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

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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.

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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.

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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.

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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)

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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

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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)

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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."

Hello, thought I would check out a forum as I am starting a new med.

First I will recap my journey to this point:

I was diagnosed as having Psoriatic arthritis around 1992.

I was told that by the time I was 55 I would be in a wheelchair.  I took just about everything imaginable between then and 1998.  Methotrexate, sulfa, don’e even remember it all.  Nothing made any difference.

In 1998 I was ready to give up and my primary care Dr recommended a hand specialist in the area that had done surgery on people from all over.  I told him I was at the end of my rope.  He said “There’s a new med out called enbrel, let’s try that”.  I started enbrel and it saved my life.  A miracle drug.

In 2011 we moved to mexico.  I stopped the enbrel as my insurance would not cover it there.  It took several years for it to wear off.  When it did both the psoriasis and arthritis came back with a vengance.

In 2018 we moved back to the us and started enbrel again.  Much better but not as effective as it once was.  They switched me to humira.  It did nothing.  Just recently I was switched to otezla.  Bad trip.  Stomach problems, nausea,  diarrhea, nausia, migraine, trembling inside and out.

Now they are going to send me taltz.  I am curious of experiences people have had with it.

So thanks for having me.  Should I have posted this in the pa forum?

AbbVie today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for RINVOQ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis.

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"Psoriatic arthritis is a complex heterogeneous disease with manifestations across multiple domains, including joints and skin, causing daily pain, fatigue and stiffness," said Michael Severino, M.D., vice chairman and president, AbbVie. "We look forward to working with regulatory authorities and hope to bring RINVOQ to people living with this debilitating disease as quickly as possible."

The applications are supported by data from two Phase 3 studies across a broad range of more than 2,000 patients with active psoriatic arthritis.1,2 In both studies, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo.1,2 RINVOQ 15 mg also achieved non-inferiority versus adalimumab in terms of ACR20 response at week 12.1 Patients receiving RINVOQ also experienced greater improvements in physical function (HAQ-DI) and skin symptoms (PASI 75), and a greater proportion achieved minimal disease activity.* Overall, the safety profile of RINVOQ in psoriatic arthritis was consistent with previously reported results across the Phase 3 rheumatoid arthritis clinical trial program, with no new significant safety risks detected.

*Physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Skin symptoms were measured by a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75). Minimal disease activity is defined as the fulfillment of five of seven outcome measures: Tender joint count ≤1; swollen joint count ≤1; PASI ≤1 or body surface area-psoriasis ≤3 percent; Patient's Assessment of Pain Numerical Rating Scale (NRS) ≤1.5; Patient Global Assessment-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and Leeds Enthesitis Index ≤1.

About RINVOQ™ (upadacitinib)

Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing. Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

Started getting eye problems after a few weeks on Taltz.
Eyes aching like I was punched in them. It then changed to when I wore glasses to see the PC screen. (quite a lot)
Its now very sunny in the Uk and I have slight head ache and eye ache. I had my last injection 18th April and was about to take it monthly. I missed my last injection, so now just over 5 weeks ago.
I am wanting it out of my system so I know if its Taltz that's causing it.
Opticians tested my eyes in January. They had another look when I started with problems. They couldn't find anything major. My eyes were very slightly dry and my distance vision had deteriorated a little.
I phoned dermatologist personal receptionist and asked if it was ok to stop temporary. Also with the Virus about. She said she had heard of someone else with the same problem.
Got call back with the Ok to stop and see her on review date.


My question is....How long before Taltz is out of my system

This study compared Humira (adalimumab) and Fumaric Acid Esters (FAE) on cardiovascular disease markers in psoriasis patients.

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Background:
The effect of adalimumab and fumaric acid esters (FAE) on the cardiovascular risk associated with psoriasis has only been investigated scarcely in randomized controlled studies.

Objective:
The aim of this prospective, randomized controlled head‐to‐head trial was to compare the influence of adalimumab and FAE on cardiovascular disease markers in psoriasis patients.

Methods:
65 patients with moderate to severe plaque psoriasis were randomly assigned to adalimumab or FAE treatment for 6 months. Cardiovascular hemodynamic parameters (flow mediated dilation (FMD), nitro‐glycerine mediated dilation (NMD) and carotid intima media thickness (CIMT), blood pressure) were assessed at baseline(v0) and after 6 months(v6). Cutaneous disease severity, inflammatory and lipid cardiovascular risk markers were analysed at baseline(v0), after three(v3) and six months(v6).

Results:
After 6 months of treatment FMD in the adalimumab group increased significantly (v0 5,9% (6,4% S.D), v6 8,0% (4,8% S.D.), p=0,048) but not in the FAE group. (v0 7,0% (4,1% S.D), v6 8,4% (6,1% S.D.), p=0,753) This was paralleled by a significant decrease of hsCRP in the adalimumab group in comparison to the FAE group (v0: 0,39 mg/dl (0,38 S.D.), v6: 0,39mg/dl (0,48 S.D.), p=0,043). No significant changes were observed in any other hemodynamic parameters. FAE, however, additionally decreased total cholesterol (p=0,046) and apolipoprotein B (p=0,041) levels compared to adalimumab. Mean PASI (psoriasis area severity score) reduction was greater but not significant (p=0,116) under adalimumab treatment compared to FAE treatment ( ‐71,1% (29,9 S.D) vs. ‐54,6% (45,7%)).

Conclusion:
In our study both treatments were documented to exert effects on the cardiovascular system. While adalimumab showed anti‐inflammatory effects and improved FMD, FAE interacted favourably with the cholesterol metabolism.

This study suggests Cosentyx (secukinumab) resulted in complete normalization of quality of life (QoL) in a substantial proportion of psoriasis patients, and their families, regardless of their prior treatment history.

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Introduction:
Psoriatic disease is associated with considerable impairment of Quality of life (QoL). The PROSE study (NCT02752776) investigated the impact of secukinumab treatment on patient‐reported outcomes (PRO) in patients with moderate‐to‐severe psoriasis stratified by their treatment history.

Methods:
PROSE was a prospective, non‐randomised, multicentre study. Patients were categorized at baseline according to treatment history as naïve (naïve to any systemic therapy [N=663]), conventional systemic (previously exposed to ≥1 conventional systemic (CS) therapy [N=673]), and biologics (previously exposed to ≥1 biologic therapy [N=324]). QoL PROs, efficacy and safety of secukinumab 300 mg were assessed for a period of 52 weeks.

Results:
The primary objective was met with 70.8% patients achieving a Dermatology Life Quality Index (DLQI) 0/1 response at Week 16 (naϊve, 74.7%; CS, 71.3%; biologic, 61.7%), with effects sustained up to Week 52. Mean Family‐DLQI (FDLQI) score decreased from 11.5 at baseline (naϊve, 11.3; CS, 11.4; biologic, 12.1) to 2.5 at Week 16 (naϊve, 2.5; CS, 2.3; biologic: 3.5). Substantial improvements in EuroQoL 5‐Dimension Health Questionnaire, Numeric Rating Scale for pain, itching and scaling, Health Assessment Questionnaire‐Disability Index, Treatment Satisfaction Questionnaire for Medication, and Patient Benefit Index were also observed at Week 16. The QoL gains were associated with substantial improvements in Psoriasis Area and Severity Index and Investigator Global Assessment mod 2011 0/1 response. No meaningful difference was observed in the efficacy or QoL improvements across patient subpopulations. All QoL and efficacy parameter improvements were sustained up to Week 52. Secukinumab treatment was well‐tolerated, and no new safety signals were observed.

Conclusion:
Secukinumab treatment resulted in complete normalization of QoL in a substantial proportion of psoriasis patients, and their families, regardless of their prior treatment history.

Has anyone else using Tremfya noticed an increase in eye light sensitivity ?

It has been said that people with psoriasis can suffer with increased light sensitivity and I remember Stelara made my eyes more sensitive to sunlight.

I'm finding now we are getting a lot more brighter sunshine my eyes start to feel more sensitive and get very dry and I keep squinting, after coming back inside it starts to wear off and after a couple of hours my eyes are back to normal.

I think I will go back to putting sunglasses on when going out in the garden as I used to with Stelara, but was wondering if anyone else has noticed an increase in eye light sensitivity with Tremfya ?

This study set out to confirm the effectiveness and safety of Cimzia (certolizumab) in patients with psoriasis and psoriatic arthritis in routine clinical practice.

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Background:
Certolizumab, a pegylated tumour necrosis factor‐α inhibitor, reduced disease activity in randomised trials of patients with psoriasis and psoriatic arthritis. Real‐life data are missing.

Objective:
To confirm the effectiveness and safety of certolizumab in patients with psoriasis and psoriatic arthritis in routine clinical practice.

Methods:
In this retrospective study involving 11 Italian sites, patients with psoriasis and psoriatic arthritis received subcutaneous certolizumab (400 mg loading dose at 0, 2 and 4 weeks, followed by 200 mg every 2 weeks) for up to 52 weeks. Primary outcomes included mean change from baseline in Psoriasis Area and Severity Index (PASI) and modified Nail Psoriasis Severity Index (mNAPSI) scores, and the proportion of patients achieving a 75%, 90% or 100% reduction in PASI score. Other endpoints included Disease Activity Score computed on 44 joints correlated to the erythrocyte sedimentation rate during the first hour (DAS44‐ESR), Tender Joint Count (TJC), Swollen Joint Count (SJC), pain (visual analogue scale [VAS] score), inflammatory markers and quality of life (QOL).

Results:
In the study were enrolled 153 patients (mean age: 55 years). Certolizumab reduced the mean PASI score from baseline by 4.45, 6.30 and 7.58 at weeks 12, 24 and 52, respectively (p<0.001 for all). At weeks 24 and 52, 69.6% and 83.3% of patients had a PASI score ≤3. DAS44‐ESR, TJC, SJC and mNAPSI scores, and pain‐VAS were also all significantly improved from baseline at each time point. C‐reactive protein levels decreased during treatment, being significant at week 24. On multivariate analysis, psoriasis duration, baseline PASI, mNAPSI and pain‐VAS scores were found to be predictive of the improvement in PASI score at week 12.

Conclusion:
Certolizumab displayed also in the real‐life encouraging results in both psoriasis and psoriatic arthritis patients

This study suggests there is still an unmet need for more efficacious biologics for patients with psoriasis.

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Background:
Anti‐tumour necrosis factor (TNF) and anti‐interleukin (IL)‐12/23 biologics revolutionized plaque psoriasis treatment by enabling ≥75% improvement in the Psoriasis Area and Severity Index (PASI 75) in clinical trials. Modern biologics are now reported to achieve PASI 100 (complete skin clearance) in clinical trials. However, real‐world evidence of skin clearance rates with biologics is limited. PSO‐BIO‐REAL was conducted to understand the real‐world burden of plaque psoriasis.

Objective:
The primary objective of this observational study was to estimate the proportion of patients who achieved complete skin clearance at 6 months. Secondary objectives included maintenance of response and evaluation of complete skin clearance at 12 months.

Methods:
PSO‐BIO‐REAL was a multinational, prospective, real‐world, non‐interventional study of skin clearance and patient‐reported outcomes (PROs) with biologics. A total of 846 patients from the United States (32%), France (28%), Italy (22%), the United Kingdom (11%), and Germany (8%) were enrolled and followed for one year. Eligible patients were aged ≥18 years with moderate‐to‐severe plaque psoriasis who had initiated a biologic for plaque psoriasis. Patients could be biologic‐naïve or switching biologics (biologic‐experienced). Assessments were made at baseline and at Months 6 and 12.

Results:
At 6 and 12 months, 23% and 26% of patients achieved complete skin clearance, respectively. Prior to study entry, 60% were biologic‐naïve. The proportion of patients achieving complete skin clearance was lower among biologic‐experienced patients (20% at both Months 6 and 12) compared with biologic‐naïve patients (25% at Month 6, 30% at Month 12). The rate of complete skin clearance decreased as the number of prior biologics and baseline comorbidities increased.

Conclusion:
Only one in four patients achieved complete skin clearance after 6 months of treatment with biologics. The study indicates there still is an unmet need for more efficacious biologics for patients with psoriasis.