As you will know at Psoriasis Club our members have been kept updated about using their treatments with the threat of covid.

But now there is a vaccine on the horizon I was wondering how many of you will be happy to give the new vaccines a try, so let's have a poll. This is open to members and guests, members usernames will not be shown but you are welcome to comment if you wish.

I have been on a PBD (plant based diet) for 2 years.  My psoriasis slowly got worse with natural treatment (beeswax, avocado oil, almond oil, shea, vit E, coconut, cocao combinations).  I have just started a Dovobet ointment treatment.  

I think exercise is important and I do eat meat occasionally.  I use grapeseed oil to make pancakes and fry onions and garlic.  I have one or 2 drinks of alcohol a day.

So, short history few years back I had tingling in my pinky finger after nerve conductivity turned out I had cubital tunnel syndrome so they moved the nerve, then about a year after that same thing in my other hand.  I mention this only as it could pertain to the current issue.

About 4-5 days ago I woke up with my left arm feeling asleep from the elbow down into my hand.  A bit worrisome but I thought I had most likely slept wrong and pinched a nerve and it would go away.  But it hasn't, it does feel better at times and worse at times so not sure why and it's mostly towards the wrist and the last three fingers of my hand (although with numbness it really is hard to tell exact spots)  So I decided to google possible causes.  The one that stood out the most as it described it the closest was one that suggested possible psoriatic arthritis.  So does that sound familiar to any of you?  The rheumatologist already has given me a that diagnosis due to my ankles so that also makes me wonder.  Curious if it is a symptom anyone here experienced.

Janssen will present data showing Tremfya (guselkumab) improved fatigue in patients with psoriatic arthritis.

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The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which showed TREMFYA® (guselkumab) improved fatigue in adult patients with active psoriatic arthritis (PsA) and maintained response through 52 weeks of active treatment, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale. TREMFYA improved fatigue during the placebo-controlled periods of both studies at week 24, and through one year of active treatment. In both studies, TREMFYA had positive effect on fatigue, in addition to other clinical outcomes, including ACR20 response. TREMFYA is FDA-approved for administration as a 100 mg subcutaneous (SC) injection every eight weeks (q8w), following two starter doses at weeks 0 and 4.

Data assessing fatigue outcomes of the studies will be presented as a poster presentation (Abstract #0347) on Friday, November 6 from 9:00 - 11:00 a.m. EST during ACR Convergence 2020, the American College of Rheumatology (ACR) virtual annual meeting.

Fatigue is considered one of the three most important symptoms by patients with active PsA, and moderate to severe fatigue occurs in up to 50 percent of these patients. Fatigue is defined as an overwhelming, sustained sense of exhaustion and decreased capacity for physical and mental work. It includes a range of experiences, from tiredness to exhaustion, which can interfere with normal daily function and reduce health-related quality of life. Fatigue is ranked high by patients regarding impact on life and priority for improvement.

"Fatigue associated with psoriatic arthritis can have a serious impact on patients' health-related quality of life and can lead to social isolation and loss of employment," said Proton Rahman,i M.D., Professor of Medicine, Rheumatology, Memorial University in Newfoundland, Canada and presenting author of the study. "These findings from the DISCOVER-1 and DISCOVER-2 studies showing an improvement in fatigue a full year into treatment with TREMFYA add to the previously presented 52-week data demonstrating an improvement in joint and skin symptoms. Considered together, the data are encouraging for active psoriatic arthritis patients who struggle with multiple symptoms."

Novartis say significant reduction of synovitis (joint lining inflammation) was demonstrated with Cosentyx (secukinumab) at week 12  vs. placebo, with improvements as early as week 11.

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Novartis today announced 12-week results from the first-of-its-kind Phase IIIb ULTIMATE randomized controlled trial, which demonstrated the significant treatment response of Cosentyx® (secukinumab) on synovitis (joint lining inflammation) in psoriatic arthritis (PsA) versus placebo. Synovitis was assessed using an advanced and sensitive imaging technique called Power Doppler ultrasonography (PDUS). These data are being presented at the American College of Rheumatology (ACR) All-Virtual Annual Meeting, November 5-9, 2020.

“Psoriatic arthritis can have a significant impact on a patient’s joints. Joint lining inflammation, also known as synovitis, if left untreated, can cause pain to worsen, joint damage and may decrease physical function,” said Dr. Maria A. D’Agostino, Professor of Rheumatology at the Catholic University of Rome. “These data are highly encouraging, showing Cosentyx can significantly reduce synovitis at Week 12 versus placebo with results seen as early as Week 1, and that ultrasound is a sensitive and objective tool to monitor joint inflammation in PsA patients.”

The use of a standardized ultrasound synovitis score (GLOESS) as the primary endpoint showed objectively the significant benefit of Cosentyx versus placebo on synovitis at Week 12 with an early improvement observed from Week one. Treatment with Cosentyx also significantly improved key secondary endpoints versus placebo, including ACR20 (68% vs 34%, respectively), ACR50 (46% vs 9%, respectively) and enthesitis (mean change from baseline in Spondyloarthritis Research Consortium of Canada enthesitis index score [SPARCC] of -2.4 vs -1.7 respectively). The safety profile of Cosentyx through 12 weeks was consistent with previous studies.

Novartis anticipates disclosing full 24-week data from the ongoing ULTIMATE trial at the European League Against Rheumatism (EULAR) annual meeting in 2021 and final analysis at ACR 2021.

"As a strong believer in the diagnostic and treatment monitoring benefits of ultrasound, this first large randomized double-blind placebo-controlled clinical trial in PsA with an ultrasonographic primary endpoint is incredibly exciting. The ability to use a sensitive imaging technique to assess synovitis and enthesitis in PsA represents a breakthrough in how we conceptualize treatment goals,” said Dr. Catherine Bakewell of Intermountain Medical Group in Salt Lake City, UT and an investigator in the ULTIMATE study. “In addition to other measures, PDUS helps to provide earlier insight into treatment response, and that patients are more effectively treated across multiple domains of this heterogeneous psoriatic disease spectrum.”

PsA is a complex disease with multiple manifestations driving patient symptoms. In PsA, synovitis may lead to joint damage and if left untreated, the joint damage can be irreversible. In addition to reducing synovitis, Cosentyx has been proven to provide long-lasting inhibition of radiographic progression in PsA, limiting joint damage and helping to improve outcomes for patients with this debilitating condition.

Bristol Myers Squibb have announced phase 3 trial evaluating the efficacy and safety of deucravacitinib, the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor.

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Bristol Myers Squibb today announced positive results from POETYK PSO-1, the first pivotal Phase 3 trial evaluating deucravacitinib (BMS-986165), a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. POETYK PSO-1 evaluated 6 mg of deucravacitinib once daily and met both co-primary endpoints versus placebo, with more patients achieving Psoriasis Area and Severity Index (PASI) 75, defined as at least a 75 percent improvement in PASI, and a static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib.

The trial also met multiple key secondary endpoints, including showing deucravacitinib was superior to Otezla® (apremilast) in the proportion of patients reaching a PASI 75 response and sPGA 0/1 at Week 16. The overall safety profile of deucravacitinib in the POETYK PSO-1 trial was consistent with previously reported Phase 2 results.

“With limited oral therapeutic options available for psoriasis, there remains a significant need for safe and effective oral therapies. This makes the positive topline results for deucravacitinib in the POETYK PSO-1 trial exciting for the psoriasis community,” said April Armstrong, M.D., M.P.H., Associate Dean and Professor of Dermatology at the University of Southern California. “These findings indicate deucravacitinib has the potential to be a new treatment option for people living with psoriasis and may provide clinically meaningful improvements with the convenience of oral administration.”

The company and principal investigators will complete a full evaluation of the POETYK PSO-1 data and share the detailed results at a future medical meeting. POETYK PSO-1 is the first of two global Phase 3 studies designed to evaluate safety and efficacy of deucravacitinib compared to placebo and Otezla in patients with moderate to severe plaque psoriasis. Results from the second study, POETYK PSO-2, are expected in the first quarter of 2021. In addition to psoriasis, deucravacitinib is being studied in a wide spectrum of immune-mediated diseases, and the company will present results from its Phase 2 trial in psoriatic arthritis at the American College of Rheumatology (ACR) Convergence 2020, taking place virtually November 5-9, 2020.

“We are encouraged by the efficacy and safety profile observed in the POETYK PSO-1 study, which supports the strong potential we see for deucravacitinib, our novel, oral, selective TYK2 inhibitor, to be an important new therapy in psoriasis,” said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. “We recognize there is a significant unmet need for new therapeutic options for people with immune-mediated diseases, such as psoriasis, and are committed to pursuing potential new medicines that will give physicians additional choices to effectively treat and manage their patients.”

Sun Pharma have published 5 year results for Ilumya / Ilumetri (tildrakizumab)

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Sun Pharma today  announced  that  one  of  its  wholly  owned subsidiaries presented positive, five-year Phase 3 data for ILUMYA® (tildrakizumab-asmn) from the combined  reSURFACE  1  and  reSURFACE  2  extension  studies.  Patients  with  moderate-to-severe plaque  psoriasis  who  continued  to  receive  ILUMYA  through  five  years  of  continuous  treatment maintained consistent and extensive skin clearance with no new safety issues reported. These data were presented for the first time at the 29th European Academy of Dermatology and Venereology (EADV) Virtual Congress.“These results are important as we now have five-year  data  reinforcing  our  understanding  that ILUMYA may provide patients with sustained skin clearance and a well understood safety profile that was comparable to placebo,”said Richard Langley,M.D.,FRCPC, professor of medicine and director of research, Department of Medicine, Dalhousie University. “ILUMYA is a valued option for patients in  the  treatment  of  moderate-to-severe  plaque  psoriasis,  and  these  findings  are  reassuring  for physicians and their patients living with this chronic disease.”In an analysis of the pooled reSURFACE 1 and reSURFACE 2 extension studies, patients received ILUMYA100mg or 200mg through five years of continuous treatment. ILUMYA 100mg is approved in  the  U.S.,  Japan  and  Australia,  and  200  mg  is  additionally  approved  under  the  brand  name ILUMETRI™ in Europe.

In patients who were treated with ILUMYA 100mg, clear or almost clear skin (PASI 90) was achieved by 65.9% of patients and 32.8% of patients achieved completely clear skin (PASI  100)  at  Week  244.  The  standard  goal of  treatment,  a  PASI  75  response,  was  achieved  by 88.7%  of  patients  at  Week  244.1 The  long-term  analyses  also  showed  absolute  PASI  <1/<3/<5 scores  at  Week  28  (50.8%,  85.1%  and  96.4%,  respectively)  were  sustained  through  Week  244 (47.7%,  78.8%  and  88.7%,  respectively). Absolute  PASI  scores  can  provide  an  indication  of  the extent of residual disease after treatment. Achievement of an absolute PASI score of <3 has been proposed as comparable to a PASI 90 response, which is equivalent to clear or almost clear skin.

ILUMYA  100  mg  was  well-tolerated  during  the  Phase  3  trials.  The  three  adverse  reactions  that occurred more frequently than placebo and ≥1% in clinical trials were upper respiratory infections (14% vs. 12%), injection site reactions (3% vs. 2%) and diarrhea (2% vs. 1%). Furthermore, the analysis  demonstrated  similar  exposure-adjusted  incidence  rates  of  malignancies  throughout  five years  of  study.  A  majority  of  malignancies  were  singular  events  with  similar  incidence  rates  as seen in the general US population.

“These impressive results show that ILUMYA keeps working year-on-year, maintaining a high level of  skin  clearance  and  a  durable  safety  profile  regardless  of  baseline  level  of  skin  disease,  age  or background illnesses,” said Abhay Gandhi, CEO, Sun Pharma, North America. “Patients living with moderate-to-severe plaque psoriasis need therapies they can use over long periods of time without loss of efficacy, and weare pleased these data show that ILUMYA is a sustainable choice for patients over the long term.”

This study looked at psoriasis patients and bullous pemphigoid (BP) a rare skin condition that causes itching, redness and blisters.

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Background:
Although the association of bullous pemphigoid (BP) and psoriasis is well‐established, the clinical and immunological features of patients with coexisting BP and psoriasis are yet to be investigated.

Objective:
We aimed to estimate the prevalence of psoriasis among patients with BP and to elucidate the clinical and immunological characteristics of BP patients with comorbid psoriasis.

Methods:
A retrospective cohort study including all consecutive patients diagnosed with BP throughout the years 2009‐2019 in a tertiary referral center.

Results:
The study encompassed 273 patients with BP, of whom 11 (4.0%; 95% CI, 2.3‐7.1%) had comorbid psoriasis. The onset of psoriasis preceded that of BP in 81.8% of patients by a median (range) latency of 26.5 (5.0‐34.0) years. Compared to BP patients without psoriasis, those with BP and comorbid psoriasis were significantly younger at the onset of BP (71.8 [9.3] vs. 79.4 [9.8] years; P=0.023), had a milder erosive phenotype (erosion/blister BPDAI mean [SD] score; 5 [4.1] vs. 22.3 [15.2]; P=0.025), lower levels of anti‐BP180 NC16A serum autoantibodies (236.6 [266.3] vs. 556.2 [1323.6] U/ml; P=0.008) as well as a higher prevalence of isolated linear C3 deposits (36.4% vs. 14.1%; P=0.043) and a lower prevalence of linear immunoglobulin G deposits (36.4% vs. 68.7%; P=0.025) along the dermal‐epidermal junction by direct immunofluorescence microscopy.

Conclusions:
Patients with BP and comorbid psoriasis present at a younger age with milder erosive phenotype and lower levels of pathogenic autoantibodies.

This needs a lot more looking in to, but it suggests that psoriasis patients using bio's have a low risk of ending up in hospital due to covid.

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Background:
The multi-morbid burden and use of systemic immunosuppressants in people with psoriasis may confer greater risk of adverse COVID-19 outcomes but data are limited.

Objective:
Characterize the course of COVID-19 in psoriasis and identify factors associated with hospitalization.

Methods:
Clinicians reported psoriasis patients with confirmed/suspected COVID-19 via an international registry, PsoProtect. Multiple logistic regression assessed the association between clinical/demographic characteristics and hospitalization. A separate patient-facing registry characterized risk-mitigating behaviours.

Results:
Of 374 clinician-reported patients from 25 countries, 71% were receiving a biologic, 18% a non-biologic and 10% no systemic treatment for psoriasis. 348 (93%) fully recovered from COVID-19, 77 (21%) were hospitalized and nine (2%) died. Increased hospitalization risk was associated with older age (multivariable-adjusted OR 1.59 per 10 years, 95% CI 1.19-2.13), male sex (OR 2.51, 95% CI 1.23-5.12), non-white ethnicity (OR 3.15, 95% CI 1.24-8.03) and comorbid chronic lung disease (OR 3.87, 95% CI 1.52-9.83). Hospitalization was more frequent in patients using non-biologic systemic therapy than biologics (OR 2.84, 95% CI 1.31-6.18). No significant differences were found between biologic classes. Independent patient-reported data (n=1,626 across 48 countries) suggested lower levels of social isolation in individuals receiving non-biologic systemic therapy compared to biologics (OR 0.68, 95% CI 0.50-0.94).

Conclusion:
In this international moderate-severe psoriasis case series, biologics use was associated with lower risk of COVID-19-related hospitalization than non-biologic systemic therapies, however further investigation is warranted due to potential selection bias and unmeasured confounding. Established risk factors (being older, male, non-white ethnicity, comorbidities) were associated with higher hospitalization rates.

Clinical Implications:
We identify risk factors for COVID-19-related hospitalization in psoriasis patients, including older age, male sex, non-white ethnicity and comorbidities. Use of biologics was associated with lower hospitalization risk than non-biologic systemic therapies.

Tapinarof is a potential first-in-class, steroid-free, cosmetically elegant, once-daily therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream being developed for the treatment of plaque psoriasis and atopic dermatitis. To date, over 2,200 subjects have enrolled in 18 clinical trials of tapinarof.

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Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that two posters on tapinarof will be presented during the upcoming 2020 Fall Clinical Dermatology Conference to be held virtually Oct. 29-Nov. 1, 2020. The two presentations will cover data from Dermavant’s successful Phase 3 PSOARING pivotal trials in addition to a maximal use pharmacokinetics study.

“Having recently reported positive Phase 3 PSOARING 1 and PSOARING 2 results for tapinarof cream 1% in adult patients with plaque psoriasis, we are excited to share these efficacy and safety data at Fall Clinical,” said David Rubenstein, MD, PhD, Chief Scientific Officer of Dermavant. “These study outcomes reinforce the potential, subject to approval by the U.S. Food and Drug Administration, of tapinarof, a non-steroidal topical cream, to become a first-line treatment option for patients with plaque psoriasis. I would like to thank everyone who has been involved in the PSOARING program.”

Tremfya (guselkumab) gets a positive recommendation for psoriatic arthritis in the EU.

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Janssen announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the expanded use of TREMFYA (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) in the European Union (EU). Guselkumab is currently approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Hi, when i 1st developed Pustular Psoriasis in 2002 through 2003 was the worst time of my life. My left hand and foot worst case possible. The pain with pustular is unforgiving. Since the skin is shedding every 4 days to the normal of 28 days..in a 4 day period i maybe got 3 or 4 hours of relief. When patients talk about flare up's, pustular is a non-stop flare up. You name it..i did it. Creams made it worst and so did uv lights and laser. I was on stelara, which i had to check my liver function every 30 days..no relief and i stopped it. I sold my home in 2003 and rented a hotel on the beach for a month because my new house that i was having built wasn't ready. I sent my 2 children and my 90 year old father-in-law to stay with my mom. In 2 weeks i was clear of the most horrible thing i ever went through. It is stress related. My kids were teens and my father-in-law was a lot to care for. Now in 2020 with all we are going through with covid-19, i am 64. My husband is 77 and has had problems with diabetic ulcers on his foot. I noticed a few blisters on the heel of my foot early this year. so with all of this going on psoriasis is back on the left foot and it is spreading at a alarming rate. The flare up's are very hard to deal with. I did see my Dr and of course they gave me the cream..that's a no-no. With some medical issues at my age it's very hard to sit in the sun. But i must say, i used calamine lotion and it is a life saver. I have a jacuzzi in my bathroom. I put baby oil in it while i am in there. Then when my skin is dry i put thin layers of the calamine lotion on my foot.. let it dry and keep doing this until u don't feel anything. Also before i go to bed i use aveeno night time lotion for sensitive skin and i put it all over my feet. I don't rub it in, i let it sit on the skin. I must say, my case is not good and it is not going away. But it pretty much stopped the flareups that most people would never understand. I would love to go back to the beach for a month. But with covid-19 im afraid. I wish all of you patients with this horrible disease to do yoga exercise anything that can get you stress-free.

AnaptysBio publish phase 2 data on imsidolimab for the treatment of generalized pustular psoriasis (GPP)

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AnaptysBio, Inc a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced positive topline data from an interim analysis of its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe generalized pustular psoriasis (GPP), also known as the GALLOP trial. GPP is a chronic, life-threatening, rare inflammatory disease with no approved therapies.

“We are encouraged by the rapid onset, overall safety and promising efficacy profile demonstrated to date by imsidolimab for the treatment of patients suffering with GPP,” said Paul F. Lizzul, chief medical officer of AnaptysBio. “We look forward to engaging with regulatory authorities to progress imsidolimab into Phase 3, and in doing so offer a potential therapeutic intervention for these patients with high unmet medical need.”

“GPP is a life-threatening disease that seriously debilitates patient lives with no approved therapies,” said Johann Gudjonsson, Associate Professor of Dermatology, University of Michigan. “The efficacy and safety demonstrated in this trial further validates the potential for IL-36 receptor inhibition in helping GPP patients. I look forward to advancement of imsidolimab for the treatment of GPP and for other inflammatory conditions where this target and pathway may play an important role.”

Study Data
Key data available to date from the 8 patients enrolled in the GALLOP trial are as follows:

• Mean baseline value on the modified Japanese Dermatology Association severity index total score (mJDA-SI) was 9 (Table 1), body surface area covered by erythema and pustules was 24% and the serum C-reactive protein (CRP) was 56 mg/L. Patients were on average 51 years of age, 50% female and diagnosed with GPP for 4.3 years.
  
• Six of 8 (75%) patients treated with imsidolimab monotherapy achieved the primary endpoint of improvement in the CGI scale on Day 29. Two of 8 (25%) patients were considered to have not met the primary endpoint because they dropped out of the trial prior to Day 29.  
  
• mJDA-SI score, which incorporates both dermatological and systemic aspects of GPP, decreased on average by 29% on Day 8 and 54% on Day 29. Erythema with skin pustules, which clinically defines GPP, decreased by 60% on Day 8 and 94% on Day 29. Serum CRP, which is an indicator of systemic inflammation, was normal (less than 5 mg/L) for 5 of the 6 patients achieving the primary endpoint on Day 29.     
  
• Genotypic testing indicated homozygous wild-type IL-36RN, CARD14 and AP1S3 alleles for all 8 patients. We believe this suggests that imsidolimab is broadly applicable to pustular diseases irrespective of genetic drivers.
  
• Anti-drug antibodies were not detected as of Day 29 in any patient.
  

Imsidolimab was generally well-tolerated and most treatment-emergent adverse events were mild to moderate in severity and resolved without sequelae. No infusion or injection site reactions were observed. One patient dropped out of the trial due to a diagnosis of Staphylococcal aureus bacteremia in the first week, which was a serious adverse event deemed to be possibly drug-related. Because the patient was symptomatic prior to dosing and had a prior medical history of bacteremia, a common comorbidity of GPP, the Company does not believe this event is likely attributable to imsidolimab. Another patient dropped out of the study on Day 22 due to investigator reported inadequate efficacy. One patient contracted COVID-19 during the course of the trial, which was mild, unrelated to imsidolimab, and did not lead to study discontinuation.

An end-of-Phase 2 meeting, based upon data available from the 8 patients enrolled in the GALLOP trial, is anticipated in Q4 2020. In July 2020, the FDA granted orphan drug designation to imsidolimab for the treatment of GPP based upon GALLOP clinical data.

The Company plans to report full data from the GALLOP trial at a medical conference in 2021.

EDP1815 is an investigational oral biologic in development for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19.

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Evelo Biosciences, Inc a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, today announced that it has dosed the first patients in its Phase 2 clinical trial evaluating EDP1815 for the treatment of mild to moderate psoriasis. EDP1815 is an investigational oral biologic in development for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19.

“We are pleased to announce the dosing of the first patients in our Phase 2 clinical trial in mild to moderate psoriasis,” said Duncan McHale, M.B.B.S., Ph.D., Chief Medical Officer of Evelo. “In Phase 1b studies, EDP1815 demonstrated an ability to resolve systemic inflammation and provide clinical benefit to patients with psoriasis. Based on these data, EDP1815 may offer an improved profile to existing products and others in development. EDP1815 has the potential to be an effective, well-tolerated, and convenient medicine for millions of patients with mild to moderate psoriasis. Our Phase 2 trial, if successful, will enable us to advance into confirmatory registrational studies, following meetings with health authorities such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). We look forward to interim data by mid-2021, as we continue to progress this important therapy toward market.”

EDP1815-201 is a double-blind, placebo-controlled, dose-ranging Phase 2 trial designed to evaluate three doses of the enteric capsule formulation of EDP1815 versus placebo in 225 patients with mild to moderate psoriasis over a 16-week treatment period. The primary endpoint is mean reduction in Psoriasis Area and Severity Index (PASI) score at 16 weeks. Key secondary endpoints include other clinical measures of disease such as Physician’s Global Assessment (PGA), Body Surface Area (BSA), PGA x BSA, Psoriasis Symptom Inventory (PSI), Dermatology Life Quality Index (DLQI), and Lesion Severity Score (LSS). Interim data from the study is expected by mid-2021.

About EDP1815 in Psoriasis
EDP1815 is an investigational oral biologic being developed for the treatment of inflammatory diseases. EDP1815 is a strain of Prevotella histicola, selected for its specific pharmacology. In the second and third quarter of 2019, Evelo reported positive Phase 1b interim clinical data in two cohorts of patients with mild to moderate psoriasis. EDP1815 was well tolerated at both doses, with no overall difference reported from placebo. There was a reduction in mean LSS and PASI score after 28 days of dosing in both cohorts who received EDP1815. In the high dose cohort alone, there was a continued reduction in both mean LSS (of 24% vs. placebo of 7%) and PASI score (of 21% vs. placebo of 3%) at 42 days – 14 days following the last dose of the drug. This may indicate a sustained clinical effect and dose response. EPD1815 was also observed to limit the systemic production of multiple inflammatory cytokines, including IL-6, IL-8, TNF, and IL-1, which are well-established mediators of potentially harmful effects in patients with inflammatory diseases.

I changed my prescription and have 3 Humira pens left that are expired in 2021. I don't want to throw them away or send to someone personally. I'd like to donate to medical groups or hospitals but don't know how. Please give me some suggestion. Thanks.

Hi all, I was wondering if anyone can help me with a few questions regarding my first injection of Taltz. I took my first injection last night (administered by my friend who is a nurse) I my stomach. It is the pen and we did let it sit out to get to room temperature. I can handle the pain of the injection no problem. But right after it almost felt like I had pulled a muscle in my upper thigh area and I was walking with a limp. After waking up today, my lower back and hip are so tight that it hurts to barely move my right leg. That is the side of my abdomen where it was injected. Has anyone else experienced this? Did I maybe tense up? I also took a very long car ride yesterday to evacuate from Hurricane Delta so my entire body was tense and aching. But I was just so desperate to start my injections because my entire scalp is covered with plaques and is bleeding. Just wondering if this is normal? 

Thanks in advance!

Synalar gel

Patient information leaflet

Synalar® gel

fluocinolone acetonide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor , pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:

1. What Synalar gel is and what it is used for
2. What you need to know before you use Synalar gel
3. How to use Synalar gel
4. Possible side effects
5. How to store Synalar gel
6. Contents of the pack and other information

1. WHAT SYNALAR GEL IS AND WHAT IT IS USED FOR

Synalar gel contains fluocinolone acetonide which is a steroid and reduces inflammation.

It is used to treat certain inflammatory conditions such as seborrhea and psoriasis of the scalp and other hairy parts of the body. It may also be used to treat certain inflammatory conditions of the skin on other parts of the body.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE SYNALAR GEL

Do not use Synalar gel:

If you are allergic to fluocinolone acetonide or any of the other ingredients of this medicine (listed in section 6).
Where infection is the main cause of the skin problem.
For acne.
For nappy rash or itchiness around the genital area.
If you have a skin condition called rosacea which is red rash, sometimes with spots and pustules, on the cheeks of the face.
If you have a skin condition called perioral dermatitis which is a dry sore red rash around the mouth
If it is for a child under the age of one.
If breast-feeding, do not apply to the breasts prior to nursing.
Make sure your doctor knows if any of the above affects you.

Warnings and precautions

Synalar gel should be kept away from the eyes.
If using Synalar gel on the face or on children (over the age of 1 year), do not use for more than 5 days. Your doctor will tell you if your treatment should be longer than this.
Waterproof dressings should not be used for children, or the face, and only in adults if your doctor tells you. The affected area should be thoroughly cleaned before putting on a waterproof dressing. Ask your doctor for instructions.
Do not use more gel than the doctor tells you, especially if you are pregnant or breast-feeding.
If too much gel is used for too long, you may develop stretch marks, thinning of the skin, or visible small veins.
Other medicines and Synalar gel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

If you go into hospital, let the medical staff know that you are using Synalar gel.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant,or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Synalar gel should not affect your ability to drive or use machinery.

Important information about some of the ingredients of Synalar gel

Some of the ingredients in your gel may cause a reaction, such as: Methyl and propyl parahydroxybenzoate [E218 and E216] – may cause local skin reactions (possibly delayed). Propylene glycol [E1520] – may cause skin irritation.

3. HOW TO USE SYNALAR GEL

Always use Synalar gel exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Screw the nozzle onto the end of the tube. This will allow you to apply your gel directly on to the affected part of the skin at the roots of the hair.

Unless your doctor tells you differently, a small amount of gel should be massaged into the affected area every night and every morning at roughly the same time.

Once the condition is under control you can reduce the treatment and apply the gel once or twice a week. Use the gel for as long as directed by your doctor (normally 5 days on the face and on children).

If you forget to use Synalar gel

If you forget to apply the gel at the correct time, do so as soon as you remember.

If accidentally swallowed

If you accidentally swallow the gel, contact your nearest doctor or hospital.

If you have any further questions on the use of this medicine ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines Synalar gel can cause side effects, although not everybody gets them. The following side effects have been reported but how often they occur is unknown:

an allergic (itchy) reaction to the gel
irritation where the gel has been applied
a worsening of acne, rosacea and dermatitis around the mouth (see section 2)
patches of pale skin (depigmentation)
localised increased hair growth
if too much gel is used for too long, you may develop stretch marks, thinning of the skin or visible small veins. In addition some of the steroid rubbed in to the skin may enter the blood stream. Effects such as roundness of the face, muscle wasting and fluid retention, as sometimes seen when steroids are given as tablets, may occur. The risk of these possible effects is higher in children. If this happens, your doctor may decide to stop treatment.
Do not be alarmed by this list of possible side effects. You may not have any of them.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE SYNALAR GEL

Keep this medicine out of the sight and reach of children. It could harm them.

Store Synalar gel below 25°C. Keep the gel in the tube it came in.



This leaflet was last revised in February 2019

This study says when treatment is interrupted, Ilumya  / Ilumetri (tildrakizumab) provides durable maintenance of five to six months.

Quote:

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Background:
As treatment interruptions occur during psoriasis management in clinical practice, it is important to know the duration of clinical response after treatment withdrawal.

Objectives:
To report time to and predictors of relapse in patients who were tildrakizumab 100 and 200 mg responders (≥75% improvement in Psoriasis Area and Severity Index; PASI 75) at week 28 re‐randomized to placebo from reSURFACE 1 trial.

Methods:
Post‐hoc analysis of adult patients with moderate‐to‐severe plaque psoriasis from a 64‐week phase 3 trial. Relapse was primarily defined as loss of PASI 75 response. Both relapse defined as loss of PASI 90 and loss of absolute PASI <2 response were included as sensitivity analyses. PASI 75, PASI 90, and PASI <2 responders re‐randomized to placebo at week 28 and followed‐up until week 64 were included. Kaplan‐Meier (KM) estimates of the 64‐week relapse rate were calculated. Log‐rank test to compare KM curves from responders to tildrakizumab 100 and 200 mg was used. Independent predictors of relapse were explored.

Results:
Median time to loss of PASI 75/PASI 90/PASI <2 response from week 28 was 142/111/112 days with tildrakizumab 100 mg and 172/140/113 days with tildrakizumab 200 mg, respectively (all not significant). Around 20% of patients did not relapse (either maintained a PASI 75 response or were lost to follow‐up) during the 36‐week period. Increase in body mass index (BMI) (hazard ratio, HR [95% confidence interval, CI] for loss of PASI 75 response: 1.0345 [1.0112 – 1.0582]) and increase in disease duration (HR [95% CI]: 1.0151 [1.0028 – 1.0275] for loss of PASI 75 response) were associated with an increased risk of relapse, regardless of the relapse definition.

Conclusions:
When treatment is interrupted, tildrakizumab provides durable maintenance of efficacy with a median time to loss of PASI 75 response of five to six months, irrespective of the dose. Interventions on modifiable risk factors for relapse, such as BMI, may improve personalized long‐term psoriasis management.

after failing on kyntheium. i was told by dr to come off it.and i would be getting a telephone consultation. 
i got my consultation over the phone. only thing i knew nothing about it. as i got my appointment letter the day after the fone call. so obviously missed it. at this point my psoriasis and arthritis kicked in big time.. in absolute agony i ring the dermatology department. asking for another appointment. i got my fone consultation.. or rather i didnt as they rang the wrong number!! so i ring again.. and give them my number again. ok they said we will ring you. but it will be in 6 days time as the drs are busy. all the while im unable to walk at this point due to arthritis. my right foot swelled. cracked and split. so i got my fone consultation.. or rather i didnt cos guess what.. they rang wrong number again. so i ring back. fuming they agree to another consultation, and yippee they actually foned right number, so after speaking to the dr she said i should go back on cosentyx. ok i said, dr said it should be with you in 10 days.. great i said. waited 3 weeks n nothing. rang dermatology. and,, she forgot to process the prescription.. i havn slept in a month due to sever pain and sore skin. i cant walk. cant sit or lay down due to pain,,, sorry for the rant but needed to get it off my chest. and im tempted to seek legal advice. you wouldnt leave a dog in this much pain 

The European Medicines Agency (EMA) have set out new measures to avoid fatal dosing errors with methotrexate.

*The UK have said they will mirror the EMA advice.

Quote:Information for patients:

• If you are taking methotrexate for rheumatoid arthritis, psoriasis or Crohn’s disease, you must take it just once a week.
  
• Take your methotrexate medicine on the same day every week.
  
• Follow the instructions on the packaging of your methotrexate medicine.
  
• You will receive a patient card with your methotrexate tablets (or oral liquid). Read it carefully because it tells you how to take your medicine.
  
• Show your patient card to any new healthcare professional who treats you so that they know that you take your methotrexate medicine once a week.
  
• See your doctor at once if you get a sore throat, fever, mouth ulcers, diarrhoea, vomiting, skin rashes, bleeding or unusual weakness. These can be signs of taking too much methotrexate.
  
• Always attend your scheduled clinic visits and blood test appointments. They are important for making sure that your methotrexate medicine is working and that it is not causing any concern.
  
• If you are not sure about how to take your methotrexate medicine or you have any questions about it, talk to your doctor or pharmacist.
  

Quote:Information for healthcare professionals:

• Methotrexate for inflammatory conditions is intended for use just once a week. Serious side effects including fatalities have occurred when methotrexate is taken more often.
  
• Only physicians with expertise in using methotrexate medicines should prescribe them.
  
• Healthcare professionals who prescribe or dispense methotrexate for inflammatory conditions should:
  • read the educational materials for oral methotrexate medicines;
    
  • ensure that they are familiar with the latest changes to the summaries of product characteristics for methotrexate medicines used for inflammatory conditions;
    
  • give clear instructions to the patient (or carer) about once-weekly dosing;
    
  • check carefully that the patient (or carer) understands that the medicine must be used once a week, and do this each time a new prescription is issued or the medicine is dispensed;
    
  • decide together with the patient (or carer) on which day of the week the patient uses methotrexate;
    
  • counsel the patient (or carer) about signs of methotrexate overdose and give instructions to promptly seek medical advice in case of suspected overdose.