[Treatment of plaque psoriasis with biologics. A meta-analysis of randomized controlled trials].
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Zhang
Zhengguang
Z
Institut für Klinische Pharmakologie, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. zhangzhengguang@hotmail.com
Schmitt
Jochen
J
Wozel
Gottfried
G
Kirch
Wilhelm
W
D000068879:Adalimumab; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068800:Etanercept; D019317:Evidence-Based Medicine; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use; D000069285:Infliximab; D011565:Psoriasis / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology; D016032:Randomized Controlled Trials as Topic; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D001688:Biological Products; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000069285:Infliximab; D000068879:Adalimumab; D000068800:Etanercept; C472181:efalizumab