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.

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.