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 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: |
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Withdrawal due to drug toxicity |
Serious/named adverse events |
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Vitamin D or vitamin D analogues |
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Chronic plaque psoriasis of trunk and limbs |
Intervention |
Intervention |
Intervention |
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Once daily: 220/1000 Twice daily: 487/1000 |
Once or twice daily: 23/1000 |
Skin atrophy Twice daily: 1.9/1000 |
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Placebo |
Placebo |
Placebo |
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Once daily: 76/1000 Twice daily: 122/1000 |
Once or twice daily: 29/1000 |
Skin atrophy Twice daily: 3.2/1000 |
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No active comparator1 |
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Children with chronic plaque psoriasis of trunk and limbs* |
Intervention |
Intervention |
Intervention |
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Twice daily: 605/1000* |
NA* |
NA* |
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Placebo |
Placebo |
Placebo |
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Twice daily: 441/1000* |
NA* |
NA* |
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No active comparator1 |
NA* |
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Scalp psoriasis |
Intervention |
Intervention |
Intervention |
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Once daily: 387/1000 |
Once daily: 81/1000 |
NA |
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Placebo |
Placebo |
Placebo |
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Once daily: 219/1000 |
Once daily: 52/1000 |
NA |
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No active comparator1 |
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Potent corticosteroids |
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Chronic plaque psoriasis of trunk and limbs |
Intervention |
Intervention |
Intervention |
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Once or twice daily: 394/1000 |
Once daily: 10/1000 Twice daily: 25/1000 |
Skin atrophy Once or twice daily: 5.5/1000 |
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Placebo |
Placebo |
Placebo |
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Once or twice daily: 77/1000 |
Once daily: 79/1000 Twice daily: 0/1000 |
Skin atrophy Once or twice daily: 0/1000 |
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No active comparator1 |
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Scalp psoriasis |
Intervention |
Intervention |
Intervention |
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Once or twice daily: 632/1000 |
Once or twice daily: 9.5/1000 |
NA |
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Placebo |
Placebo |
Placebo |
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Once or twice daily: 223/1000 |
Once or twice daily: 41/1000 |
NA |
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No active comparator1 |
NA |
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Vitamin D or analogue and potent steroid, applied one in the morning and one in the evening |
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Chronic plaque psoriasis of trunk and limbs |
Intervention |
Intervention |
Intervention |
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611/1000 |
13/1000 |
NA |
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No placebo |
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Active comparator |
Active comparator |
Active comparator |
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Calcipotriol Twice daily 469/1000 |
Calcipotriol Twice daily 26/1000 |
NA |
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Combined vitamin D or analogue and potent steroid |
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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 |
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No placebo |
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Active comparator |
Active comparator |
Active comparator |
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Vitamin D Once daily: 193/1000 |
Vitamin D Once or twice daily: 27/1000 |
Skin atrophy Vitamin D Twice daily: 1.8/1000 |
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Scalp psoriasis |
Intervention |
Intervention |
Intervention |
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Once daily: 800/1000 |
Once daily: 17/1000* |
NA |
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Placebo |
Placebo |
Placebo |
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Once daily: 500/1000 |
Once daily: 0/1000* |
NA |
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No active comparator1 |
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Very potent corticosteroids |
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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 |
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Placebo |
Placebo |
Placebo |
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Once or twice daily: 13/1000 |
Once or twice daily: 6.0/1000 |
Skin atrophy Once or twice daily: 0/1000 |
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No active comparator1 |
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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 |
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Placebo |
Placebo |
Placebo |
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Once or twice daily: 80/1000 |
Placebo Once or twice daily: 5.9/1000 |
Placebo Skin atrophy Once or twice daily: 11/1000 |
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No active comparator1 |
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Tazarotene |
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Chronic plaque psoriasis of trunk and limbs |
Intervention |
Intervention |
Intervention |
||||
Once daily: 58/1000 |
Once daily: 107/1000 |
Skin atrophy Once daily: 0/1000 |
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Placebo |
Placebo |
Placebo |
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Once daily: 20/1000 |
Once daily: 44/1000 |
Skin atrophy Once daily: 0/1000 |
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No active comparator1 |
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Short-contact dithranol 2 |
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Chronic plaque psoriasis of trunk and limbs |
Intervention |
Intervention |
Intervention |
||||
Once daily: 430/1000 |
Once daily: 82/1000 |
NA |
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No placebo |
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Active comparator |
Active comparator |
Active comparator |
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Calcipotriol twice daily: 588/1000 |
Calcipotriol twice daily: 39/1000 |
NA |
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Coal tar |
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Chronic plaque psoriasis of trunk and limbs* |
Intervention |
Intervention |
Intervention |
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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* |
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No placebo |
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Active comparator |
Active comparator |
Active comparator |
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Calcipotriol Twice daily: 214/1000 to 723/1000 depending on follow-up* |
Calcipotriol Twice daily: 0–40/1000 depending on follow-up* |
NA* |
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Tacromilus |
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Psoriasis of the face and flexures* |
Intervention |
Intervention |
Intervention |
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Twice daily: 652/1000* |
Twice daily: 0/1000* |
NA* |
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Placebo |
Placebo |
Placebo |
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Twice daily: 309/1000* |
Twice daily: 25/1000* |
NA* |
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No active comparator1 |
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Pimecrolimus |
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Psoriasis of the flexures* |
Intervention |
Intervention |
Intervention |
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Twice daily: 714/1000* |
Twice daily: 0/1000* |
Skin atrophy Twice daily: 0/1000* |
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Placebo |
Placebo |
Placebo |
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Twice daily: 207/1000* |
Twice daily: 0/1000* |
Skin atrophy Twice daily: 0/1000* |
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No active comparator1 |
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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: |
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Withdrawal due to drug toxicity |
Serious/named adverse events |
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NBUVB vs PUVA |
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Plaque psoriasis |
Intervention |
Intervention |
Intervention |
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Twice weekly 647/1000 |
Twice weekly 38/1000 |
NA |
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No placebo |
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Active comparator |
Active comparator |
Active comparator |
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Oral PUVA (twice weekly) 915/1000 |
Oral PUVA (twice weekly) 47/1000 |
NA |
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PUVA (oral) |
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Palmoplantar pustulosis |
Intervention |
Intervention |
Intervention |
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3–4 times weekly 941/1000 |
3–4 times weekly 29/1000* |
Burn 3–4 times weekly 147/1000* |
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Placebo |
Placebo |
Placebo |
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No treatment 500/1000 |
No treatment 0/1000* |
No treatment 0/1000* |
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No active comparator1 |
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PUVA (cream) |
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Palmoplantar pustulosis* |
Intervention |
Intervention |
Intervention |
|||||||
3 times weekly 952/1000* |
3 times weekly 45/1000* |
NA* |
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No placebo |
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Active comparator |
Active comparator |
Active comparator |
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NBUVB 3 times weekly 429/1000* |
NBUVB 3 times weekly 0/1000* |
NA* |
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NBUVB plus vitamin D or analogues |
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Plaque psoriasis* |
Intervention |
Intervention |
Intervention |
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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* |
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No placebo |
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Active comparator |
Active comparator* |
Active comparator* |
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3 times weekly NBUVB alone 611/1000* |
3 times weekly NBUVB alone 28/1000* |
Burn 3 times weekly NBUVB alone 111/1000* |
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BBUVB plus vitamin D or analogues |
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Plaque psoriasis* |
Intervention |
Intervention |
Intervention |
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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* |
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No placebo* |
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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* |
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Liquor carbonic distillate (equivalent 2.3% coal tar) plus NBUVB |
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Plaque psoriasis* |
Intervention |
Intervention |
Intervention |
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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* |
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No placebo |
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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* |
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Dithranol plus BBUVB |
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Psoriasis* |
Intervention |
Intervention |
Intervention |
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3 times weekly UV + twice daily topical 625/1000* |
NA* |
NA* |
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No placebo |
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Active comparator |
Active comparator |
Active comparator |
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3 times weekly BBUVB alone 458/1000* |
NA* |
NA* |
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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 |
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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 |
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Palmoplantar pustulosis |
Intervention |
Intervention |
Intervention |
652/1000 |
NA |
Hypertension 37/1000* |
|
Placebo |
Placebo |
Placebo |
|
200/1000 |
NA |
Hypertension 0/1000* |
|
Acitretin – 25 mg |
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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 |
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PUVA (oral) |
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Skin cancer – SCC |
Plaque (84%), guttate (12%) and erythrodermic (4%) psoriasis |
Relative risk compared with the general population
Absolute increase in risk
|
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NBUVB |
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Skin cancer |
Insufficient data available |
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Methotrexate |
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Liver fibrosis, bone marrow suppression and pneumonitis |
No long-term data available |
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Ciclosporin |
|||||||||||||||||||||||||||
Hypertension, renal impairment, gout and hyperuricaemia |
No long-term data available |
||||||||||||||||||||||||||
Acitretin |
|||||||||||||||||||||||||||
Hyperlipidaemia, hepatotoxicity, skeletal AEs and cheilitis |
No long-term data available |
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Abbreviations: PUVA, psoralen plus UVA; RR, relative risk; SCC, squamous cell carcinoma. |
ISBN: 978-1-4731-1107-3