations of clinical trial data to determine the tolerability of drugs. Copyright © 2017 John Wiley & Sons, Ltd.