The search strategy used MeSH and keyword headings, using the search string psoriasis AND ( biologics OR etanercept OR adalimumab OR infliximab OR ustekinumab ) AND ( safety OR adverse events OR side effects ). A prospective analysis of two Phase 3 trials and open-label extensions has allowed assessment of the safety profile of up to four years of etanercept treatment.16 A total of 506 patients entered a Phase 3 trial; 208 of these were in a double-blind study and were randomized to receive either etanercept (25 or 50mg) or placebo twice weekly (BIW) for the first 12 weeks, followed by etanercept 25mg BIW for further 12 weeks. While more long-term safety data on current biologic therapies continues to emerge, new therapeutic agents for psoriasis will be launched. Biologics used to treat psoriatic diseases block T cell receptors or block proteins in the immune system, such as tumor necrosis factor-alpha (TNF- ) or interleukins (IL) 12 and 23. In the past year, more safety data has emerged on biologic therapies and it continues to be encouraging, said Mark Lebwohl, MD chair of department of dermatology at the Icahn School of Medicine at Mount Sinai, in New York, NY, and chairman emeritus of the National Psoriasis Foundation Medical Board. 1 The increasing use of biologic medications may reflect the generally high efficacy rates, relatively good safety profiles and demonstrated improvement in quality of life. Sinai in New York, NY, agreed that biologics are efficacious for psoriasis. New, promising therapies are in development for psoriasis (brodalumab, ixekizumab, and secukinumab, which specifically target interleukin IL -17, and guselkumab and tildrakizumab, which specifically target IL-23); the IL-17 and IL-23 cytokines constitute part of the TH17 axis that is thought to be at the core of psoriasis pathogenesis. Data to support increased mortality in the psoriatic population continues to be collected and reported. Emerging long-term data on the safety of ustekinumab are reviewed in subsequent paragraphs. The data, therefore, support the stable safety profile of long-term adalimumab use in patients with moderate to severe psoriasis.
Safe use of biologic agents requires thorough risk assessment of potential candidates for treatment and careful monitoring during and after therapy. Safety data from an integrated analysis of five RA trials of s.c. abatacept have been reported recently 81, 82. Recent guidelines from the National Psoriasis Foundation point to new directions in research and therapy that will continue to shape psoriasis therapy. The final oral agent used in psoriasis, methotrexate, seems to have less efficacy than cyclosporine but can be used more long-term. While efficacy data on the TNF inhibitors are fairly clear, safety has long been an area of debate. Forthcoming data in coming months and years will continue to elucidate the safety profiles of biologic therapies and provide a clearer outlook on risk/benefit profiles in specific circumstances. Keywords: psoriasis, therapy, interleukin-17, biologics, emerging, treatment. IIII clinical trials; however, more recent data continue to support its efficacy.
Assessing The Safety Of Biologic Agents In Patients With Rheumatoid Arthritis
California dermatologist takes his training to a new level to serve his countryMarch 01, 2012By Lisette Hilton. New safety profile data continues to emerge on biologics used in psoriasis. According to the Food and Drug Administration (FDA), data on the safety and efficacy of alefacept treatment beyond 2 courses are limited. If there is active disease, TB treatment must be begun before initiation of the biologic. The authors concluded that these findings suggest that efalizumab maintains, and in some patients continues to improve, efficacy during long-term therapy. Last Updated 23 December 2015The psoriasis market has become increasingly lucrative owing to the growing use of biologics. Research & Data Brand Trends & Insights. The interleukin-12 (IL-12)/23 inhibitor ustekinumab has experienced strong uptake since its launch for psoriasis in 2009 and has established an earlier position in the treatment algorithm on the strength of its favorable efficacy, safety profile, and convenient dosing. How do physicians view emerging topical therapies with new mechanisms? What new treatments have been approved by the FDA for use in psoriatic arthritis? Safety profile of all three drugs seems to be reassuring until now, although long-term data are still not available. The first biologic agents to be used to treat moderate-to-severe psoriasis were TNF alpha antagonists. At Week 12, patients taking adalimumab could continue taking their assigned dose for a 48-week extension, and patients in the placebo group were switched to adalimumab 80 mg at Week 12 and then adalimumab 40 mg eow (Gordon et al. Acitretin is a second generation retinoid used in the treatment of psoriasis.
Management Of Multiple Sclerosis
Biologics Disease modifying Molecule therapy Psoriatic arthritis Tumor necrosis factor. This article assimilates all of the relevant data concerning both old and new biologic molecules, and provides an evidence-based review of the current and emerging therapeutic options for PsA. The real world use of anti-TNF agents is associated with good drug retention in the short term. Whilst these trials have demonstrated some efficacy in PsA and a favorable safety profile, the emergence of more efficacious molecules means that alefacept is now unlikely to gain a dominant status in the hierarchical management of PsA.