Monthly Archives: March 2021

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Long-term data from Janssens Phase III DISCOVER-2a trial show that TREMFYA (guselkumab), a selective IL-23 inhibitor, lead to skin clearance and joint symptom relief for up to two years in patients with active psoriatic arthritis (PsA).

Janssens TREMFYA was approved for the treatment of adults with moderate to severe plaque psoriasis (PsO) in the U.S. back in July 2017 and then again in July 2020 for adults with active PsA. The latter approval was based on trial data from the DISCOVER-1 and DISCOVER-2, both of which showed that the treatment led to at least 20% improvement in joint symptoms (ACR 20) by 24 weeks.

TREMFYA is a selective inhibitor of IL-23, a key cytokine that fuels an inflammatory immune response associated with symptoms of PsO and PsA.

"PsA can be a chronically painful and debilitating disease, and many PsA patients are still searching for enduring relief of their symptoms," said study investigator Philip J. Mease, M.D., of the Swedish Medical Center/Providence St. Joseph Health and the University of Washington, Seattle, Washington. "These data, which show that the observed benefits of TREMFYA in PsA continue through two years, represent positive news for physicians and patients alike."

Findings from the new trial show that 56% and 55% of patients who took TREMFYA every four and every eight weeks, respectively, experienced at least a 50% improvement in the ACR score through 100 weeks. Approximately 62% of patients who took TREMFYA every 4 weeks and 55% of patients who took TREMFYA every eight weeks with clinically meaningfulbaseline PsO also achieved complete skin clearance by follow up.

Approximately 59% and 53% of those who had clinically meaningful baseline skin involvement who received TREMFYA every four weeks and eight weeks, respectively, experienced complete skin clearance by week 100. Additionally, 76% of patients treated with TREMFYA every four weeks and 74% treated every eight weeks had at least a 20% improvement in the ACR by the long-term follow-up period.

TREMFYA every four weeks also demonstrated significant inhibition of radiographic progression of joint structural damage at week 24. Rates of radiographic progression of joint damage observed from week 52 to 100 in patients who received the treatment every four and eight weeks were also numerically lower than those reported from baseline to week 52.

In terms of durability, the investigators of the DISCOVER-2a trial found that treatment with TREMFYA led to robust joint and skin response rates and improvements in outcome measures through the two-year follow-up period. Up to 90% of patients randomly assigned to TREMFYA also continued their assigned therapy through week 100. Overall, no new safety signals were observed through week 112.

"PsA is a chronic inflammatory disease of the skin, joints, and soft tissue and therefore, sustained control of this inflammation is important to physicians and patients," saidAlyssa Johnsen, M.D., Ph.D., Janssen Research & Developments Vice President and Rheumatology Disease Area Leader. "These long-term study results further bolster our confidence in the ability of TREMFYA to significantly improve the diverse manifestations of PsA over time."

Janssen said in a statement that the data from the DISCOVER-2a trial will soon be presented in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference, held March 16 through 20, 2021.

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Janssen's Psoriatic Arthritis Drug Proves Long-Term Efficacy in Two-Year Trial - BioSpace

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J Rheumatol. 2021 Mar 15:jrheum.201671. doi: 10.3899/jrheum.201671. Online ahead of print.

ABSTRACT

The coronavirus disease 2019 (COVID-19; caused by SARS-CoV-2) pandemic has affected the healthcare system on a global scale, and we utilized the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2020 annual meeting to examine how COVID-19 might affect patients with psoriatic disease (PsD) and the clinicians who care for them. Pressing issues and concerns identified included whether having psoriasis increased the risk of acquiring COVID-19, vaccine safety, and the acceptability of telehealth. The general message from rheumatologists, dermatologists, infectious disease specialists, and patient research partners was that data did not suggest that having PsD or its treatment significantly increased risk of infection or more severe disease course, and that the telehealth experience was a success overall.

PMID:33722951 | DOI:10.3899/jrheum.201671

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Psoriasis and Psoriatic Arthritis in the Context of the COVID-19 Pandemic: A Plenary Session From the GRAPPA 2020 Annual Meeting - DocWire News

WESTLAKE VILLAGE, Calif., March 17, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, will present safety, efficacy, and patient-reported outcomes from its Phase 2 open-label long-term safety study investigating roflumilast 0.3% cream in adult patients with mild-to-severe chronic plaque psoriasis at the Innovations in Dermatology: Virtual Spring Conference 2021.

Psoriasis can significantly impact all aspects of a patients life, including adverse physical, emotional, and social effects, said Dr. Linda Stein Gold, MD, Henry Ford Health System and Chair, Innovations in Dermatology. Current topical treatments for plaque psoriasis are often ineffective for long-term treatment, are not well tolerated, or are ill-suited for use in some areas of the body. We are excited to present data demonstrating that roflumilast addresses these limitations with the added benefit of a favorable long-term safety and efficacy profile.

A poster presentation will feature new long-term efficacy and safety data on topical roflumilast 0.3% cream at 52- to 64-weeks (Dr. Linda Stein Gold). Additionally, two poster presentations will feature analyses of improved burden of signs and symptoms and improved itch severity (Dr. Leon Kircik), and itch-related sleep loss in adults with chronic plaque psoriasis (Dr. Linda Stein Gold) from the original Phase 2b study of roflumilast cream over a 12-week treatment period.

Arcutis also recently released positive topline data from the pivotal Phase 3 studies of roflumilast cream in plaque psoriasis, and plans to present the full results of those studies in the near future, as well as submit a New Drug Application later this year.

In addition to the plaque psoriasis presentations, Dr. Melinda Gooderham will present the results from the Phase 2 study of roflumilast cream 0.15% and 0.05% in patients with mild-to-moderate atopic dermatitis.

Existing topical treatments prescribed to psoriasis patients have significant shortcomings, which lead to difficult trade-offs between efficacy, safety, and tolerability, said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis Chief Medical Officer. These data reinforce our conviction that topical roflumilast, if approved by the FDA, has the potential to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions by reducing the need to make such trade-offs.

Arcutis is investigating roflumilast as a once-daily, nonsteroidal treatment for plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp psoriasis. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4). Based on results from the pivotal Phase 3 studies, topical roflumilast potentially delivers efficacy comparable to the results of published clinical studies of high-potency steroid/calcipotriene or high-potency steroid/tazarotene combination products, but with safety and tolerability that supports chronic use in all areas of the body, and little or none of the local tolerability issues associated with many competitive agents.

For more information, visit the Innovations in Dermatology Spring Conference virtually and https://www.arcutis.com or follow the company on LinkedIn and Twitter.

About Plaque PsoriasisPsoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

About Atopic DermatitisAtopic dermatitis (AD) is the most common type of eczema, occurring in approximately 6% of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Given that most of the patients are pediatric, the safety and tolerability of AD therapies is paramount.

About Topical Roflumilast CreamRoflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors for dermatology. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis.

About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The companys lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter.

Forward Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Investor and Media ContactHeather Rowe Armstrongharmstrong@arcutis.com 805-418-5006 ext. 740

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Arcutis Biotherapeutics to Showcase Long-term Safety, Efficacy, and Patient-Reported Outcomes of Roflumilast Cream for Chronic Plaque Psoriasis at...

You may not have a choice about needing a mobility aid, but how you feel about it is completely up to you.

If someone had told me at 25 that I would be walking with a cane by age 30, I wouldnt have believed them.

In my case, the cause wasnt injury or accident, but psoriatic arthritis (PsA) a chronic, autoimmune disease that causes inflammation, joint pain, fatigue, and mobility limitations in 30 percent of people with psoriasis.

During the first arthritis flare-up that landed me in the hospital, I literally could not stand on my own feet.

Over the next several years, as doctors prescribed one medication regimen after another, I faced a daunting new reality: I could no longer walk without assistance.

How could I find the right mobility device to suit my needs and how could I get used to moving through the world with it?

Here are a few things I learned in my search to restore my mobility and maximize my quality of life with PsA.

Several weeks after the onset of PsA, I found I was still unable to walk, so I bought the cheapest manual wheelchair I could find. I chose a wheelchair partly because it was a familiar cultural icon, and I didnt know much about my other options.

Once I delved more deeply into the world of mobility devices, I realized just how many options there are.

Broadly speaking, people with mobility issues have a choice between walking aids and seated mobility devices.

Walking aids include:

Seated mobility devices include:

Since physical activity has been shown to improve both PsA symptoms and overall health, most users will want to choose the device that allows them to be as active as possible while also staving off pain and fatigue.

My manual wheelchair served me well in the short term, before I was able to find the right combination of medications to manage my symptoms. However, I soon realized that I wanted to be more active even if it meant dealing with more physical pain.

Over the course of the next several years, as biologic drugs began to suppress some of my disease activity, I transitioned to using a rollator, then forearm crutches, and then finally, a cane.

All this experimentation was expensive. I wish I had known that many device companies allow prospective users to rent or try out different mobility aids and determine which one best suits their needs.

I also wish I had consulted with a doctor, occupational therapist, or physical therapist to learn how to use these devices correctly, since improper usage cannot only decrease the helpfulness of your mobility aid, but may even have a negative impact on your posture or cause you greater discomfort.

When choosing your own mobility device(s), be open to multiple possibilities and dont be shy about asking for information on device usage from those in the know.

Even when I first got diagnosed with PsA, the last thing I wanted was to feel like a sick person.

I soon realized that I could keep my life as active and vibrant as possible by taking an open-minded, strategic approach to mobility aids.

Its true that certain activities like skiing, hiking, and climbing are no longer feasible for me, but Im lucky to be mobile enough that there are many things I can still do, if I have the right mobility aid on hand.

For instance, my arm crutches are ideal for nature walks, since they stabilize and support both sides of my body while leaving me flexible to maneuver.

When going to a museum or other accessible indoor attraction, I opt for a wheelchair, which lets me move through the space smoothly and view exhibits without pain or fatigue.

Now that my symptoms are mostly well-controlled, thanks to medication, I can often get by with a folding cane. It provides minimal support when I get tired, and it also serves as a signaling device to alert people that I may move slowly or need to sit down from time to time.

When choosing the mobility aid thats right for you, think about what you want or need to get done on a particular day. Ask yourself what accessibility challenges you might encounter, and which device would help you face them with comfort and confidence.

Prior to my PsA diagnosis, I assumed that disability was a stable, fixed category or, at least, a linear progression from wellness to illness.

One of the most surprising aspects of living with a chronic disease is how much my symptoms can fluctuate from one day or week to the next. Even in a single day, I often have periods in the morning and at night when my joints feel stiff and my range of motion is limited.

Once you know to expect these fluctuations, you become better able to plan your day even if that means expecting a bit of unpredictability.

These emotional and logistical aspects of living with PsA require both flexibility and resilience.

It can be discouraging to lapse into an arthritis flare-up and find oneself back in a wheelchair after weeks of walking around with a less intensive mobility aid.

It can also be frustrating to find that certain devices may not work well for you at times when particular joints are giving you trouble. For instance, forearm crutches can be terrific for taking pressure off of weak knees or ankles, but they put a significant strain on a users shoulders and wrists.

As you pick a mobility aid, check in with yourself to figure out which body parts need extra support, and be prepared for the prospect that your mobility needs might shift depending on factors like the time of day or the weather.

The changeable nature of PsA symptoms can be hard for nondisabled onlookers to understand.

I have had friends ask me excitedly if I was cured when they saw me using a cane on a good day, instead of my usual rollator.

Conversely, Ive encountered nosiness and skepticism from colleagues who had only met me at a meeting, seated, and later ran into me on the street and demanded, Whats with the cane?

Try not to get thrown off by these moments, and try not to feel like youre pretending or being dramatic by making use of a mobility aid. Only you are inside your body only you know what you need.

For me, the adjustment to this new world of mobility aids was emotionally fraught, since it meant reconciling myself to the fact of my disability. After all, those of us with PsA dont use our mobility aids in the way someone with a broken leg might use crutches.

We know that our symptoms are treatable with medication, but that PsA cant be cured. As a result, we may feel the need to integrate mobility devices into our sense of identity.

This can be difficult, especially if one doesnt use the same device every day. No matter what, it takes time to get used to how it feels to use a mobility aid.

Accepting that these tools are extensions of your body tools that accompany you through the world and help you live the life you want takes even longer.

Be patient with others, and with yourself, as you figure out which equipment works best for you.

You may not have a choice about how large a role mobility aids play in your daily routine, but how you feel about them is completely up to you.

Michael M. Weinstein has written about disability, illness, and gender for venues including The New Yorker, The Los Angeles Review of Books, and Michigan Quarterly Review. He holds a PhD in English from Harvard and an MFA from the University of Michigan, where hes currently a Zell Creative Writing Fellow. Hes currently at work on a book about the social and romantic lives of transgender Americans. You can find him on Twitter and Instagram.

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4 Tips for Navigating the World of Mobility Aids for PsA - Healthline

The joint and skin response rates of adults with active psoriatic arthritis observed with Tremfya (guselkumab) were maintained over two years.

The Janssen Pharmaceutical Companies of Johnson & Johnson have released long-term data from the Phase III DISCOVER-2 study showing that the skin clearance, joint symptom relief and safety of Tremfya(guselkumab) previously demonstrated through 24 weeks and one year (week 52) in adults with active psoriatic arthritis (PsA) continued through two years (week 112).

Tremfya is currently the only IL-23 inhibitor therapy approved in the US to treat both adults with active PsA and adults with moderate to severe plaque psoriasis (PsO). The PsA approval was based on results from DISCOVER-1 and DISCOVER-2 previously published inThe Lancet.

At week 100, 59 percent of patients receiving Tremfya every four weeks (q4w) and 53 percent of those receiving Tremfya every eight weeks (q8w) achieved complete skin clearance (assessed using the Psoriasis Area Severity Index [PASI]). Among patients who had clinically meaningful PsO at baseline, 62 percent of Tremfya q4w patients and 55 percent of Tremfya q8w patients achieved complete skin clearance as measured by the Investigator Global Assessment (IGA) score of 0.

Additionally, 76 percent of the patients receiving Tremfya q4w and 74 percent of those receiving Tremfya q8w achieved at least 20 percent improvement in joint pain (assessed using the American College of Rheumatology [ACR 20] response criteria). Moreover, 56 percent of Tremfya q4w patients and 55 percent of Tremfya q8w patients achieved at least 50 percent improvement in ACR score.

The study also assessed radiographic progression. At 24 weeks, Tremfya q4w demonstrated statistically significant inhibition of radiographic progression of joint structural damage (measured by PsA-modified van der Heijde-Sharp [vdH-S scores]). Tremfya q8w afforded numerically, but not statistically significant, less radiographic progression compared with placebo. From week 52-100, low rates of radiographic progression of joint damage were observed in patients receiving TREMFYA q4w (0.75) and Tremfya q8w (0.46), which were both further numerically reduced from the results observed during weeks 0-52 (1.06, q4w; 0.99, q8w).

In the group of patients who crossed over from placebo to Tremfya q4w at week 24, mean changes in vdH-S scores were 1.12 from week 0-24 while receiving placebo and 0.34 from week 24-52 and 0.13 from week 52-100 while receiving Tremfya q4w, indicating that further numerical improvements were also made through year two in this group.

According to Janssen, approximately 90 percent of patients randomised to Tremfya q4w or q8w continued treatment with Tremfya through Week 100.

No new safety signals were observed in the safety analysis conducted through week 112.

PsA is a chronic inflammatory disease of the skin, joints, and soft tissue and therefore, sustained control of this inflammation is important to physicians and patients, said Dr Alyssa Johnsen, Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. These long-term study results further bolster our confidence in the ability of Tremfya to significantly improve the diverse manifestations of PsA over time.

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Data shows long-term efficacy of Tremfya in active psoriatic arthritis - European Pharmaceutical Review

NORTH CHICAGO, Ill., March 17, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplementalNew Drug Application (sNDA) for upadacitinib in the treatment of adult patients with active psoriatic arthritis. The updated Prescription Drug User Fee Act (PDUFA) action date has been extended three months to late Q2 2021.

AbbVie recently received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require additional time for a full review of the submission.

Separately, AbbVie received a similar request from the FDA related to the sNDA for upadacitinib in atopic dermatitis, which is being prepared and will be submitted to the FDA shortly.

"We remain confident in the sNDA and are committed to working with the FDA to bring upadacitinib to patients living with psoriatic arthritis and other immune-mediated diseases," saidMichael Severino, M.D., vice chairman and president, AbbVie.

About Upadacitinib (RINVOQ)

Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases.It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2.InAugust 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is also approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs and active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 15 mg. Phase 3 trials of RINVOQ in ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis and giant cell arteritis are ongoing.

Important Safety Information about RINVOQ (upadacitinib)

RINVOQ U.S. Use and Important Safety InformationRINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

What is the most important information I should know about RINVOQ?RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

What should I tell my HCP BEFORE starting RINVOQ?Tell your HCP if you:

Tell your HCP about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.

What should I tell my HCP AFTER starting RINVOQ?Tell your HCP right away if you:

What are the common side effects of RINVOQ?These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.

RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.You are encouraged to report negative side effects of prescription drugs to the FDA. Visithttp://www.fda.gov/medwatchor call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. VisitAbbVie.com/myAbbVieAssistto learn more.

Please click here for theFull Prescribing InformationandMedication Guide.

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 its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com/. Follow @abbvie on Twitter, Facebook, Instagram, YouTubeand LinkedIn.

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 2020 Annual Report on Form 10-K, which has been filed with theSecurities 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.

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AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Adults with Active Psoriatic Arthritis...