Psoriasis

After many years at the University of California, San Francisco, Lindsey A. Criswell, MD, MPH, DSc, began a new chapter in February 2021 as the director of the National Institute of Arthritis and Musculoskeletal and Skin Disease, part of the National Institutes of Health. NIH Director Francis S. Collins, MD, PhD, selected her for the post.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator,” Dr. Collins said in a prepared statement. “Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well positioned to direct NIAMS.” Dr. Criswell, a rheumatologist, was named a full professor of medicine at UCSF in 2007 and had served as vice chancellor of research at the university since 2017. She has authored more than 250 peer-reviewed scientific papers, and her efforts have contributed to the identification of more than 30 genes linked to autoimmune disorders. In her first media interview, Dr. Criswell opens up about her mentors, operational challenges posed by the COVID-19 pandemic, and highlights many NIAMS research projects underway.

Who inspired you most early in your career as a physician scientist? I have had great opportunities to work with fabulous mentors. Wallace (Wally) Epstein, MD, was my mentor when I was a rheumatology fellow and junior faculty member at UCSF. He was broadly admired for the breadth of his experience as a clinician and a researcher, and he was noteworthy at that time for his strong support for women and students of color. One of the many things I appreciated about him was his diverse range of interests outside of work, which included cello playing and woodworking.

Another mentor was Ephraim (Eph) Engleman, MD, the first academic rheumatologist in California. Eph continued to see patients beyond the age of 100. Perhaps his most important contributions were his efforts towards advocacy for funding for research and education in rheumatology. A prodigy violinist, he too had a broad range of personal interests.

What research into the genetics and epidemiology of human autoimmune disease that you have been a part of has most surprised you, in term of its ultimate clinical impact? Some of my most rewarding and impactful work has focused on the shared genetic basis of autoimmune diseases. We’ve identified dozens of genes that contribute to the risk and outcome of rheumatoid arthritis, lupus, and other autoimmune disorders. These discoveries regarding shared genes and pathways among such a diverse set of conditions have helped to inform optimal therapeutic target and treatment strategies across multiple diseases. For example, exploration of RA genes and pathways has revealed that approved agents for other conditions, such as cancer, may be appropriately repurposed for the treatment of RA. These are critical observations that have the potential to dramatically accelerate progress in developing new therapies for autoimmune diseases, such as RA.

Did you have much interaction with Stephen I. Katz, MD, PhD, your longtime predecessor who passed away unexpectedly in 2018? If so, what do you remember most about him? I regret that I had very little interaction with Steve, but I am well aware of the impact he had on NIAMS, NIH, and the research enterprise overall. He inspired so many people in a personal way, and I am energized by the legacy that he left behind.

What are your goals for the early part of your tenure as the new director of NIAMS? An important goal is getting to know the NIAMS community and expanding my knowledge of the Institute’s musculoskeletal and skin portfolios. I am also conducting outreach to Institute/Center directors and other NIH leadership to increase opportunities for input and advice. In doing this, I am identifying shared research interests, best practices, and potential partners for possible future collaborations. Another important goal is to increase NIAMS’ visibility within and beyond NIH. Ultimately, I want to contribute to the great work of the Institute and improve the lives of people with rheumatic, musculoskeletal, and skin diseases.

How would you characterize your management style? I like to lead with a flat hierarchy and work collectively to address opportunities and challenges. I value team building and tend to tap a variety of perspectives and expertise at all levels to achieve consensus, where possible.

The Accelerating Medicines Partnership (AMP) program was launched in 2014, with projects in three disease areas including the autoimmune disorders RA and lupus. What are some recent highlights from this program with respect to RA and lupus? AMP RA/SLE was dedicated to identifying promising therapeutic targets for RA and systemic lupus erythematosus. AMP-funded researchers have applied cutting-edge technologies to study cells from the synovial tissues of the joints of people with RA, and from the kidneys of people with lupus nephritis. In 2014, studying tissues in patients where the disease is active was a novel approach, since most research was conducted in mouse models or human blood samples.

The AMP RA/SLE Network developed a rich dataset that is available to the research community. Investigators are now using the data to facilitate RA and lupus research. For example, using AMP data, NIAMS-supported researchers identified potential biomarkers that could help predict an imminent RA flare. Work from another NIAMS-supported group suggests that targeting the regulatory transcription factor HIF-1, which drives inflammation and tissue damage, might be an effective approach for treating renal injury in lupus.

The data generated are accessible to the scientific community through two NIH websites: the database of Genotypes and Phenotypes (dbGaP) and the Immunology Database and Analysis Portal (IMMPORT).

Given the success of AMP RA/SLE, NIH plans to launch an “AMP 2.0” later in 2021. The AMP Autoimmune and Immune-Mediated Diseases (AMP AIM) program will provide an opportunity to leverage the accomplishments of AMP RA/SLE to new conditions, including psoriatic spectrum diseases and Sjögren’s syndrome.

What are some recent highlights from NIAMS-supported research in skin diseases? NIAMS-supported investigators continue to make significant strides in our understanding of skin biology and disease. For example, researchers recently demonstrated that imiquimod, a drug used to treat precancerous skin lesions, can help mouse ear wounds heal without scarring.

Another team addressed the safety and potential benefit of Staphylococcus hominis A9, a bacterium isolated from healthy human skin, as a topical therapy for atopic dermatitis.

Moving forward, AMP AIM will refine and extend the single-cell analysis of tissues to additional diseases, including psoriasis, setting the stage for the discovery of new therapeutic targets for the disease.

How has the COVID-19 pandemic changed the landscape of research, at least for the short term? This is a once-in-a-century pandemic that none of us were fully prepared for. We understand that it has been particularly challenging for women scientists, scientists with young children, and trainees and junior faculty who are at critically important and vulnerable stages of their careers. There isn’t a lab or clinical setting that hasn’t been negatively impacted in some way.

During the pandemic, the NIH instituted administrative flexibilities to support the grantee community, including extensions in time. In addition, the agency has issued several funding opportunities specific to COVID-19, some of which involve NIAMS participation.

What is NIAMS doing to help early/young investigators as well as female investigators and those from minority groups? Structural racism in biomedical research is a heightened concern. Earlier this year, Dr. Collins established the UNITE initiative to address structural racism and promote racial equity and inclusion at the NIH and within the larger biomedical community that we support. NIAMS is fully committed to this effort. One example is the Diversity Supplement Program, which is designed to attract and encourage eligible individuals from underrepresented populations to research careers.

Early-stage investigators are another top priority. In a tribute to the beloved former NIAMS director, NIH recently established the Stephen I. Katz Early Stage Investigator Research Grant Program. The R01 award provides support for a project unrelated to an early investigator’s area of postdoctoral study. (No preliminary data are allowed.) This award mechanism is a unique opportunity for early-stage investigators to take their research in a completely new direction.

Managing work and family life is an important concern, particularly for female investigators. Many NIH grant awards allow for reimbursement of actual, allowable costs incurred for childcare and parental leave. The NIH is exploring initiatives to promote research continuity and retention of eligible investigators facing major life events, such as pregnancy, childbirth, and adoption, at vulnerable career stages.

Who inspires you most in your work today? I am inspired by the ongoing struggles of our patients, junior investigators, and by the committed staff members on my team.

[email protected]

After many years at the University of California, San Francisco, Lindsey A. Criswell, MD, MPH, DSc, began a new chapter in February 2021 as the director of the National Institute of Arthritis and Musculoskeletal and Skin Disease, part of the National Institutes of Health. NIH Director Francis S. Collins, MD, PhD, selected her for the post.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator,” Dr. Collins said in a prepared statement. “Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well positioned to direct NIAMS.” Dr. Criswell, a rheumatologist, was named a full professor of medicine at UCSF in 2007 and had served as vice chancellor of research at the university since 2017. She has authored more than 250 peer-reviewed scientific papers, and her efforts have contributed to the identification of more than 30 genes linked to autoimmune disorders. In her first media interview, Dr. Criswell opens up about her mentors, operational challenges posed by the COVID-19 pandemic, and highlights many NIAMS research projects underway.

Who inspired you most early in your career as a physician scientist? I have had great opportunities to work with fabulous mentors. Wallace (Wally) Epstein, MD, was my mentor when I was a rheumatology fellow and junior faculty member at UCSF. He was broadly admired for the breadth of his experience as a clinician and a researcher, and he was noteworthy at that time for his strong support for women and students of color. One of the many things I appreciated about him was his diverse range of interests outside of work, which included cello playing and woodworking.

Another mentor was Ephraim (Eph) Engleman, MD, the first academic rheumatologist in California. Eph continued to see patients beyond the age of 100. Perhaps his most important contributions were his efforts towards advocacy for funding for research and education in rheumatology. A prodigy violinist, he too had a broad range of personal interests.

What research into the genetics and epidemiology of human autoimmune disease that you have been a part of has most surprised you, in term of its ultimate clinical impact? Some of my most rewarding and impactful work has focused on the shared genetic basis of autoimmune diseases. We’ve identified dozens of genes that contribute to the risk and outcome of rheumatoid arthritis, lupus, and other autoimmune disorders. These discoveries regarding shared genes and pathways among such a diverse set of conditions have helped to inform optimal therapeutic target and treatment strategies across multiple diseases. For example, exploration of RA genes and pathways has revealed that approved agents for other conditions, such as cancer, may be appropriately repurposed for the treatment of RA. These are critical observations that have the potential to dramatically accelerate progress in developing new therapies for autoimmune diseases, such as RA.

Did you have much interaction with Stephen I. Katz, MD, PhD, your longtime predecessor who passed away unexpectedly in 2018? If so, what do you remember most about him? I regret that I had very little interaction with Steve, but I am well aware of the impact he had on NIAMS, NIH, and the research enterprise overall. He inspired so many people in a personal way, and I am energized by the legacy that he left behind.

What are your goals for the early part of your tenure as the new director of NIAMS? An important goal is getting to know the NIAMS community and expanding my knowledge of the Institute’s musculoskeletal and skin portfolios. I am also conducting outreach to Institute/Center directors and other NIH leadership to increase opportunities for input and advice. In doing this, I am identifying shared research interests, best practices, and potential partners for possible future collaborations. Another important goal is to increase NIAMS’ visibility within and beyond NIH. Ultimately, I want to contribute to the great work of the Institute and improve the lives of people with rheumatic, musculoskeletal, and skin diseases.

How would you characterize your management style? I like to lead with a flat hierarchy and work collectively to address opportunities and challenges. I value team building and tend to tap a variety of perspectives and expertise at all levels to achieve consensus, where possible.

The Accelerating Medicines Partnership (AMP) program was launched in 2014, with projects in three disease areas including the autoimmune disorders RA and lupus. What are some recent highlights from this program with respect to RA and lupus? AMP RA/SLE was dedicated to identifying promising therapeutic targets for RA and systemic lupus erythematosus. AMP-funded researchers have applied cutting-edge technologies to study cells from the synovial tissues of the joints of people with RA, and from the kidneys of people with lupus nephritis. In 2014, studying tissues in patients where the disease is active was a novel approach, since most research was conducted in mouse models or human blood samples.

The AMP RA/SLE Network developed a rich dataset that is available to the research community. Investigators are now using the data to facilitate RA and lupus research. For example, using AMP data, NIAMS-supported researchers identified potential biomarkers that could help predict an imminent RA flare. Work from another NIAMS-supported group suggests that targeting the regulatory transcription factor HIF-1, which drives inflammation and tissue damage, might be an effective approach for treating renal injury in lupus.

The data generated are accessible to the scientific community through two NIH websites: the database of Genotypes and Phenotypes (dbGaP) and the Immunology Database and Analysis Portal (IMMPORT).

Given the success of AMP RA/SLE, NIH plans to launch an “AMP 2.0” later in 2021. The AMP Autoimmune and Immune-Mediated Diseases (AMP AIM) program will provide an opportunity to leverage the accomplishments of AMP RA/SLE to new conditions, including psoriatic spectrum diseases and Sjögren’s syndrome.

What are some recent highlights from NIAMS-supported research in skin diseases? NIAMS-supported investigators continue to make significant strides in our understanding of skin biology and disease. For example, researchers recently demonstrated that imiquimod, a drug used to treat precancerous skin lesions, can help mouse ear wounds heal without scarring.

Another team addressed the safety and potential benefit of Staphylococcus hominis A9, a bacterium isolated from healthy human skin, as a topical therapy for atopic dermatitis.

Moving forward, AMP AIM will refine and extend the single-cell analysis of tissues to additional diseases, including psoriasis, setting the stage for the discovery of new therapeutic targets for the disease.

How has the COVID-19 pandemic changed the landscape of research, at least for the short term? This is a once-in-a-century pandemic that none of us were fully prepared for. We understand that it has been particularly challenging for women scientists, scientists with young children, and trainees and junior faculty who are at critically important and vulnerable stages of their careers. There isn’t a lab or clinical setting that hasn’t been negatively impacted in some way.

During the pandemic, the NIH instituted administrative flexibilities to support the grantee community, including extensions in time. In addition, the agency has issued several funding opportunities specific to COVID-19, some of which involve NIAMS participation.

What is NIAMS doing to help early/young investigators as well as female investigators and those from minority groups? Structural racism in biomedical research is a heightened concern. Earlier this year, Dr. Collins established the UNITE initiative to address structural racism and promote racial equity and inclusion at the NIH and within the larger biomedical community that we support. NIAMS is fully committed to this effort. One example is the Diversity Supplement Program, which is designed to attract and encourage eligible individuals from underrepresented populations to research careers.

Early-stage investigators are another top priority. In a tribute to the beloved former NIAMS director, NIH recently established the Stephen I. Katz Early Stage Investigator Research Grant Program. The R01 award provides support for a project unrelated to an early investigator’s area of postdoctoral study. (No preliminary data are allowed.) This award mechanism is a unique opportunity for early-stage investigators to take their research in a completely new direction.

Managing work and family life is an important concern, particularly for female investigators. Many NIH grant awards allow for reimbursement of actual, allowable costs incurred for childcare and parental leave. The NIH is exploring initiatives to promote research continuity and retention of eligible investigators facing major life events, such as pregnancy, childbirth, and adoption, at vulnerable career stages.

Who inspires you most in your work today? I am inspired by the ongoing struggles of our patients, junior investigators, and by the committed staff members on my team.

[email protected]

After many years at the University of California, San Francisco, Lindsey A. Criswell, MD, MPH, DSc, began a new chapter in February 2021 as the director of the National Institute of Arthritis and Musculoskeletal and Skin Disease, part of the National Institutes of Health. NIH Director Francis S. Collins, MD, PhD, selected her for the post.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator,” Dr. Collins said in a prepared statement. “Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well positioned to direct NIAMS.” Dr. Criswell, a rheumatologist, was named a full professor of medicine at UCSF in 2007 and had served as vice chancellor of research at the university since 2017. She has authored more than 250 peer-reviewed scientific papers, and her efforts have contributed to the identification of more than 30 genes linked to autoimmune disorders. In her first media interview, Dr. Criswell opens up about her mentors, operational challenges posed by the COVID-19 pandemic, and highlights many NIAMS research projects underway.

Who inspired you most early in your career as a physician scientist? I have had great opportunities to work with fabulous mentors. Wallace (Wally) Epstein, MD, was my mentor when I was a rheumatology fellow and junior faculty member at UCSF. He was broadly admired for the breadth of his experience as a clinician and a researcher, and he was noteworthy at that time for his strong support for women and students of color. One of the many things I appreciated about him was his diverse range of interests outside of work, which included cello playing and woodworking.

Another mentor was Ephraim (Eph) Engleman, MD, the first academic rheumatologist in California. Eph continued to see patients beyond the age of 100. Perhaps his most important contributions were his efforts towards advocacy for funding for research and education in rheumatology. A prodigy violinist, he too had a broad range of personal interests.

What research into the genetics and epidemiology of human autoimmune disease that you have been a part of has most surprised you, in term of its ultimate clinical impact? Some of my most rewarding and impactful work has focused on the shared genetic basis of autoimmune diseases. We’ve identified dozens of genes that contribute to the risk and outcome of rheumatoid arthritis, lupus, and other autoimmune disorders. These discoveries regarding shared genes and pathways among such a diverse set of conditions have helped to inform optimal therapeutic target and treatment strategies across multiple diseases. For example, exploration of RA genes and pathways has revealed that approved agents for other conditions, such as cancer, may be appropriately repurposed for the treatment of RA. These are critical observations that have the potential to dramatically accelerate progress in developing new therapies for autoimmune diseases, such as RA.

Did you have much interaction with Stephen I. Katz, MD, PhD, your longtime predecessor who passed away unexpectedly in 2018? If so, what do you remember most about him? I regret that I had very little interaction with Steve, but I am well aware of the impact he had on NIAMS, NIH, and the research enterprise overall. He inspired so many people in a personal way, and I am energized by the legacy that he left behind.

What are your goals for the early part of your tenure as the new director of NIAMS? An important goal is getting to know the NIAMS community and expanding my knowledge of the Institute’s musculoskeletal and skin portfolios. I am also conducting outreach to Institute/Center directors and other NIH leadership to increase opportunities for input and advice. In doing this, I am identifying shared research interests, best practices, and potential partners for possible future collaborations. Another important goal is to increase NIAMS’ visibility within and beyond NIH. Ultimately, I want to contribute to the great work of the Institute and improve the lives of people with rheumatic, musculoskeletal, and skin diseases.

How would you characterize your management style? I like to lead with a flat hierarchy and work collectively to address opportunities and challenges. I value team building and tend to tap a variety of perspectives and expertise at all levels to achieve consensus, where possible.

The Accelerating Medicines Partnership (AMP) program was launched in 2014, with projects in three disease areas including the autoimmune disorders RA and lupus. What are some recent highlights from this program with respect to RA and lupus? AMP RA/SLE was dedicated to identifying promising therapeutic targets for RA and systemic lupus erythematosus. AMP-funded researchers have applied cutting-edge technologies to study cells from the synovial tissues of the joints of people with RA, and from the kidneys of people with lupus nephritis. In 2014, studying tissues in patients where the disease is active was a novel approach, since most research was conducted in mouse models or human blood samples.

The AMP RA/SLE Network developed a rich dataset that is available to the research community. Investigators are now using the data to facilitate RA and lupus research. For example, using AMP data, NIAMS-supported researchers identified potential biomarkers that could help predict an imminent RA flare. Work from another NIAMS-supported group suggests that targeting the regulatory transcription factor HIF-1, which drives inflammation and tissue damage, might be an effective approach for treating renal injury in lupus.

The data generated are accessible to the scientific community through two NIH websites: the database of Genotypes and Phenotypes (dbGaP) and the Immunology Database and Analysis Portal (IMMPORT).

Given the success of AMP RA/SLE, NIH plans to launch an “AMP 2.0” later in 2021. The AMP Autoimmune and Immune-Mediated Diseases (AMP AIM) program will provide an opportunity to leverage the accomplishments of AMP RA/SLE to new conditions, including psoriatic spectrum diseases and Sjögren’s syndrome.

What are some recent highlights from NIAMS-supported research in skin diseases? NIAMS-supported investigators continue to make significant strides in our understanding of skin biology and disease. For example, researchers recently demonstrated that imiquimod, a drug used to treat precancerous skin lesions, can help mouse ear wounds heal without scarring.

Another team addressed the safety and potential benefit of Staphylococcus hominis A9, a bacterium isolated from healthy human skin, as a topical therapy for atopic dermatitis.

Moving forward, AMP AIM will refine and extend the single-cell analysis of tissues to additional diseases, including psoriasis, setting the stage for the discovery of new therapeutic targets for the disease.

How has the COVID-19 pandemic changed the landscape of research, at least for the short term? This is a once-in-a-century pandemic that none of us were fully prepared for. We understand that it has been particularly challenging for women scientists, scientists with young children, and trainees and junior faculty who are at critically important and vulnerable stages of their careers. There isn’t a lab or clinical setting that hasn’t been negatively impacted in some way.

During the pandemic, the NIH instituted administrative flexibilities to support the grantee community, including extensions in time. In addition, the agency has issued several funding opportunities specific to COVID-19, some of which involve NIAMS participation.

What is NIAMS doing to help early/young investigators as well as female investigators and those from minority groups? Structural racism in biomedical research is a heightened concern. Earlier this year, Dr. Collins established the UNITE initiative to address structural racism and promote racial equity and inclusion at the NIH and within the larger biomedical community that we support. NIAMS is fully committed to this effort. One example is the Diversity Supplement Program, which is designed to attract and encourage eligible individuals from underrepresented populations to research careers.

Early-stage investigators are another top priority. In a tribute to the beloved former NIAMS director, NIH recently established the Stephen I. Katz Early Stage Investigator Research Grant Program. The R01 award provides support for a project unrelated to an early investigator’s area of postdoctoral study. (No preliminary data are allowed.) This award mechanism is a unique opportunity for early-stage investigators to take their research in a completely new direction.

Managing work and family life is an important concern, particularly for female investigators. Many NIH grant awards allow for reimbursement of actual, allowable costs incurred for childcare and parental leave. The NIH is exploring initiatives to promote research continuity and retention of eligible investigators facing major life events, such as pregnancy, childbirth, and adoption, at vulnerable career stages.

Who inspires you most in your work today? I am inspired by the ongoing struggles of our patients, junior investigators, and by the committed staff members on my team.

[email protected]

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The risk of developing psoriatic arthritis (PsA) may increase as the severity of psoriasis increases, results from a large analysis of U.S. medical records demonstrated.

Factors that predict the development of psoriasis in patients with psoriasis include nail, inverse, and scalp psoriasis; family history of PsA; as well as severity of skin disease. And like psoriasis, “PsA is associated with a multitude of comorbidities, including cardiovascular disease, metabolic syndrome, Crohn’s disease, obesity, diabetes, uveitis, anxiety, and depression, with correspondingly higher healthcare utilization and direct healthcare costs,” wrote corresponding author Joseph F. Merola, MD, MMSc, and colleagues. The study was published online in the Journal of the American Academy of Dermatology. “Timely and accurate diagnosis of PsA is important for improved patient outcomes and appropriate disease management and may prevent prolonged inflammation that leads to structural joint damage and worsening physical function,” they added.

The mean time of onset of PsA among patients with psoriasis who develop PsA is 10 years after the first signs of psoriasis appear. An estimated 20%-30% of patients with psoriasis have a concurrent diagnosis of PsA, and the annual incidence of PsA has been reported to be 2.7 cases per 100 patients with psoriasis. While previous studies have suggested that a higher incidence of PsA is associated with greater disease severity, there are limited data in the United States on the topic.

For the study, Dr. Merola, a dermatologist and rheumatologist who directs the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston, and his colleagues drew from the Optum EHR database to identify adult patients newly diagnosed with psoriasis between Jan. 1, 2009, and March 31, 2019. Patients diagnosed with psoriasis or PsA prior to the index date were excluded from the analysis for evaluation of incidence but included for evaluation of prevalence. The patients were followed from the index date until the earliest PsA event, death, or end of study or follow-up, whichever came first. The researchers calculated the incidence of PsA among adults with psoriasis as the number of incident PsA events divided by the number of patient-years (PY) at risk, which was reported as the raw incidence per 100 psoriasis PY. They calculated the prevalence of PsA among adults with psoriasis as “the number of prevalent PsA events divided by the number of eligible patients with [psoriasis] and reported by years in the follow-up period,” which was a median of 3.7 years.

A total of 114,868 patients were included in the analysis. At baseline, their mean age was 54 years, 53% were female, 89% were White, and 39% were obese. Most patients (102,553) were on nonsystemic agents during the year after their psoriasis diagnosis, while 6,345 were on nonbiologic systemic therapies (NBSTs) and 5,970 were on biologics. The researchers classified patients as having mild psoriasis if they were taking nonsystemic agents, moderate disease if they were taking NBSTs, or severe disease if they were taking biologics.

The overall incidence rate of PsA was 2.9 events per 100 PY and increased by severity of disease. When calculated by severity, the incidence was 2.1 events per 100 PY for patients with mild psoriasis, 9.9 events per 100 PY for those with moderate psoriasis, and 17.6 events per 100 PY for those with severe psoriasis.

When the researchers excluded patients diagnosed with PsA up to 1 year after being diagnosed with psoriasis, the overall incidence was lower (1.7 events per 100 PY), with similar trends for categories of treatment severity. Specifically, the incidence was 1.5, 3.1, and 4.7 events per 100 PY among those with mild, moderate, and severe psoriasis, based on their treatment groups, respectively.

Among the 120,523 patients with psoriasis who were eligible for the assessment of prevalence of PsA, the overall 5-year prevalence of PsA was 14.2% and rose with severity of disease: 9.9% in patients with mild psoriasis, 35% in patients with moderate psoriasis, and 54.9% in patients with severe psoriasis.

Other predictors of PsA onset for both index-date cohorts included weight of 90 kg or greater, female gender, age group 25-65 years (compared with the age group over 65 years), and rheumatic risk factors such as wrist pain and unspecified rheumatism.

“To ensure timely diagnosis and treatment for management and prevention of PsA, patients with [psoriasis] should be routinely screened, especially those with more severe disease and other PsA risk factors,” the authors advised.

Dr. Merola and colleagues acknowledged certain limitations of their analysis, including the potential for selection bias and its reliance on EHR data which “lacked clinical measures of disease severity such as the PASI, and data on BSA were not available for all study participants; therefore, treatment groups were used as a surrogate for disease severity,” they wrote. “As a result, some patients may have been miscategorized, especially patients with severe disease who were untreated.”

The study was sponsored by Novartis. Dr. Merola disclosed that he is a consultant and/or investigator for Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharmaceuticals, Biogen, Pfizer, EMD Serono, Avotres, and LEO Pharma. Four authors are Novartis employees, or employees of a consulting company that provides services to Novartis; and another author disclosed serving as an investigator or consultant for several pharmaceutical companies, including Novartis.

[email protected]

The risk of developing psoriatic arthritis (PsA) may increase as the severity of psoriasis increases, results from a large analysis of U.S. medical records demonstrated.

Factors that predict the development of psoriasis in patients with psoriasis include nail, inverse, and scalp psoriasis; family history of PsA; as well as severity of skin disease. And like psoriasis, “PsA is associated with a multitude of comorbidities, including cardiovascular disease, metabolic syndrome, Crohn’s disease, obesity, diabetes, uveitis, anxiety, and depression, with correspondingly higher healthcare utilization and direct healthcare costs,” wrote corresponding author Joseph F. Merola, MD, MMSc, and colleagues. The study was published online in the Journal of the American Academy of Dermatology. “Timely and accurate diagnosis of PsA is important for improved patient outcomes and appropriate disease management and may prevent prolonged inflammation that leads to structural joint damage and worsening physical function,” they added.

The mean time of onset of PsA among patients with psoriasis who develop PsA is 10 years after the first signs of psoriasis appear. An estimated 20%-30% of patients with psoriasis have a concurrent diagnosis of PsA, and the annual incidence of PsA has been reported to be 2.7 cases per 100 patients with psoriasis. While previous studies have suggested that a higher incidence of PsA is associated with greater disease severity, there are limited data in the United States on the topic.

For the study, Dr. Merola, a dermatologist and rheumatologist who directs the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston, and his colleagues drew from the Optum EHR database to identify adult patients newly diagnosed with psoriasis between Jan. 1, 2009, and March 31, 2019. Patients diagnosed with psoriasis or PsA prior to the index date were excluded from the analysis for evaluation of incidence but included for evaluation of prevalence. The patients were followed from the index date until the earliest PsA event, death, or end of study or follow-up, whichever came first. The researchers calculated the incidence of PsA among adults with psoriasis as the number of incident PsA events divided by the number of patient-years (PY) at risk, which was reported as the raw incidence per 100 psoriasis PY. They calculated the prevalence of PsA among adults with psoriasis as “the number of prevalent PsA events divided by the number of eligible patients with [psoriasis] and reported by years in the follow-up period,” which was a median of 3.7 years.

A total of 114,868 patients were included in the analysis. At baseline, their mean age was 54 years, 53% were female, 89% were White, and 39% were obese. Most patients (102,553) were on nonsystemic agents during the year after their psoriasis diagnosis, while 6,345 were on nonbiologic systemic therapies (NBSTs) and 5,970 were on biologics. The researchers classified patients as having mild psoriasis if they were taking nonsystemic agents, moderate disease if they were taking NBSTs, or severe disease if they were taking biologics.

The overall incidence rate of PsA was 2.9 events per 100 PY and increased by severity of disease. When calculated by severity, the incidence was 2.1 events per 100 PY for patients with mild psoriasis, 9.9 events per 100 PY for those with moderate psoriasis, and 17.6 events per 100 PY for those with severe psoriasis.

When the researchers excluded patients diagnosed with PsA up to 1 year after being diagnosed with psoriasis, the overall incidence was lower (1.7 events per 100 PY), with similar trends for categories of treatment severity. Specifically, the incidence was 1.5, 3.1, and 4.7 events per 100 PY among those with mild, moderate, and severe psoriasis, based on their treatment groups, respectively.

Among the 120,523 patients with psoriasis who were eligible for the assessment of prevalence of PsA, the overall 5-year prevalence of PsA was 14.2% and rose with severity of disease: 9.9% in patients with mild psoriasis, 35% in patients with moderate psoriasis, and 54.9% in patients with severe psoriasis.

Other predictors of PsA onset for both index-date cohorts included weight of 90 kg or greater, female gender, age group 25-65 years (compared with the age group over 65 years), and rheumatic risk factors such as wrist pain and unspecified rheumatism.

“To ensure timely diagnosis and treatment for management and prevention of PsA, patients with [psoriasis] should be routinely screened, especially those with more severe disease and other PsA risk factors,” the authors advised.

Dr. Merola and colleagues acknowledged certain limitations of their analysis, including the potential for selection bias and its reliance on EHR data which “lacked clinical measures of disease severity such as the PASI, and data on BSA were not available for all study participants; therefore, treatment groups were used as a surrogate for disease severity,” they wrote. “As a result, some patients may have been miscategorized, especially patients with severe disease who were untreated.”

The study was sponsored by Novartis. Dr. Merola disclosed that he is a consultant and/or investigator for Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharmaceuticals, Biogen, Pfizer, EMD Serono, Avotres, and LEO Pharma. Four authors are Novartis employees, or employees of a consulting company that provides services to Novartis; and another author disclosed serving as an investigator or consultant for several pharmaceutical companies, including Novartis.

[email protected]

The risk of developing psoriatic arthritis (PsA) may increase as the severity of psoriasis increases, results from a large analysis of U.S. medical records demonstrated.

Factors that predict the development of psoriasis in patients with psoriasis include nail, inverse, and scalp psoriasis; family history of PsA; as well as severity of skin disease. And like psoriasis, “PsA is associated with a multitude of comorbidities, including cardiovascular disease, metabolic syndrome, Crohn’s disease, obesity, diabetes, uveitis, anxiety, and depression, with correspondingly higher healthcare utilization and direct healthcare costs,” wrote corresponding author Joseph F. Merola, MD, MMSc, and colleagues. The study was published online in the Journal of the American Academy of Dermatology. “Timely and accurate diagnosis of PsA is important for improved patient outcomes and appropriate disease management and may prevent prolonged inflammation that leads to structural joint damage and worsening physical function,” they added.

The mean time of onset of PsA among patients with psoriasis who develop PsA is 10 years after the first signs of psoriasis appear. An estimated 20%-30% of patients with psoriasis have a concurrent diagnosis of PsA, and the annual incidence of PsA has been reported to be 2.7 cases per 100 patients with psoriasis. While previous studies have suggested that a higher incidence of PsA is associated with greater disease severity, there are limited data in the United States on the topic.

For the study, Dr. Merola, a dermatologist and rheumatologist who directs the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston, and his colleagues drew from the Optum EHR database to identify adult patients newly diagnosed with psoriasis between Jan. 1, 2009, and March 31, 2019. Patients diagnosed with psoriasis or PsA prior to the index date were excluded from the analysis for evaluation of incidence but included for evaluation of prevalence. The patients were followed from the index date until the earliest PsA event, death, or end of study or follow-up, whichever came first. The researchers calculated the incidence of PsA among adults with psoriasis as the number of incident PsA events divided by the number of patient-years (PY) at risk, which was reported as the raw incidence per 100 psoriasis PY. They calculated the prevalence of PsA among adults with psoriasis as “the number of prevalent PsA events divided by the number of eligible patients with [psoriasis] and reported by years in the follow-up period,” which was a median of 3.7 years.

A total of 114,868 patients were included in the analysis. At baseline, their mean age was 54 years, 53% were female, 89% were White, and 39% were obese. Most patients (102,553) were on nonsystemic agents during the year after their psoriasis diagnosis, while 6,345 were on nonbiologic systemic therapies (NBSTs) and 5,970 were on biologics. The researchers classified patients as having mild psoriasis if they were taking nonsystemic agents, moderate disease if they were taking NBSTs, or severe disease if they were taking biologics.

The overall incidence rate of PsA was 2.9 events per 100 PY and increased by severity of disease. When calculated by severity, the incidence was 2.1 events per 100 PY for patients with mild psoriasis, 9.9 events per 100 PY for those with moderate psoriasis, and 17.6 events per 100 PY for those with severe psoriasis.

When the researchers excluded patients diagnosed with PsA up to 1 year after being diagnosed with psoriasis, the overall incidence was lower (1.7 events per 100 PY), with similar trends for categories of treatment severity. Specifically, the incidence was 1.5, 3.1, and 4.7 events per 100 PY among those with mild, moderate, and severe psoriasis, based on their treatment groups, respectively.

Among the 120,523 patients with psoriasis who were eligible for the assessment of prevalence of PsA, the overall 5-year prevalence of PsA was 14.2% and rose with severity of disease: 9.9% in patients with mild psoriasis, 35% in patients with moderate psoriasis, and 54.9% in patients with severe psoriasis.

Other predictors of PsA onset for both index-date cohorts included weight of 90 kg or greater, female gender, age group 25-65 years (compared with the age group over 65 years), and rheumatic risk factors such as wrist pain and unspecified rheumatism.

“To ensure timely diagnosis and treatment for management and prevention of PsA, patients with [psoriasis] should be routinely screened, especially those with more severe disease and other PsA risk factors,” the authors advised.

Dr. Merola and colleagues acknowledged certain limitations of their analysis, including the potential for selection bias and its reliance on EHR data which “lacked clinical measures of disease severity such as the PASI, and data on BSA were not available for all study participants; therefore, treatment groups were used as a surrogate for disease severity,” they wrote. “As a result, some patients may have been miscategorized, especially patients with severe disease who were untreated.”

The study was sponsored by Novartis. Dr. Merola disclosed that he is a consultant and/or investigator for Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharmaceuticals, Biogen, Pfizer, EMD Serono, Avotres, and LEO Pharma. Four authors are Novartis employees, or employees of a consulting company that provides services to Novartis; and another author disclosed serving as an investigator or consultant for several pharmaceutical companies, including Novartis.

[email protected]

Key clinical point: Patients with psoriatic arthritis (PsA) performed poorly in all dimensions of the European Quality of Life (EQ-5D) scoring of quality of life (QoL) as compared with the general population, thus reflecting the detrimental effect of PsA on QoL.

Major finding: Overall, 87.3% and 69.8% of patients with PsA experienced pain/discomfort and anxiety/depression, respectively. Patients with PsA presented worse results in all dimensions of the EQ-5D scale and had a lower mean QoL score compared to the general population (0.651 vs. 0.793; P < .001) with worsened QoL in patients with concomitant use of nonsteroidal anti-inflammatory drugs (P = .035) and comorbidities (P = .003).

Study details: Findings are from a cross-sectional study including 212 adult patients with PsA from a single-center pharmacy in Minas Gerais, Brazil.

Disclosures: This study was supported by Minas Gerais Research Support Foundation and National Council for Scientific and Technological Development. Several of the authors declared receiving educational scholarships, grants, or personal fees from several sources.

Source: Moraes FA et al. Value Health Reg Issues. 2021 Aug 12. doi: 10.1016/j.vhri.2021.06.003.

Key clinical point: Patients with psoriatic arthritis (PsA) performed poorly in all dimensions of the European Quality of Life (EQ-5D) scoring of quality of life (QoL) as compared with the general population, thus reflecting the detrimental effect of PsA on QoL.

Major finding: Overall, 87.3% and 69.8% of patients with PsA experienced pain/discomfort and anxiety/depression, respectively. Patients with PsA presented worse results in all dimensions of the EQ-5D scale and had a lower mean QoL score compared to the general population (0.651 vs. 0.793; P < .001) with worsened QoL in patients with concomitant use of nonsteroidal anti-inflammatory drugs (P = .035) and comorbidities (P = .003).

Study details: Findings are from a cross-sectional study including 212 adult patients with PsA from a single-center pharmacy in Minas Gerais, Brazil.

Disclosures: This study was supported by Minas Gerais Research Support Foundation and National Council for Scientific and Technological Development. Several of the authors declared receiving educational scholarships, grants, or personal fees from several sources.

Source: Moraes FA et al. Value Health Reg Issues. 2021 Aug 12. doi: 10.1016/j.vhri.2021.06.003.

Key clinical point: Patients with psoriatic arthritis (PsA) performed poorly in all dimensions of the European Quality of Life (EQ-5D) scoring of quality of life (QoL) as compared with the general population, thus reflecting the detrimental effect of PsA on QoL.

Major finding: Overall, 87.3% and 69.8% of patients with PsA experienced pain/discomfort and anxiety/depression, respectively. Patients with PsA presented worse results in all dimensions of the EQ-5D scale and had a lower mean QoL score compared to the general population (0.651 vs. 0.793; P < .001) with worsened QoL in patients with concomitant use of nonsteroidal anti-inflammatory drugs (P = .035) and comorbidities (P = .003).

Study details: Findings are from a cross-sectional study including 212 adult patients with PsA from a single-center pharmacy in Minas Gerais, Brazil.

Disclosures: This study was supported by Minas Gerais Research Support Foundation and National Council for Scientific and Technological Development. Several of the authors declared receiving educational scholarships, grants, or personal fees from several sources.

Source: Moraes FA et al. Value Health Reg Issues. 2021 Aug 12. doi: 10.1016/j.vhri.2021.06.003.

Key clinical point: Significant improvement in work productivity was observed in a real-world cohort of patients with psoriatic arthritis (PsA) treated with a tumor necrosis factor inhibitor (anti-TNF).

Major finding: At the final follow-up visit, the overall activity impairment decreased from 55.0 ± 21.5 to 16.3 ± 18.2 (P < .001). Moreover, absenteeism, mean presenteeism, and work productivity loss showed significant improvement upon treatment at the 9-month follow-up visit (all P < .001).

Study details: Findings are from a noninterventional, prospective, and observational cohort study including 120 patients with PsA who were receiving anti-TNF treatment.

Disclosures: This study was supported by AbbVie. Some of the authors declared receiving speaker’s fees, consulting fees, or research grants from various sources including AbbVie.

Source: Karadag O et al. Clin Rheumatol. 2021 Sep 3. doi: 10.1007/s10067-021-05893-3.

Key clinical point: Significant improvement in work productivity was observed in a real-world cohort of patients with psoriatic arthritis (PsA) treated with a tumor necrosis factor inhibitor (anti-TNF).

Major finding: At the final follow-up visit, the overall activity impairment decreased from 55.0 ± 21.5 to 16.3 ± 18.2 (P < .001). Moreover, absenteeism, mean presenteeism, and work productivity loss showed significant improvement upon treatment at the 9-month follow-up visit (all P < .001).

Study details: Findings are from a noninterventional, prospective, and observational cohort study including 120 patients with PsA who were receiving anti-TNF treatment.

Disclosures: This study was supported by AbbVie. Some of the authors declared receiving speaker’s fees, consulting fees, or research grants from various sources including AbbVie.

Source: Karadag O et al. Clin Rheumatol. 2021 Sep 3. doi: 10.1007/s10067-021-05893-3.

Key clinical point: Significant improvement in work productivity was observed in a real-world cohort of patients with psoriatic arthritis (PsA) treated with a tumor necrosis factor inhibitor (anti-TNF).

Major finding: At the final follow-up visit, the overall activity impairment decreased from 55.0 ± 21.5 to 16.3 ± 18.2 (P < .001). Moreover, absenteeism, mean presenteeism, and work productivity loss showed significant improvement upon treatment at the 9-month follow-up visit (all P < .001).

Study details: Findings are from a noninterventional, prospective, and observational cohort study including 120 patients with PsA who were receiving anti-TNF treatment.

Disclosures: This study was supported by AbbVie. Some of the authors declared receiving speaker’s fees, consulting fees, or research grants from various sources including AbbVie.

Source: Karadag O et al. Clin Rheumatol. 2021 Sep 3. doi: 10.1007/s10067-021-05893-3.

Key clinical point: Obesity was associated with a higher disease activity and poorer quality of life (QoL) in patients with psoriatic arthritis (PsA), thus emphasizing the need to consider obesity during the management of patients with PsA.

Major finding: Patients with obesity had a significantly higher PsA QoL questionnaire and psychological status measured by the Hospital Anxiety and Depression Scale compared with nonobese patients (P < .001). Even the disease activity index for PsA score was higher in patients with obesity (P < .05), whereas Psoriasis Area and Severity Index was similar between both groups (P = .154).

Study details: Findings are from a cross-sectional study including 1,033 patients with PsA, of which 62.9% of patients were nonobese and 37.1% were obese.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Gok K et al. Rheumatol Int. 2021 Aug 28. doi: 10.1007/s00296-021-04971-8.

Key clinical point: Obesity was associated with a higher disease activity and poorer quality of life (QoL) in patients with psoriatic arthritis (PsA), thus emphasizing the need to consider obesity during the management of patients with PsA.

Major finding: Patients with obesity had a significantly higher PsA QoL questionnaire and psychological status measured by the Hospital Anxiety and Depression Scale compared with nonobese patients (P < .001). Even the disease activity index for PsA score was higher in patients with obesity (P < .05), whereas Psoriasis Area and Severity Index was similar between both groups (P = .154).

Study details: Findings are from a cross-sectional study including 1,033 patients with PsA, of which 62.9% of patients were nonobese and 37.1% were obese.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Gok K et al. Rheumatol Int. 2021 Aug 28. doi: 10.1007/s00296-021-04971-8.

Key clinical point: Obesity was associated with a higher disease activity and poorer quality of life (QoL) in patients with psoriatic arthritis (PsA), thus emphasizing the need to consider obesity during the management of patients with PsA.

Major finding: Patients with obesity had a significantly higher PsA QoL questionnaire and psychological status measured by the Hospital Anxiety and Depression Scale compared with nonobese patients (P < .001). Even the disease activity index for PsA score was higher in patients with obesity (P < .05), whereas Psoriasis Area and Severity Index was similar between both groups (P = .154).

Study details: Findings are from a cross-sectional study including 1,033 patients with PsA, of which 62.9% of patients were nonobese and 37.1% were obese.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Gok K et al. Rheumatol Int. 2021 Aug 28. doi: 10.1007/s00296-021-04971-8.

Key clinical point: Endothelial dysfunction (ED) was inversely correlated with the severity of depressive symptoms in patients with psoriatic arthritis (PsA).

Major finding: Overall, 40% of PsA patients experienced depressive symptoms according to the Hospital Anxiety and Depression Scale (HDS). ED as measured by flow-mediated dilatation was negatively correlated with HDS score (Pearson’s coefficient [ρ] −0.339; P = .016), intensity of pain, and disease activity in PsA score (both ρ, −0.507; P = .001).

Study details: Findings are from a cross-sectional study including 50 patients with PsA between 30 and 75 years of age and without any previous history of heart disease or diabetes.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: De Lorenzis E et al. Front Med. 2021 Aug 27. doi: 10.3389/fmed.2021.669397.

Key clinical point: Endothelial dysfunction (ED) was inversely correlated with the severity of depressive symptoms in patients with psoriatic arthritis (PsA).

Major finding: Overall, 40% of PsA patients experienced depressive symptoms according to the Hospital Anxiety and Depression Scale (HDS). ED as measured by flow-mediated dilatation was negatively correlated with HDS score (Pearson’s coefficient [ρ] −0.339; P = .016), intensity of pain, and disease activity in PsA score (both ρ, −0.507; P = .001).

Study details: Findings are from a cross-sectional study including 50 patients with PsA between 30 and 75 years of age and without any previous history of heart disease or diabetes.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: De Lorenzis E et al. Front Med. 2021 Aug 27. doi: 10.3389/fmed.2021.669397.

Key clinical point: Endothelial dysfunction (ED) was inversely correlated with the severity of depressive symptoms in patients with psoriatic arthritis (PsA).

Major finding: Overall, 40% of PsA patients experienced depressive symptoms according to the Hospital Anxiety and Depression Scale (HDS). ED as measured by flow-mediated dilatation was negatively correlated with HDS score (Pearson’s coefficient [ρ] −0.339; P = .016), intensity of pain, and disease activity in PsA score (both ρ, −0.507; P = .001).

Study details: Findings are from a cross-sectional study including 50 patients with PsA between 30 and 75 years of age and without any previous history of heart disease or diabetes.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: De Lorenzis E et al. Front Med. 2021 Aug 27. doi: 10.3389/fmed.2021.669397.

Key clinical point: Treatment modification was frequently observed in a cohort of patients with psoriatic arthritis (PsA) receiving disease-modifying antirheumatic drugs (DMARD), highlighting the need for more effective therapies.

Major finding: Overall, 57.3% of patients were treated with biologic DMARDs either as monotherapy or in combination with conventional synthetic DMARDs (csDMARD), whereas 37.7% and 4.4% of patients were treated with csDMARDs and targeted synthetic DMARDs, respectively. Treatment modifications in the previous year were reported by 48.4% of patients, with major reasons being lack of efficacy (38%) and remission or major improvement in the disease (14%).

Study details: Findings are from a retrospective observational cross-sectional study including 316 adults with established PsA and psoriasis who received DMARD treatment for at least 183 days in the previous year.

Disclosures: This work was funded by Bristol Myers Squibb, Germany. Some of the authors declared receiving speaker’s fees and compensation for consultancy or board memberships from Bristol Myers Squibb. Dr. Daamen and Dr. Rothnie declared being current or previous employees of Bristol Myers Squibb.

Source: Behrens F et al. Mod Rheumatol. 2021 Aug 26. doi: 10.1080/14397595.2020.1816597.

Key clinical point: Treatment modification was frequently observed in a cohort of patients with psoriatic arthritis (PsA) receiving disease-modifying antirheumatic drugs (DMARD), highlighting the need for more effective therapies.

Major finding: Overall, 57.3% of patients were treated with biologic DMARDs either as monotherapy or in combination with conventional synthetic DMARDs (csDMARD), whereas 37.7% and 4.4% of patients were treated with csDMARDs and targeted synthetic DMARDs, respectively. Treatment modifications in the previous year were reported by 48.4% of patients, with major reasons being lack of efficacy (38%) and remission or major improvement in the disease (14%).

Study details: Findings are from a retrospective observational cross-sectional study including 316 adults with established PsA and psoriasis who received DMARD treatment for at least 183 days in the previous year.

Disclosures: This work was funded by Bristol Myers Squibb, Germany. Some of the authors declared receiving speaker’s fees and compensation for consultancy or board memberships from Bristol Myers Squibb. Dr. Daamen and Dr. Rothnie declared being current or previous employees of Bristol Myers Squibb.

Source: Behrens F et al. Mod Rheumatol. 2021 Aug 26. doi: 10.1080/14397595.2020.1816597.

Key clinical point: Treatment modification was frequently observed in a cohort of patients with psoriatic arthritis (PsA) receiving disease-modifying antirheumatic drugs (DMARD), highlighting the need for more effective therapies.

Major finding: Overall, 57.3% of patients were treated with biologic DMARDs either as monotherapy or in combination with conventional synthetic DMARDs (csDMARD), whereas 37.7% and 4.4% of patients were treated with csDMARDs and targeted synthetic DMARDs, respectively. Treatment modifications in the previous year were reported by 48.4% of patients, with major reasons being lack of efficacy (38%) and remission or major improvement in the disease (14%).

Study details: Findings are from a retrospective observational cross-sectional study including 316 adults with established PsA and psoriasis who received DMARD treatment for at least 183 days in the previous year.

Disclosures: This work was funded by Bristol Myers Squibb, Germany. Some of the authors declared receiving speaker’s fees and compensation for consultancy or board memberships from Bristol Myers Squibb. Dr. Daamen and Dr. Rothnie declared being current or previous employees of Bristol Myers Squibb.

Source: Behrens F et al. Mod Rheumatol. 2021 Aug 26. doi: 10.1080/14397595.2020.1816597.

Key clinical point: Exposure-response analysis predicted 15 mg upadacitinib daily would achieve robust efficacy in patients with psoriatic arthritis (PsA) with a limited decrease in hemoglobin or occurrence of serious infections.

Major finding: The potential benefits of increasing upadacitinib plasma exposure beyond 15 mg daily were not consistent, with 8% and 7% higher percentage of patients predicted to achieve 50% and 70% improvement in American College of Rheumatology response levels, respectively, with 30 mg upadacitinib compared to 15 mg at week 12 but not at week 24. At week 24, the percentage of patients with serious infection was 2% for both upadacitinib doses, and the percentage of patients with hemoglobin decrease >2 g/dL was 3% and 4% for 15 mg and 30 mg upadacitinib, respectively.

Study details: Findings are from an analysis of two phase 3 studies, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with PsA with an inadequate response to biologic or nonbiologic disease-modifying antirheumatic drugs.

Disclosures: This work was funded by AbbVie. The authors declared being current/former employees of AbbVie and may hold stocks/stock options.

Source: Muensterman E et al. Clin Transl Sci. 2021 Aug 31. doi: 10.1111/cts.13146.

Key clinical point: Exposure-response analysis predicted 15 mg upadacitinib daily would achieve robust efficacy in patients with psoriatic arthritis (PsA) with a limited decrease in hemoglobin or occurrence of serious infections.

Major finding: The potential benefits of increasing upadacitinib plasma exposure beyond 15 mg daily were not consistent, with 8% and 7% higher percentage of patients predicted to achieve 50% and 70% improvement in American College of Rheumatology response levels, respectively, with 30 mg upadacitinib compared to 15 mg at week 12 but not at week 24. At week 24, the percentage of patients with serious infection was 2% for both upadacitinib doses, and the percentage of patients with hemoglobin decrease >2 g/dL was 3% and 4% for 15 mg and 30 mg upadacitinib, respectively.

Study details: Findings are from an analysis of two phase 3 studies, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with PsA with an inadequate response to biologic or nonbiologic disease-modifying antirheumatic drugs.

Disclosures: This work was funded by AbbVie. The authors declared being current/former employees of AbbVie and may hold stocks/stock options.

Source: Muensterman E et al. Clin Transl Sci. 2021 Aug 31. doi: 10.1111/cts.13146.

Key clinical point: Exposure-response analysis predicted 15 mg upadacitinib daily would achieve robust efficacy in patients with psoriatic arthritis (PsA) with a limited decrease in hemoglobin or occurrence of serious infections.

Major finding: The potential benefits of increasing upadacitinib plasma exposure beyond 15 mg daily were not consistent, with 8% and 7% higher percentage of patients predicted to achieve 50% and 70% improvement in American College of Rheumatology response levels, respectively, with 30 mg upadacitinib compared to 15 mg at week 12 but not at week 24. At week 24, the percentage of patients with serious infection was 2% for both upadacitinib doses, and the percentage of patients with hemoglobin decrease >2 g/dL was 3% and 4% for 15 mg and 30 mg upadacitinib, respectively.

Study details: Findings are from an analysis of two phase 3 studies, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with PsA with an inadequate response to biologic or nonbiologic disease-modifying antirheumatic drugs.

Disclosures: This work was funded by AbbVie. The authors declared being current/former employees of AbbVie and may hold stocks/stock options.

Source: Muensterman E et al. Clin Transl Sci. 2021 Aug 31. doi: 10.1111/cts.13146.

Key clinical point: Golimumab was effective for both musculoskeletal and cutaneous manifestations along with good drug persistence in patients with moderate-to-severe psoriatic arthritis (PsA) and concomitant psoriasis in a long-term real-life clinical setting.

Major finding: Disease activity in PsA score (P < .0001) and psoriasis activity and severity index score (P < .01) improved significantly after 6, 12, 24, 36, and 48 months of treatment. The retention rate of golimumab was 82.8%, 73.4%, 62.0%, and 54.4% at 6, 12, 24, and 48 months, respectively. The major reasons for drug discontinuation were primary/secondary inefficacy.

Study details: Findings are from a retrospective observational study including 105 patients with moderate-to-severe PsA and concomitant psoriasis with high disease activity and elevated prevalence of comorbidities and who started treatment with golimumab.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Chimenti MS et al. Clin Rheumatol. 2021 Aug 19. doi: 10.1007/s10067-021-05874-6.

Key clinical point: Golimumab was effective for both musculoskeletal and cutaneous manifestations along with good drug persistence in patients with moderate-to-severe psoriatic arthritis (PsA) and concomitant psoriasis in a long-term real-life clinical setting.

Major finding: Disease activity in PsA score (P < .0001) and psoriasis activity and severity index score (P < .01) improved significantly after 6, 12, 24, 36, and 48 months of treatment. The retention rate of golimumab was 82.8%, 73.4%, 62.0%, and 54.4% at 6, 12, 24, and 48 months, respectively. The major reasons for drug discontinuation were primary/secondary inefficacy.

Study details: Findings are from a retrospective observational study including 105 patients with moderate-to-severe PsA and concomitant psoriasis with high disease activity and elevated prevalence of comorbidities and who started treatment with golimumab.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Chimenti MS et al. Clin Rheumatol. 2021 Aug 19. doi: 10.1007/s10067-021-05874-6.

Key clinical point: Golimumab was effective for both musculoskeletal and cutaneous manifestations along with good drug persistence in patients with moderate-to-severe psoriatic arthritis (PsA) and concomitant psoriasis in a long-term real-life clinical setting.

Major finding: Disease activity in PsA score (P < .0001) and psoriasis activity and severity index score (P < .01) improved significantly after 6, 12, 24, 36, and 48 months of treatment. The retention rate of golimumab was 82.8%, 73.4%, 62.0%, and 54.4% at 6, 12, 24, and 48 months, respectively. The major reasons for drug discontinuation were primary/secondary inefficacy.

Study details: Findings are from a retrospective observational study including 105 patients with moderate-to-severe PsA and concomitant psoriasis with high disease activity and elevated prevalence of comorbidities and who started treatment with golimumab.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Chimenti MS et al. Clin Rheumatol. 2021 Aug 19. doi: 10.1007/s10067-021-05874-6.