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Patient has used a biological therapy for the treatment of psoriasis less than 90 days before day 0

Official Title: Role of Il-17a in Difficult to Treat Variants of Psoriasis Including Palmo-plantar Psoriasis Resource links provided by NLM:. Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. Subject has used any non biological systemic therapy for the treatment of psoriasis (including Psoralen Ultra-Violet A (PUVA) therapy), systemic steroids or systemic immunosuppressants less than 28 days before Day 0. Subject who has used any biological therapy for the treatment of psoriasis less than 90 days before Day 0. Patients with psoriasis have an increase in serum levels of tumor necrosis factor alpha (TNF-alpha), Interleukin-17 (IL-17), IL-22, IL-6 as well as a the chemokine S100A913. Patient has used a non-biological systemic therapy for the treatment of psoriasis less than 30 days before Day 0. Patient has used a biological therapy for the treatment of psoriasis less than 90 days before day 0. Patient has used a non-biological systemic therapy for the treatment of psoriasis less than 30 days before Day 0. Patient has used a biological therapy for the treatment of psoriasis less than 90 days before day 0.

Patient has used a biological therapy for the treatment of psoriasis less than 90 days before day 0 2Numerous topical and systemic therapies are available for the treatment of the cutaneous manifestations of psoriasis. Biologic agents used in the treatment of psoriasis include the anti-TNF agents adalimumab, etanercept, and infliximab, the anti-interleukin (IL)-12/23 antibody ustekinumab, and the anti-IL-17 antibody secukinumab. Patients with less acute disease can be treated with acitretin or methotrexate as first-line agents. The treatment of psoriasis has undergone a revolution with the advent of biologic therapies, including infliximab, etanercept, adalimumab, efalizumab, and alefacept. Psoriasis is a life-long chronic inflammatory skin condition affecting approximately 2 of the general population. Most patients have plaques with silver-white scale and an erythematous base. The dosing of ustekinumab is more spaced out than previous biologics with subcutaneous injections given at week 0, week 4, and then at 12 week intervals, making treatment more convenient. For these patients, choice of systemic therapy has to be individualized and payer considerations come into play. Methotrexate is a mainstay agent, and many payers require it be used prior to biologic therapy. Ustekinumab is dosed by body weight with patients under 100kg prescribed 45mg at Week 0, Week 4, and then every 12 weeks thereafter for maintenance; those weighing over 100kg are dosed at 90mg on the same schedule.

Plaques are not as thick and the lesions are less scaly. Third-line therapy which refers to systemic biological therapies that use molecules designed to block specific molecular steps important in the development of psoriasis, such as the TNF antagonists adalimumab, etanercept and infliximab, and ustekinumab, anti-IL12-23 monoclonal antibody. Photochemotherapy uses a photosensitising drug (eg, PUVA) to treat patients with more extensive or resistant disease. Biological therapies of proven benefit in severe psoriasis include etanercept, adalimumab and infliximab, which target tumour necrosis factor. Surveys of patient support groups have found most patients were not satisfied with the control obtained with standard therapies. Other than acitretin (an oral retinoid) all systemic treatments, including biological therapies, are immunosuppressive and are contraindicated in patients with cancer or infections. May be daily, alternate days or less, used long-term, often years. Weeks 0, 2, 6, 12. Aetna considers biological therapies adalimumab (Humira), apremilast (Otezla), etanercept (Enbrel), infliximab (Remicade), secukinumab (Cosentyx), and ustekinumab (Stelara) medically necessary for adults aged 18 years and older with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy when the following selection criteria are met:. If there is active disease, TB treatment must be begun before initiation of the biologic.

Treatment Of Psoriasis

Patient has used a biological therapy for the treatment of psoriasis less than 90 days before day 0 3Chronic plaque psoriasis is a lifelong disease with a substantial impact on the physical well-being and quality of a patient s life. However, long-term treatment in patients with moderate to severe psoriasis is limited by the potential for toxic effects on organs, such as renal, hepatic or bone marrow, in addition to teratogenicity and malignancies that are associated with the traditional systemic therapies. Intra-articular injection with corticosteroids has been used to treat psoriatic arthritis flare-ups when one or two joints are involved. Psoriasis is a common; typically chronic papulosquamous skin disease that may be associated with a seronegative spondyloarthropathy. Psoriasis patients are not only more likely to have CV risk factors but severe psoriasis may serve as an independent risk factor for CV mortality. (used in other inflammatory diseases such as inflammatory bowel disease, rheumatoid arthritis and ankylosing spondylitis). Systemic therapy is effective, in treating severe disease (affecting more than 5 body surface area) and disease significantly involving the hands, feet or genitalia, however they have greater potential for toxicity. Psoriasis is a chronic inflammatory skin condition that is often associated with systemic manifestations. Systemic biologic therapies are effective treatments formoderate to severe psoriasis. Approximately 90 percent of affected patients have plaque psoriasis, characterized by well-defined round or oval plaques that differ in size and often coalesce6 (Figure 1). Inverse psoriasis is less scaly than the plaque form and occurs in skin folds such as flexor surfaces and perineal, inframammary, axillary, inguinal, and intergluteal areas (Figure 2). 10 to 50 mg orally per day. Biologics and small-molecule drugs being developed to treat psoriasis are showing encouraging results, but high costs could limit their use. Tofacitinib is already used to treat rheumatoid arthritis, and has shown positive results in clinical trials for psoriasis, so its manufacturer, Pfizer, has submitted it for FDA approval for use in psoriasis. For adult patients with severe chronic plaque psoriasis, treatment with specific biological agents as systemic monotherapy (other than methotrexate), can be subsidised through the PBS under sections 85 and 100 arrangements of the National Health Act 1953. After this, they must have a minimum 5 year break in PBS subsidised biological therapy before they are eligible to start another cycle. 300 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, and 3, followed by monthly maintenance dosing of 300 mg starting at week 4. Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg. Lifetime risks of serious adverse events from biologic treatment are less than risks patients face on a daily basis. Non-biologic systemic therapies, taken orally or by injection, can be used for patients with moderate-to-severe psoriasis who have not improved from other methods of treatment. Despite better safety and efficacy than drugs like methotrexate and cyclosporine, insurance companies often require patients to have failed less expensive oral treatments before covering biologics.

Chronic Plaque Psoriasis. Symptoms, Causes And Treatment

Although non-biological therapies, including methotrexate and ciclosporin, show significant efficacy their side effect profiles have precluded their long term use for moderate to severe psoriasis. The commonest side effects were headache, chills, fever, nausea, vomiting, or myalgia occurring on the day of injection or in the following two days during the initial three weeks of therapy. Several anti-TNF drugs have been used successfully to treat psoriasis and PsA.