Introduction

The Deutsche Dermatologische Gesellschaft (DDG) and the Berufsverband Deutscher Dermatologen (BVDD) have initiated a project to develop evidence-based guidelines for the treatment of plaque psoriasis. The full version of the Guidelines has been published in the Journal der Deutschen Dermatologischen Gesellschaft (JDDG 2006 Suppl 2) and is available at http://www.psoriasis-leitlinie.de [149]. This article summarizes the key points of the Guidelines.

Background

Psoriasis vulgaris is a common and chronic inflammatory skin disease which has the potential to significantly reduce the quality of life in severely affected patients. The incidence of psoriasis in Western industrialized countries is 1.5–2% [2]. Studies on the impairment of life quality have shown that, depending on the severity of the disease, a significant burden may exist in the form of a disability or psychosocial stigmatization [3]. Patient surveys have shown that the mental and physical impairment associated with psoriasis is comparable to that of other significant chronic conditions, such as type 2 diabetes or chronic respiratory diseases [4].

Patient surveys have shown that only 25% of psoriasis patients are highly satisfied with the outcome of their treatment, another 50% indicate moderate satisfaction, and approximately 20% report low treatment satisfaction [5]. In addition, there is a high non-compliance rate in the intake of medication of up to 40% [1].

Experience has shown that treatment selection for patients with psoriasis vulgaris is more commonly based on traditional concepts than on evidence-based data on the efficacy of various therapeutic options. In addition, it appears that systemic therapies are occasionally not applied in situations where they are needed due to the increased effort involved in monitoring the patients for unwanted side effects and possible interactions with other drugs.

Goal of the Guidelines

The overall objective of the Guidelines is to provide dermatologists in clinics and private practice with an accepted and evidence-based decision-making tool for the selection and implementation of a suitable and efficacious treatment for patients with psoriasis vulgaris. The focus of the Guidelines is on the induction therapy of mild, moderate, and severe plaque-type psoriasis in adults.

  1. 1.

    Physicians’ personal experiences and traditional therapeutic concepts should be supplemented and, if necessary, replaced by an evidence-based assessment of the efficacy of individual therapies in psoriasis vulgaris.

  2. 2.

    The guidelines provide in-depth explanations of the available systemic and topical treatments for psoriasis, including the different photo- and photochemical therapies, and provide detailed descriptions of the administration and safety aspects.

  3. 3.

    By providing background information on the profile of the available drugs, including efficacy, safety, and aspects of practicality and costs, the Guidelines should facilitate the process of selecting an appropriate treatment for each individual patient. This should help increase compliance and optimize the benefit/risk ratio of psoriasis therapies.

Methods

A detailed description of the methodology employed in developing the Guidelines can be found in the Method Report on the Guidelines (http://www.psoriasis-leitlinie.de).

Basis of data

A systematic search of the literature was carried out in May 2005 with the objective of assessing the effectiveness of individual therapeutic options. This search yielded 6,224 publications of which 142 studies fulfilled the inclusion criteria for the Guidelines (see Box 1) and were therefore included in the assessment of the effectiveness of the relevant treatment. Various other aspects were evaluated on the basis of information presented in available literature, without a systematic analysis, and the years of personal experience of the experts.

figure a

Evidence assessment

The efficacy and effectiveness of each intervention was evaluated using evidence-based criteria.

The methodological quality of each individual study was assessed using the following grades of evidence (GE):

A1 :

Meta-analysis that includes at least one randomized study with grade A2 evidence. In addition, the results of the different studies included in the meta-analysis must be consistent with one another.

A2 :

A high-quality (e.g. sample-size calculation, flow chart, intention-to-treat (ITT) analysis, sufficient size) randomized, double-blind comparative clinical study.

B:

Randomized clinical study of lesser quality or other comparative study (non-randomized, cohort, or case-control study).

C:

Non-comparative study.

D:

Expert opinion.

Individual interventions (i.e., as monotherapy) were rated according to the following levels of evidence (LE):

  1. 1.

    Intervention is supported by studies with grade A1 evidence or studies with grade A2 evidence whose results are predominantly consistent with one another.

  2. 2.

    Intervention is supported by studies with grade A2 evidence or studies with grade B evidence whose results are predominantly consistent with one another.

  3. 3.

    Intervention is supported by studies with grade B evidence or studies with grade C evidence whose results are predominantly consistent with one another.

  4. 4.

    Little or no systematic empirical evidence

figure b

Therapeutic recommendation

A distinct rating of the therapeutic options or a strict clinical algorithm cannot be defined for the treatment of psoriasis vulgaris. The criteria for selecting a particular therapy are complex. The decision for a specific treatment should be based on the profile of the available drugs and the characteristics of a given patient. The decision for or against a therapy remains a case-by-case decision. These Guidelines provide a reasonable form of assistance in deciding on a suitable therapy and are an instrument for optimizing the required therapeutic process.

The recommendations formulated in the text are supported graphically in selected key recommendations by the following indications of the strength of the therapeutic recommendation:

↑↑:

Measure is highly recommended

↑:

Measure is recommended

→:

Neutral

↓:

Measure is not recommended

↓↓:

Measure is highly inadvisable

The strength of the recommendation reflects both a treatment’s efficacy and the level of evidence supporting it as well as aspects of safety, practicality, and the cost/benefit ratio. A consensus on the strength of the recommendation was reached during the Consensus Conference.

Results

Therapeutic options are named and discussed in alphabetical order.

Therapeutic strategies

Fig. 1
figure 1

Overview of the therapeutic options evaluated for chronic plaque psoriasis (the therapeutic options are listed alphabetically and do not represent a ranking)

Evaluation of topical and systemic therapies in tabular form

These tables are intended to provide a rough orientation for evaluating the therapeutic options. Cumulative calculations of the individual aspects for the overall evaluation of the therapeutic options are not possible and cannot be drawn upon for the final analysis of a therapeutic option. The product assessment for each individual patient may deviate greatly. A direct comparison between systemic and topical therapies is not possible because of the different severity of the psoriasis lesions of patients treated with topical or systemic treatments. The evaluations reported here were made on the basis of data extracted from the literature and expert opinions.

For further details refer to the Methods Report at www.psoriasis-leitlinie.de

Topical monotherapy

figure c

Phototherapy and systemic monotherapy

figure d

(a) Efficacy The evaluation of the efficacy column reflects the percentage of patients who achieved a reduction in the baseline Psoriasis Area and Severity Index (PASI) of ≥75%.

Scale

Systemic therapy

Topical therapy

++++

Approx. 90%

Approx. 60%

+++

Approx. 70%

Approx. 45%

++

Approx. 50%

Approx. 30%

+

Approx. 30%

Approx. 15%

+/−

Approx. 10%

Approx. 5%

Not defined

Not defined

The evidence level applies only to the estimate of efficacy.

(b) Safety/tolerance in induction therapy or maintenance therapy This refers to the risk of occurrence of severe adverse drug reactions or the probability of adverse drug reactions that would result in the discontinuation of therapy.

(c) Practicality (Patient) This evaluation analyzes the effort involved in handling and administrating the treatment regimen by the patient.

(d) Practicality (Physician) This aspect considers the amount of work (documentation, explanation, monitoring), personnel and equipment needs, time for physician/patient interaction, remuneration of therapeutic measures, invoicing difficulties/risk of recourse claims from the health insurance companies.

(e) Cost/benefit Consideration of the costs of an induction therapy or a maintenance therapy.

The evaluations of safety/tolerance in induction therapy or maintenance therapy as well as practicality for the physician or patient and the cost/benefit were performed using a scale ranging from poor (–) to good (++++). The gradation between these two extremes was made based on expert opinion and unsystematic literature search. A level of evidence was not given for these evaluations since no systematic literature review was performed.

Evaluation of topical therapies

Calcineurin inhibitors

Table 1 Tabular summary
figure e
figure f

Corticosteroids

Table 2 Tabular summary
figure g
figure h

Coal tar

Table 3 Tabular summary
figure i
figure j

Dithranol

Table 4 Tabular summary
figure k
figure l

Tazarotene

Table 5 Tabular summary
figure m
figure n

Vitamin D3 and analogues

Table 6 Tabular summary
figure o
figure p

Phototherapy

Table 7 Tabular summary
figure q
figure r

Evaluation of systemic therapies

Efalizumab

Table 8 Tabular summary
figure s
Table 9 Laboratory controls during treatment with efalizumab
figure t
figure u
Etanercept
Table 10 Tabular summary
figure v
Table 11 Laboratory controls during treatment with etanercept
figure w
Infliximab
Table 12 Tabular summary
figure x
Table 13 Laboratory controls during treatment with infliximab
figure y

Cyclosporine

Table 14 Tabular summary
figure z
Table 15 Laboratory controls during treatment with cyclosporine
figure aa

Fumaric acid esters

Table 16 Tabular summary
Table 17 Dosage regimen for Fumaderm therapy
figure ab
Table 18 Laboratory controls during treatment with fumaric acid esters
figure ac

Methotrexate

Table 19 Tabular summary
figure ad
Table 20 Laboratory controls during treatment with MTX [137]
figure ae

Retinoids

Table 21 Tabular summary
figure af

aDouble contraception is recommended (e.g., condom + pill; IUD/Nuva-Ring + pill; cave: no low-dosed progesterone preparations/mini-pills) during and up to 2 years after the end of therapy; effectiveness is reduced by acitretin

Table 22 Laboratory controls during treatment with Acitretin
figure ag

Other therapies

Climate/balneotherapy

Table 23 Tabular summary
figure ah
figure ai

Psychosocial therapy

figure aj
figure ak

Notes on the use of the Guidelines

The presentation of the therapies deliberately focused on those aspects deemed particularly relevant by a panel of experts. Aspects which are not of specific importance for a certain intervention, but which are part of the physician’s general obligations to the patient, such as the investigation of intolerance and allergies toward certain drugs or the exclusion of contraindications, are not individually listed, but it is nevertheless taken for granted that these are part of the physician’s duty to provide care.

It is recommended that each and every user carefully reads and follows the product information and compare it with the recommendations in the Guidelines on dosaging, contraindications, and drug interactions for completeness and currentness. Every dose or application is administered at the user’s own risk. The authors and the publishers kindly request that users inform them of any inaccuracies that they might notice. The users are requested to keep themselves constantly informed of any new findings subsequent to the publication of the Guidelines.