Synalar gel

Patient information leaflet

Synalar® gel

fluocinolone acetonide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor , pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:

1. What Synalar gel is and what it is used for
2. What you need to know before you use Synalar gel
3. How to use Synalar gel
4. Possible side effects
5. How to store Synalar gel
6. Contents of the pack and other information

1. WHAT SYNALAR GEL IS AND WHAT IT IS USED FOR

Synalar gel contains fluocinolone acetonide which is a steroid and reduces inflammation.

It is used to treat certain inflammatory conditions such as seborrhea and psoriasis of the scalp and other hairy parts of the body. It may also be used to treat certain inflammatory conditions of the skin on other parts of the body.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE SYNALAR GEL

Do not use Synalar gel:

If you are allergic to fluocinolone acetonide or any of the other ingredients of this medicine (listed in section 6).
Where infection is the main cause of the skin problem.
For acne.
For nappy rash or itchiness around the genital area.
If you have a skin condition called rosacea which is red rash, sometimes with spots and pustules, on the cheeks of the face.
If you have a skin condition called perioral dermatitis which is a dry sore red rash around the mouth
If it is for a child under the age of one.
If breast-feeding, do not apply to the breasts prior to nursing.
Make sure your doctor knows if any of the above affects you.

Warnings and precautions

Synalar gel should be kept away from the eyes.
If using Synalar gel on the face or on children (over the age of 1 year), do not use for more than 5 days. Your doctor will tell you if your treatment should be longer than this.
Waterproof dressings should not be used for children, or the face, and only in adults if your doctor tells you. The affected area should be thoroughly cleaned before putting on a waterproof dressing. Ask your doctor for instructions.
Do not use more gel than the doctor tells you, especially if you are pregnant or breast-feeding.
If too much gel is used for too long, you may develop stretch marks, thinning of the skin, or visible small veins.
Other medicines and Synalar gel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

If you go into hospital, let the medical staff know that you are using Synalar gel.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant,or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Synalar gel should not affect your ability to drive or use machinery.

Important information about some of the ingredients of Synalar gel

Some of the ingredients in your gel may cause a reaction, such as: Methyl and propyl parahydroxybenzoate [E218 and E216] – may cause local skin reactions (possibly delayed). Propylene glycol [E1520] – may cause skin irritation.

3. HOW TO USE SYNALAR GEL

Always use Synalar gel exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Screw the nozzle onto the end of the tube. This will allow you to apply your gel directly on to the affected part of the skin at the roots of the hair.

Unless your doctor tells you differently, a small amount of gel should be massaged into the affected area every night and every morning at roughly the same time.

Once the condition is under control you can reduce the treatment and apply the gel once or twice a week. Use the gel for as long as directed by your doctor (normally 5 days on the face and on children).

If you forget to use Synalar gel

If you forget to apply the gel at the correct time, do so as soon as you remember.

If accidentally swallowed

If you accidentally swallow the gel, contact your nearest doctor or hospital.

If you have any further questions on the use of this medicine ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines Synalar gel can cause side effects, although not everybody gets them. The following side effects have been reported but how often they occur is unknown:

an allergic (itchy) reaction to the gel
irritation where the gel has been applied
a worsening of acne, rosacea and dermatitis around the mouth (see section 2)
patches of pale skin (depigmentation)
localised increased hair growth
if too much gel is used for too long, you may develop stretch marks, thinning of the skin or visible small veins. In addition some of the steroid rubbed in to the skin may enter the blood stream. Effects such as roundness of the face, muscle wasting and fluid retention, as sometimes seen when steroids are given as tablets, may occur. The risk of these possible effects is higher in children. If this happens, your doctor may decide to stop treatment.
Do not be alarmed by this list of possible side effects. You may not have any of them.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE SYNALAR GEL

Keep this medicine out of the sight and reach of children. It could harm them.

Store Synalar gel below 25°C. Keep the gel in the tube it came in.



This leaflet was last revised in February 2019

This study says when treatment is interrupted, Ilumya  / Ilumetri (tildrakizumab) provides durable maintenance of five to six months.

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Background:
As treatment interruptions occur during psoriasis management in clinical practice, it is important to know the duration of clinical response after treatment withdrawal.

Objectives:
To report time to and predictors of relapse in patients who were tildrakizumab 100 and 200 mg responders (≥75% improvement in Psoriasis Area and Severity Index; PASI 75) at week 28 re‐randomized to placebo from reSURFACE 1 trial.

Methods:
Post‐hoc analysis of adult patients with moderate‐to‐severe plaque psoriasis from a 64‐week phase 3 trial. Relapse was primarily defined as loss of PASI 75 response. Both relapse defined as loss of PASI 90 and loss of absolute PASI <2 response were included as sensitivity analyses. PASI 75, PASI 90, and PASI <2 responders re‐randomized to placebo at week 28 and followed‐up until week 64 were included. Kaplan‐Meier (KM) estimates of the 64‐week relapse rate were calculated. Log‐rank test to compare KM curves from responders to tildrakizumab 100 and 200 mg was used. Independent predictors of relapse were explored.

Results:
Median time to loss of PASI 75/PASI 90/PASI <2 response from week 28 was 142/111/112 days with tildrakizumab 100 mg and 172/140/113 days with tildrakizumab 200 mg, respectively (all not significant). Around 20% of patients did not relapse (either maintained a PASI 75 response or were lost to follow‐up) during the 36‐week period. Increase in body mass index (BMI) (hazard ratio, HR [95% confidence interval, CI] for loss of PASI 75 response: 1.0345 [1.0112 – 1.0582]) and increase in disease duration (HR [95% CI]: 1.0151 [1.0028 – 1.0275] for loss of PASI 75 response) were associated with an increased risk of relapse, regardless of the relapse definition.

Conclusions:
When treatment is interrupted, tildrakizumab provides durable maintenance of efficacy with a median time to loss of PASI 75 response of five to six months, irrespective of the dose. Interventions on modifiable risk factors for relapse, such as BMI, may improve personalized long‐term psoriasis management.

after failing on kyntheium. i was told by dr to come off it.and i would be getting a telephone consultation. 
i got my consultation over the phone. only thing i knew nothing about it. as i got my appointment letter the day after the fone call. so obviously missed it. at this point my psoriasis and arthritis kicked in big time.. in absolute agony i ring the dermatology department. asking for another appointment. i got my fone consultation.. or rather i didnt as they rang the wrong number!! so i ring again.. and give them my number again. ok they said we will ring you. but it will be in 6 days time as the drs are busy. all the while im unable to walk at this point due to arthritis. my right foot swelled. cracked and split. so i got my fone consultation.. or rather i didnt cos guess what.. they rang wrong number again. so i ring back. fuming they agree to another consultation, and yippee they actually foned right number, so after speaking to the dr she said i should go back on cosentyx. ok i said, dr said it should be with you in 10 days.. great i said. waited 3 weeks n nothing. rang dermatology. and,, she forgot to process the prescription.. i havn slept in a month due to sever pain and sore skin. i cant walk. cant sit or lay down due to pain,,, sorry for the rant but needed to get it off my chest. and im tempted to seek legal advice. you wouldnt leave a dog in this much pain 

The European Medicines Agency (EMA) have set out new measures to avoid fatal dosing errors with methotrexate.

*The UK have said they will mirror the EMA advice.

Quote:Information for patients:

• If you are taking methotrexate for rheumatoid arthritis, psoriasis or Crohn’s disease, you must take it just once a week.
  
• Take your methotrexate medicine on the same day every week.
  
• Follow the instructions on the packaging of your methotrexate medicine.
  
• You will receive a patient card with your methotrexate tablets (or oral liquid). Read it carefully because it tells you how to take your medicine.
  
• Show your patient card to any new healthcare professional who treats you so that they know that you take your methotrexate medicine once a week.
  
• See your doctor at once if you get a sore throat, fever, mouth ulcers, diarrhoea, vomiting, skin rashes, bleeding or unusual weakness. These can be signs of taking too much methotrexate.
  
• Always attend your scheduled clinic visits and blood test appointments. They are important for making sure that your methotrexate medicine is working and that it is not causing any concern.
  
• If you are not sure about how to take your methotrexate medicine or you have any questions about it, talk to your doctor or pharmacist.
  

Quote:Information for healthcare professionals:

• Methotrexate for inflammatory conditions is intended for use just once a week. Serious side effects including fatalities have occurred when methotrexate is taken more often.
  
• Only physicians with expertise in using methotrexate medicines should prescribe them.
  
• Healthcare professionals who prescribe or dispense methotrexate for inflammatory conditions should:
  • read the educational materials for oral methotrexate medicines;
    
  • ensure that they are familiar with the latest changes to the summaries of product characteristics for methotrexate medicines used for inflammatory conditions;
    
  • give clear instructions to the patient (or carer) about once-weekly dosing;
    
  • check carefully that the patient (or carer) understands that the medicine must be used once a week, and do this each time a new prescription is issued or the medicine is dispensed;
    
  • decide together with the patient (or carer) on which day of the week the patient uses methotrexate;
    
  • counsel the patient (or carer) about signs of methotrexate overdose and give instructions to promptly seek medical advice in case of suspected overdose.
    

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

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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.

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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.

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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.

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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