LNSLNS

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 drug’s 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.

DOI: 10.3238/arztebl.2014.0035b

On behalf of the German psoriaris guideline group 2006.

Prof. Dr. med. univ. Jörg C. Prinz

Klinik und Poliklinik für Dermatologie und Allergologie, München

Joerg.Prinz@med.uni-muenchen.de

Dr. med. Volker Streit

Buchholz

Conflict of interest statement

Professor Prinz has received consultancy fees (advisory board) from Novartis, Wyeth, Pfizer, Serono, Abbott, Janssen-Cilag, and Actelion. He has received speaker honoraria from Biogen-Idec, Novartis, Wyeth, Pfizer, Merk-Serono, Essex pharma, MSD, Galdema, Centocor, Abbott, and Janssen-Cilag/Janssen-Ortho. He has received study support (third party funding) from Wyeth, Merk-Serono, Essex pharma, Centocor, Abbott, and Janssen-Cilag/Janssen-Ortho. Additionally, he has received non-monetary resources from Biogen-Idec and Wyeth.

Dr Streit has received consultancy fees (advisory board) from Serono, Wyeth, and Abbott. He has received speaker honoraria from Wyeth and Abbott. He has received study support (third party funding) from Wyeth and Abbott.

1.
Schott G, Dünnweber C, Mühlbauer B, Niebling W, Pachl H, Ludwig WD:
Does the pharmaceutical industry influence guidelines? Two examples from Germany. Dtsch Arztebl Int 2013; 110(35–36): 575–83 VOLLTEXT
2.
National Institute for Health and Care Excellence: TA 103 Etanercept and efalizumab for the treatment of adults with psoriasis. NICE Technology appraisal guidance 103—Issued: July 2006. http://guidance.nice.org.uk/TA103 (last accessed on 23. 9. 2013).
3.
National Institute for Health and Care Excellence: About NICE. What we do. Evidence-based guidance and advice. www.nice.org.uk/aboutnice/whatwedo/what_we_do.jsp (last accessed on 23. 9. 2013).
4.
Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF), Ärztliche Zentralstelle Qualitätssicherung (ÄZQ): Das Leitlinien-Manual von AWMF und ÄZQ. Entwicklung und Implementierung von Leitlinien in der Medizin. Z Arztl Fortbild Qualitatssich 2001;95(Suppl I):4–84. www.awmf.org/leitlinien/awmf-regelwerk/awmf-publikationen-zu-leitlinien/leitlinien-manual.html (last accessed on 23. 9. 2013).
1.Schott G, Dünnweber C, Mühlbauer B, Niebling W, Pachl H, Ludwig WD:
Does the pharmaceutical industry influence guidelines? Two examples from Germany. Dtsch Arztebl Int 2013; 110(35–36): 575–83 VOLLTEXT
2.National Institute for Health and Care Excellence: TA 103 Etanercept and efalizumab for the treatment of adults with psoriasis. NICE Technology appraisal guidance 103—Issued: July 2006. http://guidance.nice.org.uk/TA103 (last accessed on 23. 9. 2013).
3.National Institute for Health and Care Excellence: About NICE. What we do. Evidence-based guidance and advice. www.nice.org.uk/aboutnice/whatwedo/what_we_do.jsp (last accessed on 23. 9. 2013).
4.Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF), Ärztliche Zentralstelle Qualitätssicherung (ÄZQ): Das Leitlinien-Manual von AWMF und ÄZQ. Entwicklung und Implementierung von Leitlinien in der Medizin. Z Arztl Fortbild Qualitatssich 2001;95(Suppl I):4–84. www.awmf.org/leitlinien/awmf-regelwerk/awmf-publikationen-zu-leitlinien/leitlinien-manual.html (last accessed on 23. 9. 2013).

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