Volker Streit

S3 – Guidelines on the treatment of psoriasis vulgaris (English version). Update

Psoriasis vulgaris is a common and often chronic inflammatory skin disease. The incidence of psoriasis in Western industrialized countries ranges from 1.5% to 2%. Patients afflicted with severe psoriasis vulgaris may experience a significant reduction in quality of life. Despite the large variety of treatment options available, surveys have shown that patients still do not received optimal treatments. To optimize the treatment of psoriasis in Germany, the Deutsche Dermatologi sche Gesellschaft (DDG) and the Berufsverband Deutscher Dermatologen (BVDD) have initiated a project to develop evidence‐based guidelines for the management of psoriasis. They were first published in 2006 and updated in 2011. The Guidelines focus on induction therapy in cases of mild, moderate and severe plaque‐type psoriasis in adults including systemic therapy, UV therapy and topical therapies.

German evidence-based guidelines for the treatment of Psoriasis vulgaris (short version)

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 ranges from 1.5 to 2%. Despite the large variety of treatment options available, patient surveys have revealed insufficient satisfaction with the efficacy of available treatments and a high rate of medication non-compliance. To optimize the treatment of psoriasis in Germany, the Deutsche Dermatologische Gesellschaft and the Berufsverband Deutscher Dermatologen (BVDD) have initiated a project to develop evidence-based guidelines for the management of psoriasis. The guidelines focus on induction therapy in cases of mild, moderate, and severe plaque-type psoriasis in adults. The short version of the guidelines reported here consist of a series of therapeutic recommendations that are based on a systematic literature search and subsequent discussion with experts in the field; they have been approved by a team of dermatology experts. In addition to the therapeutic recommendations provided in this short version, the full version of the guidelines includes information on contraindications, adverse events, drug interactions, practicality, and costs as well as detailed information on how best to apply the treatments described (for full version, please see Nast et al., JDDG, Suppl 2:S1–S126, 2006; or http://www.psoriasis-leitlinie.de).

German S3-guidelines on the treatment of psoriasis vulgaris (short version)

Psoriasis vulgaris is a common and often chronic inflammatory skin disease. The incidence of psoriasis in Western industrialized countries ranges from 1.5 to 2%. Patients afflicted with severe psoriasis vulgaris may experience a significant reduction in quality of life. Despite the large variety of treatment options available, patient surveys have revealed insufficient satisfaction with the efficacy of available treatments and a high rate of medication non-compliance (Richards et al. in J Am Acad Dermatol 41(4):581–583, 1999). To optimize the treatment of psoriasis in Germany, the Deutsche Dermatologische Gesellschaft (DDG) and the Berufsverband Deutscher Dermatologen (BVDD) have initiated a project to develop evidence-based guidelines for the management of psoriasis first published in 2006 and now updated in 2011. The Guidelines focus on induction therapy in cases of mild, moderate, and severe plaque-type psoriasis in adults. This short version of the guidelines presents the resulting series of therapeutic recommendations, which were based on a systematic literature search and discussed and approved by a team of dermatology experts. In addition to the therapeutic recommendations provided in this short version, the full version of the guidelines includes information on contraindications, adverse events, drug interactions, practicality, and costs, as well as detailed information on how best to apply the treatments described (for full version please see Nast et al. in JDDG Suppl 2:S1–S104, 2011 or http://www.psoriasis-leitlinie.de).

S3-Leitlinie zur Therapie der Psoriasis vulgaris Update 2011

Alexander Nast, Wolf-Henning Boehncke, Ulrich Mrowietz, Hans-Michael Ockenfels, Sandra Philipp, Kristian Reich, Thomas Rosenbach, Adel Sammain, Martin Schlaeger, Michael Sebastian, Wolfram Sterry, Volker Streit, Matthias Augustin, Ricardo Erdmann, Joachim Klaus, Joachim Koza, Siegrid Müller, Hans-Dieter Orzechowski, Stefanie Rosumeck, Gerhard Schmid-Ott, Tobias Weberschock, Berthold Rzany (1) Division of Evidence Based Medicine (dEBM), Klinik für Dermatologie, Venerologie und Allergologie, Charité – Universitätsmedizin Berlin (2) Zentrum der Dermatologie und Venerologie, Klinikum der Johann Wolfgang Goethe Universität, Frankfurt/M. (3) Klinik für Dermatologie, Venerologie, Allergologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel (4) Hautund Allergieklinik, Klinikum Hanau (5) Psoriasisstudienzentrum, Klinik für Dermatologie, Venerologie und Allergologie, Charité – Universitätsmedizin Berlin (6) Dermatologikum Hamburg (7) Niedergelassener Dermatologe, Osnabrück (8) Niedergelassener Dermatologe, Oldenburg (9) Niedergelassener Dermatologe, Mahlow (10) Klinik für Dermatologie, Venerologie und Allergologie, Charité – Universitätsmedizin Berlin (11) Niedergelassener Dermatologe, Buchholz (12) Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Dermatologie und Venerologie, Hamburg (13) Deutscher Psoriasis Bund e.V. (14) Pflegevertreterin, Ravenstein (15) Institut für Klinische Pharmakologie und Toxikologie, Charité – Universitätsmedizin Berlin (16) Berolina Klinik, Löhne

No robust argument.

Almost all the arguments listed by Schott et al. (1) as the basis for their criticism of the evaluation of efalizumab are invalid. The cited NICE guidance TA103 (2) is not a guideline but a technical appraisal (3) of the cost effectiveness of efalizumab and etanercept; it is therefore not comparable to a clinical guideline. Contrary to their statement (Table 2 in the article)—“efalizumab is explicitly recommended for induction therapy. This recommendation is inconsistent with the drugs approval status”—the authors omit to mention that: The S3 guideline stipulates strict adherence to the indication for biologicals (p34), Efalizumab, with the weakest strength of recommendation (↑), carries a lower rating than etanercept (↑↑) The guideline equally restricts the use of efalizumab (“Therapy should not be continued if an improvement of at least 50% of the initial findings is not observed after the first 12 weeks of treatment”) as the TA 103 (p5, 1.4): “Further treatment with efalizumab is not recommended in patients unless their psoriasis has responded adequately at 12 weeks… .” The assertions in Table 2 of the article, that the NICE guideline “contains no statement concerning the effects of efalizumab on health-related quality of life […] and concerning the efficacy of efalizumab in previously treated patients,” are incorrect. The TA 103 documents (p 13, 4.1.2.2.): “DLQI outcomes were reported in four trials, all of which reported a statistically significantly greater reduction in patients taking efalizumab” and comments regarding efalizumab and etanercept (p 18) that “… these drugs … were as effective in patients who had not responded to other available treatments as in those who were treatment naive” (2). The allocation of evidence levels was done methodically under the supervision of the AWMF and strictly according to AWMF regulations (4). The recommendation for efalizumab (on a grey underlay) requires a consensus based statement from all authors. Schott et al. should be invited to submit a correction.