Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis. To study the safety of adalimumab in patients with psoriasis and history of coronary atherosclerosis or with at least three risk factors for coronary atherosclerosis. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. This randomized, controlled trial included 30 patients with moderate to severe psoriasis and a history, or multiple risk factors, of coronary atherosclerosis. Although adalimumab may reduce vascular inflammation in patients with moderate to severe psoriasis, this effect is not large enough to be demonstrated in a study with a small sample size. Randomized Multicenter Placebo-controlled Trial on the Effect of Adalumumab on Vascular Inflammation in Patient With Moderate to Severe Psoriasis.
A major goal of the Gelfands research program is improving psoriasis patient outcomes in the skin and joints, while lowering the risk of diabetes, cardiovascular disease and mortality. Vascular Inflammation in Psoriasis (VIP) Trials. The purpose of the VIP trials is to determine the impact of psoriasis treatment on key markers of cardiovascular risk such as lipid metabolism (HDL function) and aortic inflammation measured by 18-FDG-PET/CT. The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. Discontinue Humira if a patient develops a serious infection or sepsis. Association Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events A Meta-analysis of Randomized Controlled Trials.
Similar to clinical trials in RA, trials in psoriatic arthritis (PsA) have shown excellent clinical results with the tumour necrosis factor (TNF) blockers, etanercept, infliximab, and adalimumab in a variety of domains including the joints, quality of life, function, and slowing of disease progress as evidenced radiologically. During the past several years, we have witnessed remarkable advances in the treatment of the inflammatory arthritides as a result of the use of targeted, immunological therapies, such as the tumour necrosis factor (TNF) inhibitors. On average, the patients had nearly a 20 year history of psoriasis and a 15 year history of inflammatory arthritis. Four biologic therapies (adalimumab, efalizumab, etanercept and infliximab) which had been thoroughly revised, are now licensed for the treatment of moderate-to-severe psoriasis. These drugs have a potential for serious side effects, such as hepatotoxicity and nephrotoxicity (methotrexate, cyclosporine) teratogenicity (oral retinoids), and skin cancer (photo/chemotherapy), which limits their long-term use. Severe cases of psoriatic arthritis, which fail non-steroidal anti-inflammatory drugs or that present with polyarticular joint involvement or destructive progression, are approached using systemic administration of many of the disease-modifying antirheumatic drugs, which proved effective in rheumatoid arthritis therapy, including methotrexate, sulfasalazine and cyclosporine. A 2008 Phase III clinical trial (ATLAS) demonstrated that Humira reduced the signs and symptoms of ankylosing spondylitis for up to 36 months in 74 of patients. Moderate to severely active psoriatic arthritis – joint inflammation which affects about 1 in every 10 psoriasis patients.
Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Humira. The safety of Humira in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months. Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia. Preclinical data on fertility effects of adalimumab are not available. Vascular disorders. In the Vascular Inflammation in Psoriasis (VIP), multicenter trial that was designed to compare the effects of different treatment regimens (12 weeks of adalimumab vs. (12 weeks of adalimumab vs. phototherapy vs. placebo) on vascular inflammation as measured by FDG-PET/CT, we also aim to determine the role of FDG-PET/CT in measuring and assessing psoriasis activity in the skin. Three-dimensional reconstructed images of automatically segmented lesions were comparable with the clinical distribution of skin lesions in all patients. In a psoriatic patient, that acute inflammation doesn’t have a stopping point, Mehta said. Ongoing clinical trials are also looking at the effects of systemic psoriatic disease treatment on cardiovascular health. Anti-tumor necrosis factor alpha treatment with adalimumab improves significantly endothelial function and decreases inflammatory process in patients with chronic psoriasis. Methotrexate reduces incidence of vascular diseases in veterans with psoriasis or rheumatoid arthritis. Et al, Soluble biomarkers of cartilage and bone metabolism in early proof of concept trials in psoriatic arthritis: effects of adalimumab versus placebo. Adalimumab is undergoing trials for use in treating psoriasis and psoriatic arthritis. It has been approved by the FDA for treatment of moderate-to-severe cases in adults. 2012, 16 March: Humira could be associated with a significant decrease in vascular inflammation, a major risk factor of cardiovascular disease 31. The selected articles included randomized controlled trials (RCTs) and observational studies (prospective and retrospective cohort and case control studies). In order to address whether MTX alone may result in a similar degree of changes, a third RCT was conducted comparing the vascular effect of MTX plus infliximab with MTX alone in patients with early RA. Subclinical carotid atherosclerosis in patients with psoriatic arthritis.
Psoriatic Arthritis Treatment: Biological Response Modifiers
In the ongoing randomized Vascular Inflammation in Psoriasis (VIP) trial, investigators have assigned patients to receive adalimumab, phototherapy, or placebo for 12 weeks before crossing over to open-label adalimumab. Feldman, what such studies reveal regarding inflammatory disease may not only improve patients length and quality of life, but they could also affect how patients, insurers, and the government view psoriasis treatments.