Humanized anti-CD25 monoclonal antibody as a salvage therapy for steroid-refractory acute graft-versus-host disease after hematopoietic stem cell transplantation / 中华血液学杂志

Objective: To investigate the efficacy of humanized anti-CD25 monoclonal antibody for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients. Methods: A total of 64 patients with SR-aGVHD between June 2019 and October 2020 in Suchow Hopes Hematology Hospital were enrolled in this study. Humanized anti-CD25 monoclonal antibodies 1 mg·kg(-1)·d(-1) were administered on days 1, 3, and 8, and then once per week according to the disease progression. Efficacy was assessed at days 7, 14, and 28 after humanized anti-CD 25 treatment. Results: Of the 64 patients with a median age of 31 (15-63) years, 38 (59.4%) were male and 26 (40.6%) were female. The overall response (OR) rate of the humanized CD25 monoclonal antibody in 64 patients with SR-aGVHD on days 7, 14, and 28 were 48.4% (31/64), 53.1% (34/64), and 79.7% (51/64), respectively. Liver involvement is an independent risk factor for poor efficacy of humanized CD25 monoclonal antibody for SR-aGVHD at day 28 (OR=9.588, 95% CI 0.004-0.291, P=0.002). The median follow-up time for all patients was 17.1 (0.2-50.8) months from the start of humanized CD25 monoclonal antibody therapy. The 1- and 2-year OS rates were 63.2% (95% CI 57.1% -69.3%) and 52.6% (95% CI 46.1% -59.1%), respectively. The 1- and 2-year DFS rates were 58.4% (95% CI 52.1% -64.7%) and 49.8% (95% CI 43.4% -56.2%), respectively. The 1- and 2-year NRM rates were 28.8% (95% CI 23.1% -34.5%) and 32.9% (95% CI 26.8% -39.0%), respectively. The results of the multifactorial analysis showed that liver involvement (OR=0.308, 95% CI 0.108-0.876, P=0.027) and GVHD grade Ⅲ/Ⅳ (OR=9.438, 95% CI 1.211-73.577, P=0.032) were independent risk factors for OS. Conclusion: Humanized CD25 monoclonal antibody has good efficacy and safety for SR-aGVHD. This study shows that SR-aGVHD with pretreatment grade Ⅲ/Ⅳ GVHD and GVHD involving the liver has poor efficacy and prognosis and requires early intervention.

Anti-CD25 monoclonal antibody as a salvage therapy for steroid-refractory acute graft-versus-host disease in 80 patients receiving allogeneic hematopoietic stem cell transplantation / 中华内科杂志

Objective To investigate the efficacy of anti-CD25 monoclonal antibody for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients.Methods A total of 80 patients with SR-aGVHD from January 1st 2012 to December 31st 2016 were enrolled in this study.Acute GVHD were classified as classic aGVHD (n=72) and late-onset aGVHD (n=8).Anti-CD25 monoclonal antibodys (mAb) were administrated on days 1,4,8,15,and 22.The efficacy of anti-CD25 mAb was evaluated at day 28 after the initial treatment.The associated factors of clinical outcome were analyzed.Results The overall response (OR) rate of anti-CD25 mAb was 75％ (60/80),with complete response (CR) rate,partial response (PR) rate and no response(NR) rate 52.5％ (42/80),22.5％ (18/80),and 25％ (20/80),respectively.GVHD-relapse was not observed with a median follow-up time of 394.5 days (range,12-1 761 days).The 6-month overall survival (OS) rate was 68.4％ (95％CI 63.2％-73.6％).The 1-year OS rate was 63.1％ (95％CI 57.6％-68.6％),and 2-years OS rate was 50.7％ (95％CI 44.3％-57.1％).Non-relapse mortality (NRM) rate of 1 and 3 years was 32.6％ (95％CI 27.2％-38％) and 41.7％ (95％CI 35.3％-48.1％),respectively.The 1 and 2 years cumulative incidence of chronic graft versus host disease (cGVHD) was 32.9％ (95％CI 26.4％-39.4％) and 38.9％ (95％CI 31.8％-46.0％).By univariate and multivariate analysis,liver involvcment was an independent poor risk factor of SR-aGVHD (OR=4.66,95％ CI 1.145-18.962,P=0.032).Conclusion Anti-CD25 mAb serves as an alternative and effective salvage therapy for SR-aGVHD at present.Liver involvement is a predictive factor of poor response in patients with SR-aGVHD.

CD25 Monoclonal Antibody (Basiliximab) Used in High Risk Kidney Recipient (Single Center Experience) / 대한이식학회지

PURPOSE: CD25 monoclonal antibody (basiliximab, BA) has been reported an excellent effect on induction immunosuppression than ALG, ATG, OKT3 in renal transplantation. Since we can use BA only in the group of high risk kidney recipient, we want to evaluate the effect of BA treated group by comparing with conventional 3 drugs combination group (calcineurin inhibitor/cyclosporine or tacrolimus, mycophenolate mofetil and prednisolon). METHODS: Total 103 recipients were treated by BA and conventional 3 drugs from March 2000 through February 2006, and these cases were compared with 122 recipients without BA. Government guidelines for using BA were in cadaveric transplantation, more than 4 HLA mismatching, zero DR antigen matching, retransplantation and more than 80% positive PRA. The episode of acute rejection (AR), steriod resistant acute rejection, change of serum creatinine, maintaining dosage of calcineurin inhibitor (CNI) and other side effects were compared between groups. RESULTS: The rate of AR within 12 months after transplantation was 11.7% in BA group while 9.0% in control group (P=0.451). The steroid resistant acute rejection was 16.6% in BA group and 27.3% in control group (P=0.119). Rejection free graft survival adjusted various clinical risk factors by Cox-regression test were no significance between groups. Serum creatinine level at one year after transplantation was 1.61+/-.1 and 1.46+/-.7 mg/dL in BA and control group, and recipients number whose SCr over 1.5 mg/dL were 39.0% and 32.7% (P=0.326). Cyclosporin dosage at one year in BA and control group were 4.21 and 3.62 mg/kg (P=0.202) and 0.11 and 0.17 mg/kg in tacrolimus group (P=0.291). Incidence of PTDM and viral infection were all no difference statistically between groups. CONCLUSION: In conclusion, BA induction immunosuppression with CNI, mycophenolate mofetil and prednisolon used in high risk kidney recipient effectively control the acute rejection and steroid resistant acute rejection for one year at least the same as control group. But since there was no more beneficial effect in BA added to Tac group than conventional Tac based immunosuppression, this 4 drug combination is better avoided if possible.

Evaluation of anti-CD25 monoclonal antibody to prevent acute rejection after renal transplantation / 中国免疫学杂志

Objective:To investigate the effect of anti-CD25 monoclonal antibody in preventing acute rejection after renal transplantation.Methods:71 patients were randomly divided into two groups;treatment gourp( n =26)and control group( n =45).The treatment group received anti-CD25 monoclonal antibody twice before and after renal transplantation.The occurrence of rejection postoperation and renal function and T lymphocyte subtypes were sequentially monitored.Results:The occurrence of aute rejection in treatment group in 1,3,6 and 12 months after renal transplantation was 7.7% ,19.2%,23.1% and 30.8%,while it was 15.6%,28.9%,35.6% and 46.7% in control group.There was significant difference between the two groups( P0.05 ).Conclusion:It suggests that anti-CD25 monoclonal antibody reduce the occurrence of acute rejection and have no influence on T lymphocyte subtypes.