Table Info

Table 1.

Demographics and baseline characteristics [pooled SINUS-24/-52 studies, subgroup of patients with nasal polyp score (NPS) = 8 and intention-to-treat (ITT) population]

Characteristic	Patients with NPS = 8 (n = 98)	ITT population (n = 724)
Age, years	53.8 (13.2)	51.4 (12.8)
Male sex, n (%)	55 (56)	437 (60)
Region, n (%)
Asia	8 (8)	49 (7)
Latin America	29 (30)	137 (19)
East Europe	22 (22)	216 (30)
Western countries	39 (40)	322 (44)
Time since first NP diagnosis, years	13.5 (10.9)	11.0 (9.5)
Prior NP surgery, n (%)	58 (59)	459 (63)
Time since most recent surgery, years	10.1 (6.9)	7.2 (6.4)
Number of previous surgeries, n (%)^*
1	36 (62)	254 (55)
2	8 (14)	94 (20)
≥ 3	14 (24)	111 (24)
SCS use in past 2 years, n (%)	82 (84)	538 (74)
Asthma, n (%)	59 (60)	428 (59)
NSAID-ERD, n (%)	32 (33)	204 (28)
NPS (0–8)	8.0 (0.0)	6.0 (1.3)
NC score (0–3)	2.7 (0.4)	2.4 (0.6)
LMK-CT total score (0–24)	18.9 (3.9)	18.4 (4.1)
LoS score (0–3)	2.9 (0.3)	2.7 (0.5)
Anterior rhinorrhea (0–3)	2.4 (0.6)	2.1 (0.7)
Posterior rhinorrhea (0–3)	2.3 (0.8)	2.0 (0.8)
TSS (0–9)	8.0 (1.2)	7.2 (1.4)
Rhinosinusitis VAS (0–10)	8.3 (2.2)	7.9 (2.1)
UPSIT score (0–40)	11.5 (6.3)	14.0 (8.2)
UPSIT anosmia^†, n (%)	88 (91)^‡	551 (78)^‡
SNOT-22 total score (0–110)	56.9 (21.6)	50.9 (20.7)
PNIF (L/min)	33.8 (45.1)	87.1 (56.1)
PNIF group (L/min), n (%)
< 97.5	93 (94.9)	453 (62.6)
≥ 97.5–< 138.4	2 (2.0)	150 (20.7)
≥ 138.4	3 (3.1)	121 (16.7)

All data are mean (standard deviation) unless otherwise stated. ^* Percentages calculated using number of patients with surgery as denominator; ^† UPSIT < 18; ^‡ n = 97 (NPS = 8 population), n = 710 (ITT population). SCS: systemic corticosteroids; NSAID-ERD: nonsteroidal anti-inflammatory drug-exacerbated respiratory disease; NC: nasal congestion/obstruction; LMK-CT: Lund-Mackay computed tomography; LoS: loss of smell; TSS: total symptom score; VAS: visual analog scale; UPSIT: University of Pennsylvania Smell Identification Test; SNOT-22: 22-item Sinonasal Outcome Test; PNIF: peak nasal inspiratory flow

Supplementary materials

The supplementary material for this article is available at: https://www.explorationpub.com/uploads/Article/file/100951_sup_1.pdf.

Declarations

Acknowledgments

The authors thank Asif H. Khan (Sanofi) for insights and guidance, and Carole Mercier and Christine Taniou (Axial Group) for their support with statistical analyses, which was funded by Sanofi and Regeneron Pharmaceuticals Inc. Medical writing/editorial assistance was provided by Olympia Gianfrancesco, PhD, of Adelphi Group, funded by Sanofi and Regeneron Pharmaceuticals Inc.

Author contributions

MW, CB, CH, MC, JM, SN, YD, PJR, HS, and JAJN: Conceptualization, Writing—original draft, Writing—review & editing. JM: Formal analysis. All authors contributed to manuscript revision, read, and approved the submitted version.

Conflicts of interest

MW: ALK-Abelló, AstraZeneca, GlaxoSmithKline, Novartis, Sanofi, Stallergenes Greer, Takeda—advisory board member, lecture fees, and research grants. MC, JM, PJR, and JAJN: Sanofi—employees, may hold stock and/or stock options in the company. CB: ALK, AstraZeneca, GlaxoSmithKline, Mylan, Novartis, Sanofi, Stallergenes Greer—advisory board member and speakers’ fees. CH: AstraZeneca, Dianosic, GlaxoSmithKline, Sanofi—advisory board member. SN, YD, and HS: Regeneron Pharmaceuticals Inc.—employees, may hold stock and/or stock options in the company.

Ethical approval

The SINUS-24 and SINUS-52 studies were conducted according to the principles laid down in the Declaration of Helsinki. Institutional review boards and independent ethics committees reviewed and approved the protocols, informed consent forms, and patient information before study initiation. A full list of institutional review boards and independent ethics committees is shown in Table S1.

Consent to participate

All patients provided signed written informed consent prior to study participation.

Consent to publication

Not applicable.

Availability of data and materials

Qualified researchers may request access to data and related study documents. Patient-level data will be anonymized and study documents will be redacted to protect the privacy of trial patients. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.vivli.org/.

Funding

The SINUS trials and the analyses contained within this manuscript were sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov Identifiers: NCT02912468 (SINUS-24) and NCT02898454 (SINUS-52). Sanofi and Regeneron Pharmaceuticals Inc. designed the SINUS-24 and SINUS-52 studies, collected the data, and, in collaboration with the authors, contributed to analysis, data interpretation, manuscript preparation, and the decision to publish.

Copyright

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