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Nucala efficacy in CRSwNP
SYNAPSE: Both co-primary endpoints were met: median change from baseline in total endoscopic nasal polyps score at Week 52, Nucala (n=206):-1.0, placebo (n=201):0.0 (p<0.0001); median change in mean nasal obstruction VAS score during Week 49-52, Nucala (n=206):-4.41, placebo (n=201):-0.82 (p<0.0001).1*
Nasal obstruction was the most common nasal polyps symptom reported by both patients and physicians.4
Figure based on Han JK et al. Lancet Respir Med. 2021;9:1141-1153.
*SYNAPSE is a 52-week, randomised, double-blind, parallel group Phase III study assessing the clinical efficacy and safety of Nucala 100mg SC as an add-on to maintenance treatment in adults with severe bilateral nasal polyps, compared to placebo.1
†Co-primary endpoint: median change in mean nasal obstruction VAS score during Weeks 49-52. Score decreases and baseline scores are medians. Score decrease indicates improvement. Baseline scores are out of 10. Nucala, n=206; placebo, n-201.2
SC, subcutaneous; VAS, visual analogue scale.
Nucala significantly reduces nasal obstruction scores1,2
Median change from baseline in nasal obstruction VAS score during Weeks 49-52:
Nucala (n=206): -4.41, placebo (n=201): -0.82 (p<0.0001)1
Figure based on Han JK et al. Lancet Respir Med. 2021;9:1141-1153 (Supplementary).
Nucala helps prevent repeat nasal polyp surgery.1,3
In patients with refractory-to-treatment
nasal polyps (study population, n=407).
Secondary endpoint: time to nasal polyps surgery; results at Week 52, HR: 0.43, 95% CI (0.25–0.76); p=0.0032. Nucala: n=18/206, placebo: n=46/201.1
In patients with refractory-to-treatment
nasal polyps with baseline blood eosinophil count ≥300 eosinophils/µL (n=278):
Post-hoc analysis: results at week 52: HR:0.31; 95% CI (0.15-0.64) Nucala: n=10/139 vs placebo: n=35/139.3
†Need for surgery based on time to nasal polyps surgety. Secondary endpoint: time to first nasal polyps surgery within the study. At Week 52, 18/206 (9%) participants treated with Nucala had had surgery vs. 46/201 (23%) with placebo. For the purpose of this study, nasal polyps surgery was defined as any procedure involving instruments resulting in incision and removal of tissue or dilation of the air passages in the nasal cavity.1
‡Post hoc subgroup analysis in participants with ≥300 cells/µL. at Week 52, 10/139 (7%) participants treated with Nucala had had surgery vs. 35/139 (25%) with placebo.3
CI, confidence interval; HR, hazard ratio; NP, nasal polyps; OCS, oral corticosteroids; SC, subcutaneous; VAS, visual analogue scale.
Nucala helps to reduce OCS use.1,2,3
In patients with refractory-to-treatment nasal polyps (study population n=407):1
OR: 0.58, 95% CI:0.36, 0.92; p=0.0201*
In patients with refractory-to-treatment
nasal polyps with baseline blood eosinophil count ≥300 eosinophils/µl (n=278):3
Post hoc analysis results at Week 52: odds ratio 0.49, 95% CI: 0.28, 0.86. Nucala: n=139, placebo: n=139.3
*SYNAPSE is a 52-week, randomised, double-blind, parallel group Phase III study assessing the clinical efficacy and safety of Nucala 100mg SC as an add-on to maintenance treatment in adults with severe bilateral nasal polyps, compared to placebo. Secondary endpoint: proportion of subjects requiring systemic steroids for nasal polyps until week 52. Number of participants with ≥1 course of OCS, Nucala: 52/206 (25%), placebo: 74/201 (37%).1
†Post hoc subgroup analysis in participants with baseline blood eosinophil count ≥300 eosinophils/µL. Participants with ≥1 course of OCS, Nucala: n=37/139 (27%), placebo: n=58/139 (42%).3
CI, confidence interval; OCS, oral corticosteroid; OR, odds ratio; SC, subcutaneous.
SELECTED SAFETY INFORMATION
Warnings/Precautions: Should not be used to treat acute asthma exacerbations. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after starting treatment. Abrupt discontinuation of corticosteroids after initiation of mepolizumab treatment is not recommended.
Allergic reactions: Acute and delayed systemic reactions, including hypersensitivity reactions, have occurred following administration of mepolizumab. Patients should be instructed to seek medical attention immediately if allergic reactions occur. In the event of a hypersensitivity reaction, appropriate treatment as clinically indicated should be initiated.
Parasitic infections: Pre-existing helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with mepolizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Organ-threatening or life-threatening manifestations of EGPA and HES: has not been studied
Adverse reactions: In clinical studies in patients with severe refractory eosinophilic asthma and EGPA, headache, injection site reactions and back pain were the most commonly reported adverse reactions during treatment. In patients with CRSwNP: headache and back pain. In patients with HES: headache, urinary tract infection, injection site reactions and pyrexia.
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REFERENCES
- Han JK et al. Lancet Respir Med. 2021;9:1141-1153
- Han JK et al. Lancet Respir Med. 2021;9:1141-1153 (Supplementary)
- Bachert C et al. J Allergy Clin Immunol. 2022 May;149(5):1711-1721
- Frontiers | Patients Unmet Needs in Chronic Rhinosinusitis With Nasal Polyps Care: A Patient Advisory Board Statement of EUFOREA (frontiersin.org)
Nucala is a trademark of the GSK group of companies
PM-NO-MPL-WCNT-230004 June 2023
