Lilly syas Taltz demonstrated superiority in improving active psoriatic arthritis compared to Humira.

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Eli Lilly announced today Taltz (ixekizumab) met the primary and all major secondary endpoints in the Phase 3b/4 SPIRIT-H2H study, which evaluated the efficacy and safety of Taltz versus Humira® (adalimumab) in patients with active psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drug (DMARD)-naive. The SPIRIT-H2H trial is the first completed large head-to-head (H2H) superiority study in active PsA. This open-label, randomized, controlled trial is the first and only H2H study that utilizes on-label dosing for both Taltz and Humira and includes concomitant conventional DMARDs.

At 24 weeks, patients treated with Taltz met the primary endpoint by demonstrating superiority in improving the signs and symptoms of active PsA compared to Humira as measured by the proportion of patients simultaneously achieving at least a 50-percent reduction in disease activity, as defined by the American College of Rheumatology (ACR50), as well as complete skin clearance as measured by the Psoriasis Area and Severity Index (PASI100). In addition, Taltz met the major secondary endpoints.

"The positive results from the SPIRIT-H2H trial reinforce that Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "These results provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis."

A total of 566 active PsA patients were enrolled in the study to evaluate the efficacy and safety of Taltz compared to Humira. Patients with active PsA were randomized to receive Taltz at the approved dose (160-mg starting dose followed by 80 mg every four weeks), or Humira (40 mg every two weeks) for a total of 52 weeks, with the primary analysis conducted at 24 weeks. Patients meeting criteria for moderate-to-severe plaque psoriasis received the approved dose of Taltz (160-mg starting dose followed by 80 mg every two weeks from Week 2 to Week 12 and every four weeks thereafter) or Humira (80-mg starting dose followed by 40 mg every two weeks, one week after the initial dose).

"In the SPIRIT-H2H trial, Taltz demonstrated superiority in improving active psoriatic arthritis compared to Humira," said Philip Mease, M.D., Swedish Medical Center/Providence St. Joseph Health and University of Washington. "This study will help raise awareness and better inform conversations between patients and their healthcare providers about treatment options for active psoriatic arthritis."    

In SPIRIT-H2H, the safety profile of Taltz was consistent with previously reported results. No new safety signals were detected.

Lilly plans to submit detailed data from the SPIRIT-H2H study for disclosure at scientific meetings and in peer-reviewed journals in 2019.

So my son finds the Clobex Shampoo is to annoying to apply and it is thinning his already fine and very blond hair which makes the psoriasis easier for others to see. Any one tried any shampoos that are easy to apply and work for you? By easy to apply, I mean it works like an actual shampoo...you put it on, lather, let it sit for a few minutes and rinse off. His scalp is pretty bad. Starting the Stelara pretty soon but would be great if he didn't feel he had to hide in a hat every day...

Has anyone tried CBD oil (Cannabidoil)? It is now legal in Canada and I have a friend who I just discovered has Psoriasis. She swears by CBD oil skin cream and hemp oil for her scalp.

Hi, Just a quick introduction from me to your forum. I have had psoriatic arthritis since the mid 90s and have had most of the treatments prescribed over the years.I was just wondering if anyone he's any problem with eyes itching..I began treatment of taltz on Wednesday and have developed itching of my eyes today.I wondered if it was common. I have took loratadine tablets daily and eyedrops but it's not working. Any advice would be greatly appreciated.
Thanks in advance. . grifter123

This study suggests long‐term, low‐dose acitretin in patients with psoriasis is unlikely to cause significant liver or lipid problems.

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Background:
This retrospective observational study aimed to investigate the long‐term safety, drug survival, and factors associated with the survival of acitretin in a real‐world setting.

Methods:
Data of adult patients with psoriasis who attended Siriraj Hospital between 2012 and 2017 and were treated with acitretin were reviewed. Demographic data and clinical courses were recorded. The Kaplan–Meier curve and Cox regression were used to calculate drug survival and the factors associated with drug survival, respectively.

Results:
Of 104 patients, 56 and 48 were male and female, respectively, with a mean treatment duration of 3.2 years. The mean cumulative dose per patient was 19.28 ± 7.84 mg/day. Acitretin was administered to 73, 39, 24, and six patients for more than 1, 3, 5, and 10 years, respectively. Most side effects were mild and tolerable; only nine patients withdrew acitretin due to side effects. No patients developed clinical features of cirrhosis or uncontrolled hyperlipidemia. The drug survival rates were 79%, 69.5%, 61.2%, 57.6%, and 53.5% at 1, 2, 3, 4, and 5 years, respectively, higher than those of previous studies. Patients without obesity, metabolic syndrome, and dyslipidemia did not have a significantly longer acitretin survival compared to patients with these comorbidities.

Conclusions:
Long‐term, low‐dose acitretin in patients with psoriasis is unlikely to cause significant liver or lipid problems. In countries with difficulty accessing biological agents for psoriasis, acitretin may have a high drug survival rate due to its long‐term safety. This study has several limitations: its retrospective nature, single‐center study design, and small sample size.

Does anyone get blisters on there palms and feet.  Has anyone found something that can stop it.  I’m on enbrell and using fluocinonide cream but the blisters are so bad I can barely walk. I use baking soda to bathes to help with the pain and soreness.  Any input would be appreciated.

Janssen has said in it's new phase 3 data that Tremfya has beaten Cosentyx in a head to head.

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The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the ECLIPSE study demonstrating that TREMFYA® (guselkumab) was superior to Cosentyx® (secukinumab)* in treating adults with moderate to severe plaque psoriasis for the primary endpoint assessed at week 48.  Data from the multi-center, randomized, double-blind head-to-head Phase 3 study demonstrated that 84.5 percent of patients treated with TREMFYA achieved at least 90 percent improvement in their baseline Psoriasis Area Severity Index (PASI) score at week 48, compared with 70.0 percent of patients treated with Cosentyx (p<0.001).

These data, to be presented at the 3rd Inflammatory Skin Disease Summit in Vienna, December 12-15, mark the first-ever results from a head-to-head study comparing an interleukin (IL)-23-targeted biologic therapy (TREMFYA) with an IL-17 inhibitor (Cosentyx). ECLIPSE is Janssen's fourth TREMFYA Phase 3 study in plaque psoriasis and is part of a comprehensive clinical development program that also includes ongoing Phase 3 studies in psoriatic arthritis and Crohn's disease.

ECLIPSE incorporated six major secondary endpoints that used a fixed statistical sequence procedure to control for multiple comparisons and included both shorter and longer-term analyses.  TREMFYA demonstrated non-inferiority to Cosentyx in the first major secondary endpoint, with 84.6 percent of patients on TREMFYA achieving a PASI 75 response at both weeks 12 and 48 vs. 80.2 percent of those on Cosentyx (p<0.001), however, it did not demonstrate superiority (p=0.062).  Because superiority was not demonstrated for the first major secondary endpoint, p-values for all the subsequent major secondary endpoints were considered nominal.

Three of the remaining major secondary endpoints evaluated efficacy at week 48, including achievement of a PASI 100 response and Investigator's Global Assessment (IGA) scores of 0 (cleared), or 0 or 1 (cleared or minimal disease). At week 48, 58.2 percent of patients receiving TREMFYA achieved a PASI 100 response, compared with 48.4 percent of patients receiving Cosentyx; 62.2 percent of patients receiving TREMFYA achieved an IGA score of 0 compared to 50.4 percent of patients receiving Cosentyx; and 85.0 percent of patients receiving TREMFYA achieved an IGA score of 0 or 1 compared to 74.9 percent of patients receiving Cosentyx (all comparisons with nominal p≤ 0.001).

The remaining major secondary endpoints assessed non-inferiority of TREMFYA versus Cosentyx at week 12. The percentage of patients achieving a PASI 75 response at week 12 was 89.3 percent for TREMFYA and 91.6 percent for Cosentyx (p<0.001 for non-inferiority); the percentage of patients achieving a PASI 90 response at week 12 was 69.1 percent for TREMFYA and 76.1 percent for Cosentyx (p=0.127 for non-inferiority).

"The response-over-time curves show that maximum response rates with TREMFYA are achieved after six months and are maintained over time through one year, achieving superiority at the primary endpoint of the study," said lead study investigator Richard Langley, M.D., FRCPC, Professor, Division of Clinical Dermatology & Cutaneous Science, Department of Medicine, Dalhousie University. "Results of the study confirm a slightly more rapid onset of response with Cosentyx, but importantly, in a chronic disease like psoriasis, these data provide new insights into comparative longer-term efficacy."

Through week 44, 27 patients (5.1 percent) randomized to the TREMFYA arm discontinued treatment compared with 48 patients (9.3 percent) randomized to the Cosentyx arm.

The safety profiles observed for TREMFYA and Cosentyx in ECLIPSE were consistent with the known safety profiles seen in the respective registration trials and current prescribing information. Similar percentages of patients receiving TREMFYA (77.9 percent), and Cosentyx (81.6 percent) reported at least one adverse event (AE).  Serious AEs were reported in 6.2 percent of patients receiving TREMFYA and 7.2 percent of patients receiving Cosentyx. Serious infections occurred in six patients receiving TREMFYA and five patients receiving Cosentyx.

"Fortunately for patients, there are many good treatment options available for plaque psoriasis today. However, to make the best recommendation for their patients from among these options, physicians need long term comparative safety and efficacy data.  We're proud to have conducted this important trial to help guide clinical practice and continue to build on the robust database of clinical information that we've been able to generate on TREMFYA, the first IL-23 inhibitor," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC.

I'm going to see the derm next week about switching to Taltz. I've been on Stelara for about 10 years (1 month after it was approved). It just doesn't seem to be as effective at my extremities. PsA in my feet is ridiculous, as is Plaques on my toes. Stelara has never done anything for my nether region.  From what I can tell Talz theoreticlly should be better in all areas, but of course I'll never know unless I try it...

Which brings me to my question about cutting over to Taltz from Stelara. There are no guidlines for this, and you can't completely wash out as you'd have to be off Stelara for like a year. I remember the rheumy wanted me to wash out of the Humira for 3 months. It's not her joints that might get permanantly damaged of course. Fortunately, it was being perscribed by a derm that didn't really care what I did, because it was so new she had position to say anything. Is there any real need to wash out or just jump right in and be ready with a Z-pack if I get sick?

Oh and nice place ya'll got here, 1st post!  

Thx,
Jay

Hi!

Has anyone tried hyperbaric chamber for psoriasis? Or psoriatic arthritis?

Thank-you

Hi Everyone,


I live in California.   I have moderate-severe psoriasis.  It covers my legs, arms, head, my back and few nasty spots on my forehead and side of my face.  I have tried lifestyle changes, I fixed some issues with my gut like Small Intestinal Bacterial overgrowth (SIBO) and yeast issues.That didn't help.     I have tried red light therapy in a tanning salon.  And I have been doing Phototherapy.  The problem has been I have Blonde hair and Blue eyes so very photosensitive.  I  can get to about 450 Lumens and then I burn.  

I was desperate at one point when I had a bad reaction to the light therapy and I was up all night with pins and needles pain and itching out of my mind.  My niece convinced me to try these lights which are a combination infrared, red and blue light.  

Honestly, it did not really help the psoriasis but these are for inflammation, pain etc. I no longer have pain in my hands, back, knees and feet from Osteoarthritis! I use the pads on my head and the eye mask everyday.  The light therapy has really helped me cope with depression, anxiety too. So I consider it a very worthwhile investment! 

Anyway, The doctor decided to do a punch biopsy to confirm my diagnosis.   I got a terrible MRSA infection from that. Over that now. Yeah!


Back on the light therapy - started at the bottom level 200 and I am only back up to 250 now.  

My Dermatologist wanted me to start on Cosentyx.  
I have been very reluctant to jump on that.  Without the drug, In the past I have had chronic sinus  infections, bronchitis and Candida.  So, I worry about suppressing my immune system.

But I have just hit a wall with this disease and I think I am ready.  My husband and I Love to travel, go to Belize etc.  That is out until my skin is better because I can't stand to be in a hot humid environment. 

So that is my long background. I hope I haven't overshared.  I am really looking for support and information on other people's experiences with  Cosentyx.  Did they experience Candida, complications etc.  

I really appreciate having this forum!!

Cheers,

I've had mild plaque psoriasis for about 18 years (elbows, knees ankles) and only recently started really looking to understand it, as it (luckily) doesn't severely affect my daily life.

One thing I've come to realize, is my immune system is generally way worse than the average person when it comes to flu/cold. I get sick more often and more severely than most people. Anyone else notice this? Can/is it attributed to psoriasis? Or am I just a wuss?

Looks like the boy will be starting Stelara in a couple weeks. He hasn't had the flu shot this year, I know the Stelara will lower his immunity to flu's and colds and it is a bad flu year over here. I will discuss with the medical professionals, so of course know this is opinion only, but what are your thoughts on flu shot and psoriasis? I read somewhere (here?) that some people think the flu shot aggravates P. I also wonder about the interactions between drugs AND if it is the prudent thing to do if there is no interactions.

This study compared Calcipotriol/betamethasone dipropionate (Cal/BD) [0.005%/0.05%] aerosol foam (*no mention of Enstilar by name but that would be my guess) against Otezla (apremilast), Methotrexate, Acitretin, and Fumaric Acid Esters (FAE)

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Background:
Plaque psoriasis has significant impact on patients’ quality of life. Topical therapy is considered the treatment mainstay for mild‐to‐moderate disease according to guidelines. Calcipotriol/betamethasone dipropionate (Cal/BD) [0.005%/0.05%] aerosol foam is indicated for psoriasis vulgaris treatment in adults. Cal/BD foam trials demonstrated improved efficacy and similar safety in this population. Psoriasis treatment is complicated by the broad range of disease presentation, variability, and therapeutic options; particularly decisions on transition from topical to non‐biologic systemic treatment are difficult. Assessing comparative effectiveness of treatment options provides meaningful value to treatment decisions.

Objective:
To compare efficacy of Cal/BD foam individual patient data from pooled trials with efficacy of non‐biologic systemic treatments based on aggregated patient characteristics and treatment outcomes.

Methods:
Individual data from 4 Cal/BD foam trials in 749 psoriasis patients were pooled to conduct matching‐adjusted indirect comparisons. Literature review identified non‐biologic systemic treatment trials where methods, populations, and outcomes align with Cal/BD foam trials. Of 3,090 screened publications, 4 studies of apremilast, methotrexate, acitretin, or Fumaric Acid Esters (FAE) were included.

Results:
After baseline matching, patients treated with 4 weeks of Cal/BD foam had greater Physician's Global Assessment 0/1 response compared to those treated with 16 weeks of apremilast (52.7% vs. 30.4%; P<0.001). Patients treated with Cal/BD foam had significantly greater Psoriasis Area and Severity Index (PASI) 75 response at Week 4 compared to 16 weeks of apremilast treatment (51.1% vs. 21.6%; P<0.001). Cal/BD foam patients demonstrated significantly greater PASI 75 response improvements at Week 4 versus 12 weeks of methotrexate (50.8% vs. 33.5%; P<0.001) or acitretin (50.9% vs. 31.7%; P=0.009), and comparable response to FAE (42.4% vs. 47.0%; P=0.451).

Conclusions:
Despite recent treatment advances, unmet needs for psoriasis patients remain. Cal/BD foam offers improved efficacy in baseline matched psoriasis patients compared to apremilast, methotrexate, or acitretin, and comparable efficacy to FAE.

Bryhali lotion has been given FDA approval for use with psoriasis.

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Bausch Health announced it expects to start distribution of Bryhali (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month.

What is Bryhali Lotion?

• Bryhali Lotion is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if BRYHALI Lotion is safe and effective in children under 18 years of age.
  

Important Safety Information

• Bryhali Lotion is for use on skin only. Do not use bryhali Lotion in your mouth, eyes, or vagina.
  

Before you use Bryhali Lotion, tell your healthcare provider about all your medical conditions, including if you:

• Have had irritation or other skin reaction to a steroid medicine in the past
  
• Have a skin infection
  
• Have diabetes
  
• Have adrenal gland or liver problems
  
• Are pregnant or plan to become pregnant
  
• Are breastfeeding or plan to breastfeed. It is not known if Bryhali Lotion passes into your breast milk. If you do breastfeed, do not apply Bryhali Lotion to your nipple or areola to avoid getting it in your baby's mouth
  

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroids by mouth or injection, or use other products on your skin that contain corticosteroids.
What are the possible side effects of Bryhali Lotion?
Bryhali Lotion may cause serious side effects, including:

• A condition where your adrenal glands stop working
  
• Cushing's syndrome, a condition caused by too much exposure to the hormone cortisol
  
• High blood sugar (hyperglycemia)
  
• Skin reactions at the treated site
  
• Vision problems such as cataracts and glaucoma. Tell your doctor about any blurred vision or other vision problems during treatment
  
• Effects on growth and weight in children
  

The most common side effects of Bryhali Lotion include: burning, stinging, itching, dryness (application site dermatitis), upper respiratory tract infection, and high blood sugar (hyperglycemia).

Use:

• Apply a thin layer of Bryhali Lotion to the affected areas once daily.
  
• Treatment beyond 8 weeks is not recommended. Discontinue treatment if control is not achieved before 8 weeks.
  
• Do not use with occlusive dressings unless directed by a physician.
  
• Avoid use on the face, groin, or axillae.
  
• Not for oral, ophthalmic, or intravaginal use.
  

I'm about to start Taltz tomorrow. I'm excited after reading a few posts but I have a question. I'm a pretty fat guy with a big ol belly. I always used an autopen with Humira (Did nothing for me) in my leg. I never minded the slight pain. I've got the prefilled syringe for Taltz. Would you old pros still recommend I try to do it in my stomach even though I'm really fat there? Or should I suck it up and try the legs?

Hello from newbie ItchyTeri!!
Just wanted to pop by and say 'Hi' to all fellow sufferers lurking here.
I only found this group today. I've not been one to join groups regarding my skin condition, but thought I might just as well.
I've had Psoriasis for many years now. Always had dry skin even as a teenager, with mild eczema to start with. The Psoriasis kicked in with childbirth, just one weird spot on the leg to start with, which grew and spread and got worse and worse as time went on.
I've used various cremes and ointments over the years. None of which has cleared my skin up. Some worked better than others just to hold it in check, but as one patch starts to clear, many more spots break through. It's an endless cycle.
A few years ago I got sent for Photo Therapy - what a godsend!!  I cleared up and was FREE - but only for a while. A couple of weeks later, and here we go again...Only Worse than before. Nothing I do seems to hit the mark.
I've had three sessions in the light box up to now. Just been referred for another session, but won't get to that one for at least a year due to crappy waiting times. Only one booth here where I live, unless I wanted to travel 60 miles to the next one.
Anyroadup. Here I am saying hallloooooooooo!!
Teri x

This study suggests Women showed higher expectations and rated specific needs in psoriasis treatment higher than men.

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Background:
Though patient needs are key drivers of treatment decisions, they are rarely systematically investigated in routine care.

Objective:
This study aimed at analysing needs and expectations from the patient perspective in the German and Swiss psoriasis registries PsoBest and SDNTT with respect to treatment choice, age and gender.

Methods:
The German and Swiss psoriasis registries observe patients recruited at first‐time use of systemic drugs. Within 10 years, clinical (Psoriasis Area Severity Index (PASI), Body Surface Area (BSA)) and patient‐reported outcomes are documented, including the Dermatology Quality of Life Index (DLQI) and the Patient Benefit Index (PBI), characterizing patient needs for treatment. The analysis dataset includes n=4,894 patients from PsoBest and n=449 from SDNTT with mean follow‐up time of 7.5 months.

Results:
5,343 patients registered between 2008 and 2016 were included in the analyses (at baseline: 59.6% male, mean age 47.6 years±14.5, PASI 14.2±9.7, BSA 22.7±19.7, DLQI 11.3±7.2).The most important patient needs were to “get better skin quickly” and to “be healed of all skin defects”.

Subgroup analyses by age revealed significant differences in needs, especially higher needs regarding social impairments in patients younger than 65 years. Patients 65 years or older attributed more importance to sleep quality, less dependency on medical visits, fewer side effects and confidence in the therapy. Out of 25 items reflecting patient needs, 20 items were rated significantly more important by women than men, with the greatest differences regarding feeling of depression, sleep quality and everyday productivity. Divided by treatment, needs were rated differently, recommending individualized and targeted choice of therapy.

Conclusion:
Age and gender stratify patient needs. Women showed higher expectations and rated specific needs in psoriasis treatment higher than men. Analyzing the patient needs on an individual level will facilitate shared decisions by patient and physician in finding the optimal personalized treatment.

This picture happen last year around August 2017  after it rebound and is way much worse then before is almost 90 % cover my body . I have been taking cyclosporine and steriods cream for a year  . So i have decide to stop western medicine since then , and try natural healing ways . My experience is healthy diet do make a difference on my natural healing journey. As per now my face are completely clear compare to the below picture i attached. Sadly was , my other body part has not much improvement.
Until recently i have make up my mind to back to western medicine path, as i really cant endure the pain anymore.. as most of you will understand how i feel if you were a severe one. I went back to my derm specialist , she had advised me on Stelara. Hope to get some good or even bad reviews about this medicine here based on own experience. Yes i do read at other article that someone post about stelara, but i hope some of you response here and i really have questions to ask .

I have rheumatoid psoriasis, I have also had low platelet count which was put in remission with prednisone. The prednisone was horrible but “fixed” both issues (I thought) but it was temporary. Platelets are in normal range but psoriasis it out of control. Humira stopped working after year and a half, stellara never helped, after loading doses and two more shots on consentx I have now developed pustules covering the soles of my feet and palms of my hands and on my scalp.  So, my new doctor going to try embrell but while I wait for insurance approval I’m back on prednisone. Problem is prednisone makes me feel sick, raging angry, messed up dreams and as you can infer from this post depressed.

Hi
my name is Karen, I live in Brisbane, Australia and I am originally from the United Kingdom. I am a single mum of four and I work full time as a truck driver for a large postal company.
My Psoriasis first appeared when I was about ten and I believe was triggered by my dad getting a promotion, us moving house and having to start straight into a new high school. First sign was on my scalp, over the years it has spread around my body and now at the grand old age of fifty two I have Psoriasis  pretty much everywhere in varying degrees.
I find stress aggravates it, certain foods, alcohol and the cold weather. 
I haven't met anyone else locally who suffers from Psoriasis so I am hoping to participate and learn from others on this site,
thanks
 Karen