Current Issue : October - December Volume : 2017 Issue Number : 4 Articles : 5 Articles
Introduction: Introducing biosimilar infliximab for the treatment in rheumatology\n(rheumatoid arthritis and ankylosing spondylitis) and inflammatory bowel disease (Crohnââ?¬â?¢s\ndisease and ulcerative colitis) may reduce treatment costs associated with biologics.\nThis study aimed to investigate the budget impact of adopting biosimilar infliximab in\nfive European countries, considering that the budget impact includes the adoption of\nbiosimilar infliximab and the availability of biologic alternatives such as vedolizumab,\nbiosimilar etanercept, biosimilar rituximab, and other relevant factors.\nMethods: An existing budget impact model was adapted to forecast the budget\nimpact in the UK, Germany, France, Spain, and Italy. Epidemiological parameters\nwere derived from published literature reviewed in July 2015. Current market shares\nof biologics were derived from Therapy Watch (2012/2013 data). Respondents in a\nDelphi panel, conducted in 2015 and consisting of several leading rheumatologists\nand gastroenterologists from different nationalities, were asked to forecast uptake of\nbiosimilar infliximab and estimate the proportion of patients eligible for a particular type\nof biological treatment, including biosimilar infliximab. Scenario analyses assessed the\ninfluence of various factors, including price reductions, on the budget.\nResults: Uptake of biosimilar infliximab was particularly expected for naÃ?¯ve patients;\nswitching patients that already received other biologics was not expected much. Market\nshares after 5 years of biosimilar infliximab were âË?¼2% in rheumatology in all five countries\nand in gastroenterology ranged from 4% in France to over 30% in Italy. Except for France,\nbudgets were expected to decrease for rheumatologic diseases. For gastroenterology,\nbudgets were expected to decrease in Spain and Italy. Budgets were expected to\nincrease substantially in the UK and Germany, due to the introduction of vedolizumab\nin the studied period. In France, budget was expected to slightly increase for ankylosing\nspondylitis, Crohnââ?¬â?¢s Disease, and ulcerative collitis. Savings in budget were expected in all\ncountries, for all diseases, when larger price discounts on biosimilar infliximab were used.\nDiscussion and Conclusion: This study has shown that only when price reductions are\nlarge enough (i.e., 50% or more), physicians indicated that they will prescribe biosimilars.\nPolicy makers should ensure substantial price reductions and stimulate physicians to use\nbiosimilar products, to obtain savings in healthcare budgets....
Background: Alzheimerââ?¬â?¢s disease (AD) is a globally prevalent neurodegenerative condition, clinically characterized\nby progressive memory loss and gradual impairment of cognitive functions. Bapineuzumab is a fully humanized\nmonoclonal antibody that binds to neurotoxic amyloid proteins in the brain, enhancing their clearance. We\nperformed this systematic review and meta-analysis to evaluate the safety and efficacy of bapineuzumab in patients\nwith mild to moderate Alzheimerââ?¬â?¢s disease.\nMethods: We performed a web-based literature search of PubMed, Ovid, EBSCO, Scopus, Embase, Cochrane\nCENTRAL, and web of science using the relevant keywords. Data were extracted from eligible records and pooled\nas mean difference (MD) or risk ratio (RR) values with their 95% confidence interval (CI), using Review Manager\nsoftware (version 5.3 for windows). Heterogeneity was measured by Chi-square and I-square tests.\nResult: The pooled effect estimate from six randomized clinical trials (n = 2380) showed that bapineuzumab\nsignificantly reduced the cerebrospinal fluid concentration of phosphorylated tau proteins (Standardized MD = âË?â??5.53,\n95% CI [âË?â??8.29, âË?â??2.76]). However, the bapineuzumab group was not superior to the placebo group in terms of change\nfrom baseline in Alzheimerââ?¬â?¢s disease assessment scale (ADAS)-Cog11 (MD = 0.14, 95% CI [âË?â??0.72, 0.99]), disability\nassessment for dementia (DAD) scale (MD = 1.35, 95% CI [âË?â??1.74, 4.43]), and mini-mental state examination (MMSE)\nscores (MD = 0.08, 95% CI [âË?â??0.31, 0.47]). Regarding safety, bapineuzumab increased the risk of serious treatmentemergent\nadverse events (RR = 1.18, 95% CI [1.02, 1.37]) and cerebral vasogenic edema (RR = 40.88, 95% CI [11.94, 135.\n95]). All bapineuzumab doses (0.15, 0.5, 1, and 2 mg/kg) were similar to placebo in terms of change from baseline in\nADAS-cog11, DAD, and MMSE scores, except for the 0.15 mg/kg dose, which caused a significant worsening on the\nADAS-cog11 scale (MD = 5.6, 95% CI [0.22, 10.98]).\nConclusions: Considering the lack of clinical efficacy, combined with the significant association with serious adverse\nevents, bapineuzumab should not be used to treat patients with mild to moderate AD. Future studies should\ninvestigate the effect of combining bapineuzumab with other therapeutic strategies and reevaluate the efficacy of\ntargeting amyloid Ã?² proteins in AD therapy....
Background: The prognosis of children with juvenile dermatomyositis (JDM) has improved remarkably since the\n1960ââ?¬â?¢s with the use of corticosteroid and immunosuppressive therapy. Yet there remain a minority of children\nwho have refractory disease. Since 2003 the sporadic use of biologics (genetically-engineered proteins that\nusually are derived from human genes) for inflammatory myositis has been reported. In 2011ââ?¬â??2016 we investigated our\ncollective experience of biologics in JDM through the Childhood Arthritis and Rheumatology Research Alliance (CARRA).\nMethods: The JDM biologic study group developed a survey on the CARRA member experience using biologics\nfor Juvenile DM utilizing Delphi consensus methods in 2011ââ?¬â??2012. The survey was completed online by the\nCARRA members interested in JDM in 2012. A second survey was similarly developed that provided more\nopportunity to describe their experiences with biologics in JDM in detail and was completed by CARRA members\nin Feb 2013. During three CARRA meetings in 2013ââ?¬â??2015, nominal group techniques were used for achieving\nconsensus on the current choices of biologic drugs. A final survey was performed at the 2016 CARRA meeting.\nResults: One hundred and five of a potential 231 pediatric rheumatologists (42%) responded to the first survey in\n2012. Thirty-five of 90 had never used a biologic for Juvenile DM at that time. Fifty-five of 91 (denominators vary)\nhad used biologics for JDM in their practice with 32%, 5%, and 4% using rituximab, etanercept, and infliximab,\nrespectively, and 17% having used more than one of the three drugs. Ten percent used a biologic as monotherapy, 19%\na biologic in combination with methotrexate (mtx), 52% a biologic in combination with mtx and corticosteroids, 42% a\ncombination of a biologic, mtx, corticosteroids (steroids), and an immunosuppressive drug, and 43% a combination of a\nbiologic, IVIG and mtx. The results of the second survey supported these findings in considerably more detail with\nmultiple combinations of drugs used with biologics and supported the use of rituximab, abatacept, anti-TNFÃ?± drugs,\nand tocilizumab in that order. One hundred percent recommended that CARRA continue studying biologics for JDM.\nThe CARRA meeting survey in 2016 again supported the study and use of these four biologic drug groups.\nConclusions: Our CARRA JDM biologic work group developed and performed three surveys demonstrating that\npediatric rheumatologists in North America have been using multiple biologics for refractory JDM in numerous scenarios\nfrom 2011 to 2016. These survey results and our consensus meetings determined our choice of four biologic therapies\n(rituximab, abatacept, tocilizumab and anti-TNFÃ?± drugs) to consider for refractory JDM treatment when indicated and to\nevaluate for comparative effectiveness and safety in the future....
Background: Ustekinumab is a fully human monoclonal antibody against the p40 subunit of interleukin (IL) 12 and\n23 which is involved in the pathogenesis of several inflammatory diseases. Ustekinumab is approved for psoriasis\nand psoriatic arthritis treatment and has been successfully evaluated in phase II and III trials for patients with Crohn�s\ndisease (CD).\nCase presentation: We report here the case of a patient who became pregnant during treatment with ustekinumab\nfor a refractory CD and which ended in miscarriage.\nConclusion: Ustekinumab is a relatively new pharmacotherapy and in addition to this clinical case, we reviewed the\npublished literature concerning the use of this treatment during pregnancy and its consequences on pregnancy and\nfetus outcome....
Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of ThorinaneÃ?® and InhixaÃ?®,\nbiosimilars of the Low Molecular Weight Heparin (LMWH) enoxaparin. The authorization path is considerably different from\nthe guidelines published by the EMA in 2009, as well as from the recommendations from the International Society on\nThrombosis and Haemostasis published in 2013. Indeed, both of them recommended that LMWHs biosimilars therapeutic\nequivalence should be demonstrated in at least one adequately designed clinical trial. Shortly after enoxaparin biosimilars\napproval, EMA published a revised version of its guideline, no longer requiring the execution of a clinical study in patients\nat risk of venous thromboembolism.\nAlso the assessment of safety shows some relevant flaws, as it relies only on a 20 healthy volunteers study, clearly\nunderpowered to draw any conclusions about the safety profile of the drug.\nIn our opinion, the approach taken by EMA for approval of enoxaparin biosimilars raises serious concerns about their\nactual, clinical ââ?¬Å?similarityââ?¬Â.\nOn these grounds, with the endorsement of the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian\nSociety for Angiology and Vascular Medicine (SIAPAV), we elaborated the present document aimed at reviewing and\nreappraising some critical points regarding the introduction of biosimilars of LMWH in Europe.\nMoreover, we would strongly advise the Italian National Health Authorities not to entrust safety assessment to the\npost-marketing surveillance only, but to promote well designed and powered studies aimed at establish the actual\nefficacy and safety of LMWH biosimilars....
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