Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial

Sterry, Wolfram; Ortonne, Jean‐Paul; Kirkham, Bruce; Brocq, Olivier; Robertson, Deborah; Pedersen, Ronald; Estojak, Joanne; Molta, Charles; Freundlich, Bruce

doi:10.1136/bmj.c147

Cited by 204 publications

(183 citation statements)

References 25 publications

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“…The clinical benefits of etanercept are well established with regard to peripheral joint disease and skin symptoms 17,20,21,22,23,29 . Thus, in pivotal trials, 12-week treatment with etanercept led to significant increases, relative to placebo, in the proportion of patients with PsA achieving the PsARC and PASI 75-level skin clearance.…”

Section: Discussionmentioning

confidence: 99%

“…Despite the greater constraints on the patient population in the former and the longer study durations in the latter studies, a consistent picture of etanercept's safety and efficacy has emerged from this literature. PsARC response has been reported in about 70%-87% of patients within 6 months of etanercept treatment 17,19,22,23,36 . Where PsARC data are available, it appears that the bulk of the response occurs within the initial 4-12 weeks of treatment 17,22,36 and is maintained for periods of ≥ 2 years 19 .…”

Section: Discussionmentioning

confidence: 99%

“…There are currently 4 TNF inhibitors available to Canadian physicians for treating PsA: etanercept 17,19,20,21,22,23 , infliximab 18,24 , adalimumab 16,25,26 , and golimumab 27 . Of these biologics, etanercept has the longest record of postmarketing use in PsA, having received approval in Canada for this indication in 2004.…”

Section: Rheumatologymentioning

confidence: 99%

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Effectiveness and Safety of Etanercept in Patients with Psoriatic Arthritis in a Canadian Clinical Practice Setting: The REPArE Trial

Gladman¹,

Bombardier²,

Thorne³

et al. 2011

J Rheumatol

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Objective.To describe the longterm effectiveness and safety of etanercept in Canadian patients with psoriatic arthritis (PsA), treated over 24 months in clinical practice.Methods.Patients with active PsA (≥ 3 tender and ≥ 3 swollen joints) were recruited from 22 centers. Etanercept was administered at 50 mg/week subcutaneously. In addition to clinical assessment of skin and joint disease, conducted at baseline and at Months 6, 12, 18, and 24, regular patient interviews were conducted by telephone. Patient responses related to health status, disability, and work productivity were scored using the patient global assessment tool, the Health Assessment Questionnaire (HAQ), the Health and Labour Questionnaire (HLQ), and the Fatigue Severity Scale.Results.Out of 110 patients, 71 (65%) maintained etanercept treatment through the end of our study. All clinical measures of disease severity, including joint tenderness/pain, joint swelling, and Psoriasis Area and Severity Index score, improved significantly between baseline and Month 6 of etanercept treatment and remained constant thereafter. By the end of our study, 79% of patients achieved a Psoriatic Arthritis Response Criteria response, and 56% of patients achieved a 0.5-point improvement on HAQ, indicating clinically significant improvement in disability; 14% of patients finished our study free of disability (HAQ = 0). Patients’ work productivity and fatigue improved significantly in parallel with these clinical and functional improvements.Conclusion.Continuous treatment with etanercept over 2 years in a clinical setting improved clinical symptoms of PsA while reducing fatigue, improving work productivity, and ameliorating or eliminating disability.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Effectiveness and Safety of Etanercept in Patients with Psoriatic Arthritis in a Canadian Clinical Practice Setting: The REPArE Trial

Gladman¹,

Bombardier²,

Thorne³

et al. 2011

J Rheumatol

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“…son un comparativo en el que se extraen datos obtenidos de diversos ensayos clínicos [13][14][15][16][17][18][19][20][21][22] . La eficacia a largo plazo es muy difícil de comparar entre los distintos tratamientos, dados los diferentes diseños de los estudios y el bajo número de pacientes que en muchos casos llegan al final para aná-lisis PASI 75.…”

Section: Desarrollo De La Selección Del Fármaco Biológicounclassified

Elección de fármaco biológico en la psoriasis moderada-grave. Protocolo

Guerra¹

2012

Más Dermatol.

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RESUMENHasta la fecha, se han publicado diferentes guías clínicas acerca del tratamiento de la psoriasis en placas moderada-grave. Sin embargo, no se ha publicado un protocolo que recoja los puntos que deben considerarse en la elección de fármacos biológicos en la psoriasis moderada-grave.Las características basales de gravedad (PASI) de los pacientes no permiten por sí solas establecer a priori la selección del fármaco biológico. La presencia de caracterís-ticas individuales del paciente o de la enfermedad y la forma de administración a menudo determinan el perfil de eficacia y seguridad de cada fármaco en cada paciente. Valoraremos, por tanto, en el proceso de selección de un determinado fármaco biológico, los factores que permiten tomar una decisión terapéutica individualizada, como son eficacia, seguridad, contraindicaciones, precauciones y otros datos.Este protocolo debe ser revisado periódicamente, puesto que los datos recogidos a lo largo del tiempo sobre estas terapias aún jóvenes, el mayor número de pacientes en tratamiento, los datos de los registros (BIOBADADERM) todavía con escaso recorrido, los nuevos estudios y la incorporación de fármacos nuevos aportarán información que modificará la toma de decisión de tratamiento biológico en un futuro.Palabras clave: protocolo, terapia biológica, guías clínicas, etanercept, adalimumab, infliximab, ustekinumab. ABSTRACTTo date, various clinical guides have been published about the treatment of moderate-severe plaque psoriasis. However, no protocol has been published that summarizes the aspects to be considered when choosing the biologic drug for treatment of moderate-severe psoriasis.The Psoriasis Area and Severity Index (PASI) does not by itself allow making an a priori choice of biologic drug for patients. The individual characteristics of the patient or of the disease, as well as the form of administering the drug, often determine the efficacy and safety profile of each drug for each individual patient. Therefore, in the process of choosing a particular biologic drug, we will evaluate the factors that help decision making regarding individualized therapy, such as efficacy, safety, contraindications, precautions and other data.This protocol should be reviewed regularly because the data collected over time about these still novel therapies, the larger number of patients receiving treatment, the data from records (BIOBADADERM) that have only recently been implemented, the new studies and the incorporation of new drugs will all provide more information that will modify future decision making about biologic treatment.

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“…The high dose was more effective (23x, 23B). One study with a mixed population of plaque psoriasis and psoriatic arthritis patients was not included in the analysis [51].…”

Section: Efficacy Etanerceptmentioning

confidence: 99%

Biologicals in the Treatment of Plaque Psoriasis: Drug Selection by Means of the SOJA Method

Janknegt¹

2016

J Pharma Care Health Sys

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The treatment of plaque psoriasis is changing because of the introduction of new treatment options. The goal of this article is to allow a transparent and rational choice of medicines by means of the System of Objectified Judgement Analysis. The following selection criteria (relative weight) were applied: approved indications (40), drug interactions (60), clinical efficacy (400), safety (300), dosage frequency (100) and documentation (100). Acquisition cost was not taken into consideration to allow a preselection on quality aspects only. Adalimumab, etanercept, infliximab and ustekinumab were compared on these criteria. Infliximab and ustekinumab showed the highest scores and are the most suitable medicines for the treatment of severe plaque psoriasis. Of course, cost will play a key role in the final selection in individual hospitals. Weight Approved indications 40 Drug Interactions 60Clinical efficacy 400Safety 300Dosage frequency 100 Documentation 100Total 1000 Selection Criteria Approved IndicationsThe number of licensed indications is a good measure of the applicability and documentation of the drugs. Although this analysis is limited to the treatment of plaque psoriasis, the fact that a drug is approved for (almost) all indications listed below is, from a formulary point of view, advantageous to another drug, which is approved for only one or two applications.The percentage of the maximum score for approved indications was obtained as follows (Table 2): IndicationMaximum Score (%)Plaque psoriasis 50% Psoriatric arthritis 20%Rheumatoid arthritis 10% Spondylitis ankylopoetica 10%Inflammatory bowel disease 10% Drug interactionsInteractions play a role only in patients who use other drugs which may interact with biologicals. However, it is a relevant criterion from a formulary point of view.The score for each drug was dependent on the frequency and severity of observed drug interactions. Clinical efficacyClinical efficacy is always a very important selection criterion for any group of drugs. The score for each drug was derived from the results of double-blind comparative studies. SafetyThe extent and the severity of adverse effects is another important selection criterion for drugs. A distinction was made between "minor" side effects, such as gastrointestinal disturbances or skin reactions, occurring in clinical trials and severe or even life-threatening adverse reactions observed with large scale use of the drugs. The evaluation of the "minor" adverse effects was based on results of double blind comparative clinical studies.

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Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial

Cited by 204 publications

References 25 publications

Effectiveness and Safety of Etanercept in Patients with Psoriatic Arthritis in a Canadian Clinical Practice Setting: The REPArE Trial

Effectiveness and Safety of Etanercept in Patients with Psoriatic Arthritis in a Canadian Clinical Practice Setting: The REPArE Trial

Elección de fármaco biológico en la psoriasis moderada-grave. Protocolo

Biologicals in the Treatment of Plaque Psoriasis: Drug Selection by Means of the SOJA Method

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