Tarpeyo (budesonide) / Everest Medicines, Calliditas, Stada - LARVOL DELTA

The influence of CD27-CD21+ B cells and IgA plasma cell changes in patients with IgA nephropathy on the prognosis of treatment with Nefecon (ChiCTR) - P4 | N=96 | Not yet recruiting | Sponsor: Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University; Shenzhen Second People's Hospital, The First Affiliated Hospi

New P4 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and safety evaluation of Nefecon combined with low-dose mycophenolate mofetil in the treatment of primary IgA nephropathy: a prospective, multicenter, single arm study (ChiCTR) - P=N/A | N=40 | Recruiting | Sponsor: The first affiliated hostipal of nanchang university; The first affiliated hostipal of nanchang university

New trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Real-World Study of Nefecon in the Treatment of IgA Nephropathy After Kidney Transplantation (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Shanghai Changhai Hospital; Shanghai Changhai Hospital

New trial • Glomerulonephritis • IgA Nephropathy • Renal Disease • Transplantation

The latest pharmacotherapeutic options for the treatment of IgA nephropathy in the pediatric population. (PubMed, Expert Opin Pharmacother) - "The higher disease activity and longer life expectancy in pediatric patients create a critical need for the evaluation of modern therapies in children with IgAN. Thus, it is crucial to prioritize pediatric clinical trials and to focus on removing the barriers that limit their implementation."

Journal • Review • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Pediatrics • Renal Disease

Nefecon in IgA nephropathy: real-world renal efficacy, safety profile, and treatment response from a 9-month retrospective cohort analysis. (PubMed, Int Urol Nephrol) - "In real-world practice, Nefecon demonstrates significant efficacy in reducing proteinuria, improving renal function, and achieving high remission rates in IgAN patients over 9 months, with a favorable safety profile. Subgroup analyses highlight that baseline renal function, proteinuria severity, biopsy interval, and combination with immuno-suppressants may influence treatment response. Larger prospective studies are needed to validate these findings."

Journal • Real-world evidence • Retrospective data • Acne Vulgaris • Glomerulonephritis • IgA Nephropathy • Renal Disease

Matching-adjusted indirect comparison of kidney function in patients with immunoglobulin A nephropathy treated with nefecon or sparsentan. (PubMed, J Comp Eff Res) - P3 | "Aim: We compared the effects of nefecon, an oral targeted-release budesonide formulation, and sparsentan, an oral, dual endothelin-angiotensin receptor antagonist, on estimated glomerular filtration rate (eGFR) in patients with immunoglobulin A nephropathy, a leading cause of chronic kidney disease. Materials & We conducted an anchored matching-adjusted indirect comparison (MAIC) using patient-level data from NefIgArd (NCT03643965; n = 364), a randomized (1:1) trial of nefecon plus optimized renin-angiotensin system inhibitor (RASi) therapy versus placebo plus RASi; and aggregate data from PROTECT (NCT03762850; n = 404), a randomized (1:1) trial of sparsentan versus irbesartan, an angiotensin receptor blocker...Sensitivity analysis results were consistent with the main findings. In patients with immunoglobulin A nephropathy, nefecon plus optimized RASi may preserve kidney function to a greater extent than sparsentan."

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

Early Therapy with Nefecon in IgAN: Two Case Reports Demonstrating Improved Clinical Outcomes (KIDNEY WEEK 2025) - "Initial treatment with hydroxychloroquine and an angiotensin II receptor blocker showed minimal benefit. This proactive approach contrasts with traditional reactive strategies and warrants further study on timing, duration, and biomarker-guided management to improve long-term outcomes. Figure 1 Proteinuria and Urinary Creatinine Levels during Follow-up Visits"

Case report • Clinical • Clinical data • Diabetes • Diabetic Nephropathy • Glomerulonephritis • Hypertension • IgA Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Duration of Absolute Proteinuria Response with Nefecon in Patients with Primary IgAN: Results from the Two-Year NefIgArd Trial (KIDNEY WEEK 2025) - "These data show that nefecon treatment enables a substantial proportion of patients to achieve absolute target proteinuria levels for sustained periods and experience improved kidney outcomes. Proportion of patients experiencing an absolute UPCR response (defined as UPCR ≤1 g/gram) for at least 6, 9, 12, and 18 months"

Clinical • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

When IgA Strikes Twice: The Battle Beyond Transplant (KIDNEY WEEK 2025) - "Initial management included losartan 100 mg daily, which led to a modest improvement in proteinuria (1.2 g/g) and creatinine (1.7 mg/dL)...Targeted-release budesonide (TRF-budesonide; Tarpeyo) was initiated at 16mg/d in addition to standard triple immunosuppression and resulted in a significant reduction in proteinuria (0.9g/g), resolution of hematuria, and stabilization of allograft function over 4 months (Figure)...Its targeted mechanism at the gut mucosal immunity provides the necessary immunosuppressive effect while avoiding additional systemic immunosuppression in this high-risk population. We encourage clinical trials to establish long-term efficacy and safety in the transplant population."

Cardiovascular • Diabetes • Diabetic Nephropathy • Glomerulonephritis • Hypertension • IgA Nephropathy • Metabolic Disorders • Nephrology • Transplantation

Creation and Initial Demographics of the PERFORM Patient Registry: Novel Real-World Registry of Patients Treated for IgAN in the United States (KIDNEY WEEK 2025) - "To address this need, the PERFORM Patient Registry TM (PPR) has been created to assess longitudinal disease characteristics, healthcare utilization, clinical management, and treatment utilization patterns of patients treated with delayed release budesonide (Tarpeyo®) for IgAN in the United States (US). Conclusion While enrollment is ongoing, the current PPR population contains a varied cohort of patients treated with Tarpeyo® for IgAN. This registry will allow for further understanding of IgAN management and outcomes for patients treated with Tarpeyo® for IgAN."

Clinical • Real-world • Real-world evidence • Glomerulonephritis • IgA Nephropathy • Pediatrics • Renal Disease

Therapies for IgAN in the Cure Glomerulonephropathy Network (CureGN) (KIDNEY WEEK 2025) - "Few participants (n=5) received newer IgAN therapies (eg, sparsentan, targeted delayed-release budesonide)...Conclusion The impact of traditional IST on long term kidney function requires further exploration. Despite availability of novel IgAN therapies, conservative management (RAS inhibition, SGLT2i) and traditional IST remain most used."

Glomerulonephritis • IgA Nephropathy • Renal Disease

Safety Profile of Combined Nefecon and Sparsentan Therapy (KIDNEY WEEK 2025) - "Our findings show that compared to monotherapy, combined use of Nefecon and sparsentan reduces the spectrum of AEs. Table 1 *denotes previously reported."

Clinical • Glomerulonephritis • IgA Nephropathy

Nefecon Treatment in Patients with IgAN: A Real-World Observational Study (KIDNEY WEEK 2025) - "Nefecon, a new oral targeted-release formulation of budesonide which acts on gut mucosal immune system, has been proven in reducing proteinuria and slowing down kidney function lost in patients with IgAN. Five patients(31%) developed facial edema during follow-up. Conclusion After 6 months, Nefecon has demonstrated promising preservation of kidney function aligning with significant proteinuria reduction, with a rather safe profile in IgAN patients."

Clinical • Observational data • Real-world • Real-world evidence • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

Efficacy and Safety of Nefecon in Patients with IgAN: A Real-World Study (KIDNEY WEEK 2025) - "Conclusion NEFECON may reduce proteinuria and preserve eGFR levels in IgAN patients, with a favourable safety profile. Table 1 and Figure 1"

Clinical • Real-world • Real-world evidence • Acne Vulgaris • Dyspepsia • Glomerulonephritis • IgA Nephropathy • Renal Disease

Beyond Nine Months: Real-World Efficacy and Safety of Extended Nefecon Therapy in IgAN (KIDNEY WEEK 2025) - "Nefecon, a targeted-release budesonide, showed short-term efficacy in the 9-month NefIgArd trial. Its targeted delivery offered a more favorable safety profile, supporting the benefit of extended treatment duration beyond 9 months. Clinical characteristics of the Nefecon group and control group after PSM"

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Chronic Kidney Disease • CNS Disorders • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease • Sleep Disorder • Women's Health

Nefecon (Targeted-Release Formulation of Budesonide) for IgAN: Two Case Reports (KIDNEY WEEK 2025) - "Initial treatment included methylprednisolone, prednisone, and telitacicept...The patient received irbesartan and entecavir...Discussion These cases highlight the potential of Nefecon as an effective therapy for IgAN, even in patients with advanced histologic damage and impaired renal function. The observed clinical benefits, including reduction in proteinuria and stabilization of renal function, supports its therapeutic value in real-world settings."

Case report • Clinical • Glomerulonephritis • Hepatitis B • Hepatology • IgA Nephropathy • Infectious Disease • Inflammation • Lupus Nephritis • Nephrology • Renal Disease

Efficacy of Budesonide Delayed-Release Capsules in the Treatment of IgAN and IgA Vasculitis Nephritis in Pediatric Patients (KIDNEY WEEK 2025) - "Background Nefecon, a targeted-released budesonide for the gut-associated lymphoid tissue at Peyer’s patches (the principal site of Gd-IgA1 production), has been approved for the treatment of adult IgA nephropathy (IgAN) worldwide. Conclusion This first real-world evidence in pediatric IgAN/IgAVN indicates that Nefecon achieved significant reductions in both proteinuria and hematuria within 12 weeks. However, long-term efficacy and safety data warrant further investigation."

Clinical • Glomerulonephritis • IgA Nephropathy • Nephrology • Pediatrics • Renal Disease • Vasculitis

Real-World Treatment for IgAN in the Veterans Health Administration (KIDNEY WEEK 2025) - "IgAN treatments, including systemic glucocorticoids (SGC), other immunosuppressants (azathioprine, mycophenolate, or cyclophosphamide), angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), sodium-glucose co-transporter 2 inhibitors (SGLT2i), and novel treatments (iptacopan, sparsentan, targeted delayed-release budesonide) were ascertained using pharmacy records and categorized as continued use at IgAN diagnosis, incident use at IgAN diagnosis, discontinued use after IgAN diagnosis, or no use...Conclusion Low rates of existing and novel treatment use in this cohort reveal an opportunity to improve adherence to draft updates to IgAN guidelines that suggest using immunomodulating agents concurrently with supportive therapies such as ACEi/ARBs and SGLT2is. Many people discontinued treatments, suggesting a possible role for novel therapies as alternative options."

Clinical • HEOR • Real-world • Real-world evidence • Ankylosing Spondylitis • Chronic Kidney Disease • Dermatitis • Dermatology • Glomerulonephritis • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • IgA Nephropathy • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Renal Disease • Rheumatology • Seronegative Spondyloarthropathies

Real-World Experience with Targeted-Release Budesonide in the Treatment of IgAN (KIDNEY WEEK 2025) - "At the initiation of Tarpeyo, ten patients were receiving renin-angiotensin-aldosterone system (RAAS) inhibitors, including three patients on sparsentan. No serious infections were reported during the treatment period. Conclusion At our center, Tarpeyo produced outcomes comparable to those observed in the Phase III NefIgArd trial, with a significant reduction in proteinuria and an acceptable safety and tolerability profile."

Clinical • Real-world • Real-world evidence • Acne Vulgaris • Cardiovascular • Glomerulonephritis • Hypertension • IgA Nephropathy • Infectious Disease • Lupus Nephritis • Nephrology • Renal Disease

Efficacy and Safety of a Targeted-Release Formulation of Budesonide in Patients with IgAN and Severe Renal Impairment: A Real-World Study (KIDNEY WEEK 2025) - "Funding Government Support – Non-U.S. Conclusion Nefecon, when administered to IgAN patients with severe renal impairment and persistent proteinuria, was well-tolerated and resulted in a significant reduction in both proteinuria and hematuria, along with an improvement in eGFR. Changes in (a, b) UPCR, (c, d) UACR, (e, f) urinary RBC count, and (g, h) eGFR during treatment with Nefecon."

Clinical • Real-world • Real-world evidence • Glomerulonephritis • IgA Nephropathy • Renal Disease

Absolute Proteinuria over Time with Nefecon vs. Placebo in Patients with IgAN: Results from the Phase 3 NefIgArd Trial (KIDNEY WEEK 2025) - "Conclusion In the NefIgArd trial, nefecon led to a substantial and sustainable reduction in proteinuria; no appreciable reduction was seen with placebo. Mean proteinuria levels below 1 g/gram were observed with nefecon from 6 months and continued throughout the off-treatment phase to month 24."

Clinical • P3 data • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Investigating Extended Nefecon Treatment Beyond Nine Months in Patients with IgAN: The Phase 4 NefXtend Trial (KIDNEY WEEK 2025) - P4 | "Description Nefecon is an oral, targeted-release budesonide formulation approved for immunoglobulin A nephropathy (IgAN). Safety outcomes include adverse events (AEs), serious AEs, and AEs of special interest (steroid effects, infections). This trial will evaluate whether extending nefecon treatment to 2 years may provide additional, better-sustained proteinuria reduction and more complete kidney function preservation vs only 9 months of treatment in patients with IgAN."

Clinical • P4 data • Cardiovascular • Diabetes • Glomerulonephritis • Hypertension • IgA Nephropathy • Infectious Disease • Metabolic Disorders • Renal Disease

Targeting IgAN Early: Considerations for Adding Potentially Disease Modifying Therapy to Frontline Treatment (KIDNEY WEEK 2025) - "Sponsored by Calliditas. A New Era for IgAN: The Importance of Early Intervention • Transforming IgAN Care: Key Advances to Guidelines That Are Redefining the Standard • For IgAN Patients at Risk of Progression: Start TARPEYO to Target a Key Source of IgAN at Diagnosis"

Glomerulonephritis • IgA Nephropathy

IgA nephropathy with monotypic IgA-κ deposits: a case report and literature review. (PubMed, Front Med (Lausanne)) - "After 12 months of follow-up, the patient was treated with maximal tolerated doses of renin-angiotensin system inhibitors combined with Nefecon, the patient's urine protein decreased significantly and renal function was stable, and no hematological disorders were found during the follow-up...Moreover, IgAN with monotypic IgA-κ deposits and proliferative glomerulonephritis with monoclonal IgA deposits (PGNMID) share similarities in pathological manifestations. Therefore, rigorous monitoring of hematological indices in IgAN patients with monotypic IgA-κ deposits is essential to remain vigilant against misdiagnosis or missed diagnosis of early-stage PGNMID."

Journal • Glomerulonephritis • Hematological Disorders • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

Novel therapies improve prognosis of IgAN and limit the applicability of the International IgA Nephropathy Prediction Tool. (PubMed, Clin Kidney J) - "We included 677 immunoglobulin A nephropathy (IgAN) patients (Peking University First Hospital, 2003-23) treated with endothelin receptor antagonists, Nefecon, sodium-glucose cotransporter 2 inhibitors, hydroxychloroquine or telitacicept, a BAFF/APRIL inhibitor. In this study, both versions of both models demonstrated limited performance and overestimated risks. Given the prognostic improvement with novel IgAN therapies, these prediction tools may need updating for use in currently treated patients."

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