BATTLE TESTED IN CRSwNP: EXPLORE SYNAPSE

All primary and secondary endpoints were met with statistical significance.1

SYNAPSE: Study design1

SYNAPSE study design detailing the run-in, treatment and follow-up period
SYNAPSE study design detailing the run-in, treatment and follow-up period

Description

52-week, multicenter, randomized, double-blind, placebo-controlled, Phase 3 study with NUCALA 100 mg or placebo SC once every 4 weeks added to SOC* in 407 adult patients with recurrent chronic rhinosinusitis with nasal polyps.

*Defined as daily mometasone furoate nasal spray in addition to saline nasal irrigations, and courses of systemic corticosteroids and/or antibiotics as required.

Select inclusion criteria

  • At least 1 prior endoscopic nasal polyp surgery for the removal of nasal polyps over the past 10 years
  • Intranasal corticosteroid therapy for >8 weeks prescreening
  • Endoscopic bilateral nasal polyps score >5 out of a maximum of 8 (range of 0 to 4 in each nostril; higher score indicates worse status)
  • Nasal obstruction symptom score >5 out of a maximum of 10 (ranges from 0=none to 10=as bad as you can imagine)
  • Overall nasal polyp symptom score >7 out of a maximum of 10 (ranges from 0=none to 10=as bad as you can imagine)

Co-primary endpoints/results

  • LS mean change from baseline in total endoscopic nasal polyp score (centrally read) at Week 52: NUCALA + SOC, –0.87, vs placebo + SOC, 0.06; P<0.001.
  • LS mean change from baseline in median nasal obstruction score during Weeks 49-52: NUCALA + SOC, –4.40, vs placebo + SOC, –2.54; P<0.001.

LS means from an analysis using mixed model repeated measures with covariates of treatment group, geographic region, baseline score, and log(e) baseline blood eosinophil count visit, interaction terms for visit by baseline and visit by treatment.

Key secondary endpoint

  • Time to first nasal polyps surgery up to Week 52
    • Defined as any procedure involving instruments resulting in incision and removal of tissue (polypectomy) in the nasal cavity and the sinuses

Select secondary endpoints

  • Change from baseline in overall symptom score at Weeks 49-52
  • Change from baseline in mean individual symptom score for loss of smell at Weeks 49-52
  • Change from baseline in SNOT-22 total score at Week 52
  • Proportion of patients requiring systemic steroids for nasal polyps up to Week 52

Symptom scores

  • Based on daily patient-reported symptom severity using visual analog scale of 0 to 10 (0=none, 10=as bad as you can imagine)
  • Symptoms reported included nasal obstruction, nasal discharge, mucus in throat, facial pain, loss of smell

SNOT-222,3

  • A disease-specific measure of health-related quality of life that includes 22 items assessing symptoms and impact associated with CRS
  • Score ranges from 0 to 110; each item scored from 0 (no problem) to 5 (the problem is as bad as it can be)
  • 6 domains: nasal, non-nasal, ear/facial, sleep, fatigue, and emotional consequences

Nasal polyp score

  • Polyps on each side of the nose were graded on a categorical scale (0=no polyps, 1=small polyps in the middle meatus not reaching below the inferior border of the middle concha, 2=polyps reaching below the lower border of the middle turbinate, 3=large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha, 4=large polyps causing almost complete congestion/obstruction of the inferior meatus)
  • Total score (sum of both nostrils) ranged from 0 to 8

SYNAPSE BASELINE CHARACTERISTICS1,2

All patients in SYNAPSE had severe recurrent nasal polyps with a need for repeat surgery

Baseline characteristics of patients in the SYNAPSE clinical trial
Baseline characteristics of patients in the SYNAPSE clinical trial

†Defined as any procedure involving instruments resulting in incision and removal of tissue (polypectomy) in the nasal cavity and the sinuses.  

‡Higher scores indicate greater disease severity. 

§ACQ-5 score of ≥1.5 indicates poorly controlled asthma.4

ACQ-5=Asthma Control Questionnaire (5-item); AERD=aspirin-exacerbated respiratory disease; CRS=chronic rhinosinusitis; LS=least squares; NP=nasal polyp; SC=subcutaneous; SCS=systemic corticosteroid; SD=standard deviation; SNOT-22=sino-nasal outcome test (22-item); SOC=standard of care; VAS=visual analog scale.

Patient profiles with nasal polyps Patient profiles with nasal polyps

YOU MAY KNOW PATIENTS LIKE MICHAEL IN YOUR PRACTICE

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Nasal polyps with comorbid AERD patient profile Nasal polyps with comorbid AERD patient profile

EXPLORE NUCALA DATA IN CRSwNP PATIENTS

VIEW NUCALA EFFICACY