[The role of biological drugs in the treatment of psoriasis, results from 9 randomized placebo-controlled trials].
BACKGROUND
Recognition the key role of TNF-alpha in the pathogenesis of psoriasis makes possible to use new and efficacious drugs in the treatment. In the years past more trials were published, which are examining the efficacy of different biological drugs. There is no analysis which is including all the trials with biological drugs.


OBJECTIVE
The authors compared the efficacy of biological drugs - efalizumab, etanercept, infliximab - in the treatment of psoriasis. The evidences on effect of biological drugs were synthesized. The safety of drugs also was examined.


METHODS
The authors searched the MEDLINE database for all trials with TNF-alpha in the treatment of psoriasis. The authors conducted a meta-analysis with the results of trials. The random effect model were used for the data synthesis, the results were probed with Mantel-Haenszel test.


RESULTS
Data were combined from 13 trials included 4165 patients. All the three examined biological drugs are significantly superior to placebo treatment in improving the symptoms of psoriasis. Data from 3 trials included 1242 patients prove, that using 1 mg/kg etanercept the proportion of patients whom skin response improved at least 75% is greater with 25% than using placebo (RD = 0.25 95% Cl 0.21-0.29). Data from 5 trials included 995 patients show, that using 2 x 25 mg etanercept the proportion of patients whom skin response improved at least 75% is greater with 29% than using placebo (RD = 0.29 95% Cl 0.24-0.33). Data from 5 trials included 759 patients prove, that using 5 mg/kg infliximab the proportion of patients whom skin response improved at least 75% is greater with 73% than using placebo (RD = 0.73 95% Cl 0.68-0.78). Biological treatment of 3 patients improves 1 patient's skin-symptoms at least with 75% (NNT = 2.7 95% Cl 2.6-2.9).


CONCLUSIONS
According to the available data the TNF-alpha inhibitors are effective in improving the symptoms of psoriasis non-responding to the conventional treatment. After the meta-analysis of data infliximab seems to be the most effective biological treatment.
Kemény
Lajos
L
Szegedi Tudományegyetem, Szent-Györgyi Albert Orvos- es Gyógyszerésztudományi Centrum, Borgyógyászati es Allergológiai Klinika.
Brodszky
Valentin
V
Kárpáti
Krisztián
K
Gulácsi
László
L
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents / Q000627:therapeutic use*; D000068800:Etanercept; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D000069285:Infliximab; D011565:Psoriasis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D007074:Immunoglobulin G; D007155:Immunologic Factors; D018124:Receptors, Tumor Necrosis Factor; D000069285:Infliximab; D000068800:Etanercept; C472181:efalizumab