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Efficacy of dupilumab in patients with a history of prior sinus surgery for chronic rhinosinusitis with nasal polyps
Author(s) -
Hopkins Claire,
Wagenmann Martin,
Bachert Claus,
Desrosiers Martin,
Han Joseph K.,
Hellings Peter W.,
Lee Stella E.,
Msihid Jérôme,
Radwan Amr,
Rowe Paul,
Amin Nikhil,
Deniz Yamo,
Ortiz Benjamin,
Mannent Leda P.,
Rout Rajesh
Publication year - 2021
Publication title -
international forum of allergy and rhinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.503
H-Index - 46
eISSN - 2042-6984
pISSN - 2042-6976
DOI - 10.1002/alr.22780
Subject(s) - medicine , dupilumab , nasal polyps , chronic rhinosinusitis , sinusitis , placebo , randomized controlled trial , surgery , clinical endpoint , functional endoscopic sinus surgery , pathology , asthma , alternative medicine
Background Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease treated with sinus surgery when refractory to medical intervention. However, recurrence postsurgery is common. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor for interleukin 4 (IL‐4) and IL‐13, key and central drivers of type 2 inflammation. We report the efficacy of dupilumab in patients with CRSwNP from the SINUS‐24/SINUS‐52 trials (NCT02912468/NCT02898454), by number of prior surgeries and time since last surgery. Methods Patients were randomized to placebo or dupilumab 300 mg every 2 weeks. Post hoc subgroup analyses were performed for patients with 0, ≥1, 1/2, or ≥3 prior surgeries, and for patients who had surgery within <3, 3 to <5, 5 to <10, or ≥10 years. Efficacy outcomes at 24 weeks included co‐primary endpoints nasal polyp score (NPS) and nasal congestion (NC), and Lund‐Mackay (LMK), 22‐item Sino‐Nasal Outcome Test (SNOT‐22), and smell scores. Results Of 724 patients randomized, 459 (63.4%) had ≥1 prior surgery. Baseline sinus disease (NPS, NC, LMK) and olfactory dysfunction (University of Pennsylvania Smell Identification Test [UPSIT] and loss of smell) scores were worse for patients with ≥3 prior surgeries vs no surgery. Baseline NPS and LMK were worse in patients with <3 years since last surgery than in patients with ≥5 years since last surgery. Dupilumab significantly improved all outcome measures vs placebo in all subgroups by number of surgeries and by time since last surgery. Improvements in NPS and LMK were greater in patients with <3 years since last surgery than patients with ≥5 years. Safety results were consistent with the known dupilumab safety profile. Conclusion Dupilumab improved CRSwNP outcomes irrespective of surgery history, with greater improvements in endoscopic outcomes in patients with shorter duration since last surgery.