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ACELYRIN, INC., Affibody AB and Inmagene Biopharmaceuticals Announce Data from Global Phase 2 Trial of Izokibep in Patients with Psoriatic Arthritis…

Posted: June 3, 2022 at 1:08 pm

Data suggest efficacy over standard of care for the treatment of psoriatic arthritis

Izokibep was well-tolerated, having a safety profile consistent with previous studies and the IL-17A inhibitor therapeutic class

Supports hypothesis that izokibep offers greater efficacy with high potency and small size, as well as strategy of evaluating IL-17A inhibition's potential for transformative efficacy across many disease states

LOS ANGELES and SOLNA, Sweden, and SHANGHAI, June 3, 2022 /PRNewswire/ -- ACELYRIN, INC., Affibody AB and Inmagene Biopharmaceuticals today announced data from a 16-week, global, Phase 2 clinical trial of izokibep in 135 patients with psoriatic arthritis (PsA) presented by Frank Behrens, MD, Associate Professor of Medicine, Head of Rheumatology Clinical Research, University Hospital & Deputy Director Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Goethe-University Frankfurt, Germany and a founding member of the Group of Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), during a podium session at the 2022 European Alliance of Associations for Rheumatology (EULAR) Congress in Copenhagen.

The randomized double-blind, placebo-controlled, Phase 2 clinical trial evaluated the safety and efficacy of izokibep dosed 80 mg every two weeks (Q2W) or 40 mg Q2W, versus placebo Q2W, in adult patients with active PsA. The global study assessed various endpoints at 16 weeks including the American College of Rheumatology (ACR) response, the Leeds Enthesitis Index (LEI), the Psoriasis Area and Severity Index (PASI) score and Quality of Life via the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire.

Endpoint

Placebo

Izokibep 80 mg Q2W

Izokibep 40 mg Q2W

ACR50

p-value

13%

52%

0.0006

48%

0.0014

Leeds Enthesitis1

(% LEI=0)

p-value for means

10%

88%

0.0003

63%

0.0095

PASI752

p-value

14%

85%

<0.0001

83%

<0.0001

PsAID

(% beyond MCID)

p-value

12%

41%

0.0017

31%

0.0418

1FAS, observed data for LEI > 0 at baseline N=43 (32%) post-hoc analysis2FAS, observed data for psoriasis BSA 3% at baseline N=74 (55%) post-hoc analysis

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"Psoriatic arthritis is a painful and debilitating inflammatory disease of the peripheral joints, skin, and nails, and it can also affect the spine," said Professor Behrens. "Furthermore, residual entheseal pain and inflammation,which occurs in up to 60% of patients, is associated with more severe disease, poorer quality of life and is considered one of the most significant unmet needs of psoriatic arthritis patients. The data presented at EULAR demonstrate there is potential opportunity for increased therapeutic efficacy in joints, entheseal pain and inflammation resolution and improved quality of life, all of which would be meaningful for patients living with psoriatic arthritis."

Izokibep was well-tolerated in the study, having a favorable safety profile consistent with that previously observed for izokibep and the IL-17A inhibitor therapeutic class. The most commonly reported AEs were injection site reaction and injection site erythema, the majority of which was mild.

"The improvements demonstrated in arthritis, psoriasis and enthesitis are exciting relative to responses reported for the current standard of care," observed Professor Peter Taylor, Norman Collison chair of musculoskeletal sciences at the University of Oxford. "Combined with theclinically meaningful improvement in disease-specific quality of life and well-tolerated safety profile, izokibep seemspromising for patients living with the painful and debilitating symptoms of psoriatic arthritis, and I am eager to see its continued development for patients."

ACELYRIN holds worldwide rights to izokibep except development and commercialization rights by Inmagene in selected Asian countries, including China, Hong Kong, South Korea, and Taiwan, and excluding Japan. Affibody holds commercialization rights in the Nordic countries.

About izokibep

To date, more than 300 patients many for up to three years have received izokibep, a unique, antibody mimetic, interleukin-17A (IL-17A) inhibitor designed to overcome the limitations of monoclonal antibodies. With high potency and small molecular size, izokibep can reach high drug exposure levels through a single, subcutaneous injection that monoclonal antibodies require IV administration to achieve. Additionally, the small size of izokibep about one tenth the size of a monoclonal antibody enables its potential to reach targeted tissues that may otherwise be inaccessible to the much larger monoclonal antibodies.

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory musculoskeletal condition affecting the peripheral joints, the skin (with psoriasis), the nails, and in approximately 30 percent of individuals, the spine. Left under-treated, PsA leads to chronic joint pain, swelling, and damage with a high potential for permanent disability. Psoriatic arthritis pathology is dominated by pro-inflammatory T-helper (Th-17) cells that lead to over expression of IL-17, IL-23, and TNF cytokines.

About ACELYRIN

ACELYRIN, INC. is a Los Angeles area-based biopharma company focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating development and commercialization of promising drug candidates and leveraging its expertise to rapidly advance these medicines to patients. For more information, please visit http://www.acelyrin.com

About Affibody AB

Affibody AB is a clinical-stage biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod. Affibody is a holding of Patricia Industries. For more information, please visit http://www.affibody.com

About Inmagene Biopharmaceuticals

Inmagene Biopharmaceuticals, with wholly owned subsidiaries in San Diego, Shanghai, Hangzhou, and Wuhan, is a leading biotech company focused on immunology-related therapeutic areas. Believing in "borderless innovation", the Inmagene team integrates efficient resources worldwide to develop drugs for patients globally. Inmagene is operating twelve "Smart Innovation" programs to create and develop novel drug candidates for the global market. For more information, please visit http://www.inmagenebio.com

Disclaimer

This press release contains forward-looking statements. While ACELYRIN, INC., Affibody AB, and Inmagene Biopharmaceuticals consider the projections to be based on reasonable assumptions, these forward-looking statements may be called into question by numerous hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements.

Cision

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ACELYRIN, INC., Affibody AB and Inmagene Biopharmaceuticals Announce Data from Global Phase 2 Trial of Izokibep in Patients with Psoriatic Arthritis...

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Kim Kardashian fans shocked after they see what her hands really look like in new pics… – The US Sun

Posted: at 1:08 pm

FANS of Kim Kardashian have long debated why the reality star is so often spotted covering her hands with various types of gloves when she goes out.

Now, they may have their answer, as the SKIMS founder was recently snapped with her hands bare, which appeared old and wrinkled.

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In a series of new pictures, Kim was seen exiting a car. As she braced herself with her left hand, photos revealed her thin and bony frame.

On Reddit, fans were shocked by what they saw.

"Her skin looks like paper!" one fan exclaimed, as another added: "Where are the gloves when you need'em?!"

Still, one pointed out: "Hands tend to show age first, but she is also thin which lends itself to more visible blood vessels and tendons."

And another pointed out: "Doesnt she have psoriasis? Topical corticosteroids can cause the skin to become thin and age quickly."

Indeed, the 41-year-old has been open about herbattle with psoriasis, a skin disease that causes red, itchy, scaly patches.

The flare-ups most commonly occur on the knees, elbows, trunk, and scalp.

TheKeeping Up With the Kardashiansalum revealed she first began to deal with psoriasis in her mid-20s.

In an article for her sisterKourtneysbrandPoosh, Kim wrote: When I was 25, I had my first psoriasis flare-up.

I got a common cold, and since psoriasis is an autoimmune condition, this triggered it. It was all over my stomach and legs.

She continued: "Luckily, in my apartment complex at the time, my neighbor was a dermatologist. I showed it to him, and he said to come into the office, and he would give me a shot of cortisone, and then hopefully, it would go away (since it was my first big outbreak).

"I did this, and my psoriasis completely went away for about five years.

KardashianmatriarchKris Jenner, 66, also has psoriasis, though Kim was her only child to inherit the condition.

Kim explained in the Poosh story that her psoriasis returned when she was in her early 30s.

The model is currently celebrating the release of her newhigh-end skincare linecalled SKKN.

As part of the launch, she has admitted that her beauty "is not natural" and would take hours of work each morning, including stem cell facials and lasers.

In an interview with the New York Times, The Kardashiansstar explained she has a nine-step system that "might seem scary to some."

She added: "Thats why Im here to break it down, to be like, Theyre all necessary."

The Hulu star then dived into her appearance and revealed: "So many people want to act like they dont care about how they look.

"Im not acting like it comes easier or its all-natural. You just dont wake up and use whatever. You wake up, you use ingredients.

While using her SKKN samples, theKeeping Up With the Kardashiansalum demonstrated her lengthy routine.

She headed off to the bathroom and washed her face to remove the makeup from a previous photo shoot.

As part of her skincare routine, Kim cleansed, exfoliated, and patted her face with a combination of glow oil and face cream.

She concluded: I always go down to my chest - down to my nipples always down to nips.

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Artificial intelligence could shorten the diagnosis of psoriatic arthritis – Vaughan Today

Posted: at 1:07 pm

Artificial intelligence (AI) tool can drastically reduce diagnostic time for psoriatic arthritis patients, welcomes the educated community in a press release.

Its primarily dermatologists who treat patients with psoriasis and we have the opportunity to ask them about potential joint pain because about 10% of them may have osteoarthritis but without knowing it, recalls lead author Dr. Jonathan Shapiro of McCabe Health Services. The statement was quoted by Ramat Hasharon.

Since patients do not always associate joint pain with skin problems, they will talk to their general practitioner or orthopedic surgeon. But the latter can miss a psoriatic arthritis diagnosis because these symptoms are not very specific, leading to delayed care and risks of irreversible lesions and disability, he continues.

In this retrospective study, Dr. Shapiro and colleagues discover ways to recognize early

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Break the vicious cycle of stress and psoriasis – Deccan Herald

Posted: May 28, 2022 at 8:24 pm

Ria, one of my patients with psoriasis under treatment, was frustrated when she had to miss her meeting because of her psoriasis flare. This was after spending 15 stressful days preparing for the meeting. Psoriasis flares triggered by stress are a common reason for frustration and depression among psoriasis patients like Ria.

In todays competitive world, work-related stress is very common. Other stressful situations in life such as managing relationshipsand adjusting to an increased workload also can flare existing psoriasis. The International Journal of Dermatology found that 31% to 88% of people reported their first psoriasis event within a year of a stressful situation.

In fact, in some patients, fear of psoriasis flare-ups also caused stress and further triggered psoriasis. Effective stress management is very important to breaking this vicious cycle.

Psoriasis patients should not get disheartened because a well-planned stress management can help them lead a healthy and comfortable life. Early treatment after professional consultation with a dermatologist has been found to significantly reduce the frequency and severity of flares in many.

Newer, novel therapies like biologics, have proven to be a boon for psoriasis patients, including those with frequent and severe flares. Adherence to the recommended treatment and regular access to dermatologists for follow-ups, ensures a long-term and flare-free period and a clear skin. This saves them from social and psychological issues such as depression while improving the quality of their life.

Hence in addition to timely medication and skincare, stress management is imperative for a holistic management of psoriasis.

Here are some stress management tips for psoriasis patients:

Learn about psoriasis

Knowing about psoriasis, its symptoms, ways to predict flare-ups, and what effects psoriasis can have on the body is important. Discussion with dermatologists about different treatment options, including the newest ones like biologics helps in making informed decisions. Identifying personal triggers for flare-ups assists in managing psoriasis better. Additionally, having the right understanding about the condition can help alleviate fear and help one make informed choices.

Seek support

We cannot eliminate stress from our lives but definitely can keep a check on it through proper stress management techniques. Sharing your concerns and problems with friends, family or colleagues always helps to get their support to streamline work and avoid stress. Connecting with psoriasis patient groups garners support and guidance, through shared experiences and problem-solving methods for effective psoriasis management.

Set priorities

With well-set priorities and a well-planned, goal-oriented routine, psoriasis patients can juggle multiple responsibilities without stress. A disciplined approach to skincare, medicine schedule and regular follow-up with the doctor for monitoring progress complement a stress-free routine to manage psoriasis better.

(The writer is a Dermatology Consultant attwotertiary care hospitals)

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Bouchard Nodes and Psoriatic Arthritis: Causes and Treatments – Healthline

Posted: at 8:24 pm

Arthritis is a group of more than 100 conditions that cause inflammation or swelling in your joints. Many of these types of arthritis can develop in the joints between your finger bones.

The most common form of arthritis is called osteoarthritis. It usually develops after years of wear and tear on a joint causes the cartilage to break down.

One of the classic signs of osteoarthritis in the middle joint of a finger is the formation of bumps called Bouchard nodes. The presence of Bouchard nodes can help differentiate osteoarthritis from other types of arthritis that can affect your hands, like psoriatic arthritis.

Keep reading to learn more about Bouchards nodes, including why they develop and why theyre an important part of an arthritis diagnosis.

One of the biggest challenges in diagnosing arthritis of the finger joints is differentiating between osteoarthritis and psoriatic arthritis.

The presence of Bouchards nodes is a classic sign of hand osteoarthritis that can help with this differentiation. Theyre named after the French doctor Charles-Joseph Bouchard.

Bouchards nodes are hard, bony bumps that form along the middle joints of your fingers. These joints are called your proximal interphalangeal joints.

Bouchards nodes can cause:

You can develop Bouchards nodes in one or many fingers. Theyre called Heberdens nodes when they form on the joints near the end of your fingers, which are called your distal phalangeal joints.

Bouchards nodes are less common and are associated with more severe arthritis.

Bouchards nodes form when the cartilage between your finger bones wears down. The role of this cartilage is to reduce friction in your joints. When it wears away, your bones start to rub together. This can damage the joint and trigger the development of new bony tissue.

New bone tissue can cause the ends of your fingers to become misaligned and crooked.

Risk factors for the development of hand osteoarthritis include:

About 1 in 4 people with psoriasis also have psoriatic arthritis, which can cause joint pain, swelling, and stiffness.

Psoriatic arthritis tends to develop 5 to 10 years after a psoriasis diagnosis.

But people with psoriasis can also develop other types of arthritis, like osteoarthritis, and differentiating between them can be difficult.

In a 2021 study published in the Journal of Rheumatology, researchers found that the prevalence of osteoarthritis was:

Osteoarthritis is caused by a degeneration of the cartilage in your joints from repetitive wear and tear. Psoriatic arthritis is caused by joint damage from your immune system attacking healthy cells. People with psoriasis can develop both types of arthritis.

Psoriatic arthritis is caused by a misdirected immune response where your immune system attacks your joints. Symptoms can range from mild to severe. Symptoms depend on where your arthritis develops, but they can include:

You may go through flare-ups or periods when your symptoms are worse than usual. Some people have severe problems with many joints, and other people have mild symptoms in only one or two joints.

The development of psoriatic arthritis still isnt fully understood. Between one-third and one-half of people with psoriatic arthritis also have a relative with psoriasis or psoriatic arthritis. It most commonly develops between the ages of 30 to 50.

Osteoarthritis is the most common type of arthritis, and it becomes more common with age. In the United States, its estimated that 80 percent of people over age 65 have signs of osteoarthritis.

Osteoarthritis is caused by the wear and tear on joints that happens over the course of many years. It tends to develop slowly and gets worse over time as the joint continues to sustain damage.

Theres no cure for osteoarthritis, but treatment can help manage your symptoms.

Symptoms are similar to those of other types of arthritis and include:

Psoriatic arthritis commonly affects the hands. It can also appear in the knees, ankles, and feet.

Symptoms of psoriatic arthritis in the hands are similar to other types of arthritis. They can include:

Your hands might not be affected evenly. Swelling often affects a whole finger with the most swelling around your middle knuckle. The joint at the end of your finger may also be deformed.

You may notice changes to the texture of your fingernails such as pitting, ridging, or crumbling.

About 23 to 27 percent of people with psoriasis develop symptoms on their nails.

Some people with psoriatic arthritis may also have areas of red, dry, and scaly skin on their hands or palms. Psoriasis can develop on any part of your body but most commonly affects your:

While theres no particular treatment for Bouchards nodes, your doctor can help you manage other symptoms of arthritis in your hands.

Treatment for arthritis usually starts with a conservative, noninvasive approach. Your doctor may suggest:

If medication and other conservative treatments fail, your doctor may recommend surgery. But surgery performed to repair hand arthritis is uncommon because the complication and failure rates are high.

The two primary surgeries used to treat arthritis of the hand include:

Hand arthritis can negatively impact your quality of life. You may be able to reduce your discomfort with a combination of home remedies and changing your movement habits.

Here are some tips to make living with hand arthritis easier:

Bouchards nodes are one of the characteristic signs of osteoarthritis of the finger joints, not psoriatic arthritis. They appear as bony bumps along the middle joint of a finger. Doctors use the presence of these bumps to differentiate osteoarthritis from other types of arthritis.

Arthritis in your hands can be very uncomfortable, but your doctor can help you develop a treatment plan. Your doctor will likely first recommend conservative treatments like changing your movement habits or taking NSAIDs. If these dont reduce your discomfort, they may recommend surgery.

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Cost per Responder Analysis of Secukinumab versus Adalimumab in the Treatment of Psoriatic Disease – DocWire News

Posted: at 8:24 pm

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

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The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Risankizumab (SKYRIZI) in Crohn’s Disease – BioSpace

Posted: at 8:24 pm

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.

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SOURCE AbbVie

Company Codes: NYSE:ABBV

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

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Post-traumatic arthritis: What it is, symptoms, and more – Medical News Today

Posted: at 8:24 pm

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.

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Nail Psoriasis Severity Index: What it is, symptoms, and treatment – Medical News Today

Posted: May 25, 2022 at 4:35 am

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.

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

Posted: at 4:35 am

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.

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

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