Ventyx have started phase 2 trial of its selective, allosteric TYK2 inhibitor VTX958 for the treatment of moderate to severe plaque psoriasis.

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Ventyx Biosciences today announced that the first patient has been dosed in a Phase 2 trial of its selective, allosteric TYK2 inhibitor VTX958 for the treatment of moderate to severe plaque psoriasis.

“Dosing of the first patient in the Phase 2 SERENITY trial of VTX958 is a major accomplishment for Ventyx and an important step towards providing a new treatment option for patients suffering from moderate to severe plaque psoriasis who are in need of more effective oral therapies,” said Dr. William Sandborn, President and Chief Medical Officer. “Our Phase 1 single-ascending dose and multiple-ascending dose data established an excellent safety profile with dose-dependent pharmacokinetic and pharmacodynamic data supporting class-leading target coverage of TYK2-mediated pathways. The wide therapeutic window of VTX958 observed in our Phase 1 trial will allow us to explore a broad range of doses in Phase 2 trials, including doses designed to achieve biologic-like IC90 coverage of TYK2-mediated cytokines, such as IL-23. Topline data from the Phase 2 SERENITY trial are expected in the fourth quarter of 2023. We plan to provide further updates across our wholly-owned development pipeline, including our three Phase 2 trials of VTX958, at our R&D day on January 26, 2023.”

The Phase 2 SERENITY trial is a randomized, double-blind, placebo-controlled, dose-ranging trial to evaluate the safety and efficacy of VTX958 in patients with moderate to severe plaque psoriasis. The trial will enroll approximately 200 patients randomized to one of four VTX958 doses or placebo for a 16-week double-blind treatment period. The primary efficacy endpoint will evaluate the proportion of subjects achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI-75) at week 16.

In addition to the SERENITY Phase 2 trial, Ventyx is on track to initiate two additional Phase 2 trials of VTX958 in psoriatic arthritis and Crohn’s disease before the end of the year.

My name is Jenna, and it's great to meet you! I used to be on this site quite a lot back in 2018 when I was still in college and first starting my journey with psoriasis. I have had a pretty bad flare up over the last few months, and kept thinking about when I used to be on here every day, and how absolutely awesome and supportive the people are.

Over the last few years I bounced from Humira to Taltz, and just recently started using Cosentyx. I've had a nightmare of a time getting on this new medication due to change of insurance (hence the recent flare up), and would love to hear if anyone else has experience with Cosentyx.

I'd also love to hear about other people's psoriasis journeys, and maybe make some new friends 

Otezla (apremilast) significantly improved skin-related quality of life in patients with psoriasis.

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Introduction/Background:
Manifestations of psoriasis in special areas are difficult to treat and are associated with a high disease burden and significant quality of life (QoL) impairment. Topical therapies may be inadequate for these patients, necessitating systemic treatment.

Objective:
The objective of EMBRACE was to evaluate the impact on QoL, efficacy, and safety of apremilast 30 mg BID in patients with limited skin involvement with plaque psoriasis manifestations in special areas and impaired QoL.

Methods:
EMBRACE (NCT03774875) was a phase 4, randomized, placebo-controlled, multinational study. Patients had plaque psoriasis not controlled by topical therapy; lack of response, contraindication, or intolerance to conventional first-line systemic therapy; psoriasis in ≥1 special area (including visible locations, scalp, nails, genital areas, or palmoplantar areas); Psoriasis Area and Severity Index (PASI) ≥3 to ≤10; and Dermatology Life Quality Index (DLQI) >10. The primary endpoint was DLQI response (≥4-point reduction) at Week 16.

Results:
Of 277 randomized patients (apremilast: n=185; placebo: n=92), 221 completed Week 16 (apremilast: n=152; placebo: n=69). The primary endpoint (≥4-point reduction in DLQI at Week 16) was met by significantly more patients receiving apremilast (73.3%) versus placebo (41.3%; P<0.0001). Significantly greater improvement in affected body surface area (BSA) and PASI was observed with apremilast versus placebo at Week 16. There were also significantly greater improvements with apremilast versus placebo in itch numeric rating scale (−2.5 vs −0.9, P<0.0001) and skin discomfort/pain visual analog scale (−21.5 vs −5.4, P=0.0003) and greater achievement of Patient Benefit Index ≥1 (77% vs 40%, P<0.0001) at Week 16. No new safety signals were observed.

Conclusions:
Apremilast significantly improved skin-related QoL in patients with limited skin involvement with plaque psoriasis in special areas and highly impaired QoL. The safety profile was consistent with prior apremilast studies.

Hi All..new here, the leaflet on enstilar says do not use on genital area, my dermatologist told me to use it there!! Anyone had any issues with it, need to use on the foreskin.
Thank you.

Hi All,

I've suffered from psoriasis for over 20 years and just started Talz on October 1st. Since I started, I've noticed that my tonsils are swollen, and I snore. I don't typically snore. My daughter just got over a cold with a cough, so I wasn't sure if I was coming down with her cold or if the swollen tonsils and snoring were because of the medication. Has anyone else experienced this? Thanks!

This study aimed to evaluate mitochondrial ß-oxidation, intermediary metabolism, and mitochondrial content in psoriasis patients.

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Background:
Psoriasis is strongly associated with insulin resistance (IR). Lipid profile disturbances and upregulation of enzymes crucial for fatty acid oxidation have been reported in patients with psoriasis. Mitochondrial ß-oxidation is altered in patients with IR. Common mitochondrial dysfunction may be involved in the origin of both diseases.

Objective:
This study aimed to evaluate mitochondrial ß-oxidation, intermediary metabolism, and mitochondrial content in psoriatic patients with or without IR and compare them to healthy controls.

Methods:
The participants were divided into three groups: 1) psoriasis and IR (n = 26); 2) psoriasis without IR (n = 17); and 3) healthy controls (n = 17). Quantification of amino acids and acylcarnitines (AC) by tandem mass spectrometry, determination of urinary organic acids by gas chromatography/mass spectrometry (GC/MS), and mitochondrial DNA quantification were performed in all groups.

Results:
When comparisons were made between the two psoriatic groups, no differences were found between: C5DC+C6OH, C16:1, Met/Leu, Met/Phe, C16:1/C16, and C5DC+C6OH/C4DC+C5OH ratios. Nine analytes were different: phenylalanine, Cit/Phe, and Cit/Tyr ratios, C0, C3, C5, C6DC, C16, and C18:1OH. There were no correlations between psoriasis area and severity index (PASI), body mass index (BMI), and duration of disease with ACs. A higher proportion of patients with psoriasis showed increased urine levels of uric acid and hippuric acid (p= 0.01). The mtDNA content was significantly higher in cases than in controls, with no differences between IR and non-IR psoriatic patients.

Conclusions:
Psoriasis patients with and without IR have a different acylcarnitine profile reflecting impaired ß-oxidation. A distinctive profile of acylcarnitines suggests an involvement of mitochondrial function associated with an increase in stearoyl CoA desaturase (SCD) activity in psoriatic patients with and without IR.

Results from a 52 week retrospective study to assess the effectiveness and safety of Ilumetri / Ilumya (tildrakizumab) in a real life setting.

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Background:
Tildrakizumab is a humanized monoclonal antibody that binds selectively the p19 subunit of interleukin-23. It is approved for treatment of moderate-severe chronic plaque psoriasis.

Objectives:
We conducted a 52-week retrospective study to assess the effectiveness and safety of tildrakizumab in a real-life setting.

Methods:
Our retrospective study included 237 consecutive adults with moderate-to-severe plaque psoriasis, enrolled in 10 different Italian centers, treated with tildrakizumab up to week 52. Patient characteristics, comorbidities, previous treatments, and the PASI (Psoriasis Area and Severity Index) score at each visit (baseline, week 16, week 28 and week 52) were retrieved from the electronic medical records. The percentages of patients achieving 75%, 90% and 100% (PASI 75, PASI 90 and PASI 100) improvement in PASI with respect to baseline PASI were registered.

Results:
At week 52, 90.91%, 73.55% and 58.68% of patients achieved a PASI reduction ≥ 75% (PASI 75), PASI 90 and PASI 100, respectively. An absolute PASI ≤2 was reached by 85.95% at week 52. Compared to Phase 3 clinical trials, we observed similar rates of PASI 75/90 responses and higher percentages of patients achieving PASI 100. Patients who had not responded to previous biologic treatments and patients with cardio-metabolic comorbidities were significantly more likely to achieve PASI 100 at week 28 and PASI 90 at week 52. The higher body mass index did not interfere with the odds of reaching PASI 75/90/100 at each time-point. No significant safety findings were recorded throughout the study, and none of the patients had to interrupt the treatment because of adverse events

Conclusion:
Our data suggest that the efficacy of tildrakizumab for plaque psoriasis in “real-life” clinical practice is comparable with Phase 3 clinical trials with higher percentages of patients achieving complete skin clearance (PASI 100) at weeks 16, 28 and 52.

Is it considered rude to scratch in public?  Or is it embarrassing to those around you if you do scratch?

We've moved into town from the countryside where there was a lot of privacy.  Our new house is not yet unpacked. We are laboring through this move, carrying heavy boxes, moving furniture, etc.  We had curtains open, window blinds open, neighbor houses surrounding us, sunlight shining in, and I reached both hands to my scalp and had a little scratching while standing and resting a moment.

"The neighbors will see you!" my partner exclaimed.

Huh?

That was the first indication I had from him that maybe my scratching is embarrassing to him.

What is the etiquette for scratching?

Are there different rules for scratching in public versus scratching in your own home?  I DO vacuum up any flakes I leave on the floor or chairs at home.  But I wonder, now, if my idle scratching within my home is unsettling to my partner and that he hasn't said anything, yet.

How do you cope with itching when you are with other people in general and with your intimate family in particular?

U.S. Food and Drug Administration (FDA) approves Sotyktu (deucravacitinib), oral treatment for adults with moderate-to-severe plaque psoriasis.

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Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) approved Sotyktu™(deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu is not recommended for use in combination with other potent immunosuppressants.

The approval is based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla® (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis. The superior efficacy of Sotyktu compared to placebo and Otezla was demonstrated at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks. See below for more information.

“Sotyktu has the potential to become the new standard of care oral treatment for people with moderate-to-severe plaque psoriasis, given its profile in helping patients achieve clearer skin as demonstrated in the POETYK PSO clinical program,” said April Armstrong, MD, MPH, clinical investigator in the POETYK PSO-1 trial and Associate Dean and Professor of Dermatology at the University of Southern California. “People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”

“The approval of Sotyktu represents an exciting day for patients suffering from moderate-to-severe plaque psoriasis who are not satisfied with topical and conventional treatments. This is another extraordinary achievement for Bristol Myers Squibb, as we bring forward a new mechanism of action, the first oral treatment approved in nearly 10 years, and the first orally dosed once-daily treatment for moderate-to-severe plaque psoriasis,” said Samit Hirawat, MD, Chief Medical Officer, Bristol Myers Squibb. “We believe Sotyktu is a breakthrough in the treatment of patients with this condition, and we’re excited about its potential in other immune-mediated diseases.”

In the POETYK PSO trials, at Week 16, the most common adverse reactions (≥1 percent and higher than placebo) in patients on Sotyktu were upper respiratory infections (19.2 percent), blood creatine phosphokinase increase (2.7 percent), herpes simplex (2.0 percent), mouth ulcers (1.9 percent), folliculitis (1.7 percent) and acne (1.4 percent). In addition, 2.4 percent of patients on Sotyktu, 3.8 percent of patients on placebo, and 5.2 percent of patients on Otezla experienced adverse reactions leading to discontinuation.

This study evaluated the effectiveness and safety of Ilumetri / Ilumya (tildrakizumab) in patients with moderate-to-severe plaque psoriasis in a real-world setting.

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Background:
Plaque psoriasis is a chronic inflammatory disorder affecting the skin and impacting quality of life. Tildrakizumab (TIL) is an IL-23 inhibitor licensed for moderate-to-severe plaque psoriasis. Regulatory approval of medicinal products is based on safety and efficacy data from randomized controlled trials (RCTs) which impose stringent selection criteria. Long-term non-interventional studies (NIS) are needed to establish effectiveness and safety in daily practice bridging the gap between RCTs and the real-world setting.

Objectives:
This analysis of the NIS TILOT seeks to evaluate effectiveness and safety of TIL in patients with moderate-to-severe plaque psoriasis in a real-world setting. Secondary objectives include the assessment of the Dermatology Life Quality Index (DLQI), treatment satisfaction and course of scalp and nail disease using Physician Global Assessment (PGA).

Methods:
Interim analysis at 52 weeks (W) of the ongoing non-interventional, prospective, long-term multicenter study TILOT.

Results:
The effectiveness analysis included 412 patients. The mean [standard deviation, SD] Psoriasis Area and Severity Index (PASI) score was 16.0 [9.1] at baseline improving by 82.4% (95% confidence interval [CI], 78.9-86.0) to 2.1 [2.9] at W52. The proportion of patients achieving PASI scores of <3 and <5 increased over time peaking at 74.6% (95% CI, 69.3-79.4) and 88.4% (95% CI, 84.3-91.8) at W52. Scalp-PGA and nail-PGA improved by 79.8% (95% CI, 75.6-84.0) and 72.7% (95% CI, 63.9-81.6), respectively. DLQI of 0/1 was achieved by 48.2% (95% CI, 42.3-54.2). 9 out of 10 physicians and patients expressed a high level of treatment satisfaction. No new safety signals were observed.

Conclusions:
This prospective cohort study demonstrates a high degree of effectiveness and a reassuring safety profile of TIL in a real-world setting over 52 weeks. Patients with scalp and nail involvement or pruritus showed marked improvements.

Bit random but has anybody experienced hair loss cause by their P? 

I have been clear of P for about 6 years on adlimumab and have recently had a breakout of guttate P after being ill for a few days. At the same time as the P coming back i developed a bald patch the size of a coin in my beard, this has grown to about the size of a tea bag.

Ive had a beard since i left school, this is doing my head in!

Following on form this thread Spesolimab IL-36 for pustular psoriasis The U.S. Food and Drug Administration (FDA) has approved Spevigo for the treatment of generalized pustular psoriasis (GPP) flares in adults.

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The U.S. Food and Drug Administration is the first regulatory authority to approve spesolimab as a treatment option for generalized pustular psoriasis (GPP) flares in adults, Boehringer Ingelheim announced today. Spesolimab, marketed in the U.S. as SPEVIGO®, is a novel, 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 the pathogenesis of GPP.

“GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications,” said Mark Lebwohl, M.D., 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. “The approval of spesolimab is a turning point for dermatologists and clinicians. We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares.”

“This important approval reflects our successful efforts to accelerate our research with the aim to bring innovative treatments faster to the people most in need,” said Carinne Brouillon, Member of the Board of Managing Directors, responsible for Human Pharma, Boehringer Ingelheim. “We recognize how devastating this rare skin disease can be for patients, their families and caregivers. GPP can be life-threatening and until today there have been no specific approved therapies for treating the devastating GPP flares. It makes me proud that with the approval of SPEVIGO® we can now offer the first U.S. approved treatment option for those in need.”

The FDA’s approval of spesolimab is based on results from the pivotal EFFISAYIL® 1 Phase II clinical trial. In the 12-week trial, patients experiencing a GPP flare were treated with 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. After one week, 54% of patients treated with spesolimab showed no visible pustules compared to placebo (6%).

In addition to the U.S. approval, spesolimab is currently under review by several other regulatory authorities. To date, spesolimab has received Breakthrough Therapy Designation in the U.S., China and Taiwan, Priority Review in the U.S. and China, Orphan Drug Designation in the U.S., Korea, Switzerland and Australia, Rare Disease Designation and fast track in Taiwan, for the treatment of GPP flares. The European Medicines Agency validated the marketing authorization application for spesolimab in GPP in October 2021 and the submission is currently under evaluation.

Distinct from plaque psoriasis, GPP is a rare and potentially life-threatening neutrophilic skin disease, characterized by episodes of widespread eruptions of painful, sterile pustules. Given that it is so rare, recognizing the symptoms can be challenging and consequently lead to delays in diagnosis.

Regarding weight I totally agree. I think it's very personal and only matters if a person is happy. In my case I do know that I need to lose some weight to be healthier and happier.

I wasn't disagreeing with Caroline but was curious as to if there was any documented research that shows a correlation between psoriasis and being overweight. I've gained weight since being diagnosed and my psoriasis is better now and I currently am not on meds for psoriasis which is another reason I was curious.

I often have different opinions than others on some things, but that's all it is, an opinion. I'm the first person to say I don't know what I'm talking about.

This study suggests there is an increased risk of suicidality in patients with psoriasis in particular with the presence of arthritis.

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Background:
Psoriasis has a devastating psychological impact on patients’ quality of life. However, the relationship between suicidality and psoriasis remains unclear.

Objective:
This study analyzed and compared the risk of suicidality (suicidal ideation, suicide attempt, and completed suicide) between patients with psoriasis and the general population.

Methods:
This nationwide, population-based, retrospective, cohort study analyzed the Korean National Health Insurance Service claim data from 2005 to 2018.

Results:
The study included 348,439 patients with psoriasis aged over 18 years and with age- and sex-matched controls. The risk of suicidality was higher in the psoriasis group than in the control group (adjusted hazard ratio [aHR] 1.21; 95% confidence interval [CI], 1.18-1.24). The aHR of suicidality was higher in the psoriatic arthritis group (aHR, 1.46; 95% CI, 1.39-1.54) than in the psoriasis-alone group (aHR, 1.17; 95% CI, 1.13-1.20). However, the severity of psoriasis and suicidality showed no correlation (mild psoriasis group: aHR, 1.22; 95% CI, 1.18-1.25; moderate-to-severe psoriasis group: aHR, 1.16; 95% CI, 1.10-1.23).

Conclusion:
Patients with psoriasis have an increased risk of suicidality. In particular, the presence of arthritis in patients had a more significant effect on the risk of suicidality.

This study looked at the baseline characteristics of patients with moderate to severe psoriasis achieving super response with Tremfya (guselkumab)

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Background:
Psoriasis is a chronic immune-mediated inflammatory skin disease that often leads to a diminished quality of life. Goals of treating patients with psoriasis have shifted with more focus on achieving near or complete clearance of the skin. Guselkumab, a fully human monoclonal antibody targeting interleukin-23, is effective in treating moderate-to-severe psoriasis.

Objective:
To describe the baseline characteristics of patients with moderate-to-severe psoriasis achieving super-response (Psoriasis Area and Severity Index [PASI] 100 response at Weeks 20 and 28) after commencing guselkumab treatment.

Methods:
Pooled data from VOYAGE-1 and VOYAGE-2 studies identified super-response; baseline demographic, disease, and pharmacokinetic characteristics were compared with non-super-response. A stepwise logistic regression analysis identified which factors were potentially predictive of super-response status, with significance level of 0.1.

Results:
A subset of patients randomized to guselkumab comprised this post hoc analysis (n=664); 271 patients achieved super-response vs 393 with non-super-response. Patient age at study entry and baseline body weight (≤90 kg vs >90 kg), PASI, and Investigator’s Global Assessment (IGA) score were significant predictors of super-response status, with odds ratios (95% confidence intervals) of 0.98 (0.967-0.993; p=0.003), 1.42 (1.026-1.977; p=0.034), 0.97 (0.955-0.993; p=0.007), and 0.66 (0.433-0.997; p=0.048), respectively. More patients with super-response achieved an early response: Week 2 PASI 75 (5.5% vs 1.8%) and Week 8 PASI 100 (22.5% vs 3.3%) vs non-super-response. Median serum guselkumab concentrations through Week 28 were slightly greater in patients with super-response vs non-super-response.

Conclusion:
Guselkumab was more likely to achieve early clinical responses (complete skin clearance) in younger patients, less obese patients, and patients with less severe psoriasis.

This study looked at the effect of Skyrizi (risankizumab) in the treatment of psoriatic arthritis.

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Background:
Psoriatic arthritis (PsA) is a chronic inflammatory disease that reduces quality of life. This study assessed the effects of risankizumab (RZB) on the achievement of minimal clinically important differences (MCID) in patient-reported outcomes (PROs).

Methods:
KEEPsAKE-1 and -2 are randomized, placebo-controlled Phase 3 clinical studies assessing RZB (150mg) vs placebo (PBO) in adult patients with PsA with inadequate response or intolerance to disease-modifying antirheumatic drugs and/or biologics. Patients were randomized 1:1 to receive RZB or PBO for 24 weeks; starting at Week 24, all patients received RZB 150 mg through Week 52. PROs assessed were Patient’s Global Assessment of Disease Activity (PtGA), Patient’s Assessment of Pain, Health Assessment Questionnaire – Disability Index (HAQ-DI), Short-Form 36 Physical and Mental Component Summary scores (PCS and MCS, respectively), 5-Level EQ-5D (EQ-5D-5L), Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue), and Work Productivity and Activity Impairment (WPAI). The proportion of patients achieving MCID at Weeks 24 and 52 are reported. Odds ratios of achieving MCID with RZB treatment at Week 24, relative to PBO, were estimated by logistic regression controlling for baseline and stratification factors.

Results:
In KEEPsAKE-1, RZB- vs PBO-treated patients were more likely to report MCID in all PROs at Week 24; similar results were obtained in KEEPsAKE-2, except for SF-36 MCS and WPAI presenteeism domain. In KEEPsAKE-1 and KEEPsAKE-2, 65% and 62% of RZB-treated patients, respectively, reported MCID in PtGA at Week 24, which increased to 74% and 68%, respectively, at Week 52. Approximately 48% of all PBO-treated patients reported MCID in PtGA at Week 24 and, after initiating RZB, >65% reported MCID at Week 52. Results were similar in the remaining PROs.

Conclusions:
These data demonstrate that patients with PsA receiving RZB treatment are more likely to report clinically important improvements in PROs compared with patients receiving PBO.

Hi

I was diagnosed with guttate psoriasis in early childhood. I've been on loads of treatments over the last 20 years including topicals, light treatment and a short stint on cyclosporin. About 4 years ago I decided to stop all treatment for a while and see how my skin was, I changed my diet and lifestyle and worked on my stress levels which is a huge trigger for flare-ups. I've flared a couple of times a year since coming off treatment and always have a baseline level of active patches which I had just learnt to accept. I'm not particularly self-conscious about the appearance of my psoriasis so that helped me not worry so much about having a break from treatment. 

After catching covid in January I have been in a constant cycle of flaring up then my skin settles for a couple of days before flaring again. Over the last couple of weeks, I've had a HUGE flare-up, my skin is a mess and the patches are everywhere - on my face, in my ears on my scalp and everywhere else imaginable. I can't sleep and I'm struggling to concentrate on anything other than my skin, it really is horrid.

I am ready to try some treatment again but I want to start with topicals again rather than just being given a referral to dermatology straight away which has happened in the past.

I'm hoping someone has some advice on the best topicals to ask for so I can go to the GP armed with loads of information, I always found dovobet to be really effective, is this still an option? 

Any advice welcome on how to go back into treatment after such a long break. xx

This study looked at psoriasis and the progression of parkinson’s disease.

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Background:
Epidemiological studies have suggested psoriasis was associated with an increased risk of Parkinson’s disease (PD). However, whether psoriasis has an effect on PD progression is not explored yet.

Objectives:
To evaluate the causal role of psoriasis in PD progression.

Methods:
We conducted a two-sample Mendelian randomization analysis using summary statistics from genome-wide association study of psoriasis (N=33,394), age at onset (N=28,568) and progression (N=4,093) of PD.

Results:
One standard deviation increase in genetically determined psoriasis risk was significantly associated with faster progression to dementia (OR=1.07, 95 % CI: 0.1.03~1.1, P=4.71E-04). Meanwhile, higher psoriasis risk was nominally associated with faster progression of PD measured by time to Hoehn and Yahr stage 3 (OR=1.05, 95 % CI: 1.02~1.08, P=1.53E-03) and depression (OR=1.06, 95 % CI: 1.02~1.11, P=1.77E-03) of PD. The results were robust under all sensitivity analyses.

Conclusions:
These results suggested psoriasis accelerated overall progression of PD, and increased risk of dementia and depression of PD. A deeper understanding of neuroinflammation and immune response is likely to elucidate the potential pathogenesis of PD progression and identify novel therapeutic targets.

FDA U.S. Food and Drug Administration have approved Zoryve (roflumilast) for the treatment of plaque psoriasis in Individuals age 12 and older.

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Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. The first and only topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis, ZORYVE provides rapid clearance of psoriasis plaques and reduces itch in all affected areas of the body. ZORYVE — a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation — is uniquely formulated to simplify disease management for people living with plaque psoriasis.

“Today Arcutis has reached a major milestone, with our ability to offer this next generation topical PDE4 inhibitor to both adults and adolescents with plaque psoriasis. ZORYVE’s combination of efficacy, safety, and tolerability, coupled with our proprietary HydroARQ Technology formulation, is designed to fit into patients’ everyday lives with no restrictions on duration of use,” said Frank Watanabe, President and CEO of Arcutis. “Additionally, ZORYVE has been shown to rapidly clear plaques and reduce itch across all areas of the body. ZORYVE is the only topical for which data focused on the treatment of intertriginous plaques — a common area affected by plaque psoriasis — have been specifically generated. This FDA approval is the fruition of our efforts, and we are excited to launch ZORYVE, with expected product availability by mid-August.”

Topical therapies remain the primary treatment option for the vast majority of individuals with plaque psoriasis, a common immune-mediated skin disease that affects approximately nine million people in the U.S. and is the most frequent type of psoriasis occurring in both adults and adolescents. Severity can range between mild, moderate, and severe, with itch being the most burdensome and frequently reported symptom.

While the disease may affect any area of the body, plaques in certain areas, like the face, elbows and knees, genitalia, and intertriginous areas (areas of skin-to-skin contact), present unique treatment challenges. As a result, individuals with psoriasis are often prescribed multiple topical medications for different areas, which makes for a complicated treatment regimen.

“In multiple clinical trials, ZORYVE was proven to be safe and effective, with improvements in disease clearance in hard-to-treat areas like knees and elbows, as well as in sensitive areas such as the face, genitalia, and intertriginous areas. ZORYVE is very well tolerated, which is an important consideration for treating a chronic skin disease such as plaque psoriasis,” said Mark Lebwohl M.D., FAAD, principal investigator and Dean for Clinical Therapeutics and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai. “With this FDA approval, adults and adolescents with psoriasis and their dermatologists have a new steroid-free treatment option for use on all affected areas of the body.”

ZORYVE features HydroARQ Technology™, a proprietary drug delivery formulation that creates a non-greasy moisturizing cream that spreads easily and absorbs quickly.

“Plaque psoriasis is a challenging disease and finding the right treatment option can be complicated, especially if individuals have to use multiple treatments for different parts of their body. We welcome a new treatment option that can make a meaningful difference for adults and adolescents with plaque psoriasis,” says Leah M. Howard, President and CEO of the National Psoriasis Foundation. “Our hope is that new treatments translate into improved outcomes and help alleviate the burdens of chronic disease for people impacted by psoriasis.”

Arcutis intends to make ZORYVE widely available via key wholesaler and national dermatology pharmacy channels as a new treatment option by mid-August, and the Company is dedicated to affordable access to therapy. The ZORYVE Direct patient support program will help commercially insured individuals with plaque psoriasis get access and start ZORYVE treatment as prescribed by their healthcare provider quickly and easily by helping them navigate the payer process, lowering the out-of-pocket cost for eligible patients, and offering programs that support staying on therapy.† Arcutis will also offer the Arcutis Cares patient assistance program (PAP) – the first of its kind for a topical psoriasis treatment – that will provide ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.‡

With this approval, Arcutis has access to, and plans to draw, an additional $125 million tranche as part of the Company’s non-dilutive financing agreement with SLR Capital Partners. Combined with the Company’s cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2022, this additional $125 million will provide for capital resources of over $400 million to support the launch and commercialization efforts for ZORYVE, as well as continue to advance the Company’s pipeline development initiatives.

I am 63 years old and have only had psoriasis for two years. It started in my face, but after a few weeks my whole body was covered with spots, bumps and flakes. Once the diagnosis was made, the search for a remedy that would adequately combat the symptoms began.
- Skilarence gave me severe diarrhea after a few months, so I couldn't continue with it.
- Methotrexate (MTX) had little effect on my psoriasis. Because the drug can be a heavy attack on the liver and other organs, the disadvantages outweighed the benefits.

Then the biologicals came into the picture.
- Hyrimoz adalimumab (an injection every two weeks) did work a bit, but my legs especially remained full of flaky spots.
- Ilumetri Tildrakizumab (an injection every three months) has made the psoriasis spots almost completely disappear in a few months. The starting injection was at the end of March 2022 and from April 2022 the injection must be repeated every three months. The effect on the psoriasis is excellent. I barely have any flaky spots. But...

HERE COMES MY QUESTION
In May 2022 I started experiencing joint pain in varying places. It often starts at the end of the afternoon or in the evening. Sometimes in an ankle, then in a finger, sometimes a whole hand or just one toe, shoulder, knee or elbow. Sometimes it is so intense that I can hardly walk or that the pain keeps me from sleeping. The pain is almost always gone the next day and the affected joint is still a bit stiff. Almost every day there is a joint that hurts at night.

Joint pain is not a known side effect of Ilumetri, but even a rheumatologist had no logical explanation and found it suspicious that these complaints only occur after starting this biological.
Because Ilumetri is a relatively new drug, this joint pain may still be missing from the list of possible side effects. 

I am curious if there are other patients who receive Ilumetri injections and have joint complaints.