The US Patient-Centred Outcomes Research Institute (PCORI) said it will fund a $8.6 million study to compare treatment options for people with psoriasis, and a $10.6 million study to compare the effectiveness of treatment options for multiple sclerosis.
Psoriasis is an autoimmune skin disorder that affects 6.7 million Americans. Patients often prefer ultraviolet B light (UVB) therapy, because the available drugs can have serious side effects. However, UVB typically requires treatment in a doctor’s surgery several times a week, which can be a major burden for patients.
The study, to be carried out at the University of Pennsylvania, will compare the effectiveness of UVB in a doctor’s surgery versus the same treatment delivered at home.
The multiple sclerosis research, led by Daniel Ontaneda, a neurologist in Cleveland Clinic’s Mellen Center for multiple sclerosis, will be the first to compare two treatment options for patients recently diagnosed with the relapsing-remitting form of the disease.
Currently there are two approaches to treating the disease: an escalation approach, which starts with a drug that is considered safe but with a modest likelihood of controlling disease activity and escalating to more potent therapies if necessary, or starting with a more potent drug that has the rare potential for side effects, as the first-line treatment.
There is currently no data from comparing these two approaches in a head-to-head clinical trial.
The trial aims to determine which approach is better at slowing brain volume loss, is safer, is more effective, or is better tolerated. The study will measure how well participants function in several areas, including cognition, arm and leg function, and eyesight. Participants’ perspectives of their symptoms, quality of life and satisfaction with their treatment, will be factored into the study.
The data will help people with relapsing-remitting multiple sclerosis to weigh the balance between the two treatment options and allow payers and government agencies to make more informed decisions on medication coverage, with the overall cost of long-term disability being a driving factor.
The study results will also help guide overall treatment philosophy and will be applicable to a wide range of both existing and new multiple sclerosis drugs.
The Cleveland Clinic study is one of five multiple sclerosis studies, with a total value of $38 million, that have recently been approved by PCORI.
PCORI has approved $1.9 billion in funding since 2012 for more than 600 studies in patient-centred clinical comparative effectiveness research, to give patients, caregivers and clinicians the evidence needed to make better-informed healthcare decisions.
www.pcori.org
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