Tuesday, July 16, 2024

New Drug For Psoriasis 2017

The Story Of Ketoconazole

New Drug Approved by FDA in July – 2017

In spite of all those toxic over-the-counter drugs the recent case about the ketoconazole looks more funny than serious.

In July of 2013 the European Medicines Agency issued the warning about the oral ketoconazole and its dangerous effects on liver.

The drug which is on the market about 30 years is suddenly bad, dangerous and not recommended to take? And who is responsible for the damaged health of the millions of people who took the drug? Nobody? Or nobody during those 30 years damaged his health taking this drug, so there is no problem?

How is it possible that this and many similar poisons get on the market in the first place?

Even more funny is the journey the EU decided to release the warning. In July of 2011 France requested the EU to review the ketoconazole safety after the French medicines agency concluded that the benefits of this drug are not worthy the other toxic effects.

So the EU was working hard just 2 years and now in July of 2013 it issued the statement that it recommends the oral ketoconazole to be banned. So actually it took just 14 years to issue the warning about this extremely toxic drug since the European Medicines Agency points to the study from 1999 as the reference that supports its decision .

They could better take a look at the study from 1986 which concluded that single dose at 50mg/kg of ketoconazole inhibited the bile flow and bile acid synthesis up to 92%. That study was just 27 years ago .

References:

Examples Of Clinical Reasons To Avoid Pharmacologic Treatment With Methotrexate Cyclosporine Or Acitretin

  • Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease
  • Breastfeeding
  • Cannot be used due to risk of treatment-related toxicity
  • Pregnancy or currently planning pregnancy
  • Significant comorbidity prohibits use of systemic agents
  • Table: Brands of Targeted Immune Modulators and FDA-approved Indications:

    Brand Name

    New Plaque Psoriasis Treatment Debuts This Month

    timerupdate

    A new drug designed to treat plaque psoriasis was approved by Health Canada this month with the help of a local dermatologist.

    Dr. Melinda Gooderham ran clinical trials of Tremfya out of her practice, Skin Centre for Dermatology, on Monaghan Rd.

    It was approved Nov. 10, after about two years of worldwide clinical testing. It’s expected to hit the market in December.

    Psoriasis is a hereditary condition that causes external and internal inflammation of the skin. On the outside, the immune system sends abnormal signals to the skin, telling the skin to grow faster. Skin then builds up on top of itself creating thick, red scaly plaques.

    Its effects can take a toll on those suffering from the disease, often causing depression and anxiety.

    “It can reduce someone’s quality of life,” Gooderham said.

    Tremfya selectively blocks a key inflammatory protein that causes plaque psoriasis to grow.

    It’s comparable to Costenyx, another plaque psoriasis injection treatment that Gooderham helped get approval in 2015.

    They both block the signal that tells to skin to grow, but Tremfya stops the initial protein that causes other proteins to produce, while Costenyx blocks the subsequent proteins.

    Both drugs are successful in treating moderate-to-severe psoriasis – which means greater than 10 per cent of body surface area – it just depends how they react with the patient, Gooderham said.

    “It was pretty amazing,” Gooderham said of Tremfya’s results.

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    Jorge Georgakopoulos Western University

    Supervisor: Project Title:

    Lay Summary

    An estimated 500,000 Canadians are living with psoriasis across our nation. Although there are many forms of psoriasis, plaque psoriasis represents an overwhelming 90% of these cases. To individuals who do not have this disease, plaque psoriasis is no more than skin changes characterized by raised, red patches with a silvery white build-up of dead skin seen on ones scalp, knees, elbows and lower back.

    Halobetasol Propionate Foam 005%

    Progress On Psoriasis, From

    Halobetasol propionate foam, 0.05 percent is a topical corticosteroid that the FDA first approved, as a generic, in May 2018. In April 2019, it became available under the brand name Lexette.

    Its used to treat plaque psoriasis in adults. Its goal is to clear up the skin.

    Twice a day, the foam is applied in a thin layer and rubbed into the skin. Lexette can be used for up to 2 weeks.

    The most common side effects of Lexette are pain at the application site and headache.

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    Nership Agreement For A Gel Formulation Of Dovobet In Japan: Treatment For Psoriasis Vulgaris

    Notice: This press release is an English translation of the original Japanese version.

    Tokyo, Japan â June 22, 2017 â LEO Pharma K.K. , LEO Pharma K.K.’s parent company LEO Pharma A/S , and Kyowa Hakko Kirin Co., Ltd. announce that the three companies entered into a distribution and co-promotion agreement on June 21, 2017 for a gel formulation of Dovobet®, which is a new form of Dovobet® in Japan. LEO Pharma K.K. has filed an application for the manufacturing and marketing approval of this product for psoriasis vulgaris in Japan.

    Dovobet® is a fixed dose combination of a topical product containing calcipotriol hydrate and betamethasone dipropionate , which has been approved in more than 90 countries, including the U.S., since being launched in Denmark in 2001 as a topical drug for psoriasis vulgaris, and is widely used as a first-line treatment for psoriasis. Dovobet® Ointment was launched in Japan in September 2014. From which time LEO Pharma K.K. and Kyowa Hakko Kirin have been jointly conducting marketing activities.

    The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

    Fda Approves Injectable Psoriasis Drug For Tough Cases

    A new drug to treat tough cases of the skin condition psoriasis has won approval from the U.S. Food and Drug Administration.

    Valeant Pharmaceuticals’ injectable drug Siliq was approved for adults with moderate-to-severe psoriasis that isn’t responding to other recommended treatments. However, the drug carries a warning about increased risk for suicidal behavior.

    Psoriasis is characterized by raised patches of red skin and flaking. The condition usually begins between ages 15 and 35 and is thought to be an autoimmune disorder, meaning the body mistakenly attacks healthy cells.

    “Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today’s approval provides patients with another treatment option for their psoriasis,” said the FDA’s Dr. Julie Beitz.

    Beitz is director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

    The drug is intended for patients who are candidates for systemic therapytreatment with pills or injectable drugs that travel through the bloodstreamor phototherapy , and have failed to respond or stopped responding to past therapies, the FDA said.

    The drug works by inhibiting the inflammatory response that contributes to development of plaque psoriasis, the most common form of the skin disease, the FDA said.

    “Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment,” Beitz said in an agency news release.

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    Pasi90 Model And Typical Drug Efficacies

    Similar to the PASI75 model, the time-varying drug effect and dose-effect relationship in PASI90 endpoint were well described by an exponential model and Emax model, respectively. The final estimated parameters of PASI90 longitudinal model are listed in Table 4. The dose-response difference of ustekinumab was not significant and estimating ED50 resulted in a poor model estimation accuracy. Therefore, ED50 for ustekinumab was fixed to 0 subsequently. The ED50 values of guselkumab, tildrakizumab and risankizumab were 2.95 mg , 7.16 mg and 13.3 mg , respectively. The placebo effect for PASI90 model was estimated and the results were listed in Supplementary Table S2. Body weight showed an effect on placebo component A of the PASI90 placebo effect model which was consistent as PASI75 model.

    TABLE 4. Final parameter estimates of PASI90 longitudinal model.

    FIGURE 4. The model predicted typical time course of PASI90 response of each drug. Lines are model predictions for average body weight 90 kg subjects. Circles represent the observed efficacy data, and the symbol size is proportional to the sample size. PASI90, 90% reduction from baseline Psoriasis Area and Severity Index score.

    TABLE 5. Model predicted PASI90 response of treatments at different time points.

    Other New Treatment Options For Psa

    New treatment for psoriasis

    Some other potential treatments for PsA include the following:

    • Light therapy: This may be a safe and inexpensive treatment option to improve skin symptoms. UVB is a type of UV light that reduces psoriasis-inducing cytokines and promotes the production of vitamin D, which is an important vitamin in treating autoimmune conditions.
    • Weight management: This may play a key role in managing and treating PsA. A 2018 systematic review suggests that people with obesity had a

    There is no one-size-fits-all approach for treating PsA.

    Current guidelines from the American College of Rheumatology and the National Psoriasis Foundation advise the use of TNF inhibitors, such as infliximab or adalimumab, as the first-line treatment for PsA.

    They suggest that people whose conditions do not respond to their first TNF inhibitor should try another TNF inhibitor rather than using IL-17 or IL-23 inhibitors, such as guselkumab or ixekizumab.

    Factors such as a persons preference for oral medication and the location and severity of their symptoms may influence which treatment is best for them. Oral small-molecule medications, such as methotrexate, may be the best treatment option for those who experience frequent infections during treatment with TNF inhibitors or those who have a strong preference for oral treatment.

    Although these are the current guidelines, the best treatment option will depend on a persons specific situation.

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    Impact Of Biologics On Comorbidities

    Psoriasis imposes a psychological burden on patients. The prevalence of having depression or anxiety is higher in psoriasis patients than in controls . A systematic review and meta-analysis investigating 18 studies including a total of 1,767,583 participants, of whom 330,207 had psoriasis, reported that patients with psoriasis had a significantly higher likelihood of suicidal ideation, suicide attempts, and completed suicides . Strober et al. evaluated the effect of biologic therapy on depression in psoriasis patients utilizing Psoriasis Longitudinal Assessment and Registry . The incidence rates of depressive symptoms were 3.01 , 5.85 , and 5.70 per 100 patient-years for biologics, phototherapy, and conventional therapy, respectively. Compared with conventional therapy, biologics reduced the risk for depressive symptoms , whereas phototherapy did not .

    Kaushik and Lebwohl also described specific comorbidities and insights to choose the appropriate systemic treatment in patients with moderate-to-severe psoriasis . The choice of appropriate biologic therapy for a patient is often determined by the presence of comorbidities.

    Pasi75 Model And Typical Drug Efficacies

    The PASI75 longitudinal model established in this study could well describe the time-varying drug effect and dose-response relationship. The parameter estimates of drugs for the PASI75 model are provided in Table 2. In the structural model, Edrug is an exponential function dependent on time. The parameter Emax represents the maximum efficacy, and the parameter k is the rate constant describing the onset of each drug. The Emax for apremilast was fixed, otherwise the estimation for apremilast showed larger RSE%. For each of the drug, the parameter k was estimated with an acceptable estimation accuracy. ED50 showed the potency of each drug. For risankizumab, alefacept and methotrexate, the dose-response relationships were not obvious. Therefore, the ED50 for these drugs was fixed to 0. For all the drugs except apremilast, the dose regimen is higher than ED50. Take adalimumab for example, the ED50 value was estimated to be 23.1 mg and the clinical dosage is 40 mg every 2 weeks which means the drug effect is easy to access maximum effect. The placebo effect for PASI75 model was also estimated which was shown in Supplementary Table S1. Body weight effect was included in the parameter A in the PASI75 placebo effect model which resulted in a better model fit.

    TABLE 2. Final parameter estimates of PASI75 longitudinal model.

    TABLE 3. Model predicted PASI75 response of treatments at different time points.

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    Promising New Treatment Option For Chronic Plaque Psoriasis

    Date:
    Beth Israel Deaconess Medical Center
    Summary:
    A new study tested the efficacy of tildrakizumab, an antibody that targets only a very specific immune system pathway. More than 60 percent of all patients who received the active medication showed improvement, compared to less than 10 percent of patients who received placebos.

    Affecting more than 6 million Americans, chronic plaque psoriasis manifests as patches of red, scaly skin most frequently on the scalp, elbows and knees. Chronic plaque psoriasis most often appears in adolescence or mid-life and can require lifelong medication. Until the 1990s, physicians had few options to offer their patients with moderate-to-severe psoriasis. Up to a quarter of patients with psoriasis suffer from these more aggressive cases that can affect anywhere from 10 to a 100 percent of the surface of the skin.

    Now, two Phase 3 trials have demonstrated that a biologic agent called tildrakizumab is efficacious and well-tolerated in patients with moderate-to-severe chronic plaque psoriasis. The findings appeared in the journal Lancet and represent a major step forward in the treatment of the skin disorder.

    An antibody that targets only a very specific pathway, tildrakizumab belongs to a class of treatments called biologic agents, or biologics for short. Different from traditional pharmaceutical drugs, biologics are based on molecules that the body makes naturally — like antibodies — repurposed to treat disease.

    Story Source:

    Indirect Comparison Using Nma

    New Oral Medication For Psoriasis
    • Eaton J.N.
    • et al.

    Br J Dermatol.

    BIWBSANMANo.PASI 75PASI 90PASI 100Q2WQ4W

    Treatment Proportion of maximum area under the curve, median
    PASI 75
    Method 1Method 1: Network meta-analysis estimation of percent of maximum AUC using both week 12 and 16 data available for each drug. Method 2Method 2: Network meta-analysis estimation of percent of maximum AUC using only week 12 data for each drug. Method 1Method 1: Network meta-analysis estimation of percent of maximum AUC using both week 12 and 16 data available for each drug. Method 2Method 2: Network meta-analysis estimation of percent of maximum AUC using only week 12 data for each drug. Method 1Method 1: Network meta-analysis estimation of percent of maximum AUC using both week 12 and 16 data available for each drug. Method 2Method 2: Network meta-analysis estimation of percent of maximum AUC using only week 12 data for each drug.
    Placebo

    AUCBIWPASI 75PASI 90PASI 100Q2WQ4WQ8WQ12W

    • Ades A.E.
    • et al.

    Med Decis Making.

    J Comput Graph Stat.

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    Promising Results For Drug For Psoriatic Arthritis

    Psoriatic arthritis causes painful joint swelling, but new medication Taltz might help

    HealthDay Reporter

    FRIDAY, May 26, 2017 — A new drug might help ease the pain and disability of a form of arthritis often linked to psoriasis.

    According to Stanford University researchers, psoriatic arthritis is an inflammatory joint disorder tied to an out-of-control immune response. The disease affects about one in every 200 people and is often accompanied by the autoimmune skin disorder psoriasis.

    Psoriatic arthritis typically arises after the age of 30 and can bring stiffness, pain and swelling of the joints, leading to real disability if treatments don’t help.

    The new study focused on more than 300 adult patients across 10 countries. These patients were no longer seeing an effect from standard biologic drugs or had never experienced a benefit in the first place.

    That’s not uncommon.

    “Only about half of psoriatic arthritis patients who are given TNF inhibitors get better,” study lead author Dr. Mark Genovese said in a Stanford news release.

    So, his team tried out a newer drug called Taltz , already approved to fight psoriasis. The study was funded by the drug’s maker, Eli Lilly & Co.

    Patients were randomly assigned to receive injections of either Taltz or an inactive placebo. Over 6 months, about one-third got Taltz injections every two weeks, another third received the placebo every two weeks, while the remaining third received alternate injections of Taltz and the placebo.

    New Era Of Psoriasis Treatment

    In the 1960s and ’70s, new info about how the immune system — your body’s defense against germs — plays a role in psoriasis led to several new treatments. Drugs like corticosteroids, cyclosporine, and methotrexate became mainstays for managing the disease. For the next few decades, though, advances in treatment slowed down.

    Thanks to recent progress in research, that’s history.

    Scientists studying other autoimmune diseases found new insights about the immune system. It turns out that some of the problems in those conditions are active in psoriasis, as well.

    The new info brought treatments that target specific areas of your immune system. Called biologics, these drugs launched a new era of psoriasis treatment. New biologic therapies work well to treat psoriasis, and other new treatments are close to FDA approval.

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    Empty Stomach Vs With Meal: Fluconazole And Itraconazole

    The study Influence of concomitant food intake on the oral absorption of two triazole antifungal agents, itraconazole and fluconazole from 1994 compared the absorption of two of the most prescribed and effective antifungal drugs fluconazole and itraconazole.

    The influence of food on the pharmacokinetics of the triazole antimycotics fluconazole and itraconazole was investigated in a randomised, parallel group, single dose study in 24 healthy subjects. Each group took either a 100 mg capsule of fluconazole or a 100 mg capsule of itraconazole, pre-prandially or after a light meal or a full meal, in a three-way crossover design. Gastric and intestinal pH were measured with a co-administered radiotelemetric pH capsule, and gastric emptying time of the capsule was taken as the maximum gastric residence time of drug and food. The plasma AUC and Cmax of itraconazole were significantly different under the various conditions and the mean AUC was greatest after the full meal. The bioavailability of itraconazole relative to that after the full meal, was 54% on an empty stomach and 86% after a light meal. The criteria for bioequivalence were not attained. In contrast, the bioavailability of fluconazole relative to the full meal was 110% pre-prandially and 102% after the light meal , and the criteria for bioequivalence were attained.

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