Synthetic hypericin, the active ingredient in HyBryte™ (hypericin ointment 0.25%), is a potent photosensitizer that is topically applied to skin lesions and then activated by fluorescent light the following day.

Quote:

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Soligenix a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that following the validation of synthetic hypericin's biologic activity in the positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL), as well as positive proof-of-concept (PoC) demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, the Company will be expanding this novel therapy under the research name SGX302 into psoriasis, a large and underserved market with a significant unmet medical need.

Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy (PDT) that is expected to avoid much of the long-term risks associated with other PDT treatments. Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the root cause of psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using ultraviolet (UV) light associated with more severe potential long-term toxicities.  The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin (much more than UV light) potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH study in CTCL.  Synthetic hypericin or HyBryte™ (tradename used in CTCL) was demonstrated in this study to be equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment) and patch (37%, p=0.0009) lesions of this orphan disease caused by malignant T-cells.  Further, this treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UV A or B exposure. The use of synthetic hypericin coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis.

"Similar to CTCL, psoriasis is a chronic disease where the management of side effects and toxicities is as important as the management of the disease itself. Having treated both CTCL and psoriasis patients for over 20 years and having seen first-hand how they struggle to find good treatment options, access to an additional effective and safe therapy would add significantly to patient care and quality of life," stated Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego and an investigator in the Phase 3 FLASH study.  "The success of synthetic hypericin in targeting malignant T-cells during CTCL clinical trials is a promising indicator of the ability of SGX302 to provide a much-needed approach for the treatment of mild-to-moderate psoriasis, also caused by dysregulated T-cells. This success is further supported by both the previous synthetic hypericin PoC study in psoriasis and by the success, albeit confounded by potentially severe toxicity, of other photodynamic therapies in psoriasis."

"During the last year, we have made announcements of several important development milestones that we have achieved with HyBryte™ (synthetic hypericin) in the treatment of early stage CTCL.  We have clearly validated synthetic hypericin's biologic activity with the Phase 3 FLASH study in this orphan disease, where we expect to file a New Drug Application (NDA) in the first half of next year. We believe it is now appropriate to expand synthetic hypericin's or SGX302's development into different cutaneous T-cell diseases such as psoriasis, as a component of our long-term strategy to enhance the value of this unique compound," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "Psoriasis is an ongoing unmet medical need, with as many as 7.5 million people in the U.S. and 60-125 million people worldwide affected by this incurable disease. Given our promising results with hypericin to date, including a small Phase 1/2 PoC clinical trial in mild-to-moderate psoriasis, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease."

Dr. Schaber continued, "As we get closer to initiating a follow-on Phase 2a clinical trial in mild-to-moderate psoriasis, we will provide further details regarding trial design and timeline; however, our high level plan in the interim is to evaluate different topical formulations of synthetic hypericin to ensure optimal absorption for broadly treating this disease.  In parallel, we will be working with our psoriasis clinical experts to finalize a protocol with a plan to initiate study enrollment in the latter part of 2022.  Given our current cash position and the expected cost of the Phase 2a trial, we do not anticipate needing to raise additional capital to support this Phase 2a trial as we continue to advance towards NDA filing and U.S. commercialization of HyBryte™ in the treatment of CTCL." 

About Synthetic Hypericin

Synthetic hypericin, the active ingredient in HyBryte™ (hypericin ointment 0.25%), is a potent photosensitizer that is topically applied to skin lesions and then activated by fluorescent light the following day.  This novel treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other PDTs that depend on UV exposure.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 1/2 PoC clinical study using synthetic hypericin, efficacy was demonstrated in patients with CTCL (58.3% response, p=0.04) and psoriasis (80% response, p<0.02). Subsequently, a Phase 3 study in CTCL has further confirmed the biological efficacy of synthetic hypericin (termed HyBryte™ in the context of CTCL).

The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly in 6 week cycles. In the first double-blind treatment cycle, 116 patients received HyBryte™ treatment and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (using the standard Composite Assessment of Index Lesions Severity [CAILS] score) compared to only 4% of patients in the placebo group after just 6 weeks of treatment (p=0.04). Further treatment with synthetic hypericin treatments increased the number of treatment successes to 40% and 49% after 12 and 18 weeks, respectively (p<0.0001 for both). Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment in Cycle 1) and patch (37%, p=0.0009) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions. This is also relevant to psoriasis where the lesions can be thicker than the patches observed in CTCL.

In a subset of patients evaluated during their third treatment cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix.   

HyBryte™ in CTCL has received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA) and promising innovative medicine designation from the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom. Hypericin has also received orphan designation from the FDA for T-cell lymphoma.

A question, has anyone the experience that in the two days before the injection, complaints like stifness comes back?

I feel more stifness, more fatigue, my knees start to hurt, my lower back pain is coming back on the 12th day. On the 14th day i will inject myself an the day after the injection, all these complaints vanish again.

Does anyone recognize this?

The United States Food and Drug Administration (FDA) have updated warnings on three Janus Kinase (JAK) inhibitors.

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Issue:
The FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib) and Rinvoq (upadacitinib) to include information about the risks of serious heart-related events, cancer, blood clots, and death.

Based on the review of a large randomized safety clinical trial, the FDA has concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR. This trial compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz.

The FDA is requiring new and updated warnings for two other arthritis medicines in the same drug class as Xeljanz, called Janus kinase (JAK) inhibitors, Olumiant and Rinvoq. Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated. However, since they share mechanisms of action with Xeljanz, FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial.

Two other JAK inhibitors, Jakafi (ruxolitinib) and Inrebic (fedratinib), are not indicated for the treatment of arthritis and other inflammatory conditions and so are not a part of the updates being required to the prescribing information for Xeljanz, Xeljanz XR, Olumiant, and Rinvoq. If FDA becomes aware of any additional safety information or data that warrants updates to the prescribing information for these medicines, the FDA may take further action and will alert the public.

Background:
Xeljanz/Xeljanz XR, Olumiant, and Rinvoq are used to treat certain serious, chronic, and progressive inflammatory conditions. All three medicines are approved to be used alone or with other drugs to treat rheumatoid arthritis, a condition in which the body attacks its own joints, causing pain, swelling, joint damage, and loss of function. Xeljanz is also approved to treat psoriatic arthritis, a condition that causes joint pain and swelling; ulcerative colitis, which is a chronic, inflammatory disease affecting the colon; and polyarticular course juvenile idiopathic arthritis, a type of childhood arthritis.

Patients who are taking Xeljanz/Xeljanz XR, Olumiant, or Rinvoq should tell their health care professional if they are a current or past smoker, or have had a heart attack, other heart problems, stroke, or blood clots in the past as these may put them at higher risk for serious problems with the medicines. Patients starting these medicines should also tell their health care professional about these risk factors. Patients should seek emergency help right away if they have any symptoms that may signal a heart attack, stroke, or blood clot. Treatment with these medicines is associated with an increased risk of certain cancers including lymphoma and lung cancer. Patients should also talk to their health care professional if they have any questions or concerns.

Health Professionals should consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Xeljanz/Xeljanz XR, Olumiant, or Rinvoq. This is particularly the case in patients who are current or past smokers, those with other cardiovascular risk factors, those who develop a malignancy, and those with a known malignancy other than a successfully treated nonmelanoma skin cancer. Reserve these medicines for patients who have had an inadequate response or intolerance to one or more TNF blockers. Counsel patients about the benefits and risks of these medicines and advise them to seek emergency medical attention if they experience signs and symptoms of a heart attack, stroke, or blood clot.

Health care professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program

Morning folks!  New member Kellie here.  Hoping to find insight on Otezla side effects.  I've been on it about 6-weeks and have worked through the usual nausea and headache but am experiencing one symptom not discussed.  

Anyone experience very sensitive skin on this stuff?  I have moderate plaque psoriasis that's responding very well to Otezla but now I'm getting this weird reaction.  It almost feels I'm feverish but my temp is fine..  Today the sensitivity is throughout my torso but not limbs.  So bizarre.  I'm not even sure it's the Otezla causing it.  Anyone have thoughts or info?

Thanks very much for your replies!

Hey y'all
It's been a couple years since I've posted anything in the forum. I've had so much going on, it's been crazy. I'd been thinking about this forum a lot in the last couple months and had been wanting to find support somewhere. Y'all were so supportive before and I know y'all are excellent folks. 

I had joined because I have had psoriasis since I was a teen. I'm 38 now. I've been on creams and done light therapy with short relief over the years. 

In 2019, when I joined, my Dr put me on methotrexate. It seemed to work. But the side effects were something else. Brain fog, fatigue, easily distracted. I honestly believe that it brought out adult ADHD that I didn't know I have. Well, the med capped off and stopped working this past April.

In April, my Dr prescribed Humira 40mg. It seemed to work at first. But in June, my psoriasis came back with a vengeance. It is worse than it has ever been. It's everywhere except my face and feet. It's even on the palms of my hands. It is debilitating and is killing my self-esteem. And my fatigue is worse than ever. I'm thankful my bf has been so very supportive or I'd feel worse. If that's even possible. 

So, my Dr has put me on Taltz 80mg. I am to begin the first double dose, week 0, tomorrow. I'm quite nervous. Humira didn't hurt at first but towards the end, the injects started to be a bit painful. I do not like to infect pain on myself. But, at this point, I don't care. I just want the itching, burning, and pain to end. 

Does anyone have any tips or thoughts on Taltz?

This study looked at the efficacy and safety of the anti-interleukin-23p19 monoclonal antibody Ilumya / Ilumetri (tildrakizumab) in patients with psoriatic arthritis (PsA)

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Objectives:
To evaluate efficacy and safety of the anti-interleukin-23p19 monoclonal antibody tildrakizumab in patients with psoriatic arthritis (PsA).

Methods:
In this randomised, double-blind, placebo-controlled, phase IIb study, patients with active PsA were randomised 1:1:1:1:1 to tildrakizumab 200 mg every 4 weeks (Q4W); tildrakizumab 200, 100 or 20 mg Q12W; or placebo Q4W. Patients receiving tildrakizumab 20 mg or placebo switched to tildrakizumab 200 mg Q12W at W24; treatment continued to W52. The primary efficacy endpoint was proportion of patients with ACR20 response (≥20% improvement by American College of Rheumatology criteria) at W24. Secondary efficacy endpoints were assessed without adjustment for multiplicity. Safety was evaluated from treatment-emergent adverse events (TEAEs).

Results:
391/500 patients screened were randomised and treated. At W24, 71.4%–79.5% of tildrakizumab-treated versus 50.6% of placebo-treated patients achieved ACR20 (all p<0.01). Patients receiving tildrakizumab versus placebo generally achieved higher rates of ACR50, Disease Activity Score in 28 joints with C reactive protein <3.2, minimal disease activity and 75%/90%/100% improvement from baseline Psoriasis Area and Severity Index responses at W24 and through W52. Improvement in dactylitis and enthesitis was not observed; results were mixed for other outcomes. Responses in patients switched to tildrakizumab 200 mg at W24 were consistent with treatment from baseline. TEAEs and serious TEAEs occurred in 64.5% and 3.3%, respectively, of all patients through W52 and were comparable among treatment arms.

Conclusions:
Tildrakizumab treatment significantly improved joint and skin manifestations of PsA other than dactylitis and enthesitis. Treatment was generally well tolerated through W52.

This study constructed the most comprehensive structural variations (SV) map for psoriasis

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Background:
Structural variations (SVs, defined as DNA variants ≥50 bp) have been associated with various complex human diseases. However, research to screen the whole genome for SVs predisposing to psoriasis is still lacking.

Objectives:
This study aimed to investigate the association of SVs and psoriasis.

Methods:
We performed a genome-wide screen on SVs using an imputation method on 5 independent cohorts with 45,386 subjects from the Chinese Han population. Fine mapping analysis, genetic interaction analysis and RNA expression analysis were conducted to explore the mechanism of SVs.

Results:
We obtained 4,535 SVs in total and identified 2 novel deletions (esv3608550, OR=2.73, P<2.00×10-308; esv3608542, OR=0.47, P=7.40×10-28) at 6q21.33 (MHC), 1 novel Alu element insertion (esv3607339, OR=1.22, P=1.18×10-35) at 5q33.3 (IL12B), and confirmed 1 previously reported deletion (esv3587563, OR=1.30, P=9.52×10-60) at 1q21.2 (LCE) for psoriasis. Fine mapping analysis including SNPs and small Insertions/Deletions (InDels) revealed that esv3608550 and esv3608542 were independently associated with psoriasis, and a novel independent SNP (rs9378188, OR=1.65, P=3.46×10-38) was identified at 6q21.33. By genetic interaction analysis and RNA expression analysis, we speculate that the association of 2 deletions at 6q21.33 with psoriasis might relate to their influence on the expression of HLA-C.

Conclusions:
Our study constructed the most comprehensive SV map for psoriasis thus far and enriched the genetic architecture and pathogenesis of psoriasis as well as highlighted the nonnegligible impact of SVs on complex diseases.

NICE the National Institute for Health and Care Excellence UK recommends Xeljanz (tofacitinib) for juvenile psoriatic arthritis.

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NICE has published final draft guidance which recommends tofacitinib (also known as Xeljanz) as an option for treating juvenile psoriatic arthritis in people 2 years and older.

The treatment is available for young people whose arthritis has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) and only if:

• A tumour necrosis factor (TNF)-alpha inhibitor is not suitable or does not control the condition well enough.   
  
• The company provides tofacitinib according to the commercial arrangement.
  

Clinical evidence shows that tofacitinib is effective when compared with a placebo and indirect comparisons suggest it has a similar effect to other treatments for the same indication.

Active polyarticular juvenile arthritis and juvenile psoriatic arthritis are types of juvenile idiopathic arthritis. Juvenile idiopathic arthritis is an inflammation of the joints that begins in people under 16 years of age where the cause or trigger is uncertain or unknown. In total about 3,000 in England have juvenile idiopathic arthritis.

There are more than 1,000 people in England who would be eligible for treatment with tofacitinib.

Does anyone know what happens after we have used our single use syringes and am I doing it right ?

Once I'm finished here is what I do.

1. The swab I use to clean the skin goes in the bathroom waste bin.
   
2. The cardboard box, inner packaging, leaflet and needle cap I put in the recycle bin.
   
3. The syringe goes in my yellow sharps bin.
   

NICE The National Institute for Health and Care Excellence UK have given approval for the use of Cosentyx (secukinumab) in children.

Quote:

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Recommendations:

1.1 Secukinumab is recommended as an option for treating plaque psoriasis
in children and young people aged 6 to 17 years, only if:

• the disease is severe, as defined by a total Psoriasis Area and Severity
  Index (PASI) of 10 or more and
  
• the disease has not responded to other systemic treatments, including
  ciclosporin, methotrexate and phototherapy, or these options are
  contraindicated or not tolerated and
  
• the company provides the drug according to the commercial
  arrangement.
  

1.2 Stop secukinumab treatment at 12 weeks if the psoriasis has not responded adequately. An adequate response is defined as a 75%  reduction in the PASI score (PASI 75) from when treatment started.

1.3 Choose the least expensive treatment if patients (or their parents or carers) and their clinicians consider secukinumab to be one of a range of suitable treatments. Take into account availability of biosimilar products, administration costs, dosage, price per dose and commercial arrangements.

1.4 Take into account how skin colour could affect the PASI score and make any appropriate clinical adjustments.

1.5 These recommendations are not intended to affect treatment with secukinumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. This decision should be made jointly by the clinician, the child or young person and their parents or carers.

This could be bad news for some of the Janus kinase (JAK) inhibitors for treating psoriasis.

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FDA (U.S. Food and Drug Administration) requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions.

Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety clinical trial, we have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). This trial compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz. A prior DSC based upon earlier results from this trial, reported an increased risk of blood clots and death only seen at the higher dose.

We are requiring new and updated warnings for two other arthritis medicines in the same drug class as Xeljanz, called Janus kinase (JAK) inhibitors, Olumiant (baricitinib) and Rinvoq (upadacitinib). Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated. However, since they share mechanisms of action withXeljanz, FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial.

Two other JAK inhibitors, Jakafi (ruxolitinib) and Inrebic (fedratinib), are not indicated for the treatment of arthritis and other inflammatory conditions and so are not a part of the updates being required to the prescribing information for Xeljanz, Xeljanz XR, Olumiant, and Rinvoq. Jakafi and Inrebic are used to treat blood disorders and require different updates to their prescribing information. If FDA becomes aware of any additional safety information or data that warrants updates to the prescribing information for these medicines, we may take further action and will alert the public.

Hello!  

Thank you for membership in this forum.  I look forward to getting to know you, to your help, and to learning more about psoriasis.

I saw a dermatologist in April 2021 and had two punch biopsies.  Before the biopsies, the doctor said that it looked like I had Psoriasis.  However, pathologist report said it was possibly a "drug-induced psoriasis or psoriasiform drug eruption."  

The literature for Humira says that a user may develop new or worsening psoriasis. I have been on Humira for Crohn's Disease since 2007.  Humira has given me a wonderful remission from Crohn's, and I have returned to an active lifestyle following many years of illness.  

I am 56-year-old female who developed Crohn's at the age of 21. With this remission, I returned to the love of my teenage years--roller skating--and found the sport of Artistic Roller Skating (think figure skating) was open for all ages.  The rashes are annoying wherever they are on my body, but the part that is most concerning involves my feet since they spend a lot of time in skates.

My dermatologist gave me prescriptions for Augmented Betamethasone ointment (and lotion for scalp) as needed when psoriasis is present.  He said that it could take a few months to see results.  The prescription contains 11 refills for a one-year period.  He also prescribed a Desonide ointment for delicate skin.  I assumed that with so many refills, this medication could be used long-term. 

The rash was originally located in only a couple places on my shins and arms and in my scalp.   Now it is on my legs from hip to toes, a little on my front torso, on my back torso, and lightly on my forehead.  

I developed thin skin and bleeding in my instep, ankle, and on the two fingers I most commonly used to apply the ointments (I always washed hands with soap and water after applying), so I quit using the ointments on August 25, 2021, but resumed the today (August 31) on a few spots that had become extra painful/itchy.  

Through this forum, I am learning that topical steriods are not good long term . . . or maybe not good at all.  I hope to learn more.   Did the use of the ointments possibly cause more rashes?  I have been using Lubriderm lotion or Cetaphil Cream after morning showers and bathing with colloidal oatmeal on most afternoons, hoping that moisturizing will help.

The cost for the office visit with biopsies was nearly $700, with my co-pay being $60.  When I was 21-years-old and met the gastroenterologist who diagnosed Crohn's Disease, the initial consultation cost was only $55.  I don't know how US medicine became so expensive.

Thank you for reading.

During lockdown here on Exmoor, I was looking online for something and I came across black cherry juice concentrate.

In title, it said something about how good black cherry juice is for arthritis, gout etc etc and I thought to myself; “I wonder if it would work on PSA sufferers ?”

Well, I purchased a couple of bottles and when they arrived on my doorstep, I mixed some with with my Pepsi Max and drank it for around two weeks.
I noticed that the swelling went down in my fingers and the aches & pains had eased right up in my body.

Now, black cherry juice is NOT a cure for psoriatic arthritis, but it does take around 75% of the pain away and to be honest, that’s better than nothing and better than taking pills !

Where to purchase black cherry juice ?

Supermarkets, health food shop’s, online auction sites etc.

For the poor PSA sufferers out there, give black cherry juice a go, you’ve nothing to loose, well, around £13

GB

Caroline passed this on to me and although the abstract doesn't mention psoriasis, is does mention "inflammatory arthritis" so some of you may find it interesting.

Quote:

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Objectives:
The impact of inflammatory arthritis (IA) on male fertility remains unexplored. Our objective was to evaluate the impact of IA on several male fertility outcomes; fertility rate (number of biological children per man), family planning, childlessness and fertility problems.

Methods:
We performed a multicentre cross-sectional study (iFAME-Fertility). Men with IA 40 years or older who indicated that their family size was complete were invited to participate. Participants completed a questionnaire that included demographic, medical and fertility-related questions. To analyse the impact of IA on fertility rate, patients were divided into groups according to the age at the time of their diagnosis: ≤30 years (before the peak of reproductive age), between 31 and 40 years (during the peak) and ≥41 years (after the peak).

Results:
In total 628 participants diagnosed with IA were included. Men diagnosed ≤30 years had a lower mean number of children (1.32 (SD 1.14)) than men diagnosed between 31 and 40 years (1.60 (SD 1.35)) and men diagnosed ≥41 years (1.88 (SD 1.14)).This was statistically significant (p=0.0004).The percentages of men diagnosed ≤30 and 31–40 years who were involuntary childless (12.03% vs 10.34% vs 3.98%, p=0.001) and who reported having received medical evaluations for fertility problems (20.61%, 20.69% and 11.36%, p=0.027) were statistically significant higher than men diagnosed ≥41 years.

Conclusions:
This is the first study that shows that IA can impair male fertility. Men diagnosed with IA before and during the peak of reproductive age had a lower fertility rate, higher childlessness rate and more fertility problems. Increased awareness and more research into the causes behind this association are urgently needed.

New guy here. I did an intro post with most of my details. Have had PS since somewhere around 2010. Currently on Humira but want to get my diet in order and then come off the Humira.

I have done some research on PS and anti-inflam diets. WOW. Everything I currently eat is a big no no. Well,I guess then its no wonder i have PS lol.

Im trying to comprehend how this will work because we are talking about a huge lifestyle change for me.



Long story short. I DONT COOK.    Well, make that I "DIDNT" cook. I guess I do now.

The main snag I see is that I am a meat eater and I need my proteins. I lift weights. I hate the use the term "bodybuilder" (since i dont look like one lol) but thats the general idea. I see "no red meat" listed. Ok, that sucks but maybe not the end of the world. Then I see proteins listed as Salmon and Trout. lol. ok. Thats it???

What I dont see much guidance on is CHICKEN?!? I see eggs sometimes listed as bad, sometimes not. But I dont see much listed about actual chicken. If I were to dream that I could be on a strict bodybuilder type diet...that would typically be tons of chicken breast. So is chicken ok or is it no good or what??


Any guidance on these foods would be nice:


chicken?

veal?

any other good meat options besides fish?

eggs? I sometimes see them listed as a no no. What about egg whites? what about egg substitutes?


fruits in general. i see "no citrus fruits" and then i see on the "good" side stuff like blueberrys and cherries. lol. ok. Thats it though? What other fruits are ok?


What about green grapes? I see that "sour grapes" may be a no no. Are all green grapes considered sour? I hope not lol



what about protein powders? I am assuming most would have gluten? or would they be considered too "processed"?


The main snag for me (besides the obvious huge lifestyle change) is I dont see how i will get enough protein. Say, 200grams per day or thereabouts.



Thanks for any suggestions or ideas.  

Peace, JonJon

JonJon here. Currently 54 years old. Ive had Psoriasis since somewhere around 2010. Maybe even some symptoms as far back as 2008ish? It started on my elbows and I didnt pay much attention to it but you know how that goes.

Some years back I was taking Methotrexate and one thing lead to another and now i am on Humira.

Other than Humira I am not on ANY meds. Even with the Humira I still have plenty of scalp issues and some visible spots including one on my face which has been there a good while.

At this point my plan is to totally change my diet and to come off of Humira entirely. it is what it is.

When I look at "Psoriasis diets" or anti inflam diets, they basically rule out EVERYTHING I eat. Of course that is also a good clue as to why I ended up with Ps in the first place

I am also quite overweight. about 236lbs at 5.8".....which I read is also a contributor to chronic inflammation. Since I have a goal to be around 185lbs anyway, there is no way around a massive diet overhaul.

Stats. 7-29-2021

54 y.o.

5'8" 236lbs (goal 185ish)

taking Humira. Plan to come off of it eventually. Am on no other meds.

Ill be asking some diet and cooking questions im sure! lol

Cheers, JonJon

Interesting article about a woman that had problems with onset of remitting seronegative symmetrical synovitis with pitting oedema and palmoplantar psoriasis flare-up after covid vaccination.

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An 83-year-old woman referred to the dermatology division of our hospital because of recent acute onset of stiffness with limitation in basic activities of daily living and pain, swelling and palmar skin eruption of both hands. All symptoms showed up 48 h after the second administration of BNT162b2 Pfizer/BioNTech® Sars-Cov-2 vaccine.

The patient presented with a history of palmoplantar psoriasis since 1996, in long-standing remission with methotrexate (MTX) 10 mg every 10 days. She took also anti-hypertensive and oral antidiabetic medications. She had no history of rheumatic or allergic diseases.

At physical examination, both hands on palmar side showed psoriasis with erythematous, scaly plaques, while on dorsum and wrist joints, painful oedema was present. Dactylitis was also detected in all fingers associated with severe functional impairment. Musculoskeletal ultrasound (MSUS) revealed tenosynovitis of the digital extensor tendon and the carpal extensor tendon of wrists based on the presence of hypoechoic signals around the tendon sheath with power Doppler signal both in transverse and in longitudinal planes. Acute phase reactants were elevated, rheumatoid factor was negative, and X-rays revealed no joint erosions. The scenario indicated a flare-up of palmar psoriasis associated with the onset of psoriatic arthritis with remitting seronegative symmetrical synovitis with pitting oedema (RS3PE). The patient started oral prednisone (25 mg once daily) and increased MTX dosage (10 mg weekly), with a rapid clinical improvement.

New onset or exacerbation of psoriatic disease following vaccinations, though rare, is reported in literature. To date, the cases of psoriasis flare-up have been described with influenza, pneumococcal polysaccharide, Bacillus Calmette–Guerin (BCG) and tetanus–diphtheria vaccines.

In this case, the close temporal link between Sars-Cov-2 vaccination and the onset of psoriasis flare-up associated with joint involvement suggests a possible causal association between the two events.

It is known that vaccination itself triggers an IFN-gamma and TNF-α release from Th1 cells, which could represent a possible mechanism for vaccination-induced psoriatic disease.

Polyethylene glycol (PEG) – one of the compounds of BNT162b2 – could also have been the cause for the systemic reaction observed, acting as the antigen that activated the immune pathway as reported in other cases.

RS3Pe syndrome is characterized by symmetrical synovitis and swelling of both the upper and lower extremities. RS3PE syndrome may overlap several rheumatic disorders such as polymyalgia rheumatica, rheumatoid or psoriatic arthritis, especially at the onset in the elderly, similar to our case. The aetiology of the disease is still unknown, although some authors have related it to genetic predisposition, infectious diseases or α-TNF released by tumours or a paraneoplastic syndrome when recovery was observed after a complete tumour removal. In literature, two cases of RS3PE following intravesical instillation of BCG8, are reported.

Typical RS3PE treatment includes NSAIDs, hydroxychloroquine and corticoids, and full recovery usually occurs between 3 and 36 months after starting corticoid treatment.

To the best of our knowledge, this is the first case of palmoplantar psoriasis flare-up and RS3PE onset after Sars-Cov-2 vaccination. Currently, BNT162b2 Pfizer/BioNTech ® remains a very safe and effective vaccine10 and its use is strongly recommended.

Its been well over a year since I stopped my treatment, due to problems with my eyes. Still have problems but very mild.

Last night, I had my fist injection of ilumetri. See how that goes. Scared it will affect my eyes, if I tell the truth

ANYWAY. 
A few weeks ago I was given oral steroids (prednisone) for inflammation in my nose. Had them a few years ago. Not a problem.
Only a short 5 day treatment but boy did it clear my skin .
After 5 days its pretty amazing. I didnt even know Prednisone was used to clear Psoriasis. Apparently its only short term and works way better in men.
I cant find anything about it on here.

Hi everyone, it's been a while since I last posted.

So I've been trying to dodge covid while slowly getting covered in psoriasis. My derm convinced me to hold off going on to any meds while covid was in full swing and over the last year or so im now at a point where I have no choice. 

I was previously on Fumaderm which was a miracle drug for me where I got full clearance on just 1 full strength tablet. I then got moved to skillerence but I  had very bad stomach pains and ended up stopping them.

So a year later im in need of more meds and for my sins I asked to try skillerence again. I got on so well with Fumaderm I want to give it another go. 

So I'm now on 3 initial tablets a day and although I've had stomach pains im determined to see it through. 

Second time lucky? Fingers crossed.

Galapagos reports positive topline results with selective TYK2 inhibitor GLPG3667 in Phase 1b psoriasis study.

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Galapagos reports positive topline results with tyrosine kinase 2 (TYK2) inhibitor GLPG3667 in a Phase 1b study in psoriasis patients. GLPG3667 was discovered by Galapagos.

Galapagos evaluated GLPG3667, a proprietary selective TYK2 compound, in a randomized, placebo-controlled, double-blind Phase 1b study in 31 patients with diagnosis of moderate to severe plaque psoriasis. Patients were randomized in a 1:1:1 ratio to a daily oral dose of GLPG3667 (low dose or high dose) or placebo, for a total of four weeks. Main objectives were to evaluate the safety and tolerability of GLPG3667 as well as signs of clinical activity at Week 4.

GLPG3667 was well tolerated in this Phase 1b trial. One patient in the low dose group interrupted the study for one day for exacerbation of psoriasis. The majority of treatment related adverse events (AEs) were mild in nature and transient. There were no deaths or serious adverse events (SAEs) in this 4-week study. At Week 4, four out of 10 patients in the high dose group had a PASI1 50 response, defined as at least a 50% improvement in PASI from baseline, compared to one out of 10 subjects on placebo. There were no subjects with a PASI 50 response on the low dose of GLPG3667. The four responders in the high dose group of GLPG3667 achieved a 52%, 65%, 74% and 81% improvement respectively in their PASI scores from baseline, while the subject randomized to placebo improved by 52%. Positive efficacy signals were also observed with the high dose for other endpoints, including affected Body Surface Area and physician and patient global assessment, versus placebo at Week 4.

“We are pleased with the efficacy signal and safety profile observed with GLPG3667 in patients with psoriasis over a 4-week period,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos. “Based on these results, we aim to initiate a global Phase 2b program in psoriasis next year as part of a program to develop our selective oral TYK2 inhibitor GLPG3667 broadly in inflammatory indications.”

“The PASI 50 scores and other efficacy data after only four weeks of treatment, combined with the safety profile observed, are very supportive for moving this compound into a larger trial in psoriasis. People living with psoriasis remain in need of alternative treatments, especially oral ones,” said Prof. Dr. Diamant Thaci, Professor of Medicine at the Comprehensive Center for Inflammation Medicine, University of Lübeck, Germany.

Galapagos intends to submit study outcomes with GLPG3667 for publication at scientific conferences and in peer-reviewed medical journals.

GLPG3667 is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established.