Otezla Resulted in Clinically and Statistically Significant Improvements in Measures of Genital Psoriasis at Week 16.

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Amgen today announced positive top-line results from the DISCREET trial, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla® (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. The study showed that oral Otezla 30 mg twice daily achieved a clinically meaningful and statistically significant improvement, compared with placebo, in the primary endpoint of the modified static Physician's Global Assessment of Genitalia (sPGA-G) response (defined as an sPGA-G score of clear or almost clear with at least a 2-point reduction from baseline) at week 16.

In addition, all secondary endpoints were also met with meaningful and significant improvements in Genital Psoriasis Itch Numerical Rating Scale (GPI-NRS) response (defined as at least a 4-point reduction from baseline in GPI-NRS item score within the Genital Psoriasis Symptoms for subjects with a baseline score of ≥ 4); affected body surface area (BSA) change from baseline; Dermatology Life Quality Index (DLQI) change from baseline; and static Physician's Global Assessment (sPGA) response (defined as sPGA score of clear or almost clear  with at least a 2-point reduction from baseline) at week 16 with Otezla versus placebo.

"Genital psoriasis is associated with a high level of stigmatization and burden of disease and can be experienced in up to 63% of psoriasis patients over the course of their disease. Despite the use of topical therapies for the treatment of genital psoriasis, many patients still have challenges managing their disease, prompting experts to recommend the use of systemic therapies," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "The results from the DISCREET trial further add to the growing body of evidence on the safety and effectiveness of Otezla in moderate to severe plaque psoriasis, including manifestations with high unmet medical needs, such as genital psoriasis."

The type and rate of adverse events observed in this trial were consistent with the known safety profile of Otezla. The most commonly reported adverse events that occurred in at least 5% of patients in either treatment group were diarrhea, headache, nausea and nasopharyngitis.

Patients completing the double-blind phase of the trial continued or switched to Otezla during the  extension phase of the study and will be treated through week 32. The study is ongoing and is planned to complete in the first half of 2022.

Detailed results from the 16-week double-blind phase of the study will be submitted for presentation at an upcoming medical conference.

I have a cold for the fist time since on immune suppressants. 
My friend was on oral treatment and was told to just stop taking the tablets until its cleared.
I am on Ilumetri which is taken every 3 months. So stopping it isnt possible. 
How does it effect my body fighting the cold? Does it just take longer than normal?

Duncan

Deucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasis Accepted by U.S. Food and Drug Administration (FDA) and Validated by European Medicines Agency (EMA)

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Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 10, 2022. These latest regulatory milestones are in addition to the NDA acceptance by Japan's Ministry of Health, Labour and Welfare for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.

“There is a strong need for more effective and well-tolerated oral therapies for people living with moderate to severe plaque psoriasis, as many remain undertreated or even untreated,” said Jonathan Sadeh, M.D., MSc., senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb. “Findings from the pivotal POETYK-PSO trials demonstrate the potential of deucravacitinib to elevate the oral standard of care for individuals who are candidates for systemic therapy. We look forward to continuing to work with the FDA and EMA with the goal of bringing deucravacitinib to patients and physicians as quickly as possible.”

The regulatory applications are based on positive results from the pivotal POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once daily deucravacitinib in patients with moderate to severe plaque psoriasis versus placebo and Otezla® (apremilast). Deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla. Deucravacitinib was well-tolerated with a low rate of discontinuation due to adverse events, with no clinically meaningful lab abnormalities. Primary results were presented at the American Academy of Dermatology Virtual Meeting Experience in April 2021, and additional analyses were presented at the European Academy of Dermatology and Venereology 30th Anniversary Congress in September 2021.

Bristol Myers Squibb thanks the patients and investigators involved in the POETYK-PSO clinical trial program.

About Deucravacitinib

Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action and is the first and only selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferon (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Deucravacitinib achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Deucravacitinib selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2 or JAK3.

Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. In addition to POETYK PSO-1 and POETYK PSO-2, Bristol Myers Squibb is evaluating deucravacitinib in three other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462); POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435). Deucravacitinib is not approved for use in any country.

Hello everyone.  My name is Mike.  I have been recently diagnosed with psoriasis and psoriasis arthritis.  Although I would say I have had a for a lot longer.  Until recently the outbreaks and joint pain I have had where minor.  When I go see the doctor about them, it was blamed on my smoking, bad diet, poor hygiene and so on.   

It was only in the last year when the psoriasis started affecting my skin and joints really bad.  I went from a small patch on my elbow to having psoriasis on my face, hands, feet, chest and nails.  The pain in my knees and lower back was enough to keep me from sleeping.  After a few months of taking tests I finally got my diagnosis of psoriasis.

The tropical creams I am applying to my skin seem to keep the psoriasis in check or in some areas put it in remission.  The strong anti-inflammatory drugs I am taking keep the joint pain down so I can sleep. I would tell you the names of the drugs I am using, but they are not here at the computer and I am too lazy to get up and get them  LOL

But I am happy to have the diagnosis of psoriasis and doing something that helps out.  I am also happy to be here talking with people who are in a similar condition to me and understand what it is like.  I look forward to interacting and getting to know you better.

I hope this introduction is good enough.  Feels like I said too much.  Maybe I didn't say enough!!!  Maybe I should redo the introduction!!!  I hate introductions, everyone seeing me for the first time.  What will they think of me?  I hope I came across in a good way.  They say first impressions are everything.  Definitely should do the introduction again.

Oh by the way I have a tendency to overthink things  LOL  Well I am just going to stop that right now and click on that "Post Thread" button before I redo this introduction yet again!!!!

While awaiting a couple vaccines before starting Methotrexate, my dermo doc prescribed the ointments named in the subject line.  I began using Calcipotriene on Friday night.  Then applied it twice a day on Saturday and Sunday.  On Monday, I switched to twice a day Mometasone.  Her instructions are to use the Mometasone on Monday through Friday, the Calcipotriene on Saturday and Sunday and to do this for two weeks.  After two weeks, she said to reverse the ointments.  Calcipotriene will then be used during the week with Mometasone on weekends.  

The Calcipotriene alone was not relieving the itching, pain, or swollen/thicker areas but it was very slightly reducing size, but that may have been wishful thinking and not a true observation.  Since Monday, though, the pain and itching has reduced plentifully.  The patches have gone from screaming red to a moderate pink, and the painful swelling is gone.  Still a good bit of thickness and extra skin flakes, though.  

I can use the Triamcinolone for up to two weeks a month in sensitive places.  

The dermo doc also told me that sweat can aggravate the rash, so I've changed habits and now wash off in the cold skating rink water and dry off and then change into dry clothing.  I still shower at home after skating and apply moisturizing cream.  I also no longer apply a moisturizing cream before bed since I have sweaty hot flashes while sleeping.   A lighter lotion before bed seems to not trap the night sweats as much and I feel more comfortable.

I am hopeful that this will not lead to thinning of the skin as I found myself earlier this year.  I am thankful to have found a better dermatologist.  Thankful, always, for the help given here at PClub.  

I have recently suffered sore legs and numbness. My doctor's initial diagnosis is the valves in my veins are not holding so the blood is not able to get back up to my heart properly. This is causing me pain and burning sensations. I have some scans to do and I am going to see some vein specialists. LAtely when I wake up my left leg and now my left hand is numb.

I started Cosentyx about two months before getting these symptoms. I asked them but they say no reports of this being associated.

Has anyone experienced these symptoms while on a biologic?

Thanks

I saw a dermatologist in April 2021 who took two punch biopsies and prescribed the betamethasone and desonide ointments.   The only caution he gave was that they could thin the skin.  

And he provided a 12-month refill supply for the ointments.  His manner was terse, quick, reluctant.  He came across as arrogant, conceited, not very into dermatology but more into power within his practice.  All the staff in the office were young, attractive women, too.

I will be seeing a new dermatologist next week.   This doctor is new to the area (as I am, too, having moved here a year ago).  Part of her training was at Oregon Health Sciences University where I had gone for consultations relating to Crohn's Disease before starting Humira in 2007.  At least, I feel confident in OHSU as the best Oregon offered for medical care.  And it gives me hope that this doctor will be more approachable and may take the time to explain options and help me understand.  

Psoriasis Club has helped me more than the dermatologist I saw in April.  It has given me hope that these daily miseries of the skin will ease.

Do you have advice for this upcoming visit?

Have you ever encountered a doctor who really should never have become a doctor?

Have you had exceptional care from your dermatologist?  What does exceptional care look like?

What is the best of the best or the worst of the worst?

Thank you.
FW

I have been taking Skilarence for well over a year and with some success. It has never fully disappeared but has certainly helped. Recently my skin has had a bad flare up and I’m wondering if Skilarence has stopped working? Is this a thing? Can it stop working after a time? If yes then what might be my new options?

I've spent several hours this week visiting other support forums, mainly for Crohn's, searching for others with Inflammatory Bowel Disease and Psoriasis.  With each and every forum, I found two common things unseen here at Psoriasis Club.

Thing One:  Quack promotions of fad devices, fad gimicks, outrageously unsubstantiated claims.

Thing Two:  Intrusive advertising that interrupts the flow of the topic thread.

Thank you, Fred, for your integrity, maintaining the values of this club, and keeping it an informative place free of advertising, snake oil salesfolks, and bullies.  PsoriasisClub is a rare gem.

This study looked at automating the psoriasis PASI score

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Background:
The Psoriasis Area and Severity Index (PASI) score is commonly used in clinical practice and research to monitor disease severity and determine treatment efficacy. Automating the PASI score with deep learning algorithms, like Convolutional Neural Networks (CNNs), could enable objective and efficient PASI scoring.

Objectives:
To assess the performance of image-based automated PASI scoring in anatomical regions by CNNs and compare the performance of CNNs to image-based scoring by physicians.

Methods:
Imaging series were matched to PASI subscores determined in real life by the treating physician. CNNs were trained using standardized imaging series of 576 trunk, 614 arm and 541 leg regions. CNNs were separately trained for each PASI subscore (erythema, desquamation, induration and area) in each anatomical region (trunk, arms and legs). The head region was excluded for anonymity. Additionally, PASI-trained physicians retrospectively determined image-based subscores on the test set images of the trunk. Agreement with the real-life scores was determined with the intraclass correlation coefficient (ICC) and compared between the CNNs and physicians.

Results:
Intraclass correlation coefficients between the CNN and real-life scores of the trunk region were 0.616, 0.580, 0.580 and 0.793 for erythema, desquamation, induration and area, respectively, with similar results for the arms and legs region. PASI-trained physicians (N = 5) were in moderate–good agreement (ICCs 0.706–0.793) with each other for image-based PASI scoring of the trunk region. ICCs between the CNN and real-life scores were slightly higher for erythema (0.616 vs. 0.558), induration (0.580 vs. 0.573) and area scoring (0.793 vs. 0.694) than image-based scoring by physicians. Physicians slightly outperformed the CNN on desquamation scoring (0.580 vs. 0.589).

Conclusions:
Convolutional Neural Networks have the potential to automatically and objectively perform image-based PASI scoring at an anatomical region level. For erythema, desquamation and induration scoring, CNNs performed similar to physicians, while for area scoring CNNs outperformed physicians on image-based PASI scoring.

Hello. I have been using Protpic on my face and my Penis, it seems to be the only thing to work down there. Does anyone know if Vectical is safe for use down there? Its Ointment.

What is your daily skin care regimen?  Is it different depending on the season being winter or summer?  As it gets colder here, the heater is on, and the air inside the house is dryer.  Will that make the psoriasis worse?

This will be my new thread for my journey on Ilumetri (Ilumya in the USA)

This is my 7th try on a Bio and although most have done well for psoriasis, I have never found one that can keep the psoriatic arthritis under control long term. You can read my last try of Tremfya here Tremfya for psoriatic arthritis Fred's journey which will also point you to my other threads about my journeys if you are interested.

Ilumetri is only prescribed for psoriasis in France at the moment but I will be one of the first trying it for psoriatic arthritis. The recommended dose is 100mg but I'm starting straight off with 200mg as I'm 95Kg and it's been found that those over 90Kg or with a very high PASI score benefit from a double dose.

Though not yet recommended for psoriatic arthritis we are hoping the double dose will kick in fast, so it's two shots followed by another two shots at week four then a maintenance dose of two shots every 12 weeks.

I have also signed up for a trail to evaluate the safety and efficacy of Ilumetri and because I'm using it for psoriatic arthritis it may help them seek approval for treating that in the future.

Thanks to Tremfya I only have a few small patches of psoriasis on my shins and one hand, but it's handy that this annoying little patch on the side of my belly has flared up this week as I will be able to see how Ilumtri deals with it. (I won't be using anything else apart from coconut oil as a moisturiser)



Today I would score the psoriasis at: 3

Now for the psoriatic arthritis. It is flaring again at the moment and to be honest it's getting me down a little so again it will be good to see how Ilumteri works.

I'm going to have to score the psoriatic arthritis today at: 18

Here is a picture of one shot, I will be using two of these and it's no big deal as I've been injecting Bio's for a long time now.




*To note before I get going, I have been feeling very tired recently, my dermatologist said it was do to the high inflammation I have going on.

Job done one shot each side of the belly well away from the belly button, no problems and my journey begins.

Watch this space, members are welcome to comment if they wish in this thread but I will also be keeping a locked copy in the members only boards of my posts for easy reference here: [Group Specific]

Johnson & Johnson are seeking approval from the U.S. Food and Drug Administration (FDA) to treat pediatric patients ages 5 years and older with psoriatic arthritis.

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Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).

The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated diseases. Data extrapolation is the process of estimating response, trends or effects based on previous observations from patients with closely related conditions. With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population. A decision from the U.S. FDA is anticipated in late 2022.

“As children and their families manage the debilitating symptoms of juvenile psoriatic arthritis, it is critical that their physicians have a breadth of treatment options to consider,” said Alyssa Johnsen, M.D., Ph.D., Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. “With this latest submission, we’re excited to work with the U.S. FDA to evaluate this potential therapeutic option that could help meet the needs of children living with psoriatic arthritis.”

The UK government have issued a safety update for Xeljanz (tofacitinib) which is used for psoriatic arthritis.

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Tofacitinib should not be used in patients older than 65 years of age, people who are current or past smokers, or individuals with other cardiovascular (such as diabetes or coronary artery disease) or malignancy risk factors unless there are no suitable treatment alternatives.

Advice for healthcare professionals:

Information on cardiovascular events

• a clinical safety trial in patients with rheumatoid arthritis aged 50 years or older with at least one cardiovascular risk factor (Study A3921133) found that the JAK inhibitor tofacitinib was associated with an increased risk of major adverse cardiovascular events compared with TNF-alpha inhibitors (etanercept or adalimumab)
  
• the following predictive risk factors were identified: age older than 65 years, current or past smoking, history of diabetes, and history of coronary artery disease (including past myocardial infarction, coronary heart disease, stable angina pectoris, or coronary artery procedures)
  
• only consider use of tofacitinib in patients with these cardiovascular risk factors, irrespective of indication, if no suitable treatment alternative is available
  

Information on malignancy

• the same clinical safety trial in patients with at least one cardiovascular risk factor (some of which are also malignancy risk factors) found that tofacitinib was associated with an increased risk of malignancies (with the analysis excluding non-melanoma skin cancer [NMSC]), particularly lung cancer and lymphoma, compared with TNF-alpha inhibitors
  
• the following predictive risk factors were identified: age older than 65 years and current or past smoking
  
• only consider use of tofacitinib in patients with these and other malignancy risk factors (current or previous history of malignancy other than successfully treated NMSC), irrespective of indication, if no suitable alternative treatment is available
  

Advice for healthcare professionals to give to patients:

• tofacitinib treatment has been associated with an increased risk of heart attacks and certain cancers compared with another type of treatment (TNF-alpha inhibitors) – the incidence of these events is low and they have been linked to existing risk factors for these conditions such as older age or smoking
  
• patients who are already at increased risk of cardiovascular events or cancers should only be offered treatment with tofacitinib if their doctor feels there are no other suitable treatment options for their condition
  
• do not stop taking tofacitinib without first talking to your doctor
  
• always read the leaflet that accompanies your medicines and talk to your doctor, nurse, or pharmacist if you are concerned about any side effects
  

Novartis release phase lllb data for their UnoReady pen with Cosentyx (secukinumab)

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Novartis today announced data from an international Phase IIIb study, which showed treatment with Cosentyx® (secukinumab) 300 mg in a 2 mL autoinjector (UnoReady® pen) resulted in high efficacy and convenient administration in adults with moderate to severe plaque psoriasis1. These data were presented at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress.

“Chronic diseases like psoriasis can often be difficult to manage and adherence to treatments can be a challenge for patients,” said Professor Bardur Sigurgeirsson, University of Iceland, lead author of the MATURE study. “This study shows that a 300 mg dose of Cosentyx can be delivered in one injection, making it more convenient and simpler for patients to use, without compromising efficacy or safety.”

The MATURE study assessed the use of a Cosentyx 300 mg autoinjector, versus two 150 mg pre-filled syringes or placebo. Patients using the 300 mg autoinjector reported significantly improved skin clearance measured by Psoriasis Area and Severity Index (PASI) 75 and 90 versus placebo.

“We’re always looking for ways to improve usability and adherence of all our therapies, so people get the most benefit and treatments are convenient to administer. With the Cosentyx 300 mg autoinjector, people with psoriasis can better manage their symptoms with fewer injections. It’s great to know that all adults who trialed the Cosentyx UnoReady autoinjector said they were satisfied with how it worked,” said Todd Fox, Global Head of Medical Affairs for Immunology, Hepatology and Dermatology, Novartis.

The study showed high patient satisfaction, with 100% of those in the Cosentyx 300 mg UnoReady group reporting they were “very satisfied” or “satisfied” at Week 28. The safety profile reported was consistent with previous studies, and no new safety signals were observed.

The UnoReady pen was approved for use in Europe in November 2020 for all patients requiring a 300 mg dose of Cosentyx. Cosentyx is approved in over 100 countries at doses up to 300 mg for adults with moderate to severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

AbbVie have presented results from new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, evaluating Skyrizi (risankizumab) in adults with active psoriatic arthritis for one year.

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AbbVie today presented results from new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, evaluating risankizumab (SKYRIZI®, 150 mg) in adults with active psoriatic arthritis for one year (52 weeks). These results were featured during the "Late Breaking News, Reviews and Updates" session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

KEEPsAKE-1 included adult patients with active psoriatic arthritis who responded inadequately to non-biologic disease-modifying anti-rheumatic drugs (DMARDs). KEEPsAKE-2 included adult patients with active psoriatic arthritis who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). In the first phase of the studies (Period 1), patients were randomized to risankizumab or placebo until week 24. At week 24, the open label extension (Period 2) began, and all patients were treated with risankizumab.

The new long-term data from the open-label extension period showed that 70 and 58 percent of patients initially treated with risankizumab achieved American College of Rheumatology 20 (ACR20) response in KEEPsAKE-1 and KEEPsAKE-2 respectively at one year, where patients with missing data were categorized as non-responders. Among patients initially treated with risankizumab, 43 percent in KEEPsAKE-1 and 32 percent in KEEPsAKE-2 achieved ACR50 response, and 26 percent in KEEPsAKE-1 and 17 percent in KEEPsAKE-2 achieved ACR70 response at one year.

Additionally, at one year, 68 and 64 percent of patients initially treated with risankizumab and with a body surface area ≥3 percent at baseline achieved a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) in KEEPsAKE-1 and KEEPsAKE-2, respectively.

"Millions of people still suffer daily with symptoms of psoriatic arthritis, driving us to advance treatment options for these patients," said Thomas Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "These new analyses at one year support the potential of risankizumab to maintain improvements across multiple manifestations of psoriatic arthritis."

In terms of improvement in physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]), patients initially randomized to risankizumab reported mean reduction (i.e., improvement) of 0.41 and 0.26 from baseline in HAQ-DI score for KEEPsAKE-1 and KEEPsAKE-2, respectively, at week 52.

In addition, pooled results from KEEPsAKE-1 and KEEPsAKE-2 showed that 76 and 55 percent of patients achieved the resolution of dactylitis and resolution of enthesitis, respectively, at week 52.

"Dactylitis is a common symptom in psoriatic arthritis that can cause severe swelling in the fingers and toes that result in everyday tasks becoming difficult," said Lars Erik Kristensen, M.D., Ph.D., consultant and head of science at the Parker Institute Copenhagen Denmark, associate professor, Lund Sweden, SUS University Hospital. "These results provide important insights on how both biologic-naïve and experienced patients may benefit from treatment with risankizumab."

Both KEEPsAKE-1 and KEEPsAKE-2 demonstrated consistent long-term safety profiles with those shared at week 24, with no new safety findings observed from week 24 through week 52.1 Serious treatment-emergent adverse events (TEAE) occurred at 7.4 events/100 patient-years (E/100 PYs) and 9.4 E/100 PYs in KEEPsAKE-1 and KEEPsAKE-2, respectively. Rates of serious infections in KEEPsAKE-1 and KEEPsAKE-2 were 2.8 and 2.0 E/100 PYs, respectively. The rates of TEAEs leading to discontinuation of the study drug in KEEPsAKE-1 was 2.3 E/100 PYs and 1.6 E/100 PYs in KEEPsAKE-2.1 In KEEPsAKE-1, there were two deaths and both were not related to the study drug per investigator. There were no deaths reported in KEEPsAKE-2.1 In KEEPsAKE-2, three major adverse cardiac events (MACE) were reported, which were not related to the study drug per the investigator. No MACE were reported in KEEPsAKE-1.

In January 2021, AbbVie announced positive top-line results from the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, showing that risankizumab (150 mg) achieved the primary endpoint of ACR20 response versus placebo during the 24-week double-blinded, placebo-controlled, parallel-group period (period 1).

UCB have published two year data evaluating the long-term safety, tolerability and efficacy of Bimzelx (bimekizumab) through to two years in adult patients with moderate to severe plaque psoriasis.

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UCB, a global biopharmaceutical company, today announced new interim results from the BE BRIGHT open-label extension (OLE) study evaluating the long-term safety, tolerability and efficacy of BIMZELX® (bimekizumab) through to two years in adult patients with moderate to severe plaque psoriasis who completed one of the three Phase 3 pivotal studies. These data, together with additional findings from the Phase 3/3b clinical program for bimekizumab in psoriasis, were presented today across nine UCB-supported abstracts at the 30th European Academy of Dermatology and Venereology (EADV) Congress.

Bimekizumab is the first selective IL-17A and IL-17F inhibitor to be approved in the European Union for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

“Following the recent approval of bimekizumab in Europe, we are pleased to share new two-year data at EADV supporting the clinical value of bimekizumab in the treatment of moderate to severe psoriasis. The range of longer-term efficacy and safety data presented offer important new insights for the dermatology community and reflect our commitment to improving the standard of care for people with psoriasis,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

Interim data from the BE BRIGHT study presented at EADV showed that patients treated with bimekizumab achieved sustained levels of skin clearance (PASI 90 and PASI 100) through to two years with continuous maintenance dosing, and that bimekizumab was generally well tolerated, with no new safety signals identified. Switching to bimekizumab following 24 weeks of adalimumab treatment (BE SURE) resulted in a sustained increase in PASI 90 and PASI 100 responder rates up to two years. In addition, switching to bimekizumab following 52 weeks of ustekinumab treatment (BE VIVID) resulted in a sustained increase in PASI 100 responder rates up to week 100. Patients switching to bimekizumab after an inadequate response to ustekinumab at week 52 also showed sustained improvements in levels of skin clearance (PASI 90 and PASI 100).

“In clinical practice, patients with moderate to severe plaque psoriasis may need to transition between biologics to optimally control their disease. Longer-term results from the BE SURE study and the BE BRIGHT open-label extension study shared at EADV 2021 demonstrated that switching from adalimumab to bimekizumab helped more patients with moderate to severe psoriasis to achieve and maintain completely clear skin, as measured by PASI 100, through two years of treatment,” said Professor Diamant Thaçi, Institute and Comprehensive Center for Inflammation Medicine, University Hospital of Lübeck, Lübeck, Germany.

Longer-term results from BE SURE and BE BRIGHT open-label extension trial 

After completing the phase 3 BE SURE trial, patients could enrol in the OLE study. In bimekizumab-randomized patients (320 mg every four weeks [Q4W] through two years), PASI 90 response rates were 91.2 percent at both weeks 16 and 104. PASI 100 response rates in this group were 61.6 percent at week 16 and 72.3 percent at week 104. In bimekizumab-randomized patients (320 mg Q4W for 16 weeks, and then every eight weeks [Q8W] through two years), the percentage of patients reaching PASI 90 was 89.4 percent at week 16 and 89.7 percent at week 104. Levels of PASI 100 response in this group were 62.8 percent at week 16 and 68.1 percent at week 104.

Switching from adalimumab to bimekizumab 320 mg Q4W resulted in sustained response rates (PASI 90 and PASI 100) through to two years (week 104), which were comparable to the response rates seen in patients receiving continuous bimekizumab treatment.2 Bimekizumab was well tolerated over two years, with no new safety signals.

Bimekizumab data up to two years in patients switching from ustekinumab±
This analysis included adult patients from BE VIVID who were initially randomized to ustekinumab 45 mg / 90 mg (by weight) at weeks 0 / four, then every 12 weeks, or bimekizumab 320 mg Q4W through week 52.  Based on the PASI 90 response at week 52, patients entering the OLE were re-randomized to bimekizumab 320 mg Q4W or Q8W.

At entry to the OLE study, 44.9 percent of ustekinumab-treated patients and 73.6 percent of bimekizumab-treated patients had achieved PASI 100. For all patients who switched from ustekinumab to bimekizumab the PASI 100 response increased to 65.4 percent at week 56, 78.7 percent at week 68 and 69.9 percent at week 100, which was comparable to the response rate seen in patients receiving continuous bimekizumab treatment at week 68 (75.4 percent) through week 100 (68.8 percent). For patients who switched to bimekizumab following an inadequate response to ustekinumab at week 52, high levels of response were achieved. At week 56, after one dose of bimekizumab, 77.3 percent of these patients achieved PASI 90 and 40.9 percent achieved PASI 100. These responses were sustained and further improved at week 100, with 84.1 percent and 54.5 percent of patients achieving PASI 90 and PASI 100, respectively. There were no unexpected safety findings in patients who switched from ustekinumab to bimekizumab during the OLE.

Pooled safety data from up to two years of treatment in Phase 2 and 3 clinical trials
Across Phase 2 and 3 trials, the total bimekizumab exposure was 3109. patient-years (N=1789). Treatment emergent adverse events (TEAEs) occurred at an exposure-adjusted incidence rate (EAIR) of 202. per 100 patient-years, serious TEAEs were seen at an EAIR of 5.9 new cases per 100 patient-years and TEAEs leading to discontinuation at 3.8 new cases per 100 patient-years. The most common TEAEs in the Phase 2 and 3 trials with bimekizumab were nasopharyngitis (EAIR: 19.1 new cases per 100 patient-years), oral candidiasis (12.6 new cases per 100 patient-years) and upper respiratory tract infection (8.9 new cases per 100 patient-years).  The EAIR for oral candidiasis showed a decrease compared with one year of bimekizumab treatment (12.6 new cases per 100 patient-years versus 16.4 new cases per 100 patient-years) and was lower with bimekizumab dosed Q8W (9.6 per 100 patient-years) compared with Q4W (16.4 per 100 patient-years). The majority of cases (98.5 percent of patients experiencing oral candidiasis) were mild or moderate and rarely led to study discontinuation.

*The recommended bimekizumab dose for adult patients with plaque psoriasis is 320 mg (given as two subcutaneous injections of 160 mg) at week 0, four, eight, 12, 16 and every eight weeks thereafter. For some patients with a body weight ≥ 120 kg who did not achieve complete skin clearance at week 16, 320 mg every four weeks after week 16 may further improve treatment response. In the studies reported at EADV 2021, patients received maintenance dosing of bimekizumab 320 mg Q4W or Q8W.

Evelo Biosciences Announces Positive Phase 2 Clinical Data with EDP1815 in Psoriasis; Confirms Ability to Harness the Small Intestinal Axis, SINTAX™, to Treat Systemic Inflammatory Disease

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Evelo Biosciences a clinical stage biotechnology company developing SINTAX medicines as a new modality of orally delivered treatments for inflammatory disease, today announced positive data from its Phase 2 study evaluating EDP1815 versus placebo for the treatment of mild and moderate psoriasis. A statistically significant reduction in the Psoriasis Area and Severity Index (PASI) score, as measured by the proportion of patients achieving at least 50% improvement in PASI from baseline at the week 16 timepoint, was observed in the study. EDP1815 is an investigational oral biologic currently in development for the treatment of a broad range of inflammatory diseases, including clinical programs in psoriasis, atopic dermatitis, and COVID-19.

“These clinical results represent a significant advancement for those who live with inflammatory disease. This is the first Phase 2 study to demonstrate that we can harness the small intestinal axis to make a clinical impact on patients with an oral product candidate with safety and tolerability data comparable to placebo,” said Simba Gill, Chief Executive Officer of Evelo. “Based on these data, we intend to advance EDP1815 towards registration studies in psoriasis. We look forward to discussing our proposed next steps with health and regulatory authorities. This milestone brings us one step closer to realizing our vision of transforming healthcare by developing broadly acting oral, safe, effective, and affordable medicines to address the unmet needs of hundreds of millions of patients who live with inflammatory diseases.”

In the Phase 2 study, the PASI scores were assessed by both mean changes from baseline and responder rates. The primary endpoint was the mean percentage change in PASI between treatment and placebo and was prespecified as a Bayesian analysis. The Bayesian approach provides an estimate of the probability that EDP1815 is superior to placebo. The 16-week primary endpoint gave probabilities that EDP1815 is superior to placebo ranging from 80% to 90% across the prespecified analyses and cohorts.

The responder endpoint reports the proportion of patients who had a meaningful clinical response, which is defined as PASI-50 or greater. 25% to 32% of patients across the three cohorts who were treated with EDP1815 achieved a PASI-50 at week 16 compared to 12% on placebo. In cohorts 1 and 2 this difference in response rate was statistically significant (p <0.05). Cohort 3 was directionally similar (25% vs. 12%). The pooled PASI-50 response across all three EDP1815 cohorts, an exploratory analysis, was 29% vs. 12% for placebo and was also statistically significant with a p-value of 0.027. An increase in the number of capsules of EDP1815 did not lead to a dose response.

Additionally, several patients on EDP1815 achieved a PASI-75 or better, which was sustained or improved post treatment. For individuals who had a PASI-50 response or better, consistent effects in secondary and exploratory endpoints, including improvements in patient reported outcomes such as Dermatology Life Quality Index (DLQI) and Psoriasis Symptom Inventory (PSI), were observed.

EDP1815 was observed to be well tolerated in the Phase 2 study. The safety data were comparable to placebo and consistent with what was previously reported in a Phase 1b study. Adverse events (AEs) classified as “gastrointestinal” were comparable between active and placebo groups, with no meaningful differences in rates of diarrhea, abdominal pain, nausea, or vomiting. There were no related serious adverse events.

“I am very encouraged to see this Phase 2 data of EDP1815 in psoriasis,” said Benjamin Ehst, M.D., Ph.D., Board-certified Dermatologist, Investigator and Clinical Associate Professor with the Oregon Medical Research Center, and Chief Investigator of EDP1815-201. “It advances our scientific understanding of how to treat systemic inflammatory diseases and offers the prospect of a truly novel modality of treatment for patients with psoriasis. A drug with the combination of efficacy and safety results as observed here will likely be well received by dermatologists and their patients with mild and moderate disease, who are often faced with limited treatment options.”

EDP1815-201 is a double-blind, placebo-controlled, dose-ranging Phase 2 study designed to evaluate three doses of an enteric capsule formulation of EDP1815 versus placebo in 249 patients with mild and moderate psoriasis over a 16-week treatment period. In the study, the PASI scores were assessed by both mean changes from baseline and responder rates. The primary endpoint is mean percentage reduction in PASI score at 16 weeks. Secondary endpoints include the proportion of study participants who achieve a PASI-50 response or greater and other clinical measures of disease such as Physicians Global Assessment (PGA), Body Surface Area (BSA), PGA x BSA, PSI, and DLQI. Today’s results report out on the initial treatment phase of the study, which is now complete, and includes the 16-week treatment period with a 4-week follow-up. A six-month follow-up phase of the study is ongoing.

I began with this disease 6 months ago, plaque psoriasis in all my body.

2 moths ago i began to take Artemisia Annua pills, is a plant, now i'm almost fully recovered.

Cheers and I hope  all of you will heal.