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Center for Global Research Data

Lead Investigator: Miriam Oron, Skintelligence ltd.
Title of Research Proposal: Test the prospects of expending the Skintelligence algorithm for predicting response to treatment with Alefacept and Ustekinumab in psoriatic patients affected with type I diabetes
Vivli Data Request: 4047
Funding Source: Commercial Funding – Skintelligence ltd.
Potential Conflicts of Interest: I am one of five founders of Skintelligence ltd., a private company developing clinical decision support systems for predicting response to biological therapies. We are collecting data on failed and successful biological therapies. Since the company does not sell drugs, we don’t see a conflict of interest but felt the need to inform you this research is funded by a governmental grant through the company.
Summary of the Proposed Research:

Psoriasis is a chronic autoimmune disease with genetic predisposition, involving systemic inflammation and dermal lesions of silvery white plaques that can be itchy and irritating.  The complex multifactorial nature of the disease is the cause of the variety in clinical presentation and severity of symptoms, as well as for the unpredictable response to the various therapies.   

Patients diagnosed with moderate to severe disease are prescribed biological drugs after exhausting phototherapy, non-steroidal and steroidal treatments.  In most cases, these drugs are prescribed on a trial and error method since there is not enough data to predict treatment response of patients. Their high cost ($20,000-50,000 per patient a year) and short presence in the market are the main reasons for lack of sufficient clinical data and indeterminate clinical response.   Nonetheless, the superior efficacy of the biological drugs, compared with other optional therapies, in patients that tolerate the side effects, attest to their expected existence in the market.   

A tool for predicting response to biological therapy in patents would benefit both, patients and the health care system.  The more data we include on patient outcome and medications, the higher the chances of supporting the physician in prescribing efficient therapies. 

Prescribing effective medication for patients diagnosed with both psoriasis and type I diabetes is even more complex and risky, due to the potency of the biological drugs.  Our study might be insightful in identifying specific patient’s features that influence therapeutic outcome. 

Requested Studies:
Inducing Remission in New Onset Type 1 Diabetes Mellitus With Alefacept (Amevive®) 

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Study ID: NCT00965458
Sponsor ID: DAIT ITN045AI