Category Archives: Psoriasis

This article was originally published here

Vaccines (Basel). 2022 Apr 20;10(5):646. doi: 10.3390/vaccines10050646.

ABSTRACT

BACKGROUND: The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab in psoriatic arthritis, but it did not include a pharmacoeconomic analysis. The objective of this study was to compare the cost per responder of secukinumab versus adalimumab in patients with psoriatic disease.

METHODS: The cost per responder was calculated by multiplying the cost of treatment by the number needed to treat for each therapy. The 52-week primary endpoint was the American College of Rheumatology response rate (ACR) 20; secondary endpoints were ACR 50, Psoriasis Area and Severity Index (PASI) 90, and minimal disease activity (MDA).

RESULTS: The cost per responder for ACR 20 was 19,846 versus 19,766 for secukinumab and adalimumab, respectively, whereas the costs per responder for ACR 50 and PASI 90 were 27,820 versus 27,384 and 22,102 versus 32,375 for secukinumab and adalimumab, respectively. The cost per MDA responder was 34,072 and 38,906 for secukinumab versus adalimumab.

CONCLUSIONS: The costs per responder associated with the psoriatic arthritis end points were similar for adalimumab and secukinumab; conversely, the costs for psoriasis and composite end points were lower for secukinumab.

PMID:35632402 | DOI:10.3390/vaccines10050646

Read more here:
Cost per Responder Analysis of Secukinumab versus Adalimumab in the Treatment of Psoriatic Disease - DocWire News

NORTH CHICAGO, Ill., May 27, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced The Lancet published results from three pivotal Phase 3 clinical trials ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study) evaluating risankizumab (SKYRIZI) in patients with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

Data from the three studies formed the basis of the company's application for approval by the global health authorities. The publication of ADVANCE and MOTIVATE reports the efficacy and safety results of the two induction studies evaluating clinical remission and endoscopic response with intravenous (IV) risankizumab versus placebo over 12 weeks.1 The publication of FORTIFY shares the results of the maintenance study evaluating the safety and efficacy of subcutaneous (SC) risankizumab versus placebo (the withdrawal from IV risankizumab) over 52 weeks in patients who achieved clinical response during the ADVANCE and MOTIVATE studies.2

The use of risankizumab for Crohn's disease is not approved and its safety and efficacy remain under regulatory review.

About Crohn's DiseaseCrohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea and abdominal pain.3,4,5 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients.2,3 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the diseasenot only physically, but also emotionally and economically.6

About the ADVANCE and MOTIVATE Studies7,8,9,10The ADVANCE and MOTIVATE studies are Phase 3, multicenter, randomized, double-blind, placebo-controlled induction studies designed to evaluate the efficacy and safety of two doses of risankizumab, 600 mg and 1200 mg, in adults with moderate to severe Crohn's disease, compared to placebo. Both studies included different sets of primary and secondary endpoints for outside U.S. (OUS) protocol and U.S. protocol. The primary endpoints were achievement of clinical remission (per PRO-2 for the OUS protocol, which was measured by daily stool frequency and abdominal pain score, and per CDAI for the U.S. protocol, which was measured by a CDAI score less than 150) and endoscopic response (for both protocols) at week 12. Endoscopic response is defined as a decrease in SES-CD of greater than 50 percent from baseline (or at least a greater than or equal to 50 percent decrease from baseline in patients with isolated ileal disease and a baseline SES-CD of 4), as scored by a central reviewer.

The ADVANCE study included a mixed population of patients who had responded inadequately or were intolerant to conventional and/or biologic therapy. The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy. Topline results of the studies were shared in January 2021. More information can be found on http://www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE: NCT03104413).

About the FORTIFY Study11,12The FORTIFY study is a Phase 3, multicenter, randomized, double-blind, control group, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg and 360 mg as maintenance therapy versus withdrawal in patients who responded to risankizumab induction treatment in the ADVANCE and MOTIVATE studies. This study included different sets of primary and secondary endpoints for the OUS analysis plan and U.S. analysis plan due to regulatory requirements in the different regions. The co-primary endpoints were achievement of endoscopic response and clinical remission at week 52. Endoscopic response is defined as a decrease in SES-CD of greater than 50 percent from baseline (or at least a greater than or equal to 50 percent decrease from baseline in patients with isolated ileal disease and a baseline SES-CD of 4), as scored by a central reviewer. Clinical remission is defined by SF/AP, which was measured by daily stool frequency and abdominal pain score, in the OUS analysis plan and defined by CDAI, which was measured by a CDAI score less than 150, in the U.S. analysis plan.

Topline results were announced in June 2021. An open label extension of FORTIFY will continue to assess the long-term safety of risankizumab in subjects who completed participation in FORTIFY. More information can be found on http://www.clinicaltrials.gov (NCT03105102).

About SKYRIZI (Risankizumab) SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.13,14 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease.7 The approved dose for SKYRIZI for moderate to severe plaque psoriasis and active psoriatic arthritis in the European Union is 150 mg (either as two 75 mg pre-filled syringe injections or one 150 mg prefilled pen or pre-filled injection) administered by subcutaneous injections at week 0 and 4 and every 12 weeks thereafter. The use of risankizumab in Crohn's disease is not approved and its safety and efficacy have not been established by regulatory authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.7,9,15,16,17

EU Indications and Important Safety Information about SKYRIZI (Risankizumab)7SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not a complete summary of all safety information.

See SKYRIZI full summary of product characteristics (SmPC) at http://www.ema.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 D'Haens G., et al. Risankizumab as Induction Therapy for Crohn's Disease. Lancet.

2 Ferrante M., et al. Risankizumab as Maintenance Therapy for Crohn's Disease. Lancet.

3 Kaplan, G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec; 12(12):720-7. Doi: 10.1038/nrgastro.2015.150.

4 The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed on January 11, 2022.

5 Crohn's disease. Symptoms and Causes. Mayo Clinic. 2022. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed on January 11, 2022.

6 The Economic Costs of Crohn's Disease and Ulcerative Colitis. Access Economics Pty Limited. 2007. Available at: https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf. Accessed on January 11, 2022.

7 AbbVie. Data on File: ABVRRTI71474.

8 AbbVie. Data on File: ABBVRRI71526.

9 A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03105128. Accessed on December 18, 2020.

10 A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03104413. Accessed on December 18, 2020.

11 AbbVie. Data on File: ABVRRTI72293.

12 A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed May 21, 2021.

13 SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf.

14 Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.

15 A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on January 13, 2022.

16 A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on January 13, 2022.

17 Pipeline Our Science | AbbVie. AbbVie. 2022. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on January 13, 2022.

View original content:https://www.prnewswire.com/news-releases/the-lancet-publishes-results-from-phase-3-induction-and-maintenance-programs-evaluating-risankizumab-skyrizi-in-crohns-disease-301556449.html

SOURCE AbbVie

Company Codes: NYSE:ABBV

Read the original here:
The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Risankizumab (SKYRIZI) in Crohn's Disease - BioSpace

Post-traumatic arthritis is any kind of arthritis that occurs from an acute injury to the joints. Although post-traumatic arthritis usually resolves spontaneously after a few months, some cases of post-traumatic arthritis may become chronic.

Post-traumatic arthritis may arise many years after an acute injury has occurred. It can take the form of osteoarthritis or inflammatory arthritis.

This article will provide a detailed account of post-traumatic arthritis, its symptoms, causes, diagnosis, treatment, management, and outlook for a person.

Arthritis is a condition that affects a persons joints. Symptoms such as inflammation, pain, stiffness, and reduced mobility may affect any joint over any length of time.

As a recent article explains, post-traumatic arthritis is any form of arthritis that results from a direct and acute traumatic injury to the joints.

When trauma causes the smooth surfaces of joints to become irregular, they rub against each other, which causes accelerated wear of the cartilage.

On average, 2050% of people with joint trauma may develop post-traumatic arthritis. Post-traumatic arthritis is a type of arthritis and can take either of two forms: osteoarthritis and inflammatory arthritis.

Osteoarthritis is the most common form of arthritis worldwide. It arises due to joint usage over a period of time. Inflammatory arthritis is less common, and it often arises due to an autoimmune reaction that causes high amounts of joint inflammation.

Certain body parts are more likely to develop post-traumatic arthritis than others. These include the:

Post-traumatic arthritis has a highly variable development phase. Some people with this condition will notice symptoms a few months after the acute injury, such as:

Other people may not have any arthritis symptoms for 1020 years after the injury.

Most cases of post-traumatic arthritis resolve spontaneously after around 23 months. However, doctors consider this condition chronic if symptoms persist after 6 months.

A person should consult a doctor if they notice any symptoms at any time after an injury.

The cause of post-traumatic arthritis is an acute traumatic injury to a persons joints. Research has shown that such injuries can arise from several sources, including:

Although a single traumatic incident can cause post-traumatic arthritis, the risk also further increases with:

As a recent study explains, it is only possible for doctors to diagnose post-traumatic arthritis after arthritis symptoms have begun.

Although there is some variation, a 2022 review details the more common diagnostic methods:

Doctors must consider the results of several such diagnostic tests before making a confident arthritis diagnosis. They will also ask about any past traumatic injury to diagnose post-traumatic arthritis.

Read more about arthritis from our dedicated hub.

When trauma occurs, doctors can perform surgery if a person has sustained an injury to the joint. If there is a fracture within the joint, surgeons may realign joint surfaces. This will help limit the severity of the joint damage and slow the degenerative process.

Treatment also focuses on minimizing the symptoms, which may involve the following interventions:

If a persons post-traumatic arthritis becomes chronic, treatment will vary from case to case. The 2022 review notes that several types of treatment can slow disease progression. These include:

A person can discuss with a doctor the nonsurgical and, in some cases, surgical options to consider what is the most appropriate treatment.

One measure to help prevent trauma or fracture within the joint would be to avoid activities like high intensity and high impact sports.

For people who experience symptoms of arthritis, at-home measures may prove somewhat effective. For example, they can take over-the-counter painkillers to relieve symptoms and pain.

Other measures may also include seeking mental health care to help manage the psychological impact of this condition on their quality of life. An individual can consult a medical professional to explore other methods to manage this condition in the long term.

The symptoms that occur during the acute phase of post-traumatic arthritis may spontaneously resolve after a couple of months. However, the condition may slowly progress through a long period of no symptoms referred to as a clinically asymptomatic latency period.

Even acute post-traumatic arthritis can be challenging to live with due to the pain and reduced mobility that it may cause.

Moreover, those individuals who develop chronic forms of the disease will have to consult a doctor to find the most suitable way to manage symptoms.

When someone develops arthritis after an acute traumatic injury to the joints, doctors refer to it as post-traumatic arthritis, which is a form of arthritis. This condition may resolve without medical assistance.

However, some people will develop a chronic form of post-traumatic arthritis. These individuals may require long-term medical care and, in some severe cases, surgery to replace the affected joint.

Go here to read the rest:
Post-traumatic arthritis: What it is, symptoms, and more - Medical News Today

Nail psoriasis is a type of psoriasis that causes visible changes to the nails. Doctors may use nail psoriasis scoring systems to assess the severity of the symptoms.

Nail psoriasis causes various symptoms on the fingernails and toenails, such as nail separation, discoloration, or crumbling nails. It is a type of psoriasis, which is an immune-mediated condition that affects the skin.

Doctors may use a scoring system called the Nail Psoriasis Severity Index (NAPSI) to determine the severity of a persons symptoms.

The results may help doctors recommend suitable treatments, which may include topical creams, corticosteroid injections, or oral medications.

This article looks at nail psoriasis in more detail, including the possible symptoms, the scoring systems that doctors may use to diagnose the condition, and the treatment options.

Nail psoriasis is a condition that can affect people with psoriasis. Psoriasis is an immune-mediated condition in which the immune system attacks healthy tissue, resulting in inflammation and faster skin cell growth that can cause plaques and scales to form on the skin.

Psoriasis can affect different organs and tissues throughout the body, including the nails and the joints.

According to the National Psoriasis Foundation, about 50% of people with psoriasis have psoriasis on their nails, while close to 90% of people with psoriasis will have nail psoriasis at some point during their life.

Learn more about nail psoriasis.

The NAPSI is a scoring system that doctors can use to evaluate the extent of nail psoriasis.

NAPSI divides each nail into quadrants. A doctor will examine each quadrant and score it depending on which clinical signs or symptoms are present.

A 2019 study notes that these signs include:

The doctor will score the nail bed and the nail matrix, which is the area of specialized cells at the base of the nail that produces the nail plate. They assign each a score of 04, depending on the number of affected quadrants. This creates a total score of 08 for each nail.

A doctor will then add up the NAPSI scores for all the fingers, thumbs, and toenails they have examined, giving them a final total NAPSI score in the range of 0160.

A score of zero means that no signs are present, and the numbers increase with the quantity or severity of symptoms present. The higher the NAPSI score, the more severe the nail psoriasis.

The Severity of Nail Psoriasis Score (SNAPS) is another scoring system that doctors may use to evaluate the severity of nail psoriasis. SNAPS looks for four signs of fingernail psoriasis:

Depending on the severity of these signs, a doctor will determine a SNAPS score in the range of 040.

Treatment for nail psoriasis may take time because the nails grow slowly. The American Academy of Dermatology Association (AAD) suggests that it may take 6 months or more to clear certain symptoms, such as a buildup of debris under the nail.

People may need to apply topical treatments one or two times a day for several months to treat nail psoriasis.

A doctor may sometimes create a treatment plan that includes a combination of treatment options. One type may be topical treatments, which are those that people apply directly to the nails. Examples include:

If topical treatments are not effective, people may require medical treatment at a doctors office. Medical treatment options may include:

For severe cases of nail psoriasis, people may need to take an oral medication that works throughout the body to treat psoriasis. These medications include:

Learn more about oral medications for psoriasis.

People will need to contact a primary care physician or dermatologist if they notice any unusual changes to their fingernails or toenails.

The healthcare professional will be able to examine the nails and determine whether the symptoms are due to nail psoriasis or another condition, such as a fungal infection.

It is important to treat nail psoriasis to prevent the symptoms from worsening or becoming painful. Without treatment, the nails may deteriorate, and a person could find it difficult to use the hands or feet.

Changes to the nails may also be a sign of psoriatic arthritis, a type of arthritis that can affect some people with psoriasis. The early diagnosis and treatment of psoriatic arthritis are important to prevent the condition from worsening.

Learn about the differences between nail psoriasis and nail fungal infections.

The outlook for people with nail psoriasis may depend on the severity of the symptoms. Nail psoriasis symptoms may fluctuate over time, and although they will resolve by themselves in some cases, treatment will be necessary in others.

Relapses are common for people with nail psoriasis, so it can be beneficial to find ways to manage the symptoms in the long term.

A range of treatments can effectively treat the symptoms of nail psoriasis, but it may take several months of regular treatment to see results because nails grow slowly.

Nails psoriasis is a form of psoriasis that affects the nails, causing symptoms such as crumbling, pitting, discoloration, and separation of the nail from the nail bed. It can occur in the fingernails or toenails.

Doctors may use a scoring system, such as NAPSI or SNAPS, to determine the severity of the symptoms.

The treatment options for nail psoriasis include corticosteroids, topical ointments, and oral medications.

Anyone who notices any signs of nail psoriasis should contact a doctor or dermatologist. Treatment can help clear the symptoms and prevent the condition from worsening.

See the original post:
Nail Psoriasis Severity Index: What it is, symptoms, and treatment - Medical News Today

ORLANDO, Fla. (Ivanhoe Newswire) - According to the National Psoriasis Foundation, more than eight million people in the United States have psoriasis. Now, research is showing this skin disease affects other organs in the body, including your heart.

When you think of psoriasis, you probably think of red, itchy, scaly skin patches. But scientists are finding out this common disease affects more than the skin.

Ben Kaffenberger, a medical dermatologist, at The Ohio State University explained That inflammation thats present in the skin thats causing this skin to swell and to thicken, it is much more than skin deep. Its causing a full body inflammatory process.

Recent studies have shown that inflammation impacts your bodys cardiovascular system.

That patient with psoriasis has a much higher risk of having heart disease, dying of heart disease, than a patient that doesnt, Dr. Kaffenberger told Ivanhoe.

A recent review of 90 studies found patients with psoriasis had a higher risk of ischemic heart disease, stroke, and peripheral arterial disease. They also had more heart disease risk factors, like obesity, high blood pressure, high cholesterol, and diabetes. Another study found psoriasis was linked to an increased risk of developing a heart arrhythmia. But there are things you can do to lower your risk of heart problems and improve your psoriasis symptoms, including stopping smoking, decreasing your alcohol consumption, eating more fresh fruits, fresh vegetables, less processed foods, detailed Dr. Kaffenberger.

Taking your prescribed medicines may also help. A study published in Cardiovascular Research found that biologic drugs used to treat psoriasis may also reduce the risk of heart disease.

Psoriasis is often mistaken for other skin diseases, like eczema, ringworm, hives, or even skin cancer. A dermatologist can help you determine if your skin rashes are psoriasis.

View post:
Health Beat: Psoriasis inflames the heart | Health Beat | wfmz.com - 69News WFMZ-TV

By David Bautz, PhD

NASDAQ:SNGX

READ THE FULL SNGX RESEARCH REPORT

Business Update

SGX302 for Psoriasis

Soligenix, Inc. SNGX will be developing synthetic hypericin (the active ingredient in HyBryte) as part of a photodynamic therapy in mild-to-moderate psoriasis patients under the research name SGX302. Psoriasis is a common, chronic, noncontagious, multisystem inflammatory condition that most commonly presents on the skin of the elbows, knees, scalp, back, and thighs. There are multiple types of psoriasis, with plaque psoriasis, being the most common and affecting 80-90% of all individuals with psoriasis. Plaque psoriasis involves the hyperproliferation of epidermal keratinocytes that results in red or white, scaly, and typically itchy skin lesions. In addition, approximately 20% of psoriasis patients suffer from psoriatic arthritis, an inflammatory joint disease associated with psoriasis (Zacharlae, 2003). There is no known cure for the disease, thus depending upon the severity of the condition and how responsive it is to treatment, some patients are on therapy for life.

While psoriasis itself is not life-threatening, there are several conditions that are associated with the disease, including cardiovascular disease (Shlyankevich et al., 2014) and hypertension (Armstrong et al., 2013). In addition, patients with psoriasis have an increased risk for a number of non-skin cancers, including cancer of the lung, upper gastrointestinal tract, urinary tract, liver, and pancreas (Richard et al., 2013).

The severity of psoriasis is dependent on how much of a person's body surface area (BSA) is affected by the condition. Mild psoriasis typically covers

Soligenix previously tested synthetic hypericin in a small Phase 1/2 trial involving 13 patients with psoriasis (Rook et al., 2010). Results showed that of the 11 evaluable patients, six responded to treatment with hypericin. There were no deaths or serious adverse events and the only reported adverse events were mild to moderate and included itching, burning, erythema, and pruritis at that application site.

The company is currently evaluating different topical formulations of synthetic hypericin while at the same time working with psoriasis experts to finalize a clinical trial protocol. We anticipate a Phase 2a study initiating in the second half of 2022. We estimate that the company has sufficient capital to conduct the trial without the need to raise additional capital.

HyBryte NDA Anticipated in Second Half of 2022

Soligenix previously completed a Phase 3 clinical trial of HyBryte (SGX301, synthetic hypericin) in patients with cutaneous T cell lymphoma (CTCL). The FLASH (Fluorescent Light Activated Synthetic Hypericin) trial was a randomized, double blind, placebo controlled study that enrolled 169 patients with either Stage IA, IB, or IIA mycosis fungoides (the most common type of CTCL) (NCT02448381).

The trial consisted of three treatment cycles, with each cycle lasting eight weeks. Each study subject had three target lesions treated during the trial. In Cycle 1, patients were randomized 2:1 (n=116 for SGX301; n=50 for placebo) to receive twice weekly treatment of either 0.25% SGX301 or placebo (an ointment with the same light exposure as for SGX301) for six weeks, with treatment response determined at the end of the eighth week. In Cycle 2, all subjects received 0.25% SGX301 on their target lesions, and for those that decided to continue in the trial there was a third treatment cycle where 0.25% SGX301 was applied to all of the patient's lesions.

The results for Cycle 1 showed a statistically significant treatment response in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessed at 8 weeks with 16% of patients receiving SGX301 responding compared to only 4% receiving placebo responding (P=0.04).

In Cycle 2, a total of 155 patients received 0.25% SGX301 on their target lesions (110 receiving 12 weeks of SGX301 and 45 receiving six weeks of placebo treatment followed by six weeks of SGX301 treatment). The results of Cycle 2 showed that continued treatment out to 12 weeks resulted in increased efficacy as shown by a 40% responder rate (P0.0001 compared to both placebo and six-week treatment data). Response rates further improved in Cycle 3 with 49% of patients electing to receive SGX301 for 18 weeks demonstrating a 50% or greater reduction in the combined CAILS. (P0.0001 compared to the end of Cycle 1).

Importantly, after 12 weeks of treatment with HyBryte, there is a similar response on both patch (37% response; P=0.0009) and plaque (42% response; P0.001) lesions when compared to Cycle 1 placebo lesion responses.

HyBryte is a safe and well tolerated CTCL treatment that shows positive effects in a relatively short period of time and has increasing efficacy with continued use. Since CTCL is a long-lasting condition, safety and tolerability are at the forefront of prescribing physicians concerns when treating patients, and many other CTCL therapies have a number of potential serious side effects, particularly with extended use. We believe the data that Soligenix has compiled for SGX301 in treating CTCL positions it as a promising front-line therapy for a large percentage of patients.

Soligenix is now in a position to submit an NDA to the U.S. FDA for HyBryte in the second half of 2022. HyBryte has received both Orphan Drug and Fast Track designations from the U.S. FDA as well as Orphan Drug designation from the European Medicines Agency (EMA).

The company is planning to commercialize HyBryte in the U.S. in lieu of seeking a commercialization partnership. Since the CTCL market is a specialized market, Soligenix can cost effectively market the drug with a launch cost of less than $10 million. This way, the company is able to keep 100% of the drug's value. For overseas markets, we anticipate a commercial partnership and the company is currently in discussions with potential partners. Approval will be sought first in the U.S. followed by other key markets worldwide.

Arbitration with Emergent BioSolutions Offers Potential Upside

Soligenix is currently involved in an arbitration dispute with Emergent BioSolutions, Inc. EBS in which Soligenix alleges that EBS fraudulently induced the company into entering into contracts with its subsidiaries and that the subsidiaries breached agreements with Soligenix. The disputed agreements pertain to the manufacture of RiVax bulk drug substance (BDS) that Emergent released despite the BDS being out-of-specification. This resulted in Soligenix having to suspend the Phase 1c trial evaluating RiVax in healthy adults. Soligenix presented its case at an arbitration hearing in January 2022 and we anticipate a decision on the case this summer. Manufacturing issues have been a problem for EBS in other circumstances, as shown in the report from the House Select Subcommittee on the Coronavirus Crisis titled "The Coronavirus Vaccine Manufacturing Failures of Emergent BioSolutions" from May 2022. While difficult to predict how the arbitration may be decided, the fact that EBS has a history of poor manufacturing practices likely bodes well for Soligenix, which is seeking in excess of $19 million from EBS.

Financial Update

On May 13, 2022, Soligenix announced financial results for the first quarter of 2022. The company reported revenues of $0.2 million for the first quarter of 2022, compared to $0.1 million for the first quarter of 2021. The revenues are derived from government contracts and grants to support the development of RiVax along with grants to support the development of SGX943, ThermoVax, and CiVax. R&D expenses for the first quarter of 2022 were $1.7 million, compared to $1.3 million for the first quarter of 2021. The increase was primarily due to increased expenses associated with the preparation of the upcoming HyBryte NDA filing. G&A expenses for the first quarter of 2022 were $2.6 million, compared to $1.0 million for the first quarter of 2021. The increase was primarily due to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc.

Soligenix exited the first quarter of 2022 with approximately $22.9 million in cash and cash equivalents. As of May 6, 2022, Soligenix had approximately 43.1 million shares outstanding, and when factoring in stock options, warrants, and the potential convertible debt the fully diluted share count is approximately 47.6 million.

Conclusion

Soligenix has a number of important milestones/events upcoming in 2022, including the NDA filing for HyBryte and the initiation of a psoriasis clinical trial for SGX302, both of which we anticipate in the second half of 2022. The current cash position, along with additional financial instruments available to the company, should provide funding into 2023, and the arbitration outcome with EBS provides potential upside to the company's cash position. We have removed CiVax from our model as the current COVID-19 vaccines are seeing oversupply issues and we believe there is not likely to be a follow up vaccine market. With this change our valuation decreased to $4.00 per share.

SUBSCRIBE TO ZACKS SMALL CAP RESEARCHtoreceive our articles and reports emailed directly to you each morning. Please visit ourwebsitefor additional information on Zacks SCR.

DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.

Go here to see the original:
SNGX: Phase 2a Trial of SGX302 in Psoriasis to Initiate in Second Half of 2022 - Benzinga - Benzinga

BARCELONA, Spain, May 23, 2022 Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, announced today the commercial launch in Denmark of Wynzora cream (50 g/g calcipotriol and 0.5 mg/g betamethasone as dipropionate), developed for the topical treatment of mild to moderate plaque psoriasis in adults including scalp.Denmark joins Spain, Germany and the United Kingdom, which were the first European countries to make the cream available on prescription. Following the launch of this innovative topical, Almirall became the only biopharmaceutical company in Europe to offer psoriasis patients multiple options covering the entire spectrum of the disease, from topicals to oral systemics and biologics.

Powered byPAD Technology, a new method of mixing oil and water, Wynzora Cream is the only calcipotriol and betamethasone dipropionate topical that allows the combination of active ingredients in an aqueous cream2,3. Wynzora offers high efficacy and fast onset of action within 1 week.3,4 The results from a pooled analysis of two randomized Phase III trials demonstrated that this CAL/BDP PAD-cream offered superior efficacy and patient quality of life in the topical treatment of psoriasis in comparison to the calcipotriol and betamethasone dipropionate gel formulation for all efficacy endpoints including PGA treatment success, mPASI, and PASI75 after 8 weeks of once-daily use4.

After eight weeks of treatment, the clinical investigation also showed that a significantly greater proportion of subjects treated with CAL/BDP PAD-cream reported that psoriasis had no effect at all on their life (DLQI 0 or 1) compared to CAL/BDP gel4. Superior patient treatment convenience (PTCS) at Week 8 was also achieved with CAL/BDP PAD-cream compared to the CAL/BDP gel.4

The results of pooled data from Phase III clinical trials were published in the Journal of the European Academy of Dermatology and Venereology (JEADV)4.Psoriasis is one of the world's most prevalent skin diseases, affecting approximately at least 100 million individuals worldwide5 and about 2.2% of adults in Denmark (102,000 estimated people)6. The disease negatively affects quality of life and represents a significant burden in the daily life of 71% of patients[vii], affecting the overall emotional wellbeing of 88% of people who suffer from the condition[viii].

I find it highly commendable that new innovation and improvement in topical treatment of psoriasis is brought to light. Based on the phase III trials, the PAD formulation may provide additional benefit to patients with mild to moderate plaque psoriasis in terms of efficacy, quality of life and favourable safety profile of the CAL/BDP PAD-cream stated Lars Iversen, Professor, Aarhus University Hospital.

The Danish Psoriasis Association is pleased to learn that this novel innovative treatment is made available to Danish psoriasis patients. The possibility to improve the quality of life and adherence to treatment are obviously very important features in topical treatment of psoriasis, said Lars Werner, Managing Director, Danish Psoriasis Association.

The deployment of Wynzora Cream in the rest of Europe is on track for 2022. Almirall started marketing the cream in the UK, Spain and Germany in February and expects to roll out in other European countries in the coming months once national marketing authorisations are granted. The product has received regulatory approval in 14 countries in Europe with the name Wynzora, and in Austria with the name Winxory.

"The launch of Wynzora Cream in Europe is on schedule and we are very pleased that Danish patients can now have this novel treatment option available to them. Initial feedback on the product in the UK, Germany and Spain is very positive and we are convinced that this innovative formulation will represent a substantial improvement for patients thanks to its galenic characteristics," said Gianfranco Nazzi, CEO of Almirall.

The Wynzora journey started more than a decade ago fuelled by our desire to meet the demand of patients through our innovative PAD Technology. It is a special feeling to see this new drug being made available also to patients in our home country, Denmark, while we continue the global roll-out., stated Jesper J. Lange, CEO of MC2 Therapeutics, developer of the PAD Technology and Wynzora Cream.

In February 2021, Almirall and MC2 Therapeutics entered into a strategic agreement under which MC2 Therapeutics granted Almirall exclusive European rights to commercialise Wynzora Cream for treatment of plaque psoriasis. Both companies announced the successful completion of a decentralised procedure in July 2021. The cream is also commercialized in the US by MC2 Therapeutics in collaboration with another company.

About pooled analysis of two randomized Phase III trials

WYNZORA (CAL/BDP PAD-cream) demonstrated superiority for all efficacy end points after 8 weeks of treatment. PGA treatment success for CAL/BDP PAD-cream (43.2%) was greater than CAL/BDP gel (31.9%; P<0.0001), the mean percent reduction in mPASI for CAL/BDP PAD-cream was 64.6% compared to 56.4% for CAL/BDP gel (P<0.0001), DLQI 0/1 was obtained by 43.8% in CAL/BDP PAD-cream versus 34.2% CAL/BDP gel (P=0.0005) and superior patient treatment convenience (PTCS) at Week 8 (40.4) was achieved with CAL/BDP PAD-cream compared to CAL/BDP gel (37.0; P<0.0001). There was no adverse drug reaction reported with a frequency of >1%, associated with CAL/BDP PAD-cream.4

About Almirall

Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patients needs through science to improve their lives. Our Noble Purpose is at the core of our work: Transform the patients' world by helping them realize their hopes and dreams for a healthy life. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange and is a member of the IBEX35 (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2021 were 836.5 million euros.

For more information, please visit almirall.com

[ii] Prstegaard M, et al. Phase 3 trial demonstrates superior patient treatment convenience of MC2-01 calcipotriene plus betamethasone dipropionate cream compared to current topical suspension. J of Skin. 2020;4(5):s62

[iii] Stein Gold L, et al. A phase 3, randomized trial demonstrating the improved efficacy and patient acceptability of fixed dose calcipotriene and betamethasone dipropionate cream. J Drugs Dermatol. 2021;20(4): 420-425 doi:10.36849/JDD.5653.

[iv] Pinter A, et al. A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis. JEADV 2022; 36, 228236.

[v] World Health Organization. (2016). Global report on psoriasis. World Health Organization. https://apps.who.int/iris/handle/10665/204417

[vi] ParisiR,IskandarI Y K,KontopantelisE,AugustinM,GriffithsC E M,AshcroftD Met al.National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling studyBMJ2020;369:m1590doi:10.1136/bmj.m1590

[vii] National Psoriasis Foundation 2008 Survey Snapshot. Available from: PTT-24087-quality-of-life-issues-and-measurement-in-patients-with-psor (researchgate.net)

[viii] Armstrong AW, Schupp C, Wu J, et al. PLoS One. 2012;7(12):e52935;

Read this article:
Almirall launches the innovative Wynzora cream in Denmark for the treatment of mild to moderate plaque psoriasis including scalp in adults[i] -...

A skin rash is an irritated or swollen area of skin and is often a symptom of other medical issues, such as allergies or substance intolerances. Affected areas may redden, itch, cause pain, blister or become raw. Skin rashes can appear quickly or over time, and while most will disappear quickly, some rashes may need long-term treatment if symptoms persist.

Though there are many types of skin rashes, below are some of the most common.

Eczema is a very common skin rash that causes swelling and may involve dryness, itching, scaly patches, infections and blisters. Eczema occurs in newborns, children and adults, and it affects more than 31 million people in the U.S., according to the National Eczema Association. This skin condition can present in many forms, including:

A number of factors contribute to eczema, among them being a persons environment and genetics. In most cases of eczema, an environmental factor triggers an immune response reaction, causing inflammation and eczema symptoms in the skin. This instance is often referred to as a flare up.

Atopic dermatitis is a common form of skin rash and the most common type of eczema. It can affect people of all age groups, from newborns to seniors. This type of skin rash is caused by an overreaction of the immune system to small irritants.

Atopic dermatitis is most common in children, with some reports saying close to 25% of children in the U.S. may have the disease, says Joshua Grosshandler, an Ohio-based dermatologist and fellow of the American Academy of Dermatology. All races can be affected but, in the U.S., there seems to be a higher number of African Americans and Asians than Caucasians.

Dr. Grosshandler explains that atopic dermatitis typically affects those with an atopic diathesis, or a predisposition to seasonal allergies, asthma and food allergies. Atopic dermatitis is a complex disease and is not fully understood.

Research suggests that family history of atopic dermatitis, food allergies, seasonal allergies, asthma, the immune system and environment all likely have a role in causing atopic dermatitis, says Dr. Grosshandler. Atopic dermatitis is a chronic potential lifelong condition and cannot be cured, so the goal of treatment is to control the condition, which includes reducing flares, decreasing symptoms like itch and improving the appearance of the skin.

A variety of medications and skin care routines can be used to help control symptoms, according to Dr. Grosshandler, including:

If youve ever gone hiking only to come home itching and scratching around your ankles, elbows or arms, you may have experienced contact dermatitisirritation or inflammation caused by coming into contact with an allergen or substance like poison ivy, poison oak or another external factor.

Contact dermatitis refers to a group of skin conditions for which the rash is due to direct contact with a causative agent either resulting in the irritation of the skin or an allergic reaction, says Dr. Grosshandler. The two main types are allergic contact dermatitis and irritant contact dermatitis.

Allergic contact dermatitis refers to a skin rash that appears as a delayed allergic reaction. This type of rash may appear one to two days after the skin is exposed to an allergen, such as poison ivy.

Irritant contact dermatitis refers to when skin cells are damaged due to exposure to an irritating substance. These reactions make up nearly 80% of all contact dermatitis cases, according to the National Eczema Association.

Both types of contact dermatitis can develop in anyone, although there are some groups that have a higher risk, such as those with atopic dermatitis, adds Dr. Grosshandler. Some allergens known to cause the condition include nickel, urushiol (the oil in poison ivy, poison oak and poison sumac), fragrance and latex.

Symptoms of contact dermatitis are often itchy, bumpy or flaky skin around the affected area. More severe cases can result in oozing blisters and heavy swelling. Symptoms may also cause disruptions in sleep and day-to-day activities due to discomfort.

To treat contact dermatitis:

Dermatologists may also prescribe steroids to help address itching and accompanying symptoms. In both allergic and irritant cases of contact dermatitis, its important to know and avoid the substance that causes the reaction. For severe allergic reactions, contact your health care provider.

Rosacea is very common in the U.S., with reports of 14 million people affected, according to the American Academy of Dermatology Association. It typically occurs in individuals between 30 and 50 years of age, with women being more likely to be affected than men.

There are four types of rosacea:

Fair-skinned individuals with light hair, light eyes and a Northern European ancestry have the classic background for rosacea, but it can affect those of all skin colors and genetic backgrounds, says Dr. Grosshandler.

The exact cause of rosacea is unknown, but there are multiple theories that involve genetics, environmental factors, vascular changes, inflammation and the immune system, explains Dr. Grosshandler. Sun exposure, for example, can cause the symptoms to intensify. Untreated rosacea tends to worsen over time.

While there isnt a cure for rosacea, there are different approaches to help manage the symptoms. Common rosacea triggers to consider avoiding include:

Medication can also be used to help treat rosacea. Prescription medications [to treat rosacea] include topical metronidazole, topical sodium sulfacetamide sulfur, topical ivermectin, topical azelaic acid, topical tetracycline, topical oxymetazoline, oral tetracycline antibiotics and vascular lasers such as the PDL, says Dr. Grosshandler. He also suggests implementing a consistent skin care routine with sunscreen, gentle cleansers and moisturizers to help manage outbreaks.

Psoriasisa type of rash identified by the itchy, red, scaly texture it creates on skinis thought to be caused by an autoimmune disorder, and it can follow a viral infection such as strep throat. However, the underlying cause of psoriasis is still unknown. If left untreated, psoriasis can worsen and become very painful.

Psoriasis is a common skin condition with approximately 2% of the population affected, says Dr. Grosshandler. Psoriasis can start at any age, but ages 15 to 25 and 50 to 60 are two peaks to see it present.

There are several types of psoriasis, according to the National Institute of Arthritis and Musculoskeletal Diseases.

Much like eczema, experts think psoriasis may be caused by a mixture of geneticspeople with the condition tend to have relatives who also suffer from psoriasisand environmental triggers. Mental health problems, being overweight, infection and some medications are also known triggers of psoriasis.

Medicinal treatment options for psoriasis include topical steroids, topical vitamin D creams, methotrexate (an immune suppressor used to slow the growth and division of cells), retinoids, biologic response monitors (injectable medications used to block, decrease or stop inflammation) Phosphodiesterase 4 (PDE4) inhibitors (used to suppress rapid cell turnover and inflammation) and immunosuppressants, among others.

Phototherapythe use of ultraviolet (UV) light on the affected area of skinis a treatment method typically used when large areas of the body are affected. This treatment can be offered in a doctors office or, if prescribed a proper UV light, at home.

While some rashes are not harmful and can be treated with gentle washing, others can be more severe and spread at rapid rates. If you experience skin rash symptoms, speak with your health care provider to discuss proper diagnosis and treatment.

Find a dermatologist near you

Zocdoc helps you find and book top-rated doctors, on demand. Visit them in their offices, or video chat with them from home. Check out the dermatologists in your area.

Dermatologists Near Me

Follow this link:
Your Guide To Types Of Skin Rashes - Forbes

As with other medical conditions, the understanding of psoriasis has changed over time. Psoriasis likely affected the earliest humans, but it was not until the 1800s that doctors recognized psoriasis as its own condition.

Through the ages, psoriasis has gone from being a feared condition to one that people can treat to control most, if not all, of their symptoms effectively.

Several philosophers both well-known and less prominent from ancient civilizations described psoriasis-like lesions on the skin.

In Ancient Greece, Hippocrates (460377 B.C.E.) described inflammatory skin conditions, including psoriasis, using two words: psora, meaning itch, and lopoi, describing dry, scaly skin.

Centuries later, in the Roman Empire, a nobleman named Cornelius Celsus (25 B.C.E.50 C.E.) described a skin condition that affects the skin and nails.

Starting in ancient times and persisting through the Middle Ages, people did not write much about skin conditions. When they did, they tended to lump them together.

The grouping of skin conditions did not end for several centuries. During the Middle Ages, people living with psoriasis shared the same treatment essentially being cast out from society as people living with leprosy.

During the Renaissance, an Italian named Girolamo Mercuriale (15301606) wrote a book called De Morbis Cutaneis (Diseases of the Skin). This book, which became one of the more important works on skin diseases, described psoriasis as a skin condition called lepra grecorum.

In 1809, an English doctor named Robert Willan (17571812) produced a simple diagnostic description of several skin conditions, including psoriasis. He also defined some psoriasis types, including guttate, scalp, and palmar psoriasis. However, in his description, he used the term lepra vulgaris.

Many consider Willan to be the founder of dermatology as a medical practice.

Doctors continued to group leprosy and psoriasis until the 1800s, when an Austrian physician named Ferdinand Ritter von Hebra (18161880) wrote the book Atlas der Hautkrankeiten (Atlas of Skin Diseases). Unlike many before him, von Hebra separated leprosy from psoriasis in his works.

Many look to von Hebra as the father of modern dermatology and still see his book as one of the most influential books on skin diseases of all time. In 1841, he named psoriasis.

Then, in 1860, Ernest Bazin connected psoriasis to a form of arthritis, calling it arthritic psoriasis.

Also in the 1800s, Dr. Heinrich Kbner noted that psoriasis plaques appear in uncommon areas due to skin abrasion, burns, bruises, and other injuries. This is now known as the Kbner phenomenon, but scientists still do not understand why it occurs.

Throughout the rest of the 1800s into the 1900s, doctors continued to describe and refine what they knew about psoriasis.

As the 20th century progressed, doctors and researchers learned more about the disease and developed detailed descriptions of various subtypes.

In 1973, John M. Moll and Verna Wright made a milestone discovery. They published a paper describing how psoriasis and psoriatic arthritis form part of the same unique disease, explaining that it is different than rheumatoid arthritis.

Researchers today understand that psoriasis is more than just a skin disease. It is a chronic autoimmune disorder that causes systemic inflammation. This newer understanding has helped shape modern medical treatments, including the use of biologics.

Advances in knowledge about psoriasis through the years have led to changes in the treatment landscape. In more recent years, the quality of available treatment has improved dramatically.

Early treatments focused mostly on internal medication. The rationale for this stemmed from the belief that applying a topical treatment to a skin lesion would drive the infection inward, leading to infection of the organs.

Beginning in the 1700s and persisting into the 19th century, early psoriasis treatments often included options such as mercury and arsenic. Little is known about what effect they had on psoriasis or the person, but these treatments can be toxic. As recently as 1956, medical literature mentioned the use of mercury in topical ointments for psoriasis.

As the years progressed, so did psoriasis treatment options:

Read the original post:
Psoriasis: A brief history plus what we know now - Medical News Today

Clinicians should be aware of differences between male and female patients with psoriasis, how the disease manifests and how treatment should be approached.

With psoriasis, differences in disease manifestation and treatment outlook and goals exist between male and female patients using systemic agents, including conventional system agents (CSA) and tumor necrosis factor inhibitors or ustekinumab (TNFi/UST). However, few studies have addressed sex differences as they pertain to systemic agent use, such as CSA discontinuation and switch from CSA to TNFi/UST.

Past research has shown that female patients have higher expectations for achieving treatment goals than male patients. Female patients anticipate faster skin improvement and a return to normal life, even though male patients may present with more severe psoriasis. These differences in psoriasis severity and treatment goals between male and female patients may determine how clinicians manage their treatment. Female patients, for example, may discontinue treatment prematurely or request a treatment change if their skin clearance is slower than expected.

For a paper published in Frontiers in Pharmacology, my colleagues and I utilized a health administrative database to examine sex differences in patterns of CSA use and determine factors linked with switching to (or adding) a TNFi/UST. Our retrospective cohort study included 1,644 patients with psoriasis (mean age, 61; 55.7% female) who started a CSA between 2002 and 2015. The study team used Cox regression models with the Least Absolute Shrinkage and Selecting Operator (LASSO) to identify socioeconomic and clinical characteristics that predicted switch/add-on TNFi/UST.

We observed similar rates for switch and add-on of TNFi/UST between male and female patients with psoriasis. However, most predictors of switch/add-on were sex-specific. For example, among males, we found an increased risk for longer psoriasis disease duration and obesity by at least 2.3-fold. Among female patients, prior use of NSAIDs and the presence of certain mental health disorders increased the risk for switch/add-on by 2.7-fold. Interestingly, female patients with rheumatoid arthritis (RA) as a comorbidity had a 60% reduced risk for switch/add-on (Table).

Our findings may help clinicians improve the management of male and female patients with moderate-to-severe psoriasis in need of systemic agent treatment. Since most countries with a universal healthcare system reimburse biologic agents only for patients who do not respond well to CSA or among whom CSA are contraindicated, a need exists to improve access to biologic agents. For male patients with obesity and for those who have lived with psoriasis for an extended time, and for female patients who experience pain or mental health symptoms, treatment with biologic agents may save them the burden of going through a failed treatment experience and help improve their psoriasis outcomes faster, especially since biologic agents are known for being more effective than CSA.

My colleagues and I also included variables related to psoriasis treatments such as the type of initial CSA received, the specialty of the prescriber, and prior use of topical agents and phototherapy. However, none of these variables were selected by our model, thus possibly indicating that the decision of the healthcare professional to prescribe a biologic agent among male and female patients with psoriasis was mostly based on patients clinical profiles and not on these factors.

We were surprised to find that psoriatic arthritis (PsA) was not associated with a risk for switch in both male and female patients, while RA was linked with a decreased risk for switch among female patients. Since PsA and RA are immune-mediated conditions for which biologic agents can also be prescribed, additional research is warranted to better understand the reduced risk for switch/add-on of TNFi/UST among female patients with both psoriasis and RA.

Additionally, larger studies, specifically those focused on psoriasis severity, are needed to confirm our findings and their impact on clinical practice and provincial drug policy. Larger studies will also allow comparisons between individual CSAs and the assessment of predictors of switch to TNFi/UST and those for receiving these agents as add-on, separately.

View post:
Examining Sex Differences in the Management of Psoriasis - Physician's Weekly