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Wyeth Launches New Innovative Delivery System For Enbrel(R) (etanercept)

Enbrel (etanercept), Wyeths biological treatment for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis, is now available as a new easytouse prefilled autoinjector device, known as the Enbrel MYCLIC pen.

The Enbrel MYCLIC pen is a singleuse autoinjector, designed to deliver Enbrel as a 50mg subcutaneous injection. It has been developed to offer easeofuse and enhance patient confidence with the injection process.

The Enbrel MYCLIC pen incorporates a number of features to help patients including a mechanism to prevent accidental or premature misfiring of the pen device, and a large window to display the progress of the injection. The pen also features an audible click to confirm that the injection has been completed. The design philosophy has been to minimise the opportunity for any patient confusion or mistakes.

Dr Vignesh Rajah, Wyeths Medical Director in the UK, says “Extensive research has gone into the development of the Enbrel MYCLIC pen to ensure its easeofuse and patientfriendliness. Our aim throughout has been to focus on features that enable the patient to feel comfortable with, and confident about, the injection process.”

“We believe patients with limited dexterity will, in particular, welcome the new Enbrel MYCLIC pen,” continued Dr Rajah. “In addition, patients who suffer from a fear of needles will appreciate the fact that the Enbrel MYCLIC pen has a needle safety shield to keep the needle hidden before, during, and after the injection.”

Dr Ali Jawad, Consultant Rheumatologist at the Royal London Hospital said “Looking at the daytoday concerns of the patients we see, I am very pleased that an easytouse autoinjector system is being introduced for Enbrel patients. Enbrel has an established efficacy and safety profile in the treatment of rheumatoid arthritis and related conditions, and now, by improving the delivery system, Wyeth is taking a further important step forward in meeting the needs of patients and those who care for them.”

The Enbrel MYCLIC pen is licensed for use in all Enbrel adult indications and is available for both new and existing Enbrel patients. In addition to the new Enbrel MYCLIC pen (50mg dose), Enbrel continues to be available as a prefilled syringe (25mg and 50mg doses) and as a powder for mixing with solvent solution (25mg dose).

Please note all patients should receive training from a healthcare professional familiar with the use of the device before using the Enbrel MYCLIC pen. Wyeth has been delivering a comprehensive healthcare professional training programme for the Enbrel MYCLIC pen prior to its launch for healthcare professionals.

Enbrel in rheumatoid arthritis (RA) 1

In RA Enbrel has been shown to significantly reduce the pain and swelling in patients joints, as well as the number of joints that are affected. Data also shows that the addition of Enbrel to an RA patients treatment can result in a nearly threefold reduction in the number of sick days taken in comparison to patients who are given methotrexate alone.2

Enbrel in psoriasis

Psoriasis patients receiving etanercept showed significant improvement in their disease severity measured by the Physician Global Assessment of Psoriasis (PGA) and Psoriasis Area and Severity Index (PASI) and achieved sustained and longterm relief of psoriasis symptoms. Data shows that mean improvement in PASI score was 68% at week 54 for continuous use of etanercept.3

Enbrel in ankylosing spondylitis (AS)

Currently biologics are an effective treatment for the spinal symptoms of AS and can have a significant impact on individuals. Enbrel has been shown to improve spinal mobility, back pain and inflammation in people with AS.4

References

1. Enbrel SmPC. medicines.org.uk Last accessed September 1st 2009

2. Emery P et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET) a randomised, doubleblind, parallel treatment trial. The Lancet, 2008; 372 37582.

3. Ortonne J P et al. Efficacy and safety of continuous versus paused etanercept treatment in patients with moderateto severe psoriasis over 54 weeks the CRYSTEL study. Expert Rev. Dermatol. 3(6), 657665 (2008

Septiembre 13th, 2009 by admin

Can Psychosocial Stress At Work Put At Risk Of Developing Rheumatoid Arthritis?

A Swedish study published in one of the latest issue of Psychotherapy and Psychosomatics discloses new relationships between stress at work and development of rheumatoid arthritis.

Psychosocial work stress, in terms of high psychological demands, low decision latitude or the combination of these stressors (job strain), is associated with an increased risk of several diseases (e.g. cardiovascular disease), but it has not been studied in relation to rheumatoid arthritis (RA). However, research on the relationship between psychosocial work stress and immunological parameters also suggests a possible association with inflammatory conditions, including RA. In order to investigate whether high psychological job demands, low decision latitude and job strain are associated with the risk of developing RA, a group of Swedish investigators used data from EIRA, a large populationbased casecontrol study with incident cases of RA. The study base comprised the population, aged 18 65 years, in middle and southern parts of Sweden during 1996 2003. In total, 1,221 cases and 1,454 controls participated.

Psychological job demands and job decision latitude were measured according to questions developed by Karasek and Theorell. Questions were posed about participants present work situations; both demands and decision latitude were categorized using the quartiles among the controls (each gender separately) as cutoff points. High psychological job demands, as well as high decision latitude, were defined as a score above the upper quartile. Low psychological job demands, as well as low decision latitude, were defined as a score below the lower quartile. Job strain was defined as the combination of high demands and low decision latitude.

The investigators also performed a classification of psychological job demands and decision latitude based on a job exposure matrix (JEM), in order to avoid potential bias due to differential recall between cases and controls. Among the controls, mean scores of demands and decision latitude were calculated for each latest reported occupation (each gender separately) where the number of controls was at least 3. Both cases and controls were then given the mean scores according to their latest reported occupation. Cutoff points of psychological job demands and decision latitude were calculated in the same way as described above. The odds ratios (OR) of developing RA with 95% confidence intervals (CI) were calculated for high compared with low psychological job demands and low compared with high decision latitude. Job strain was compared with relaxed working conditions (low psychological job demands and high decision latitude) and with conditions without job strain. OR were interpreted as relative risks, as the study was populationbased, and were adjusted for age, sex, residential area, smoking and social class.

High psychological job demands tended to be associated with a decreased risk of RA, especially in the JEMderived data (OR = 0.8, 95% CI = 0.6 1.0). Low decision latitude was associated with an increased risk of RA (selfreported data OR = 1.6, 95% CI = 1.2 2.2, JEMderived data OR = 1.3, 95% CI = 1.0 1.7). Selfreported job strain was associated with a 30% higher risk of RA, compared with relaxed working conditions, but the CI was wide and the result was not confirmed by JEMderived data.

To summarize few methodological considerations, the investigators conclude that the observed association between low decision latitude and risk of developing RA is most likely real, and that the influence of various biases is of limited magnitude. The main new finding of this study was that low decision latitude was associated with an increased risk of developing RA, according to both selfreported and JEMderived information. Low decision latitude is also the component in the demandcontrol model that has most consistently been related to risk of cardiovascular disease. Furthermore, some evidence that those with high psychological job demands had a decreased risk of RA was found.

Septiembre 1st, 2009 by admin