Another new treatment in the pipeline for treating psoriasis.

Quote:

---

Can-Fite BioPharma a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that pre-clinical studies with skin cells, modeling psoriasis in humans, show that Piclidenoson, the Company’s drug candidate for the treatment of psoriasis, destroys pathological skin cells. The Company’s scientists reported that in a cell culture of human HaCaT cells, incubated with Piclidenoson, cell apoptosis was induced with an increase in the caspase protein, known to mediate apoptotic responses.

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies.

The Company expects to announce topline results during Q1 2022 from its randomized, double blind, active and placebo-controlled study currently being conducted in Europe, Israel, and Canada. The study’s primary endpoint is the proportion of patients who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16. Secondary endpoints include non-inferiority to Otezla® in weeks 16 and 32. Patients enrolled in the study have been selected based on their over-expression of A3AR, Can-Fite’s therapeutic target.

“The data shown in our lab experiments are important and support the mechanism of action of Piclidenoson and supply additional support for the drug effect. We are encouraged by the positive interim analysis data reported last year based on 200 patients’ data and hope that it will be reproducible and that psoriasis patients will benefit from safety and long term relief from the symptoms of psoriasis,” stated Can-Fite CEO.

The psoriasis therapeutic market is estimated to reach $11.3 billion by 2025. Piclidenoson has been out-licensed for the indication of psoriasis in major markets including Canada, Europe, and Asia with deal terms including potential upcoming milestone payments and double-digit royalties upon regulatory approval.

This study looked at the prevalence and factors associated with sleep disturbance in adult patients with psoriasis.

Quote:

---

Background:
Sleep, which is crucial for restoring of physiological functions and health, is reportedly impaired in psoriasis. The role of different potential sleep confounding factors, including detailed pruritus characteristics, and the complex interplay between psychological variables (anxiety and depression), pruritus and sleep disturbance in psoriasis remain insufficiently investigated.

Objectives:
To investigate sleep characteristics and to identify clinical, demographic, and psychological factors associated with sleep disturbance in psoriasis.

Methods:
This cross-sectional study included 334 psoriasis patients (response rate 86%) and 126 control subjects (response rate 82%). Measures included sleep quality [Pittsburgh Sleep Quality Index (PSQI)], psoriasis severity, pruritus characteristics, including average pruritus intensity [Visual Analogue Scale (VAS)], severity of comorbidities, anxiety and depression (Hospital Anxiety and Depression Scale – HADS), and quality of life (Dermatology Life Quality Index – DLQI, and Short Form 12 – SF12).

Results:
Fifty-nine percent of patients, and 34% of control subjects (P<0.001) suffered from sleep disturbance (PSQI>5). Patients slept 1 hour less than control subjects (median 6 vs. 7 hours, P<0.001). Patients without pruritus had less impaired sleep (global PSQI) than patients with strong (P<0.001) and very strong pruritus (P<0.001). Anxiety (HADS-A) and depression (HADS-D) levels were the strongest predictors of sleep impairment, followed by pruritus exacerbation at night, age, female sex, pruritus exacerbation in the morning, average pruritus intensity (VAS), diagnosed depression and gastroesophageal reflux disease, altogether explaining 32% - 37% of the variance in global sleep quality. Both, anxiety (HADS-A) and depression (HADS-D) were significant mediators explaining the association between pruritus intensity (VAS) and sleep impairment in 42% and 37%, respectively.

Conclusions:
Sleep disturbance in patients with psoriasis is highly prevalent. Patients with psoriasis should be assessed for sleep impairment, pruritus, anxiety, and depression. Reduction of pruritus should be considered as an important therapeutic goal, along with therapies aimed at reducing anxiety and depression.

I thought it would be interesting to get some history from our members about their psoriasis.

Copy and paste the questions and add your answers. *You can also add other comments and replies if you wish and leave questions blank if you don't want to share.

#1 What age did you think something was going wrong:

#2 How many years later was it that you got a diagnoses:

#3 When you got a diagnoses how did it make you feel:

#4 What was your first treatment:

#5 Did you think it was a temporary thing:

#6 How long before you got to see a dermatologist:

#7 What did you think of your first dermatologist:

#8 Have you ever given up on a prescribed treatment:

#9 How do you feel you are being treated today:

#10 What would you say to the younger you at #1:

This is a voluntary recall notice of Taro Clobetasol Propionate Ointment USP.

Quote:

---

Taro Pharmaceuticals U.S.A is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level.

This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022 ”. No other lots of this product are impacted. Lot AC13786 is being recalled due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing.

R. pickettii is present in the natural environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised, or whose skin is not intact (i.e. sunburn, psoriasis, abrasions), there is a reasonable possibility that systemic infections may occur if the product is contaminated with R. pickettii due to the presence of the corticosteroid component which enhances absorption of the ointment.

If this bacterium is circulating in the human blood stream it can cause life-threatening, invasive infections such sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues. To date, Taro has not received any adverse event reports related to this lot.

*This recall is being conducted with the knowledge of the US Food and Drug Administration.

So I know that those red scaly patches itch. And I know moisturizing helps. I know scratching is to be avoided if at all possible. BUT... I admit that I scratch way more often than I should. So I was wondering, what do you do to ignore that itch??

I've found I can refrain from scratching if I'm out in public or around people, at least not that satisfying digging in scratching. Although there have been times I've excused myself to go find a secluded spot to scratch.

I've also found that with scalp psoriasis I can go outside in the sun and since I have long hair I can shake my head and watch the specks that fall shimmer in the sunlight as they blow away, a bit like a snow globe! I'm easily amused at times. But that only lasts a few seconds so isn't really helpful. Actually it might even be a little bit weird.

So how do you ignore the itch?

This months poll above asks: What effect has Alcohol had on your psoriasis and/or psoriatic arthritis ?

Voting is open to members and guests, our members can also leave a comment if they wish.

Around January 2021, a persistent but calm and subtle rash on my ankle bloomed into a troublesome, painful, patch.  A primary care doctor referred me to a dermatologist who took two punch biopsies.  

Before I found Psoriasis Club:

This first dermatologist told me incorrect information regarding Humira and Psoriasis.  He prescribed Betamethasone 0.05% for the legs, a similar formula lotion for the scalp, and Desonide Ointment 0.05% for sensitive areas and skin folds.   

His manner was arrogant and rushed.  He provided little information.  Patches continued to spread upon my lower legs and appear on my torso, arms, genitals, and more across my scalp.

I finally searched for support online when my fingertips and the insteps of my feet began bleeding.  I had developed thinning skin from the topical steroids.

When I found Psoriasis Club:

I learned about overusing topical steroids.  I learned about different medical therapies.  I read that a couple members had managed their skin through diet alone.   This club offered me information that the first dermatologist failed to provide.  This club inspired me to find a better doctor.  

While the dietary changes didn't affect my skin, I did reduce my sugar intake significantly and feel better for it, overall.  I rely less on wheats, also.  My overall diet has improved.  

My current dermatologist: 

I'm receiving good, compassionate, intelligent care, now.  My current dermatologist has provided information on how to use topical steroids, changed the ointments, added a Vitamin D derivative, provided a schedule for usage.  She's offered light therapy, Methotrexate, and Folic Acid.  She provided printed information on this condition and assurance that there are other medications to try.  

Best of all:

I understood the options discussed by this doctor because I read about prescribed treatments here.  Psoriasis Club has helped me to be informed about my condition and the treatments.  

I'm finally, finally, finally . . . finally! . . . feeling some relief.

On this last day of 2021, I feel contemplative, looking back over the year.  I'm hopeful, looking forward to skin improvement and the continued sense of belonging in a community of patchy people from all around the world here at Psoriasis Club.

The Medicines and Healthcare products Regulatory Agency (MHRA) UK are advising anyone using Dermaved cream stop using it immediately.

Quote:

---

Individuals who have purchased Dermaved Sensitive Cream via the company’s website are today being asked to stop using it and return the product after it was found to contain a potent steroid.

The MHRA, who issued the recall, has worked to ensure that Dermaved Sensitive Cream is removed from sale.

Dermaved Sensitive Cream is not a licensed medicine and has been marketed in the UK as a natural Ayurvedic product for sensitive skin.

The MHRA’s analysis of the product found the presence of the steroid clobetasol propionate. This is the active ingredient in topical (on the skin) Prescription-Only medicines used for the treatment of a range skin conditions such as psoriasis and eczema.

Creams containing steroids should be used sparingly and as directed by the prescriber. They should also not be used on children under 1 year of age. Long-term use can rarely cause local complications such as skin thinning and if inappropriately used, can worsen conditions such as eczema.

MHRA has previously issued warnings for products called Zudaifu cream and Yiganerjing Cream which contained the same steroid ingredient.

This could be good news for those with pustular psoriasis.

Quote:

---

Boehringer Ingelheim announced today new data from the pivotal Phase II EffisayilTM trial, which showed spesolimab, a first-in-class investigational treatment, significantly improved signs and symptoms of generalized pustular psoriasis (GPP) in patients experiencing a flare.

GPP is a rare, life-threatening neutrophilic skin disease, which is distinct from plaque psoriasis. It is characterized by episodes of widespread eruptions of painful, sterile pustules (blisters of non-infectious pus). There is a high unmet need for treatments that can rapidly and completely resolve the symptoms of GPP flares. Flares greatly affect a person’s quality of life5 and can lead to hospitalization with life-threatening complications, such as heart failure, renal failure and sepsis and even death.

In the 12-week trial, 53 patients experiencing a GPP flare were treated with a single intravenous dose of spesolimab or placebo. Most patients at the outset of the trial had a high or very high density of pustules and impaired quality of life. Results after one week demonstrated that:

54% of patients treated with spesolimab showed no visible pustules compared to 6% of those treated with placebo;
43% of patients treated with spesolimab showed clear/almost clear skin compared to 11% of those in the placebo group.

Pustular and skin clearance continued for the duration of the study. This clearance was accompanied by clinically significant improvements in quality of life and symptoms such as pain and fatigue, compared to placebo.
Over the 12-week duration of the study, non-serious infections rates were higher in the spesolimab group compared with placebo, with no pattern regarding pathogen and affected organs. Two patients reported to have drug reactions with eosinophilia and systemic symptoms.

“With no approved treatments in the U.S. or E.U. for GPP flares, there is a significant unmet need for people with this distressing and painful skin condition, that often requires emergency care,” said Mark Lebwohl, MD, lead investigator and publication author, and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, Kimberly and Eric J. Waldman Department of Dermatology, New York. “These clinical trial results show that spesolimab has the potential to completely clear the skin of the signs and symptoms of a GPP flare after only one week, with sustained effect observed for up to 12 weeks.”

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for the treatment of GPP, and Breakthrough Therapy Designation for spesolimab for the treatment of GPP flares. This designation is for therapies treating serious or life-threatening conditions where early clinical evidence suggests a substantial improvement compared to existing treatments. The Chinese Regulatory Authority Centre for Drug Evaluation (CDE) also recently granted Breakthrough Therapy Designation for spesolimab for the treatment of GPP flares.

“At Boehringer Ingelheim, we are committed to finding transformative therapies to help advance treatment for people who urgently need them,” said Dr Emmanuelle Clerisme-Beaty, Head of Clinical Development and Medical Affairs, Dermatology, Boehringer Ingelheim. “The findings indicate that spesolimab may have a significant and positive impact on patients experiencing a GPP flare.”

The clinical program for spesolimab includes two other trials that are currently underway. First, the Effisayil-2 trial is designed to investigate spesolimab as a maintenance treatment to prevent the occurrence of GPP flares. The Effisayil-ON trial is an open label five-year extension study to investigate the longer term efficacy and safety of spesolimab in patents with GPP.

About spesolimab
Spesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in several autoimmune diseases pathogeneses, including GPP.  It is the first investigational treatment to specifically target the IL-36 pathway for the treatment of GPP flares that has been evaluated in a statistically powered, randomized, placebo-controlled trial. Spesolimab is also under investigation for the prevention of GPP flares and for the treatment of other neutrophilic skin diseases, such as palmoplantar pustulosis (PPP) and hidradenitis suppurativa (HS).

About the EffisayilTM 1 clinical trial
Effisayil™ 1 (NCT03782792) was a 12-week Phase II trial investigating patients with a GPP flare (N=53), randomly assigned 2:1 to a single 900 mg intravenous dose of spesolimab or placebo. The primary endpoint was a GPP Physician Global Assessment (GPPGA) pustulation subscore of 0 (no visible pustules) at week one. The key secondary endpoint was a GPPGA score of 0/1 (clear/almost clear skin) at week one.

After one week, 54% of patients (19 out of 35) treated with spesolimab showed no visible pustules (GPPGA score of 0), compared to 6% of patients (1 out of 18) treated with placebo ( P<0.001). In addition, 43% of patients (15 out of 35) treated with spesolimab showed clear/almost clear skin (GPPGA score of 0/1), compared to 11% of patients (2 out of 18) in the placebo group ( P=0.024).

After one week, adverse events were reported in 66% of patients treated with spesolimab and 56% of those receiving placebo. Infections were reported by 17% and 6% of patients in the spesolimab and placebo groups respectively. Serious adverse events were reported in 6% of patients treated with spesolimab.

Cosentyx (secukinumab) has been approved by the Food and Drug Administration (FDA) for use in juvenile psoriatic arthritis (JPsA)

Quote:

---

Novartis, today announced the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older. Cosentyx is now the first biologic indicated for ERA, and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology.

“Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,” said Hermine Brunner, M.D., Cincinnati Children’s Hospital. “The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes.”

ERA and JPsA, subtypes of juvenile idiopathic arthritis (JIA), are autoimmune diseases. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with low back pain or tenderness at the palpation of the hips. JPsA is characterized by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers and/or toes or psoriatic skin changes in a first-degree relative. If left untreated, they can lead to high levels of pain and disability.

“This marks the second and third US pediatric approval this year for Cosentyx, following pediatric psoriasis approval and further reinforces the proven efficacy and safety of the therapy. With more than 500,000 adult and pediatric patients treated worldwide since launch, healthcare professionals and patients can feel confident in Cosentyx,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “Furthermore, we are pleased to build on our strong heritage of bringing innovative treatments to young people living with rheumatic diseases, which began with the FDA approval of Ilaris. We are committed to bringing Cosentyx to this pediatric community globally as part of our ambition to expand Cosentyx to 10 indications in areas of high unmet need.”

The approved pediatric dosing for Cosentyx in children and adolescents is 75 mg (15 kg or more to less than 50 kg) or 150 mg (50 kg or more). It is administered as a subcutaneous injection by a pre-filled syringe or Sensoready® pen every 4 weeks after initial loading doses. With appropriate guidance/instruction from a healthcare professional, Cosentyx can be administered by an adult caregiver outside of a healthcare provider’s office via a single-dose prefilled syringe or Sensoready® pen.

The approval is based on data from the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled 86 children and adolescents aged 2 to 18 years old with a confirmed diagnosis of ERA or JPsA according to a modified International League of Associations for Rheumatology classification criteria. The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104). In children and adolescents aged 2 to 18 years old, the study demonstrated that patients with active JPsA (n = 34; mean age: 12.) treated with Cosentyx had a longer time to flare, showing an 85% reduction in the risk of flare (P<0.001) versus placebo. The study also demonstrated that patients with active ERA (n = 52; mean age: 13.7) treated with Cosentyx had a significantly longer time to flare, showing a 53% reduction in the risk of flare versus placebo. Safety in this pediatric population was consistent with the known safety profile of Cosentyx for the treatment of plaque psoriasis, PsA, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

Rinvoq (upadacitinib) is an Oral prescription medicine approved for the treatment of patients with psoriatic arthritis.

Dosage: The recommended dose is 15 mg once daily with or without food. Do not split, break, crush, or chew the tablet.

Tell your HCP (doctor) if you:

• Are being treated for an infection, have an infection that won’t go away or keeps coming back, or have symptoms of an infection, such as:
  
• Fever, sweating, or chills
  
• Shortness of breath
  
• Warm, red, or painful skin or sores on your body
  
• Muscle aches
  
• Feeling tired
  
• Blood in phlegm
  
• Diarrhoea or stomach pain
  
• Cough
  
• Weight loss
  
• Burning when urinating or urinating more often than normal
  
• Have TB or have been in close contact with someone with TB.
  
• Are a current or past smoker.
  
• Have had a heart attack, other heart problems, or stroke.
  
• Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
  
• Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
  
• Live, have lived, or have travelled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
  
• Have recently received or are scheduled to receive a vaccine. People who take Rinvoq should not receive live vaccines.
  
• Are pregnant or plan to become pregnant. Based on animal studies, Rinvoq may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start Rinvoq. You should use effective birth control (contraception) to avoid becoming pregnant while taking Rinvoq and for at least 4 weeks after your last dose.
  
• Are breastfeeding or plan to breastfeed. Rinvoq may pass into your breast milk. You should not breastfeed while taking Rinvoq and for at least 6 days after your last dose.
  

• Medicines for fungal or bacterial infections
  
• Rifampicin or phenytoin
  
• Medicines that affect your immune system
  

• Serious infections. Rinvoq can lower your ability to fight infections. Serious infections have happened while taking Rinvoq, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting Rinvoq and check you closely for signs and symptoms of TB during treatment with Rinvoq. You should not start taking Rinvoq if you have any kind of infection unless your HCP tells you it is okay. You may be at higher risk of developing shingles (herpes zoster).
  
• Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
  
• Cancer and immune system problems. Rinvoq may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer.
  
• Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
  
• Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with Rinvoq. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.[
  
• Tears in the stomach or intestines and changes in certain laboratory tests. Your HCP should do blood tests before you start taking Rinvoq and while you take it. Your HCP may stop your Rinvoq treatment for a period of time if needed because of changes in these blood test results.
  

• Tell your HCP right away if you have any symptoms of an infection. Rinvoq can make you more likely to get infections or make any infections you have worse.
  
• Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Rinvoq, including:
  • Discomfort in the centre of your chest that lasts for more than a few minutes or that goes away and comes back
    
  • Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
    
  • Pain or discomfort in your arms, back, neck, jaw, or stomach
    
  • Shortness of breath with or without chest discomfort
    
  • Breaking out in a cold sweat
    
  • Nausea or vomiting
    
  • Feeling light-headed
    
  • Weakness in one part or on one side of your body
    
  • Slurred speech
    
• Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with Rinvoq, including:
  • Swelling
    
  • Pain or tenderness in the leg
    
  • Sudden unexplained chest pain
    
  • Shortness of breath
    
• Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.
  

Hi i seem to have treatment resistant psoriasis. I had it in a couple of small patches- on on my neck and the other would develop related to certain underarm spray, whilst I was in my early twenties. It was mild and did not bother me and the creams seemed to keep it at bay. It was only 5 years ago it flard up big time. I have it all over my body except my face. I tried Acitretin for 18 months and that did not help. It just made my hair fall out. So now I am starting light therapy tomorrow. I hope it works. I would like to hear from anyone else who has had this and what their experiences are. Also, my self esteem is totally gone as I

Johnson & Johnson today announced new Tremfya (guselkumab) efficacy and safety data from the Phase 3b Cosmos trial, evaluating this selective interleukin IL23 inhibitor in adults with active psoriatic arthritis (PsA)

Quote:

---

Johnson & Johnson today announced new TREMFYA® (guselkumab) efficacy and safety data from the Phase 3b COSMOS trial, evaluating this selective interleukin (IL)-23 inhibitor in adults with active psoriatic arthritis (PsA) who demonstrated inadequate efficacy or intolerance to tumor necrosis factor inhibition (TNFi). Results showed significantly higher proportions of patients treated with TREMFYA had improvement in joint signs and symptoms and complete skin clearance versus placebo at week 24 in this documented TNFi-IRa patient population, which is often more difficult to treat. Furthermore, improvements in signs and symptoms of PsA were maintained or numerically increased through one year (week 48) among TREMFYA-randomized patients.

“Active psoriatic arthritis is a heterogenous disease and a significant number of patients do not respond adequately to TNF inhibition,” said lead author Laura Coates, M.D., Ph.D., Associate Professor, University of Oxford, UK.b “The COSMOS data demonstrate that TREMFYA significantly improved signs and symptoms of active psoriatic arthritis across multiple clinical disease domains, including patient reported outcomes, with treatment effects observed by week four. These findings reinforce the utility of this alternative mechanism of action as a therapeutic option for adults with active psoriatic arthritis who have not responded to one or more therapies.”

Results show:
Joint Symptom Improvement:

    44.4 percent (84/189) of patients who received TREMFYA versus 19.8 percent (19/96) of patients who received placebo achieved at least 20 percent improvement in the American College of Rheumatology criteria (ACR20) at week 24, the study’s primary endpoint. Results of the Early Escape (EE)-correction sensitivity analysisd indicated an ACR20 response rate of 48.1 percent (91/189) in the TREMFYA group. 54.9 percent of placebo patients who crossed over to TREMFYA at week 24 achieved ACR20 at week 48.
    ACR20 response rates continued to improve across different analysis sets during the first year – 57.7 percent of TREMFYA patients at week 48 utilizing non-responder imputation [NRI] and >80 percent of week 24 responders maintained a response at week 48.
    TREMFYA-treated patients had higher ACR20 and ACR50 response rates versus placebo as early as weeks four and eight, respectively.
    At week 24, TREMFYA-treated patients had a greater least square (LS) mean change in Disease Activity in Psoriatic Arthritis (DAPSA)e score (-14.5 vs -5.7) and a higher DAPSA low disease activity (LDA) response rate (29.6 percent vs 13.5 percent) versus placebo, which increased over time to 44.4 percent at week 48.1 At week 24, the proportion of patients achieving DAPSA remission was numerically higher in the TREMFYA group versus placebo (5.3 percent vs 2.1 percent).
    Among patients affected at baseline, numerically higher proportions of TREMFYA-treated patients than placebo patients had resolved enthesitisf (39.7 percent vs 18.8 percent) or dactylitisg (44.8 percent vs 25 percent) at week 24.

Improvements in Physical Function, Health-Related Quality of Life (HRQoL) and Fatigue:

    At week 24, higher proportions of TREMFYA-treated patients versus placebo (37.5 percent vs 16.1 percent) achieved clinically meaningful improvements in physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]),h which increased to 53.4 percent at week 48.
    TREMFYA-treated patients also reported better physical aspects of HRQoL (Short Form [SF]-36 Physical Component Summary [PCS] scores) versus placebo.
    At week 24, higher proportions of TREMFYA-treated patients achieved a ≥4-point increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) versus placebo (42.9 percent vs 20.8 percent), reflecting a clinical meaningful improvement in fatigue.1,j This response was maintained and increased over time to 55.6 percent at week 48.

Complete Skin Clearance:

    At week 24, the proportion of patients with ≥3 percent body surface area psoriatic involvement and an Investigator's Global Assessment (IGA)k score of ≥2 at baseline achieving complete skin clearance (100 percent improvement in Psoriasis Area Severity Index [PASI])l was significantly higher among those receiving TREMFYA than those receiving placebo (30.8 percent vs 3.8 percent).
    At week 48, more than half of patients (53.4 percent) receiving TREMFYA (utilizing NRI) achieved complete skin clearance (PASI 100).

Consistent Safety Profile:

    The TREMFYA treatment group demonstrated low rates of adverse events (AEs) leading to discontinuation and serious AEs (SAEs), which were comparable to that of the placebo group.
    Through week 56, time-adjusted incidences of SAEs and AEs leading to treatment discontinuation, and serious infections were 6.3, 2.7, and 0.8 per 100 patient years, respectively.1 In the TREMFYA treatment group, one patient experienced a major adverse cardiovascular event at week 44; one malignancy occurred (prostatic adenocarcinoma); and two patients reported psychiatric disorders as SAEs.1 One case of suspected, but unconfirmed, inflammatory bowel disease was reported around one month after the patient discontinued TREMFYA due to an influenza-like illness.
    Two TREMFYA-treated patients had a serious infection: one TREMFYA-randomized patient was hospitalized with community-acquired pneumonia diagnosed at week 12 (history of chronic obstructive pulmonary disease and heart disease) and the patient recovered with antibiotic treatment and resumed study agent. The second patient was hospitalized with acute pneumonia (week 48), who recovered following antibiotic therapy and continued TREMFYA.1 No opportunistic infections, cases of active TB, or deaths occurred.
    These safety findings in TNFi-IR PsA patients through week 56 of COSMOS expand upon, and are consistent with, the accumulated TREMFYA safety profile established in psoriasis (PsO) patients receiving TREMFYA through five years (VOYAGE 1 and 2) and those seen in bio-naïve and TNFi-experienced PsA patients evaluated in DISCOVER-1 (one year) and DISCOVER-2 (two years).

“Results from this study provide further evidence that TREMFYA is effective in treating patients with various manifestations of active psoriatic arthritis even when TNF inhibitor treatment has failed,” said Soumya D. Chakravarty, M.D., Ph.D., Senior Director, Strategic Lead, Rheumatology Therapeutic Area, Janssen Scientific Affairs, LLC. “Active psoriatic arthritis is a chronic and often debilitating disease, so patients need treatment options with durable efficacy and an established safety profile. It is our goal to advance therapeutic options for people living with active psoriatic arthritis to enhance their chances to live life with reduced symptoms of active PsA.”

Protagonist therapeutics announces the selection of oral peptide PN-235 into phase 2 clinical development program for multiple indications including psoriasis.

Quote:

---

Protagonist Therapeutics today announced the selection of PN-235 (JNJ-77242113) as the final candidate for all clinical studies in multiple indications based on intervention of the Interleukin-23 (IL-23) pathway, under the Company's collaboration with Janssen Biotech, Inc. (Janssen). In addition to the previously announced Phase 2 clinical study of PN-235 in psoriasis, new Phase 2 clinical studies of PN-235 in inflammatory bowel diseases (IBD) are expected to commence in late 2022. Further development of PN-232 (JNJ-7510586) will be discontinued in favor of PN-235 based on its superior potency, and overall pharmacokinetic and pharmacodynamic profile.

"We are delighted to see PN-235 emerge as the clear focal point going forward, after over four-plus years of a highly productive and ongoing collaboration with Janssen," said Dinesh V. Patel, PhD, President and CEO of Protagonist. "We look forward to exploring the full potential of a highly differentiated, oral targeted therapy like PN-235, thereby potentially addressing persistent unmet needs of patients with immune-mediated diseases like psoriasis and IBD."

Protagonist will earn a $25 million milestone in connection with the initiation of the first Phase 2 study of PN-235 in psoriasis in early 2022. Protagonist is also eligible for a $10 million milestone in connection with the start of the second indication-based Phase 2 study. Protagonist is eligible for up to approximately $900 million in development-related milestone payments, in addition to the $87.5M in milestones already earned. Under the terms of the collaboration, Janssen will conduct all future clinical studies, including these anticipated Phase 2 studies, and will be solely financially responsible for any such studies.

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

Quote:

---

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)

Quote:

---

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