Meeting Coverage
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NKF
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Reduced 24-hour UPCR by 38.3%
by
Kristen Monaco
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Senior Staff Writer, MedPage Today
May 16, 2024
LONG BEACH, Calif. — Iptacopan (Fabhalta) was safe and effective for reducing proteinuria in biopsy-confirmed immunoglobulin A nephropathy (IgAN), according to interim findings from the phase III APPLAUSE-IgAN study presented here.
Meeting the first of the two primary endpoints, iptacopan added to supportive care yielded a 38.3% (95% CI 26.0-48.6) reduction in 24-hour urine protein-creatinine ratio (UPCR) at 9 months relative to placebo, Dana Rizk, MD, of University of Alabama at Birmingham, said at the National Kidney Foundation (NKF) Spring Clinical meeting.
There were also reductions in UPCR from first morning void by the second week of treatment. This continued to steadily drop through month 9, ending with a 35.8% (95% CI 22.6-46.7) relative reduction between the arms.
Iptacopan is the first potential treatment for IgAN that specifically targets the alternative complement pathway, Rizk noted during a presentation of the late-breaking findings.
“The alternative complement pathway has been implicated in the pathogenesis of IgAN,” NKF President Sylvia Rosas, MD, commented in a statement. “It gives patients hope that a novel therapeutic intervention may lead to slowing progression of chronic kidney disease and avoiding kidney failure.”
Rosas, who wasn’t involved with the study, underscored the need for more effective, targeted therapies for IgAN patients. It’s estimated up to 30% of people with persistent proteinuria will progress to kidney failure within 10 years.
Iptacopan was first approved in December 2023 for the treatment of paroxysmal nocturnal hemoglobinuria. The twice-daily oral treatment acts as a factor B inhibitor of the alternative complement pathway.
“There is at least some school of thought that this is addressing the matter of inflammation,” said Rizk, but added that the supporting data suggest the agent works “more broadly in a larger IgAN population, not just the ones we thought of as being highly inflamed and having E lesions and C lesions.”
“The main challenge for us is going to be then selecting that patient who then requires this broad immunosuppressive approach,” Rizk said in response to a question of where this therapy would fall in the line of treatment.
Recently, there’s been a push toward new therapeutics for this rare and progressive condition, also known as Berger’s disease. The very first drug specifically indicated to reduce proteinuria in IgAN was budesonide (Tarpeyo), approved in December 2021. Last February, the FDA also granted accelerated approval to sparsentan (Filspari), the first non-immunosuppressive therapy for IgAN.
The interim results presented by Rizk reflected 250 patients who reached month 9 or had discontinued treatment. The study population for the main efficacy analysis included those with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 and UPCR ≥1 g/g based on a 24-hour urine collection at baseline. There was also a smaller group of patients with severe renal impairment (eGFR 20 to
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