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Shared Rheumatology-Primary Care Telehealth Model Brings Services to Rural Areas
Even in large urban areas there aren’t enough rheumatologists to go around, and as a 2015 American College of Rheumatology workforce study projected, the number of rheumatology providers is expected to drop by 25% by the year 2030, while the demand for patient care in rheumatology is expected to increase by more than 100%.
The shortage of rheumatology care is even more acute in rural areas, but as a pilot project supported by the Arthritis Foundation shows, linking rheumatologists to health centers in remote and underserved locations via telehealth can help community providers improve care for patients with rheumatic diseases.
The novel collaborative model was described by Alfredo Rivadeneira, MD, professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina (UNC) School of Medicine in Chapel Hill, North Carolina.
“We found that this pilot, a unique partnership in North Carolina, improves access to rheumatology care to a rural population with high satisfaction scores. It underlines the importance of seeking collaboration with community providers when implementing these programs. It also allows timely specialty care and alleviates the barriers relating to transportation, insurance coverage, and telecommunication challenges,” he said at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.
Too Many Patients, Too Few Rheumatologists
Access to health is challenging for people from traditionally underserved racial and ethnic backgrounds, especially in states such as North Carolina, where 40% of the population lives in rural counties, which have higher age-adjusted mortality than more densely populated areas of the state, Dr. Rivadeneira said.
In addition, 42% of the North Carolina residents seen at the state’s 42 Federally Qualified Health Centers (FQHCs) don’t have health insurance, which is higher than the average of 23% uninsured seen at FQHCs in other states.
There are currently approximately 250 rheumatology providers in North Carolina, the majority of whom work in the states’ three academic medical centers. Currently, North Carolina has an estimated population of 10 million people, which is projected to increase to 11.7 million by 2030. And by 2030, 20% of North Carolinians will be aged ≥ 65 years, Dr. Rivadeneira said, highlighting the need for expanded rheumatology care.
Although telehealth services could be an option for expanding services to underserved communities, only 14 of the 42 FQHCs in the state use telehealth and only on a limited basis because it is not sufficiently reimbursed.
Rivadeneira pointed to a 2022 study that showed how patients with rheumatic and musculoskeletal disease patients in North Carolina were less likely to use online patient portals if they lived in rural areas; came from racial or ethnic minority backgrounds; were older, men, had lower economic status (Medicaid enrollment or uninsured); or spoke a language other than English as their primary tongue.
Pilot Project
To help smooth out some of the above-mentioned disparities, Dr. Rivadeneira and colleagues, in collaboration with the Arthritis Foundation, started a pilot project in 2022 designed to enhance access to rheumatology specialty care for rural residents through a shared telehealth model between the UNC rheumatology clinic and two separate Piedmont Health Services clinics in rural areas.
The project includes tailored educational sessions designed to empower Piedmont Health Services providers for evaluating and managing patients with rheumatic diseases.
Patients with prior diagnoses of rheumatologic diseases who were lost to rheumatology specialty care follow-up and those with new rheumatic symptoms who had transportation and/or financial barriers to receiving specialty care are triaged to the shared telemedicine visits.
Providers conduct monthly clinic sessions via shared visits between the on-site Piedmont Health Services provider and patients, with off-site UNC rheumatology fellows and attending physicians connected virtually.
The educational component of the project includes monthly didactic sessions offered to all Piedmont Health Services providers across 12 locations.
The topics that were chosen cover the most common rheumatologic conditions seen by community providers, including evaluating pain from a rheumatology perspective; using antinuclear antibodies and other serologies; evaluating and managing rheumatoid arthritis, lupus, gout, giant cell arteritis, polymyalgia rheumatica, and osteoarthritis; and methotrexate management and complications.
“One of the aspects of this pilot that I want to emphasize is the importance of having the generalists with the patient, relaying the objective data, especially the physical exam, and that’s one of the great features of this model. It also provides a stable platform for telehealth to the individual patients, as many of these patients don’t have access to health technology,” Dr. Rivadeneira said.
Thumbs Up
Both patients and general practitioners in the Piedmont Health system expressed high degrees of satisfaction with the shared telehealth program. Patients especially liked the time they saved not having to travel to see a specialist, and a large majority agreed that the visits were “as good as” in-person visits, felt that their concerns were addressed appropriately during the virtual visit, expressed overall satisfaction, and said they would like to continue virtual visits.
Physicians expressed a high degree of satisfaction with the rheumatology didactic sessions and said that the sessions enhanced their knowledge of evaluating and managing or co-managing rheumatologic diseases, as well as helping them to feel comfortable about applying this knowledge to patient care.
Dr. Rivadeneira noted that the pilot study was limited by low levels of Piedmont Health Services physician participation (two out of 45 total participated in shared visits), and only three or four providers typically took part in each didactic session.
How to Improve?
In a follow-up study, the investigators asked Piedmont Health Services providers about barriers to rheumatology care, the most common and challenging diseases they encountered, how to improve the didactic components, and their perspectives on the pilot and how it may have affected referral patterns to rheumatology care.
The providers identified the cost of diagnostic evaluations and medications, transportation, long wait times, and language as the main barriers to patient access of rheumatology care.
“Additionally, over a third of them encountered patients on a weekly basis that were overdue for a visit with a rheumatologist,” Dr. Rivadeneira said.
“Direct participation in the physical exam by the primary care provider enhances greatly, in my opinion, these telehealth visits. Focused didactic sessions, electronic handouts and/or quick access guides could empower more rural community providers to manage rheumatic diseases,” he concluded.
In the Q&A following the presentation, Laura Cappelli, MD, MHS, MS, associate professor of medicine in the division of rheumatology at Johns Hopkins School of Medicine in Baltimore, asked Dr. Rivadeneira how rheumatologists involved felt about the program and whether his team did any surveying or qualitative work with them.
“Just so you know, the rheumatologist was me,” he replied.
“I’m very picky about telemedicine,” he continued. “I don’t like it, I prefer, as most of us do, to have the patient there. But having the provider there, doing the exam, and you guiding them — I can ask, ‘Did you check their joints? Did you check their strength?’ — makes a huge difference and makes me feel comfortable with the sessions.”
Dr. Rivadeneira added that if a particular case was too complex or too vague to adequately assess via telehealth, he would arrange to see the patient in person.
The project was supported by the Arthritis Foundation. Dr. Rivadeneira and Dr. Cappelli reported no conflicts of interest.
A version of this article appeared on Medscape.com.
Even in large urban areas there aren’t enough rheumatologists to go around, and as a 2015 American College of Rheumatology workforce study projected, the number of rheumatology providers is expected to drop by 25% by the year 2030, while the demand for patient care in rheumatology is expected to increase by more than 100%.
The shortage of rheumatology care is even more acute in rural areas, but as a pilot project supported by the Arthritis Foundation shows, linking rheumatologists to health centers in remote and underserved locations via telehealth can help community providers improve care for patients with rheumatic diseases.
The novel collaborative model was described by Alfredo Rivadeneira, MD, professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina (UNC) School of Medicine in Chapel Hill, North Carolina.
“We found that this pilot, a unique partnership in North Carolina, improves access to rheumatology care to a rural population with high satisfaction scores. It underlines the importance of seeking collaboration with community providers when implementing these programs. It also allows timely specialty care and alleviates the barriers relating to transportation, insurance coverage, and telecommunication challenges,” he said at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.
Too Many Patients, Too Few Rheumatologists
Access to health is challenging for people from traditionally underserved racial and ethnic backgrounds, especially in states such as North Carolina, where 40% of the population lives in rural counties, which have higher age-adjusted mortality than more densely populated areas of the state, Dr. Rivadeneira said.
In addition, 42% of the North Carolina residents seen at the state’s 42 Federally Qualified Health Centers (FQHCs) don’t have health insurance, which is higher than the average of 23% uninsured seen at FQHCs in other states.
There are currently approximately 250 rheumatology providers in North Carolina, the majority of whom work in the states’ three academic medical centers. Currently, North Carolina has an estimated population of 10 million people, which is projected to increase to 11.7 million by 2030. And by 2030, 20% of North Carolinians will be aged ≥ 65 years, Dr. Rivadeneira said, highlighting the need for expanded rheumatology care.
Although telehealth services could be an option for expanding services to underserved communities, only 14 of the 42 FQHCs in the state use telehealth and only on a limited basis because it is not sufficiently reimbursed.
Rivadeneira pointed to a 2022 study that showed how patients with rheumatic and musculoskeletal disease patients in North Carolina were less likely to use online patient portals if they lived in rural areas; came from racial or ethnic minority backgrounds; were older, men, had lower economic status (Medicaid enrollment or uninsured); or spoke a language other than English as their primary tongue.
Pilot Project
To help smooth out some of the above-mentioned disparities, Dr. Rivadeneira and colleagues, in collaboration with the Arthritis Foundation, started a pilot project in 2022 designed to enhance access to rheumatology specialty care for rural residents through a shared telehealth model between the UNC rheumatology clinic and two separate Piedmont Health Services clinics in rural areas.
The project includes tailored educational sessions designed to empower Piedmont Health Services providers for evaluating and managing patients with rheumatic diseases.
Patients with prior diagnoses of rheumatologic diseases who were lost to rheumatology specialty care follow-up and those with new rheumatic symptoms who had transportation and/or financial barriers to receiving specialty care are triaged to the shared telemedicine visits.
Providers conduct monthly clinic sessions via shared visits between the on-site Piedmont Health Services provider and patients, with off-site UNC rheumatology fellows and attending physicians connected virtually.
The educational component of the project includes monthly didactic sessions offered to all Piedmont Health Services providers across 12 locations.
The topics that were chosen cover the most common rheumatologic conditions seen by community providers, including evaluating pain from a rheumatology perspective; using antinuclear antibodies and other serologies; evaluating and managing rheumatoid arthritis, lupus, gout, giant cell arteritis, polymyalgia rheumatica, and osteoarthritis; and methotrexate management and complications.
“One of the aspects of this pilot that I want to emphasize is the importance of having the generalists with the patient, relaying the objective data, especially the physical exam, and that’s one of the great features of this model. It also provides a stable platform for telehealth to the individual patients, as many of these patients don’t have access to health technology,” Dr. Rivadeneira said.
Thumbs Up
Both patients and general practitioners in the Piedmont Health system expressed high degrees of satisfaction with the shared telehealth program. Patients especially liked the time they saved not having to travel to see a specialist, and a large majority agreed that the visits were “as good as” in-person visits, felt that their concerns were addressed appropriately during the virtual visit, expressed overall satisfaction, and said they would like to continue virtual visits.
Physicians expressed a high degree of satisfaction with the rheumatology didactic sessions and said that the sessions enhanced their knowledge of evaluating and managing or co-managing rheumatologic diseases, as well as helping them to feel comfortable about applying this knowledge to patient care.
Dr. Rivadeneira noted that the pilot study was limited by low levels of Piedmont Health Services physician participation (two out of 45 total participated in shared visits), and only three or four providers typically took part in each didactic session.
How to Improve?
In a follow-up study, the investigators asked Piedmont Health Services providers about barriers to rheumatology care, the most common and challenging diseases they encountered, how to improve the didactic components, and their perspectives on the pilot and how it may have affected referral patterns to rheumatology care.
The providers identified the cost of diagnostic evaluations and medications, transportation, long wait times, and language as the main barriers to patient access of rheumatology care.
“Additionally, over a third of them encountered patients on a weekly basis that were overdue for a visit with a rheumatologist,” Dr. Rivadeneira said.
“Direct participation in the physical exam by the primary care provider enhances greatly, in my opinion, these telehealth visits. Focused didactic sessions, electronic handouts and/or quick access guides could empower more rural community providers to manage rheumatic diseases,” he concluded.
In the Q&A following the presentation, Laura Cappelli, MD, MHS, MS, associate professor of medicine in the division of rheumatology at Johns Hopkins School of Medicine in Baltimore, asked Dr. Rivadeneira how rheumatologists involved felt about the program and whether his team did any surveying or qualitative work with them.
“Just so you know, the rheumatologist was me,” he replied.
“I’m very picky about telemedicine,” he continued. “I don’t like it, I prefer, as most of us do, to have the patient there. But having the provider there, doing the exam, and you guiding them — I can ask, ‘Did you check their joints? Did you check their strength?’ — makes a huge difference and makes me feel comfortable with the sessions.”
Dr. Rivadeneira added that if a particular case was too complex or too vague to adequately assess via telehealth, he would arrange to see the patient in person.
The project was supported by the Arthritis Foundation. Dr. Rivadeneira and Dr. Cappelli reported no conflicts of interest.
A version of this article appeared on Medscape.com.
Even in large urban areas there aren’t enough rheumatologists to go around, and as a 2015 American College of Rheumatology workforce study projected, the number of rheumatology providers is expected to drop by 25% by the year 2030, while the demand for patient care in rheumatology is expected to increase by more than 100%.
The shortage of rheumatology care is even more acute in rural areas, but as a pilot project supported by the Arthritis Foundation shows, linking rheumatologists to health centers in remote and underserved locations via telehealth can help community providers improve care for patients with rheumatic diseases.
The novel collaborative model was described by Alfredo Rivadeneira, MD, professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina (UNC) School of Medicine in Chapel Hill, North Carolina.
“We found that this pilot, a unique partnership in North Carolina, improves access to rheumatology care to a rural population with high satisfaction scores. It underlines the importance of seeking collaboration with community providers when implementing these programs. It also allows timely specialty care and alleviates the barriers relating to transportation, insurance coverage, and telecommunication challenges,” he said at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.
Too Many Patients, Too Few Rheumatologists
Access to health is challenging for people from traditionally underserved racial and ethnic backgrounds, especially in states such as North Carolina, where 40% of the population lives in rural counties, which have higher age-adjusted mortality than more densely populated areas of the state, Dr. Rivadeneira said.
In addition, 42% of the North Carolina residents seen at the state’s 42 Federally Qualified Health Centers (FQHCs) don’t have health insurance, which is higher than the average of 23% uninsured seen at FQHCs in other states.
There are currently approximately 250 rheumatology providers in North Carolina, the majority of whom work in the states’ three academic medical centers. Currently, North Carolina has an estimated population of 10 million people, which is projected to increase to 11.7 million by 2030. And by 2030, 20% of North Carolinians will be aged ≥ 65 years, Dr. Rivadeneira said, highlighting the need for expanded rheumatology care.
Although telehealth services could be an option for expanding services to underserved communities, only 14 of the 42 FQHCs in the state use telehealth and only on a limited basis because it is not sufficiently reimbursed.
Rivadeneira pointed to a 2022 study that showed how patients with rheumatic and musculoskeletal disease patients in North Carolina were less likely to use online patient portals if they lived in rural areas; came from racial or ethnic minority backgrounds; were older, men, had lower economic status (Medicaid enrollment or uninsured); or spoke a language other than English as their primary tongue.
Pilot Project
To help smooth out some of the above-mentioned disparities, Dr. Rivadeneira and colleagues, in collaboration with the Arthritis Foundation, started a pilot project in 2022 designed to enhance access to rheumatology specialty care for rural residents through a shared telehealth model between the UNC rheumatology clinic and two separate Piedmont Health Services clinics in rural areas.
The project includes tailored educational sessions designed to empower Piedmont Health Services providers for evaluating and managing patients with rheumatic diseases.
Patients with prior diagnoses of rheumatologic diseases who were lost to rheumatology specialty care follow-up and those with new rheumatic symptoms who had transportation and/or financial barriers to receiving specialty care are triaged to the shared telemedicine visits.
Providers conduct monthly clinic sessions via shared visits between the on-site Piedmont Health Services provider and patients, with off-site UNC rheumatology fellows and attending physicians connected virtually.
The educational component of the project includes monthly didactic sessions offered to all Piedmont Health Services providers across 12 locations.
The topics that were chosen cover the most common rheumatologic conditions seen by community providers, including evaluating pain from a rheumatology perspective; using antinuclear antibodies and other serologies; evaluating and managing rheumatoid arthritis, lupus, gout, giant cell arteritis, polymyalgia rheumatica, and osteoarthritis; and methotrexate management and complications.
“One of the aspects of this pilot that I want to emphasize is the importance of having the generalists with the patient, relaying the objective data, especially the physical exam, and that’s one of the great features of this model. It also provides a stable platform for telehealth to the individual patients, as many of these patients don’t have access to health technology,” Dr. Rivadeneira said.
Thumbs Up
Both patients and general practitioners in the Piedmont Health system expressed high degrees of satisfaction with the shared telehealth program. Patients especially liked the time they saved not having to travel to see a specialist, and a large majority agreed that the visits were “as good as” in-person visits, felt that their concerns were addressed appropriately during the virtual visit, expressed overall satisfaction, and said they would like to continue virtual visits.
Physicians expressed a high degree of satisfaction with the rheumatology didactic sessions and said that the sessions enhanced their knowledge of evaluating and managing or co-managing rheumatologic diseases, as well as helping them to feel comfortable about applying this knowledge to patient care.
Dr. Rivadeneira noted that the pilot study was limited by low levels of Piedmont Health Services physician participation (two out of 45 total participated in shared visits), and only three or four providers typically took part in each didactic session.
How to Improve?
In a follow-up study, the investigators asked Piedmont Health Services providers about barriers to rheumatology care, the most common and challenging diseases they encountered, how to improve the didactic components, and their perspectives on the pilot and how it may have affected referral patterns to rheumatology care.
The providers identified the cost of diagnostic evaluations and medications, transportation, long wait times, and language as the main barriers to patient access of rheumatology care.
“Additionally, over a third of them encountered patients on a weekly basis that were overdue for a visit with a rheumatologist,” Dr. Rivadeneira said.
“Direct participation in the physical exam by the primary care provider enhances greatly, in my opinion, these telehealth visits. Focused didactic sessions, electronic handouts and/or quick access guides could empower more rural community providers to manage rheumatic diseases,” he concluded.
In the Q&A following the presentation, Laura Cappelli, MD, MHS, MS, associate professor of medicine in the division of rheumatology at Johns Hopkins School of Medicine in Baltimore, asked Dr. Rivadeneira how rheumatologists involved felt about the program and whether his team did any surveying or qualitative work with them.
“Just so you know, the rheumatologist was me,” he replied.
“I’m very picky about telemedicine,” he continued. “I don’t like it, I prefer, as most of us do, to have the patient there. But having the provider there, doing the exam, and you guiding them — I can ask, ‘Did you check their joints? Did you check their strength?’ — makes a huge difference and makes me feel comfortable with the sessions.”
Dr. Rivadeneira added that if a particular case was too complex or too vague to adequately assess via telehealth, he would arrange to see the patient in person.
The project was supported by the Arthritis Foundation. Dr. Rivadeneira and Dr. Cappelli reported no conflicts of interest.
A version of this article appeared on Medscape.com.
FROM RA SUMMIT 2024
Second Ustekinumab Biosimilar Gets FDA Approval
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
Clinical Characteristics of Severe PsA
Key clinical point: Patients with psoriatic arthritis (PsA) who had severe vs non-severe disease according to the modified Composite Psoriatic Disease Activity Index (mCPDAI) showed higher disease activity, experienced more pain, and had higher disease impact both at baseline and during follow-up.
Major finding: At baseline, 36.1% of patients had severe PsA as assessed by mCPDAI. A significantly higher disease activity, disease impact, number of tender or swollen joints, and pain and reduced function were observed in patients with severe vs non-severe disease at baseline and follow-up (all P < .01). Male sex and severity of skin involvement at baseline were the factors associated with the severe PsA at last follow-up (both P ≤ .01).
Study details: This retrospective analysis of a longitudinal study included 177 patients with peripheral PsA who were followed for at least 1 year.
Disclosures: This study did not receive any funding or sponsorship. Ennio Lubrano and Fabio Perrotta declared being members of the editorial board of Rheumatology and Therapy. Silvia Scriffignano declared no conflicts of interest.
Source: Lubrano E, Scriffignano S, Perrotta FM. Clinical characteristics of "severe" peripheral psoriatic arthritis: A retrospective analysis of a longitudinal cohort. Rheumatol Ther. 2024 (Apr 9). doi: 10.1007/s40744-024-00667-0 Source
Key clinical point: Patients with psoriatic arthritis (PsA) who had severe vs non-severe disease according to the modified Composite Psoriatic Disease Activity Index (mCPDAI) showed higher disease activity, experienced more pain, and had higher disease impact both at baseline and during follow-up.
Major finding: At baseline, 36.1% of patients had severe PsA as assessed by mCPDAI. A significantly higher disease activity, disease impact, number of tender or swollen joints, and pain and reduced function were observed in patients with severe vs non-severe disease at baseline and follow-up (all P < .01). Male sex and severity of skin involvement at baseline were the factors associated with the severe PsA at last follow-up (both P ≤ .01).
Study details: This retrospective analysis of a longitudinal study included 177 patients with peripheral PsA who were followed for at least 1 year.
Disclosures: This study did not receive any funding or sponsorship. Ennio Lubrano and Fabio Perrotta declared being members of the editorial board of Rheumatology and Therapy. Silvia Scriffignano declared no conflicts of interest.
Source: Lubrano E, Scriffignano S, Perrotta FM. Clinical characteristics of "severe" peripheral psoriatic arthritis: A retrospective analysis of a longitudinal cohort. Rheumatol Ther. 2024 (Apr 9). doi: 10.1007/s40744-024-00667-0 Source
Key clinical point: Patients with psoriatic arthritis (PsA) who had severe vs non-severe disease according to the modified Composite Psoriatic Disease Activity Index (mCPDAI) showed higher disease activity, experienced more pain, and had higher disease impact both at baseline and during follow-up.
Major finding: At baseline, 36.1% of patients had severe PsA as assessed by mCPDAI. A significantly higher disease activity, disease impact, number of tender or swollen joints, and pain and reduced function were observed in patients with severe vs non-severe disease at baseline and follow-up (all P < .01). Male sex and severity of skin involvement at baseline were the factors associated with the severe PsA at last follow-up (both P ≤ .01).
Study details: This retrospective analysis of a longitudinal study included 177 patients with peripheral PsA who were followed for at least 1 year.
Disclosures: This study did not receive any funding or sponsorship. Ennio Lubrano and Fabio Perrotta declared being members of the editorial board of Rheumatology and Therapy. Silvia Scriffignano declared no conflicts of interest.
Source: Lubrano E, Scriffignano S, Perrotta FM. Clinical characteristics of "severe" peripheral psoriatic arthritis: A retrospective analysis of a longitudinal cohort. Rheumatol Ther. 2024 (Apr 9). doi: 10.1007/s40744-024-00667-0 Source
Meta-Analysis Identifies IL17A Inhibitor as a Better Treatment Option in Biologic-Naive Patients with PsA
Key clinical point: Treatment with an interleukin-17A inhibitor (IL-17Ai) may be desirable in biologic-naive patients with psoriatic arthritis (PsA) as it proved to be more effective and safer compared with other biologics.
Major finding: A higher number of patients achieved the composite endpoint of ≥50% improvement in American College of Rheumatology and 100% improvement in Psoriasis Area Severity Index (pooled risk ratio [RR] 1.56; 95% CI 1.29-1.88; P < .001) and enthesitis resolution (pooled RR 1.22; 95% CI 1.02-1.47) with IL17Ai vs TNFi. The probability of adverse events was the lowest with phosphodiesterase-4 inhibitor (PDE4i) followed by IL-17Ai.
Study details: Findings are from a network meta-analysis of 17 studies including biologic-naive patients with PsA treated with IL inhibitor, TNFi, PDE4i, and Janus kinase inhibitors.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lin J, Ren Y. Different biologics for biological-naïve patients with psoriatic arthritis: A systematic review and network meta-analysis. Front Pharmacol. 2024;15:1279525 (Mar 12). doi: 10.3389/fphar.2024.1279525 Source
Key clinical point: Treatment with an interleukin-17A inhibitor (IL-17Ai) may be desirable in biologic-naive patients with psoriatic arthritis (PsA) as it proved to be more effective and safer compared with other biologics.
Major finding: A higher number of patients achieved the composite endpoint of ≥50% improvement in American College of Rheumatology and 100% improvement in Psoriasis Area Severity Index (pooled risk ratio [RR] 1.56; 95% CI 1.29-1.88; P < .001) and enthesitis resolution (pooled RR 1.22; 95% CI 1.02-1.47) with IL17Ai vs TNFi. The probability of adverse events was the lowest with phosphodiesterase-4 inhibitor (PDE4i) followed by IL-17Ai.
Study details: Findings are from a network meta-analysis of 17 studies including biologic-naive patients with PsA treated with IL inhibitor, TNFi, PDE4i, and Janus kinase inhibitors.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lin J, Ren Y. Different biologics for biological-naïve patients with psoriatic arthritis: A systematic review and network meta-analysis. Front Pharmacol. 2024;15:1279525 (Mar 12). doi: 10.3389/fphar.2024.1279525 Source
Key clinical point: Treatment with an interleukin-17A inhibitor (IL-17Ai) may be desirable in biologic-naive patients with psoriatic arthritis (PsA) as it proved to be more effective and safer compared with other biologics.
Major finding: A higher number of patients achieved the composite endpoint of ≥50% improvement in American College of Rheumatology and 100% improvement in Psoriasis Area Severity Index (pooled risk ratio [RR] 1.56; 95% CI 1.29-1.88; P < .001) and enthesitis resolution (pooled RR 1.22; 95% CI 1.02-1.47) with IL17Ai vs TNFi. The probability of adverse events was the lowest with phosphodiesterase-4 inhibitor (PDE4i) followed by IL-17Ai.
Study details: Findings are from a network meta-analysis of 17 studies including biologic-naive patients with PsA treated with IL inhibitor, TNFi, PDE4i, and Janus kinase inhibitors.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lin J, Ren Y. Different biologics for biological-naïve patients with psoriatic arthritis: A systematic review and network meta-analysis. Front Pharmacol. 2024;15:1279525 (Mar 12). doi: 10.3389/fphar.2024.1279525 Source
Real World Study Confirms Efficacy of Risankizumab in PsA
Key clinical point: Risankizumab led to considerable improvements in skin- and joint-associated clinical outcomes in patients with psoriatic arthritis (PsA) who were followed-up for >28 weeks.
Major finding: Of the 31 patients with clinical disease activity index for PsA > 4 at baseline, 11 patients achieved remission at a follow-up visit between 28 and 40 weeks (P < .004). Risankizumab also led to a significant reduction in the mean psoriasis area severity index score between weeks 28 and 40 vs baseline (0.3 vs 8.4; P < .001).
Study details: Findings are from a prospective, multicenter real-world study including 40 patients with PsA who were treated with 150 mg risankizumab at week 0 and week 4 and every 12 weeks subsequently.
Disclosures: This study did not receive any funding. Five authors declared receiving consulting fees or honoraria from or having other ties with various sources. The other authors declared no conflicts of interest.
Source: Graceffa D, Zangrilli A, Caldarola G, et al. Effectiveness of risankizumab for the treatment of psoriatic arthritis: A multicenter, real-world study. Int J Dermatol. 2024 (Apr 7). doi: 10.1111/ijd.17156 Source
Key clinical point: Risankizumab led to considerable improvements in skin- and joint-associated clinical outcomes in patients with psoriatic arthritis (PsA) who were followed-up for >28 weeks.
Major finding: Of the 31 patients with clinical disease activity index for PsA > 4 at baseline, 11 patients achieved remission at a follow-up visit between 28 and 40 weeks (P < .004). Risankizumab also led to a significant reduction in the mean psoriasis area severity index score between weeks 28 and 40 vs baseline (0.3 vs 8.4; P < .001).
Study details: Findings are from a prospective, multicenter real-world study including 40 patients with PsA who were treated with 150 mg risankizumab at week 0 and week 4 and every 12 weeks subsequently.
Disclosures: This study did not receive any funding. Five authors declared receiving consulting fees or honoraria from or having other ties with various sources. The other authors declared no conflicts of interest.
Source: Graceffa D, Zangrilli A, Caldarola G, et al. Effectiveness of risankizumab for the treatment of psoriatic arthritis: A multicenter, real-world study. Int J Dermatol. 2024 (Apr 7). doi: 10.1111/ijd.17156 Source
Key clinical point: Risankizumab led to considerable improvements in skin- and joint-associated clinical outcomes in patients with psoriatic arthritis (PsA) who were followed-up for >28 weeks.
Major finding: Of the 31 patients with clinical disease activity index for PsA > 4 at baseline, 11 patients achieved remission at a follow-up visit between 28 and 40 weeks (P < .004). Risankizumab also led to a significant reduction in the mean psoriasis area severity index score between weeks 28 and 40 vs baseline (0.3 vs 8.4; P < .001).
Study details: Findings are from a prospective, multicenter real-world study including 40 patients with PsA who were treated with 150 mg risankizumab at week 0 and week 4 and every 12 weeks subsequently.
Disclosures: This study did not receive any funding. Five authors declared receiving consulting fees or honoraria from or having other ties with various sources. The other authors declared no conflicts of interest.
Source: Graceffa D, Zangrilli A, Caldarola G, et al. Effectiveness of risankizumab for the treatment of psoriatic arthritis: A multicenter, real-world study. Int J Dermatol. 2024 (Apr 7). doi: 10.1111/ijd.17156 Source
Bone Erosions Highly Prevalent in Early, Untreated PsA
Key clinical point: A quarter of patients with early psoriatic arthritis who were naive to disease-modifying antirheumatic drugs (DMARD) reported bone erosions, with a decreased prevalence being observed in patients with shorter duration of PsA symptoms (<8 months).
Major finding: Overall, 4655 hand and feet joints were assessed in 122 patients, of whom 24.6% patients had bone erosions at baseline, with higher Disease Activity features observed in patients who did vs did not have bone erosions (P < .05). Prevalence of erosion was less in patients who had a <8 months vs >24 months of PsA symptoms (17.5% vs 24.3%).
Study details: This study included 122 newly diagnosed, DMARD-naive patients with early PsA from the Leeds Spondyloarthropathy Register for Research and Observation cohort who were assessed for bone erosions using conventional radiography or ultrasound.
Disclosures: This study was supported by the UK National Institute for Health Research Leeds Biomedical Research Centre. Sayam R. Dubash received support from Leeds Cares charity. The other authors declared no conflicts of interest.
Source: Hen O, Di Matteo A, Dubash SR, et al. High prevalence of radiographic erosions in early, untreated PsA: Results from the SpARRO cohort. RMD Open. 2024;10:e003841 (Apr 5). doi: 10.1136/rmdopen-2023-003841 Source
Key clinical point: A quarter of patients with early psoriatic arthritis who were naive to disease-modifying antirheumatic drugs (DMARD) reported bone erosions, with a decreased prevalence being observed in patients with shorter duration of PsA symptoms (<8 months).
Major finding: Overall, 4655 hand and feet joints were assessed in 122 patients, of whom 24.6% patients had bone erosions at baseline, with higher Disease Activity features observed in patients who did vs did not have bone erosions (P < .05). Prevalence of erosion was less in patients who had a <8 months vs >24 months of PsA symptoms (17.5% vs 24.3%).
Study details: This study included 122 newly diagnosed, DMARD-naive patients with early PsA from the Leeds Spondyloarthropathy Register for Research and Observation cohort who were assessed for bone erosions using conventional radiography or ultrasound.
Disclosures: This study was supported by the UK National Institute for Health Research Leeds Biomedical Research Centre. Sayam R. Dubash received support from Leeds Cares charity. The other authors declared no conflicts of interest.
Source: Hen O, Di Matteo A, Dubash SR, et al. High prevalence of radiographic erosions in early, untreated PsA: Results from the SpARRO cohort. RMD Open. 2024;10:e003841 (Apr 5). doi: 10.1136/rmdopen-2023-003841 Source
Key clinical point: A quarter of patients with early psoriatic arthritis who were naive to disease-modifying antirheumatic drugs (DMARD) reported bone erosions, with a decreased prevalence being observed in patients with shorter duration of PsA symptoms (<8 months).
Major finding: Overall, 4655 hand and feet joints were assessed in 122 patients, of whom 24.6% patients had bone erosions at baseline, with higher Disease Activity features observed in patients who did vs did not have bone erosions (P < .05). Prevalence of erosion was less in patients who had a <8 months vs >24 months of PsA symptoms (17.5% vs 24.3%).
Study details: This study included 122 newly diagnosed, DMARD-naive patients with early PsA from the Leeds Spondyloarthropathy Register for Research and Observation cohort who were assessed for bone erosions using conventional radiography or ultrasound.
Disclosures: This study was supported by the UK National Institute for Health Research Leeds Biomedical Research Centre. Sayam R. Dubash received support from Leeds Cares charity. The other authors declared no conflicts of interest.
Source: Hen O, Di Matteo A, Dubash SR, et al. High prevalence of radiographic erosions in early, untreated PsA: Results from the SpARRO cohort. RMD Open. 2024;10:e003841 (Apr 5). doi: 10.1136/rmdopen-2023-003841 Source
Deucravacitinib Improves Patient-Reported Outcomes in PsA
Key clinical point: Deucravacitinib improved patient-reported outcomes (PRO) for physical and social functioning, mental health, fatigue, and pain in patients with active psoriatic arthritis (PsA).
Major finding: At week 16, 6 mg deucravacitinib vs placebo led to significant changes in functional ability as assessed by the Health Assessment Questionnaire-Disability Index (−0.26; 95% CI −0.42 to −0.10) and the 36-Item Short-Form Health Survey physical component summary (3.3; 95% CI 0.9 to 5.7), with similar outcomes for 12 mg deucravacitinib. Improvements were also noted in mental health and quality of life at week 16 with deucravacitinib vs placebo.
Study details: Findings are from a phase 2, double-blind trial that included 203 patients with active PsA who were randomly assigned (1:1:1) to receive 6 mg deucravacitinib daily (n = 70), 12 mg deucravacitinib daily (n = 67), or placebo (n = 66) for 16 weeks.
Disclosures: This study was sponsored by Bristol Myers Squibb. The authors declared no conflicts of interest.
Source: Strand V, Gossec L, Coates LC, et al. Improvements in patient-reported outcomes after treatment with deucravacitinib in patients with psoriatic arthritis: Results from a randomized phase 2 trial. Arthritis Care Res (Hoboken). 2024 (Mar 26). doi: 10.1002/acr.25333 Source
Key clinical point: Deucravacitinib improved patient-reported outcomes (PRO) for physical and social functioning, mental health, fatigue, and pain in patients with active psoriatic arthritis (PsA).
Major finding: At week 16, 6 mg deucravacitinib vs placebo led to significant changes in functional ability as assessed by the Health Assessment Questionnaire-Disability Index (−0.26; 95% CI −0.42 to −0.10) and the 36-Item Short-Form Health Survey physical component summary (3.3; 95% CI 0.9 to 5.7), with similar outcomes for 12 mg deucravacitinib. Improvements were also noted in mental health and quality of life at week 16 with deucravacitinib vs placebo.
Study details: Findings are from a phase 2, double-blind trial that included 203 patients with active PsA who were randomly assigned (1:1:1) to receive 6 mg deucravacitinib daily (n = 70), 12 mg deucravacitinib daily (n = 67), or placebo (n = 66) for 16 weeks.
Disclosures: This study was sponsored by Bristol Myers Squibb. The authors declared no conflicts of interest.
Source: Strand V, Gossec L, Coates LC, et al. Improvements in patient-reported outcomes after treatment with deucravacitinib in patients with psoriatic arthritis: Results from a randomized phase 2 trial. Arthritis Care Res (Hoboken). 2024 (Mar 26). doi: 10.1002/acr.25333 Source
Key clinical point: Deucravacitinib improved patient-reported outcomes (PRO) for physical and social functioning, mental health, fatigue, and pain in patients with active psoriatic arthritis (PsA).
Major finding: At week 16, 6 mg deucravacitinib vs placebo led to significant changes in functional ability as assessed by the Health Assessment Questionnaire-Disability Index (−0.26; 95% CI −0.42 to −0.10) and the 36-Item Short-Form Health Survey physical component summary (3.3; 95% CI 0.9 to 5.7), with similar outcomes for 12 mg deucravacitinib. Improvements were also noted in mental health and quality of life at week 16 with deucravacitinib vs placebo.
Study details: Findings are from a phase 2, double-blind trial that included 203 patients with active PsA who were randomly assigned (1:1:1) to receive 6 mg deucravacitinib daily (n = 70), 12 mg deucravacitinib daily (n = 67), or placebo (n = 66) for 16 weeks.
Disclosures: This study was sponsored by Bristol Myers Squibb. The authors declared no conflicts of interest.
Source: Strand V, Gossec L, Coates LC, et al. Improvements in patient-reported outcomes after treatment with deucravacitinib in patients with psoriatic arthritis: Results from a randomized phase 2 trial. Arthritis Care Res (Hoboken). 2024 (Mar 26). doi: 10.1002/acr.25333 Source
Enthesitis or Dactylitis Remission Associated with Improved Patient-Reported Outcomes in PsA
Key clinical point: Among biologic-naive, guselkumab-treated patients with psoriatic arthritis (PsA), enthesitis resolution (ER) was associated with dactylitis resolution (DR), and those achieving ER or DR showed improvements in patient-reported outcomes.
Major finding: At weeks 24, 52, and 100, guselkumab-treated patients who achieved DR were more likely to achieve ER, and vice versa (all P < .05). At week 24, a higher proportion of patients who did vs did not achieve ER reported minimal pain (30%-45% vs 11%-21%; all P < .001), with similar pain outcomes in patients who did vs did not achieve DR.
Study details: This post hoc analysis included 739 biologic-naive patients with PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with crossover to guselkumab (100 mg every 4 weeks) at week 24, of whom 68.6% and 44.9% of patients had enthesitis and dactylitis, respectively.
Disclosures: This study was supported by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owning Johnson and Johnson stock or stock options. The other authors declared receiving consulting fees from or having other ties with various sources, including Janssen.
Source: Rahman P, McInnes IB, Deodhar A, et al. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis. Clin Rheumatol. 2024;43:1591-1604 (Mar 12). doi: 10.1007/s10067-024-06921-8 Source
Key clinical point: Among biologic-naive, guselkumab-treated patients with psoriatic arthritis (PsA), enthesitis resolution (ER) was associated with dactylitis resolution (DR), and those achieving ER or DR showed improvements in patient-reported outcomes.
Major finding: At weeks 24, 52, and 100, guselkumab-treated patients who achieved DR were more likely to achieve ER, and vice versa (all P < .05). At week 24, a higher proportion of patients who did vs did not achieve ER reported minimal pain (30%-45% vs 11%-21%; all P < .001), with similar pain outcomes in patients who did vs did not achieve DR.
Study details: This post hoc analysis included 739 biologic-naive patients with PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with crossover to guselkumab (100 mg every 4 weeks) at week 24, of whom 68.6% and 44.9% of patients had enthesitis and dactylitis, respectively.
Disclosures: This study was supported by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owning Johnson and Johnson stock or stock options. The other authors declared receiving consulting fees from or having other ties with various sources, including Janssen.
Source: Rahman P, McInnes IB, Deodhar A, et al. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis. Clin Rheumatol. 2024;43:1591-1604 (Mar 12). doi: 10.1007/s10067-024-06921-8 Source
Key clinical point: Among biologic-naive, guselkumab-treated patients with psoriatic arthritis (PsA), enthesitis resolution (ER) was associated with dactylitis resolution (DR), and those achieving ER or DR showed improvements in patient-reported outcomes.
Major finding: At weeks 24, 52, and 100, guselkumab-treated patients who achieved DR were more likely to achieve ER, and vice versa (all P < .05). At week 24, a higher proportion of patients who did vs did not achieve ER reported minimal pain (30%-45% vs 11%-21%; all P < .001), with similar pain outcomes in patients who did vs did not achieve DR.
Study details: This post hoc analysis included 739 biologic-naive patients with PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with crossover to guselkumab (100 mg every 4 weeks) at week 24, of whom 68.6% and 44.9% of patients had enthesitis and dactylitis, respectively.
Disclosures: This study was supported by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owning Johnson and Johnson stock or stock options. The other authors declared receiving consulting fees from or having other ties with various sources, including Janssen.
Source: Rahman P, McInnes IB, Deodhar A, et al. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis. Clin Rheumatol. 2024;43:1591-1604 (Mar 12). doi: 10.1007/s10067-024-06921-8 Source
Durable Improvements Across PsA Disease Domains with Guselkumab
Key clinical point: Guselkumab treatment led to durable improvements in key Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (PsA)-recognized domains through 2 years and showed a consistent safety profile in biologic or Janus kinase inhibitor-naive patients with active PsA.
Major finding: At week 100, more than 50% of patients receiving guselkumab (100 mg every 4 or 8 weeks) achieved achieved a low PsA Disease Activity Index, had enthesitis resolution, dactylitis resolution, and 100% improvement in Psoriasis Area and Severity Index. No new safety signals were observed.
Study details: This post hoc analysis included 442 biologic or Janus kinase inhibitor-naive patients with active PsA and previous inadequate response or intolerance to standard nonbiologics who received 100 mg guselkumab every 4 or 8 weeks through week 100.
Disclosures: This study was supported by Janssen Research & Development (R&D), LLC. Three authors declared being employees of Janssen R&D and owning Johnson and Johnson stocks or stock options. Several authors declared receiving honoraria from or having other ties with various sources, including Janssen.
Source: Coates LC, Gossec L, Zimmermann M, et al. Guselkumab provides durable improvement across psoriatic arthritis disease domains: Post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. 2024;10:e003977 (Mar 26). doi: 10.1136/rmdopen-2023-003977 Source
Key clinical point: Guselkumab treatment led to durable improvements in key Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (PsA)-recognized domains through 2 years and showed a consistent safety profile in biologic or Janus kinase inhibitor-naive patients with active PsA.
Major finding: At week 100, more than 50% of patients receiving guselkumab (100 mg every 4 or 8 weeks) achieved achieved a low PsA Disease Activity Index, had enthesitis resolution, dactylitis resolution, and 100% improvement in Psoriasis Area and Severity Index. No new safety signals were observed.
Study details: This post hoc analysis included 442 biologic or Janus kinase inhibitor-naive patients with active PsA and previous inadequate response or intolerance to standard nonbiologics who received 100 mg guselkumab every 4 or 8 weeks through week 100.
Disclosures: This study was supported by Janssen Research & Development (R&D), LLC. Three authors declared being employees of Janssen R&D and owning Johnson and Johnson stocks or stock options. Several authors declared receiving honoraria from or having other ties with various sources, including Janssen.
Source: Coates LC, Gossec L, Zimmermann M, et al. Guselkumab provides durable improvement across psoriatic arthritis disease domains: Post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. 2024;10:e003977 (Mar 26). doi: 10.1136/rmdopen-2023-003977 Source
Key clinical point: Guselkumab treatment led to durable improvements in key Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (PsA)-recognized domains through 2 years and showed a consistent safety profile in biologic or Janus kinase inhibitor-naive patients with active PsA.
Major finding: At week 100, more than 50% of patients receiving guselkumab (100 mg every 4 or 8 weeks) achieved achieved a low PsA Disease Activity Index, had enthesitis resolution, dactylitis resolution, and 100% improvement in Psoriasis Area and Severity Index. No new safety signals were observed.
Study details: This post hoc analysis included 442 biologic or Janus kinase inhibitor-naive patients with active PsA and previous inadequate response or intolerance to standard nonbiologics who received 100 mg guselkumab every 4 or 8 weeks through week 100.
Disclosures: This study was supported by Janssen Research & Development (R&D), LLC. Three authors declared being employees of Janssen R&D and owning Johnson and Johnson stocks or stock options. Several authors declared receiving honoraria from or having other ties with various sources, including Janssen.
Source: Coates LC, Gossec L, Zimmermann M, et al. Guselkumab provides durable improvement across psoriatic arthritis disease domains: Post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. 2024;10:e003977 (Mar 26). doi: 10.1136/rmdopen-2023-003977 Source
Risankizumab Offers Long-term Protection Against PsA
Key clinical point: Risankizumab showed long-term efficacy and tolerability in patients having active psoriatic arthritis (PsA) with previous inadequate response or intolerance to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR).
Major finding: At week 100, more than half the patients who received risankizumab continuously (64.3%) or switched from placebo to risankizumab (62.1%) achieved ≥20% improvement in the American College of Rheumatology criteria (ACR20), with Minimal Disease Activity being reported by nearly 35% of patients in both cohorts. Risankizumab showed a consistent safety profile with no new concerns.
Study details: This long-term efficacy and safety analysis of the KEEPsAKE 1 trial included 828 csDMARD-IR patients with active PsA who received risankizumab or placebo followed by risankizumab till week 100.
Disclosures: This study was funded by AbbVie. Seven authors declared being employees of or holding stocks or stock options in AbbVie. Several authors declared serving as consultants or speakers for or having other ties with various sources, including AbbVie.
Source: Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the phase 3 KEEPsAKE 1 randomized clinical trial. Rheumatol Ther. 2024 (Mar 18). doi: 10.1007/s40744-024-00654-5 Source
Key clinical point: Risankizumab showed long-term efficacy and tolerability in patients having active psoriatic arthritis (PsA) with previous inadequate response or intolerance to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR).
Major finding: At week 100, more than half the patients who received risankizumab continuously (64.3%) or switched from placebo to risankizumab (62.1%) achieved ≥20% improvement in the American College of Rheumatology criteria (ACR20), with Minimal Disease Activity being reported by nearly 35% of patients in both cohorts. Risankizumab showed a consistent safety profile with no new concerns.
Study details: This long-term efficacy and safety analysis of the KEEPsAKE 1 trial included 828 csDMARD-IR patients with active PsA who received risankizumab or placebo followed by risankizumab till week 100.
Disclosures: This study was funded by AbbVie. Seven authors declared being employees of or holding stocks or stock options in AbbVie. Several authors declared serving as consultants or speakers for or having other ties with various sources, including AbbVie.
Source: Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the phase 3 KEEPsAKE 1 randomized clinical trial. Rheumatol Ther. 2024 (Mar 18). doi: 10.1007/s40744-024-00654-5 Source
Key clinical point: Risankizumab showed long-term efficacy and tolerability in patients having active psoriatic arthritis (PsA) with previous inadequate response or intolerance to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR).
Major finding: At week 100, more than half the patients who received risankizumab continuously (64.3%) or switched from placebo to risankizumab (62.1%) achieved ≥20% improvement in the American College of Rheumatology criteria (ACR20), with Minimal Disease Activity being reported by nearly 35% of patients in both cohorts. Risankizumab showed a consistent safety profile with no new concerns.
Study details: This long-term efficacy and safety analysis of the KEEPsAKE 1 trial included 828 csDMARD-IR patients with active PsA who received risankizumab or placebo followed by risankizumab till week 100.
Disclosures: This study was funded by AbbVie. Seven authors declared being employees of or holding stocks or stock options in AbbVie. Several authors declared serving as consultants or speakers for or having other ties with various sources, including AbbVie.
Source: Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the phase 3 KEEPsAKE 1 randomized clinical trial. Rheumatol Ther. 2024 (Mar 18). doi: 10.1007/s40744-024-00654-5 Source