Detailed Outcome Data

Appendix 3Detailed Outcome Data

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Health-Related Quality of Life

Table 43

Change From Baseline in DLQI Score (ITT Set).

Skin Clearance

Table 44

Change From Baseline of Affected BSA (ITT Set).

Signs and Symptoms of Psoriasis

Table 45

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

Table 46

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

Table 47

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

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Publisher

Canadian Agency for Drugs and Technologies in Health, Ottawa (ON)

NLM Citation

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.

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

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

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