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Posts tagged ‘JAMA’

Monitoring TNF alpha antidrug antibodies may optimize Rheumatoid Arthritis Treatment

May 2nd, 2011


There is a lot going on in the Rheumatoid Arthritis (RA) market at the moment with news last week from Pfizer that tofacitinib had met its study endpoints.  A number of new products in the pipeline will have an impact on this Pharma market.

RA is an autoimmune disease that causes chronic inflammation of the joints. It’s a particularly painful and crippling disease for those affected.  Monoclonal antibodies such as adalimumab (Humira), infliximab (Remicade) and natalizumab (Tysabri) have been shown to be effective at relieving RA symptoms through their inhibition of Tumor Necrosis Factor-α (TNF-α).

However, as Sally Church in a post on Pharma Strategy Blog notes, one of the challenges of these biologics is that about 28% of RA patients develop antidrug antibodies, resulting in resistance and lower treatment response.

Sally reviews recent research published in the Journal of the American Medical Association (JAMA) by Geertje Bartelds and colleagues that looked at the correlation between outcomes and development of antibodies to adalimumab (Humira).

The findings from this research suggest that we may be able to optimize RA treatment based on monitoring of antidrug antibodies.  You can read more about this research on Pharma Strategy Blog.

Whole Genome Sequencing will open up new era of Personalized Medicine

April 21st, 2011


Sally Church on Pharma Strategy Blog discusses two papers and an editorial on Whole Genome Sequencing published in the Journal of the American Medical Association (JAMA) this week.

The ability to sequence and screen the entire genetic information of an individual is now within reach.  DNA sequencing costs have decreased over a 100-fold over the past 3 years, a rate faster than Moore’s law on computer power increases with time would predict.

Sally in her post on Pharma Strategy Blog discusses the two JAMA papers that look at whole genome sequencing in cancer patients.  The first paper by Link and colleagues from Washington University, St Jude Children’s Research Hospital and University of Chicago is a sad case of a woman diagnosed with breast cancer at 37, ovarian cancer at 39 who died of treatment related AML (tAML) aged 42.  Whole genome sequencing showed that she had a novel deletion of 3 exons of the TP53 gene.  Screening her children for this deletion will help identify potential future risk.

In the second paper, Welch and colleagues at Washington University report on the whole genome sequencing of a 39 year old woman initially diagnosed with AML, and how this led to discovery of a novel insertional translocation on chromosome 17 that produced a pathogenic PML-RARA gene fusion.  Once this was discovered after sequencing, the patient’s diagnosis and treatment was changed to incorporate this knowledge, with an improved prognosis; she remains in remission according to the paper.

The cost of whole genome sequencing is still too high for it to be part of routine screening for everyone, but the time will come in the not too distant future when this is cost effective, opening up a new era of personalized medicine.

Sally Church has published an in-depth analysis of whole genome sequencing and a review of the JAMA papers on Pharma Strategy Blog that is well worth reading.

The relationship between HRT and Breast Cancer

April 18th, 2011


Sally Church on Pharma Strategy Blog discusses the issue of to what extent hormone replacement therapy (HRT) is linked to a higher incidence of breast cancer?

 The relationship between HRT and Breast CancerRecent data published in the Journal of the American Medical Association (JAMA) showed a reduction in breast cancer incidence for those taking conjugate equine estrogens.  This is in sharp contrast to other studies that suggest a higher incidence of breast cancer in HRT users.

As Sally discusses in her thoughtful post, part of the reason for the difference “may lie in the type of hormone treatments given (estrogen only versus combination therapy) and variations in patient groups.”

Additionally, Sally notes that the differences “can be explained in the long-term follow-up after treatment.”

You can read more about this controversial topic on Pharma Strategy Blog.