Long-term dupilumab effect on lung function in multiple subgroups of pediatric patients with uncontrolled asthma

SESSION TITLE: Asthma Biologic Update SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/10/2023 12:00 pm - 12:45 pm PURPOSE: Improving lung function is key to managing pediatric asthma. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13, key and central drivers of type 2 inflammation in multiple diseases. Long-term dupilumab use in EXCURSION (NCT03560466) sustained exacerbation reductions in 6–11-year-old patients with uncontrolled, moderate-to-severe type 2 asthma who had completed the parent study, VOYAGE (NCT02948959); rapid improvement in lung function was observed in patients who switched from placebo to dupilumab although numerically higher lung function improvements were seen in dupilumab/dupilumab vs placebo/dupilumab treatment arms. The purpose of this post hoc analysis was to compare lung function improvement between treatment arms across multiple subgroups in EXCURSION. METHODS: Patients received add-on dupilumab 100/200 mg or placebo every 2 weeks (q2w) for 52 Weeks in VOYAGE and dupilumab 100/200 mg q2w or 300 mg q4w for 52 Weeks in EXCURSION. Endpoint was change from parent study baseline (PSBL) in percent predicted (pp) FEV1 by gender, asthma duration, age at asthma onset, and age at dupilumab start for dupilumab/dupilumab groups and age at Week 0 for placebo/dupilumab. Asthma duration was dichotomized at the median value of 5.50 years. RESULTS: At Week 0, 106 patients were included in placebo/dupilumab arm and 209 in dupilumab/dupilumab arm in EXCURSION. At Week 52, change from PSBL in ppFEV1 in dupilumab/dupilumab vs placebo/dupilumab was numerically greater with male gender (LS mean difference [LSMD]: 2.65 [95% CI ‑1.91–7.22] for males, 1.55 [‑4.39–7.49] for females; interaction p-value: P=0.74); shorter asthma duration (LSMD: 4.38 [‑0.88–9.64] for shorter, ‑0.17 [‑4.85–4.51] for longer duration; P=0.33); older age at onset (LSMD: 0.12 [‑5.10–5.34] for 0–2 years, 1.59 [‑5.56–8.74] for 3–5 years, 3.75 [‑2.86–10.35] for 6–11 years; P=0.73); and younger age at dupilumab start (LSMD: 2.61 [‑3.14–8.36] for ≥6 to <9 years, 1.52 [‑3.00–6.04] for ≥9 to <12 years; P=0.84). None of these differences between subgroups reached statistical significance. CONCLUSIONS: Improved lung function response to dupilumab over 1–2 years of treatment in 6–11-year-old patients with uncontrolled, moderate-to-severe type 2 asthma while numerically different did not differ statistically by gender, asthma duration, or age at onset or dupilumab start. CLINICAL IMPLICATIONS: Children with uncontrolled, moderate-to-severe type 2 asthma can benefit from dupilumab treatment over 1–2 years regardless of their gender, asthma duration, or age at onset or dupilumab start. DISCLOSURES: No relevant relationships by Arman Altincatal Consultant relationship with AstraZeneca Please note: 2018-present Added 04/14/2023 by Leonard Bacharier, value=Honoraria Author relationship with Elsevier Please note: 2018 - present Added 04/14/2023 by Leonard Bacharier, source=Web Response, value=Royalty Consultant relationship with OM Pharma Please note: 2022 - present Added 04/14/2023 by Leonard Bacharier, source=Web Response, value=Consulting fee Consultant relationship with Avillion Please note: 2022 - present Added 04/14/2023 by Leonard Bacharier, source=Web Response, value=Consulting fee Consultant relationship with Recludix Please note: 2022-present Added 04/14/2023 by Leonard Bacharier, value=Honoraria Consultant relationship with Regeneron Pharmaceuticals Please note: 2018-present by Leonard Bacharier, value=Honoraria Consultant relationship with GlaxoSmithKline Please note: 2018-present by Leonard Bacharier, value=Honoraria Removed 04/14/2023 by Leonard Bacharier, source=Web Response Consultant relationship with AstraZeneca Please note: 2018-present Added 04/14/2023 by Leonard Bacharier, value=Honoraria Grant/Research support relationship with Sanofi Please note: 2018-present by Leonard Bacharier, value=Grant/Research Support Grant/Research support relationship with Vectura Please note: 2018-2020 by Leonard Bacharier, value=Grant/Research Support Removed 04/14/2023 by Leonard Bacharier, source=Web Response Grant/Research support relationship with NIH Please note: 2018-present by Leonard Bacharier, value=Grant/Research Support Data Safety Monitoring Board member relationship with DBV Technologies Please note: 2018-present by Leonard Bacharier, value=Consulting fee Data Safety Monitoring Board member relationship with CF Foundation Please note: 2018-present by Leonard Bacharier, value=Consulting fee Speaker/Speaker's Bureau relationship with Sanofi Please note: 2018-present by Leonard Bacharier, value=speaker fees Consultant relationship with Sanofi Please note: 2018-present Added 04/14/2023 by Leonard Bacharier, value=Honoraria Speaker/Speaker's Bureau relationship with Regeneron Pharmaceuticals Please note: 2018-present by Leonard Bacharier, value=speaker fees Advisory Committee Member relationship with Regeneron Pharmaceuticals Please note: 2018-present by Leonard Bacharier, value=Honoraria Speaker/Speaker's Bureau relationship with GlaxoSmithKline Please note: 2018-present by Leonard Bacharier, value=speaker fees Removed 04/14/2023 by Leonard Bacharier, source=Web Response Consultant relationship with GlaxoSmithKline Please note: 2018-present Added 04/14/2023 by Leonard Bacharier, value=Honoraria Speaker/Speaker's Bureau relationship with AstraZeneca Please note: 2018-present by Leonard Bacharier, value=speaker fees Removed 04/14/2023 by Leonard Bacharier, source=Web Response Advisory Committee Member relationship with Sanofi Please note: 2022-2023 Added 04/14/2023 by Adnan Custovic, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Sanofi Please note: 2022 Added 04/14/2023 by Adnan Custovic, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Stallergens-Greer Please note: 2022 Added 04/14/2023 by Adnan Custovic, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with AstraZeneca Please note: 2022-23 Added 04/14/2023 by Adnan Custovic, source=Web Response, value=Honoraria Advisory Committee Member relationship with Worg Pharmaceuticals Please note: 2022 Added 04/14/2023 by Adnan Custovic, source=Web Response, value=Consulting fee No disclosure on file for Sharon Dell Employee relationship with Regeneron Please note: 2018-present by Yamo Deniz, value=Salary Board Member relationship with NOVARTIS Please note: 2010-2022 by Antoine Deschildre, value=Honoraria Advisory Committee Member relationship with SANOFI REGENERON Please note: 2020-2021 by Antoine Deschildre, value=Honoraria Speaker/Speaker's 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