Numerous topical and systemic therapies are available for the treatment of the cutaneous manifestations of psoriasis. Treatment modalities are chosen on the basis of disease severity, relevant comorbidities, patient preference (including cost and convenience), efficacy, and evaluation of individual patient response 1. Biologics approved for the treatment of psoriasis include:. Etanercept, infliximab and adalimumab belong to the class of biological medicines called tumour necrosis factor-alpha (TNF ) blockers. Ustekinumab targets interleukin-12 (IL-12) and IL-23. Concurrent diseases such as congestive heart failure or liver disease preclude the use of currently available systemic therapies. NICE recommends that etanercept (Enbrel), adalimumab (Humira), ustekinumab (Stelara) and secukinumab (Cosentyx) can be prescribed for people with severe psoriasis who have not responded to other systemic treatments such as PUVA, methotrexate, ciclosporin and acitretin. Infliximab (Remicade) can be offered for the treatment of very severe plaque psoriasis if the psoriasis has not responded to other systemic treatments such as PUVA, methotrexate or ciclosporin. The most common side effects that are reported include injection site reactions, upper respiratory infections, headache, dizziness, and stomach pain. Click here for a list of all our available resources for download.
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:. As of November 16, 2011, alefacept (Amevive) is no longer available in the U.S. market. Other systemic treatments for psoriasis include methotrexate or cyclosporine. Combination therapies that include biologic agents may be particularly appropriate for a number of specific groups of patients with psoriasis (Table 2) 45 48. Another five of the 15 treatment-pathway studies were available only as abstracts with no details of the sequence assumptions. Cost-effectiveness models of first-line biologics for moderate to severe plaque psoriasis either do not include subsequent treatment regimens or include only some of the regimens recommended in current treatment guidelines.
Biologic drugs are a relatively new class of treament for psoriasis and psoriatic arthritis. While biologics have been used to treat disease for more than 100 years, modern-day techniques have made biologics much more widely available as treatments in the last decade. Stelara (ustekinumab) works by selectively targeting the proteins, or cytokines, interleukin-12 (IL-12) and interleukin 23 (IL-23). Screening for tuberculosis (TB) or other infectious diseases is required before starting treatment with Cosentyx, Enbrel, Humira, Remicade, Simponi and Stelara. 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. This item is not available as a PBS benefit for in-patients of the hospital. These include:. After this, they must have a minimum 5 year break in PBS subsidised biological therapy before they are eligible to start another cycle. Psoriatic arthritis Psoriasis Biologic treatments Small molecule inhibitors Level of evidence of biologic agents efficacy. Adalimumab may also be the drug of choice for patients with dactylitis, enthesitis and nail disease. Infliximab has also demonstrated efficacy in psoriasis for patients with an inadequate response to etanercept: in the PSUNRISE RCT, at week 10, 65. The axial involvement also responded to therapy with ustekinumab and secukinumab, and the nail involvement, enthesitis and dactylitis associated with PsA were all improved with treatment with apremilast and sekukinumab (along with infliximab, certolizumab, etanercept, adalimumab and golimumab).
Psoriasis And Psoriatic Arthritis: Biological Therapies
Treatments for moderate-to-severe psoriasis often do not meet patient and physician expectations due to adverse effects, lack of long-term efficacy, and inconvenient administration schedules. Secukinumab is the newest biologic recently approved by the FDA for plaque psoriasis in doses of 150 and 300 mg (Table 2). Improvements in psoriasis therapies over the past decade have changed the way dermatologists treat this important disease entity, including increased use of biologic therapies. This article provides an overview of the current biologics available for the treatment of psoriasis and psoriatic arthritis, as well as patient and clinician roles in treatment. Etanercept efficacy in PsA was evaluated in an open-label extension study in which 169 patients continued treatment with etanercept 25 mg twice weekly for up to 48 weeks. These drugs include brodalumab, ixekizumab and secukinumab. Secukinumab is considered medically necessary for the treatment of plaque psoriasis (Ps) when each of the following criteria are met:. Treatments available to help manage the symptoms of plaque psoriasis include topical therapy, phototherapy, systemic therapy, and biologic DMARDs. They include etanercept, infliximab, adalimumab, secukinumab, and ustekinumab. Data for patients on adalimumab (n1879), etanercept (n1098), infliximab (n96) and ustekinumab (n450) were available. Treatments for more advanced psoriasis include narrow-band ultraviolet B (UVB) light, psoralen with ultraviolet A (UVA) light retinoids (eg, isotretinoin Accutane, Claravis, acitretin Soriatane ), methotrexate (particularly for arthritis), cyclosporine (Neoral, Sandimmune), infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira), apremilast (Otezla), and secukinumab (Cosentyx). In a study of ustekinumab in patients with moderate-to-severe psoriasis, investigators did not observe an increased trend in dose-related or cumulative toxicity with the duration of ustekinumab treatment. Recommendations from a 2013 international consensus report on treatment optimization and transitioning for moderate-to-severe plaque psoriasis include methotrexate and cyclosporine, biologic agents, and combination therapy.
Moderate To Severe Psoriasis: Biologic Drugs
Biologic therapies include adalimumab, etanercept, infliximab, secukinumab and ustekinumab. Chronic Plaque Psoriasis. There are four biologics currently licensed and used in the treatment of psoriasis in the European Union. Under their respective licenses, adalimumab, etanercept, infliximab, and ustekinumab are all indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, who have a contraindication to, or are intolerant of other systemic therapies, including ciclosporin, methotrexate, and psoralen + ultraviolet a (see Figure 2). A wealth of information about long-term safety will be available on maturity of the data being collected. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomised, double-blind, placebo-controlled, phase II regimen-finding study. Topical agents include corticosteroids, tacrolimus and other calcineurin inhibitors, tazarotene, alpha hydroxyl acids, vitamin D analogs, and combination vitamin D/corticosteroid preparations. Systemic therapy with biologics is increasingly common in the management of moderate-to-severe psoriasis.10 These agents have considerably improved the prognosis of patients by providing greater efficacy than conventional systemic therapies due to their activity on specific therapeutic targets. Although other systemic therapies are available, treatment has evolved with the biologics. Two biologics targeting IL-17A (secukinumab and ixekizumab) and one targeting the IL-17 receptor (brodalumab) are currently under research clinical development. Key efficacy findings from psoriasis RCTs of etanercept, infliximab, and adalimumab are presented here, followed by a discussion of safety and tolerability factors to consider when prescribing TNF alpha antagonists. Ustekinumab was approved by the FDA in 2009 for the treatment of moderate-to-severe plaque psoriasis (U.S. FDA, n.d.), with recommended subcutaneous injections at Weeks 0 and 4 and then every 12 weeks (Janssen Biotech, 2013b).
The efficacy of systemic treatments can be compared indirectly with meta-analyses of randomized clinical trials or directly when head-to-head trials are available. Available from: www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?