Hi guys I was wondering what I should expect when I take my first stot I've been reading your post and they have been a great deal of info but other stuff I've read kind of makes me not want to take the shot I was given a 90 dose to start as my psoriasis is really bad. All info would be appreciated thx

Hello there,
Newbie here, not sure where to go or what to do. I just stumbled across your site after feeling quite disappointed with my bodys' reaction to the treatments I have had so far. I am feeling very disillusioned and quite poorly and wondered what other peoples' experiences have been with their treatments.
Any information or discussion would be most appreciated.

BTW - I have never used a forum before - so any help or pointers there would be a help too !![/font][/size]

Following on from Otezla getting FDA approval back in March for psoriatic arthritis, Celgene have now received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for it's use in Europe.

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Celgene Corporation, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OTEZLA® (apremilast), the Company's oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications:

For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).

Alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.

Psoriasis is an immune mediated skin condition characterised by raised scaly lesions on the skin. It affects approximately 14 million people across Europe2 and about 125 million people worldwide.3 Plaque psoriasis, also called psoriasis vulgaris, is the most common form of the disease, representing about 80 percent of cases.4 Up to 30 percent of people with psoriasis may develop psoriatic arthritis, which involves pain and swelling in jointsand other manifestations and may lead to significant disability.

"This CHMP positive opinion is an important step forward for people with psoriasis and psoriatic arthritis in Europe. These immune mediated diseases are frequently debilitating and cause severe physical and emotional pain to the individual," stated Tuomo Pätsi, President, Celgene Europe, the Middle East and Africa (EMEA). "We are proud to have moved one step closer to offering patients OTEZLA®, a new, oral treatment approach that could significantly help control their symptoms and make a considerable difference to their quality of life."

In the ESTEEM studies, which form the basis of CHMP's positive opinion for apremilast in psoriasis, treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 (a 75 percent improvement in the Psoriasis Area Severity Index) scores at week 16, the primary endpoint.6,7 Patients on apremilast also benefited from significant improvements in difficult to treat areas, such as nail and scalp, and itch, known to have a marked impact on patients' quality of life and perception of disease severity.

In the PALACE program, which forms the basis for CHMP's positive opinion for apremilast in psoriatic arthritis, treatment resulted in significant and clinically meaningful improvements in the signs and symptoms of psoriatic arthritis, as measured by the modified ACR-20 (a 20 percent improvement in the American College of Rheumatology disease activity criteria) response at 16 weeks, the primary endpoint. 7,11 Patients on apremilast showed improvement across multiple disease manifestations specific to psoriatic arthritis, such as swollen and tender joints, as well as dactylitis, enthesitis and overall physical function.

In the two Phase III programs, PALACE and ESTEEM, the clinical response of OTEZLA was maintained through week 52 across multiple endpoints.

Across these phase III clinical studies, the most commonly reported adverse reactions were consistently diarrhoea, nausea, upper respiratory tract infection, tension headache and headache.6,11 These adverse reactions were mostly mild to moderate in severity. Gastrointestinal adverse reactions generally occurred within the first two weeks of treatment and usually resolved within four weeks.6,11 During the placebo-controlled phase of the clinical trials, the rate of major adverse cardiac events, serious infections, including opportunistic infections, and malignancies, was comparable between placebo and apremilast groups.

OTEZLA® was approved on March 21, 2014 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis and on September 23, 2014 for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In Canada, OTEZLA was approved for the treatment of moderate-to-severe plaque psoriasis in November 2014. A New Drug Submission (NDS) for psoriatic arthritis was submitted to Canadian Health Authorities in the second quarter of 2013. Marketing authorisation applications are ongoing in other countries, including Australia and Switzerland.

The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two to three months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).

Bad news for Stelara as Health Canada issue Important Safety Information on their website. Though rare, Health Canada say serious skin conditions (exfoliative dermatitis and erythrodermic psoriasis) have been reported in patients treated with Stelara.

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Dear Healthcare Professional:

Subject: Risk of exfoliative dermatitis and erythrodermic psoriasis with STELARA® (ustekinumab)

Janssen Inc., in consultation with Health Canada, would like to inform you of important new safety information regarding the risk of exfoliative dermatitis and erythrodermic psoriasis associated with the use of STELARA®.

STELARA® is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

Cases of exfoliative dermatitis and erythrodermic psoriasis have been reported rarely in psoriasis patients receiving STELARA®. These skin conditions can occur within a few days of the patient receiving STELARA®. They can be severe and lead to hospitalization.

The Product Monograph for STELARA® will be updated to include the adverse events of exfoliative dermatitis and erythrodermic psoriasis. Please refer to the STELARA® Product Monograph for full prescribing information.

The symptoms of exfoliative dermatitis may be indistinguishable from erythrodermic psoriasis. Advise your patients to watch for and report these symptoms. In case of occurrence of these symptoms, appropriate therapy should be initiated. Treatment with STELARA® should be discontinued if a drug reaction is suspected.

There have been rare (≥1/10,000 to<1/1,000) reports of exfoliative dermatitis and erythrodermic psoriasis in psoriasis patients receiving ustekinumab. Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of their disease.

Physicians should be alert for symptoms of exfoliative dermatitis. These can appear as redness and shedding of the skin over almost the entire area of the body, which may be itchy and/ or painful.

A copy of this letter and the Canadian Product Monograph can be accessed at the Health Canada Web site and on the Janssen Inc. Web site.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious exfoliative dermatitis or erythrodermic psoriasis or other serious or unexpected adverse reactions in patients receiving STELARA® should be reported to Janssen Inc. or Health Canada.

We're often talking on Psoriasis Club about the costs of treatment and you may find this interesting as (Secukinumab) now going under the name Cosentyx could be pressured into offering a low price, after getting recommended approval as a first line treatment for psoriasis by the Committee for Medicinal Products for Human Use (CHMP)

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A recommendation from the CHMP generally translates into an approval by the European Medicines Agency (EMA). Therefore, the drug can be expected to be launched early next year.

Cosentyx is an IL-17 inhibitor that targets the interleukin-17A, a pro-inflammatory protein. It is also being evaluated against other auto-immune diseases. The CHMP recommended the drug as a first-line treatment for the disease. This puts Novartis’ drug ahead of Johnson & Johnson’s Stelara and Pfizer Inc. and Amgen, Inc.’s co-marketed drug Enbrel.

Psoriasis is an auto-immune inflammatory disease, characterized by the formation and accumulation of scaly silver patches on the skin, with redness and itchiness. Patients are first treated with systematic therapies, such as methotrexate or ciclosporin. These therapies can be hard to tolerate, with severe side-effects. Some patients may not even respond to them. In such cases, patients are treated with drugs like Stelara or Enbrel. Stelara is a monoclonal antibody. On the other hand, Enbrel is a TNF inhibitor that blocks the action of tumor necrosis factor (TNF), associated with the body’s inflammatory response.

The first-line indication gives the drug an advantage over other available options. In earlier studies, Cosentyx was shown to have greater effectiveness than Enbrel. Novartis is currently conducting studies to evaluate Cosentyx's comparative efficacy with Stelara, results of which are due in the current quarter. Stelara generated sales of $1.5 billion in 2013. However, the drug is also prescribed for other inflammatory diseases, so not all sales can be attributed to the Psoriasis market. Amgen reported $4.5 billion in revenues from Enbrel, which is also approved for rheumatoid arthritis and psoriatic arthritis.

Cosentyx was approved for the same indication by the US Food and Drug Administration (FDA) in October. However, it is likely to face troubles on the pricing front. It will directly compete with methotrexate and other systematic treatments, for which many cheap generics are available.

Enbrel costs nearly $17,270 per year. Due to Cosentyx’s superioty, Novartis is likely to keep a higher price tag. Enbrel and Stelara are used only after first-line treatment has failed. Therefore, if Cosentyx is priced higher, insurance providers may limit its use to first-line treatment given to patients suffering from the severe stage of the disease, and not as a replacement for the two drugs.

Enbrel, which has been in the market for years and is widely used, is already being sold at heavily negotiated prices. Therefore, healthcare providers may be reluctant to shift to Cosentyx.

Despite strong trial results, Cosentyx’s success will also depend on the pricing. It can have an advantage over Stelara if ongoing trials prove its superiority over it. Stelara can cost between $28,000 and $55,000 per year, depending on the dosage. Hence, both the drugs can compete on pricing. Novartis should also expect to face pricing pressures from UK cost-watchdog National Institute for Health and Care Excellence (NICE). The agency recommends the drugs to be used by UK’s National Health Services, based on their costs, compared to additional benefits over current standard-of-care treatments. NICE can be considerably strict in its evaluations of cost-benefit analysis for new drugs. It did not approve the use of Stelara for psoriatic arthritis in March this year.

I am also a sufferer of psoriasis. Have had this horrible affliction for bout 12 years now and nothing has worked so far apart from light treatment but this was only short lived. I am now starting Fumaderm only on my 4th day. Today developed a red prickly heat rash on chest, back and arms for bout 20 mins. Is this what they call flushing? Can't wait to hear from anyone

Following on from other reports recently about Secukinumab showing good results when up against Enbrel, Novartis have announced it has received positive opinion recommending approval from the Committee for Medicinal Products for Human Use (CHMP) for a first line treatment of moderate-to-severe plaque psoriasis in adults.

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Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Cosentyx™ (secukinumab, formerly known as AIN457) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

This recommendation would mean doctors could use secukinumab first-line to treat their psoriasis patients, as an alternative to other first-line systemic treatments, which have significant side effects. Currently, all biologic treatments for psoriasis, including anti- tumor necrosis factor therapies (anti-TNFs) and ustekinumab are recommended for second-line systemic therapy in Europe.

Secukinumab (at a dose of 300 mg) is the first interleukin-17A (IL-17A) inhibitor to be recommended as a first-line treatment option for psoriasis patients who require systemic therapy in Europe. Secukinumab works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by the disease.

"This positive CHMP opinion for secukinumab as a first-line treatment of psoriasis brings us one step closer to approval in Europe and making clear skin a reality for psoriasis patients," said David Epstein, Division Head, Novartis Pharmaceuticals. "With this exciting news, we may change the way psoriasis is treated, as 50% of patients are unhappy with their current psoriasis therapies, demonstrating an urgent need for new treatments that clear skin faster and for a longer time."

The ultimate aim of psoriasis treatment is clear skin for patients. In clinical studies, 70% or more patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) with secukinumab 300 mg during the first 16 weeks of treatment.

The CHMP opinion was based on the positive results of the Phase III clinical trial program in moderate-to-severe plaque psoriasis and follows the unanimous recommendation of approval in October from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA).

The European Commission reviews the recommendations of the CHMP. The final decision on approval, usually granted in approximately two months of the CHMP opinion, will be applicable to all European Union (EU) and European Economic Area (EEA) countries.

Otezla is once again showing good results, and this time it's two years use for psoriatic arthritis.
This follows on from the announcement last March which can be found here: Otezla gets FDA approval for Psoriatic Arthritis

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Celgene Corporation, today announced that results from long-term (104-week) efficacy and safety analyses of OTEZLA® (apremilast) from the open-label phase of two PALACE phase III clinical trials were presented at the 2014 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in Boston. OTEZLA is the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

In PALACE 1, 84 percent (144/171) of patients who completed one year (52 weeks) of 30 mg twice daily therapy continued to receive OTEZLA at two years (104 weeks). Improvements in efficacy measures observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, among patients receiving OTEZLA 30 mg twice daily, the ACR20 response rate was 65.3 percent. ACR50 and 70 response rates were 34.0 percent and 19.6 percent, respectively, at week 104.

Similar findings were observed in PALACE 4. In this trial, nearly 84 percent (168/201) of DMARD-naïve patients who completed one year of OTEZLA 30 mg twice daily monotherapy continued to receive OTEZLA at two years. At week 104, among patients treated with OTEZLA 30 mg twice daily monotherapy, an ACR20, 50 and 70 response was reached by 61.4 percent, 40.7 percent and 19.2 percent of patients, respectively.

In both PALACE 1 and PALACE 4, changes in other efficacy measures—including the HAQ-DI, which assesses improvements in physical function, and swollen and tender joint counts—were also generally sustained between weeks 52 and 104 with continued OTEZLA treatment. In PALACE 4, treatment with OTEZLA in patients with pre-existing enthesitis (inflammation at sites where tendons or ligaments insert into bone) or dactylitis (inflammation of an entire digit), two key manifestations of psoriatic arthritis, resulted in improvements in enthesitis and dactylitis that were sustained through 104 weeks of treatment.

"Given the chronic nature of this condition, dealing with psoriatic arthritis can be an ongoing struggle for many people," said Alvin Wells, M.D., Ph.D., director, Rheumatology and Immunology Center, Franklin, WI. "Evidence-based data show that different treatment options are frequently required to continue to manage a patient's symptoms. At our center, we see patients with active psoriatic arthritis who present with significant disease activity despite effective prior treatments. These new data from ongoing open-label studies add to our understanding of how apremilast may help meet treatment goals in such patients."

Similar to adverse events (AEs) reported during weeks 0 to 52 in PALACE 1 and 4, most AEs reported during weeks 52 to 104 were mild or moderate in severity. The rates of diarrhea, nausea, headache and upper respiratory tract infection (URTI)—AEs reported in at least five percent of patients receiving OTEZLA 30 mg twice daily at 52 weeks in both studies—decreased or were similar between weeks 52 to 104 compared with the 0 to 52 week period. Rates of diarrhea, nausea, headache and URTI at week 104 in PALACE 1 and 4 respectively, were as follows: diarrhea (1.8 percent and 2.0 percent), nausea (0.6 percent and 2.0 percent), headache (4.7 percent and 1.0 percent) and URTI (4.7 percent and 4.5 percent). Serious AEs occurred in 4.7 percent and 5.0 percent of patients, respectively. In addition, discontinuation rates due to AEs in both studies decreased during the 52 to 104 week period compared with the 0 to 52 week period.

We have been saying for a long time now that psoriasis is an autoimmune disease, well here's an article ahead of full print that suggests psoriasis is not an autoimmune disease after all.

The basics:

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The concept that psoriasis is an autoimmune disease needs to be questioned. The autoimmune label has been based on molecular mimicry between streptococcal and keratin proteins and the existence of homologous peptides between these proteins. However it is only peripheral blood CD8, and not CD4, T lymphocytes that respond to the homologous peptides.

This ignores the fact that it is CD4 T cells which are necessary to initiate psoriasis. Recent studies on skin bacterial microbiota have found a variety of bacteria in both normal skin and psoriatic lesions. In biopsy specimens the most common phylum was Firmicutes and the most common genus streptococcus in both psoriasis and normal skin.

The innate immune system is activated in psoriasis and recent genetic findings have shown the majority of susceptibility loci are associated with innate immunity. There is a known clinical relationship between both Crohn's disease (CD) and periodontitis, and psoriasis, and psoriasis patients share mutations in some innate immunity genes with individuals with CD. It is now accepted that CD is due to a breakdown of immune tolerance (dysbiosis) to bacteria in the intestine.

These findings suggest that psoriasis is initiated by an abnormal response to bacteria in the skin due to genetic factors.

*This article is protected by copyright. All rights reserved.

More good news from Amgen and AstraZeneca about Brodalumab, after announcing phase 3 results in May about their phase lll AMAGINE-1TM study Brodalumab phase 3 results today they have announced results from AMAGINE-3TM which shows Brodalumab could be set to knock Stelara off it's perch.

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Amgen and AstraZeneca today announced that AMAGINE-3TM, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12. Brodalumab was shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100). When compared with placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75 percent improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75). A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo, according to the static Physician Global Assessment (sPGA 0 or 1). All key secondary endpoints comparing brodalumab with Stelara and placebo were also met.

Results showed that 36.7 percent of patients in the brodalumab 210 mg group, 27.0 percent of patients in the brodalumab 140 mg group, 18.5 percent of patients in the Stelara group and 0.3 percent of patients in the placebo group achieved total clearance of skin disease (PASI 100). In addition, 85.1 percent of patients in the brodalumab 210 mg group, 69.2 percent of patients in the brodalumab 140 mg group, 69.3 percent of patients in the Stelara group and 6.0 percent of patients in the placebo group achieved PASI 75.

"Despite a variety of treatment options available for psoriasis, many patients still do not meet skin clearance goals," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These results are of particular importance as they are the first to demonstrate superiority to Stelara in achieving total skin clearance, and the second positive pivotal Phase 3 study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis."

The most common adverse events that occurred in the brodalumab arms (more than 5 percent of patients in either group) were common cold, joint pain, upper respiratory tract infection and headache. Serious adverse events occurred in 1.4 percent of patients in the 210 mg group and 1.6 percent of patients in the 140 mg group compared with 0.6 percent for Stelara and 1.0 percent for placebo during the placebo-controlled period.

Brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F, A/F and C) to the receptor. The IL-17 receptor and cytokine family play a central role in development and clinical manifestation of plaque psoriasis.

"These results add to the growing body of evidence supporting the potential value that brodalumab may bring to the treatment of psoriasis by targeting the IL-17 receptor," said Briggs W. Morrison, M.D., executive vice president of Global Medicines Development at AstraZeneca. "We look forward to sharing results later this year from AMAGINE-2TM, our remaining head-to-head study evaluating brodalumab versus Stelara."

The AMAGINE program is composed of three Phase 3 studies designed to assess the efficacy and safety of brodalumab in patients with moderate-to-severe plaque psoriasis. Top-line results from AMAGINE-1TM, designed to assess the efficacy and safety of brodalumab compared with placebo, were released in May 2014. Detailed results from the AMAGINE-3 study will be submitted to the appropriate scientific forum for presentation and/or publication. Results from AMAGINE-2 are expected by year end.

The DCP (Department of Consumer Protection) is to hold a public hearing on November 26, 2014 08:30 at 165 Capitol Ave, Room 126, Hartford, CT 06106 following a petition for the use of medical marijuana in people with Severe Psoriasis and Psoriatic Arthritis.

Source: NO LINKS ALLOWED

That's all I have and please excuse my ignorance, but I assume this in the USA and not Hartford UK

If anyone knows more please add.

The psoriasis drugs market is set to experience huge growth over the next few years, with Stelara representing nearly 22 percent of total psoriasis sales by 2023.

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Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the psoriasis market will experience robust growth over the next decade as sales increase from $6.6 billion in 2013 to $10.7 billion in 2023 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. The continued uptake of Janssen’s interleukin (IL)-12/23 inhibitor Stelara in earlier lines of therapy and the entry of therapies with novel mechanisms of action (notably the IL-17 inhibitors), will drive sales growth. Stelara is forecast to achieve major-market sales of approximately $2.4 billion in 2023, representing nearly 22 percent of total psoriasis sales.

Emerging agents will drive sales: The launches and uptake of several emerging agents—the IL-17 inhibitors (Novartis’s secukinumab, Eli Lilly’s ixekizumab, and Amgen/AstraZeneca/Kyowa Hakko Kirin’s brodalumab), and Pfizer’s Jak inhibitor Xeljanz—will also drive sales over the 2013-2023 forecast period.

Competition from emerging biologics: TNF-alpha inhibitors and Stelara will experience competition from emerging biologics and oral agents with novel mechanisms of action. Although concerns about their long-term safety profiles will restrict uptake initially, the emerging IL-17 inhibitors, Xeljanz, and emerging IL-23 inhibitors (Sun Pharma/Merck’s tildrakizumab and Janssen’s guselkumab), will increase competition within the TNF-alpha-refractory space.

Oral therapies will expand treatment options: Although the perceived lower efficacy of Xeljanz and concerns about the drug’s safety profile will restrict is market potential, Xeljanz will also compete for use in the TNF-alpha-refractory space. Another oral agent, Celgene’s phosphodiesterase-4 inhibitor Otezla, has recently been approved for the treatment of psoriasis (in addition to psoriatic arthritis), and will present an alternative to conventional systemic therapies as an interim step prior to biological therapy.

Thought leaders are particularly interested in the emerging IL-17 inhibitors, which have shown impressive efficacy in late-stage trials, with similar efficacy to the most potent current therapy for psoriasis—Remicade (Janssen/Merck/Mitsubishi Tanabe Pharma). The efficacy and safety of emerging IL-17 inhibitors and IL-23 inhibitors are being evaluated in head-to-head clinical trials with current biologics, which will increase dermatologists’ confidence adopting these new therapies.

Although these agents will initially compete in the TNF-alpha-refractory population and in patients who lose response to Stelara, as their long-term safety profiles become more established, physicians will be comfortable prescribing them earlier—potentially as first-line biologics—in the treatment algorithm.

We've all been through that itch cycle where you just can't seem to get off, some treatments help and some can even make you itch more.
This study suggests that Enbrel (etanercept) can significantly improve the Itch (Pruritus) and Quality of Life (QoL).

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Background:
Pruritus is a clinically important symptom of psoriasis that has a major impact on quality of life (QoL).

Objective:
The objective of this study was to examine pruritus and QoL in patients with moderate-to-severe psoriasis treated with etanercept (ETN) in the PRISTINE clinical trial.

Methods:
Patients were randomized (1 : 1, double-blind) to ETN 50 mg QW or 50 mg BIW for 12 weeks, followed by 50 mg QW for 12 weeks. Pruritus was reported as 0 (no itching) to 5 (severe itching). Associations were examined between pruritus and Psoriasis Area and Severity Index, Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Screening (HADS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Euro-Qol 5D (EQ-5D) and Medical Outcomes Study (MOS) Sleep Index II.

Results:
At baseline, patients (n = 270) had a mean pruritus level of 3.6. Itching (level ≥1) was reported by 96% of patients, 62% of whom had severe itching (level ≥4) and 26% had the highest level of itching. DLQI, HADS-Anxiety, HADS-Depression, FACIT-Fatigue, EQ-5D visual analog scale, and MOS Sleep Index II were significantly associated with itch. At week 12, mean pruritus improvement in the ETN BIW/QW group was greater than in the QW/QW group (2.4 vs. 1.6, P < 0.001), but not at week 24 (2.2 vs. 2.0, P = 0.180). Patients with the most severe itching at baseline (score of 5) had a mean score of 1.7 at week 24. Overall, patients with clinically meaningful pruritus improvement at week 24 reported greater improvement in QoL measures than other patients.

Conclusion:
Most patients with moderate-to-severe psoriasis in this study (96%) reported pruritus. Pruritus improved significantly with ETN therapy and was strongly associated with improvements in QoL. These data support the clinical relevance of pruritus as an important symptom of patients with moderate/severe psoriasis.

Ever wondered how many people like you there are around the world living with psoriasis? well this report suggests the figure will be well over 40 Million by 2022.

It makes interesting reading, and it was first released in 2013 for use by businesses shaping and driving the global psoriasis market.

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Psoriasis has a complex collection of risk factors, such as genetics, lifestyle choices, and exposure to certain environmental conditions, states a new report from research and consulting firm GlobalData.

According to the report, there were approximately 36.5 million prevalent cases of psoriasis across all the US, France, Germany, Italy, Spain, UK, Japan, China, and India in 2012. By 2022, GlobalData epidemiologists forecast that this figure will reach approximately 40.93 million prevalent cases, following a 12.1% increase based on projected population growth - prevalence proportions are expected to remain constant.

Psoriasis is an immune-mediated chronic dermatological disorder characterized by redness and irritation. The condition affects individuals of both sexes and all ethnicities and ages, although there is a higher prevalence of psoriasis in the colder, northern regions of the world.

The age-standardized prevalence of psoriasis varies among different countries, from as low as 0.03% in Japan to as high as 1.84% in Germany. These regional differences may be attributable to variations in environmental factors such as the weather, as well as genetic factors, and differences in data collection across different countries.

The prevalence of psoriasis in the central region of Italy is 2.8 times greater than the prevalence in southern Italy, and similar regional differences have been reported in Spain, with psoriasis more common among the residents of central Spain, who experience colder and drier weather than individuals in the northern and southern regions.

Ethnicity may also play a part - studies have shown that Caucasians have a higher prevalence of psoriasis compared with African-Americans, but African-Americans in the US tend to suffer from a more severe form of the disease.

Psoriasis is an autoimmune disorder, so family history plays an important role in the development of the disease. Approximately 40% of psoriasis patients have first-degree relatives with the disease. Since psoriasis is categorized as an immune-mediated inflammatory disorder (IMFD), sufferers are also at an increased risk of developing other, more severe IMFDs, such as rheumatoid arthritis and Crohn’s disease. Psoriasis patients are also at risk of developing psoriatic arthritis, which is a progressive, deforming, and debilitating disease and the most common comorbidity associated with psoriasis.

However, lifestyle choices, and certain diseases and medications can affect the condition. Smoking increases the risk of developing psoriasis, and increases the severity of the disease. In addition, it has been noted that psoriasis is a common disease among obese patients, although the relationship between the two disorders remains unclear. Obesity also predisposes individuals to inverse or flexural psoriasis, which occurs in the folds of the skin. Various medications, such as lithium, anti-malarial agents, beta-blocking agents, and non-steroidal anti-inflammatory drugs (NSAIDs), are also considered as possible risk factors, though there is insubstantial evidence to prove this as yet.

The disease can be controlled with medication, but a cure has not yet been found. Psoriasis is often associated with unsightly lesions, scales, and inflammation, which can affect an individual’s self-esteem, leading nearly half of all psoriasis patients to report elevated stress levels, depression, and thoughts of suicide. Stress can trigger pathological processes, exacerbating many dermatological conditions, particularly psoriasis. Psoriasis patients suffering from these anxieties can also limit their social interactions and abuse alcohol and tobacco, further worsening their condition.

My Psoriasis did not begin to show until I turned 17 (1983). I was prescribed Oxoralen and it worked, my Psoriasis went dormant for almost a decade. I tried to get it prescribed again about 10 years ago and my Dr. said it causes cancer.

Is this true?

With the Psoriasis Area and Severity Index (PASI) first introduced in 1978, and the Dermatology Life Quality Index (DLQI) developed in 1994 is now time to move on to a newer measure for patients with psoriasis? I made the Psoriasis Score a few years ago because I never felt the PASI was easy to follow, now there is a study that is suggesting it could be time for a change.

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Abstract:
In a non-life-threatening disease such as psoriasis, treatment goals should be referred to the improvement in severity and extent of the disease and their impact on patients’ perceived health-related quality of life (HRQoL), usually measured by the Dermatology Life Quality Index (DLQI).

The ultimate goal of therapy is blanching, and an improvement of 90% or better (PASI90 response) with respect to baseline Psoriasis Area and Severity Index (PASI) is considered as treatment success by the European Medicines Agency. PASI75 response has become accepted as a less stringent reasonable therapeutic goal, but absolute PASI values might provide a better benchmark, irrespective of baseline PASI.

Anyway, objective measures of psoriasis involvement are clinically meaningful only if they correlate with significant improvements in DLQI, and especially with the achievement of a DLQI = 0–1 status, corresponding to lack of effect of the disease on patient's HRQoL. Even though PASI75 response meets therapeutic expectations in most patients, PASI90 response or better has a significantly higher impact on DLQI improvement and is associated with significantly higher DLQI = 0–1 response rates.

The introduction of anti-IL17 drugs in clinical practice bears the promise of achieving PASI90 response or better in the majority of patients, and initial data suggest that the PASI90 benchmark provides better discriminatory value as regards achievement of DLQI = 0–1 response.

Further research is required to confirm the value of absolute PASI cut-offs as a measure of therapeutic success independent of baseline and duration of treatment, and to develop newer, more practical and more accurate measures of psoriasis severity.

For those of you with psoriatic arthritis the results will come as no surprise to you, but it's an interesting little study that set out determine the effects of psoriatic arthritis (PsA) on sleep quality.

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Aim:
The purpose of this study was to determine the effects of psoriatic arthritis (PsA) on sleep quality and investigate the association between sleep quality and clinical parameters of PsA, quality of life and psychological state in patients with PsA.

Method:
Forty-one patients with PsA and 38 healthy volunteers were included in this study. In both patients and healthy controls, sleep quality was assessed by means of the Pittsburgh Sleep Quality Index (PSQI) and anxiety and depression were assessed by means of the Hospital Anxiety and Depression Scale (HADS). In addition, PsA Quality of Life (PsAQoL) Index and Psoriasis Area and Severity Index (PASI) were used on patients. Generalized pain was assessed by means of a visual analogue scale (VAS).

Results:
Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, daytime dysfunction and total PSQI scores were significantly higher in patients with PsA compared to healthy controls. Total PSQI scores significantly correlated with anxiety, generalized pain, PsAQoL scores, enthesitis and levels of C-reactive protein (CPR) and erythrocyte sedimentation rate (ESR) (P < 0.05). Also, multiple regression analysis indicated that ESR level was independently associated with total PSQI score (P <0.05, R2 = 0.325).

Conclusion:
Sleep quality is diminished in patients with PsA. Sleep disturbance is particularly associated with generalized pain, anxiety, enthesitis and levels of CRP and ESR in patients carrying the diagnosis of PsA.

Glycerine is in the skin layers. I use it as a moisturizer especially in winter. My Paloplanter and on hands and feet seem to always be seasonal.i STAY AWAY FROM WATER THAT IS NOT FILTERED. Wash with glycerine soap no itch after bath then moisturize.

I use it in many of my home made mixtures. Non alcohol watch hazel AND GLYCERINE.

SINCE using these my hands and feet P. R in remission for 4 years now. Also a spa with paraffin wax . I use at night night then add glycerine and occlusion over night. Really gets down thru the deep layers of my P. Skin.

JUST having to try DEMARDS To treat PSA. Were also talking about a new bio...

The DEMARDS really help the pain but make me too sick. I also have severe OA 2 THR. My hips r always cold . I'm probably worth more with all that metal in my hips and shoulders.

Some days during this time of year I really need the Tin Man's oil can...

So it's always trial and error. Some of us have different outcomes with meds than others.

As most of us p.with know it can be so tricky. Does anyone use a dehumidifier in damp areas of the country for PSA.?
I've read it helps with cold weather to control the moisture in the air in homes.

New drug BI 655066 moves on to phase 11 trial after showing psoriasis clearance for 66 months after one single dose Dr. James G. Krueger reported at the annual congress of the European Academy of Dermatology and Venereology. Yes you heard it right 66 months that's 5.5 Years.

Quicky version:

Key clinical point: Up to 66 months after receiving a single subcutaneous injection of a biologic agent that selectively blocks interleukin-23, six patients with moderate to severe chronic plaque psoriasis at baseline remained PASI 100 responders with clear skin.

Major finding: The PASI 75 response rate 12 weeks after receiving a single dose of the investigational agent BI 655066 was 87%, and the PASI 90 rate was 58%.

Data source: This was a first-in-humans, proof-of-concept study involving 39 psoriasis patients.


Longer version:

Quote:

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“For me, this is one of the most interesting features of this proof-of-concept study,” he added. “If this kind of activity is confirmed in the ongoing phase IIb trial, I think this represents the potential for very long-term disease modification. This could become an important agent in the future to treat psoriasis.”

BI 655066 is a monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23. Unlike ustekinumab (Stelara), which blocks both IL-23 and IL-12, BI 655066 selectively blocks only IL-23, which Dr. Krueger believes is the central driving force in activating and sustaining the T-cell subsets responsible for the hyperproliferative and inflammatory reactions that define psoriasis.
“This study is all about testing for the specific pathogenic contribution of IL-23 to psoriasis in a first-in-humans study.

Our findings really emphasize the importance of IL-23 in driving the key pathways of psoriasis,” observed Dr. Krueger, professor of investigative dermatology and director of the Milstein Medical Research Program at Rockefeller University, New York.
The study included 39 patients with moderate to severe plaque psoriasis. Their baseline PASI was 18, and they averaged more than a 20-year history of psoriasis. Twenty-four patients were randomized 3:1 to a single intravenous injection of BI 655066 at various doses ranging from 0.01 mg/kg to 5 mg/kg or to placebo in order to get an initial sense of the agent’s safety and tolerability.
In the second part of the study, 15 other participants received a single subcutaneous injection: two got placebo and the rest were randomized to BI 655066 at either 0.25 mg/kg or 1.0 mg/kg. Safety and efficacy were assessed at weeks 0, 2, 4, 12, and 24. In addition, skin biopsies were obtained at weeks 0 and 8 for immunohistochemistry studies and RNA sequencing analysis.

By week 12, the PASI 75 response rate in subcutaneous BI 655066 recipients was 87% and the PASI 90 rate was 58%. At week 24, nine patients elected to continue structured prospective follow-up while remaining off treatment, including six PASI 100 responders. Those six PASI 100 responders remained PASI 100 at ongoing follow-up 48-66 weeks after receiving their single dose of the agent.

Biopsy specimens obtained at week 8 showed normalization of the epidermal psoriasiform hyperplasia which had been present at baseline. A normal-looking granular layer had been reestablished. “This looks essentially like the pattern of normal or nonlesional skin,” according to the dermatologist.

RNA sequencing analysis and gene profiling showed normalized production of the IL-23/IL-17-induced proteins that had been strongly overexpressed at baseline, including lipocalin, beta-defensin, and psoriasin.

“The immune axis is turned down. The number of immune cells is way down, although they’re not completely eliminated. With placebo, you still see a psoriasislike pattern of the disease. With blockade of IL-23, most cases have a gene profile like nonlesional skin. This represents a profound cellular and disease modulation,” Dr. Krueger said.

Among all 39 participants, the only serious adverse event deemed possibly treatment related was a 5-minute transient ischemic attack (TIA) episode in a patient on BI 655066. This caught Dr. Krueger’s attention as a possible red flag; however, he noted that more than 200 patients have since received the biologic agent in the ongoing phase IIb trial, with no reported major adverse cardiovascular events.

“I think that TIA may just be bad luck with small numbers,” he added.

Asked what he thinks might explain the remarkably lengthy disease remission seen following a single dose of the biologic, Dr. Krueger offered two possibilities.

“It may be that IL-23 is necessary to sustain pathogenic clones of memory cells in the skin, and as we get rid of it those clones most likely apoptose. And if you’ve sufficiently removed the clones, then you don’t get the expansion. That’s guess one. Guess two would be that we’ve renormalized tolerance mechanisms in some way. Both of these hypotheses can be tested,” according to Dr. Krueger.

I started Humira on October 9. Ever since then I have been having some discomfort in my chest and a cough. I am suppose to take another shot on Thursday October 30. I am going to hold off till I talk to my dermatologist. Her office is closed on Thursday so I am going to call her Friday.

Has anyone on here that is on or have taken Humira have any side effects?