Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population

Papp, Kim; Poulin, Yves; Bissonnette, Robert; Bourcier, Marc; Toth, Darryl; Rosoph, Les; Poulin‐Costello, Melanie; Setterfield, Mike; Syrotuik, Jerry

doi:10.1016/j.jaad.2010.07.026

Cited by 91 publications

(91 citation statements)

References 14 publications

(16 reference statements)

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“…Longterm safety data (up to 4 and 5 yr treatment) are now available for etanercept and ustekinumab (Leonardi et al 2003;Papp et al 2005Papp et al , 2012dPapp et al , 2013aTyring et al 2006), suggesting a safe use of these drugs.…”

Section: Anticytokine Therapiesmentioning

confidence: 99%

Psoriasis

Meglio

Villanova

Nestle

2014

Cold Spring Harbor Perspectives in Medicine

263

202

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Psoriasis is a common chronic inflammatory skin disease with a spectrum of clinical phenotypes and results from the interplay of genetic, environmental, and immunological factors. Four decades of clinical and basic research on psoriasis have elucidated many of the pathogenic mechanisms underlying disease and paved the way to effective targeted therapies. Here, we review this progress and identify future directions of study that are supported by a more integrative research approach and aim at further improving the patients' life.This skin is me, I can't get out.

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Section: Anticytokine Therapiesmentioning

confidence: 99%

Psoriasis

Meglio

Villanova

Nestle

2014

Cold Spring Harbor Perspectives in Medicine

263

202

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“…Etanercept has proven to be effective and safe in the short term in improving psoriasis in placebo-controlled trials conducted with adult patients presenting with moderate or severe plaque psoriasis [5,6]. Controlled trials [7,8] and open-label extensions [9,10,11] have provided new evidence regarding its favourable therapeutic profile in the treatment of moderate to severe plaque psoriasis in adults and severe plaque psoriasis in children [12,13], as well as in patients presenting with concomitant psoriatic arthritis [14]. …”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Clinical Use of Etanercept for the Treatment of Moderate-to-Severe Psoriasis in Spain: Results of a Multicentric Prospective Study at 12 Months Follow-Up

Puig

Martínez²,

Carpio³

et al. 2012

Dermatology

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Background: The efficacy of etanercept in the treatment of psoriasis has been demonstrated in several clinical trials, but information regarding results derived from prospective observational studies in clinical practice is scarce. Objectives: To evaluate the efficacy and safety of etanercept administration according to routine clinical use in moderate-to-severe plaque psoriasis. Materials and Methods: Postauthorization, prospective study, carried out at 59 dermatology units in Spain. Patients diagnosed with moderate-to-severe plaque psoriasis received etanercept during a 12-month period. Results: Altogether, 444 patients were enrolled. Overall, 325 patients (73.2%) initiated etanercept treatment at a dose of 50 mg twice weekly; 96 patients (21.6%) received etanercept as a continuous regimen for the entire study period, and 348 patients (79.4%) an intermittent regimen. Among these, 185 patients (41.6% overall) received one course of treatment, stopped at various study points and did not restart etanercept treatment, whereas the remaining 163 patients (36.7% overall) stopped etanercept treatment, lost response, relapsed and were retreated. Most patients who interrupted etanercept treatment did so at month 6. Altogether, 79.7% of patients completed the study period. Etanercept treatment resulted in significant improvement in disease activity. A Psoriasis Area and Severity Index (PASI) 75 response was achieved by 76.1% of patients at month 6. Out of 252 adverse events reported, 31 were considered severe. Three possibly treatment-related malignancies were detected during the study. No opportunistic infections, tuberculosis or demyelinating events were reported. Conclusion: The PASI 75 response rate at month 6 in this observational, naturalistic study is similar to those observed in recent published trials with etanercept, and within the range of those reported for other marketed biologicals.

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“…Infectious adverse events had a major contribution: 97 per 100 patient years. Withdrawal due to adverse events occurred in 2.6% of patients [78].…”

Section: Etanerceptmentioning

confidence: 99%

“…Cardiovascular events were reported in 1.3 per 100 patient years, mostly myocardial infarction (0.6 per 100 patient years). No data from the placebo groups were reported [78].…”

Section: 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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Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population

Cited by 91 publications

References 14 publications

Psoriasis

Psoriasis

Efficacy and Safety of Clinical Use of Etanercept for the Treatment of Moderate-to-Severe Psoriasis in Spain: Results of a Multicentric Prospective Study at 12 Months Follow-Up

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

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