Zinbryta (daclizumab) / Biogen, AbbVie - LARVOL DELTA

SHORT-TERM SUBSTITUTION OF CALCINEURIN INHIBITORS (CNIS) WITH RECOMBINANT HUMANIZED ANTI-CD25 MONOCLONAL ANTIBODY (DACLIZUMAB) AS AGVHD PROPHYLAXIS IN CNIS INTOLERANT PATIENTS AFTER ALLO-HSCT (EBMT 2025) - "When CNI intolerance occurs during allo-HSCT, short-term replacement with Daclizumab can be used as an alternative to prevent aGVHD. Clinical Trial Registry: N/A"

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Infectious Disease • Nephrology • Oncology • Solid Organ Transplantation • Transplant Rejection

SHORT-TERM SUBSTITUTION OF CALCINEURIN INHIBITORS (CNIS) WITH RECOMBINANT HUMANIZED ANTI-CD25 MONOCLONAL ANTIBODY (DACLIZUMAB) AS AGVHD PROPHYLAXIS IN CNIS INTOLERANT PATIENTS AFTER ALLO-HSCT (EBMT 2025) - "When CNI intolerance occurs during allo-HSCT, short-term replacement with Daclizumab can be used as an alternative to prevent aGVHD. Clinical Trial Registry: N/A"

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Infectious Disease • Nephrology • Oncology • Solid Organ Transplantation • Transplant Rejection

Evolving Patterns of Initial RRMS Treatment in Finland (2013-2022): Insights From a Nationwide Multiple Sclerosis Register. (PubMed, Brain Behav) - "In Finland, the treatment of RRMS has shifted toward earlier diagnosis and earlier initiation of heDMTs, likely improving the prognosis of the patients."

Journal • Retrospective data • CNS Disorders • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease

Identifying Promising Immunomodulators for Type 1 Diabetes (T1D) and Islet Transplantation. (PubMed, J Diabetes Res) - P, P1/2, P2, P2/3, P3, P4 | "FDA-approved teplizumab for Stage 2 T1D is discussed along with other immunomodulators that have been tested in Phase 3 clinical trials or higher, including otelixizumab (another anti-CD3 monoclonal antibody), daclizumab (an anti-CD25 monoclonal antibody), ladarixin (CXCR1/2 inhibitor), and antithymocyte globulin (ATG)...Several immunomodulators involved in Phase 3 clinical studies of islet transplantation are also discussed, including alemtuzumab, basiliximab, etanercept, and reparixin, some already FDA-approved for other uses...This review provides background, mechanism of action, results of completed trials, and adverse effects as well as details regarding ongoing clinical trials for each of these immunomodulators. Trial Registration: ClinicalTrials.gov identifier: NCT03875729, NCT01030861, NCT00129259, NCT00385697, NCT01280682; NCT03929601, NCT04598893, NCT05757713, NCT00678886, NCT01123083, NCT00064714, NCT00468117, NCT04628481,..."

Journal • Review • Diabetes • Immunology • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus • CXCR1

Addition of Daclizumab to Standard Graft-Versus-Host Disease Prophylaxis in Patients with Thalassemia Major Undergoing Transplantation from Alternative Donor Hematopoietic Stem-Cell Transplantation: A Single-Center Retrospective Analysis from China (ASH 2024) - "This study aimed to investigate whether administering Daclizumab at a dose of 1 mg/kg on days +7, +14, +28, and +42, in addition to standard GvHD prophylaxis (tacrolimus [FK506], methotrexate [MTX], and mycophenolate mofetil [MMF]), reduces the incidence of GvHD in TM patients undergoing alternative donor HSCT...The conditioning regimen for all patients included busulfan (Bu, 1mg/kg i.v. 4x daily on days -9 to -6), cyclophosphamide (Cy, 50mg/kg i.v. once daily, days -5 to -2), fludarabine (Flu, 50mg/m² i.v. once daily from days -12 to -10), and anti-thymocyte globulin (ATG, 2.5mg/kg i.v. once daily, days -4 to -1). Sixty-six (39.05%) patients received letermovir in prophylaxis of cytomegalovirus (CMV) infection, including 65 in the Daclizumab group and 1 in the control group...The use of Daclizumab significantly reduced clinically relevant grade 3-4 aGvHD without increasing severe infections or transplant related complications, also improved post-transplant TGFS...."

Retrospective data • Acute Graft versus Host Disease • Beta-Thalassemia • Bone Marrow Transplantation • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Transplantation

Incidence, Patterns, and Outcomes of Fungal Infections in Patients with Graft Versus Host Disease Requiring Systemic Steroids Following Allogeneic Hematopoietic Cell Transplantation (ASH 2024) - "GVHD prophylaxis regimens included cyclosporine (n=116), tacrolimus or sirolimus (n=11), mycophenolate mofetil (MMF, n=125) and daclizumab (n=8). The pooled overall mortality rate due to IFIs was 23.6% (95% CI : 0.06-0.58, I2 =86.3%).CONCLUSION : Invasive fungal infections lead to significant mortality in patients with GVHD, with a higher incidence in acute GVHD as compared to chronic GVHD. Available literature is very heterogeneous, and our findings underscore the need for further research in this area."

Clinical • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Candidiasis • Chronic Graft versus Host Disease • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Respiratory Diseases • Transplantation

Immunomodulators and immunosuppressants for progressive multiple sclerosis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "The number of people with PMS with relapses is probably slightly reduced with rituximab at two years, and interferon beta-1b at three years, compared to placebo. Both drugs are also probably associated with a slightly higher proportion of withdrawals due to adverse events, as are immunoglobulins, glatiramer acetate, natalizumab, fingolimod, siponimod, and ocrelizumab; we have high confidence that this is the case with interferon beta-1a. We found only low or very low certainty evidence relating to disability progression for the included disease-modifying treatments compared to placebo, largely due to imprecision. We are also uncertain about the effect of interventions on serious adverse events, also because of imprecision. These findings are due in part to the short follow-up of the included RCTs, which lacked detection of less common severe adverse events. Moreover, the funding source of many included studies may have introduced bias into the results. Future research on..."

Clinical • Immunomodulating • Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

The short- and long-term outcomes of steroid-free regimen in liver transplantation (TTS 2024) - "At our hospital, the standard immunosuppressive therapy for blood group compatible liver transplantation is a combination of two drugs, calcineurin inhibitor (CNI) and steroids, or three drugs with mycophenolate mofetil (MMF) added to reduce the nephrotoxicity of CNI...Eight patients who received 1 gram of methylprednisolone only intraoperatively and one patient who received daclizumab instead of basiliximab and did not use steroids were also included in the Fr group... Steroid-free immunosuppressive therapy was able to maintain induction of immune tolerance without increasing postoperative acute rejection and de novo malignancies."

Hepatology • Infectious Disease • Oncology • Transplant Rejection • Transplantation

Comparison of ocrelizumab and ofatumumab:Examining clinical characteristics within the first year of market availability (EAN 2024) - "S1P receptor modulators, natalizumab, and daclizumab were the most used pre-OCR treatments, whereas glatiramer acetate, anti-CD20, and cladribine were more frequently prescribed before OFA... Differences in clinical patient characteristics and pretherapy may be explained by the market availability of additional HE-DMTs. PwMS were more often initiated with OCR as the first in-class medication compared to the subsequent OFA. The administration route of OCR (infusion) and OFA (injection) could also impact patient preferences and physician decisions in the future."

Clinical • CNS Disorders • Multiple Sclerosis

Exploration of the Shared Gene Signatures and Molecular Mechanisms between Chronic Bronchitis and Antineutrophil Cytoplasmic Antibody-associated Glomerulonephritis: Evidence from Transcriptome Data. (PubMed, Curr Pharm Des) - "Our study explores the inflammatory-immune pathways underlying CB-associated ANCA-GN and emphasizes the importance of NETs and lymphocyte differentiation, providing novel insights into the shared pathogenesis and therapeutic targets."

Gene Signature • Journal • Chronic Obstructive Pulmonary Disease • Glomerulonephritis • Inflammation • Lupus Nephritis • Nephrology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Vasculitis • ARG2 • CD73 • FKBP5 • HBEGF • HIF1A • IL2 • IL2RG • IRF1 • LYZ • NT5E • PIK3CG • RELA

Comparison of Induction Immunosuppressive Therapies in Adult Liver Transplant Recipients (IHPBA 2024) - "Induction therapy involving either anti-thymocyte globulin (n=4,487, 24.95%), alemtuzumab (n=44, 0.24%) or basiliximab/daclizumab (B/D) (n=13,454, 74.81%) were collected. Prednisone was used as part of a maintenance therapy involving a calcineurin inhibitor or cyclosporine and Mycophenolate mofetil in 12,230 (68%) of patients... Our results offer a comparative analysis of modern induction agents. Those who underwent induction with alemtuzumab experienced lower death rates and reduced risk of graft failure at 10%. B/D induction was associated with longer hospital stays and higher rates of rejection and hospitalization at 1-year post-transplant."

Clinical • Hepatology • Transplantation

Induction therapy in heart transplantation: A systematic review and network meta-analysis for developing evidence-based recommendations. (PubMed, Clin Transplant) - "With low and very low certainty in the synthetized evidence, these NMAs suggest possible superiority of rATG compared to basiliximab, but do not provide compelling evidence for the routine use of these agents in HT recipients."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Transplantation

Two for One: Unilateral Placement of Dual Kidney Transplant (ATC 2024) - "Donor characteristics : age 65 ± 9.6.Cause of death % - Stroke - Trauma 68.3 21.9 KDPI % 94 ±7 Remuzzi 5.8 ± 0.9 4 : 2 patients, 5 : 8 patients 6 : 14 patients 7 : 15 patients FG (ml/min) 57.2 ± 17.3Recipient age (median ± SD, years) 61.7 ± 10.9 Recipient sex (female male) % 48.5% / 51.5%Type of Dialysis Peritoneal dialysis 2, hemo: 37 Time on dialysis (years) 3.8 ± 3.5Immunosuppressive regimen Daclizumab /MF/GC/TAC 7 patients Timog /GC/SIROLIMUS: 6 , Timog/GC/MF/TAC 19 Basiliximab/Belatacept/MF/GC 3 Thymoglobulin/Belatacept/MF/GC 4. Double renal implants are feasible, achieving good results and with reasonable rates of morbidity and mortality. unilateral placement is a safe technique and reduces operation time, avoiding two separate incisions"

Cardiovascular • Hematological Disorders • Infectious Disease • Mood Disorders • Oncology • Septic Shock • Thrombosis • Transplantation • Venous Thromboembolism

Interleukin inhibitors and the associated risk of candidiasis. (PubMed, Front Immunol) - "IL-1 inhibitors (anakinra, canakinumab, and rilonacept), IL-2 inhibitors (daclizumab, and basiliximab), and IL-4 inhibitors (dupilumab) have rarely been associated with Candida infection. In contrast, tocilizumab, an inhibitor of IL-6, has demonstrated an elevated risk in the context of coronavirus disease 2019 (COVID-19) treatment, as evidenced by a 6.9% prevalence of candidemia among patients using the drug...Future prospective studies need to exhaustively investigate candidiasis and its associated risk factors in patients receiving IL inhibitors. Implementing enduring surveillance methods is crucial to ensure IL inhibitors safe and efficient utilization of in clinical settings."

Journal • Review • Candidiasis • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL17A • IL2 • IL23A • IL4 • IL6

The Effect of Induction Therapy on Antibody-Mediated Rejection in Kidney Transplantation: A Network Meta-Analysis Using Recent Data (ISN-WCN 2024) - " We performed a comprehensive search of databases including basiliximab, alemtuzumab, antithymocyte globulin (ATG), and daclizumab as induction regimens for KT from inception to September 1, 2023. ATG is widely used in KT induction regimens. Our study results showed that ATG reduced the risk of AMR in KT recipients when compared with other induction drugs; therefore, it appears to be an efficient choice of induction regimen to reduce AMR after KT."

Retrospective data • Anemia • Antibody-mediated Rejection • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Herpes Zoster • Leukopenia • Myocardial Infarction • Peripheral Arterial Disease • Transplant Rejection • Transplantation • Varicella Zoster

Disease-modifying therapies in managing disability worsening in paediatric-onset multiple sclerosis: a longitudinal analysis of global and national registries. (PubMed, Lancet Child Adolesc Health) - "Treatment of paediatric-onset relapsing-remitting multiple sclerosis with high-efficacy therapy substantially reduces the risk of reaching key disability milestones. This reduction in risk is most pronounced among young people with minimal or mild disability when treatment began. Children with relapsing-remitting multiple sclerosis should be treated early with high-efficacy therapy, before developing significant neurological impairments, to better preserve their neurological capacity."

Journal • Bone Marrow Transplantation • CNS Disorders • Multiple Sclerosis • Pediatrics • Transplantation

The Effect of Induction Therapy on Antibody-Mediated Rejection in Kidney Transplantation: A Network Meta-Analysis Using Recent Data. (PubMed, Transplant Proc) - "ATG is widely used in KT induction regimens. Our results showed that ATG reduced the risk of AMR in KT recipients when compared with other induction drugs; therefore, it appears to be an efficient choice of induction regimen to reduce AMR after KT."

Journal • Retrospective data • Antibody-mediated Rejection • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Herpes Zoster • Leukopenia • Myocardial Infarction • Peripheral Arterial Disease • Transplant Rejection • Transplantation • Varicella Zoster

Evaluation of novel intratumoural oxygen delivery platforms for improving radiotherapy response in hypoxic solid tumours (EACR-AACR 2024) - "Our project aims to develop oxygen-loaded PFCs nanoemulsions for direct intratumoural injection to boost patient response to radiation by alleviating PDAC hypoxia...Increasing viscosity slows down oxygen release and increases nanoemulsion’s retention at site of injection. Our oxygenated nanoemulsions are promising to alleviate hypoxia and effectively enhance radiation response to cells."

Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • HIF1A

Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis. (PubMed, Drug Saf) - "A higher risk of drug-related PML in patients whose immune system is not additionally depressed by means of neoplasms, HIV or concomitant medications is found in the neurological field. This risk is higher in MS treatment, and specifically during long-term natalizumab therapy. While this drug is still routinely prescribed in this field, considering the efficacy in reducing MS relapses, in other areas it could play a smaller role, and be gradually replaced by other safer and more recently approved agents."

Retrospective data • Review • CNS Disorders • Hematological Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Multiple Sclerosis • Oncology • Primary Immunodeficiency • Rare Diseases • Solid Tumor

Non-IL-2-blocking anti-CD25 antibody inhibits tumor growth by depleting Tregs and has synergistic effects with anti-CTLA-4 therapy. (PubMed, Int J Cancer) - "However, marketed anti-CD25 antibodies (Basiliximab and Daclizumab) were originally developed as immunosuppressive drugs to prevent graft rejection, because these antibodies can block IL-2 binding to CD25 on Teffs, which in turn destroys the function of Teffs. Moreover, our findings reveal that the Fab form of h7B7-15S has the ability to deplete Tregs, independent of the Fc region. Taken together, our studies expand the application of anti-CD25 in tumor immunotherapy and provide insight into the underlying mechanism."

Journal • Oncology • Transplant Rejection • IL2

Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "We are highly confident that, compared to placebo, two-year treatment with natalizumab, cladribine, or alemtuzumab decreases relapses more than with other DMTs. We are moderately confident that a two-year treatment with natalizumab may slow disability progression. Compared to those on placebo, people with RRMS treated with most of the assessed DMTs showed a higher frequency of treatment discontinuation due to AEs: we are moderately confident that this could happen with fingolimod, teriflunomide, interferon beta-1a, laquinimod, natalizumab and daclizumab, while our certainty with other DMTs is lower. We are also moderately certain that treatment with alemtuzumab is associated with fewer discontinuations due to adverse events than placebo, and moderately certain that interferon beta-1b probably results in a slight reduction in people who experience serious adverse events, but our certainty with regard to other DMTs is lower. Insufficient evidence is available to evaluate..."

Immunomodulating • Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

Outcomes of kidney transplantation in patients with IgA nephropathy based on induction: A UNOS data analysis. (PubMed, Clin Transplant) - "In patients with IgAN requiring a kidney transplant, Alemtuzumab induction correlates with increased IgAN recurrence. Relapse significantly affects graft survival and mortality. ATG without steroids is associated with the least graft loss and mortality."

Journal • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease • Transplantation

Addition of Daclizumab to Standard Graft-Versus-Host Disease Prophylaxis in Patients with Thalassemia Major Undergoing Transplantation from Related Haploidentical Donor and Unrelated Donor Hematopoietic Stem-Cell Transplantation: A Single-Center Retrospective Analysis from China (ASH 2023) - "This study aimed to investigate whether Daclizumab at a dose of 1 mg/Kg on days +7, +14, +28 and +42 reduced GVHD plus standard GVHD prophylaxis (tacrolimus [FK506] plus methotrexate [MTX] and mycophenolate mofetil [MMF]) in TM patients with HID-HSCT or MUD-HSCT. The results of our study analysis suggest that Daclizumab at a dose of 1 mg/kg on days +7, +14, +28 and +42 provides clinically meaningful benefits when added to standard GVHD prophylaxis in TM patients undergoing haploidentical donor and unrelated donor transplantation, including decrease in the incidence rate of aGVHD without sever infection and transplant-related complications. Four doses of Daclizumab should be included in the GVHD prophylaxis of patients with thalassemia major selected for related haploidentical donor and unrelated donor transplantation."

Retrospective data • Acute Graft versus Host Disease • Beta-Thalassemia • Bone Marrow Transplantation • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Genetic Disorders • Graft versus Host Disease • Immunology • Infectious Disease • Respiratory Diseases • Transplantation

Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "We found mostly low and very low-certainty evidence that drugs used to treat MS may not increase SAEs, but may increase withdrawals compared with placebo. The results suggest that there is no important difference in the occurrence of SAEs between first- and second-line drugs and between oral, injectable, or infused drugs, compared with placebo. Our review, along with other work in the literature, confirms poor-quality reporting of adverse events from RCTs of interventions. At the least, future studies should follow the CONSORT recommendations about reporting harm-related issues. To address adverse effects, future systematic reviews should also include non-randomized studies."

Adverse events • Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

"No association between disease modifying treatment and fatigue in multiple sclerosis". (PubMed, Mult Scler Relat Disord) - "We found no independent relationship between the use of disease-modifying treatment and fatigue in MS."

Journal • Bone Marrow Transplantation • CNS Disorders • Depression • Fatigue • Inflammation • Mood Disorders • Multiple Sclerosis • Psychiatry • Transplantation