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Psoriasis Club is a friendly on-line Forum where people with psoriasis or psoriatic arthritis
can get together and share information, get the latest news, or just chill out with others who understand. It is totally
self funded and we don't rely on drug manufacturers or donations. We are proactive against Spammers,
Trolls, And Cyberbulying and offer a safe friendly atmosphere for our members.
So Who Joins Psoriasis Club?
We have members who have had psoriasis for years and some that are newly diagnosed. Family and friends of those with psoriasis
are also made welcome. You will find some using prescribed treatments and some using the natural approach. There are people who
join but keep a low profile, there are people who just like to help others, and there are some who just like
to escape in the Off Topic Section.
Joining Couldn't Be Easier: If you are a genuine person who would like to meet others who understand,
just hit the Register button and follow the instructions.
Members get more boards and privileges that are not available to guests.
OK So What Is Psoriasis?
Psoriasis is a chronic, autoimmune disease that appears on the skin. It
occurs when the immune system sends out faulty signals that speed up the
growth cycle of skin cells. Psoriasis is not contagious. It commonly
causes red, scaly patches to appear on the skin, although some patients
have no dermatological symptoms. The scaly patches commonly caused by
psoriasis, called psoriatic plaques, are areas of inflammation and
excessive skin production. Skin rapidly accumulates at these sites which
gives it a silvery-white appearance. Plaques frequently occur on the
skin of the elbows and knees, but can affect any area including the
scalp, palms of hands and soles of feet, and genitals. In contrast to
eczema, psoriasis is more likely to be found on the outer side of the
joint.
The disorder is a chronic recurring condition that varies in severity
from minor localized patches to complete body coverage. Fingernails and
toenails are frequently affected (psoriatic nail dystrophy) and can be
seen as an isolated symptom. Psoriasis can also cause inflammation of
the joints, which is known as (psoriatic arthritis). Ten to fifteen
percent of people with psoriasis have psoriatic arthritis.
The cause of psoriasis is not fully understood, but it is believed to
have a genetic component and local psoriatic changes can be triggered by
an injury to the skin known as Koebner phenomenon. Various
environmental factors have been suggested as aggravating to psoriasis
including stress, withdrawal of systemic corticosteroid, excessive
alcohol consumption, and smoking but few have shown statistical
significance. There are many treatments available, but because of its
chronic recurrent nature psoriasis is a challenge to treat. You can find more information
Here!
Got It, So What's The Cure?
Wait Let me stop you there! I'm sorry but there is no cure. There are things that can help you
cope with it but for a cure, you will not find one.
You will always be looking for one, and that is part of the problem with psoriasis There are people who know you will be
desperate to find a cure, and they will tell you exactly what you want to hear in order to get your money. If there is a
cure then a genuine person who has ever suffered with psoriasis would give you the information for free. Most so called cures
are nothing more than a diet and lifestyle change or a very expensive moisturiser. Check out the threads in
Natural Treatments first and save your money.
Great so now what? It's not all bad news, come and join others at Psoriasis Club and talk about it. The best help is from accepting it and talking
with others who understand what you're going through. ask questions read through the threads on here and start claiming
your life back. You should also get yourself an appointment with a dermatologist who will help you find something that can
help you cope with it. What works for some may not work for others
Posted by: afternoonfix - Yesterday, 11:11 AM
- No Replies
Hello All ,
Just dropped in to say the following -two years back left a job of 27 years – and started out on my own, [ had P since a teenager]
Last year my skin was awful - legs / back / trunk - it was tough going, I was applying skin moisturisers twice a day and very, very down.
Not sure why I started –[ I was trying all sorts of creams [ had been to specialists] steroids / beehive lotion you name it etc but always came back ] – but I think I read somewhere about the properties & minerals of the ocean –
so last August I started swimming in the sea – I live in the SE of Ireland . From the first swim I felt better, now 5 months on I try to swim for 5 minutes a day [ warm shower after with a cold rinse ] and my skin is 90% better ! [some days just a small cold shower if the sea is too rough]
Not sure if it’s the cold water reduces stress levels that is the reason – but I swear its addictive and healing.
Ive not been active here for a long time. I started Uvb treatment back in March i believe.
It was great. Within probably 2 or 3 months i was nearly clear (90+%) after having bad 90%+ coverage with horrible scales. I had a few flares here and there but the treatment would zap the new psoriasis fast. I was doping 3 treatments a week. A few months ago now my doc dropped me to once a week and since then the PSO has been growing and growing again. Cold weather in Canada doesnt help.
The derm wants to take me off it. She says its not wise to keep me on it long term due to risk of cancer. But i won't go on meds and since getting a taste of clear skin im seriously considering getting my own home unit and using it conservatively. No more than 3 times a week, very short period, like a minute per side. Being careful to avoid any burning or skin irritation.
Admittedly i am a little distrustful of the derm, shes nice but shes very pharmaceutical focused and personally i dont trust and wont touch the stuff. When i started the phototherapy she told me they have 30+ years of data on UVB and that its safe, effective and doesn't have much cancer risk. But that the most data they have on biologics is 8 years. But shes pushed me very hard to go that route. I have very persistent psoriasis, we both know that the other drugs you have to go through before biologics wont work but you know... gotta follow the "protocol". I also really don't like this and it makes me very skeptical and distrustful when it comes to the way derms treat pso.
I am a person who responds well to sun, i dont burn easy. Phototherapy has been great for me. Like a miracle. But its clear 1 treatment a week, especially during the winter, isnt enough and my derm has already told me i HAVE to come off soon.
I am not looking for medical advice, but wondering if anyone has used uvb long term? I would think using it every other day indefinitely is a poor idea but using it more or less (without going overboard) as needed seasonally might be a reasonable method of treatment.
What do we think? Anyone use UVB at home? Looking for feeback and insight from people who have lots of experience with UVB.
Posted by: Fred - Sat-04-01-2025, 12:14 PM
- No Replies
Qyuns Therapeutics are developing QX004N, an IL-23p19 inhibitor for psoriasis. This is the results of a randomized clinical trial looking at it's safety and efficacy as a treatment for patients with moderate to severe plaque psoriasis.
Quote:
Objective To assess the safety, pharmacokinetics, and efficacy of QX004N in healthy individuals and patients with moderate to severe plaque psoriasis in China.
Design, Setting, and Participants This randomized clinical trial was composed of 2 parts. Part 1 was a first-in-human, single-ascending-dose, phase 1a clinical trial conducted from November 2, 2021, to January 16, 2023. Part 2 was a double-blind, multiple dose-escalation, phase 1b clinical trial conducted from February 15, 2023, to January 5, 2024, at 5 clinical centers in China, involving patients with moderate to severe plaque psoriasis.
Interventions In part 1, healthy participants in each cohort were assigned in a 4:1 ratio to receive a single subcutaneous injection of QX004N (ranging from 10 mg to 600 mg) or placebo. In part 2, patients in each cohort were assigned in a 4:1 ratio to receive QX004N or placebo at doses of 150 mg, 300 mg, and 600 mg once every 2 weeks.
Main Outcomes and Measures For part 1, the primary outcome was the safety of a single dose of QX004N in healthy participants, and the secondary outcome was the pharmacokinetic profile. For part 2, the primary efficacy end point was the proportion of patients achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) by week 12; other efficacy end points were considered secondary.
Results The phase 1a clinical trial (part 1) enrolled 55 healthy participants (mean [SD] age, 35.9 [6.0] years; 30 [54.5%] female), and the phase 1b clinical trial (part 2) enrolled 30 patients with moderate to severe plaque psoriasis. The mean (SD) age of QX004N-treated participants in part 2 was 41.4 (7.5) years, and 19 of 24 QX004N-treated participants (79.2%) were male. The mean (SD) age of the placebo cohort in part 2 was 35.3 (8.4) years, and 5 of 6 placebo-treated participants (83.3%) were male. QX004N exhibited linear pharmacokinetics and was tolerated well in both healthy participants and patients with psoriasis. Most adverse events were mild to moderate in severity, with no drug-related serious adverse events reported. The proportion of patients receiving QX004N who achieved PASI 75 at week 12 and PASI 90 (90% improvement in PASI) at week 16 in the 150-mg, 300-mg, and 600-mg cohorts was 100%, significantly higher than that in the placebo cohorts (33.3%). The maximum proportion of patients achieving Investigator’s Global Assessment score of 0 or 1 was 100% in the 3 QX004N cohorts.
Conclusions and Relevance In this randomized clinical trial, QX004N was well tolerated and demonstrated superior efficacy compared to placebo in patients with moderate to severe plaque psoriasis.
Posted by: Fred - Tue-31-12-2024, 12:40 PM
- Replies (8)
This year I gave all our members the chance to have their say on the future of Psoriasis Club and our members can read about it here [Group Specific] for those that are not a member, the good news is that we're here to stay so please do join or log-in we have well over 260,000 post in more than 7000 threads and there will be many more to come.
I want to thank our members for your continued support, I couldn't do it without you and we have built up a great community over the years. This year will be our fifteenth birthday and the future of Psoriasis Club is secure, so come on in and get posting.
Wishing you and yours a very happy and healthy New Year.
Has anyone switched from Stelara to Humira due to Psoriatic Arthritis?
PsA symptoms started a few months back. Had my appointment with the rheumatologist this morning. They suggested methotrexate first, which I shut down immediately as it didn't work for my psoriasis. They then prescribed Humira. Has anyone else made this switch, and how did you find it? Would also appreciate if anyone on Humira could let me know their experience on it.
Sorry, I haven't been on here in quite some time- this is such a good group for support of psoriasis sufferers.
I feel I need to share my journey in case it can help someone.
I've had plaque psoriasis for about 40 years, since I was in my 20s. Have had "several" general practitioners and dermatologists these years. Tried all of the creams and ointments, light treatments, etc with no real improvement.
I've had the theory for a while that it was something I was eating that was not agreeing with my system, but Every Single Doctor I asked said the diet has no effect on skin.
Well, I saw a kinesiologist this summer to help me with IBS, and he was able to do a food sensitivity test for me. Turns out I'm very sensitive to all dairy, all yeast, several fruits and vegetables, sugar. With this knowledge I started on a carnivore diet - meat and eggs, including fish - to help with IBS because that was making me miserable.
Bonus! Yes, my IBS is 90% improved - but the amazing thing is that my psoriasis is GONE. I still have some scarring, but I am not flaking off huge chunks of skin, and overall my skin feels so much better. And for an old lady this is miraculous!!!
And this is just in the past 4 months. I'm going to continue this way of eating because I feel so much better overall (obviously removing things like milk and bread that were trying to kill me -will have that effect!) It was difficult at first, but now that I'm past the initial cravings etc, it's much easier to go to the grocery. Stay to the outside, don't give in to temptation down the aisles!!!
Posted by: Fred - Tue-24-12-2024, 11:59 AM
- No Replies
Bristol Myers Squibb announces positive topline results from two pivotal phase 3 trials evaluating Sotyktu (deucravacitinib) in adults with psoriatic arthritis.
Quote:
Bristol Myers Squibb today announced results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase 3 trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu -treated patients achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo.
Additionally, the POETYK PsA-1 and POETYK PsA-2 trials met important secondary endpoints across PsA disease activity at Week 16. The overall safety profile of Sotyktu through 16 weeks of treatment in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with the established safety profile of Sotyktu observed in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.
"Psoriatic arthritis is a heterogenous disease that causes a range of different symptoms, including joint pain and swelling, as well as psoriatic skin lesions. Despite available therapies, rheumatologists continue to express a need for a safe and effective oral treatment," said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. "These POETYK PsA-1 and POETYK PsA-2 findings demonstrate that oral Sotyktu has the potential to be the first TYK2 inhibitor for people living with psoriatic arthritis and reinforce the established efficacy and safety profile of Sotyktu . We are encouraged by the positive data across both Phase 3 trials and look forward to discussing the results with health authorities."
Bristol Myers Squibb will work with key investigators to present detailed results at upcoming medical congresses.
These topline results represent the first Phase 3 clinical trials for Sotyktu in a rheumatic condition. Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.
Bristol Myers Squibb thanks the patients, investigators and clinical trial sites who participated in these clinical trials.
Posted by: Fred - Sat-14-12-2024, 14:29 PM
- Replies (12)
AbbVie have paid $200 million to get Nimble Therapeutics investigational oral peptide IL23R inhibitor in preclinical development for the treatment of psoriasis.
Quote:
IL-23 is a cytokine that activates Th17 cells, promoting an inflammatory response that contributes to tissue damage and organ dysfunction.
IL-23R is a receptor involved in the IL-23/IL-17 immune pathway, crucial in the pathogenesis of psoriasis and IBD. Upregulation of IL-23R expression is associated with increased susceptibility to IL-23 signaling, amplifying inflammation and immune responses in psoriasis and inflammatory bowel diseases (IBD), and underpinning the significant clinical efficacy of IL-23 blocking antibodies in these diseases. IL-23R antagonists block the interaction between IL-23 and its receptor, inhibiting the Th17 inflammatory pathway, cytokine production and IL23R upregulation, alleviating inflammation.
We are developing an innovative oral IL-23R antagonist by combining potent activity with gut stability and extended half-life. This medication will offer a more effective oral therapy option for patients seeking less invasive, more effective and convenient treatments.
I had a dermatology appointment yesterday. I'm seeing this doctor annually now that I've learned how to manage my psoriasis and am doing okay. I'm just so grateful to her. She is thorough and smart and committed to relieving suffering. This person could have risen to the top in any field, but she chose skin and her dedication to years of medical education and the care she has provided to me have helped me (along with many others, of course). I am better. I guess I just want to acknowledge this.
But as I get older, I think there's gonna be annual biopsies for skin cancer, too. I have two sore spots now, covered in bandages from yesterday's punch biopsies.
Maybe in the long run, having psoriasis lowers my chances of dying from skin cancer since it will be checked for regularly. I might not have ever seen a dermatologist if I didn't get psoriasis.
I have had Guttate Psoriasis for almost three years now, after a mild case of COVID (That's a story for another day}. Guttate typically resolves fairly quickly, mine did not. I was on Humira for 7 months and got moderate relief. The Humira quit working for me. I am now trying to get on Tremfya. I have had Plaque psoriasis since I was 12 years old, and that is largely in remission.
Posted by: Fred - Fri-29-11-2024, 14:07 PM
- Replies (1)
This article suggests there is a link between ultraprocessed foods and psoriasis.
Quote: Methods:
We performed a cross-sectional study using data from the Nutri-Net-Santé cohort study between November 29, 2021, and June 6, 2022. The French Institute for Health and Medical Research Institutional Review Board approved this study. All participants provided electronic informed consent. We followed the STROBE reporting guideline.
A validated self-diagnosis questionnaire was used to classify participants (aged ≥15 years) by their psoriasis status (never-had, nonactive, or active) at the time of the survey. For each participant, UPF intake in grams per day was extracted and divided into 3 tertiles, ranging from minimum (tertile 1) to maximum (tertile 3) intake. Associations were assessed using multinomial logistic regression models adjusted for age, sex, educational level, smoking status, physical activity, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), alcohol intake, and comorbidities (depression, cancer, cardiovascular disease [CVD], diabetes, hypertriglyceridemia, inflammatory bowel disease [IBD], inflammatory rheumatism), and number of dietary records completed.
Two-sided P < .05 indicated statistical significance. Data analysis was performed with SAS, version 9.4 (SAS Institute Inc).
Results:
A total of 18 528 participants (median [IQR] age, 62 [49-70] years; 13 755 females [74%], 4773 males [26%]) were included, of whom 1825 (10%) had psoriasis with 803 cases being active (4%). The active psoriasis group had a lower proportion of females (68% [546] vs 74% [12 441] and 75% [768]) and a higher proportion of individuals with BMI over 30 (16% [129] vs 9% [1524] and 11% [115]) than the never-had and nonactive groups. High-intensity physical activity was less frequent in the active and nonactive groups than in the never-had group (308 [38%] and 396 [39%] vs 6943 [42%]). Comorbidities that were more frequent in the active vs never-had group were CVD (58 [7%] vs 773 [5%]), diabetes (45 [6%] vs 623 [4%]), IBD (13 [2%] vs 151 [1%]), and inflammatory rheumatism (69 [9%] vs 455 [3%]).
In unadjusted analysis, UPF intake differed between active and never-had groups (tertile 3 odds ratio [OR], 1.52; 95% CI, 1.28-1.81; P for trend < .001). After adjustments, high UPF intake was more likely in the active group than lower UPF intake (tertile 3 adjusted OR, 1.36; 95% CI, 1.14-1.63). Sensitivity analyses showed no association for participants with a psoriasis diagnosis validated by a dermatologist.
Discussion:
Results of this study showed an association between high UPF intake and active psoriasis status. After adjustments for age, BMI, alcohol intake, and comorbidities, the results remained significant, suggesting that UPF intake has a proinflammatory action separate from high BMI.4
Study limitations included the study population differing from the French general population (notably with healthier dietary habits5), which might have led to an underestimation of association levels detected. Additionally, psoriasis cases were self-reported, possibly leading to misclassification. However, self-declaration of psoriasis had excellent sensitivity (82.2%) and specificity (98.6%) and receiver operating characteristic curve (0.90; 95% CI, 0.87-0.94) in a cross-sectional diagnostic study of 89 patients with psoriasis.6 Our models also were adjusted for known and potential confounding factors, minimizing confounding bias. However, residual bias could persist. Furthermore, the cross-sectional, observational study design prevented us from ascertaining whether elevated UPF intake precedes or is a consequence of psoriasis flare-ups.
High UPF intake was associated with active psoriasis status. More large-scale studies are needed to investigate the role of UPF intake in psoriasis onset.
Source: jamanetwork.com
*Funding: French Society of Dermatology. | Ministère de la Santé, Santé Publique France | Université Sorbonne Paris Nord.
Glad to be here. I hope that I can share my 51 years of experience as someone living with Psoriasis. As my conditioned has worsened, I hope to access the knowledge and experiences you all have.
Hello, fellow flakeys. Long-time sufferer here. Psoriasis and psoriatic arthritis has definitely made a dent in my life. I'm finally in somewhat of a remission, but I tend to develop a tolerance to meds over time. At least with all of the new meds they keep coming up with, it leaves me options for finding new ones.
I used to be married, lived on a farm, and took care of kids, cats, dogs, horses, sheep, rabbits, and a few chickens while working as a kennel attendant in a veterinarian's office. Now I'm divorced, unemployed, on disability, and live in a tiny house with a roommate and her kid.
I do have two dogs, but I lost my two cats in the last couple of years and haven't found new ones that need homes yet.
I'm finally back to my favorite hobby (cross-stitch) after a bad flare starting last year. The Cosentyx has done wonders, but I'll never be as active as I once was. I've learned to slow down, but it hasn't been easy.
I hope everyone is doing well and finding what treatment works best for them. Take care and I'll see you around.
Posted by: Fred - Tue-12-11-2024, 16:29 PM
- Replies (8)
Researchers at the University of Copenhagen have developed a patch for easier and more effective treatment of psoriasis.
Quote:
We have developed a dry patch, which contains active ingredients for treatment of psoriasis, and which reduces the frequency of use to once a day. It has the potential to make treatment more comfortable for psoriasis patients.
The patch is designed to contain two active ingredients at once and release them onto the skin at different rates.
The two ingredients are released in a controlled manner and at different rates, as they serve different functions: Salicylic acid is released immediately to remove the dead cells that have accumulated on the skin, while hydrocortisone decreases inflammation of the skin – a process that takes more time.
We have tested the prototype on pig skin and human skin cells and compared the results to the creams and ointments available at pharmacies, and our studies show that the patch is just as effective as standard treatments.
The researchers used electrospinning to produce the patch – a method where high voltage is applied to a polymer solution to produce synthetic nanofibers. The fibres are then used to make a fibre mat that may be attached to the skin like a plaster.
The researchers are still working on the patch. More research, product development and clinical trials are needed before the method is ready for use.
It's been a very long while. Sorry I have been away. I am struggling for a while with thing going on in my life. Lost my brother in 2021 and lost my dad in 2023. My plaque psoriasis are flaring up. This past July I was diagnosed with psoriatic arthritis and fibromyalgia. Currently onTriamcinolone ointment and methotrexate.
Sarah
Posted by: Fred - Sat-26-10-2024, 12:36 PM
- Replies (1)
Management of moderate to severe psoriasis with Kyntheum / Siliq (brodalumab) real world evidence from the LIBERO study.
Quote:Background:
Brodalumab, a fully human monoclonal immunoglobulin IgG2 antibody that binds the human interleukin 17 receptor subunit A, is available for the treatment of moderate-to-severe plaque psoriasis in Europe since September 2017, but so far there are only a few studies on its use in real-world conditions.
Objectives:
To assess the management of moderate-to-severe psoriasis with brodalumab 210 mg in daily practice after 12 and 52 weeks (W). In addition, patient profiles and treatment pathways are described.
Methods:
LIBERO is a prospective, multicenter, non-interventional study including adult patients with plaque psoriasis treated with brodalumab 210 mg.
Results:
In total, 638 patients (65% male, mean age: 49.3 ± 14.4 years) from 148 sites in Germany were enrolled. The majority suffered from severe (51.1%) or very severe (13.1%) psoriasis according to physician global assessment (PGA0-5). When starting with brodalumab, 58.5% were biologic naïve and 41.5% were previously treated with another biologic, mainly adalimumab (18.5%) and secukinumab (17.9%). About 74.0% of patients met the primary endpoint of an absolute PASI ≤3 at ~W12 (n = 618, LOCF). The mean PASI was reduced significantly as of ~W2 from 17.2 (±11.7) to 9.7 (±8.8) and improved further to 3.3 (±6.3) at ~W12 (p < 0.001). At ~W52 85.5% of patients reached a PGA0/1-response (primary endpoint) and 54.1% patients were assessed as completely clear (PGA0) (both n = 399, as observed). Effectiveness of brodalumab was confirmed in relevant subgroup analysis by previous treatment regimen. Most frequently reported adverse events were nasopharyngitis (4.6%), psoriasis (4.6%) and arthralgia (4.1%), new safety signals were not detected.
Conclusions:
This representative, non-interventional study confirms the short- and long-term effectiveness and safety profile of brodalumab in the management of psoriasis in daily practice as well as in relevant treatment pathways.
Posted by: Fred - Wed-23-10-2024, 12:55 PM
- Replies (6)
Not aimed specifically at psoriasis, but phase 1 was on patients with psoriasis. In early 2025, Calluna plans to advance CAL101 into Phase 2 studies in fibrotic and fibro-inflammatory indications.
Quote:
Calluna Pharma AS (Calluna), a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced the completion of Phase 1 clinical study for CAL101, Calluna’s lead product candidate. The study demonstrated a favorable safety, pharmacokinetic (PK) and immunogenicity profile for the mAb.
CAL101 is a first-in-class mAb that targets S100A4, a damage-associated molecular pattern (DAMP) protein implicated in serious and life-threatening diseases, such as idiopathic pulmonary fibrosis and systemic sclerosis. Preclinical studies have demonstrated the ability of CAL101 to prevent and treat fibrosis and modify the disease-specific activation of fibroblasts – the key effector cells driving progression of fibrosis.
Jonas Hallén M.D., Ph.D., Co-Founder and Chief Medical Officer of Calluna Pharma, commented: “We are encouraged by the findings from the Phase 1 study. These results are an important step forward in the development of our lead asset, CAL101, particularly for fibrotic and fibro-inflammatory diseases where there remains a critical need for innovative therapeutic options. We are excited as we now move into the next phase of clinical development.”
The first-in-human, randomized, double-blind, placebo-controlled Phase 1 study in 57 subjects was designed to evaluate safety, tolerability, immunogenicity and PK, and was led by Professor Dave Singh at the Medicines Evaluation Unit in Manchester, UK. The study tested single ascending doses of CAL101 in healthy volunteers and multiple ascending doses in patients with mild to moderate chronic plaque psoriasis.
Summary of key CAL101 Phase 1 study results:
CAL101 demonstrated a favorable safety profile and was well tolerated with no Serious Adverse Events across all doses tested.
Adverse Events were all mild to moderate and balanced between CAL101 and placebo.
CAL101 demonstrated a favorable PK profile with dose-dependent increases in exposure, supporting once monthly dosing.
In participants with anti-drug antibodies, titers were very low and with no impact on PK and safety.
Target engagement data supports complete target coverage at clinically relevant doses.
Posted by: Fred - Tue-15-10-2024, 11:50 AM
- Replies (2)
Currently you need two shots at 160mg each, but soon in the USA and EU you will be able to get one shot at 320mg
Quote:
UCB today announced that the U.S. Food and Drug Administration (FDA) has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of BIMZELX® (bimekizumab-bkzx).
These new device presentations add to the currently available 1 mL administration options, each containing 160 mg of bimekizumab-bkzx, and mean that patients requiring a 320 mg dose of bimekizumab-bkzx will have options for single-injection administration.
“Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. “With the new device presentations, people with moderate-to-severe plaque psoriasis who receive a bimekizumab-bkzx maintenance dose of 320 mg will have the option of a single-injection every eight weeks.”
The approval of the 320 mg device presentations is supported by data from studies evaluating the bioequivalence of bimekizumab-bkzx 320 mg given as one 2 mL subcutaneous injection, and bimekizumab-bkzx 320 mg given as two 1 mL subcutaneous injections, in healthy study participants. This is the second worldwide approval for the 320 mg single-injection administration options for bimekizumab-bkzx, following approval by the European Commission in August 2024.
These new device presentations will be available in the U.S. in Q1 2025.
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Psoriasis Cure!
How many people have Psoriasis?
In 2012 there were approximately 36.5 million prevalent cases of psoriasis, and by 2022, GlobalData epidemiologists forecast that this figure will reach approximately 40.93 million.
The condition affects individuals of both sexes and all ethnicities and ages, although there is a higher prevalence of psoriasis in the colder, northern regions of the world.
The prevalence of psoriasis in the central region of Italy is 2.8 times greater than the prevalence in southern Italy.
Caucasians have a higher prevalence of psoriasis compared with African-Americans, but African-Americans in the US tend to suffer from a more severe form of the disease.