Detailed Outcome Data

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Clinical Review Report: Halobetasol Propionate and Tazarotene (Duobrii): (Bausch Health, Canada Inc.): Indication: Psoriasis, moderate-to-severe plaque [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2020 Dec.

Cover of Clinical Review Report: Halobetasol Propionate and Tazarotene (Duobrii)

Clinical Review Report: Halobetasol Propionate and Tazarotene (Duobrii): (Bausch Health, Canada Inc.): Indication: Psoriasis, moderate-to-severe plaque [Internet].

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Appendix 3Detailed Outcome Data

Health-Related Quality of Life

Table 43Change From Baseline in DLQI Score (ITT Set)

	Total N	Baseline	Week 4		4 weeks following end of treatment (week 12)
	Total N	Mean (SD)	Mean (SD)	Mean change from baseline (SD)	Mean (SD)	Mean change from baseline (SD)
DLQI
Study 301
HP/TAZ	▬	▬	▬	▬	▬	▬
Vehicle	▬	▬	▬	▬	▬	▬
Study 302
HP/TAZ	▬	▬	▬	▬	▬	▬
Vehicle	▬	▬	▬	▬	▬	▬

: DLQI = Dermatology Life Quality Index; HP/TAZ = halobetasol propionate and tazarotene; ITT = intention to treat; SD = standard deviation.
: Source: Clinical Study Reports for Study 301¹⁰ and Study 302.¹¹

Skin Clearance

Table 44Change From Baseline of Affected BSA (ITT Set)

		BSA affected by psoriasis
		Baseline	Week 2	Week 4	Week 6	Week 8	Week 12
Study 301
HP/TAZ N = 135	Mean (SD)	▬	▬	▬	▬	▬	▬
HP/TAZ N = 135	Change from baseline, mean (SD)	▬	▬	▬	▬	▬	▬
Vehicle N = 68	Mean (SD)	▬	▬	▬	▬	▬	▬
Vehicle N = 68	Change from baseline, mean (SD)	▬	▬	▬	▬	▬	▬
Study 302
HP/TAZ N = 141	Mean (SD)	▬	▬	▬	▬	▬	▬
HP/TAZ N = 141	Change from baseline, mean (SD)	▬	▬	▬	▬	▬	▬
Vehicle N = 74	Mean (SD)	▬	▬	▬	▬	▬	▬
Vehicle N = 74	Change from baseline, mean (SD)	▬	▬	▬	▬	▬	▬

: BSA = body surface area; HP/TAZ = halobetasol propionate and tazarotene; ITT = intention to treat; SD = standard deviation.
a: Assessment of BSA affected by psoriasis did not include areas of the face, scalp, palms, soles, axillae, and other intertriginous areas.
: Source: Clinical Study Reports for Study 301¹⁰ and Study 302.¹¹

Signs and Symptoms of Psoriasis

Table 45Summary of the Signs of Psoriasis (Scaling) by Visit for the Target Lesion (ITT Set)

			% of patients
		N at baseline	Baseline	Week 2	Week 4	Week 6	Week 8	Week 12
Scaling (target lesion)
Study 301
HP/TAZ N = 135	0 – None	▬	▬	▬	▬	▬	▬	▬
	1 – Minimum	▬	▬	▬	▬	▬	▬	▬
	2 – Mild	▬	▬	▬	▬	▬	▬	▬
	3 – Moderate	▬	▬	▬	▬	▬	▬	▬
	4 – Severe	▬	▬	▬	▬	▬	▬	▬
Vehicle N = 68	0 – None	▬	▬	▬	▬	▬	▬	▬
	1 – Minimum	▬	▬	▬	▬	▬	▬	▬
	2 – Mild	▬	▬	▬	▬	▬	▬	▬
	3 – Moderate	▬	▬	▬	▬	▬	▬	▬
	4 – Severe	▬	▬	▬	▬	▬	▬	▬
Study 302
HP/TAZ N = 141	0 – None	▬	▬	▬	▬	▬	▬	▬
	1 – Minimum	▬	▬	▬	▬	▬	▬	▬
	2 – Mild	▬	▬	▬	▬	▬	▬	▬
	3 – Moderate	▬	▬	▬	▬	▬	▬	▬
	4 – Severe	▬	▬	▬	▬	▬	▬	▬
Vehicle N = 74	0 – None	▬	▬	▬	▬	▬	▬	▬
	1 – Minimum	▬	▬	▬	▬	▬	▬	▬
	2 – Mild	▬	▬	▬	▬	▬	▬	▬
	3 – Moderate	▬	▬	▬	▬	▬	▬	▬
	4 – Severe	▬	▬	▬	▬	▬	▬	▬

: HP/TAZ = halobetasol propionate and tazarotene; ITT = intention to treat.
: Source: Clinical Study Reports for Study 301¹⁰ and Study 302.¹¹

Table 46Summary of the Signs of Psoriasis (Plaque Elevation) by Visit for the Target Lesion (ITT Set)

			% of patients
		N at baseline	Baseline	Week 2	Week 4	Week 6	Week 8	Week 12
Plaque Elevation (Target Lesion)
Study 301
HP/TAZ N = 135	0 – None	▬	▬	▬	▬	▬	▬	▬
	1 – Minimum	▬	▬	▬	▬	▬	▬	▬
	2 – Mild	▬	▬	▬	▬	▬	▬	▬
	3 – Moderate	▬	▬	▬	▬	▬	▬	▬
	4 – Severe	▬	▬	▬	▬	▬	▬	▬
Vehicle N = 68	0 – None	▬	▬	▬	▬	▬	▬	▬
	1 – Minimum	▬	▬	▬	▬	▬	▬	▬
	2 – Mild	▬	▬	▬	▬	▬	▬	▬
	3 – Moderate	▬	▬	▬	▬	▬	▬	▬
	4 – Severe	▬	▬	▬	▬	▬	▬	▬
Study 302
HP/TAZ N = 141	0 – None	▬	▬	▬	▬	▬	▬	▬
	1 – Minimum	▬	▬	▬	▬	▬	▬	▬
	2 – Mild	▬	▬	▬	▬	▬	▬	▬
	3 – Moderate	▬	▬	▬	▬	▬	▬	▬
	4 – Severe	▬	▬	▬	▬	▬	▬	▬
Vehicle N = 74	0 – None	▬	▬	▬	▬	▬	▬	▬
	1 – Minimum	▬	▬	▬	▬	▬	▬	▬
	2 – Mild	▬	▬	▬	▬	▬	▬	▬
	3 – Moderate	▬	▬	▬	▬	▬	▬	▬
	4 – Severe	▬	▬	▬	▬	▬	▬	▬

: HP/TAZ = halobetasol propionate and tazarotene; ITT = intention to treat.
: Source: Clinical Study Reports for Study 301¹⁰ and Study 302.¹¹

Table 47Summary of the Signs of Psoriasis (Erythema) by Visit for the Target Lesion (ITT Set)

			% of patients
		N at baseline	Baseline	Week 2	Week 4	Week 6	Week 8	Week 12
Erythema (target lesion)
Study 301
HP/TAZ N = 135	0 – None	0	▬	▬	▬	▬	▬	▬
	1 – Minimum	0	▬	▬	▬	▬	▬	▬
	2 – Mild	15	▬	▬	▬	▬	▬	▬
	3 – Moderate	109	▬	▬	▬	▬	▬	▬
	4 – Severe	11	▬	▬	▬	▬	▬	▬
Vehicle N = 68	0 – None	0	▬	▬	▬	▬	▬	▬
	1 – Minimum	0	▬	▬	▬	▬	▬	▬
	2 – Mild	5	▬	▬	▬	▬	▬	▬
	3 – Moderate	55	▬	▬	▬	▬	▬	▬
	4 – Severe	8	▬	▬	▬	▬	▬	▬
Study 302
HP/TAZ N = 141	0 - None	0	▬	▬	▬	▬	▬	▬
	1 - Minimum	0	▬	▬	▬	▬	▬	▬
	2 – Mild	10	▬	▬	▬	▬	▬	▬
	3 – Moderate	112	▬	▬	▬	▬	▬	▬
	4 – Severe	19	▬	▬	▬	▬	▬	▬
Vehicle N = 74	0 – None	0	▬	▬	▬	▬	▬	▬
	1 – Minimum	0	▬	▬	▬	▬	▬	▬
	2 – Mild	6	▬	▬	▬	▬	▬	▬
	3 – Moderate	55	▬	▬	▬	▬	▬	▬
	4 – Severe	13	▬	▬	▬	▬	▬	▬

: HP/TAZ = halobetasol propionate and tazarotene; ITT = intention to treat.
: Source: Clinical Study Reports for Study 301¹⁰ and Study 302.¹¹

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Clinical Review Report: Halobetasol Propionate and Tazarotene (Duobrii): (Bausch Health, Canada Inc.): Indication: Psoriasis, moderate-to-severe plaque [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2020 Dec. Appendix 3, Detailed Outcome Data.
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