Appendix: Information to facilitate discussion of risks and benefits of treatments for people with psoriasis

Guidance

Topical therapies (short-term)
Phototherapy (short-term)
Systemic, non-biologic therapies (short-term)
Systemic, biologic therapies (short-term)
Long-term risks

Appendix: Information to facilitate discussion of risks and benefits of treatments for people with psoriasis

Data are provided for the proportions of people achieving remission, withdrawing due to adverse events and experiencing specific adverse events (as prioritised by the GDG) for interventions that have been recommended in this guideline. Data are based on pooled estimates where possible and from trials with populations and dosing appropriate to the intervention. For full details of the duration of treatment and dosing schedules please refer to the main text of the guideline.

Text is labelled with an asterisk when the GDG had very low confidence in the absolute estimates, for example due to confounding and inadequate sample size.

For a landscape version of the following table, please refer to the full version of the guideline.

Topical therapies (short-term)

Population (psoriasis phenotype)	N achieving remissions (clear/nearly clear or PASI75)		N experiencing:
			Withdrawal due to drug toxicity		Serious/named adverse events
Vitamin D or vitamin D analogues
Chronic plaque psoriasis of trunk and limbs	Intervention		Intervention		Intervention
	Once daily: 220/1000 Twice daily: 487/1000		Once or twice daily: 23/1000		Skin atrophy Twice daily: 1.9/1000
	Placebo		Placebo		Placebo
	Once daily: 76/1000 Twice daily: 122/1000		Once or twice daily: 29/1000		Skin atrophy Twice daily: 3.2/1000
	No active comparator¹
Children with chronic plaque psoriasis of trunk and limbs*	Intervention		Intervention		Intervention
	Twice daily: 605/1000*		NA*		NA*
	Placebo		Placebo		Placebo
	Twice daily: 441/1000*		NA*		NA*
	No active comparator¹				NA*
Scalp psoriasis	Intervention		Intervention		Intervention
	Once daily: 387/1000		Once daily: 81/1000		NA
	Placebo		Placebo		Placebo
	Once daily: 219/1000		Once daily: 52/1000		NA
	No active comparator¹
Potent corticosteroids
Chronic plaque psoriasis of trunk and limbs		Intervention		Intervention		Intervention
		Once or twice daily: 394/1000		Once daily: 10/1000 Twice daily: 25/1000		Skin atrophy Once or twice daily: 5.5/1000
		Placebo		Placebo		Placebo
		Once or twice daily: 77/1000		Once daily: 79/1000 Twice daily: 0/1000		Skin atrophy Once or twice daily: 0/1000
		No active comparator¹
Scalp psoriasis		Intervention		Intervention		Intervention
		Once or twice daily: 632/1000		Once or twice daily: 9.5/1000		NA
		Placebo		Placebo		Placebo
		Once or twice daily: 223/1000		Once or twice daily: 41/1000		NA
		No active comparator¹				NA
Vitamin D or analogue and potent steroid, applied one in the morning and one in the evening
Chronic plaque psoriasis of trunk and limbs		Intervention		Intervention		Intervention
		611/1000		13/1000		NA
		No placebo
		Active comparator		Active comparator		Active comparator
		Calcipotriol Twice daily 469/1000		Calcipotriol Twice daily 26/1000		NA
Combined vitamin D or analogue and potent steroid
Chronic plaque psoriasis of trunk and limbs		Intervention		Intervention			Intervention
		Once daily: 494/1000		Once daily: 7.5/1000			Skin atrophy Once daily: 4.2/1000
		No placebo
		Active comparator		Active comparator			Active comparator
		Vitamin D Once daily: 193/1000		Vitamin D Once or twice daily: 27/1000			Skin atrophy Vitamin D Twice daily: 1.8/1000
Scalp psoriasis		Intervention		Intervention			Intervention
		Once daily: 800/1000		Once daily: 17/1000*			NA
		Placebo		Placebo			Placebo
		Once daily: 500/1000		Once daily: 0/1000*			NA
		No active comparator¹
Very potent corticosteroids
Chronic plaque psoriasis of trunk and limbs		Intervention		Intervention			Intervention
		Once or twice daily: 625/1000		Once or twice daily: 4.6/1000			Skin atrophy Once or twice daily: 23/1000
		Placebo		Placebo			Placebo
		Once or twice daily: 13/1000		Once or twice daily: 6.0/1000			Skin atrophy Once or twice daily: 0/1000
		No active comparator¹
Scalp psoriasis		Intervention		Intervention			Intervention
		Once or twice daily: 646/1000		Once or twice daily: 0/1000			Skin atrophy Once or twice daily: 0/1000
		Placebo		Placebo			Placebo
		Once or twice daily: 80/1000		Placebo Once or twice daily: 5.9/1000			Placebo Skin atrophy Once or twice daily: 11/1000
		No active comparator¹
Tazarotene
Chronic plaque psoriasis of trunk and limbs		Intervention		Intervention			Intervention
		Once daily: 58/1000		Once daily: 107/1000			Skin atrophy Once daily: 0/1000
		Placebo		Placebo			Placebo
		Once daily: 20/1000		Once daily: 44/1000			Skin atrophy Once daily: 0/1000
		No active comparator¹
Short-contact dithranol ²
Chronic plaque psoriasis of trunk and limbs		Intervention		Intervention			Intervention
		Once daily: 430/1000		Once daily: 82/1000			NA
		No placebo
		Active comparator		Active comparator			Active comparator
		Calcipotriol twice daily: 588/1000		Calcipotriol twice daily: 39/1000			NA
Coal tar
Chronic plaque psoriasis of trunk and limbs*		Intervention		Intervention			Intervention
		Once or twice daily: 111/1000 to 519/1000 depending on formulation and follow-up*		Once or twice daily: 0–56/1000 depending on formulation and follow-up*			NA*
		No placebo
		Active comparator		Active comparator			Active comparator
		Calcipotriol Twice daily: 214/1000 to 723/1000 depending on follow-up*		Calcipotriol Twice daily: 0–40/1000 depending on follow-up*			NA*
Tacromilus
Psoriasis of the face and flexures*		Intervention		Intervention			Intervention
		Twice daily: 652/1000*		Twice daily: 0/1000*			NA*
		Placebo		Placebo			Placebo
		Twice daily: 309/1000*		Twice daily: 25/1000*			NA*
		No active comparator¹
Pimecrolimus
Psoriasis of the flexures*		Intervention		Intervention			Intervention
		Twice daily: 714/1000*		Twice daily: 0/1000*			Skin atrophy Twice daily: 0/1000*
		Placebo		Placebo			Placebo
		Twice daily: 207/1000*		Twice daily: 0/1000*			Skin atrophy Twice daily: 0/1000*
		No active comparator¹
Abbreviations: NA, not available. * GDG had very low confidence in the absolute estimates, for example due to confounding and inadequate sample size. ¹ An active comparator will only be included if no placebo comparison is available; the standard intervention will be chosen if multiple active comparators are available. ² 2/3 studies reported home-use of dithranol and in 1/3 studies the setting was unclear.

Phototherapy (short-term)

Population (psoriasis phenotype)		N achieving remissions (clear/nearly clear or PASI75)		N experiencing:
				Withdrawal due to drug toxicity				Serious/named adverse events
NBUVB vs PUVA
Plaque psoriasis		Intervention		Intervention				Intervention
		Twice weekly 647/1000		Twice weekly 38/1000				NA
		No placebo
		Active comparator		Active comparator				Active comparator
		Oral PUVA (twice weekly) 915/1000		Oral PUVA (twice weekly) 47/1000				NA
PUVA (oral)
Palmoplantar pustulosis		Intervention		Intervention				Intervention
		3–4 times weekly 941/1000		3–4 times weekly 29/1000*				Burn 3–4 times weekly 147/1000*
		Placebo		Placebo				Placebo
		No treatment 500/1000		No treatment 0/1000*				No treatment 0/1000*
		No active comparator¹
PUVA (cream)
Palmoplantar pustulosis*			Intervention			Intervention	Intervention
			3 times weekly 952/1000*			3 times weekly 45/1000*	NA*
			No placebo
			Active comparator			Active comparator	Active comparator
			NBUVB 3 times weekly 429/1000*			NBUVB 3 times weekly 0/1000*	NA*
NBUVB plus vitamin D or analogues
Plaque psoriasis*			Intervention			Intervention			Intervention
			3 times weekly UV + Twice daily topical 900/1000*			3 times weekly UV + Twice daily topical 50/1000*			Burn 3 times weekly UV + Twice daily topical 200/1000*
			No placebo
			Active comparator			Active comparator*			Active comparator*
			3 times weekly NBUVB alone 611/1000*			3 times weekly NBUVB alone 28/1000*			Burn 3 times weekly NBUVB alone 111/1000*
BBUVB plus vitamin D or analogues
Plaque psoriasis*	Intervention				Intervention					Intervention
	Up to 3 times weekly UV + Twice daily topical 449/1000 8 weeks*				Up to 3 times weekly UV + Twice daily topical 41/1000*					NA*
	No placebo*
	Active comparator				Active comparator					Active comparator
	BBUVB alone up to 3 times weekly 208/1000*				BBUVB alone up to 3 times weekly 19/1000*					NA*
Liquor carbonic distillate (equivalent 2.3% coal tar) plus NBUVB
Plaque psoriasis*	Intervention				Intervention					Intervention
	Clear (3 times weekly UV+ twice daily topical) 583/1000*				3 times weekly UV + twice daily topical 0/1000*					Burn 3 times weekly UV + twice daily topical 167/1000*
	No placebo
	Active comparator				Active comparator					Active comparator
	3 times weekly NBUVB alone 500/1000*				3 times weekly NBUVB alone 0/1000*					Burn NBUVB alone 3 times weekly 167/1000*
Dithranol plus BBUVB
Psoriasis*			Intervention			Intervention			Intervention
			3 times weekly UV + twice daily topical 625/1000*			NA*			NA*
			No placebo
			Active comparator			Active comparator			Active comparator
			3 times weekly BBUVB alone 458/1000*			NA*			NA*
Abbreviations: BBUVB, broadband UVB; NA, not available, NBUVB, narrowband UVB; PUVA, psoralen plus UVA. * The GDG had very low confidence in the absolute estimates, for example due to confounding and inadequate sample size. ¹ An active comparator will only be included if no placebo comparison is available; the standard intervention will be chosen if multiple active comparators are available.

Systemic, non-biologic therapies (short-term)

Population (psoriasis phenotype)	N achieving remissions (clear/nearly clear or PASI75)	N experiencing:
		Withdrawal due to drug toxicity	Serious/named adverse events
Methotrexate; incremental dosing (plus folic acid)
Chronic plaque psoriasis	Intervention	Intervention	Intervention
	415/1000	55/1000*	Elevated liver enzymes (>1.5–2.5 ULN) 91/1000*
	Placebo	Placebo	Placebo
	188/1000	20/1000*	Elevated liver enzymes (>1.5–2.5 ULN) 75/1000*
Ciclosporin
Chronic plaque psoriasis	Intervention	Intervention	Intervention
	2.5–3 mg 232/1000 5 mg 600/1000	0/1000*	Hypertension 391/1000 Decrease in GFR >15% 3 mg/kg: 333/1000 5 mg/kg: 500/1000*
	Placebo	Placebo	Placebo
	44/1000	0/1000*	Hypertension 333/1000 Decrease in GFR >15% 0/1000*
Ciclosporin
Palmoplantar pustulosis	Intervention	Intervention	Intervention
	652/1000	NA	Hypertension 37/1000*
	Placebo	Placebo	Placebo
	200/1000	NA	Hypertension 0/1000*
Acitretin – 25 mg
Plaque, pustular and erythrodermic psoriasis*	Intervention	Intervention	Intervention
	480/1000*	18/1000*	Cheilitis 850/1000 Hair loss 150/1000 Elevated liver enzymes (>ULN) 200/1000 Elevated cholesterol (>ULN) 0/1000*
	Placebo	Placebo	Placebo
	188/1000*	0/1000*	Cheilitis 300/1000 Hair loss 100/1000 Elevated liver enzymes (>ULN) 0/1000 Elevated cholesterol (>ULN) 53/1000*
Abbreviations: GFR, glomerular filtration rate; NA, not available; ULN, upper limit of normal. * The GDG had very low confidence in the absolute estimates, for example due to confounding and inadequate sample size.

Systemic, biologic therapies (short-term)

Population (psoriasis phenotype)	Prior biologics received	N achieving remissions (clear/nearly clear or PASI75)	N experiencing withdrawal due to drug toxicity or serious adverse events
Infliximab
Adults with severe plaque psoriasis and prior biologic exposure	Unclear	Intervention	Intervention
		723/1000	NA
		Placebo	Placebo
		0/1000*	NA
		No active comparator¹
Etanercept
Adults with severe plaque psoriasis and prior biologic exposure*	Included etanercept, infliximab, and adalimumab (proportions unclear)*	Intervention	Intervention
		370/1000*	NA*
		Placebo	Placebo
		NA*	NA*
		Active comparator	Active comparator
		Ustekinumab 556/1000*	NA*
Ustekinumab
Adults with severe plaque psoriasis and prior biologic exposure	Included etanercept, infliximab, and adalimumab (proportions unclear)	Intervention	Intervention
		619/1000	NA
		Placebo	Placebo
		170/1000	NA
		No active comparator¹
Adalimumab
Adults with severe plaque psoriasis*	Etanercept (32.1%), alefacept (23.1%), ustekinumab (23.1%), efalizumab (21.8%), infliximab (20.5%), and other (17.9%)*	Intervention	Intervention
		654/1000*	NA*
		Placebo	Placebo
		NA*	NA*
		Active comparator	Active comparator
		No prior biologic 744/1000*	NA*
Abbreviations: NA, not available. * The GDG had very low confidence in the absolute estimates, for example due to confounding and inadequate sample size. ¹ An active comparator will only be included if no placebo comparison is available; the standard intervention will be chosen if multiple active comparators are available.

Long-term risks

Outcome(s)

Population – psoriasis phenotype

Number experiencing event

PUVA (oral)

Skin cancer – SCC

Plaque (84%), guttate (12%) and erythrodermic (4%) psoriasis

Relative risk compared with the general population

PUVA exposures	RR
<100	5.1 (3.5–7.2)
100–159	8.4 (5.6–12.1)
160–336	26.5 (22.2–31.4)
≥337	68.5 (54.9–84.5)

Absolute increase in risk

PUVA exposures	SCCs	% increase in 10-year risk
<100	18	1.7%
100–159	15	2.7%
160–336	68	8.8%
≥337	34	12.7%

NBUVB

Skin cancer

Insufficient data available

Methotrexate

Liver fibrosis, bone marrow suppression and pneumonitis

No long-term data available

Ciclosporin

Hypertension, renal impairment, gout and hyperuricaemia

No long-term data available

Acitretin

Hyperlipidaemia, hepatotoxicity, skeletal AEs and cheilitis

No long-term data available

Abbreviations: PUVA, psoralen plus UVA; RR, relative risk; SCC, squamous cell carcinoma.

ISBN: 978-1-4731-1107-3