Hello everyone
I have been reading many posts to help my try to understand this horrible disease better and get an idea as to what medications/diet or other treatments are working best for others. Have had pustular psoarisis since 2014.  Getting worse all the time. Have landed in the hospital with cellulitous. Hands and feet are terrible., I am typically a very active person but this is starting to really affect me emotionally and physically. Have tried creams, methotrexate, humira, now taltz. Any advice or what worked for others I woukd appreciate.  Thanks in advance

Following on from this thread Taltz shows good results for psoriatic arthritis Lilly have announced it has now got approval for psoriatic arthritis.

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Eli Lilly announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA). Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate. Taltz should not be used in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz may increase the risk of infection. Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations.

The efficacy and safety of Taltz was determined from findings from two randomized, double-blind, placebo-controlled Phase 3 studies - SPIRIT-P1 and SPIRIT-P2 - which included more than 670 adult patients with active PsA. SPIRIT-P1 evaluated the safety and efficacy of Taltz compared to placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug. SPIRIT-P2 evaluated the safety and efficacy of Taltz compared to placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors. Across both studies, patients were required to have a diagnosis of active PsA for at least six months and at least three tender and three swollen joints. Non-responder imputation (NRI) methods were used. Inadequate responders (defined by blinded tender and swollen joint count criteria) at Week 16 received rescue therapy and were analyzed as non-responders.

In studies of biologic-naïve and TNFi-experienced patients, the primary efficacy endpoint was the proportion of patients at 24 weeks achieving ACR20 response, which represents a 20 percent reduction in a composite measure of disease activity as defined by the American College of Rheumatology (ACR).1 Results from both studies demonstrated that patients treated with Taltz achieved significant improvement in joint symptoms, as measured by ACR20, compared with placebo. At 24 weeks, patients achieved ACR20 at the following response rates:

   SPIRIT-P1: 58 percent of patients treated with Taltz vs. 30 percent for placebo1
   SPIRIT-P2: 53 percent of patients treated with Taltz vs. 20 percent for placebo1

"For patients with PsA, treatment goals often include improvement in joint symptoms," said Philip Mease, M.D., Swedish Medical Center and University of Washington. "Based on the study results, Taltz can provide significant improvement in joint symptoms for patients who had never been treated with a biologic disease-modifying antirheumatic drug as well as patients who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors."

Lilly will work with insurers, health systems and providers to ensure patients are able to access this treatment.

my daughter has severe plaque psoriasis which she has had for 11 years and has undergone all available treatment, except for stelera injections. she went for an assessment recently and was told her score was 8.5/10, which was not quite enough to qualify for treatment in Bournemouth. She is becoming suicidile. Does anyone know if there are any areas of the country where this treatment might be more readily available, because I suspect that the Bournemouth area would prefer not to spend money on this type of treatment if at all possible.

This study looked at the effectiveness of Bio treatments on  health-related quality of life (HRQoL) in psoriasis patients.

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Background:
Evidence of the comparative effectiveness of biological therapies for psoriasis on health-related quality of life (HRQoL) in routine clinical practice is limited.

Objectives:
To examine the comparative effectiveness of adalimumab, etanercept and ustekinumab on HRQoL in patients with psoriasis, and to identify potential predictors for improved HRQoL.

Methods:
This was a prospective cohort study in which changes in HRQoL were assessed using the Dermatology Life Quality Index (DLQI) and EuroQoL-5D (EQ-5D) at 6 and 12 months. Multivariable regression models were developed to identify factors associated with achieving a DLQI of 0/1 and improvements in the EQ-5D utility score.

Results:
In total, 2152 patients with psoriasis were included, with 1239 patients on adalimumab, 517 on etanercept and 396 on ustekinumab; 81% were biologic naïve. For the entire cohort, the median (interquartile range) DLQI and EQ-5D improved from 18 (13–24) and 0·73 (0·69–0·80) at baseline to 2 (0–7) and 0·85 (0·69–1·00) at 6 months, respectively (P < 0·001). Similar improvements were achieved at 12 months. At 12 months, multivariable regression modelling showed that female sex, multiple comorbidities, smoking and a higher DLQI or a lower EQ-5D utility score at baseline predicted a lower likelihood of achieving a DLQI of 0/1 or improvement in the EQ-5D. Compared with adalimumab, patients receiving etanercept, but not ustekinumab, were less likely to achieve a DLQI of 0/1. There was no significant difference between the biological therapies in EQ-5D improvement.

Conclusions:
In routine clinical practice biological therapies produce marked improvement in HRQoL, which is influenced by the choice of biological therapy, baseline impairment in HRQoL, lifestyle characteristics and comorbidities. These findings should help inform selection of optimal biological therapy for patients related to improvements in HRQoL.

Novartis have announced that Cosentyx is the first Bio to demonstrated long term efficacy and safety in nail and palmoplantar psoriasis.

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Novartis today announced first-of-its-kind long-term data showing that Cosentyx® (secukinumab) provided sustained improvements in nail and palmoplantar psoriasis out to 2.5 years. These data are unique as it is the first time any biologic has demonstrated long-term efficacy and safety in nail and palmoplantar psoriasis.

Up to 90% of psoriasis patients may develop nail psoriasis or palmoplantar psoriasis, which affects the palms of the hands and soles of the feet. Both nail and palmoplantar psoriasis heavily impact patients' quality of life leading to reduced mobility, functional impairment and physical discomfort.
Cosentyx addresses the cornerstone cytokine interleukin-17A (IL-17A) involved in the development and progression of psoriasis, and is the first and only fully human IL-17A inhibitor to show sustained skin clearance rates at 5 years in psoriasis. By working to specifically target and inhibit IL-17A, Cosentyx can more effectively address the underlying cause of the disease. To date, psoriasis treatments targeting other, less direct, pathways have not shown long-term efficacy out to 2.5 years in these hard-to-treat forms.

"Patients with nail and palmoplantar psoriasis need effective treatment options to address the significant impact these conditions can have on their day-to-day lives," said Eric Hughes, Global Development Unit Head, Immunology & Dermatology. "As an IL-17A inhibitor, Cosentyx provides a highly targeted treatment option that can not only effectively treat the plaques caused by psoriasis, as evident by recently presented 5-year data, but also hard-to-treat forms and associated arthritic conditions."

In GESTURE, 59% and 53% palmoplantar psoriasis patients who received Cosentyx 300 mg and 150 mg respectively achieved clear or almost clear palms and soles at 2.5 years (as measured by Palmoplantar Investigator's Global Assessment (ppIGA) 0/1). In the TRANSFIGURE study, patients with nail psoriasis who were treated with Cosentyx 300 mg and 150 mg showed a substantial NAPSI (Nail Psoriasis Severity Index) improvement from baseline of -73% and -63% respectively. GESTURE, the largest and longest randomized controlled trial to date in palmoplantar psoriasis patients, and TRANSFIGURE, the first large, controlled trial to report long-term results in nail psoriasis, both demonstrated strong sustainability out to 2.5 years, with a favorable and consistent safety profile, including close to zero injection site reactions or associated pain.

I would like to introduce myself, I'm Jerry and I have had psoriasis for over 20 years also. I have tried about everything and then 6-8 years ago I was put on the Humira injection and I went from 60% of my entire body covered in thick scale to less than 5%. It has also been a blessing with my arthritis.

Has anyone else using Cosentyx tried moving from 4 to 3 weeks between shots ?

It's something I'm trying and you can read more here: RE: Cosentyx for psoriatic arthritis Fred's journey

But I thought I would start another thread to ask if anyone has tried it.

When on Stelara I had to play around with the dosing regime and did find moving to a shorter period between shots helped, so I'm giving it a try with Cosentyx and would be interested to know if anyone eles has tried  a shorter than 4 weeks between shots.

Hi All, I hope your are all well and having a fantastic day.

I was googling my plaques off looking for info about acitretin when I came across this place and thought I should dip my toes in the water, so I guess I should do a brief bio;
 
I live in Tasmania, that tiny triangular island at the bottom of the Australian mainland and I have had plaque psoriasis for about 20 years.  In that time I have ended up trying most treatments "snake oil" and otherwise. After a massive flare up while on methotrexate over the past 10-12 months, I returned to my dermatologist who listened to my plea and suggested we try acitretin along with returning to UVB treatment and continuing with topicals.  So far so good apart from spending days 2 and 3 shedding skin like a demented snake,  I have now reached day 6 and I'm seeing some positive results.

Anyway enough about me..... what treatments have everyone else seen rapid results from?

Hi, this is my first experience using this forum, I have yet to read the user posts but I thought I should introduce myself first.


To get started, I haven't seen a doctor for psoriasis for almost 7 years now. I was prescribed Tenovate-M back then as a cream to apply to the affected area which did help me early on. I have been using this cream for about 7 years now(Yes, since it helped me get rid of the flaking, although temporarily). I was in India back then, have moved to the US now for about 4 years but haven't seen a physician yet. That one spot of flaking has now turned into 50 all over the body. This happened recently during a very stressful phase of life, the psoriasis and stress mode each other worse over time. Now that I am stress-free I feel I should fight psoriasis as well. Till now my flaking was random, mostly flaring up once every year, gradually spreading over the body. The cream I mentioned above helped me through these years(atleast I like to think it that way).

Currently, I am not able to get the same cream here in the US so I am trying things like MG217 and its products(doesn't seem to work) which I got from Amazon. 
I am finally going to see a doctor soon but I am happy I can also discuss this with you all here.

I do have a lot of questions to ask but I think I should be reading stuff here which is a lot of content.

This study looked at patient preference for fixed combination calcipotriol 50 μg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) foam vs gel in psoriasis patients.

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Background:
Poor adherence to topical therapy in psoriasis remains an issue; it is associated with poor clinical outcomes, reduced quality of life and increased costs. Treatment-related factors leading to poor adherence include lack of efficacy, excessive time applying medication and poor cosmetic characteristics (e.g. slow absorption, greasiness).

Objective:
To assess the topical treatment attributes that influence patient preference for fixed combination calcipotriol 50 μg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) foam vs. gel, as well as in comparison with the latest topical treatment (LTT) a patient received.

Methods:
PSO-INSIGHTFUL was a Phase IIIb, prospective, multicentre (Canada/Germany), open-label, randomized, two-arm crossover study in patients aged ≥18 years with mild-to-severe psoriasis (NCT02310646). Following a washout period of up to 4 weeks, patients were randomized 1 : 1 to once-daily Cal/BD foam for 1 week, followed by Cal/BD gel for 1 week, or vice versa. Patients completed six questionnaires evaluating patient preferences.

Results:
A total of 213 patients were randomized; 118 had received a topical treatment in the previous 3 months. Based on the Subject's Preference Assessment, 50% of patients preferred Cal/BD foam and 50% preferred Cal/BD gel. Based on the Topical Product Usability Questionnaire (TPUQ), overall mean scores were high for both Cal/BD foam and gel, and were often significantly in favour of both products compared with LTT. Greater differences between Cal/BD foam and gel vs. LTT occurred when the previous treatment was an ointment or cream. Cal/BD foam was generally preferred by younger patients (aged 18–39 years), whereas Cal/BD gel tended to be preferred by older patients (aged ≥40 years). Results from other questionnaires were aligned with the TPUQ.

Conclusions:
Patients with psoriasis have diverse needs and different preferences for topical treatment. This knowledge may help prescribers to choose the right formulation for the right patient, potentially leading to improved adherence and better treatment outcomes.

This study looked at male fertility and sperm quality in patients with psoriasis that use TNF-alpha inhibitors or fumaric acid esters.

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Objective:
Is there any influence of a therapy with TNF-alpha inhibitors or fumaric acid esters and of disease activity status on male fertility and sperm quality in patients with psoriasis?

Methods:
In this monocentric, open-label, prospective study, semen samples were collected from patients receiving either TNF-alpha inhibitors or fumaric acid esters for moderate-to-severe plaque psoriasis. Semen was analysed at baseline before onset of the systemic therapy and monitored every 3 months under therapy. Sperm parameters were assessed according to the current WHO definitions.

Results:
In total, 101 semen specimens from 27 patients were obtained. Mean Psoriasis Area and Severity Index (PASI) score at baseline was 11.05. Only 14.8% of patients showed a normozoospermia without any other abnormal seminal values. 85.2% of patients had at least one sperm/seminal abnormality, including two patients showing an azoospermia. Interestingly, 48.1% showed sperm parameters indicative of genital tract inflammation. Therapy with TNF-alpha inhibitors or fumaric acid esters did not have any negative effects on relevant sperm parameters such as mean total sperm number, sperm concentration, total and progressive motility. No major gonadal dysfunction was observed in any patient.

Conclusion:
At baseline, many patients with psoriasis showed abnormal semen/sperm parameters and remarkably elevated leukocytes and values of seminal polymorphonuclear elastase, indicating a genital tract inflammation. Thus, genital tract inflammation may represent an important comorbidity of psoriasis, little attention paid to so far. Regarding treatment with TNF-alpha inhibitors or fumaric acid esters, no major negative (side-) effects on sperm quality were observed.

Hey Everyone, I just wanted to share my feedback.  I know Cosentyx is a new drug so I wanted to do my best to share my story in hopes of helping others.  Quick Disclaimer, I take it for Rheumatoid Arthritis NOT Psoriasis, But I've gotten so much good info here I wanted to give back.

The Good
Cosentyx has reduced my symptoms by about 15%.  Not night and day but definitely noticeable.  It does seem to be working better for me than the Humira.
Havent gotten sick(except the candida)


The bad
Weight Loss(about 20 pounds or 12% loss in 7 weeks)......maybe a plus for some lol
Oral Candida(UGH sucks)
Sensation of passing out (noticing a fair amount of other RA guys are complaining about this)
Fatigue (noticing a fair amount of other RA guys are complaining about this)
Foggyness
Easy bruising

Im still on it and trying to push through to see if the side effects subside.  My doc and I are watching these side effects closely. My biggest challenge with this medication is since such few people are on it, is being able to talk with others on these side effects and get an idea of what the future holds.

So to sum my experience....Decently effective, but quite a few side effects for me and at this time we are trying to push on.  I'll post updates as I have them.  Right now I just really need this candida infection to go away, but we'll see.

My name is Grant. I got my first psoriasis outbreak at the age of 30 last month same day as the fires in Santa Rosa. For almost a month I went to the doctors office and they did not know what I had they prescribed me prednizone steriods. Then I had this old physicians assistant tell me I had psoriasis on November 4. I made an appointment with a dermatologist for November 16. Since finding out I have psoriasis I have done a lot of research online. I quit energy drinks, coffee, sugar, have been going to the tanning salon doing relight therapy bed. I am taking a probiotic, milk thistle, tumeric, fish oil, l-lysine, vit d3, lotion, dead sea salt. I have it on my arms, legs, and stomach. Right now it is worst on my arms. It is awful, and to know that there is no cure it is chronic. I saw online some people who had it, and wanted to kill themselves. I can understand why. I am trying to stay strong, and do everything I can. I do not want to take the prednizone or any steriods because it did not help very much, on some blogs people said it came back worse after they stopped using it. It helped mine a little bit but not enough then I did not know I had psoriasis just a rash. It is not worth it for me. I am trying other methods. I wish I lived near the Dead Sea and could soak in it, or that I lived by a beach. I live in Boise Idaho its getting colder by the day will snow soon. I am visiting my grandmother in Florida in December that should be nice for my psoriasis also.

Has anyone else tried this?  My doctor put me on it this summer and I've been 100% clear since. No flare ups, 100% clear for the first time in 20 years.  Very happy! 

This study compared the road to a bio treatment for psoriasis patients in 2005-2009 and 2010-2015.

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Background

A considerable disease period often precedes initiation of a biologic in patients with psoriasis. Little is known about this important period in patients’ lives. Evaluation of this ‘journey’ can reveal important insights and opportunities for physicians and health care decision makers.
Objectives

(1) To describe patient and treatment characteristics until the start of biologic treatment in patients with severe psoriasis, (2) to assess shifts in early (2005-2009) versus established (2010-2015) biologics prescription periods, (3) to assess changes in hospital/day care admissions before vs. after starting biologics.
Methods

Explorative, retrospective study on the treatment characteristics of the period until first biologic presented with descriptive statistics of patients included in the BioCAPTURE registry. Journeys of 2005-2009 and 2010-2015 were compared with statistical tests to identify important shifts.
Results

Median TUS (time until conventional systemic) was 11.0 years and median TUB (time until biologic) was 18.9 years for all patients treated from 2005-2015. Most patients received 3 different conventional antipsoriatic systemic therapies. We noticed a small trend towards a shorter journey (TUB) with only 2 conventional systemic agents instead of 3 before initiating a biologic in later years (2010-2015, vs. 2005-2009). We also noticed a significant decrease of (day care) admissions comparing the two years before, versus the two first years after starting biologic treatment (17.7 versus 8.6 admissions/100 follow-up years, p<0.001). Cyclosporine, intensive topical treatment (dithranol), retinoids and PUVA therapy lost popularity in recent years.
Conclusion

The ‘journey’ of patients with psoriasis towards a biologic is still long and characterized by many different treatments. Shifts towards fewer conventional drugs before biologic initiation and a clear decrease of hospital and day care admissions before vs. after a biologic are seen. Improvement of this journey, especially in young or recently diagnosed patients can decrease negative influences on patients’ lives and reduce societal impact.

Taltz could soon be available for the treatment of psoriatic arthritis after Lilly announced good results.

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Eli Lilly and Company announced today patients with active psoriatic arthritis (PsA) treated with Taltz (ixekizumab), who were previously intolerant or had inadequate responses to TNF inhibitors, showed improvements in the signs and symptoms of PsA across treatment groups for up to 52 weeks.

Over the 52-week extension period, the majority of patients treated with Taltz achieved at least a 20-percent improvement in disease activity, as defined by the American College of Rheumatology (ACR 20), the primary endpoint of the study extension. Patients also maintained improvements in key secondary endpoints, including skin clearance and physical function, as measured by the Psoriasis Area Severity Index (PASI) and the Health Assessment Questionnaire Disability Index (HAQ-DI) respectively.

"These data are promising for the more than 37 million people worldwide who suffer from joint and skin symptoms of psoriatic arthritis," said Dr. Lotus Mallbris, vice president, immunology platform team leader, Lilly Bio-Medicines. "In addition to the efficacy of Taltz for people with skin symptoms, we are pleased to share new data suggesting that Taltz, if approved, may provide an option for those with joint symptoms of PsA."

During the extension period of the SPIRIT-P2 study, the majority of patients treated with Taltz showed improvements at 52 weeks in disease activity of PsA. Patients were required to have a diagnosis of PsA for at least six months, at least three tender and swollen joints and a previous intolerant or inadequate response to TNF inhibitors.

Patients who received treatment with Taltz during the initial double-blind treatment period of the SPIRIT-P2 study continued the same dosing regimen (either 80-mg of Taltz once every two weeks or 80-mg of Taltz once every four weeks) during the extension period. At 52 weeks, patients who continued treatment with Taltz achieved the following response rates:

   ACR 20: 68 percent of patients treated with Taltz every four weeks, 59 percent of patients treated with Taltz every two weeks.
   ACR 50: 46 percent of patients treated with Taltz every four weeks, 38 percent of patients treated with Taltz every two weeks.
   ACR 70: 29 percent of patients treated with Taltz every four weeks, 21 percent of patients treated with Taltz every two weeks.

Patients treated with placebo during the initial double-blind treatment period of the SPIRIT-P2 study were re-randomized during the extension period at week 16 or 24 to receive either 80-mg of Taltz once every two weeks or 80-mg of Taltz once every four weeks, following a 160-mg starting dose. At 52 weeks, patients re-randomized to Taltz achieving the following response rates:

   ACR 20: 61 percent of patients treated with Taltz every four weeks and 50 percent of patients treated with Taltz every two weeks.
   ACR 50: 44 percent of patients treated with Taltz every four weeks and 35 percent of patients treated with Taltz every two weeks.
   ACR 70: 24 percent of patients treated with Taltz every four weeks and 15 percent of patients treated with Taltz every two weeks.

The observed safety profile was consistent with initial findings from the double-blind treatment period of the SPIRIT-P2 study. During the extension period, the majority of treatment-emergent adverse events were mild or moderate in severity, including injection site reaction, upper respiratory infection, nasopharyngitis and sinusitis. Serious adverse events occurred in 15 patients in the extension period, including one death.  

Lilly has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Taltz as a treatment of adult patients with active PsA. Lilly also submitted Taltz to the European Medicines Agency (EMA) for the treatment for adult patients with active PsA. Taltz is approved for adult patients with active PsA in Japan. Submissions to other regulatory agencies around the world are expected later this year.

Hey everyone.  Newbie here to this forum, but far from new to Psoriasis.  Diagnosed as a teen, and now I'm 40.  I've done numerous topicals, phototherapy, and Humira.  I took a break one year ago to try and tackle my P naturally.  Now it's coming back.  I exercise regularly.  But I admit, my diet is not the best P friendly, and I definitely enjoy my adult beverages.  And now I'm starting to get joint pains.  Went back to my derm.  He recommended Stelara.  He said his derm office administers the most Stelara in the state of WA.  So I'm feeling pretty good about it.  Labs are done, and now just waiting for the next steps.  My P isn't super crazy...elbows, half my scalp, and now showing up on legs, but it's growing and driving me crazy.  Looking forward to relief, and learning about your stories with Stelara.  Can I still enjoy my adult beverages?!?!? I will definitely be cutting back, but come on, I want to be realistic here.  

This study suggests a reconsideration of the use of the DLQI for medical and financial decision-making in psoriasis patients is needed.

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Background:
Dermatology Life Quality Index (DLQI) is the most common health-related quality of life measure in dermatology that is widely used in treatment guidelines for psoriasis. Eight out of the 10 questions of the DLQI offer a ‘not relevant’ response (NRR) option that is scored as the item had no impact on patients’ life at all.

Objective:
To explore the occurrence of NRRs on the DLQI in psoriasis patients, and to examine the effect of several socio-demographic and clinical factors on giving NRRs.

Methods:
Data were obtained from two cross-sectional surveys among psoriasis patients at two academic dermatology clinics in Hungary. Health-related quality of life was measured by employing DLQI and EQ-5D-3L, while disease severity was graded by Psoriasis Area and Severity Index (PASI). Multivariate logistic regression was applied to determine the predictors of providing NRRs.

Results:
Mean age of the 428 patients was 49 years, and 65% were males. Mean PASI, DLQI and EQ-5D-3L index scores were 8.4±9.5, 6.8±7.4 and 0.74±0.28, respectively. Overall, 38.8% of the patients had at least one NRR: 19.6% (one), 11.5% (two), 5.1% (three) and 2.6% (more than three). Most NRRs occurred in sport, sexual difficulties and working/studying items of the DLQI (28.4%, 16.4% and 14.0%, respectively). Female gender (OR 1.65; 95% CI 1.04-2.61), older age (OR 1.05; 95% CI 1.03-1.07) and higher PASI score (OR 1.03; 95% CI 1.01-1.06) were associated with providing more NRRs, whereas highly educated patients (OR 0.34; 95% CI 0.16-0.72) and those with a full-time job (OR 0.47; 95% CI 0.29-0.77) less frequently tended to tick NRRs.

Conclusion:
The high rate of psoriasis patients with NRRs, especially among women, less educated and elderly patients, indicates a content validity problem of the measure. A reconsideration of the use of the DLQI for medical and financial decision-making in psoriasis patients is suggested.

Dermira will not participate in any future development or commercialization activities of Cimzia (certolizumab pegol)

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Dermira, Inc. and UCB (Euronext:UCB) today announced the companies have agreed to end their development and commercialization agreement for CIMZIA (certolizumab pegol) in psoriasis. Following positive Phase 3 clinical trial results, UCB and Dermira announced U.S. and EU regulatory submissions for CIMZIA for the treatment of moderate-to-severe chronic plaque psoriasis in July of this year. Pending regulatory approval, UCB remains committed to commercializing CIMZIA in psoriasis worldwide.

Dermira expressed its intent to terminate the collaboration agreement, and Dermira and UCB have entered into a transition agreement to effect an orderly transition of the development and commercialization activities, pursuant to which UCB will regain U.S. and Canadian development and commercialization rights for CIMZIA for the treatment of psoriasis. Both parties will undertake a transfer of data and Dermira will not participate in any future development or commercialization activities for the product. The collaboration agreement will terminate on February 15, 2018 and the companies anticipate the completion of the transition by such date.

Janssen have announced Phase 2 results for Tremfya (guselkumab) in psoriatic arthritis.

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Janssen Research & Development announced today longer-term results from a Phase 2 study investigating TREMFYA® (guselkumab), the first selective anti-interleukin (IL)-23 monoclonal antibody to show positive results in the treatment of active psoriatic arthritis.  According to findings presented at the 2017 ACR/ARHP Annual Meeting, more than 70 percent of patients receiving TREMFYA® 100 mg subcutaneous injections achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) using observed data at week 56. These data follow initial results that showed 58 percent of patients treated with TREMFYA® achieved an ACR 20 response at week 24, the primary endpoint of the study, compared with 18.4 percent of patients receiving placebo (p<0.001). Based on the Phase 2 study results, Janssen has initiated two Phase 3 studies to evaluate the efficacy and safety of TREMFYA® in the treatment of patients with active psoriatic arthritis who may have been previously treated with anti-tumor necrosis factor (TNF) alpha therapies (DISCOVER-1), and in patients who have not received prior treatment with a biologic therapy (DISCOVER-2).

TREMFYA® received U.S. Food and Drug Administration (FDA) approval in July for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and in September the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization in the European Union for the use of TREMFYA® in the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

“Patients with active psoriatic arthritis live with substantial disease burden, experiencing joint pain, swelling and stiffness, along with painful skin plaques associated with psoriasis,” said Atul Deodhar, M.D., MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University and study steering committee member.  “It is encouraging to see that patients receiving this IL-23 inhibitor demonstrated improvement in symptoms of active psoriatic arthritis at week 24, and results were maintained through one year with guselkumab therapy.  I look forward to future results from the Phase 3 trials.”

The Phase 2 study met all primary and secondary endpoints with statistical significance at week 24.  At week 24, patients in the placebo group crossed over to receive TREMFYA®, and patients originally randomized to active treatment continued TREMFYA® therapy, both groups receiving every eight-week therapy (after 2 starter doses at weeks 0 and 4) with the final injection administered at week 44.

At week 56, based on the observed data, signs and symptoms of psoriatic arthritis including tender and swollen joints, pain and physical function [measured by the health assessment questionnaire-disability index (HAQ-DI) score], levels of skin clearance (PASI improvements) and patient-reported quality of life outcomes (measured by the SF-36 questionnaire) improved through week 24 and were maintained through week 56 in patients treated with TREMFYA®.  Select efficacy endpoints at week 56 showed:

   ACR 20 and ACR 50 responses were achieved by 74 percent and 53 percent of patients in the TREMFYA® group, respectively.  
   85 percent of patients in the TREMFYA® group demonstrated a PASI 75 response.
   78 percent of patients in the TREMFYA® group demonstrated a PASI 90 response (near complete skin clearance).
   57 percent of patients in the TREMFYA® group demonstrated a PASI 100 response (complete skin clearance).
   Mean improvements in HAQ-DI scores (which range from 0-3.0) were 0.55 for the TREMFYA® group.
   Patients in the TREMFYA® group experienced significant improvements in inflammation of the fingers and toes (dactylitis) and sites at which tendons or ligaments attach to bone (enthesitis), as well as measures of physical and mental health as reported by the SF-36 assessment tool.

Post-week 24, there were no observed differences in adverse event (AE) rates among patients with differing lengths of exposure to TREMFYA®. Through week 56, 40 percent of all patients experienced AEs, the most common of which were infections. Serious AEs were reported in six percent of patients and included one myocardial infarction and one malignancy (basal cell carcinoma). There were no deaths.

“We are proud to have introduced TREMFYA®, an important new treatment option for patients living with moderate to severe plaque psoriasis,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen.  “We are also eager to continue the study of TREMFYA® in the treatment of active psoriatic arthritis through the Phase 3 programs, recognizing that one-third of patients diagnosed with plaque psoriasis will unfortunately develop psoriatic arthritis.”