Mepolizumab

Airway resistance was associated with increased exacerbation rates in the placebo group but not the mepolizumab treatment groups MILWAUKEE, Feb. 17, 2026 /PRNewswire/ -- Mepolizumab-treated groups of children experience lower risk of airway dysfunction compared to placebo groups, according to new research being presented at the 2026 AAAAI Annual Meeting. The researchers suggest that mepolizumab may produce a potential protective effect of anti-IL5 therapy in children with small airway dysfunction, highlighting an important treatment option to optimize patient care. "In a secondary analysis of a pediatric randomized controlled trial, we assessed the association between baseline lung function impairment (measured by spirometry and impulse oscillometry) and exacerbation risk. Greater baseline obstruction was associated with higher exacerbation frequency in both placebo and mepolizumab treatment groups. Whereas greater baseline airway resistance was associated with higher exacerbation frequency mainly in the placebo group, indicating a potential protective effect of anti-IL5 therapy in children with small airway dysfunction," said co-author Courtney Gaberino, MD. Within the study, 271 participants, aged 6-17 years old, with exacerbation-prone asthma and blood eosinophils >=150/microliter, were randomized to receive placebo or mepolizumab injections added to their guideline-based care for 52 weeks. Researchers collected spirometry (GLI race-neutral values) and impulse oscillometry (IOS) data and examined the association between baseline lung function and the number of exacerbations during the trial by using negative binomial regression models. The researchers found that greater baseline airway resistance at 5Hz (R5), 5Hz-20Hz (R5-20) and the area under the curve of reactance (AX) were all associated with increased exacerbation risks for the children treated with a placebo. However, airway dysfunction as assessed by IOS was not associated with an exacerbation risk in the group of mepolizumab-treated children. In a combined model, researchers found no significant interaction between treatment group and IOS parameters in predicting the exacerbation risk (R5, R5-20, AX). Lower FEV1/FVC at the baseline was significantly associated with greater exacerbation frequency for both the placebo and mepolizumab-treatment groups of children. Visit aaaai.org to learn more about biologics. Research presented at the 2026 AAAAI Annual Meeting, February 27 – March 2 in Philadelphia, PA, is published in an online supplement to The Journal of Allergy and Clinical Immunology (JACI). The American Academy of Allergy, Asthma & Immunology (AAAAI) is the leading membership organization of more than 7,100 allergists, asthma specialists, clinical immunologists and other professionals with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI is the go-to resource for patients living with allergies, asthma and immune deficiency disorders. SOURCE American Academy of Allergy, Asthma & Immunology (AAAAI) 21% more press release views with Request a Demo

Liver signal pauses dosing in uniQure's Fabry gene therapy studyGSK's Nucala bags EU nod for COPDFDA lifts Yescarta use limits in CNS lymphoma Liver signal pauses dosing in uniQure's Fabry gene therapy studyuniQure has paused additional dosing in the mid- and high-dose cohorts of its Phase I/IIa trial of AMT-191 for Fabry disease after two patients experienced dose-limiting liver toxicity, the company said in an update presented at the WORLDSymposium.The update is based on data from 11 patients as of a Jan. 8 cutoff. The two toxicity cases involved asymptomatic grade 3 liver enzyme elevations in patients receiving the mid-level 4x10¹³ gc/kg dose. Both patients responded to corticosteroid treatment and remain in follow-up, but an independent data monitoring committee confirmed the events as dose-limiting toxicities, which triggered a protocol-mandated dosing pause in the mid- and high-dose cohorts pending further evaluation.The safety signal adds to previously disclosed adverse events at the highest 6x10¹³ gc/kg dose. A readout last September based on data from four patients showed five serious adverse events in two patients in that cohort, including two treatment-related events (chest pain and elevated troponin) and one possibly related event involving leptomeningeal enhancement. One patient in the high-dose group had also experienced an asymptomatic grade 3 liver enzyme elevation that was "not considered serious," uniQure said at the time.No additional SAEs have been observed at the 6x1013 gc/kg dose, according to the latest update.Regarding efficacy, uniQure said the new data showed sustained increases in α-Gal A enzyme activity out to more than a year. Six of the patients were also able to stop their regular enzyme replacement therapy after their α-Gal A levels rose high enough to meet preset targets.-Anna BratulicGSK's Nucala bags EU nod for COPDThe European Commission approved GSK's anti–IL-5 antibody Nucala (mepolizumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD)."For the first time, adults with uncontrolled COPD characterised by raised blood eosinophils in the EU will have the option for a monthly biologic shown to significantly reduce exacerbations," said Kaivan Khavandi, global head of respiratory, immunology and inflammation R&D at GSK. The clearance was backed by the Phase III MATINEE trial, wherein Nucala demonstrated a significant 21% reduction in the annualised rate of moderate or severe exacerbations compared with placebo. Nucala, touted as a challenger to Sanofi and Regeneron's Dupixent (dupilumab), previously secured COPD approvals in the US, UK and China.-Pavan KamatFDA lifts Yescarta use limits in CNS lymphomaThe FDA has approved a label update for Gilead Sciences' Yescarta (axicabtagene ciloleucel), removing prior limitations of use in patients with relapsed or refractory primary central nervous system lymphoma (PCNSL). According to the company's Kite unit, the decision makes Yescarta the only CAR-T cell therapy approved for relapsed or refractory large B-cell lymphoma to have this restriction lifted.The update is supported by a Phase I study led by the Dana-Farber Cancer Institute that involved 18 patients, including 13 with PCNSL. Neurologic toxicities were reported in 85% of PCNSL patients, with 31% experiencing grade 3 events, while other grade 3 or 4 adverse events included hypotension (23%), encephalopathy (15%) and seizures (15%).Gallia Levy, Kite's global head of development, said the company is "encouraged by the positive results of the safety study in patients with central nervous system lymphoma, who were previously excluded from the trials supporting Yescarta's approval."Yescarta generated $1.6 billion in 2024 sales, with Gilead scheduled to report full-year 2025 results on Feb. 11.-Anna Bratulic