Guidance

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 is provided for the proportions of people achieving remission, withdrawing due to adverse events and experiencing specific adverse events (as prioritised by the guideline development group [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 guideline.

Table 1 Topical therapies (short term): vitamin D or vitamin D analogues
Population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Chronic plaque psoriasis of trunk and limbs

Intervention:

  • Once daily: 220/1000

  • Twice daily: 487/1000

Placebo:

  • Once daily: 76/1000

  • Twice daily: 122/1000

Intervention:

  • Once or twice daily: 23/1000

Placebo:

  • Once or twice daily: 29/1000

Intervention:

Skin atrophy

  • Twice daily: 1.9/1000

Placebo:

Skin atrophy

  • Twice daily: 3.2/1000

Children with chronic plaque psoriasis of trunk and limbs

Note: the guideline development group (GDG) had very low confidence in the absolute estimates, for example, due to confounding and inadequate sample size

Intervention:

  • Twice daily: 605/1000

Placebo:

  • Twice daily: 441/1000

Intervention: Not available

Placebo: Not available

Intervention: Not available

Placebo: Not available

Scalp psoriasis

Intervention:

  • Once daily: 387/1000

Placebo:

  • Once daily: 219/1000

Intervention:

  • Once daily: 81/1000

Placebo:

  • Once daily: 52/1000

Intervention: Not available

Placebo: Not available
Table 2 Topical therapies (short term): potent corticosteroids
Population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Chronic plaque psoriasis of trunk and limbs

Intervention:

  • Once or twice daily: 394/1000

Placebo:

  • Once or twice daily: 77/1000

Intervention:

  • Once daily: 10/1000

  • Twice daily: 25/1000

Placebo:

  • Once daily: 79/1000

  • Twice daily: 0/1000

Intervention:

Skin atrophy

  • Once or twice daily: 5.5/1000

Placebo:

Skin atrophy

  • Once or twice daily: 0/1000

Scalp psoriasis

Intervention:

  • Once or twice daily: 632/1000

Placebo:

  • Once or twice daily: 223/1000

Intervention:

  • Once or twice daily: 9.5/1000

Placebo:

  • Once or twice daily: 41/1000

Intervention: Not available

Placebo: Not available

Note: No active comparator. 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.

Table 3 Topical therapies (short term): vitamin D or analogue and potent steroid, applied 1 in the morning and 1 in the evening
Population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Chronic plaque psoriasis of trunk and limbs

Intervention:

  • 611/1000

No placebo

Active comparator, calcipotriol:

  • Twice daily: 469/1000

Intervention:

  • 13/1000

Active comparator, calcipotriol:

  • Twice daily: 26/1000

Intervention: Not available

Active comparator: Not available
Table 4 Topical therapies (short term): combined vitamin D or analogue and potent steroid
Population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Chronic plaque psoriasis of trunk and limbs

Intervention:

  • Once daily: 494/1000

No placebo

Active comparator:

  • vitamin D once daily: 193/1000

Intervention:

  • Once daily: 7.5/1000

Active comparator:

  • Vitamin D once or twice daily: 27/1000

Intervention:

Skin atrophy

  • Once daily: 4.2/1000

Active comparator:

Skin atrophy

  • Vitamin D twice daily: 1.8/1000

Scalp psoriasis

Note: No active comparator. 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.

Intervention:

  • Once daily: 800/1000

Placebo:

  • Once daily: 500/1000

Intervention:

  • Once daily: 17/1000

Placebo:

  • Once daily: 0/1000

Note: the guideline development group (GDG) had very low confidence in the absolute estimates, for example, due to confounding and inadequate sample size

Intervention: Not available

Placebo: Not available
Table 5 Topical therapies (short term): very potent corticosteroids
Population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Chronic plaque psoriasis of trunk and limbs

Intervention:

  • Once or twice daily: 625/1000

Placebo:

  • Once or twice daily: 13/1000

Intervention:

  • Once or twice daily: 4.6/1000

Placebo:

  • Once or twice daily: 6.0/1000

Intervention:

Skin atrophy

  • Once or twice daily: 23/1000

Placebo:

Skin atrophy

  • Once or twice daily: 0/1000

Scalp psoriasis

Intervention:

  • Once or twice daily: 646/1000

Placebo:

  • Once or twice daily: 80/1000

Intervention:

  • Once or twice daily: 0/1000

Placebo:

  • Once or twice daily: 5.9/1000

Intervention:

Skin atrophy

  • Once or twice daily: 0/1000

Placebo:

Skin atrophy

  • Once or twice daily: 11/1000

Note: No active comparator. 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.

Table 6 Topical therapies (short term): tazarotene
Population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Chronic plaque psoriasis of trunk and limbs

Intervention:

  • Once daily: 58/1000

Placebo:

  • Once daily: 20/1000

Intervention:

  • Once daily: 107/1000

Placebo:

  • Once daily: 44/1000

Intervention:

Skin atrophy

  • Once daily: 0/1000

Placebo:

Skin atrophy

  • Once daily: 0/1000

Note: No active comparator. 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.

Table 7 Topical therapies (short term): short-contact dithranol
Population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Chronic plaque psoriasis of trunk and limbs

Intervention:

  • Once daily: 430/1000

No placebo

Active comparator, calcipotriol:

  • Twice daily: 588/1000

Intervention:

  • Once daily: 82/1000

Active comparator, calcipotriol:

  • Twice daily: 39/1000

Intervention: Not available

Active comparator: Not available

Note: two-third of studies reported home-use of dithranol and in one-third of studies, the setting was unclear.

Table 8 Topical therapies (short term): coal tar
Population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Chronic plaque psoriasis of trunk and limbs

Intervention:

  • Once or twice daily: 111/1000 to 519/1000 depending on formulation and follow-up

No placebo

Active comparator, calcipotriol:

  • Twice daily: 214/1000 to 723/1000 depending on follow-up

Intervention:

  • Once or twice daily: 0 to 56/1000 depending on formulation and follow-up

Active comparator, calcipotriol:

  • Twice daily: 0 to 40/1000 depending on follow-up

Intervention: Not available

Active comparator: Not available

Note: the guideline development group (GDG) had very low confidence in the absolute estimates, for example, due to confounding and inadequate sample size.

Table 9 Topical therapies (short term): tacrolimus
Population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Psoriasis of the face and flexures

Intervention:

  • Twice daily: 652/1000

Placebo:

  • Twice daily: 309/1000

Intervention:

  • Twice daily: 0/1000

Placebo:

  • Twice daily: 25/1000

Intervention: Not available

Placebo: Not available

1) The guideline development group (GDG) had very low confidence in the absolute estimates, for example, due to confounding and inadequate sample size.

2) No active comparator. 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.

Table 10 Topical therapies (short term): pimecrolimus
Population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Psoriasis of the flexures

Intervention:

  • Twice daily: 714/1000

Placebo:

  • Twice daily: 207/1000

Intervention:

  • Twice daily: 0/1000

Placebo:

  • Twice daily: 0/1000

Intervention:

Skin atrophy

  • Twice daily: 0/1000

Placebo:

Skin atrophy

  • Twice daily: 0/1000

1) The guideline development group (GDG) had very low confidence in the absolute estimates, for example, due to confounding and inadequate sample size.

2) No active comparator. 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.

Table 11 Phototherapy (short term)
Intervention and population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

NBUVB versus PUVA

Plaque psoriasis

Intervention:

  • Twice weekly: 647/1000

No placebo

Active comparator, oral PUVA:

  • Twice weekly: 915/1000

Intervention:

  • Twice weekly: 38/1000

No placebo

Active comparator, oral PUVA:

  • Twice weekly: 47/1000

Intervention: Not available

Active comparator: Not available

PUVA (oral)

Palmoplantar pustulosis

Note: No active comparator. 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.

Intervention:

  • 3 to 4 times weekly: 941/1000

Placebo, no treatment:

  • 500/1000

Intervention:

  • 3 to 4 times weekly: 29/1000

Placebo, no treatment:

  • 0/1000

Intervention:

Burn

  • 3 to 4 times weekly: 147/1000

Placebo, no treatment:

  • 0/1000

PUVA (cream)

Palmoplantar pustulosis

Intervention:

  • 3 times weekly: 952/1000

No placebo

Active comparator,

NBUVB:

  • 3 times weekly: 429/1000

Intervention:

  • 3 times weekly: 45/1000

No placebo

Active comparator,

NBUVB:

  • 3 times weekly: 0/1000

Intervention: Not available

Active comparator: Not available

NBUVB plus vitamin D or analogues

Plaque psoriasis

Intervention:

  • 3 times weekly UV + twice daily topical: 900/1000

No placebo

Active comparator,

NBUVB alone:

  • 3 times weekly: 611/1000

Intervention:

  • 3 times weekly UV + twice daily topical: 50/1000

No placebo

Active comparator, NBUVB alone:

  • 3 times weekly: 28/1000

Intervention:

Burn

  • 3 times weekly UV + twice daily topical: 200/1000

No placebo

Active comparator, NBUVB alone:

Burn

  • 3 times weekly: 111/1000

BBUVB plus vitamin D or analogues

Plaque psoriasis

Intervention:

  • Up to 3 times weekly UV + twice daily topical: 449/1000 8 weeks

No placebo

Active comparator, BBUVB alone:

  • up to 3 times weekly: 208/1000

Intervention:

  • Up to 3 times weekly UV + twice daily topical: 41/1000

No placebo

Active comparator, BBUVB alone:

  • up to 3 times weekly: 19/1000

Intervention: Not available

Active comparator: Not available

Liquor carbonic distillate (equivalent 2.3% coal tar) plus NBUVB

Plaque psoriasis

Intervention:

  • Clear (3 times weekly UV + twice daily topical): 583/1000

No placebo

Active comparator, NBUVB alone:

  • 3 times weekly: 500/1000

Intervention:

  • 3 times weekly UV + twice daily topical: 0/1000

No placebo

Active comparator, NBUVB alone:

  • 3 times weekly: 0/1000

Intervention:

Burn

  • 3 times weekly UV + twice daily topical: 167/1000

No placebo

Active comparator, NBUVB alone:

Burn

  • 3 times weekly: 167/1000

Dithranol plus BBUVB

Psoriasis

Intervention:

  • 3 times weekly UV + twice daily topical: 625/1000

No placebo

Active comparator, BBUVB alone:

  • 3 times weekly: 458/1000

Intervention: Not available

Active comparator: Not available

Intervention: Not available

Active comparator: Not available

Abbreviations: BBUVB, broadband UVB; NBUVB, narrowband UVB; PUVA, psoralen plus UVA; UVA, ultraviolet A; UVB, ultraviolet B.

Note: for all the interventions except NBUVB versus PUVA, the guideline development group (GDG) had very low confidence in the absolute estimates, for example, due to confounding and inadequate sample size.

Table 12 Systemic, non-biologic therapies (short-term)
Intervention and population (psoriasis phenotype) Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity Numbers experiencing serious or named adverse events

Methotrexate; incremental dosing (plus folic acid)

Chronic plaque psoriasis

Intervention:

  • 415/1000

Placebo:

  • 188/1000

Intervention:

  • 55/1000*

Placebo:

  • 20/1000*

Intervention:

Elevated liver enzymes (>1.5 to 2.5 ULN): 91/1000*

Placebo:

Elevated liver enzymes (>1.5 to 2.5 ULN): 75/1000*

Ciclosporin

Chronic plaque psoriasis

Intervention:

  • 2.5 to 3 mg: 232/1000

  • 5 mg: 600/1000

Placebo:

  • 44/1000

Intervention:

  • 0/1000*

Placebo:

  • 0/1000*

Intervention:

Hypertension:

  • 391/1000

Decrease in GFR >15%:

  • 3 mg/kg: 333/1000

  • 5 mg/kg: 500/1000*

Placebo:

Hypertension:

  • 333/1000

Decrease in GFR >15%:

  • 0/1000*

Ciclosporin

Palmoplantar pustulosis

Intervention:

  • 652/1000

Placebo:

  • 200/1000

Intervention: Not available

Placebo: Not available

Intervention:

Hypertension:

  • 37/1000*

Placebo:

Hypertension

  • 0/1000*

Acitretin – 25 mg

Plaque, pustular and erythrodermic psoriasis*

Intervention:

  • 480/1000*

Placebo:

  • 188/1000*

Intervention:

  • 18/1000*

Placebo:

  • 0/1000*

Intervention:

Cheilitis:

  • 850/1000

Hair loss:

  • 150/1000

Elevated liver enzymes (>ULN):

  • 200/1000

Elevated cholesterol (>ULN):

  • 0/1000*

Placebo:

Cheilitis:

  • 300/1000

Hair loss:

  • 100/1000

Elevated liver enzymes (>ULN):

  • 0/1000

Elevated cholesterol (>ULN):

  • 53/1000*

Abbreviations: GFR, glomerular filtration rate; ULN, upper limit of normal.

Note: The guideline development group (GDG) had very low confidence in the absolute estimates, for example, due to confounding and inadequate sample size.

Table 13 Systemic, biologic therapies (short-term)
Intervention and population (psoriasis phenotype) Prior biologics received Numbers achieving remissions (clear, nearly clear, or PASI75) Numbers experiencing withdrawal due to drug toxicity or serious adverse events

Infliximab

Adults with severe plaque psoriasis and prior biologic exposure

Unclear

Intervention:

  • 723/1000

Placebo:

  • 0/1000*

Intervention: Not available

Placebo: Not available

Etanercept

Adults with severe plaque psoriasis and prior biologic exposure*

Included etanercept, infliximab, and adalimumab (proportions unclear)*

Intervention:

  • 370/1000*

Placebo: Not available*

Active comparator, ustekinumab:

  • 556/1000*

Intervention: Not available*

Placebo: Not available*

Active comparator: Not available*

Ustekinumab

Adults with severe plaque psoriasis and prior biologic exposure

Included etanercept, infliximab, and adalimumab (proportions unclear)

Intervention:

  • 619/1000

Placebo:

  • 170/1000

Intervention: Not available

Placebo: Not available

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:

  • 654/1000*

Placebo: Not available*

Active comparator, no prior biologic:

  • 744/1000*

Intervention: Not available*

Placebo: Not available*

Active comparator: Not available*

Note: For the interventions infliximab and ustekinumab, there were no active comparators. 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.

Table 14 Long-term risks
Intervention and outcome(s) Population – psoriasis phenotype Number experiencing event

Psoralen plus ultraviolet A (PUVA; oral)

Skin cancer – squamous cell carcinoma (SCC)

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

Relative risk compared with the general population:

  • PUVA exposure <100; relative risk (RR) <100

  • PUVA exposure 100 to 159; RR 100 to 159

  • PUVA exposure 160 to 336; RR 160 to 336

  • PUVA exposure ≥337; RR ≥337

Absolute increase in risk:

  • PUVA exposure <100; SCCs 18; 1.7% increase in 10-year risk

  • PUVA exposure 100 to 159; SCCs 15; 2.7% increase in 10-year risk

  • PUVA exposure 160 to 336; SCCs 68; 8.8% increase in 10-year risk

  • PUVA exposure ≥337; SCCs 34; 12.7% increase in 10-year risk

Narrowband UVB (NBUVB)

Skin cancer

Insufficient data available

Insufficient data available

Methotrexate

Liver fibrosis, bone marrow suppression and pneumonitis

No long-term data available

No long-term data available

Ciclosporin

Hypertension, renal impairment, gout and hyperuricaemia

No long-term data available

No long-term data available

Acitretin

Hyperlipidaemia, hepatotoxicity, skeletal adverse events and cheilitis

No long-term data available

No long-term data available