Im on my third dose, soon to be 4th of bimzelx and have noticed spots some almost as big as boils under my arms and on my flanks but i can get them everywhere even on my fingers. i normally have 5 or 6 under each arm/flank and two on each arm.
with cosentyx i started getting a red rash under my armpits. inverted p?  and that hasnt gone away in fact its spread slightly and the spots have come to play as well. they struggle to get a head and im trying to get some fucidin to help. i did get a few spots with cosentyx but nothing like this.

also my face flares up all the time under my beard, and on my forehead.
and ive got p inbetween my toes.

anyone else?

i am alan and live in the uk
i have been on bimzelx for 3 months and prob 90% clear but having some side effects
before that cosentyx successfully for a few ears and before that stelara for many years good for p but not so good for pa
i am 61 years old  barely married, still working and after suffering with p for 42 years i have finally got used to the shame of looking diseased and ugly. i have suffered mental illness anxiety and depression on and off for the same time ive had p.  linked maybe?
ive joined up on here hoping there are people here who can answer a few questions i have about my medication and other aspects of lifestyle changes diet etc to manage my symptoms better.
i am happy and have hobbies including motorbikes (riding and tinkering),  guitar playing, watching football, romance, and boring people to death with long intros on forums.

alan

Comparing Tremfya to Stelara 104-week multicentre retrospective study in Italy.

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Background:
Guselkumab is a humanized monoclonal antibody that binds selectively to the p19 subunit of interleukin-23, which has shown efficacy in patients with previous incomplete response to ustekinumab in the NAVIGATE clinical trial.

Objectives:
We conducted a 104-week multicenter retrospective study to assess the effectiveness and safety of guselkumab in patients affected by plaque psoriasis with an inadequate response to ustekinumab in a real-life setting.

Methods:
Our retrospective study included 233 adults affected by moderate-to-severe plaque psoriasis, enrolled in 14 different Italian centers, and treated with guselkumab after failing therapy with ustekinumab. Patient characteristics and PASI (Psoriasis Area and Severity Index) score at each visit (baseline, weeks 16, 52 and 104) were recorded. The percentages of patients achieving 75%, 90% and 100% (PASI 75, PASI 90 and PASI 100) improvement in PASI, compared with baseline, were registered.

Results:
At week 52, PASI 75 was reached by 89.88% of patients, PASI 90 by 71.43%, PASI 100 by 58.83% and absolute PASI ≤ 2 by 90.48%. At week 104, similar effectiveness results were observed. Compared to the NAVIGATE trial, we observed higher rates of PASI 75/90/100. Patients with the involvement of difficult-to-treat areas were significantly less likely to achieve PASI90 and PASI100 at week 16. Obese patients had significantly lower rates of PASI75 and PASI≤2 at week 52. At week 104, comparable responses were observed among all patients’ subgroups, regardless of BMI status, involvement of difficult-to-treat areas, presence of cardiometabolic comorbidities and concomitant psoriatic arthritis. No significant safety findings were reported throughout the study.

Conclusion:
Our data suggest that the efficacy of guselkumab in patients with inadequate response to ustekinumab for plaque psoriasis in “real-life” clinical practice is comparable with NAVIGATE study with higher percentages of patients achieving PASI90 and PASI100 at weeks 16, 52 and 104.

Does anyone have experience using Ambetter insurance for their Tremphya prescription? I know I need pre-approval but want to see want an Ambetter user might have to say.

Hi all again 

I am off course searching a lot of stuff about psa, and listened to some podcasts where also food was mentioned. I was wondering did some of you had concrete results with certain foods to avoid? That would trigger flares?

Would eating vegetarian help avoiding symptoms of inflammation. 

Like I heard about dairy, sugar, soda and all that. And I understand that smoking and drinking etc would not help off course with this kind of disease.

I was wondering about your experiences and what maybe worked for you (or not). About certain foods, etc lifestyle changes.

Greetings!

Looking at pruritis in different clinical variants of psoriasis.

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Background:
Pruritus, which is the most frequent subjective symptom of psoriasis, may cause significant discomfort, embarrassment, and even interfere with patients normal daily activities. However, the perception of itch in various psoriasis subtypes remains unknown.

Objectives:
The aim of this study was to investigate and to characterize pruritus in different clinical variants of psoriasis.

Methods:
This cross-sectional, binational, multicentre study included 295 subjects suffering from 9 different clinical subtypes of psoriasis: large-plaque psoriasis (n=45), nummular psoriasis (n=32), guttate psoriasis (n=31), scalp psoriasis (n=32), inverse psoriasis (n=23), erythrodermic psoriasis (n=33), palmoplantar psoriasis vulgaris (n=33), palmoplantar pustular psoriasis (n=42) and generalized pustular psoriasis (n=23). Measures included sociodemographic and anthropometric data, detailed pruritus characteristics including but not limited to pruritus intensity, frequency, and extend, as well as psoriasis severity.

Results:
The lifetime prevalence of pruritus in each clinical variant of psoriasis was similar and quite high, reaching up to 100% in some disease subtypes (i.e. nummular psoriasis, scalp psoriasis and generalized pustular psoriasis). Psoriasis severity correlated with pruritus intensity in scalp psoriasis, palmoplantar pustular psoriasis and generalized pustular psoriasis. The age, duration of psoriasis and BMI did not interfere with the intensity of itch.

Conclusions:
Pruritus is highly prevalent in each clinical variant of psoriasis. However, the sensation of itch is very individual, difficult to universally describe even in the same subtype.

A Delphi panel study to identify current evidence and gain advanced insights into generalized pustular psoriasis (GPP)

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Background:
Generalized pustular psoriasis (GPP) is a rare and highly heterogenous skin disease, characterized by flares of neutrophilic pustules and erythema. As a rare disease with few clinical studies and no standardized management approaches, there is a paucity of knowledge regarding GPP.

Objectives:
Conduct a Delphi panel study to identify current evidence and gain advanced insights into GPP.

Methods:
A systematic literature review was used to identify published literature and develop statements categorized into four key domains: clinical course and flare definition; diagnosis; treatment goals; and holistic management. Statements were rated on a Likert scale by a panel of dermatologists in two rounds of online questionnaires; the threshold for consensus was agreement by ≥80%.

Results:
Twenty-one panelists reached consensus on 70.9%, 61.8%, 100.0%, and 81.8% of statements in the “clinical course and flare definition”, “diagnosis”, “treatment goals”, and “holistic management of GPP” domains, respectively. There was clear consensus on GPP being phenotypically, genetically, and immunologically distinct from plaque psoriasis. Clinical course is highly variable, with an extensive range of complications. Clinical and histologic features supporting GPP diagnosis reached high levels of agreement, and although laboratory evaluations were considered helpful for diagnosis and monitoring disease severity, there was uncertainty around the value of individual tests. All acute and long-term treatment goals reached consensus, including rapid and sustained clearance of pustules, erythema, scaling and crust, clearance of skin lesions, and prevention of new flares. Potential triggers, associated comorbidities, and differential diagnoses achieved lower rates of consensus, indicating that further evidence is needed.

Conclusions:
Global consensus between dermatologists was reached on clinically meaningful goals for GPP treatment, on key features of GPP flares, and on approaches for assessing disease severity and multidisciplinary management of patients. On this basis, we present a management algorithm for patients with GPP for use in clinical practice.

This study compared Cosentyx (secukinumab) with narrow band ultraviolet B (nb-UVB) phototherapy in new onset moderate to severe plaque psoriasis patients.

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Background:
Biologic treatments have been studied mainly in patients with a long-term history of psoriasis and previous treatment failures.

Objectives:
The purpose of this primary analysis of the STEPIn study is to determine whether early intervention with secukinumab in patients with new-onset moderate to severe plaque psoriasis is superior to standard of care treatment with narrow band ultraviolet B (nb-UVB) phototherapy.

Methods:
The STEPIn study is a randomised, open-label, multicentre study to investigate early intervention with 52 weeks of secukinumab 300 mg administered subcutaneously vs. standard treatment with nb-UVB phototherapy in patients with new-onset (≤12 months) moderate to severe plaque psoriasis (NCT03020199). The primary and additional secondary endpoints were ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) at Week 52 and Investigator's Global Assessment (IGA mod 2011) 0/1 response at Week 52, respectively.

Results:
In the secukinumab and nb-UVB study arms, 77/80 and 76/80 randomised patients received at least one dose of study treatment, respectively. The primary endpoint was achieved: 91.1% (70/77) of patients achieved a PASI 90 response at Week 52 in the secukinumab arm vs. 42.3% (32/76) in the nb-UVB arm (P<0.0001, odds ratio [OR] estimate [95% confidence intervals, CI] = 16.3 [5.6, 46.9]). The additional secondary endpoint was also achieved: 85.7% of patients achieved an IGA 0/1 response at Week 52 in the secukinumab arm vs. 36.8% in the nb-UVB arm (P<0.0001). The safety data were consistent with the safety profiles of secukinumab and nb-UVB with no new or unexpected safety signals.

Conclusions:
Secukinumab was superior to nb-UVB in treating patients with new-onset moderate to severe plaque psoriasis. The high and sustained skin clearance observed indicates that biologic treatment for psoriasis may be more effective if used early in the disease course.

This study evaluated reported outcomes of patients with generalized pustular psoriasis (GPP) who were treated with Spevigo (spesolimab)

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Background:
Generalized pustular psoriasis (GPP) is a rare inflammatory skin disease with a considerable clinical burden. In the EffisayilTM 1 study, spesolimab, an anti-interleukin-36 receptor monoclonal antibody, demonstrated efficacy in treating GPP flares.

Objectives:
To evaluate patient-reported outcomes (PROs) of patients with GPP who were treated with intravenous (IV) spesolimab 900 mg in the EffisayilTM 1 study.

Methods:
53 patients presenting with a GPP flare were randomized (2:1) to receive a single dose of IV spesolimab 900 mg or placebo and were followed for 12 weeks. Four PROs [pain visual analog scale (pain VAS); Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT–Fatigue); Dermatology Life Quality Index (DLQI); and Psoriasis Symptom Scale (PSS)] were assessed throughout the 12-week study. Minimal clinically important differences (MCIDs) were defined. All data are reported descriptively.
Results

In patients who received spesolimab, improvements from baseline (median [Q1, Q3]) were observed in pain VAS (–21.3 [–55.3, –3.1]), FACIT–Fatigue (7.0 [1.0, 20.0]), DLQI (–2.5 [–8.0, 1.0]), and PSS (−4.0 [−7.0, 0.0]) within 1 week of treatment. These improvements were sustained over 12 weeks and corresponded to the achievement of MCIDs at Week 1, which were also sustained over 12 weeks. Patients in the placebo arm experienced improvements in PROs and achievement of MCIDs after receipt of open-label spesolimab at Week 1.

Conclusions:
Patients with a GPP flare treated with spesolimab achieved improvements in PROs by Week 1, which were sustained for 12 weeks, and achieved MCIDs as early as Week 1.

A real-world experience from a cohort of interleukin-17 inhibitors for psoriasis.

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Background:
Real-world studies on the use of biologics in psoriasis (Pso) are increasing, but still scarce. Trough concentrations (Cts) of interleukin-17 inhibitors (IL-17i) seem promising for clinical decision making, but their value in daily practice has yet to be proven.

Objectives:
To report on IL-17i effectiveness, treatment modifications, and Ct use in our clinic.

Methods:
Data was collected from IL-17i treated Pso patients followed up in the PsoPlus clinic at the Dermatology department, Ghent University Hospital, Belgium. Descriptive statistics and Kaplan-Meier analysis were performed.

Results:
A total of 111 patients were included, counting for 134 IL-17i courses (secukinumab, ixekizumab, and brodalumab). Fifty-five percent of the patients were bio-naive prior to IL-17i initiation. During maintenance, merely 97.0% and 77% achieved near-complete and complete skin clearance, respectively. Major reasons for treatment modification were: suboptimal response (63.0%) and safety issues (9.3%). Reported modifications were: switch (25.4%), dose escalation (11.9%), dose de-escalation (6.7%), treatment association (6.0%), and IL-17i stop (3.0%). Overall drug survival was 69.0 months, without difference between the different IL-17i (p=0.078). Ixekizumab tended to have the highest survival. Drug survival was higher in bio-naive subjects compared to bio-experienced subjects (p=0.011). Ct was measured in 20 patients, and interpreted post hoc. In 85% the clinical decision was in accordance with the Ct (e.g. substantiated need for dose escalation). For the other cases, the Ct would have led to another clinical decision if known at that time.

Conclusions:
This real-world study showed that IL-17i are very effective drugs for Pso, with ixekizumab as leading biologic. Prior bio-experience seemed to impact IL-17i drug survival. Treatment modifications were mainly performed in case of insufficient response, primarily via switch and dose escalation, and least frequently in ixekizumab patients. Ct might rationalize clinical decision making, however there is need for standardized algorithms to corroborate its use.

This study evaluated the effectiveness and safety profile of Siliq / Kyntheum (brodalumab) over a period of 104 weeks in the everyday practice.

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BACKGROUND:
Brodalumab, a fully human IgG2k antibody blocking the receptor of IL17, is characterized by a rapid onset of action with high skin clearance rates in clinical trials. Since setting PASI90/100 or absolute PASI≤3 as treatment goals has become attainable, evaluating effectiveness and safety profile of biologic agents, such as brodalumab, in a real-world setting is essential.

OBJECTIVE:
The aim of this study was to evaluate the effectiveness and safety profile of brodalumab over a period of 104 weeks in the everyday practice. Clinical predictive factors of initial (week 12/16) response to treatment and long-term drug survival were also investigated.

METHODS:
In this monocentric, retrospective study, PASI90/100 and absolute PASI≤1/3 were assessed in 91 patients with moderate-to-severe skin psoriasis under brodalumab at weeks 12/16, 24, 52, and 104 of treatment. At week 12/16, patients with an absolute PASI≤3 were defined as „initial-responders” and ≤1 as “super-responders”. Clinical parameters, such as age, gender, BMI, comorbidities, and previous systemic treatment were assessed in order to predict “super-responders”. Drug survival and its prognostic factors were also evaluated.

RESULTS:
PASI90/100 was reached in 81.1/66.0% at week 12/16. This response rate increased at week 104, where 87.1/80.7% had PASI90/100 and 84.9% had absolute PASI≤1. The presence of > 3 comorbidities, prior treatment with > 2 systemic agents, and obesity tended to be negative predictive factors of “super-response”. Previous exposure to IL17 inhibitors had no impact on both PASI<1 and PASI<3 initial response. One- and two-year drug survival probability was 87.6% and 77.32%, respectively. “Initial responders” and anti-IL17 drug naïve patients had better drug survival. Drug discontinuation occurred in 24.2%, mostly due to secondary failure and arthralgia was the most common adverse event that led to discontinuation.

CONCLUSIONS:
Our study confirms the high effectiveness and good safety profile of brodalumab in the real-world setting.

Well Ilumetri failed, I only made 1 year and it's time to move on yet again in the search for a bio that will keep the psoriatic arthritis away or at least let me live with it a bit more comfortable.

You can read my last journey here Ilumetri for psoriatic arthritis Fred's journey if you wish and there are others if you start digging, but the main reason I use a bio is because I want to be able to do things and move, this will be my 8th bio and I'm really hoping this one will ate least give me some comfort for a few years.

This time I'm starting on the recommended dose two injections of 160 mg each today then weeks 4, 8, 12, 16 and every 8 weeks thereafter.



Psoriasis Score: 4

Right Shin



Right foot



Mrs Fred got on of my scalp for me.



Psoriatic Arthritis Score: 7

Hands a bit painful.





One thumb showing the classic psoriatic arthritis lifting from the bed.



Wish me luck everyone I really could do with this one working as the psoriatic arthritis is getting me down a bit now.

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

Following on from this thread Bimzelx FDA cannot approve the application in its current form the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) resubmission for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis.

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UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) resubmission for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. The FDA designated the resubmission as ‘Class 2’ with a six-month review period. The FDA action is expected in the second quarter of 2023. 

“The FDA acceptance of our resubmitted application for bimekizumab is positive news that moves us one step closer to providing the first dual IL-17A and IL-17F inhibitor to address the unmet needs of people with moderate to severe plaque psoriasis in the U.S. We will continue to work with the FDA through the review process with the goal of bringing bimekizumab to the dermatology community in the U.S. as soon as possible,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

In November 2022, UCB announced resubmission of the BLA for bimekizumab, for the treatment of adults with moderate to severe plaque psoriasis, following receipt of a complete response letter in May 2022. 

Hii to all, my fans (haha no kidding)

Hi everbody,

I will track my progress here for myself but also for people who would like to follow

Yesterday I went to the rheumy and she prescribed me the Cosentyx which I hope will help.The plan is to do a shot of 300 mg each week for six weeks and then I have an appointment again. Im curious If I will notice differences, hopefully yess. Im also following a physio program to strengthen my tendons, muscles, because mostly I have pain surrounding the attachments of the tendon (knee-elbow) and hopefully It will help with my tow which is quite swollen and red.

The conversation yesterday about switching the bio's went quite good, my rheumy listens well and is empathic and I am thankful for that.

My injection didn't go very smoothly I screwed it up a bit, I did it in the leg as well but quite painful and It spilled a bit, never happend before. Maybe next time the belly or where do you do it? Never happend with humira though.

But maybe I still have to progress in this field though, Im still sort of an amateur who will become a PROo haha

Allright till next week!

Hi,

I was wondering about how many hours people can work , while having PsA. I was wondering about this because I am kind of in the middle of searching appropriate jobs  as well. I used to work around 36 hours a week on the computer. But due to my PsA in the ellbow i couldnt do that anymore. When I work on the pc my arm starts to hurt after some time still.

And im wondering about people here,  could you work less hours because of your psa? Did you had to switch jobs maybe?

Like the rheum told me, I treat people working in construction who have psoriatic arthritis and some people I know with PsA run marathons.

But she also told me that, when you have PsA you are probably more sensitive on your tendons as well so you''ll be quicker to get an overload. Which kind of contradicts her statement about marathons and construction labor right?

It found that kind of confusing.

Or should this all be possible when you are on the right meds?

It seems to me that id better search for a job with a lot of variety, in standing walking sitting and may be an adapted workspace?

I wonder how you people do this, or had to make changes or anything.

Greetings 

This phase 2a trial was to examine the efficacy and safety of orismilast for psoriasis using a first-generation immediate release (IR) formulation.

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Background:
Orismilast is a high-potency phosphodiesterase 4 (PDE4) inhibitor with enhanced selectivity for the PDE4B and PDE4D subtypes.

Objectives:
The objective of this phase 2a trial was to examine the efficacy and safety of orismilast for psoriasis using a first-generation immediate release (IR) formulation. The objective of the subsequent phase 1 trial was to test new formulations designed to minimise the gastrointestinal (GI)-related adverse events (AEs) observed with the first-generation IR formulation. We examined: 1) pharmacokinetic (PK) properties of orismilast modified release (MR) and IR, 2) food effects on PK properties of orismilast MR or IR, 3) safety of orismilast MR compared to placebo.

Methods:
In a phase 2a prospective, randomised, double-blind, placebo-controlled trial, patients with moderate-to-severe psoriasis were randomised to receive 30 mg oral orismilast IR or placebo over 16 weeks. The single-site phase 1 trial consisted of three parts: 1) participants received a single 30 mg dose of orismilast MR and IR (open-label), 2) participants received 30 mg orismilast MR or IR under either fasting condition, following a high-fat meal or low-fat meal (open-label), and 3) participants received up to 60 mg orismilast MR twice-daily or a placebo for 17 days (double-blind).

Results:
In the phase 2a trial, treatment with orismilast IR significantly improved the mean Psoriasis Area Severity Index (PASI) score at week 16 compared to placebo. The phase 1 trial revealed comparable PK properties of the orismilast MR and IR formulations, with participants in the orismilast MR group experiencing fewer GI-related AEs than those receiving orismilast IR (16.7% vs 33.3%).

Conclusion:
Orismilast IR displayed higher efficacy compared to placebo in patients with moderate-to-severe psoriasis at week 16. Orismilast MR had similar PK properties and fewer GI disorders compared to the IR formulation in healthy participants. Future development of orismilast will be based on the MR formulation.

Hi everybody i am Steven 31 and diagnosed with psa in late may. Im having ongoing tendons problems still, but im trying my first biological humira (hyrimoz) buttt my toe is still swelling, I had it before i know its dactylitis. But its a sign that the biological isn't working properly right? 

Im having a meet with my rheum in 2 weeks, want to try a different biological, i think cosentyx cause im mostly having irritation en pain around the attachment of the tendons in my elbow en knee for years now, really bad with walking etc can't walk long. And it  I was wondering if guys or girls;  might have suggestions on this part? On which biological might work regarding tendon issues.

Im doing fysio as well it helps a bit but it won't make it completely better. Still figuring a lot of stuff out, so feel free to respond if you have something on this matter!

Thank you!

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.