Comparative effects of biological therapies on the severity of skin symptoms and health-related quality of life in patients with plaque-type psoriasis: a meta-analysis
ABSTRACT The comparative effects of biological response modifiers (BRMs) on the severity of psoriasis and its effects on health-related quality of life (HRQoL) have not been evaluated.
To conduct a meta-analysis to assess the effects of available biological agents on the severity of psoriasis, as well as to provide data on the effects of these agents on HRQoL.
Medline and other databases were searched for randomized controlled trials (>or= 10 weeks' duration in adults) comparing biological therapies for moderate-to-severe psoriasis with placebo. A Mantel-Haenszel fixed-effects model was employed to estimate the pooled relative risks (RR) of patients achieving >or= 75% reduction of baseline Psoriasis Area and Severity Index (PASI 75) after >or= 10 weeks of treatment. Similar analyses were also conducted on PASI 50 and PASI 90. Using a random-effects model, we estimated the likelihood of achieving PASI 50, PASI 75, and PASI 90 at 10-12 weeks and 24 weeks. Data on the effects of different BRMs (vs. placebo) on HRQoL were also presented. Numbers (%) of patients discontinuing treatment were presented as a general index of drug tolerability.
Patients receiving infliximab 5 mg/kg intravenously at weeks 0, 2, and 6, then every 8 weeks, had the highest RR of achieving PASI 75, with a pooled RR value of 25.48 (95% confidence interval [CI], 14.04-46.23); followed by etanercept 50 mg administered subcutaneously (SC) twice weekly with RR = 11.92 (95% CI, 8.17-17.39); etanercept 25 mg SC twice weekly with RR = 10.68 (95% CI, 6.15-18.57); efalizumab 1-2 mg/kg SC per week with RR = 7.47 (95% CI, 5.20-10.73); and alefacept administered weekly (various doses) with RR = 3.37 (95% CI, 2.18-5.23). (All RR values were estimated vs. placebo.) Similar findings were observed with regard to proportions of patients achieving PASI 50 and PASI 90. The random-effects analysis suggested that infliximab significantly increased the likelihood of achieving PASI 50, PASI 75, and PASI 90 compared with placebo at 10-12 weeks; however, there were no significant differences between biological treatments at 24 weeks. Each BRM improved HRQoL compared with placebo according to findings from the Dermatology Life Quality Index. Proportions of patients discontinuing treatment were similar in active-treatment and placebo groups.
Infliximab significantly reduced disease severity by both fixed- and random-effects models. All biological therapies improved HRQoL compared with placebo, and proportions of patients discontinuing treatment were similar in active-treatment and placebo groups. The analysis is potentially limited by statistical factors and did not systematically account for different toxicity profiles, but the findings establish a foundation for head-to-head comparative trials.
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ABSTRACT: We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible.Cadernos de Saúde Pública 11/2013; 29:s17-s31. DOI:10.1590/0102-311X00157013 · 0.89 Impact Factor
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ABSTRACT: La terapia biológica representa una alternativa bien establecida en el manejo de la psoriasis moderada y grave. Sin embargo, su elevado coste, la experiencia relativamente limitada en su empleo clínico y la abundancia de publicaciones existentes hacen necesario el desarrollo de unas directrices basadas en la evidencia científica disponible y en el consenso de un grupo de expertos. El objetivo ideal del tratamiento de la psoriasis es conseguir y mantener a largo plazo un blanqueamiento completo o prácticamente completo o, en su defecto, una mínima afectación localizada y controlable con tratamientos tópicos. Aunque la evidencia disponible permite comparar de forma directa o indirecta la eficacia y las posibilidades de fracaso terapéutico primario o secundario de los diferentes fármacos según parámetros objetivos, las limitaciones en la extrapolación de los ensayos clínicos a la clínica diaria condicionan que la elección del fármaco y de la pauta de administración se realicen de forma individualizada en función de las características de cada paciente. La presente actualización de las directrices para el tratamiento de la psoriasis con agentes biológicos de la Academia Española de Dermatología y Venereología (AEDV) incorpora la información más reciente disponible a este respecto.Actas Dermo-Sifiliográficas 10/2013; 104(8):694–709. DOI:10.1016/j.ad.2013.04.003
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ABSTRACT: In addition to the critical need of measuring tools for drug development of spondyloarthritis (SpA), these tools are also valuable for patient management. An early diagnosis, determination of early therapeutic response, and monitoring therapeutic response have now become increasingly important because effective therapies are available, and therapies such as anti-tumor necrosis factor (TNF) drugs are even more effective if used in early disease stages. In this review, we focus on disease activity measurements and monitoring in axial SpA and psoriatic arthritis (PsA). Both axial SpA and PsA have heterogeneous clinical manifestations. Therefore, in addition to the measurement of each clinical domain, composite measures inclusive of all clinical domains can be very helpful and are more likely to give complete and reliable information about the disease activity. A major focus of this review is to describe the recently developed composite measures for axial SpA and PsA. Copyright © 2014 Elsevier Ltd. All rights reserved.Bailliè re s Best Practice and Research in Clinical Rheumatology 10/2014; 28(5):711-728. DOI:10.1016/j.berh.2014.10.004 · 3.06 Impact Factor