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

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

  • National Institute for Health and Care Excellence (NICE)