Supplementary Online Content - American Medical Association

Supplementary Online Content

Bachert C, Mannent L, Naclerio RM, et al. Effect of subcutaneous dupilumab on nasal polyp burden in patients with chronic sinusitis and nasal polyposis: a randomized clinical trial. JAMA. doi:10.1001/jama.2015.19330

eTable 1. Outcomes and associated clinically-important differences eTable 2. Change from baseline in additional secondary endpoints in patients with chronic sinusitis with nasal polyposis treated with placebo or dupilumab added to MFNS eTable 3. Change from baseline to Week 32 in patients with chronic sinusitis with nasal polyposis treated with placebo or dupilumab added to MFNS for 16 weeks, plus 16 weeks of MFNS-only eTable 4. Change from baseline to week 16 in efficacy endpoints in patients with chronic sinusitis with nasal polyposis and comorbid asthma treated with placebo or dupilumab added to MFNS eTable 5. Change from baseline to week 16 in efficacy endpoints in patients with chronic sinusitis with nasal polyposis without comorbid asthma treated with placebo or dupilumab added to MFNS eTable 6. Number of patients with TEAEs that occurred in 10% of patients in either treatment group, by primary system organ class and preferred term (safety population) Study Investigators

This supplementary material has been provided by the authors to give readers additional information about their work.

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eTable 1. Outcomes and associated clinically-important differences

Range/Definition

Objective/Functional

Endoscopic NPS

0-8 (both sides)

0 = no polyps; 1 = small polyps in the middle meatus not

reaching below the inferior border of the middle turbinate; 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 turbinate; 4 = large

polyps causing complete obstruction of the inferior nasal cavity

CT scan: Lund-Mackay

0-24 (point range)

Evaluates the patency using a 0-2 scale (0 = normal; 1 =

partial opacification; and 2 = total opacification) of each sinus

(maxillary, anterior ethmoid, posterior ethmoid, sphenoid,

frontal sinus on each side)

The osteomeatal complex is graded as 0 = not occluded or

2 = occluded

PNIF (AM/PM)

PNIF can be used only as a relative measurement in the same

individual over time. PNIF values of 126.7 and 158.1 L/min (or

2.1 and 2.6 L/s) have been proposed as being normal in

females and males, respectively

UPSIT (smell test)

0-40 possible correct answers

0-18 anosmia; 19-25 severe microsmia; 26-30 moderate

microsmia; 31-34 mild microsmia; and 35-40 normal

Reference

Gevaert P, Calus L, Van Zele T, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013;131(1):110-116.

Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology. 1993;31(4):183-184.

Bhattacharyya N. Test-retest reliability of CT in the assessment of chronic rhinosinusitis. Laryngoscope. 1999;109(7 Pt 1):1055-1058.

Ottaviano G, Scadding GK, Scarpa B, Accordi D, Staffieri A, Lund VJ. Unilateral peak nasal inspiratory flow, normal values in adult population. Rhinology. 2012;50(4):386-392. Scadding G, Hellings P, Alobid I, et al. Diagnostic tools in Rhinology EAACI position paper. Clin Transl Allergy. 2011;1(1):2.

Symptoms/PROs SNOT-22, total and specific items scores

0-110 (higher total scores imply greater impact on quality of life) 22-items scored on a 5-category scale (0 = no problem to 5 = problem as bad as it can be)

Doty RL, Frye RE, Agrawal U. Internal consistency reliability of the fractionated and whole University of Pennsylvania Smell Identification Test. Precept Psychophys. 1989;45(5):381-384.

Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009;34(5):447-454.

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Downloaded From: on 02/20/2022

MCID: 8.90

VAS for rhinosinusitis

0-10 cm

Fokkens W, Lund V, Mullol J; European Position

symptoms

0 = not troublesome to 10 = worst thinkable troublesome

Paper on Rhinosinusitis and Nasal Polyps

VAS 0-3 = Mild

group. European position paper on rhinosinusitis

VAS >3-7 = Moderate

and nasal polyps 2007. Rhinol Suppl.

VAS >7-10 = Severe

2007;(20):1-136.

AM/PM subject assessed daily 0-3 categorical scale

Fokkens W, Lund V, Mullol J; European Position

symptoms (nasal congestion/ 0 = no symptoms; 1 = mild symptoms; 2 = moderate

Paper on Rhinosinusitis and Nasal Polyps

obstruction, anterior

symptoms; and 3 = severe symptoms

group. European position paper on rhinosinusitis

rhinorrhea, post-nasal drip,

and nasal polyps 2007. Rhinol Suppl.

sense of smell, nocturnal

2007;(20):1-136.

awakenings)

ACQ5

7-point scale

Juniper EF, Svensson K, M?rk AC, St?hl E.

0 = no impairment to 6 = maximum impairment

Measurement properties and interpretation of

MCID: 0.5

three shortened versions of the asthma control

questionnaire. Respir Med. 2005;99:553-558.

Abbreviations: ACQ5, 5-question Asthma Control Questionnaire; CT, computed tomography; MCID, minimally clinically important difference; NPS, nasal polyp score; PNIF, peak nasal

inspiratory flow; PROs, patient-reported outcomes; SNOT-22, 22-item SinoNasal Outcome Test; UPSIT, University of Pennsylvania Smell Identification Test; VAS, visual analog scale.

?2016 American Medical Association. All rights reserved.

Downloaded From: on 02/20/2022

eTable 2. Change from baseline in additional secondary endpoints in patients with chronic sinusitis with nasal polyposis

Endpointsb,c

treated with placebo or dupilumab added to MFNS

Placebo/MFNS (Na=30)

Dupilumab/MFNS (Na=30)

Placebo vs Dupilumab

Baseline, Week 16, Change From Baseline, Week 16, Change From Difference LS P Value

Mean (SD) Mean (SD) Baseline, LS Mean (SD) Mean (SD) Baseline, LS

nd=30

nd=23

Mean (95% CI)

nd=30

nd=29

Mean (95%

Mean (95% CI)

CI)

PNIF (PM), L/min

121.3

144.7

25.8

105.2

168.3

59.2

33.4

.0028

(51.8)

(64.4)

(10.2 to 41.4)

(52.5)

(54.3)

(44.1 to 74.3) (12.0 to 54.8)

Loss of smell (AM)

2.8 (0.5)

2.5 (0.8)

-0.1

2.4 (0.9)

1.0 (1.0)

-1.4

-1.3

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