BACKGROUND AND PURPOSE: The development of different biological therapies (so-called biologics) is a great progress for the treatment of the psoriasis vulgaris. The evidence from randomized controlled trials (RCTs) of biologics, which have been licensed in Germany for the treatment of moderate-to-severe psoriasis vulgaris, were pooled in this meta-analysis. MATERIAL AND METHODS: Systematic review and meta-analysis of all RCTs, in which biologics licensed in Germany as of January 2008 for the treatment of moderate-to-severe psoriasis vulgaris were examined. Relevant trials were identified by systematic electronic literature search in MEDLINE, EMBASE, Cochrane Library, and Scopus. Primary endpoint: proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) Score (PASI75 responder), secondary endpoints: clinically relevant improvement in the quality of life, monthly incidences of study withdrawals and adverse events. PASI75 response rates were statistically pooled and represented as risk differences (RD). RESULTS: 25 articles on 16 RCTs totaling 8,057 patients with moderate-to-severe psoriasis vulgaris were qualitatively analyzed. 15 double-blind and placebo- controlled trials were compared by meta-analysis. Infliximab had the highest efficacy in the short-term therapy of moderate-to-severe psoriasis vulgaris (RD [95% confidence interval, CI] 76% [72-80%]). Adalimumab (RD [95% CI] 59% [45-73%]) was more effective than efalizumab (RD [95% CI] 24% (19-30%]) and etanercept. Treatment with etanercept showed a clear dose-response effect (50 mg twice weekly: RD [95% CI] 44% (40-48%]; 25 mg twice weekly: RD [95% CI] 30% (25-35%]). All biologics improved the quality of life of psoriasis patients. Monthly incidence rates of withdrawals due to adverse events were 1.2% for infliximab, 0.5% for etanercept, 1.0% for efalizumab, and 0.5% for adalimumab. CONCLUSION: A patient's chance to reach considerable clinical benefit differs significantly between the different biological therapies currently approved for moderate-to-severe psoriasis vulgaris. Infliximab is most effective, followed by adalimumab. Large controlled studies indicate a high safety of all biologics in the short-term treatment. Recently established registers will provide additional important safety data under real-life conditions.
BACKGROUND AND PURPOSE: The development of different biological therapies (so-called biologics) is a great progress for the treatment of the psoriasis vulgaris. The evidence from randomized controlled trials (RCTs) of biologics, which have been licensed in Germany for the treatment of moderate-to-severe psoriasis vulgaris, were pooled in this meta-analysis. MATERIAL AND METHODS: Systematic review and meta-analysis of all RCTs, in which biologics licensed in Germany as of January 2008 for the treatment of moderate-to-severe psoriasis vulgaris were examined. Relevant trials were identified by systematic electronic literature search in MEDLINE, EMBASE, Cochrane Library, and Scopus. Primary endpoint: proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) Score (PASI75 responder), secondary endpoints: clinically relevant improvement in the quality of life, monthly incidences of study withdrawals and adverse events. PASI75 response rates were statistically pooled and represented as risk differences (RD). RESULTS: 25 articles on 16 RCTs totaling 8,057 patients with moderate-to-severe psoriasis vulgaris were qualitatively analyzed. 15 double-blind and placebo- controlled trials were compared by meta-analysis. Infliximab had the highest efficacy in the short-term therapy of moderate-to-severe psoriasis vulgaris (RD [95% confidence interval, CI] 76% [72-80%]). Adalimumab (RD [95% CI] 59% [45-73%]) was more effective than efalizumab (RD [95% CI] 24% (19-30%]) and etanercept. Treatment with etanercept showed a clear dose-response effect (50 mg twice weekly: RD [95% CI] 44% (40-48%]; 25 mg twice weekly: RD [95% CI] 30% (25-35%]). All biologics improved the quality of life of psoriasispatients. Monthly incidence rates of withdrawals due to adverse events were 1.2% for infliximab, 0.5% for etanercept, 1.0% for efalizumab, and 0.5% for adalimumab. CONCLUSION: A patient's chance to reach considerable clinical benefit differs significantly between the different biological therapies currently approved for moderate-to-severe psoriasis vulgaris. Infliximab is most effective, followed by adalimumab. Large controlled studies indicate a high safety of all biologics in the short-term treatment. Recently established registers will provide additional important safety data under real-life conditions.
Authors: L Dubertret; W Sterry; J D Bos; S Chimenti; S Shumack; C G Larsen; N H Shear; K A Papp Journal: Br J Dermatol Date: 2006-07 Impact factor: 9.302
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Authors: K A Papp; S Tyring; M Lahfa; J Prinz; C E M Griffiths; A M Nakanishi; R Zitnik; P C M van de Kerkhof; Linda Melvin Journal: Br J Dermatol Date: 2005-06 Impact factor: 9.302
Authors: Alan Menter; Steven R Feldman; Gerald D Weinstein; Kim Papp; Robert Evans; Cynthia Guzzo; Shu Li; Lisa T Dooley; Cynthia Arnold; Alice B Gottlieb Journal: J Am Acad Dermatol Date: 2006-09-06 Impact factor: 11.527
Authors: Alice B Gottlieb; Robert T Matheson; Nicholas Lowe; Gerald G Krueger; Sewon Kang; Bernard S Goffe; Anthony A Gaspari; Mark Ling; Gerald D Weinstein; Anjuli Nayak; Kenneth B Gordon; Ralph Zitnik Journal: Arch Dermatol Date: 2003-12
Authors: Richard Shikiar; Mary Kaye Willian; Martin M Okun; Christine S Thompson; Dennis A Revicki Journal: Health Qual Life Outcomes Date: 2006-09-27 Impact factor: 3.186