STOCKHOLM, May 28, 2024 /PRNewswire/ --
("Calliditas"), today announced the presentations of an additional efficacy analysis of Nefecon (TARPEYO® (budesonide) delayed release capsules)) as well as a real-world analysis of the use of systemic glucocorticoids (SGC) in IgA nephropathy (IgAN). These were presented at ERA 2024 virtually and in Stockholm on May 23 - 26, 2024. The presented efficacy analysis of Nefecon and sparsentan showed that treatment with Nefecon for 9 months was associated with estimated glomerular filtration rate (eGFR) benefit compared with continuous treatment with sparsentan. Additionally, the findings of a real-world analysis of challenges associated with the use of systemic glucocorticoids demonstrate significant side effects and costs for IgAN patients treated with systemic glucocorticoids (SGC), such as Prednisone and Prednisolone. "It was wonderful to participate in ERA 2024 and present data contributing to the discussion on the need for effective treatments in IgAN," said Richard Philipson, Chief Medical Officer of Calliditas, " We continue to gather evidence that highlights the importance of treating the underlying autoimmune pathogenesis associated with IgAN, and we believe TARPEYO, as the only approved immunomodulating therapy designed to target the production of Gd-IgA1, has the potential to become a cornerstone therapy in IgAN." Poster presentation details are below and will be available on the Presentations and Publications page on the Calliditas' corporate website following the meeting. A matching-adjusted indirect comparison (MAIC) methodology is a widely accepted and relevant methodology for comparing treatments across trials in the absence of head-to-head comparisons. Here the effects of Nefecon, marketed as TARPEYO® and sparsentan, marketed as FILSPARI™, on kidney function deterioration in patients with IgAN were compared, as assessed by eGFR change from baseline at 9, 12 and 24 months. Results from the MAIC showed significantly favorable effects of Nefecon versus sparsentan on eGFR across all time points analyzed. Mean differences in the absolute change in eGFR of 5.68mL/min/1.73 m2 (95% credible interval [Crl] 3.14, 8.20; p1,2, *. Title: "Real-world challenges associated with the use of systemic glucocorticoids in a US IgAN cohort"
Per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, patients at high risk of progressive chronic kidney disease despite maximal supportive care can be considered for a 6-month course of systemic glucocorticoids (SGC), although important risks of toxicity and contraindications must be considered. There is currently limited real-world evidence describing the impact of the use of SGC on treatment-emergent toxicity and healthcare resource utilization (HCRU) in patients with IgAN. Our findings demonstrate significant side effects and costs for IgAN patients treated with SGC compared with patients not treated with SGC. Increases in severe infection incidents, inpatient visits, emergency department admissions, and ambulatory visits, underscore the careful consideration of treatment-emergent toxicity prior to initiating SGC therapy in patients with IgAN. *The optimization strategy in NefIgArd (optimized RASi) differed from the optimization strategy in PROTECT (IR), and anchoring of the two trials at optimized RASi/IR might lead to biased results. However, we also evaluated an unanchored MAIC in a sensitivity analysis and found very similar results.
The MAIC method can only adjust the relative effect estimates for any observed effect modifier available in the data, but it cannot adjust for unobserved or unobservable effect modifiers. A significant number of potential treatment effect modifiers were included in the present analysis: age, sex, race, baseline eGFR, UPCR, UACR, and urinary protein excretion.
Important Safety Information
Hypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy or switching between corticosteroids, monitor for signs of adrenal axis suppression. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B). Adverse reactions: In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%). Use in specific populations
Pregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism. Full Prescribing Information
TARPEYO is an oral 4mg delayed release formulation of budesonide, designed to remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: [email protected]
The information was sent for publication, through the agency of the contact persons set out above, on May 28, 2024, at 14.00 p.m. CET.
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