Category Archives: Psoriasis

Eight months after UCB announced that a little-watched drug candidate outperformed J&Js blockbuster Stelara, the Belgian pharma is out with full data that one investigator calls remarkable.

In the Phase III trial, 58.6% of patients who took UCBs IL-17 blocker bimekizumab were completely cleared of skin lesions after 16 weeks, compared to 20.9% of patients on Stelara. The UCB drug also outperformed Stelara at how many patients were clear after one year and at lesser benchmarks for plaque clearance, with more than 8 out of 10 patients showing 90% improvement, compared to roughly half on Stelara.

In a second study, first announced positive in November, bimekizumab was compared to placebo. In that one, 68% of patients on the treatment arm saw their skin completely clear and over 90% saw a 90% improvement. For placebo that number was 1.2%.

It really showed some quite impressive, remarkable I dont know how you want to say it, but extremely high level of responses, Kenneth Gordon, lead investigator on the placebo-controlled study, told Endpoints News.

Gordon singled out a couple distinct characteristics about the responses that stood out. Those included how sweepingly the drug alleviated symptoms, how quick it did so, and how long it lasted.

If you compare it to other clinical trials programs, both the speed and magnitude of the responses were around the highest weve seen, Gordon said.

Researchers often caution against comparing different clinical trials, such comparisons will be crucial for a drug like bimekizumab. The plaque psoriasis is a highly competitive market, suffuse with approved biologics from some of the worlds biggest drugmakers. Stelara is just one of several options patients can currently choose from.

The new data were released in abstracts for the annual American Academy of Dermatology meeting. On Friday afternoon, AbbVie also released abstracts from its open-label Phase III trial testing Skyrizi, an IL-23 inhibitor approved last year for psoriasis, against Novartis Cosentyx.

While trouncing Cosentyx, Skyrizi showed a virtually identical ability as UCBs drug to clear plaque psoriasis after one year: 66%. In addition, Eli Lillys IL-17 inhibitor beat J&J Tremfya last year in a head to head trial on psoriasis. UCB also beat AbbVies Humira last year, although results have yet to be announced.

From a medical perspective, though, Gordon suggested that asking which one is best might not be the best approach. Instead, prescribing decisions may come down to matching individual patients to the best drug.

Bimekizumab blocks multiple cytokines involved in plaque psoriasis, IL-17a and IL-17f. Because IL-17f exists in greater quantities in plaques, but IL-17a is more active, it had been an open question whether it was best to blockade both or if you could just target one and have the same effect.

Though cautioning no trial has been completed, Gordon said the latest data seem to resolve that debate. He argued the new insight, along with some of the other new molecules, represented a capstone on the progress the field has made since the chemotherapy drug methotrexate was first given to modest effect in the 1950s.

This might be culminating biologic molecule for psoriasis we have in the near future, he said. Now the question is how can we best apply each of our medications.

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UCB flashes the data behind its positive psoriasis readouts. Can it compete in a crowded field? - Endpoints News

Immune-mediated inflammatory conditions such as inflammatory bowel disease (Crohn disease [CD], ulcerative colitis [UC]), psoriasis, and rheumatoid arthritis (RA) are frequently treated with antitumor necrosis factor-alpha (TNF-) agents. TNF- inhibitors (TNFIs) have shown significant clinical safety and efficacy profiles in these inflammatory conditions; however, the potential risks of long-term use are a consistent concern of both physicians and patients.

As the TNF- pathway plays a critical role in tumor surveillance, there is concern that inhibition of this pathway could predispose patients to certain malignancies.1 One such cancer that is of great concern with respect to the TNF- pathway is melanoma.1 As the use of TNFIs and other biologics have grown increasingly popular, there has been noteworthy research interest in the actual risk of melanoma in these patients.

When evaluating a study estimating the risk of melanoma in patients receiving TNFIs, it is critical to determine if the comparison group is either the general population or patients with inflammatory conditions treated with other systemic therapy. There is a meager number of studies specifically evaluating the latter, especially studies with IBD and psoriasis. Interestingly, Esse and colleagues recently published a systematic review and meta-analysis in JAMA Dermatology specifically evaluating the risk of melanoma in patients with IBD, RA, and psoriasis who were treated with biologic therapy compared to those who had received only other conventional systemic therapy.2

The authors identified 7 studies, all of which were published between 2007 and 2019, and were cohort studies that were conducted in several countries (United States, Denmark, Sweden, and Australia). These studies included a total of 34,029 patients who received biologic therapy compared with 135,370 biologic-naive patients who had received conventional systemic therapy. Mean patient-follow duration ranged from 1 year to 5.48 years. Most studies included TNFIs, however, there were some patients receiving abatacept and rituximab were also included in the meta-analysis.

There were no significant differences found in the pooled relative risk (pRR) estimates for patients treated with biologic therapy compared with those who were treated with conventional therapy in IBD (pRR, 1.20; 95% CI, 0.60-2.40) and RA (pRR, 1.20; 95% CI, 0.83-1.74).

All of the included studies were considered high-quality studies, according to the review authors, and there was no evidence of publication bias or significant heterogeneity in the studies across the patient groups. When specifically looking at each biologic agent individually (TNFIs, abatacept, rituximab), there remained no statistically significant difference in melanoma risk when compared with patients receiving conventional therapy. If individual RA studies were excluded, sensitivity analyses showed that the pRR continued to not be statistically significant from patients receiving conventional therapy.

A key distinguishing factor of this study was inclusion of patients with inflammatory conditions whom were biologic naive and their comparison with those receiving standard therapies. This study is interesting to juxtapose with several prior studies evaluating similar melanoma outcomes. Singh and colleagues published a similar systemic review and meta-analysis in Clinical Gastroenterology and Hepatology in 2014 that specifically evaluated the risk of melanoma in patients with IBD.3 This review evaluated 12 studies that included 172,837 patients with IBD and found a pooled crude incidence rate (IR) of melanoma in patients with IBD of 27.5 cases per 100,000 person-years (95% CI, 19.9-37). Overall, IBD was associated with a 37% increased risk of melanoma. This relative risk was higher in those patients with CD (RR, 1.80; 95% CI, 1.17-2.75) compared with those with UC (RR, 1.23; 95% CI, 1.01-1.50). This increased risk of melanoma was found to be independent of biologic therapy.

Another systematic review published by Peleva and colleagues in the British Journal of Dermatology in 2018 evaluated 8 prospective cohort studies evaluating the risk of all cancers in patients with psoriasis who were treated with biologic therapies.4 The authors found an increase in nonmelanoma skin cancer (NMSC) particularly squamous cell carcinoma but there was no evidence of increased risk of melanoma. This review was limited by the inclusion of only 1 study evaluating melanoma risk in patients treated with ustekinumab.

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Melanoma Risk and Biologic Therapy: Is There a Link? - Cancer Therapy Advisor

MUMBAI, India and PRINCETON, N.J., June 12, 2020 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" including its subsidiaries and/or associate companies) today announced that one of its wholly owned subsidiaries presented further evidence of the long-term use and cost-effectiveness of ILUMYATM (tildrakizumab-asmn) in moderate-to-severe plaque psoriasis at the American Academy of Dermatology (AAD) Virtual Meeting Experience 2020.

Click to Tweet#NEWS: @SunPharma_Live announces long-term evidence offering insights into the clinical use of a treatment option in a cross section of people with moderate-to-severe plaque psoriasis. Read more: bit.ly/36VsmDI#AADVMX2020

Long-term analyses of the reSURFACE 1 and 2 extension studies found that ILUMYA offers sustained and improved results in patients with moderate-to-severe plaque psoriasis who received treatment for up to four years with no new safety concerns recorded.1,2 Furthermore, the safety profile of ILUMYA was reconfirmed in a five-year analysis that demonstrated low and similar exposure-adjusted incidence rates of malignancies from year four to year five. A majority of malignancies were singular events with similar incidence rates as seen in the general US population.3

Another post-hoc analysis of 335 patients who were predominately bio nave showed that those who achieved PASI 50 or higher after 6 months of treatment with ILUMYA saw continued improvement and sustained response rates when they maintained treatment for up to three years. Those patients who achieved PASI 90 at week 28 had rapid improvements as early as week 4.4

Mean Percent Change from Baseline PASI Score Over Time

Week 28 (n)

Week 52 (n)

Week 148 (n)

PASI 50-74 at Week 28

64.4% (34)

79.4% (34)

81.4% (22)

PASI 75-89 at Week 28

83.5% (79)

83.8% (78)

94.8% (63)

PASI 90-99 at Week 28

95% (131)

85.3% (131)

92.4% (117)

PASI 100 at Week 28

100% (91)

98% (90)

95.4% (81)

*95% confidence interval | Data are as observed and sample size at each study week is based on subjects with non-missing data.

ILUMYA 100 mg was well-tolerated, with a low rate of adverse events (AEs) that were comparable or numerically lower than placebo or etanercept based upon exposure-adjusted rates for many AE categories. The most common (1%) adverse reactions associated with ILUMYA are upper respiratory infections, infection site reactions, and diarrhea.

"Notably, 85 percent of the patients included in our analysis had never used a biologic before even though they have been living with psoriasis for over a decade," said lead investigator Kim Papp, M.D., Ph.D., founder and president of Probity Medical Research in Waterloo, Ontario, Canada. "This tells dermatologists that ILUMYA will treat different types of patients who have moderate-to-severe plaque psoriasis. ILUMYA is a good treatment option to consider for treatment navepatients; for patients having inadequate response to topicals or who are intolerant to or not responding well to oral treatments; and for any patient in need of a new treatment to address the chronic nature of this disease."

Six additional long-term analyses showed ILUMYA offers similar efficacy and safety results in patients with metabolic syndrome or patients who are over 65 years of age, factors that may make treatment more complex.5 6,7,8,9,10 Metabolic syndrome has a higher prevalence in patients with moderate-to-severe psoriasis compared to the overall population and an impact on response rates to many anti-TNF and IL-17 treatments.8 The analyses found that metabolic syndrome had minimal effect on the positive results seen in people treated with ILUMYA for up to three years and there was no increase in cardiac events or worsening of diabetes, compared to those without metabolic syndrome.

Furthermore, a 10-year cost analysis study revealed that ILUMYA is among the most cost-effective first-line therapies for treating moderate-to-severe plaque psoriasis and is more cost-effective than many other biologics, including risankizumab, secukinumab, guselkumab, ixekizumab, adalimumab, ustekinumab, etanercept, or certolizumab pegol.11

"It is exciting to share this wealth of clinical insights that continue to confirm the potential of ILUMYA to manage moderate-to-severe plaque psoriasis effectively and safely across different types of patients and as a cost-effective, first-line biologic treatment option," said Alan Mendelsohn, M.D., Associate Vice President, Dermatology Medical Affairs, Sun Pharma. "We are dedicated to continue bringing insights and support on the use of ILUMYA in daily clinical practice as well as exploring its potential for people living with other chronic autoimmune diseases."

ILUMYA is approved for adults with moderate-to-severe plaque psoriasis and is being evaluated for other possible uses. See ongoing studies below for more information.12,13 Visit http://www.ILUMYA.com to learn more about the ILUMYA SUPPORT Lighting the Way program that helps patients get started with treatment, understand cost and saving options, and connect with experts and others living with plaque psoriasis.

Please click here for Full Prescribing Information and Medication Guide.

Notable ILUMYA Analyses Presented at the AAD Virtual Meeting Experience 2020

The 2020 AAD Virtual Meeting Experience is accessible via registration here. *Abstract sponsored by Almirall who markets tildrakizumab-asmn in EU

About the reSURFACE Extension Studies

The Phase-3 studies (reSURFACE 1andreSURFACE 2) were randomized, placebo-controlled, multicenter, three-part studies designed to evaluate efficacy and safety of ILUMYA100 mg and 200 mg in moderate-to-severe plaque psoriasis compared to placebo and comparative drug and to assess safety and tolerability. Participants with at least 50 percent improvement in PASI 50 at base study completion who received ILUMYA within 12 weeks of base study end (week 52 or 64) were eligible to enroll in the extension study and continued on the same ILUMYA dose once every 12 weeks. Researchers evaluated PASI and PGA response (score of 0 or 1 with 2 grade reduction from baseline) and incidence rates for prespecified adverse events, including severe infections, cardiovascular events and drug-related hypersensitivities.

About ILUMYA(tildrakizumab-asmn)

ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States. ILUMYAhas also been approved for moderate-to-severe plaque psoriasis in Australia and under the brand name ILUMETRITM in Europe.

IMPORTANT SAFETY INFORMATION

ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any other excipients.

Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trial. If a serious hypersensitivity reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.

ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue ILUMYA until the infection resolves.

Evaluate patients for TB infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after ILUMYA treatment.

Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines.

Most common (1%) adverse reactions associated with ILUMYA include upper respiratory infections, injection site reactions, and diarrhea. Adverse reactions that occurred at rates less than 1% but greater than 0.1% in the ILUMYA group and at a higher rate than in the placebo group included dizziness and pain in extremity.

About Sun Dermatology

Sun Dermatology (the branded dermatology division of a wholly owned subsidiary of Sun Pharmaceutical Industries Inc.) is committed to expanding its dermatology portfolio to bring healthcare providers and patients around the world more treatment options and ongoing support for conditions like moderate-to-severe plaque psoriasis. Sun Pharmaceutical Industries Ltd., along with its subsidiaries, is ranked second in dermatology prescription volume within the U.S. per IQVIA and is the fourth largest specialty generic pharmaceutical company globally. In addition to ILUMYA, Sun Dermatology is comprised of several branded products with a focus on various dermatologic conditions.

About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050)

Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7% of annual revenues in R&D. For further information, please visit http://www.sunpharma.com& follow us on Twitter @SunPharma_Live.

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Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

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Sun Pharma Announces Long-term Insights into the Clinical Use of ILUMYA(TM) (tildrakizumab-asmn) in a Cross Section of People Living with...

Local steroid injections are associated with clinically meaningful improvements in active dactylitis in patients with psoriatic arthritis (PsA), according to the results of a multicenter study published in Clinical Rheumatology.

Nonsteroidal anti-inflammatory drugs (NSAIDs) and local corticosteroid injections are currently recommended for the treatment of dactylitis in patients with PsA; however, there is very little information on the efficacy of local corticosteroid injections. In an observational prospective study, investigators aimed to compare the efficacy of local steroid injections and NSAIDs on the digital flexor tendon sheath for the treatment of active dactylitis in patients with PsA.

The Leeds Dactylitis Index basic (LDI-b) score was calculated at baseline, with patients rating their local pain intensity and functional impairment on 10 cm scales for each involved digit. Assessments were repeated at 1 and 3 months, postprocedure. Researchers recorded the presence of local or systemic events at each examination.

The primary objective of interest was a clinically meaningful treatment response, defined as the reduction of visual analog pain (VAS-pain) and functional impairment (VAS-FI) scores by 5 points or VAS-pain and VAS-FI scores <2. The secondary objective of interest was complete dactylitis remission (VAS-pain=0 and VAS-FI=0).

A total of 24 patients with 38 dactylic fingers were treated with steroid injections and 22 patients with 35 dactylic fingers were treated with NSAIDs. At baseline, there was no significant difference in VAS-pain score, finger circumference, or LDI-b between groups, though VAS-FI score was significantly higher in the steroid-treated group (7.871.53) than the NSAID-treated group (6.891.82; P =.018).

Significant improvements in clinical parameters were observed at 1 and 3 months in both groups; however, there were no improvements in VAS-pain scores at either time point in the NSAID-treated group. The reduction in VAS-pain (P <.001), VAS-FI (P <.001), and LDI-b values (P =.008) was greater in the steroid-treated group compared with the NSAID-treated group at 1 month. This trend continued at 3 months, post-treatment (P <.001 for all). A clinically meaningful treatment response was observed in 87% of dactylic fingers in the steroid-treated group compared with 17% in the NSAID-treated group (P <.001) at 1 month. This difference remained significant at 3 months as well. Complete remission was observed exclusively in the steroid-treated group in 1 and 7 cases at 1 and 3 months, respectively.

According to multiple regression analysis, the steroid injections were associated with a clinical response at both 1 (odds ratio [OR], 20.104; 95% CI, 2.481-162.9; P =.002) and 3 months (OR, 27.950; 95% CI, 3.227-142.1; P =.002), postprocedure.

Researchers noted that patients were given the choice to receive local steroid injections or NSAID treatment, and that the lack of randomization represented a limitation of the study. In addition, it was unclear what long-term maintenance may be needed to maintain the efficacy of steroid injections given the short duration of the study.

[T]hese data support the use of steroid injections into the digital flexor tendon sheath for psoriatic dactylitis, the researchers concluded. [L]ocal steroid injection can be recommended as a safe and effective first-line therapy for psoriatic dactylitis.

Reference

Girolimetto N, Macchioni P, Citriniti G, et al. Effectiveness of steroid injection for hand psoriatic dactylitis: results from a multicentre prospective observational study [published online May 16, 2020]. Clin Rheumatol. doi:10.1007/s10067-020-05142-z

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Steroid Injections Improve Pain and Functionality Measures in Hand Psoriatic Dactylitis - Rheumatology Advisor

DUBLIN(BUSINESS WIRE)The Global Psoriasis Market and Competitive Landscape 2020 report has been added to ResearchAndMarkets.coms offering.

This research report provides comprehensive insights into the Psoriasis pipeline, epidemiology, market valuations, drug sales, market forecast, drug forecasts, and market shares. This research analyzes and forecasts the Psoriasis market size and drug sales. It also provides insights into Psoriasis epidemiology and late stage pipeline.

This research covers the following:

Psoriasis treatment options, Psoriasis late stage clinical trials pipeline, Psoriasis prevalence by countries, Psoriasis market size and forecast by countries, key market events and trends, drug sales and forecast by countries, and market shares by countries. The research scope includes the countries US, Germany, France, Italy, Spain, UK, Japan, Europe, Global (G7 Countries).

Research Scope:

Benefits of this Research:

Key Topics Covered:

1. Psoriasis Treatment Options

2. Psoriasis Pipeline Insights

2.1. Psoriasis Phase 3 Clinical Trials

2.2. Psoriasis Phase 2 Clinical Trials

2.3. Psoriasis Phase 1 Clinical Trials

3. Psoriasis Epidemiology Analysis by Countries

4. US Psoriasis Market Insights

4.1. Marketed Drugs for Psoriasis in US

4.2. US Psoriasis Market Size & Forecast

4.3. US Psoriasis Drugs Sales & Forecast

4.4. US Psoriasis Market Share Analysis

5. Germany Psoriasis Market Insights

5.1. Marketed Drugs for Psoriasis in Germany

5.2. Germany Psoriasis Market Size & Forecast

5.3. Germany Psoriasis Drugs Sales Forecast

5.4. Germany Psoriasis Market Share Analysis

6. France Psoriasis Market Insights

6.1. Marketed Drugs for Psoriasis in France

6.2. France Psoriasis Market Size & Forecast

6.3. France Psoriasis Product Sales Forecast

6.4. France Psoriasis Market Share Analysis

7. Italy Psoriasis Market Insights

7.1. Marketed Drugs for Psoriasis in Italy

7.2. Italy Psoriasis Market Size & Forecast

7.3. Italy Psoriasis Product Sales Forecast

7.4. Italy Psoriasis Market Share Analysis

8. Spain Psoriasis Market Insights

8.1. Marketed Drugs for Psoriasis in Spain

8.2. Spain Psoriasis Market Size & Forecast

8.3. Spain Psoriasis Product Sales Forecast

8.4. Spain Psoriasis Market Share Analysis

9. UK Psoriasis Market Insights

9.1. Marketed Drugs for Psoriasis in UK

9.2. UK Psoriasis Market Size & Forecast

9.3. UK Psoriasis Product Sales Forecast

9.4. UK Psoriasis Market Share Analysis

10. Europe Psoriasis Market Insights

10.1. Europe Psoriasis Market Size & Forecast

10.2. Europe Psoriasis Product Sales Forecast

10.3. Europe Psoriasis Market Share Analysis

11. Japan Psoriasis Market Insights

11.1. Marketed Drugs for Psoriasis in Japan

11.2. Japan Psoriasis Market Size & Forecast

11.3. Japan Psoriasis Product Sales Forecast

11.4. Japan Psoriasis Market Share Analysis

12. Global Psoriasis Market Insights

12.1. Global Psoriasis Market Size & Forecast

12.2. Global Psoriasis Product Sales Forecast

12.3. Global Psoriasis Market Share Analysis

13. Research Methodology

For more information about this report visit https://www.researchandmarkets.com/r/gig2q9

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2020 Study on the Global Psoriasis Market and Competitive Landscape - ResearchAndMarkets.com - Web Hosting | Cloud Computing | Datacenter | Domain...

And while relying on a topical treatment is a fab way of keeping skin clear, the experts at Grahams Natural Alternatives tell us many skin conditions stem from inside our bodies.

Heres their top tips for dealing with skin conditions like psoriasis, a common, chronic inflammatory disease which affects about 3% of the worldwide population!

Research shows some antioxidant rich foods like garlic, onions, green leafy veggies, avocado and broccoli can actually prevent skin conditions caused by inflammation in the body.Furthermore if you rock a diet high in anti-inflammatory foods such as berries, fish like salmon rich in omega 3 and nuts or seeds, can be great for psoriasis sufferers who experience inflamed skin as a result of their condition.

Hate to tell you, but its three of the best. Research shows gluten, sugar and alcohol can trigger a flare or worsen your existing symptoms. The team at Grahams Natural Alternatives say you might not have to give up completely, just start by limiting your intake to see if it can help reduce the symptoms, or at least avoid these foods while youre psoriasis is bad.

Psoriasis is an autoimmune disease, it is important to take an internal oil supplement full of fatty acids and omegas. The Grahams Natural Alternativesteam recommend their mega oilto heal your body from the inside out.

Regular exercise. Doing as little as 30 minutes of exercise a day can improve your mental and physical health just remember to wash the sweat off any break out zones to avoid a flare out up when you can home.

Topical treatments will work best if you combine all of the tips above, but our fave is Grahams Natural Psoriasis Cream, which has been scientifically formulated to treat psoriasis naturally.

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Psoriasis Be Gone: The Diet, Activities & Ointments You Need To Get Glowing Skin - KIIS1065

LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)-- Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced the publication of secondary efficacy and patient-reported outcomes from its Phase 2b randomized clinical trial of tapinarof cream for the treatment of atopic dermatitis in The Journal of the American Academy of Dermatology (JAAD)1, the peer-reviewed scientific publication of the American Academy of Dermatology (AAD). Tapinarof cream is a potential first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of plaque psoriasis and atopic dermatitis.

The latest analyses of the Phase 2b study published in JAAD include 75%, and 90% improvement in the Eczema Area and Severity Index from baseline (EASI75, EASI90), in addition to mean percentage change in EASI scores, the mean change in percentage of body surface area (BSA) affected, and mean change in total severity score.

Patient-reported outcomes include the proportion of patients who achieved 3-point improvement in pruritus (itch) numeric rating scale (NRS) score from baseline, subject impression of severity of atopic dermatitis symptoms, and subject impression of overall change in severity of itch symptoms from baseline to Week 12. The expanded Patient-Oriented Eczema Measure (POEM) was used to assess itch, sleep disturbance, and skin signs and symptoms, and the Daily Signs and Symptoms Severity Diary to score 11 disease-related symptoms.

Highlights from the Secondary Efficacy and Patient-Reported Outcomes

Secondary Efficacy Outcomes:

Post-hoc Analysis:

Additional Patient-Reported Outcomes:

As previously reported in JAAD2, most adverse events were mild or moderate. The most commonly reported adverse events were nasopharyngitis, folliculitis, and atopic dermatitis.

We are excited that JAAD has shared this additional evidence of tapinarofs clinical response with these secondary efficacy and patient-reported outcomes from the Phase 2b study for atopic dermatitis, said David Rubenstein, M.D., Ph.D., Chief Scientific Officer of Dermavant. Because atopic dermatitis can interfere with daily life, these outcomes are especially important to patients, their caregivers, and the physicians who treat them. Dermatologists have shared with us their interest in potential topical treatment options that can address and relieve some of the very problematic symptoms of this debilitating skin disease, and todays data speaks to the potential of tapinarof to meet this demand, subject to FDA approval.

About the Tapinarof Phase 2b Atopic Dermatitis Study

In the Phase 2b double-blind, vehicle-controlled, multicenter study, 247 adolescent and adult patients aged 12-65 years diagnosed with mild to moderate atopic dermatitis involving between 5% and 35% body surface area were enrolled. Patients were randomized 1:1:1:1:1:1 to tapinarof cream 0.5%, tapinarof cream 1.0%, or vehicle, each applied to affected areas either once daily (QD) or twice daily (BID) for 12 weeks with a 4-week follow-up. In total, 165 patients were randomized to an active arm and 82 to vehicle.

The primary endpoint of the study (previously reported and published in JAAD) was an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.2

About Atopic Dermatitis

Atopic dermatitis (AD), commonly referred to as eczema, is a chronic inflammatory skin disease that results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. AD is one of the most common inflammatory skin diseases, affecting over 28 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 30% worldwide.

People with AD are more likely to have other allergic conditions, like asthma, allergic rhinitis, and food allergies. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavants focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The companys robust medical dermatology pipeline includes both late-stage and early-development product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, psoriasis and atopic dermatitis, as well as other large markets, including vitiligo, primary focal hyperhidrosis, and acne. Dermavant is developing its lead product candidate, tapinarof (DMVT-505), as a novel therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 28 million people in the United States, respectively. For more information, please visit http://www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

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Dermavant Announces Publication in JAAD of Secondary Efficacy and Patient-Reported Outcomes in Phase 2b Clinical Trial of Tapinarof Cream for the...

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The research report is formulated with the most excellent and superior tools of collecting, recording, estimating and analyzing market data of the global Psoriasis Treatment industry. Market segmentation studies conducted with respect to product type, applications, and geography are valuable in taking any verdict about the products. Market analysis has been prepared by taking into account aspects of marketing research and analysis, market size estimations, segmentation, competitive landscaping, opportunity analysis, economic forecasting, growth rate, future trends, market drivers, opportunities, challenges, risks, entry barriers, sales channels. Market dynamics covered by the report include drivers, opportunities, challenges, risks, entry barriers, sales channels. Each division of the market is researched and isolated based on type, applications, and the end-customers.

Major market players covered in this report: Novartis International AG, Merck and Co. Inc., Johnson& Johnson, Pfizer Inc., Eli Lilly, AbbVie and Amgen

On the basis of product, this report displays the production, revenue, price, market share, and growth rate of each type, primarily split into: TNF Inhibitors, Phosphodiesterase Inhibitors, Interleukin Blockers, Others,

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including: Oral, Injectable,

Key geographies evaluated in this report are: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, etc.), Middle East& Africa (Saudi Arabia, Egypt, Nigeria and South Africa)

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Global Psoriasis Treatment Market Analysis 2020 with COVID-19 | Growth, Trend, Competitive Strategies and Forecast 2025 - Flagler Times

Treatment with tumor necrosis factor inhibitors (TNFis) vs methotrexate alone is not associated with a decreased risk for progression to psoriatic arthritis (PsA) in patients with psoriasis, according to study results presented at the European League Against Rheumatism (EULAR) 2020 E-Congress, held online from June 3 to 6, 2020.

To determine if treatment with TNFis vs methotrexate alone reduce the risk of developing PsA in patients with existing psoriasis, researchers from Oregon Health and Science University, School of Medicine, Portland, assessed data from all patients with psoriasis seen at their clinic from January 2006 to June 2019. Diagnosis of PsA was made by a rheumatologist. Continuous covariates and categoric covariates were compared by the Students t-test and Pearsons chi-squared test or Fishers test, respectively.

A total of 154 patients (51.3% women) with psoriasis who did not have PsA at baseline were included in the study. A TNFi was administered to 55.2% (n=85) and methotrexate to 44.8% (n=69) of the patients during the study period. Patients in the TNFi cohort received therapy for a mean duration of 3.950.50 years and patients in the methotrexate cohort had a mean duration of therapy of 1.930.28 years. Mean follow-up time was 5.180.49 years and 2.710.37 years for the TNFi and methotrexate cohorts, respectively.

During the study period, 22.7% of patients (n=35) developed PsA. After adjusting for propensity score, nail pitting, body surface area involved in psoriasis, and depression, the investigators found that treatment with TNFi did not significantly reduce the risk for PsA, as compared with treatment with methotrexate (HR, 0.68; 95% CI, 0.32-1.41).

Use of TNFi was not associated with a statistically significant decreased risk of incident PsA compared to methotrexate in this study, but a larger cohort with longer follow-up will have better power to estimate the true association, the researchers concluded.

Reference

Lininger N, Siegel S, Kiwalkar S, Winthrop K, Ortega Loayza A, Deodhar A. Do TNF inhibitors decrease risk of incident psoriatic arthritis in psoriasis patients compared to those treated with methotrexate alone? Presented at: EULAR 2020 E-Congress; June 3-6, 2020. Abstract FRI0555.

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Do TNFis Reduce the Risk for Progression to PsA in Patients With Psoriasis? - Rheumatology Advisor

The long-term safety and tolerability is consistent with the known safety profile of ixekizumab in multiple chronic inflammatory diseases, including psoriasis, psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA), according to study results published in Rheumatology.

Ixekizumab is a monoclonal antibody that targets interleukin-17A and is used for the treatment of several inflammatory diseases. In an integrated analysis of 21 clinical trials, the investigators aimed to characterize the long-term safety and tolerability of ixekizumab in patients with psoriasis, PsA, and axSpA.

Using data from randomized controlled trials, the researchers examined the rates of adverse events (AEs) and treatment-emergent adverse events (TEAEs), summarized by exposure-adjusted incidence rates, associated with ixekizumab use.

The pooled population included 8228 patients, of whom 5898 had psoriasis, 1401 had PsA, and 929 had axSpA. The percentage of men ranged from 48.5% to 69.9% in the analysis, with all groups including predominantly white patients (74%-91.3%). The cumulative exposure time was 20,895.9 person-years (PYs), with up to 5, 3 and 2 years of exposure for patients treated for psoriasis, PsA, and axSpA, respectively.

The overall incidence rates of patients with 1 TEAE were 29.5 per 100 PYs in the psoriasis group (86.6% of patients), 50.6 per 100 PYs in the PsA group (80.5% of patients), and 55.9 per 100 PYs in the axSpA group (80.4% of patients). Severe TEAEs were reported by 8.1% to 16.7% of patients across all groups. The most frequently reported events among all groups were nasopharyngitis (14.4%-25.7%), upper respiratory tract infections (10.5%-15.6%), and injection site reactions (9.7%-11.1%). The most commonly reported TEAEs of special interest were infections, including nasopharyngitis, upper respiratory tract infections, and bronchitis. Infections were most common during the first year, with incidence rates ranging from 49.5 to 56.6 per 100 PYs, and decreased over time to 40.1 per 100 PYs across all groups.

Major cardiovascular events, malignancies, and inflammatory bowel disease were rare, with incidence rates of <1 per 100 PYs across all groups. Serious adverse events were reported at an incidence rate of 5.4 to 6.0 per 100 PYs and remained stable over time. Discontinuation from the study due to adverse events was reported in <10% of patients in all groups.

Among the pooled population, 43 deaths were reported, including 35, 6, and 2 in the psoriasis, PsA, and axSpA groups, respectively. The predominant cause of death was major cardiovascular events in the psoriasis and PsA groups, though ixekizumab was not associated with individual causes of death.

The most significant limitation of the analysis included the survival bias that occurs in long-term study extensions, since only patients who continue to respond to treatment are enrolled in such studies.

Chronic diseases such as [psoriasis], PsA and axSpA require long-term treatment management. Therefore, long-term assessment of safety is needed to evaluate the benefit-risk of treatment, the researchers concluded. This long-term analysis on the safety of ixekizumab was consistent with previously published reports and did not show any new safety signals.

Disclosures: The clinical trial was supported by Eli Lilly and Company. Several authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of disclosures.

Reference

Genovese MC, Mysler E, Tomita T, Papp KA, Salvarani C, Schwartzman S, et al. Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials [published online May 25, 2020]. Rheumatology (Oxford). doi:10.1093/rheumatology/keaa189

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Integrated Analysis Shows Long-Term Safety, Tolerability of Ixekizumab in Psoriasis, PsA, and axSpA - Rheumatology Advisor