This study compared Siliq / Kyntheum (brodalumab) to fumaric acid esters (FAE) in terms of clinical efficacy, patient‐reported outcomes, and safety.

Quote:

---

Background:
Brodalumab is a fully human monoclonal immunoglobulin IgG2 antibody that binds to the human IL‐17 receptor subunit A and by that inhibits the biologic action of IL‐17A, 17F, 17C, and 17E. Therapy with fumaric acid esters (FAE) is a well‐established and widely used first‐line systemic treatment for subjects with moderate‐to‐severe plaque psoriasis

Objectives:
To compare brodalumab to FAE in terms of clinical efficacy, patient‐reported outcomes, and safety in subjects with moderate to severe plaque psoriasis who were naïve to systemic treatment.

Methods:
Eligible subjects were randomised 1:1 to 210 mg brodalumab injections or oral FAE according to product label in this 24‐week, open‐label, assessor‐blinded, multi‐centre, head‐to‐head phase 4 trial. The primary endpoints were having PASI75 and having sPGA score of 0 or 1 (sPGA 0/1). Subjects with missing values for the primary endpoints were considered non‐responders.

Results:
A total of 210 subjects were randomised. 91/105 subjects completed brodalumab treatment and 58/105 subjects completed FAE treatment. At Week 24, significantly more subjects in the brodalumab group compared to the FAE group had PASI75 (81.0% vs. 38.1%, p<0.001) and sPGA 0/1 (64.8% vs. 20.0%, p<0.001). In the brodalumab group, the median time to both PASI75 and to PASI90 was significantly shorter than in the FAE group (4.1 weeks vs. 16.4 weeks, and 7.4 weeks vs. 24.4 weeks, respectively, p<0.0001 for both). The rate of adverse events was lower in subjects treated with brodalumab compared to subjects treated with FAE (616.4 vs. 1195.8 events per 100 exposure years). No new safety signals were detected for brodalumab.

Conclusions:
Brodalumab was associated with rapid and significant improvements in signs and symptoms of moderate‐to‐severe plaque psoriasis, with a superior efficacy profile to what was observed with FAE in systemic‐naïve subjects over 24 weeks.

This study evaluated the effectiveness and safety of Siliq / Kyntheum (brodalumab) in patients with moderate to severe plaque type psoriasis in a real‐world setting.

Quote:

---

Background:
Brodalumab was efficacious and safe in moderate‐to‐severe plaque‐type psoriasis in the AMAGINE trials; published reports under real‐life conditions are limited.

Objectives:
To evaluate the effectiveness and safety of brodalumab in patients with moderate‐to‐severe plaque‐type psoriasis in a real‐world setting.

Methods:
This observational, retrospective study enrolled adult patients (≥18 years) with moderate‐to‐severe plaque‐type psoriasis who underwent 24‐weeks of treatment with brodalumab at 17 Italian dermatological centres. Baseline data included demographics, comorbidities, age of onset and duration of psoriasis, and previous treatments. Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), static PGA of Genitalia, Dermatology Life Quality Index and patient satisfaction were assessed at weeks 0, 4, 12 and 24; adverse events were recorded.

Results:
Seventy‐eight patients (mean age 47.9 years, 71.8% male, average disease duration 16.8 years) were enrolled. A rapid and significant reduction in mean PASI score was observed after 4‐weeks of treatment, decreasing further at weeks 12 and 24 (all P < 0.0001 vs. baseline). A higher number of cardiometabolic comorbidities and previous therapies were negatively associated with the achievement of PASI 90 at all assessments. Brodalumab was effective in bio‐experienced patients, including those who had failed on anti‐interleukin (IL)17 therapies. Quality of life and patient satisfaction increased significantly during treatment (P < 0.0001 and P < 0.01 vs. baseline, respectively). Treatment was interrupted in 9 (11.5%) patients due to adverse events (n = 4), lack of efficacy (n = 3), lost to follow‐up (n = 1) and surgical procedure (n = 1).

Conclusions:
Brodalumab is effective and safe in the treatment of moderate‐to‐severe psoriasis in a real‐world setting, including in patients with failure to anti‐IL17 therapies.

This little study suggests mothers quality of life is effected more by their child's psoriasis than fathers.

Quote:

---

Background:
Psoriasis is a chronic skin condition that in one third of cases starts in the first two decades of life. The disease might impact the quality of life (QoL) of the affected children and their caregivers. The issue of gender differences in the assessment of psychological burden of dermatological conditions has been the subject of few studies with contradictory results.

Objectives:
The aim of this study was to investigate the differences in the impact of childhood psoriasis on mothers’ and fathers’ well‐being using Family Dermatology Life Quality Index (FDLQI)

Methods:
Forty‐five children with psoriasis (31 girls and 14 boys; mean age ± standard deviation (SD) 10.53±3.44 years) and their parents (45 mothers and 45 fathers) were included in the study. Both parents of each child were asked to separately fill in the validated Polish version of the FDLQI questionnaire.

Results:
Comparing the FDLQI scores, the QoL of mothers was significantly more impaired than the QoL of fathers (13.44±6.46 versus 9.53±6.12 points; p<0.0001). In mothers, childhood psoriasis had a significantly greater impact in the areas of emotional distress (p=0.007), dealing with other people’s reactions (p<0.0001), social life (p=0.02), amount of time spent caring for the child’s skin (p=0.0001) and extra housework (p=0.0005), compared to fathers. The FDLQI scores of both mothers and fathers were independent of the impairment of children’s QoL or the severity of psoriasis, except for positive correlation between mothers’ FDLQI scores and children’s BSA (R=0.31; p=0.03).

Conclusions:
Differences in the impact of childhood skin diseases on mothers’ and fathers’ well‐being should be taken into consideration while developing educational programs for patients and their families. There is a need for further, multi‐centre research, that would take into account geographical and cultural differences, in order to reliably assess the impact of childhood psoriasis on various aspects of caregivers’ QoL.

Hi all,
I'm new to this forum and have just started on Tremfya with my first shot 3 days ago.
I was hoping to find others out there already taking this medication. Did it work for you? When did you start seeing results? Any side effects?
Thanks,
Bec

Guys! 

I was approved!! woohoo.. It has been sent to my chemist so wil have it in a few days and its covered by my health insurance ( always a win) 

I have a question though! Should i be taking supplements or anything at the same time? Maybe someone taking it can tell me!! 

Fingers crossed for a success story!!! ( I guess until I want to try for a family and need to stop that is!) 



Chlo

Hi guys! I am so glad i found this group! 

Only yesterday I had bloods done to see if i can start Skilarence! I hope I can! I have had Psoriasis since 2016 ( got it after strep throat) , not nearly as terrible as some people but it is certinaly enough to effect my emotional status & outfit choice!!! 

Some days I wake up & think Feck it Ill wear the short dress, but other days I just cant do it!! I have tried to change my diet, I have tried every topical treatment under the sun & I have had Light therapy ( worked well the first time, just not the second!!) 

I am due to be married next July & I really hope I can have this under control by then! I am scared about the potential side effects of the drug but if I dont try Ill never know! 

Anyway sorry for the ramble there.... Looking forward to being a part of this group! 

Hi, 

I've visited here several times, but never posted.  It helps tremendously to have a forum like this not only for information but for emotional support as well - knowing others are experiencing the same problem and not giving up.  I have flare ups on the soles of my feet and occasionally on my hands. The disease started 15 years ago, and it was after I took a course of antibiotics for an infection on my foot. I haven't tried any of the biologics.  The topicals help, but doesn't always give quick relief.  I am convinced that foods trigger the flare ups.  The only way I get significant relief is to reset my body by fasting on making my own carrot/apple juice, sweet potatoes and brown rice diet.  I was told proteins, especially animal proteins if avoided could help.

Hola everyone, 

My name is Emiliano. Just started Cosentyx 5 days ago. 

Briefing:

Got Psoriasis in 2012 after a car crash (was told it usually triggers after a traumatic event). Tried everything:

Lotions, foams, creams, diets, Methotrexate, UVB, psychoanalysis, "magic new age" therapies. The curve never stopped going up. More and more by the day. 

About 2 month ago, got approvement from my health plan. Before starting, a few general checking (Cholesterol, heart rate, glucemia, etc...), and a reinforcement on vaccines (influenza, Hepatitis, tetanus). 

I'm 37 years old, in a decent shape. Run about 20k a week. Got my Quarentine/winter belly (It's cold and dry down here in Patagonia), no more than that.

Started last Tuesday, August 16th. 2020. 

My dermatologist said we are going to compare skins clinically on the 16th week, but after only 5 days I'm feeling it. 

So far, my whole body (score 40 on this site's test) went from "dirt road" to "paved with patches". No thickness whatsoever. I now can fold my elbow skin, unthinkable 2 weeks ago. And it's been only 5 days! Fingers crossed, hope it gets better and better. 

Will post again next Sunday. 

Big thanks to the admin's of this site, and to everyone sharing experiences. Means a lot. 

PS: English isn't my born language, apologies for the grammar mistakes.

UCB says Bimekizumab beat Cosentyx in a head to head study.

Quote:

---

UCB announced positive results from the Phase 3b BE RADIANT study, a direct comparison of the investigational IL-17A and IL-17F inhibitor, bimekizumab, to the IL-17A inhibitor, Cosentyx (secukinumab) in the treatment of adult patients with moderate-to-severe plaque psoriasis.1 BE RADIANT is the first head-to-head study comparing anti-IL-17 treatments, and the first study to demonstrate superiority to secukinumab for complete skin clearance at both weeks 16 and 48.

BE RADIANT met its primary endpoint at week 16 with statistical significance, demonstrating the superiority of bimekizumab over secukinumab for complete skin clearance, as measured by a 100 percent improvement in the Psoriasis Area and Severity Index (PASI 100)

The BE RADIANT study also met all ranked secondary endpoints with statistical significance. Bimekizumab was superior to secukinumab in achieving PASI 75 at week 4 and complete skin clearance at week 48, with both monthly (Q4 week) and bi-monthly (Q8 week) dosing. The ongoing data assessment indicates that the safety profile of bimekizumab continues to be consistent with earlier clinical studies.

“With BE RADIANT, bimekizumab has demonstrated superiority over secukinumab for complete skin clearance in adult patients with moderate-to-severe psoriasis. The results mark the latest positive data readout for bimekizumab, confirming the hypothesis that targeting IL-17F, in addition to IL-17A, suppresses inflammation to a greater extent than IL-17A inhibition alone in psoriasis,” said Professor Richard Warren, Salford Royal NHS Foundation Trust and The University of Manchester, United Kingdom.

“Psoriasis places a heavy burden on patients, often causing pain, discomfort and stigma. Patients may not get the complete skin clearance that they want and may not even realize that it’s possible. Healthcare providers may also feel forced to make trade-offs between therapies that work quickly, versus those that have shown durable efficacy. The BE RADIANT results demonstrate that bimekizumab has the potential to raise the treatment bar for patients and their dermatologists. UCB is proud to lead the way in connecting science to unmet patient needs and developing bimekizumab. It is our ambition to provide a transformative experience for psoriasis patients,” said Emmanuel Caeymaex, Executive Vice President Immunology Solutions and Head of US, UCB.

Bimekizumab has a robust Phase 3 psoriasis clinical development program. Detailed findings from the BE VIVID and BE READY studies were announced in June 2020 at the American Academy of Dermatology VMX, and the BE SURE results will be presented this year. The full BE RADIANT results will be presented to the scientific community in due course.

Bimekizumab’s safety and efficacy are also currently being evaluated in Phase 3 trials for potential indications in psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa.

The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.

MC2 Therapeutics have announced that they have received U.S. Food and Drug Administration (FDA) approval for the use of Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.

Quote:

---

MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.

The FDA approval is based on the results of the US Phase 3 clinical trial against active comparator Taclonex Topical Suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%). A total of 794 patients were randomized in this trial and the primary efficacy endpoint was the proportion of patients with PGA treatment success at week 8 defined as at least a 2-grade improvement from baseline in PGA to “clear” or “almost clear”. The difference in PGA treatment success to the active comparator was 14.6% (95% CI; 7.6%, 21.6%) in favor of Wynzora Cream.

Reduction of itch as defined by at least a 4-point improvement in the 11-point peak pruritus numeric rating scale (NRS) from baseline to week 4 was assessed among patients who had at least a peak pruritus NRS score of 4 at baseline. A higher proportion of patients achieved at least a 4-point improvement in the peak pruritus NRS score at week 4 in the Wynzora Cream group (60.3%) compared to vehicle (21.4%).

“Wynzora Cream is a novel topical treatment for plaque psoriasis which offers a unique combination of high efficacy, favorable safety and excellent treatment convenience in a single product,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and lead principal investigator in the study.

Studies show that more than half of psoriasis patients are dissatisfied with their treatment and that a large proportion of patients are not treated at all.

“The FDA approval marks an important milestone for patients with plaque psoriasis”, stated Jesper J. Lange, CEO of MC2 Therapeutics and continued: “Our PAD Technology has uniquely enabled us to develop Wynzora Cream with no compromises. It drives the compelling efficacy and safety data of Wynzora Cream and transforms that data into impact for patients through a convenient formulation that allows patients to move on within minutes of a morning routine. It puts patients back in control of therapy and daily life.”

Founder and Executive Chairman of MC2 Therapeutics, Mads Clausen concurred: “Wynzora is a prime example of what we envision PAD Technology can do to help patients, physicians and payers release the full potential of topical therapies in real world settings.”

With the US approval, the recent submission of its marketing authorization application of Wynzora Cream in EU, and its ongoing interactions with payers, physicians and patient organizations MC2 Therapeutics is well on track to launch Wynzora Cream in major territories. In addition, MC2 Therapeutics continues development of its pipeline of new topical therapies within major chronic inflammatory indications such as atopic dermatitis, uremic pruritus, lichen sclerosus and dry eye.

Makers of Taltz say their new IL 23 mirikizumab is better than Cosentyx.

Quote:

---

Eli Lilly announced today that mirikizumab, an investigational monoclonal antibody that binds to the p19-subunit of IL23, met the primary and all key secondary endpoints versus placebo at Week 16 (superiority) and all key secondary endpoints versus Cosentyx (secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority) in the OASIS-2 study. OASIS-2 is a multicenter randomized, double-blind, placebo-controlled study comparing the efficacy and safety of mirikizumab to placebo and Cosentyx in patients with moderate to severe plaque psoriasis.

The safety profile was consistent with previously disclosed results for mirikizumab and known safety findings of other drugs in the IL23p19 class.

"The results from this study are promising to people around the world who are burdened by psoriasis and Lilly is grateful to the patients, providers and investigators for advancing science to benefit patients with immunologic conditions," said Patrik Jonsson, senior vice president and president of Lilly Bio-Medicines. "We look forward to bringing mirikizumab to market to provide patients with an additional treatment option that has the potential to provide near complete or complete skin clearance as measured by PASI 90 and PASI 100, with sustained results at 52 weeks."

"We are pleased with the positive results observed in the mirikizumab psoriasis development program (OASIS). Mirikizumab has the potential to be a meaningful treatment option for people living with psoriasis," said Andrew Blauvelt, M.D., M.B.A., president of Oregon Medical Research Center and a lead investigator in the OASIS program. "The data builds on our understanding of IL-23 inhibition in psoriasis and possible future applications."

In OASIS-2, the primary endpoints were the proportion of patients with a Static Physician's Global Assessment (sPGA) of (0,1) with at least a 2-point improvement and the proportion of patients with at least a 90 percent improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at Week 16 compared to placebo. Similar endpoints were evaluated at Week 16 as key secondary endpoints compared to Cosentyx. Other key secondary endpoints compared to placebo at Week 16 include the proportion of patients with at least a 75 and 100 percent improvement from baseline in Psoriasis Area and Severity Index (PASI 75/PASI 100).

Key secondary endpoints at Week 52 compared to Cosentyx included the proportion of patients with a Static Physician's Global Assessment (sPGA) of (0,1) with at least a 2-point improvement and the proportion of patients with at least a 90 and 100 percent improvement from baseline in Psoriasis Area and Severity Index (PASI 90/PASI 100).

The most common treatment-emergent adverse events (≥5%) during the induction period (up to Week 16) were nasopharyngitis and upper respiratory infections and during the combined induction and maintenance treatment periods (up to Week 52) were nasopharyngitis, upper respiratory tract infections, headache, back pain, and arthralgia. The frequency of serious adverse events was comparable across treatment arms during the induction period (<2.5%) and combined induction and maintenance periods up to 52 weeks (<6%).

Tremfya has been given FDA approval to treat psoriatic arthritis.

Quote:

---

Janssen announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation. TREMFYA is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA. The safety and efficacy of TREMFYA in PsA have been demonstrated in two pivotal Phase 3 clinical trials. TREMFYA is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. TREMFYA can be used alone or in combination with a conventional Disease Modifying Anti-Rheumatic Drug or DMARD (e.g., methotrexate).

The approval of TREMFYA was based on results from two pivotal Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which evaluated the efficacy and safety of TREMFYA administered by subcutaneous injection in adults with active PsA compared to placebo. The results showed that a significant percentage of patients treated with TREMFYA reached the studies' primary endpoint of ACR20a at 24 weeks, with 52 and 64 percent of patients achieving an ACR20 response compared to 22 and 33 percent in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.

In addition, treatment with TREMFYA improved patients' symptoms, which included skin manifestations of psoriasis, physical functioning as measured by the HAQ-DI (Health Assessment Questionnaire Disease Index)b and SF-36 Physical Component Summaryc score, and soft tissue (enthesitis and dactylitis). TREMYFA also resulted in improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F).

Hello All ,

its been a while since ive touched base , just wanted to say i've been using Astaxanthin 12mg one a day since November , and my skin for the last few months is pretty good , [ i drink and smoke also ............. ]

I hope this might help someone ,

take it easy out there ,

David

Ok been a while since I posted anything but have been reading ?. I recently saw some positive reviews from peeps who used a salicylic shampoo & left it on for up to 4 min ,rinsed then applied a 5% coal tar shampoo-let sit for 1-3 min, rinse then shampoo with a nice smelling one. Of course I was in the shower so long hubby thought I went down the drain ????

Anyone have experience with this ? I’m going crazy with the itch

Thanks for any advice

I started my new med Skyrizi my first dose was on May 27 th two shots then the end of June 27th i had two more shots
Now I don't take another two the end of September.I am starting to heal up my skin is healing. I had 60% coverage on my body i have to be careful cause these Biologics lower our immune systems.
I only go to the grocery store and Pharmacy then back home. I wear my mask everywhere and sterilize my hands and the grocery cart! Because of the Covid threat


 
would you believe it cost $38,000 for two shots I have insurance  but if stops paying the company sent me a card to use and Skyrizi will cover it for me!

hello - let me give a brief history. Been in the Semiconductor field for 20years and am required to wear either nylon or nytrile gloves, sometimes with a cotton/elastic liner.

Developed a 'rash' in the past 3 months. Started on the wrist then spread across the tender area of both hands between fingers/top of hands. I call it a rash but it is more like very tiny blisters that will weep a clear slippery fluid. And of course, very itchy and burning. Eventually the blisters open and go away then left with dry and splitting skin.

One thought is that it could be a reaction to my own sweat, the cotton liners become saturated quickly depending on activity. I am trying to change the cloth liner more often, to keep a dry barrier against my hands.

My treatment of late has been to allow my hand to dry. Then apply liberal amounts of Vaseline.

Thoughts from others that may be in the same industry?

I've tried attaching a photo, i hope it came through ok.

Thanks everyone

hello, brand new member.
can someone tell me how i can attach a picture to a post?
thank you
TD

Children could soon be prescribed Cosentyx (secukinumab)

Quote:

---

Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years.

“Psoriasis affects children much deeper than just the skin and can lead to deterioration of quality of life, potentially having a lasting impact on this vulnerable patient population,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “This is our second positive CHMP opinion for Cosentyx this year alone, following on from recent EC approval in nr-axSpA. The latest positive opinion is an important step forward in our commitment to reimagining care for children with psoriasis, giving them freedom to enjoy full and active lives.”

The positive CHMP opinion is based on two Phase III international studies in children and adolescents aged 6 to <18 years, one open‑label, two-arm, parallel‑group, multicentre study with moderate-to-severe plaque psoriasis and one randomized, double-blind, placebo and etanercept-controlled study with severe plaque psoriasis. The studies showed both low-dose (75–150 mg) and high-dose (75–300 mg) of Cosentyx were highly efficacious in rapidly improving skin symptoms and quality of life, with a favorable safety profile up to 52 weeks.

In children with moderate-to-severe plaque psoriasis, the low dose of Cosentyx provided fast and strong skin clearance, with 93% achieving Psoriasis Area Severity Index (PASI) 75 as early as Week 12, 69% achieving PASI 90 at Week 12 and 88% at Week 24, 59.5%% achieving completely clear skin (PASI 100) by Week 12 and 67% by Week 24. In patients with severe psoriasis, the low dose of Cosentyx ensured sustained skin clearance through Week 52, with PASI 90 achieved in 75% of patients1. Differences in PASI 75 in patients with severe psoriasis treated with Cosentyx were seen as early as Week 4 and in patients with moderate-to-severe psoriasis as early as Week 2.

Half of children with moderate-to-severe plaque psoriasis treated with low dose of Cosentyx reported complete relief from symptom burden of psoriasis on their quality of life by as early as Week 12, as measured by Children's Dermatology Life Quality Index (CDLQI) 0/1 responses. In children with severe plaque psoriasis treated with low dose of Cosentyx, 44.7% reported complete relief by Week 12, with 60.6% by Week 52. Cosentyx safety profile of both the low dose and high dose is comparable and consistent with the established adult psoriasis indication. No new safety signals were observed in children.

Affibody Announces Positive Top-Line Data from Phase 2 Proof-of-Concept Trial of ABY-035 in Psoriasis

Quote:

---

Affibody, a clinical stage biopharmaceutical company, today announced positive top-line data from its 52-week trial investigating the novel bispecific IL-17A inhibitor ABY-035 in patients with moderate-to-severe psoriasis (“AFFIRM-35”).

The primary endpoint of the Phase 2 AFFIRM-35 double-blind, placebo controlled, 52-week Phase 2 proof-of-concept trial was PASI 90 response defined as an at least 90% improvement of the baseline Psoriasis Area Severity Index (PASI) score after 12 weeks of treatment. In the group that finished the 80 mg Q2W induction period 15 out of 17 patients (88%) achieved a PASI 90 response and 10 out of 17 patients (59%) achieved complete or almost complete disease remission with an absolute PASI of 1 or below. The overall PASI 90 response at week 12 was 71% for all 21 subjects randomized to the 80 mg Q2W group.

Over one year, 17 out of 21 (81%) subjects in the 80 mg Q2W induction group and 18 out of 22 (82%) subjects in the 160 mg Q2W induction group achieved an absolute PASI of 1 or below and in general maintained a complete or almost complete disease remission with once monthly dosing. The majority of reported adverse events were mild and resolved during treatment. Overall, ABY-035 treatment appeared tolerable and safe.

“Our Phase 2 AFFIRM-35 trial in patients with moderate-to-severe psoriasis has shown excellent and sustained clinical response in patients. Most patients are continuing ABY-035 treatment in an ongoing open label extension study. Based on these promising results, we believe that ABY-035 has best-in-class potential for auto-immune diseases,” said David Bejker, CEO of Affibody. “The patient centric design has also enabled us to comfortably select doses for further development”.

Based on these encouraging clinical results in patients with moderate-to-severe psoriasis, the clinical development program of ABY-035 has been expanded to include further indications for development and commercialization.

“In this patient centric study, we saw direct therapeutic benefit to psoriasis patients by utilizing an experimental medicines adaptive design based on the absolute disease scores of each patient”, said Fredrik Frejd, CSO of Affibody. “Furthermore, the excellent safety and tolerability observed is highly promising, and is important for the Affibody® platform, with repeated high dose administration exceeding two years in a substantial proportion of the patients. The low molecular weight of the molecule enables a very effective way of delivering the drug subcutaneously in a convenient outpatient setting”.

AFFIRM-35 enrolled 108 moderate-to-severe psoriasis patients in centers throughout Germany to evaluate the efficacy, safety and tolerability of ABY-035. In addition to the PASI 90 primary efficacy measure, secondary endpoints included absolute and relative PASI-measures at weeks 12, 24, and 52; DLQI; itch and pain VAS; safety and tolerability, and pharmacokinetics. The core study has now been completed and continues in an open label extension study to gather further data, with some patients having been treated already more than two years with ABY-035.

ABY-035 doses of 2 mg, 20 mg, 80 mg, 160 mg and placebo were dosed in patients with moderate-to-severe psoriasis. The study comprised an induction period until week 12, followed by a patient centric response guided dose optimization period until week 24, and an individualization period allowing for response guided treatment interval prolongation until week 52.

Eli Lilly shared new results from a subgroup analysis of the Phase 3b/4, 52-week Head-to-Head study of Taltz (ixekizumab) versus Humira (adalimumab) in biologic-naïve patients with active psoriatic arthritis (PsA)

Quote:

---

Eli Lilly and Company shared new results today from a subgroup analysis of the Phase 3b/4, 52-week SPIRIT-Head-to-Head (SPIRIT-H2H) study of Taltz versus Humira (adalimumab) in biologic-naïve patients with active psoriatic arthritis (PsA). SPIRIT-H2H was the first superiority study versus Humira in PsA with a primary endpoint of simultaneous achievement of ACR50 (at least 50% improvement in disease activity as defined by the American College of Rheumatology) and PASI 100 (100% improvement in the Psoriasis Area and Severity Index) at Week 24.

In this prespecified analysis, efficacy outcomes through Week 52 were compared between Taltz and Humira in subgroups of patients on monotherapy, concomitant methotrexate (MTX), or concomitant MTX along with an additional conventional synthetic disease-modifying antirheumatic drug (csDMARD), including sulfasalazine, cyclosporine, or leflunomide. Results at 52 weeks showed improvements were seen with Taltz across multiple endpoints, with or without the use of MTX or other csDMARDs.

A higher proportion of patients treated with Taltz achieved Minimal Disease Activity (MDA) compared to Humira in the monotherapy subgroup (49% versus 33%), while response rates were similar between Taltz and Humira in the concomitant MTX subgroup (47% vs 47%) and concomitant csDMARD subgroup (47% vs 44%). MDA is an endpoint that includes fulfilling at least five of seven rheumatology outcome measures and is the treatment target according to multiple professional organizations.

More Taltz patients achieved the primary endpoint of simultaneous achievement of ACR50 and PASI 100 at Week 52 in all three subgroups:

    Monotherapy: Taltz 38%, Humira 19%
    Concomitant MTX: Taltz 39%, Humira 30%
    Concomitant csDMARDS: Taltz 40%, Humira 29%

A greater proportion of patients treated with Taltz versus Humira achieved PASI 100 when used as monotherapy (66% vs 35%), in combination with MTX (63% vs 44%), or in combination with csDMARDs (64% vs 44%) and the proportion of patients achieving ACR50 was comparable between Taltz and Humira, regardless of monotherapy (51% vs 42%), concomitant MTX (48% vs 56%), or concomitant csDMARD use (49% vs 53%).

"In this subgroup analysis of the SPIRIT-H2H study, ixekizumab showed greater improvement than adalimumab across multiple PsA endpoints when taken as monotherapy, and at least comparable efficacy when used in combination with methotrexate or other csDMARDs," said Josef Smolen, M.D., emeritus professor of medicine at the Medical University of Vienna, Austria and lead author of the abstract. "Head-to-head studies provide important insights for physicians when making treatment decisions. The results of this analysis reinforce the efficacy of ixekizumab, even as monotherapy, for patients with PsA who have had an inadequate response to csDMARDs."

The observed safety profile for Taltz in the SPIRIT-H2H study was consistent with that reported for ixekizumab in patients with moderate to severe plaque psoriasis (PsO) and PsA.

Lilly also highlighted notable results from two additional studies. The SPIRIT-P2 study demonstrated sustained improvement in signs and symptoms of PsA, as measured by ACR responses, as well as manifestations of PsA, including enthesitis, dactylitis, and skin outcomes, for up to three years in patients with prior inadequate response or intolerance to one or two tumor necrosis factor inhibitors (TNFi). In the Phase 3 COAST-X study in patients with active non-radiographic axial spondyloarthritis (nr-axSpA), patients treated with Taltz saw improvement in fatigue, spinal pain and stiffness at Week 16. In both studies, the safety profile of Taltz was consistent with previously reported results and no unexpected safety signals were found.

"To date, Taltz has reported positive results from five H2H superiority studies across PsA and PsO, including SPIRIT-H2H, IXORA-S, UNCOVER-2, UNCOVER-3 and IXORA-R, and we're pleased to share additional data from the SPIRIT-H2H subgroup analysis which provides further evidence for the use of Taltz as a first-line monotherapy treatment for patients living with PsA," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "The full breadth of Taltz data being presented at EULAR reinforce the efficacy of Taltz in treating patients with PsA and axSpA."