European Ombudsman welcomes increased Humira transparency but calls for more on global top selling drug.

This is a big report but here is the press release:

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The European Ombudsman, Emily O'Reilly, has welcomed increased transparency in the clinical testing of Humira, one of the world’s biggest selling drugs, following her inquiry into the publication of clinical study reports.

Humira, manufactured by the AbbVie pharmaceutical company, is an anti-inflammatory medicine used to treat Crohn’s disease and other common diseases including rheumatoid arthritis, psoriasis and ulcerative colitis.

But the Ombudsman also expressed concern about certain parts of four specific clinical trial reports into Humira which were withheld by the European Medicines Agency on the stated grounds of commercial interest and has asked EMA to reconsider these redactions. The Ombudsman said that the principle that public health is more important than commercial interest must be upheld.

Some information about on-going drug development may justifiably be withheld temporarily,  the Ombudsman said, but she added that all information about clinical trials, other than the personal data of patients, must ultimately be disclosed. Ms. O'Reilly has asked EMA, in such cases, to require companies to detail when, and how, any withheld information will eventually be made public.

"Any clinical information of value to doctors, patients and researchers, must be disclosed in the public interest," said the Ombudsman.

Ms O'Reilly added: "The European Medicines Agency has already taken significant steps to inject greater transparency into its work, particularly with its recent policy of proactively publishing clinical reports. My calls for further transparency should be seen in light of EMA's new responsibilities. Once the Clinical Trials Regulation becomes fully operational, EMA will have an even stronger role in ensuring the transparency of clinical trials conducted in the EU."  

The Ombudsman's own initiative inquiry looked at the specific issue of granting wider public access to three clinical study reports into Humira.

While most of the text initially withheld was disclosed during the course of the Ombudsman's inquiry, certain redactions remain, including four that the Ombudsman considers unjustified.

Ms O'Reilly said: "I very much welcome EMA's increasing transparency when it comes to three clinical trial reports on Humira. In the case of the remaining redactions of concern to me, EMA has sought to justify them on grounds of commercial interests. I am asking EMA to reconsider the need for these redactions should it receive new requests for access to these reports."

Background:
Humira, an anti-inflammatory drug, has been one of the top selling drugs of all time, with billions of euro in sales.

The Ombudsman in 2014 opened an own initiative inquiry into the decision of EMA to give only partial public access to clinical trial studies related to the approval of Humira. During her enquiry, which included 75 questions posed to EMA, most of the previously redacted text was made public. EMA's policy of proactive publication of clinical reports - welcomed by the Ombudsman - came into force in January 2015. In March 2016, EMA published detailed guidance for pharmaceutical companies on how to comply with that policy.

As the Ombudsman's inquiry had wider implications for how EMA deals with public access to documents containing information on the safety and efficacy of medicines, the Ombudsman broadened the scope of her suggestions beyond the immediate Humira context.

Morning all, I finally managed to get back and see the specialist at my local hospital and they have agreed to put me back on Fumaderm. They basically stated yesterday that if I go back on  the same dose I was on previously then they wouldn't have to apply for funding again as it was seen as a continuation of medication.
This means that I have to take 120mg tablets. 
They have initially stated to take 1 tablet every three days and then see how I go. If I tolerate this fairly well then go to 1 tablet every other day until I am eventually on 1 tablet a day.
So I took my first tablet yesterday and had a minor flush and upset stomach but I could handle it,so I don't know whether to just take another one today? What do people think? Keen to get this under control as soon as possible.
I'm also trying to find instructions for fumaderm in English, does anyone have these or can anyone provide a link to these.

Thanks.

Hey all.   I have recently been diagnosed with Pustular, Guttate, Scalp, and Nail Psoriasis.   Started with being sick, a poison ivy rash, losing sleep and stress from work, and im guessing excess drinking from stress also.    The poison ivy and cold went away, and about a week later i started breaking out everywhere, bumps, blisters, rashes, etc.   

I went to my Dr and he thought maybe I had reinfected with poison ivy and prescribed Prednisone.   That did clear up my palms and bottom of feet, and everything else seems to kind of stay at bay, until i started tapering off. Then it came back with a vengeance.   

Its been about 2 months now, and i was officially diagnosed about 2 weeks ago.   Been having trouble walking for about 6 weeks of it.   I have been using Desonate, Clobetasol Propionate, going out on my porch in the sun in bathing suit for 15-20 minutes any time i'm able(since ive been diagnosed its been sunny about 4 days, my typical luck) using Anumed Vitamin D ointment, and I have used a standard Centrum multivite which has Vit D daily.   A few days i took a Vit D pill with 1000% daily, thinking it is overkill so stopped.

There has been a little clearing of the guttate, i believe from sunlight mostly, as i find the creams/foam annoying to apply and unless a spot is really itching i dont use at all.  I tend to lean towards treating things naturally and avoiding prescriptions if I can just as a habit.  

I know if i could reduce my stress it would help, however my current work situation just wont allow it, and it should be back to normal in a few months, so i plan to tough it out.   It is a good job and pays well.

And lastly I have been looking into UVB therapy and I hope I am not chewed out for considering building my own light kit (I have many years of electronics training and experience)  I am trying to research wattages and the appropriate usage time and really just want to clear up my feet.   Small lights are readily available online for a few hundred, looking at parts required and just bulb alone could be built for under $50.    Feel free to tell me im way off here, im new to this and and comfortable accepting my idea may be a terrible one.

If anyone is curious about me im 36, married with a 3 year old daughter, used to enjoy mountain biking and kayaking, but mostly not sit in a chair with my feet up playing games on my PC.    Have been working as a Network Engineer for about 10 years now, with prior jobs in PC repair, Network Administration, Electronics repair, and a grocery store.

That was a bit long and i apologize for that.   If anyone has the patience to get through it I appreciate it.

Hello, everyone!

As a 63 year old female who has had psoriasis since age 16, I would like to provide what ever support and information that may assist others.

Presently I am on Cosentyx and have been for one year. I had moderate coverage- scalp to ankles, and have experienced about 95% clearing. The area that seems to not want to completely respond is my lower legs (knees downward). These areas improved initially , but I am still left with small reddened areas, varying in size from 1/8 to 1/2 inch, some have plaques, some do not. Summer sun has reduced them, but I am not expecting that to remain once cool weather returns.

I have not experienced any known side effects, and made it through, so far, without getting overly sick from a suppressed immune system. I am a nurse, so it's not like I am never exposed to sick people!

It is amazing to run my hands over my skin and feel smooth. It's been a long, long time!

More good news for psoriasis patients as Eli Lilly published detailed results from three pivotal Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—that demonstrated the efficacy and safety of Taltz® (ixekizumab) through 60 weeks in patients with moderate-to-severe plaque psoriasis. This publication also detailed 12-week efficacy data for patients treated with Taltz in UNCOVER-1.

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Eli Lilly and Company (NYSE: LLY) announced today that the New England Journal of Medicine has published detailed results from three pivotal Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—that demonstrated the efficacy and safety of Taltz® (ixekizumab) through 60 weeks in patients with moderate-to-severe plaque psoriasis. This publication also detailed 12-week efficacy data for patients treated with Taltz in UNCOVER-1.

In all three studies, responders to Taltz through 12 weeks demonstrated high levels of skin clearance through 60 weeks.

"This group of studies show that patients on Taltz are able to achieve high levels of efficacy, and that the majority of patients are able to maintain or continue to improve their response with continued treatment through 60 weeks," said Kenneth Gordon, M.D., a professor of dermatology at Northwestern University Feinberg School of Medicine and first author of the paper.

STUDY DESIGNS
All three studies evaluated the safety and efficacy of Taltz (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks. All three studies also evaluated response rates with Taltz every four weeks through 60 weeks. In UNCOVER-1 and UNCOVER-2, patients treated with Taltz who achieved clinical response (static Physician's Global Assessment score [sPGA] 0 or 1) at 12 weeks were re-randomized to receive Taltz (80 mg every four weeks) or placebo through 60 weeks. In UNCOVER-3, all patients completing 12 weeks continued the study receiving Taltz (80 mg every four weeks) through 60 weeks.

In all three studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index score (PASI) 75 and sPGA 0 or 1. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician's assessment of severity of a patient's psoriasis lesions overall at a specific point in time and is a recommended measure the FDA uses to evaluate effectiveness.1 In all three studies, sPGA and PASI were also assessed through 60 weeks.

RESULTS
In UNCOVER-1, Taltz given every two weeks was statistically superior to placebo, with high levels of clearance achieved at 12 weeks among patients treated with Taltz, the majority of whom achieved virtually clear (PASI 90) or completely clear skin (PASI 100, sPGA 0).

   81.8 percent of patients treated with Taltz achieved sPGA 0 or 1 compared to 3.2 percent of those treated with placebo (p < 0.001).
   89.1 percent of patients treated with Taltz achieved PASI 75 compared to 3.9 percent of patients treated with placebo (p < 0.001).
   70.9 percent of patients treated with Taltz achieved PASI 90 compared to 0.5 percent treated with placebo (p < 0.001).
   35.3 percent of patients treated with Taltz achieved complete resolution of psoriasis plaques (PASI 100) compared to zero patients treated with placebo (p < 0.001).

In UNCOVER-1 and UNCOVER-2, high levels of clearance also were achieved through 60 weeks among patients treated with Taltz every two weeks who achieved clinically meaningful response (sPGA 0 or 1) at 12 weeks, the majority of whom achieved virtually clear or completely clear skin through 60 weeks when treated with Taltz every four weeks.

In UNCOVER-1 and UNCOVER-2 through 60 weeks:

   78.3 percent of patients maintained sPGA 0 or 1.
   83.3 percent of patients achieved PASI 75.
   76.5 percent of patients achieved PASI 90.
   More than half of patients (57.5 percent) achieved complete resolution of skin plaques (PASI 100).

In UNCOVER-3, high levels of clearance were also achieved with Taltz given every four weeks through 60 weeks among patients initially treated with Taltz every two weeks:

   74.5 percent of patients achieved sPGA 0 or 1.
   83.4 percent of patients achieved PASI 75.
   73.2 percent of patients achieved PASI 90.
   More than half of patients (55.3 percent) achieved complete resolution of skin plaques (PASI 100).

"Over the last several years, advances in our understanding of psoriasis have led to the development of new treatment targets that may provide higher levels of skin clearance," said Aarti Shah, Lilly's global brand development leader for Taltz. "The results of these analyses are significant, demonstrating that the majority of patients treated with Taltz through 60 weeks achieved or maintained virtually or completely clear skin."

Information regarding the safety of Taltz is drawn from a database of 4,204 patients with moderate-to-severe plaque psoriasis who volunteered in both controlled and uncontrolled clinical trials.

Taltz may increase the risk of infection. Patients treated with Taltz had a higher rate of infections than patients treated with placebo (27 percent vs. 23 percent). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in patients treated with Taltz compared to placebo. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations.

Pfizer have released second phase 3 results on Xeljanz (tofacitinib citrate) for the treatment of psoriatic arthritis.

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Pfizer announced today top-line results from Oral Psoriatic Arthritis triaL (OPAL) Beyond, the second Phase 3 study of XELJANZ® (tofacitinib citrate) being investigated in patients with active psoriatic arthritis (PsA). This study evaluated the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients with active PsA who had an inadequate response to at least one tumor necrosis factor inhibitor (TNFi), making it the first PsA study to focus exclusively on TNFi-IR patients.1 OPAL Beyond met its primary efficacy endpoints demonstrating a statistically significant (p<0.0001) improvement with tofacitinib 5 mg BID and 10 mg BID compared to placebo treatment as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score at 3 months.1

“There is a significant need for additional PsA treatment options as many people living with the condition do not respond well to available therapies,” said Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business. “The positive results of both Phase 3 PsA studies, OPAL Broaden in DMARD-IR patients and OPAL Beyond in TNFi-IR patients, demonstrate that tofacitinib, if approved, may have potential to be an important treatment option to help address unmet needs for patients with PsA.”

Overall safety findings in this study were consistent with those observed in the broader rheumatology clinical development program for tofacitinib.

OPAL Beyond is a Phase 3, randomized, double-blind, placebo-controlled, 6-month study investigating the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily in patients with active PsA who had inadequate response to at least one TNFi due to lack of efficacy or an adverse event.1 A total of 395 subjects enrolled in the study and were randomized equally to tofacitinib 5 mg BID, tofacitinib 10 mg BID and placebo. Patients enrolled in the study were required to be on one conventional synthetic disease modifying antirheumatic drug (csDMARD) as background therapy and continue that dose for the duration of the study.

If you are using Methotrexate to treat psoriasis you must read this. I'm known to be anti methotrexate for treating psoriasis but some of our members do well on it, and before anyone shoots me down this is not a personal view.

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Objective:
Accidental daily dosing of methotrexate can result in life-threatening toxicity. We investigated methotrexate dosing errors reported to the National Coronial Information System (NCIS), the Therapeutic Goods Administration Database of Adverse Event Notifications (TGA DAEN) and Australian Poisons Information Centres (PICs).

Design and setting:
A retrospective review of coronial cases in the NCIS (2000–2014), and of reports to the TGA DAEN (2004–2014) and Australian PICs (2004–2015). Cases were included if dosing errors were accidental, with evidence of daily dosing on at least 3 consecutive days.

Main outcome measures:
Events per year, dose, consecutive days of methotrexate administration, reasons for the error, clinical features.

Results:
Twenty-two deaths linked with methotrexate were identified in the NCIS, including seven cases in which erroneous daily dosing was documented. Methotrexate medication error was listed in ten cases in the DAEN, including two deaths. Australian PIC databases contained 92 cases, with a worrying increase seen during 2014–2015. Reasons for the errors included patient misunderstanding and incorrect packaging of dosette packs by pharmacists. The recorded clinical effects of daily dosage were consistent with those previously reported for methotrexate toxicity.

Conclusion:
Dosing errors with methotrexate can be lethal and continue to occur despite a number of safety initiatives in the past decade. Further strategies to reduce these preventable harms need to be implemented and evaluated. Recent suggestions include further changes in packet size, mandatory weekly dosing labelling on packaging, improving education, and including alerts in prescribing and dispensing software.

My suggestion Fred is please give yourself a big pat on the back for all the information that you have taken your time and trouble to collate and put on here, the information is great and collectively the whole lot together is really the most comprehensive that I have come across in one place .
Thank you .

As we now have a lot of threads for the use of oral treatments for psoriasis I thought it would be easier to list them all in one thread. This should make them easier to find and will move 5 normal threads up.

Here is a list of the current oral treatments for psoriasis. (Just click and go)

Acitretin

Ciclosporine

Dimethylfumarates and Psoriasis

Fumaderm

Methotrexate

Otezla

Sulfasalazine

Leflunomide

Skilarence

Rinvoq

Sotyktu

Icotyde

*If you have any other suggestions for oral treatments please let me know.

Otezla (apremilast) is an Oral prescription medicine approved for the treatment of patients with moderate to severe plaque psoriasis and psoriatic arthritis.

Dosage:
When you first start Otezla, you'll have a 5-day titration period, which means that you'll gradually increase your dose over your first 5 days until you reach the recommended dose. This titration is meant to help reduce the gastrointestinal symptoms related to initial treatment with Otezla.

Side effects:
The most common side effects of Otezla were diarrhea, nausea, and headache. These side effects occurred within the first 2 weeks of treatment and tended to go away over time without stopping Otezla.

Immune system disorders: Hypersensitivity
Investigations: Weight decrease
Gastrointestinal Disorders: Frequent bowel movement, gastroesophageal reflux disease, dyspepsia
Metabolism and Nutrition Disorders: Decreased appetite
Nervous System Disorders: Migraine
Respiratory, Thoracic, and Mediastinal Disorders: Cough
Skin and Subcutaneous Tissue Disorders: Rash


Important Safety Information:
You must not take Otezla® (apremilast) if you are allergic to apremilast or to any of the ingredients in Otezla.

Otezla is associated with an increase in adverse reactions of depression. In clinical studies, some patients reported depression and suicidal behavior while taking Otezla. Some patients stopped taking Otezla due to depression. Before starting Otezla, tell your doctor if you have had feelings of depression, suicidal thoughts, or suicidal behavior. Be sure to tell your doctor if any of these symptoms or other mood changes develop or worsen during treatment with Otezla.

Some patients taking Otezla lost body weight. Your doctor should monitor your weight regularly. If unexplained or significant weight loss occurs, your doctor will decide if you should continue taking Otezla.

Some medicines may make Otezla less effective, and should not be taken with Otezla. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines.

Side effects of Otezla in psoriasis clinical studies were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.

Side effects of Otezla in psoriatic arthritis clinical studies were diarrhea, nausea, and headache.

These are not all the possible side effects with Otezla. Ask your doctor about other potential side effects. Tell your doctor about any side effect that bothers you or does not go away.

Tell your doctor if you are pregnant, planning to become pregnant, or planning to breastfeed. Otezla has not been studied in pregnant women or in women who are breastfeeding.

Website: otezla.com

This is a list of the current polls that are open to members and guests. Your vote is private and members are welcome to comment in each poll if they wish.

What age did you get psoriasis?

How symmetrical is your psoriasis?

How satisfied are you with your Psoriasis Physician?

Depression and psoriasis

Will there ever be a psoriasis cure?

Longest time on a successful treatment for psoriasis

Sunshine

Weight gain on biologics

Worst part of the body to get psoriasis

What about genes?

Continuing psoriasis treatment under threat of Covid-19

Psoriasis Covid Vaccine

How confident are you talking about psoriasis

How well do your family support you with psoriasis ?

Which of these treatments have you used for psoriasis ?

Has psoriatic arthritis affected your life

Ever been asked if psoriasis is contagious

Have you ever achieved psoriasis remission

Your worst area for psoriasis

How embarrassing do you find psoriasis

Alcohol [January 22]

Food [February 22]

Psoriasis awareness

Exercise [March 22]

How many of your family also have psoriasis

Psoriasis Comorbidities

Clothes and psoriasis

Injections for psoriasis

*Members can go back to the poll at a later date and change their choice.

*If you have a suggestion for a psoriasis poll please do start one or give me a shout.

This study shows tuberculosis in psoriasis patients treated with TNF antagonists still occurs despite adherence to tuberculosis prevention guidelines.

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Background:
There is limited information about active tuberculosis (TB) occurring in psoriasis patients treated with Tumor necrosis factor (TNF) antagonists.

Objective:
To describe the clinical characteristics of TB in psoriasis patients treated with TNF antagonists.

Methods:
Nationwide retrospective study of psoriasis patients having experienced TB. Cases of TB were collected via three methods: search in the national pharmacosurveillance database, questionnaire to members of the French psoriasis research group, the college of French dermatology professors. We collected demographic data, TNF antagonist used, screening for latent tuberculosis infection, median time between TNF antagonists introduction and first symptoms, tests used for diagnosing TB infection, clinical features of tuberculosis and outcome.

Results:
Eight centres reported 12 cases of TB between 2006 and 2014. They were nine men and three women with mean age of 49 years. All patients had adequate screening for latent tuberculosis. Three patients had stayed in endemic areas, three reported contact with a patient with TB. Tuberculosis presentation was extrapulmonary in 10 patients. Seven patients were treated with infliximab, four with adalimumab and one with certolizumab. The median time between TNF antagonist introduction and first symptoms of tuberculosis was 23.4 weeks (2–176). Six of the 12 patients had a positive direct examination and/or positive culture for Mycobacterium tuberculosis. Histological samples of affected organs taken from seven patients showed granulomatous inflammation in six, with caseating necrosis in five. Two of the 12 patients died of disseminated TB.

Conclusion:
This study shows tuberculosis in patients treated with TNF antagonists still occurs despite adherence to tuberculosis prevention guidelines. Prophylactic measures do not fully prevent the occurrence of tuberculosis. Rapid initiation of effective anti-tuberculosis treatment is important even in patients with negative mycobacteriological examination presenting with suggestive symptoms and organ involvement.

Hey everybody! 

I´m new on this forum and wanted to hear if anybody else has experience of the Chinese ointment Pien Tze Huang? I have a Chinese friend that brought me this cream and it´s been working very well so far. Almost as good as cortisone, but it shouldn´t dry out the skin or anything so you can keep going on a daily basis. Or that´s what I heard anyway. 

So please let me know if you have any experience in this!

Cheers

This report surveyed dermatologists in the EU5 (France, Germany, Italy, Spain, United Kingdom) to find out what they are prescribing for psoriasis patients not responding to creams and light treatments.

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Decision Resources Group finds that in the EU5, while surveyed dermatologists prefer subcutaneous TNF-alpha inhibitors AbbVie's Humira and Amgen/Pfizer's Enbrel for first-line treatment, Janssen Biotech's Stelara is also seeing increasing use in earlier-lines of therapy, driven by favorable efficacy and safety, increasing physician familiarity and convenient dosing. Among the biologics, Humira is the patient share leader, followed by Enbrel and Stelara. However, Novartis's Cosentyx, the first-in-class IL-17 inhibitor, has steadily captured market share as it gradually becomes available to dermatologists in the EU5. Celgene's Otezla, an oral PDE-4 inhibitor, is seeing only limited usage in moderate and severe patients probably because its access is limited across the EU5. However, unlike biologics, it is seeing comparable use in both the moderate and severe sub-populations.

Other key findings from the Current Treatment report:

According to surveyed EU5 dermatologists, psoriasis is the most prevalent primary condition treated by them. Common risk factors and comorbidities are family history of psoriasis, smoking, obesity, hypertension, depression, hyperlipidemia, alcohol use, psoriatic arthritis and diabetes.
   
When treating psoriasis, surveyed dermatologists tend to report earlier-line use of the biologics with which they have the most experience—Humira and Enbrel—followed by Stelara. Remicade is generally reserved as a later-line therapy. The more recently launched drugs Otezla and Cosentyx tend to be used as later-line therapies, though Otezla is seeing some use before biologics, particularly in Germany.
   
Typically, the most commonly encountered step therapy requirement for TNF-α inhibitors and Stelara is failure with two or more conventional systemic therapies. For the newest biologic, Cosentyx, step therapy measures are different compared with the requirements indicated for the established biologics and often vary from country to country.
   
Overall in the EU5, according to the surveyed dermatologists' predictions, across the spectrum of disease severity, patient share of biologics is expected to increase in one year's time from the 2016 baseline.

Comments from Decision Resources Group Analyst Sangha Mitra, Ph.D., MBA:

"Patients initiating treatment with Cosentyx have a range of treatment histories: switching from Stelara or Humira, or even naïve to biologic and Otezla treatment. In contrast, patients who begin therapy with Otezla are frequently being switched from conventional systemic therapy, or are biologic-naïve."
   
"Our research shows that the main prescribing drivers for initiating patients on Cosentyx are its efficacy and novel mechanism of action. For Otezla, key drivers cited are novel mechanism of action, safety profile and unsurprisingly the convenience of oral formulation."

We're often being told that obesity can make psoriasis worse, but this study suggests that obesity in Children is not associated with disease severity and course.

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Background/Objectives:

The current literature suggests there is a possible connection between paediatric psoriasis and obesity. However, there is a paucity of research on the influence of increased adiposity on the severity of paediatric psoriasis and disease progression. We aimed to compare the prevalence of being overweight or obese in paediatric psoriasis patients and controls and assess the potential impact of being overweight/obese on disease severity and progression of disease.

Methods:

This multicentre prospective case-control study included 289 psoriasis patients (aged < 18 years) treated and followed up by one of the four university hospitals in Turkey. The control group consisted of 151 consecutive age-matched and sex-matched children who lacked a personal or family history of psoriasis. The participants' characteristics, psoriasis-related parametres (e.g., initial subtype, psoriasis area and severity index, presence of psoriatic arthritis) and body mass index were determined.

Results:

The difference between the prevalence of being overweight/obese among psoriatics (28%) and the control group (19%) was significant (P = 0.024). Being overweight/obese had no significant impact on disease severity and unresponsiveness to topical treatment. Within a median follow-up time of 12 months, 23% of our patients with localised disease at disease onset progressed to generalised disease. The impact of being overweight/obese on disease progression was found to be non-significant; however, disease duration was found to have a significant impact on disease progression (P = 0.026).

Conclusions:

Although it is not associated with disease severity and course, increased bodyweight may be a health problem for psoriatic children.

Flixabi a biosimilar of Remicade (infliximab) manufactured and commercialized by Biogen has been given EU approval.

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The European Commission (EC) today granted marketing authorization in the European Union (EU) for FLIXABI®, an infliximab biosimilar referencing Remicade®. FLIXABI was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen (NASDAQ: BIIB). FLIXABI is indicated for the treatment of adults with rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Additionally, FLIXABI can be used in patients 6 to 17 years old with severe, active Crohn’s disease or severely active ulcerative colitis.

FLIXABI will be the second anti-TNF biosimilar to be manufactured and commercialized by Biogen in the EU. Earlier this year, Samsung Bioepis received approval for BENEPALI® (etanercept), a biosimilar referencing Enbrel®. Biogen has since launched BENEPALI in several countries across the EU. At an estimated $10Bn a year, anti-TNF therapies are among the EU’s largest drug expenditures. BENEPALI and FLIXABI will offer physicians alternatives that will drive meaningful savings across the EU.

“The approval of FLIXABI marks a major step forward for both Samsung Bioepis and Biogen. It expands our anti-TNF portfolio and furthers Biogen’s commitment to commercializing biosimilars of advanced biologics, while expanding cost-effective treatment options for patients living with chronic inflammatory conditions such as Crohn’s disease and ulcerative colitis,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “We are delighted to be the first company to bring two anti-TNF biosimilars to patients and physicians across Europe.”

As part of the submission, Samsung Bioepis provided a robust preclinical and clinical data package from head-to-head Phase 1 and Phase 3 clinical trials comparing FLIXABI with the reference product Remicade. Following biosimilar approval guidelines from the European Medicines Agency, the Phase 3 clinical trial for FLIXABI was performed to confirm equivalent efficacy, and to compare safety and immunogenicity with Remicade. The 54-week, double-blind, Phase 3 study was conducted in patients with moderate to severe RA despite methotrexate therapy. The primary end point was the American College of Rheumatology 20% (ACR20) response at week 30 in the per-protocol set (PPS). The primary end point for the study was met, with data showing that patients taking FLIXABI had an equivalent ACR20 response and a comparable safety profile to those taking Remicade.

A total of 584 patients were randomized in a 1:1 ratio to either FLIXABI (N=291, 290 analyzed) or Remicade (N=293) The ACR20 response rate at week 30 in the PPS showed equivalence of FLIXABI to Remicade: 64.1% vs. 66.0%, respectively (adjusted difference −1.88%; 95% CI: −10.26% to 6.51%). The ACR20 response rate at week 54 in the PPS confirmed equivalent efficacy, with results showing 65.3% vs. 69.2%, respectively (adjusted difference 3.07%; 95% CI: −12.00% to 5.86%) ACR20 response in the full analysis set at week 30 and week 54 also showed equivalence of FLIXABI to Remicade: 55.5% vs. 59.0%, respectively (adjusted difference 2.95%; 95% CI: −10.88% to 4.97%) at week 30 and 50.7% vs. 52.6%, respectively (adjusted difference 1.15%; 95% CI: −9.16% to 6.86%) at week 54 FLIXABI was well tolerated, with comparable safety, pharmacokinetics and immunogenicity to Remicade

Hi everyone,

Only recently came across this website and only signed up this morning.
 
I've had P for as long as I can remember, I'm 27 now, I've been on steroid creams, had UV and tried whites tar paste with varying degrees of success but invariably my P would come back stronger than ever after a while.

Recently (7 weeks ago) started on Fumaderm, starting to see some minor improvements now I think, although my moisturising regime is very good at present so could be down to this. I have experienced very little by the way of side effects I have to say, although now and again my bowels are a bit looser and I am a bit gassy! 

Currently on 4 * 120mg per day and due to visit my derm again on the 7th of June.

Glad to read about everybody's experience.

Any input/insights are more than welcome!!

Hello, I'm 55 yrs old and have had p for about 5-6 yrs. I just started my treatment on Taltz 2 days ago. My dr had put me on Humira, and after 4 months i was much worse so he gave me an rx for Taltz. I have p everywhere, arms, legs, chest, back, buttocks, under arms, and toes. I took my first dose of Taltz on Friday morning. Let me tell you, the shots sting like crazy as it is going in. (Cought me by surprise)   it's now been 48 hours and I can already see a marked change. The redness of some of my patches have started to fade. Some  are already about 50% closer to my natural skin color. If it continues to work this good, I'll put up with the sting and smile. I'll keep you posted.

Hi All
I am feeling confused and at a loss with this disease. I have PPP and nail psoriasis and take Methotrexate  and Humira at the moment.  I am on holiday at the moment in a beautiful place and it's the most relaxed and un-stressed I've been in a long time. Before I left home my psoriasis was the worst it's ever been but within 3 days of being her it had almost cleared and I was amazed!  But once I'd been in the sea a couple of times, which my dermatologist said would be good for it, it's back with a vengeance!  My feet look like a whole layer of skin needs to come off and are cut and sore so avoiding sea and sand. My nails look better than they have in ages and just as I said that one started to lift!  I'm in the best place I can be and can't  understand how or why things can change so quickly.  Has anyone tried the Aloe Vera drink and had good results?  Would like to hear people's thoughts. Thanks?

Hi everyone.  I have recently been diagnosed with Psoriasis on my penis.  It has only shown up recently in the past few months.  I did not experience it before.  I went to a doctor who gave me a cortisone cream.  I have been taking it for about 6 weeks.  About 15-20% of the Psoriasis has completely disappeared but the main part is still there.  It has VERY slowly day by day shown improved with the cream.  The doctor said it may go away completely, that it may go away completely but take a year, or that it may not go away.  So I'm just using the cream right now and hoping for the best.  I'm pretty bummed about this.  Of all places.  I suppose it could be worse though.  My main question at this point is if psoriasis typically goes away with treatment, as in if I use the cream for a year is it likely it will 100% go away and not come back?  Or does it typically stay with one throughout life?  Oh boy!... :-/