Therapeutic goals and treatment response evaluation in moderate to severe psoriasis: an experts opinion document

Figures & data

Figure 1. Project methodology flowchart. Abbreviation. SLR: systematic literature review.

Table 1. Treatment goals definitions for patients with moderate to severe psoriasis according to clinical guidelines/consensus documents.

#	Document	Definition
1	French guideline of systemic therapy [23]	-Several factors should be taken into account when establishing treatment goals for systemic therapy: Disease severity (measured as either an absolute value or by comparison with baseline values) Presence of PsA or any other comorbidities Disease impact on the physical, psychological and social well-being of the patient The risk–benefit ratio of continuous systemic treatment Patient’s point of view and level of satisfaction
2	Australian consensus of treatment goal [26]	-Not clearly stated -Based on treatment response and failure
3	European consensus of treatment goal [15]	-The ultimate goal of any psoriasis treatment is to achieve complete clearance of skin symptoms -It has to be based upon the results achievable with available treatments as indicated by the results of RCTs and the outcomes observed in clinical practice -It needs a minimal degree of improvement (principle of the lowest hurdle) and the drug-specific evaluation time points
4	Spanish consensus of systemic therapy [18,25]	-The ideal outcome is to achieve: PASI 90, PGA ≤ 1, or alternatively a minimal and controllable localised involvement with topical treatments (PGA ≤ 2 and PASI < 5), DLQI ≤ 1, prolonged remissions without loss of efficacy, no worsening of comorbidities -Criteria for an appropriate response initially and in the long term (more than 6 months), ≥1 of: PASI 75, PASI < 5, PGA ≤ 1, DLQI < 5 -Criteria for the minimum efficacy required: PASI 50, PASI <50 if the patient is satisfied with the result, DLQI < 5
5	European guideline of systemic therapy [20,21]	-Not specifically stated -PGA 0/1 (i.e. “clear”/“almost clear”) in the induction and in long-term is considered as critical
6	European consensus of apremilast / secukinumab [22]	-It uses the same criteria of the European consensus of systemic therapy [20,21]
7	Italian guideline of systemic therapy [24]	-Treatment goals should be agreed with the patient based on informed discussion PASI 75 PASI 90 There is a need to define the minimum absolute PASI (i.e. <1 or 2) DLQI < 5
8	British guideline of systemic therapy [27]	-Tailor the choice of agent to the needs of the person and take into account the following factors Psoriasis factors: Goal of therapy (e.g. PGA of clear or nearly clear) Disease phenotype and pattern of activity Disease severity and impact The presence of psoriatic arthritis (in consultation with an adult or paediatric rheumatologist) Other factors: Person’s age Past or current comorbid conditions (e.g. inflammatory bowel disease, cardiovascular disease) Conception plans Body weight Person’s views and any stated preference on administration route or frequency Adherence
9	American consensus of fototherapy and systemic therapy [16,17]	-Not specifically stated

Abbreviations. PsA: psoriatic arthritis; PASI: Psoriasis Area and Severity Index; BSA: Body Surface Area; DLQI: dermatology life quality index; RCT: randomised controlled trial; PGA: Physician’s Global Assessment.

Table 2. Main messages from the statements that achieved consensus in the Delphi process regarding to therapeutic goals in moderate to severe psoriasis.

#	Consensus (on the agreement)
1	The therapeutic goal should be:
1.1	Individualized
1.2	Adapted to the characteristics of the disease
1.3	Adapted to the characteristics of the patient
1.4	Established in general regardless of the type of drug for psoriasis
2	When establishing the therapeutic goal in moderate to severe psoriasis, it is advisable to differentiate between an ideal goal and a realistic goal
3	Ideal goals should include:
3.1	PASI 100 response, absolute PASI score 0 or skin clearance
3.2	Absence of psoriasis-related symptoms
3.3	Absence of impact of psoriasis on patient’s psychological, emotional, social and occupational domains
3.4	Achieving PASI 90 response
3.5	Achieving an absolute PASI score ≤1
3.6	Achieving an absolute PASI score ≤2
4	Realistic goals should include:
4.1	Achieving PASI 90 response
4.2	In general, realistic goals should include achieving PASI 90 response, but sometimes, achieving PASI 75 response may also be realistic
4.3	Achieving an absolute PASI score ≤2
4.4	Achieving an absolute PASI score ≤3
4.5	In general, realistic goals should include achieving an absolute PASI score ≤3, but sometimes, achieving an absolute PASI score ≤5 might also be a realistic goal
4.6	In general, realistic goals should include achieving an absolute PASI score ≤3, but, with some drugs for psoriasis, achieving a PASI score ≤1 might also be possible

Abbreviation. PASI: Psoriasis Area and Severity Index.

Table 3. Definitions of treatment response and/or failure and treatment modifications for patients with moderate to severe psoriasis according to clinical guidelines/consensus documents.

#	Document	Definition
1	French guideline of systemic therapy [23]	-Treatment response is considered as adequate if PASI 75 from baseline, or PASI 50 and a DLQI score ≤5 -Primary treatment failure as not achieving a PASI 50 response
2	Australian consensus of treatment goal [26]	-Treatment failure after induction phase: If at the end an improvement of PASI of ≥50% as compared to disease severity at the time of treatment initiation has not been achieved If at the end an improvement of PASI of ≥50% but <75% as compared to disease severity at the time of treatment initiation has been achieved (intermediate response), but DLQI ≤ 5 has not been achieved -Treatment success during maintenance phase: If an improvement of PASI of ≥75% as compared to disease severity at the time of treatment initiation has been achieved -Treatment failure during maintenance treatment: If an improvement of PASI of ≥50% as compared to disease severity at the time of treatment initiation has not been achieved If an improvement of PASI of ≥50% but <75% as compared to disease severity at the time of treatment initiation can be maintained, but DLQI <5 has not been achieved -When treatment failure modification of the treatment regimen is recommended
3	European guideline of systemic therapy [20,21]	-During induction and maintenance phase: Treatment can be continued if PASI 75 is achieved Treatment regimen should be modified if improvement of PASI 50 is not achieved If PASI response is between 50 and75%, therapy should be modified if the DLQI is >5 but can be continued if the DLQI is ≤5
4	Spanish consensus of systemic therapy [18,25]	-Primary therapeutic failure: Lack of response or primary failure occurs when at the end of the induction phase a score is equal to or greater than those constituting the criteria for moderate-to-severe psoriasis Lack of response or primary failure occurs when there is no adequate response by the end of the induction phase, according to both the physician and the patient Lack of response or primary failure occurs when a decrease in 50% from the baseline PASI score has not been achieved (or this degree of response has been lost) after the induction phase
5	British guideline of systemic therapy [27]	-Review response to biologic therapy by taking into account: Psoriasis disease severity compared with baseline (e.g. PASI) Agreed treatment goal Control of PsA disease activity and/or IBD Impact of psoriasis on the person’s physical, psychological and social functioning Benefits vs. the risks of continued treatment Views of the person undergoing treatment (and their family or carers, where appropriate) Adherence to the treatment -Assess whether the minimal response criteria have been met, as defined by: ≥50% reduction in baseline disease severity (e.g. PASI 50 response, or percentage BSA) and clinically relevant improvement in physical, psychological or social functioning (e.g. ≥4-point)

Abbreviations. PsA: psoriatic arthritis; IBD: inflammatory bowel disease; PASI: Psoriasis Area and Severity Index; BSA: Body Surface Area; DLQI: dermatology life quality index; PGA: Physician’s Global Assessment.

Table 4. Main messages from the statements that achieved consensus regarding to treatment response and/or failure and treatment modifications in moderate to severe psoriasis.

#	Consensus (on the agreement)
1	Response to treatment could be assessed by absolute PASI
2	Sometimes, the rate of PASI improvement from baseline, complements the information from the absolute PASI and is useful to assess response to treatment
3	In general, in daily practice, absolute PASI is preferred to the rate of PASI improvement from baseline to assess response to treatment
4	The absolute PASI score 0 is the most appropriate measure to assess skin clearance
5	In daily practice, when complete clear skin is selected to assess response to treatment, the PASI 100 response or the PASI absolute score 0 can be used
6	In daily practice, if PASI 75 response is not reached with a treatment (recommended doses), a treatment change would be justified even if it implies a cost increase
7	In daily practice, if an absolute PASI score ≤3 is not achieved with a treatment (recommended doses), combination therapy would be justified
8	In daily practice, if an absolute PASI score ≤5 is not achieved with a treatment (recommended doses), it would be justified: Treatment change, even if it implies a cost increase Combination therapy
9	In daily practice, if the realistic goal is not achieved with a treatment (recommended doses), a change of treatment strategy it would be justified including: Treatment change Combination therapy
10	In daily practice, if the ideal goal is reached with a treatment (recommended doses), dose reduction (dose down-titration and/or increasing the interval between doses) could be included as a change of treatment strategy
11	In daily practice, if the realistic goal is achieved with a treatment (recommended doses), dose reduction (dose down-titration and/or increasing the interval between doses) could be included as a change of treatment strategy
#	Consensus (on the disagreement)
12	The rate of PASI improvement from baseline is preferred to absolute PASI to assess response to treatment
13	In daily practice, if PASI 100 response is not achieved with a treatment (recommended doses), dose changes would be justified (treatment intensification)
14	In daily practice, if an absolute PASI score ≤1 is not achieved with a treatment (recommended doses), a treatment change would be justified even if it implies a cost increase

Abbreviations. PASI: Psoriasis Area and Severity Index.

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Data availability statement

Data sharing is not applicable to this article as this is not a study.