MDedge Rheumatology

Key clinical point: A dose of 80 mg ixekizumab every 2 (Q2W) or 4 (Q4W) weeks demonstrated rapid and consistent efficacy, regardless of the extent of initial skin involvement in patients with psoriatic arthritis (PsA).

Major finding: In both ixekizumab treatment arms (Q2W and Q4W), over one-third of patients achieved ≥20% improvement in American College of Rheumatology (ACR)20 response as early as week 4, with the number increasing to approximately half at week 24. A similar proportion of patients achieved ACR20/50/70 response at week 24 irrespective of initial psoriasis severity (P > .05).

Study details: This post hoc subgroup analysis of SPIRIT-P1 and SPIRIT-P2 included 655 patients with active PsA and plaque psoriasis who were randomly assigned to receive placebo or 80 mg ixekizumab Q2W or Q4W.

Disclosures: The sponsorship and Rapid Service Fee for this study was funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly. Several authors declared receiving grants or honoraria or having other ties with various sources, including Eli Lilly and Company.

Source: Armstrong AW, Jaleel T, Merola JF, et al. Ixekizumab demonstrates rapid and consistent efficacy for patients with psoriatic arthritis, regardless of psoriasis severity. Dermatol Ther (Heidelb). 2024;14:1615-1631 (May 30). Source

Key clinical point: A dose of 80 mg ixekizumab every 2 (Q2W) or 4 (Q4W) weeks demonstrated rapid and consistent efficacy, regardless of the extent of initial skin involvement in patients with psoriatic arthritis (PsA).

Major finding: In both ixekizumab treatment arms (Q2W and Q4W), over one-third of patients achieved ≥20% improvement in American College of Rheumatology (ACR)20 response as early as week 4, with the number increasing to approximately half at week 24. A similar proportion of patients achieved ACR20/50/70 response at week 24 irrespective of initial psoriasis severity (P > .05).

Study details: This post hoc subgroup analysis of SPIRIT-P1 and SPIRIT-P2 included 655 patients with active PsA and plaque psoriasis who were randomly assigned to receive placebo or 80 mg ixekizumab Q2W or Q4W.

Disclosures: The sponsorship and Rapid Service Fee for this study was funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly. Several authors declared receiving grants or honoraria or having other ties with various sources, including Eli Lilly and Company.

Source: Armstrong AW, Jaleel T, Merola JF, et al. Ixekizumab demonstrates rapid and consistent efficacy for patients with psoriatic arthritis, regardless of psoriasis severity. Dermatol Ther (Heidelb). 2024;14:1615-1631 (May 30). Source

Key clinical point: A dose of 80 mg ixekizumab every 2 (Q2W) or 4 (Q4W) weeks demonstrated rapid and consistent efficacy, regardless of the extent of initial skin involvement in patients with psoriatic arthritis (PsA).

Major finding: In both ixekizumab treatment arms (Q2W and Q4W), over one-third of patients achieved ≥20% improvement in American College of Rheumatology (ACR)20 response as early as week 4, with the number increasing to approximately half at week 24. A similar proportion of patients achieved ACR20/50/70 response at week 24 irrespective of initial psoriasis severity (P > .05).

Study details: This post hoc subgroup analysis of SPIRIT-P1 and SPIRIT-P2 included 655 patients with active PsA and plaque psoriasis who were randomly assigned to receive placebo or 80 mg ixekizumab Q2W or Q4W.

Disclosures: The sponsorship and Rapid Service Fee for this study was funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly. Several authors declared receiving grants or honoraria or having other ties with various sources, including Eli Lilly and Company.

Source: Armstrong AW, Jaleel T, Merola JF, et al. Ixekizumab demonstrates rapid and consistent efficacy for patients with psoriatic arthritis, regardless of psoriasis severity. Dermatol Ther (Heidelb). 2024;14:1615-1631 (May 30). Source

Key clinical point: Bimekizumab improved disease impact in a rapid and sustained manner in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD-naive) or had prior inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: A numerically higher proportion of bDMARD-naive patients receiving bimekizumab vs placebo achieved a clinically meaningful improvement in disease impact at week 4 (20.3% vs 2.5%) and 16 (36.8% vs 10.1%). These improvements were sustained till week 52 in patients who received bimekizumab continuously (49.0%) and in those who switched from placebo to bimekizumab (44.4%). Results were similar in the TNFi-IR subgroup.

Study details: Findings are from two phase 3 studies including 1112 patients with PsA who were bDMARD-naive or TNFi-IR and were randomly assigned to receive 160 mg bimekizumab every 4 weeks (n = 698) or placebo with crossover to bimekizumab at week 16 (n = 414).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees or shareholders of UCB Pharma. Other authors declared various ties with various sources, including UCB Pharma.

Source: Gossec L, Orbai AM, de Wit M, et al. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 (May 16). doi: 10.1093/rheumatology/keae277 Source

Key clinical point: Bimekizumab improved disease impact in a rapid and sustained manner in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD-naive) or had prior inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: A numerically higher proportion of bDMARD-naive patients receiving bimekizumab vs placebo achieved a clinically meaningful improvement in disease impact at week 4 (20.3% vs 2.5%) and 16 (36.8% vs 10.1%). These improvements were sustained till week 52 in patients who received bimekizumab continuously (49.0%) and in those who switched from placebo to bimekizumab (44.4%). Results were similar in the TNFi-IR subgroup.

Study details: Findings are from two phase 3 studies including 1112 patients with PsA who were bDMARD-naive or TNFi-IR and were randomly assigned to receive 160 mg bimekizumab every 4 weeks (n = 698) or placebo with crossover to bimekizumab at week 16 (n = 414).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees or shareholders of UCB Pharma. Other authors declared various ties with various sources, including UCB Pharma.

Source: Gossec L, Orbai AM, de Wit M, et al. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 (May 16). doi: 10.1093/rheumatology/keae277 Source

Key clinical point: Bimekizumab improved disease impact in a rapid and sustained manner in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD-naive) or had prior inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: A numerically higher proportion of bDMARD-naive patients receiving bimekizumab vs placebo achieved a clinically meaningful improvement in disease impact at week 4 (20.3% vs 2.5%) and 16 (36.8% vs 10.1%). These improvements were sustained till week 52 in patients who received bimekizumab continuously (49.0%) and in those who switched from placebo to bimekizumab (44.4%). Results were similar in the TNFi-IR subgroup.

Study details: Findings are from two phase 3 studies including 1112 patients with PsA who were bDMARD-naive or TNFi-IR and were randomly assigned to receive 160 mg bimekizumab every 4 weeks (n = 698) or placebo with crossover to bimekizumab at week 16 (n = 414).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees or shareholders of UCB Pharma. Other authors declared various ties with various sources, including UCB Pharma.

Source: Gossec L, Orbai AM, de Wit M, et al. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 (May 16). doi: 10.1093/rheumatology/keae277 Source

Key clinical point: Risankizumab vs placebo led to higher resolution rates for enthesitis and dactylitis at 24 weeks in patients with active psoriatic arthritis (PsA), which were sustained through 52 weeks.

Major finding: At week 24, a higher proportion of risankizumab- vs placebo-treated patients achieved resolution of enthesitis (48.4% vs 34.8%; P < .001), dactylitis (68.1% vs 51.0%; P < .001), and enthesitis + dactylitis (42.2% vs 28.6%; P < .05). More than 50% of patients who continuously received risankizumab or switched from placebo to risankizumab at week 24 achieved resolution of enthesitis, dactylitis, or both.

Study details: This integrated post hoc analysis of the KEEPsAKE 1 and KEEPsAKE 2 trials included 1407 patients with PsA and previous inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs who received risankizumab or placebo with crossover to risankizumab at week 24.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or holding stocks, stock options, or patents of AbbVie. Five authors declared ties with various sources, including AbbVie.

Source: Kwatra SG, Khattri S, Amin AZ, et al. Enthesitis and dactylitis resolution with risankizumab for active psoriatic arthritis: Integrated analysis of the randomized KEEPsAKE 1 and 2 trials. Dermatol Ther (Heidelb). 2024;14:1517-1530 (May 13). doi: 10.1007/s13555-024-01174-4 Source

Key clinical point: Risankizumab vs placebo led to higher resolution rates for enthesitis and dactylitis at 24 weeks in patients with active psoriatic arthritis (PsA), which were sustained through 52 weeks.

Major finding: At week 24, a higher proportion of risankizumab- vs placebo-treated patients achieved resolution of enthesitis (48.4% vs 34.8%; P < .001), dactylitis (68.1% vs 51.0%; P < .001), and enthesitis + dactylitis (42.2% vs 28.6%; P < .05). More than 50% of patients who continuously received risankizumab or switched from placebo to risankizumab at week 24 achieved resolution of enthesitis, dactylitis, or both.

Study details: This integrated post hoc analysis of the KEEPsAKE 1 and KEEPsAKE 2 trials included 1407 patients with PsA and previous inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs who received risankizumab or placebo with crossover to risankizumab at week 24.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or holding stocks, stock options, or patents of AbbVie. Five authors declared ties with various sources, including AbbVie.

Source: Kwatra SG, Khattri S, Amin AZ, et al. Enthesitis and dactylitis resolution with risankizumab for active psoriatic arthritis: Integrated analysis of the randomized KEEPsAKE 1 and 2 trials. Dermatol Ther (Heidelb). 2024;14:1517-1530 (May 13). doi: 10.1007/s13555-024-01174-4 Source

Key clinical point: Risankizumab vs placebo led to higher resolution rates for enthesitis and dactylitis at 24 weeks in patients with active psoriatic arthritis (PsA), which were sustained through 52 weeks.

Major finding: At week 24, a higher proportion of risankizumab- vs placebo-treated patients achieved resolution of enthesitis (48.4% vs 34.8%; P < .001), dactylitis (68.1% vs 51.0%; P < .001), and enthesitis + dactylitis (42.2% vs 28.6%; P < .05). More than 50% of patients who continuously received risankizumab or switched from placebo to risankizumab at week 24 achieved resolution of enthesitis, dactylitis, or both.

Study details: This integrated post hoc analysis of the KEEPsAKE 1 and KEEPsAKE 2 trials included 1407 patients with PsA and previous inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs who received risankizumab or placebo with crossover to risankizumab at week 24.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or holding stocks, stock options, or patents of AbbVie. Five authors declared ties with various sources, including AbbVie.

Source: Kwatra SG, Khattri S, Amin AZ, et al. Enthesitis and dactylitis resolution with risankizumab for active psoriatic arthritis: Integrated analysis of the randomized KEEPsAKE 1 and 2 trials. Dermatol Ther (Heidelb). 2024;14:1517-1530 (May 13). doi: 10.1007/s13555-024-01174-4 Source

Key clinical point: This real-world study showed that almost 1 in 6 patients with psoriatic arthritis (PsA) had potentially difficult-to-treat (D2T) disease, which was associated with extensive psoriasis, higher body mass index (BMI), and a history of inflammatory bowel disease (IBD).

Major finding: Of 467 patients, 16.5% had D2T PsA. Compared to non-D2T patients, those with D2T disease were more likely to have extensive psoriasis at diagnosis (odds ratio [OR] 5.05; P < .0001), higher BMI (OR 1.07; P = .023), and a history of IBD (OR 1.22; P = .026).

Study details: This study analyzed 467 patients with PsA from a Greek registry who had ≥6-months of disease duration, progressed on disease modifying anti-rheumatic drugs with different mechanisms of actions, and had disease activity index for PsA > 14 or were not at minimal disease activity.

Disclosures: The registry was funded by the Greek (Hellenic) Rheumatology Society. The authors declared no conflicts of interest.

Source: Vassilakis KD, Papagoras C, Fytanidis N, et al. Identification and characteristics of patients with potential difficult-to-treat Psoriatic Arthritis: Exploratory analyses of the Greek PsA registry. Rheumatology (Oxford). 2024 (May 17). doi: 10.1093/rheumatology/keae263 Source

Key clinical point: This real-world study showed that almost 1 in 6 patients with psoriatic arthritis (PsA) had potentially difficult-to-treat (D2T) disease, which was associated with extensive psoriasis, higher body mass index (BMI), and a history of inflammatory bowel disease (IBD).

Major finding: Of 467 patients, 16.5% had D2T PsA. Compared to non-D2T patients, those with D2T disease were more likely to have extensive psoriasis at diagnosis (odds ratio [OR] 5.05; P < .0001), higher BMI (OR 1.07; P = .023), and a history of IBD (OR 1.22; P = .026).

Study details: This study analyzed 467 patients with PsA from a Greek registry who had ≥6-months of disease duration, progressed on disease modifying anti-rheumatic drugs with different mechanisms of actions, and had disease activity index for PsA > 14 or were not at minimal disease activity.

Disclosures: The registry was funded by the Greek (Hellenic) Rheumatology Society. The authors declared no conflicts of interest.

Source: Vassilakis KD, Papagoras C, Fytanidis N, et al. Identification and characteristics of patients with potential difficult-to-treat Psoriatic Arthritis: Exploratory analyses of the Greek PsA registry. Rheumatology (Oxford). 2024 (May 17). doi: 10.1093/rheumatology/keae263 Source

Key clinical point: This real-world study showed that almost 1 in 6 patients with psoriatic arthritis (PsA) had potentially difficult-to-treat (D2T) disease, which was associated with extensive psoriasis, higher body mass index (BMI), and a history of inflammatory bowel disease (IBD).

Major finding: Of 467 patients, 16.5% had D2T PsA. Compared to non-D2T patients, those with D2T disease were more likely to have extensive psoriasis at diagnosis (odds ratio [OR] 5.05; P < .0001), higher BMI (OR 1.07; P = .023), and a history of IBD (OR 1.22; P = .026).

Study details: This study analyzed 467 patients with PsA from a Greek registry who had ≥6-months of disease duration, progressed on disease modifying anti-rheumatic drugs with different mechanisms of actions, and had disease activity index for PsA > 14 or were not at minimal disease activity.

Disclosures: The registry was funded by the Greek (Hellenic) Rheumatology Society. The authors declared no conflicts of interest.

Source: Vassilakis KD, Papagoras C, Fytanidis N, et al. Identification and characteristics of patients with potential difficult-to-treat Psoriatic Arthritis: Exploratory analyses of the Greek PsA registry. Rheumatology (Oxford). 2024 (May 17). doi: 10.1093/rheumatology/keae263 Source

Key clinical point: Low stress resilience during adolescence increased the risk of developing psoriatic arthritis (PsA) later in life in a cohort of >1.6 million men who were followed up for up to 51 years.

Major finding: Over nearly 51 years of follow-up, 9433 (0.6%) men developed first onset PsA. Low vs high stress resilience increased the risk for new-onset PsA by 23% in the overall cohort (adjusted hazard ratio [aHR] 1.23; 95% CI 1.15-1.32) and 53% in the subgroup of patients who were hospitalized due to severe PsA (aHR 1.53; 95% CI 1.32-1.77).

Study details: This prospective cohort study included 1,669,422 men from the Swedish Military Service Conscription Register, of whom 20.4%, 58.0%, and 21.5% had low, medium, and high stress resilience levels, respectively.

Disclosures: This study was supported by the Swedish Research Council for Health and other sources. One author declared receiving honoraria as consultant or speaker from various sources. Other authors declared no conflicts of interest.

Source: Laskowski M, Schiöler L, Åberg M, et al. Influence of stress resilience in adolescence on long-term risk of psoriasis and psoriatic arthritis among men: A prospective register-based cohort study in Sweden. J Eur Acad Dermatol Venereol. 2024 (May 20). doi: 10.1111/jdv.20069 Source

Key clinical point: Low stress resilience during adolescence increased the risk of developing psoriatic arthritis (PsA) later in life in a cohort of >1.6 million men who were followed up for up to 51 years.

Major finding: Over nearly 51 years of follow-up, 9433 (0.6%) men developed first onset PsA. Low vs high stress resilience increased the risk for new-onset PsA by 23% in the overall cohort (adjusted hazard ratio [aHR] 1.23; 95% CI 1.15-1.32) and 53% in the subgroup of patients who were hospitalized due to severe PsA (aHR 1.53; 95% CI 1.32-1.77).

Study details: This prospective cohort study included 1,669,422 men from the Swedish Military Service Conscription Register, of whom 20.4%, 58.0%, and 21.5% had low, medium, and high stress resilience levels, respectively.

Disclosures: This study was supported by the Swedish Research Council for Health and other sources. One author declared receiving honoraria as consultant or speaker from various sources. Other authors declared no conflicts of interest.

Source: Laskowski M, Schiöler L, Åberg M, et al. Influence of stress resilience in adolescence on long-term risk of psoriasis and psoriatic arthritis among men: A prospective register-based cohort study in Sweden. J Eur Acad Dermatol Venereol. 2024 (May 20). doi: 10.1111/jdv.20069 Source

Key clinical point: Low stress resilience during adolescence increased the risk of developing psoriatic arthritis (PsA) later in life in a cohort of >1.6 million men who were followed up for up to 51 years.

Major finding: Over nearly 51 years of follow-up, 9433 (0.6%) men developed first onset PsA. Low vs high stress resilience increased the risk for new-onset PsA by 23% in the overall cohort (adjusted hazard ratio [aHR] 1.23; 95% CI 1.15-1.32) and 53% in the subgroup of patients who were hospitalized due to severe PsA (aHR 1.53; 95% CI 1.32-1.77).

Study details: This prospective cohort study included 1,669,422 men from the Swedish Military Service Conscription Register, of whom 20.4%, 58.0%, and 21.5% had low, medium, and high stress resilience levels, respectively.

Disclosures: This study was supported by the Swedish Research Council for Health and other sources. One author declared receiving honoraria as consultant or speaker from various sources. Other authors declared no conflicts of interest.

Source: Laskowski M, Schiöler L, Åberg M, et al. Influence of stress resilience in adolescence on long-term risk of psoriasis and psoriatic arthritis among men: A prospective register-based cohort study in Sweden. J Eur Acad Dermatol Venereol. 2024 (May 20). doi: 10.1111/jdv.20069 Source

The largest US physician organization wrestled with the professional risks and rewards of artificial intelligence (AI) at its annual meeting, delaying action even as it adopted new policies on prior authorization and other concerns for clinicians and patients.

Physicians and medical students at the annual meeting of the American Medical Association (AMA) House of Delegates in Chicago intensely debated a report and two key resolutions on AI but could not reach consensus, pushing off decision-making until a future meeting in November.

One resolution would establish “augmented intelligence” as the preferred term for AI, reflecting the desired role of these tools in supporting — not making — physicians’ decisions. The other resolution focused on insurers’ use of AI in determining medical necessity.

(See specific policies adopted at the meeting, held June 8-12, below.)

A comprehensive AMA trustees’ report on AI considered additional issues including requirements for disclosing AI use, liability for harms due to flawed application of AI, data privacy, and cybersecurity.

The AMA intends to “continue to methodically assess these issues and make informed recommendations in proposing new policy,” said Bobby Mukkamala, MD, an otolaryngologist from Flint, Michigan, who became the AMA’s new president-elect.

AMA members at the meeting largely applauded the aim of these AI proposals, but some objected to parts of the trustees’ report.

They raised questions about what, exactly, constitutes an AI-powered service and whether all AI tools need the kind of guardrails the AMA may seek. There also were concerns about calls to make AI use more transparent.

While transparency might be an admirable goal, it might prove too hard to achieve given that AI-powered tools and products are already woven into medical practice in ways that physicians may not know or understand, said Christopher Libby, MD, MPH, a clinical informaticist and emergency physician at Cedars Sinai Medical Center in Los Angeles.

“It’s hard for the practicing clinician to know how every piece of technology works in order to describe it to the patient,” Dr. Libby said at the meeting. “How many people here can identify when algorithms are used in their EHR today?”

He suggested asking for more transparency from the companies that make and sell AI-powered software and tools to insurers and healthcare systems.

Steven H. Kroft, MD, the editor of the American Journal of Clinical Pathology, raised concerns about the unintended harm that unchecked use of AI may pose to scientific research.

He asked the AMA to address “a significant omission in an otherwise comprehensive report” — the need to protect the integrity of study results that can direct patient care.

“While sham science is not a new issue, large language models make it far easier for authors to generate fake papers and far harder for editors, reviewers, and publishers to identify them,” Dr. Kroft said. “This is a rapidly growing phenomenon that is threatening the integrity of the literature. These papers become embedded in the evidence bases that drive clinical decision-making.”

AMA has been working with specialty societies and outside AI experts to refine an effective set of recommendations. The new policies, once finalized, are intended to build on steps AMA already has taken, including last year releasing principles for AI development, deployment, and use.
 

Congress Mulling

The AMA delegates are far from alone in facing AI policy challenges.

Leaders in Congress also are examining AI guardrails, with influential panels such as the Senate Finance and House Energy and Commerce committees holding hearings.

A key congressional AI effort to watch is the expected implementation of a bipartisan Senate “road map,” which Senate Majority Leader Chuck Schumer (D-NY) and colleagues released in May, said Miranda A. Franco, a senior policy advisor at the law firm Holland & Knight.

The product of many months of deliberation, this Senate road map identifies priorities for future legislation, including:

• Creating appropriate guardrails and safety measures to protect patients.
• Making healthcare and biomedical data available for machine learning and data science research while carefully addressing privacy issues.
• Providing transparency for clinicians and the public about the use of AI in medical products and clinical support services, including the data used to train models.
• Examining the Centers for Medicare & Medicaid Services’ reimbursement mechanisms as well as guardrails to ensure accountability, appropriate use, and broad application of AI across all populations.

Congress likely will address issues of AI in healthcare in piecemeal fashion, taking on different aspects of these challenges at different times, Ms. Franco said. The Senate road map gives the key committees directions on where to proceed in their efforts to develop new laws.

“I think this is all going to be slow and rolling, not big and sweeping,” Ms. Franco told this news organization. “I don’t think we’re going to see an encompassing AI bill.”
 

AMA Policies Adopted on Other Issues

At the June meeting, AMA delegates adopted the following policies aiming to:

• Increase oversight and accountability of health insurers’ use of prior authorization controls on patient access to care.
• Encourage policy changes allowing physicians to receive loan forgiveness when they practice in an Indian Health Service, Tribal, or Urban Indian Health Program, similar to physicians practicing in a Veterans Administration facility.
• Advocate for federal policy that limits a patient’s out-of-pocket cost to be the same or less than the amount that a patient with traditional Medicare plus a Medigap plan would pay.
• Oppose state or national legislation that could criminalize in vitro fertilization.
• Limit what the AMA calls the “expensive” cost for Medicare Advantage enrollees who need physician-administered drugs or biologics.
• Help physicians address the handling of de-identified patient data in a rapidly changing digital health ecosystem.
• Support efforts to decriminalize the possession of non-prescribed buprenorphine for personal use by individuals who lack access to a physician for the treatment of opioid use disorder.
• Expand access to hearing, vision, and dental care. The new AMA policy advocates working with state medical associations to support coverage of hearing exams, hearing aids, cochlear implants, and vision exams and aids. The revised AMA policy also supports working with the American Dental Association and other national organizations to improve access to dental care for people enrolled in Medicare, Medicaid, and CHIP programs.
• Increase enrollment of more women and sexual and gender minority populations in clinical trials.

A version of this article first appeared on Medscape.com.

The largest US physician organization wrestled with the professional risks and rewards of artificial intelligence (AI) at its annual meeting, delaying action even as it adopted new policies on prior authorization and other concerns for clinicians and patients.

Physicians and medical students at the annual meeting of the American Medical Association (AMA) House of Delegates in Chicago intensely debated a report and two key resolutions on AI but could not reach consensus, pushing off decision-making until a future meeting in November.

One resolution would establish “augmented intelligence” as the preferred term for AI, reflecting the desired role of these tools in supporting — not making — physicians’ decisions. The other resolution focused on insurers’ use of AI in determining medical necessity.

(See specific policies adopted at the meeting, held June 8-12, below.)

A comprehensive AMA trustees’ report on AI considered additional issues including requirements for disclosing AI use, liability for harms due to flawed application of AI, data privacy, and cybersecurity.

The AMA intends to “continue to methodically assess these issues and make informed recommendations in proposing new policy,” said Bobby Mukkamala, MD, an otolaryngologist from Flint, Michigan, who became the AMA’s new president-elect.

AMA members at the meeting largely applauded the aim of these AI proposals, but some objected to parts of the trustees’ report.

They raised questions about what, exactly, constitutes an AI-powered service and whether all AI tools need the kind of guardrails the AMA may seek. There also were concerns about calls to make AI use more transparent.

While transparency might be an admirable goal, it might prove too hard to achieve given that AI-powered tools and products are already woven into medical practice in ways that physicians may not know or understand, said Christopher Libby, MD, MPH, a clinical informaticist and emergency physician at Cedars Sinai Medical Center in Los Angeles.

“It’s hard for the practicing clinician to know how every piece of technology works in order to describe it to the patient,” Dr. Libby said at the meeting. “How many people here can identify when algorithms are used in their EHR today?”

He suggested asking for more transparency from the companies that make and sell AI-powered software and tools to insurers and healthcare systems.

Steven H. Kroft, MD, the editor of the American Journal of Clinical Pathology, raised concerns about the unintended harm that unchecked use of AI may pose to scientific research.

He asked the AMA to address “a significant omission in an otherwise comprehensive report” — the need to protect the integrity of study results that can direct patient care.

“While sham science is not a new issue, large language models make it far easier for authors to generate fake papers and far harder for editors, reviewers, and publishers to identify them,” Dr. Kroft said. “This is a rapidly growing phenomenon that is threatening the integrity of the literature. These papers become embedded in the evidence bases that drive clinical decision-making.”

AMA has been working with specialty societies and outside AI experts to refine an effective set of recommendations. The new policies, once finalized, are intended to build on steps AMA already has taken, including last year releasing principles for AI development, deployment, and use.
 

Congress Mulling

The AMA delegates are far from alone in facing AI policy challenges.

Leaders in Congress also are examining AI guardrails, with influential panels such as the Senate Finance and House Energy and Commerce committees holding hearings.

A key congressional AI effort to watch is the expected implementation of a bipartisan Senate “road map,” which Senate Majority Leader Chuck Schumer (D-NY) and colleagues released in May, said Miranda A. Franco, a senior policy advisor at the law firm Holland & Knight.

The product of many months of deliberation, this Senate road map identifies priorities for future legislation, including:

• Creating appropriate guardrails and safety measures to protect patients.
• Making healthcare and biomedical data available for machine learning and data science research while carefully addressing privacy issues.
• Providing transparency for clinicians and the public about the use of AI in medical products and clinical support services, including the data used to train models.
• Examining the Centers for Medicare & Medicaid Services’ reimbursement mechanisms as well as guardrails to ensure accountability, appropriate use, and broad application of AI across all populations.

Congress likely will address issues of AI in healthcare in piecemeal fashion, taking on different aspects of these challenges at different times, Ms. Franco said. The Senate road map gives the key committees directions on where to proceed in their efforts to develop new laws.

“I think this is all going to be slow and rolling, not big and sweeping,” Ms. Franco told this news organization. “I don’t think we’re going to see an encompassing AI bill.”
 

AMA Policies Adopted on Other Issues

At the June meeting, AMA delegates adopted the following policies aiming to:

• Increase oversight and accountability of health insurers’ use of prior authorization controls on patient access to care.
• Encourage policy changes allowing physicians to receive loan forgiveness when they practice in an Indian Health Service, Tribal, or Urban Indian Health Program, similar to physicians practicing in a Veterans Administration facility.
• Advocate for federal policy that limits a patient’s out-of-pocket cost to be the same or less than the amount that a patient with traditional Medicare plus a Medigap plan would pay.
• Oppose state or national legislation that could criminalize in vitro fertilization.
• Limit what the AMA calls the “expensive” cost for Medicare Advantage enrollees who need physician-administered drugs or biologics.
• Help physicians address the handling of de-identified patient data in a rapidly changing digital health ecosystem.
• Support efforts to decriminalize the possession of non-prescribed buprenorphine for personal use by individuals who lack access to a physician for the treatment of opioid use disorder.
• Expand access to hearing, vision, and dental care. The new AMA policy advocates working with state medical associations to support coverage of hearing exams, hearing aids, cochlear implants, and vision exams and aids. The revised AMA policy also supports working with the American Dental Association and other national organizations to improve access to dental care for people enrolled in Medicare, Medicaid, and CHIP programs.
• Increase enrollment of more women and sexual and gender minority populations in clinical trials.

A version of this article first appeared on Medscape.com.

The largest US physician organization wrestled with the professional risks and rewards of artificial intelligence (AI) at its annual meeting, delaying action even as it adopted new policies on prior authorization and other concerns for clinicians and patients.

Physicians and medical students at the annual meeting of the American Medical Association (AMA) House of Delegates in Chicago intensely debated a report and two key resolutions on AI but could not reach consensus, pushing off decision-making until a future meeting in November.

One resolution would establish “augmented intelligence” as the preferred term for AI, reflecting the desired role of these tools in supporting — not making — physicians’ decisions. The other resolution focused on insurers’ use of AI in determining medical necessity.

(See specific policies adopted at the meeting, held June 8-12, below.)

A comprehensive AMA trustees’ report on AI considered additional issues including requirements for disclosing AI use, liability for harms due to flawed application of AI, data privacy, and cybersecurity.

The AMA intends to “continue to methodically assess these issues and make informed recommendations in proposing new policy,” said Bobby Mukkamala, MD, an otolaryngologist from Flint, Michigan, who became the AMA’s new president-elect.

AMA members at the meeting largely applauded the aim of these AI proposals, but some objected to parts of the trustees’ report.

They raised questions about what, exactly, constitutes an AI-powered service and whether all AI tools need the kind of guardrails the AMA may seek. There also were concerns about calls to make AI use more transparent.

While transparency might be an admirable goal, it might prove too hard to achieve given that AI-powered tools and products are already woven into medical practice in ways that physicians may not know or understand, said Christopher Libby, MD, MPH, a clinical informaticist and emergency physician at Cedars Sinai Medical Center in Los Angeles.

“It’s hard for the practicing clinician to know how every piece of technology works in order to describe it to the patient,” Dr. Libby said at the meeting. “How many people here can identify when algorithms are used in their EHR today?”

He suggested asking for more transparency from the companies that make and sell AI-powered software and tools to insurers and healthcare systems.

Steven H. Kroft, MD, the editor of the American Journal of Clinical Pathology, raised concerns about the unintended harm that unchecked use of AI may pose to scientific research.

He asked the AMA to address “a significant omission in an otherwise comprehensive report” — the need to protect the integrity of study results that can direct patient care.

“While sham science is not a new issue, large language models make it far easier for authors to generate fake papers and far harder for editors, reviewers, and publishers to identify them,” Dr. Kroft said. “This is a rapidly growing phenomenon that is threatening the integrity of the literature. These papers become embedded in the evidence bases that drive clinical decision-making.”

AMA has been working with specialty societies and outside AI experts to refine an effective set of recommendations. The new policies, once finalized, are intended to build on steps AMA already has taken, including last year releasing principles for AI development, deployment, and use.
 

Congress Mulling

The AMA delegates are far from alone in facing AI policy challenges.

Leaders in Congress also are examining AI guardrails, with influential panels such as the Senate Finance and House Energy and Commerce committees holding hearings.

A key congressional AI effort to watch is the expected implementation of a bipartisan Senate “road map,” which Senate Majority Leader Chuck Schumer (D-NY) and colleagues released in May, said Miranda A. Franco, a senior policy advisor at the law firm Holland & Knight.

The product of many months of deliberation, this Senate road map identifies priorities for future legislation, including:

• Creating appropriate guardrails and safety measures to protect patients.
• Making healthcare and biomedical data available for machine learning and data science research while carefully addressing privacy issues.
• Providing transparency for clinicians and the public about the use of AI in medical products and clinical support services, including the data used to train models.
• Examining the Centers for Medicare & Medicaid Services’ reimbursement mechanisms as well as guardrails to ensure accountability, appropriate use, and broad application of AI across all populations.

Congress likely will address issues of AI in healthcare in piecemeal fashion, taking on different aspects of these challenges at different times, Ms. Franco said. The Senate road map gives the key committees directions on where to proceed in their efforts to develop new laws.

“I think this is all going to be slow and rolling, not big and sweeping,” Ms. Franco told this news organization. “I don’t think we’re going to see an encompassing AI bill.”
 

AMA Policies Adopted on Other Issues

At the June meeting, AMA delegates adopted the following policies aiming to:

• Increase oversight and accountability of health insurers’ use of prior authorization controls on patient access to care.
• Encourage policy changes allowing physicians to receive loan forgiveness when they practice in an Indian Health Service, Tribal, or Urban Indian Health Program, similar to physicians practicing in a Veterans Administration facility.
• Advocate for federal policy that limits a patient’s out-of-pocket cost to be the same or less than the amount that a patient with traditional Medicare plus a Medigap plan would pay.
• Oppose state or national legislation that could criminalize in vitro fertilization.
• Limit what the AMA calls the “expensive” cost for Medicare Advantage enrollees who need physician-administered drugs or biologics.
• Help physicians address the handling of de-identified patient data in a rapidly changing digital health ecosystem.
• Support efforts to decriminalize the possession of non-prescribed buprenorphine for personal use by individuals who lack access to a physician for the treatment of opioid use disorder.
• Expand access to hearing, vision, and dental care. The new AMA policy advocates working with state medical associations to support coverage of hearing exams, hearing aids, cochlear implants, and vision exams and aids. The revised AMA policy also supports working with the American Dental Association and other national organizations to improve access to dental care for people enrolled in Medicare, Medicaid, and CHIP programs.
• Increase enrollment of more women and sexual and gender minority populations in clinical trials.

A version of this article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) for patients weighing ≥ 63 kg (139 lb). 

“Polyarticular juvenile idiopathic arthritis (JIA) can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron in a press release. 

It is estimated that nearly 300,000 children in the United States have JIA, and 1 in 4 of them have pJIA, according to the Arthritis Foundation. 

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment,” Dr. Yancopoulos continued. “The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.” 

Sarilumab, jointly developed by Sanofi and Regeneron, is an interleukin 6 receptor blocker. It was first approved in 2017 for the treatment of moderate to severely active rheumatoid arthritis (RA) in adults who had inadequate response or intolerance to at least one other disease-modifying antirheumatic drug (DMARD). 

In 2023, the FDA approved sarilumab as the first biologic treatment for polymyalgia rheumatica in adults who had inadequate response to corticosteroids and could not tolerate a corticosteroid taper. 

For pJIA, sarilumab is administered subcutaneously using a 200-mg/1.14-mL prefilled syringe once every 2 weeks. The medication can be used alone or in combination with other conventional DMARDs. 

“Use of KEVZARA in pediatric patients with pJIA is supported by evidence from adequate and well-controlled studies of KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA,” and pharmacokinetic comparability in 101 pediatric patients aged 2-17 years treated with sarilumab, according to the prescribing information. Sarilumab is not approved for pediatric patients < 63 kg “because of a lack of an appropriate dosage form.” 

The most common reported adverse reactions for sarilumab in pJIA are nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema. The pJIA trial recorded no new adverse reactions or safety concerns, compared with patients with RA. 
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) for patients weighing ≥ 63 kg (139 lb). 

“Polyarticular juvenile idiopathic arthritis (JIA) can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron in a press release. 

It is estimated that nearly 300,000 children in the United States have JIA, and 1 in 4 of them have pJIA, according to the Arthritis Foundation. 

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment,” Dr. Yancopoulos continued. “The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.” 

Sarilumab, jointly developed by Sanofi and Regeneron, is an interleukin 6 receptor blocker. It was first approved in 2017 for the treatment of moderate to severely active rheumatoid arthritis (RA) in adults who had inadequate response or intolerance to at least one other disease-modifying antirheumatic drug (DMARD). 

In 2023, the FDA approved sarilumab as the first biologic treatment for polymyalgia rheumatica in adults who had inadequate response to corticosteroids and could not tolerate a corticosteroid taper. 

For pJIA, sarilumab is administered subcutaneously using a 200-mg/1.14-mL prefilled syringe once every 2 weeks. The medication can be used alone or in combination with other conventional DMARDs. 

“Use of KEVZARA in pediatric patients with pJIA is supported by evidence from adequate and well-controlled studies of KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA,” and pharmacokinetic comparability in 101 pediatric patients aged 2-17 years treated with sarilumab, according to the prescribing information. Sarilumab is not approved for pediatric patients < 63 kg “because of a lack of an appropriate dosage form.” 

The most common reported adverse reactions for sarilumab in pJIA are nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema. The pJIA trial recorded no new adverse reactions or safety concerns, compared with patients with RA. 
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) for patients weighing ≥ 63 kg (139 lb). 

“Polyarticular juvenile idiopathic arthritis (JIA) can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron in a press release. 

It is estimated that nearly 300,000 children in the United States have JIA, and 1 in 4 of them have pJIA, according to the Arthritis Foundation. 

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment,” Dr. Yancopoulos continued. “The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.” 

Sarilumab, jointly developed by Sanofi and Regeneron, is an interleukin 6 receptor blocker. It was first approved in 2017 for the treatment of moderate to severely active rheumatoid arthritis (RA) in adults who had inadequate response or intolerance to at least one other disease-modifying antirheumatic drug (DMARD). 

In 2023, the FDA approved sarilumab as the first biologic treatment for polymyalgia rheumatica in adults who had inadequate response to corticosteroids and could not tolerate a corticosteroid taper. 

For pJIA, sarilumab is administered subcutaneously using a 200-mg/1.14-mL prefilled syringe once every 2 weeks. The medication can be used alone or in combination with other conventional DMARDs. 

“Use of KEVZARA in pediatric patients with pJIA is supported by evidence from adequate and well-controlled studies of KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA,” and pharmacokinetic comparability in 101 pediatric patients aged 2-17 years treated with sarilumab, according to the prescribing information. Sarilumab is not approved for pediatric patients < 63 kg “because of a lack of an appropriate dosage form.” 

The most common reported adverse reactions for sarilumab in pJIA are nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema. The pJIA trial recorded no new adverse reactions or safety concerns, compared with patients with RA. 
 

A version of this article appeared on Medscape.com.

An influential US panel may largely reaffirm its current recommendation in favor of screening older women to prevent osteoporotic fractures, while also repeating its call for more research to try to determine whether men would benefit from this kind of routine testing.

The US Preventive Services Task Force (USPSTF) on June 11 released a draft update of its recommendations on osteoporosis screening. The task force will accept comments on the draft through July 8. Federal law gives the USPSTF recommendations extra clout, requiring insurers to cover — without co-pay — services that get top marks “A” or “B” from the task force.

The task force intends to maintain a “B” recommendation on screening of older women, indicating that the evidence gathered to date suggests a moderate net benefit. But the draft includes a shift in the approach to this screening.

The USPSTF proposed saying that it recommends screening for osteoporosis in both women aged 65 years and older and postmenopausal women younger than 65 years who are at an increased risk for an osteoporotic fracture. The current recommendation, finalized in 2018, advises “screening for osteoporosis with bone measurement testing [emphasis added]” for these groups.

The proposed change in language — dropping the phrase “with bone measurement testing” — is intended to expand flexibility for clinicians, Esa Davis, MD, MPH, a member of USPSTF and a professor at the University of Maryland School of Medicine, Baltimore, told this news organization.

USPSTF

University of Chicago Medicine

Insufficient Evidence

The USPSTF’s “I” grade is different from a “D” grade, which is what the task force uses to recommend against the use of a service.

A “D” grade means the USPSTF says there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. (The USPSTF makes it easy to search online for grades given to preventive services, including those that got a “D.”)

The USPSTF is calling for more studies on the benefits and harms of screening for osteoporosis to prevent fractures and related morbidity and mortality in men.

“Men do get osteoporosis,” Dr. Davis said. “But unfortunately, the evidence isn’t there” to allow USPSTF to make a recommendation on screening approaches.

“Any man who has concerns about bone health should certainly talk to his clinician and figure out what is the best form of screening” he might want to do, she said.

There’s been a growing interest in the question of whether to screen men for osteoporosis and bone health. For example, Osteoporosis Canada last year updated a guideline to emphasize the need to assess older patients of both sexes for the risk for fractures. But the Canadian Task Force on Preventive Health Care in 2023 came to a conclusion in line with the USPSTF draft.

The Canadian task force recommended against routine screening in men, while adding that clinicians should be alert to changes in health that may indicate the patient has experienced or is at a higher risk for fragility fracture.
 

Risk Factors, Concerns About Tests

The USPSTF said that risk factors associated with fragility fractures are similar in men and women. These include:

• Increasing age
• Low body mass index
• Excessive alcohol intake
• Current smoking
• Chronic corticosteroid use
• History of prior fractures, falls within the past year, cerebrovascular accident, and diabetes
• Hypogonadism

The process of updating the USPSTF recommendations can serve as a chance to expand public awareness about osteoporosis, as many men may not know to raise the question of their fracture risk during medical appointments, Dr. Davis said.

“Clinicians need to be aware of the risk factors and to be able to have conversations with men,” she said.

Dr. Davis also cautioned about the need to be aware of limitations with clinical risk assessment tools. In the draft recommendation statement, the USPSTF noted that some tools and approaches may be less likely to identify Black, Hispanic, and Asian people as high risk, and subsequently, clinicians may be less likely to offer treatment to them compared with White people of the same age, bone mineral density, and clinical risk profile.

Dr. Davis had no relevant financial relationships. Dr. Jain received research funding from the Amgen Foundation.
 

A version of this article appeared on Medscape.com.

An influential US panel may largely reaffirm its current recommendation in favor of screening older women to prevent osteoporotic fractures, while also repeating its call for more research to try to determine whether men would benefit from this kind of routine testing.

The US Preventive Services Task Force (USPSTF) on June 11 released a draft update of its recommendations on osteoporosis screening. The task force will accept comments on the draft through July 8. Federal law gives the USPSTF recommendations extra clout, requiring insurers to cover — without co-pay — services that get top marks “A” or “B” from the task force.

The task force intends to maintain a “B” recommendation on screening of older women, indicating that the evidence gathered to date suggests a moderate net benefit. But the draft includes a shift in the approach to this screening.

The USPSTF proposed saying that it recommends screening for osteoporosis in both women aged 65 years and older and postmenopausal women younger than 65 years who are at an increased risk for an osteoporotic fracture. The current recommendation, finalized in 2018, advises “screening for osteoporosis with bone measurement testing [emphasis added]” for these groups.

The proposed change in language — dropping the phrase “with bone measurement testing” — is intended to expand flexibility for clinicians, Esa Davis, MD, MPH, a member of USPSTF and a professor at the University of Maryland School of Medicine, Baltimore, told this news organization.

USPSTF

University of Chicago Medicine

Insufficient Evidence

The USPSTF’s “I” grade is different from a “D” grade, which is what the task force uses to recommend against the use of a service.

A “D” grade means the USPSTF says there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. (The USPSTF makes it easy to search online for grades given to preventive services, including those that got a “D.”)

The USPSTF is calling for more studies on the benefits and harms of screening for osteoporosis to prevent fractures and related morbidity and mortality in men.

“Men do get osteoporosis,” Dr. Davis said. “But unfortunately, the evidence isn’t there” to allow USPSTF to make a recommendation on screening approaches.

“Any man who has concerns about bone health should certainly talk to his clinician and figure out what is the best form of screening” he might want to do, she said.

There’s been a growing interest in the question of whether to screen men for osteoporosis and bone health. For example, Osteoporosis Canada last year updated a guideline to emphasize the need to assess older patients of both sexes for the risk for fractures. But the Canadian Task Force on Preventive Health Care in 2023 came to a conclusion in line with the USPSTF draft.

The Canadian task force recommended against routine screening in men, while adding that clinicians should be alert to changes in health that may indicate the patient has experienced or is at a higher risk for fragility fracture.
 

Risk Factors, Concerns About Tests

The USPSTF said that risk factors associated with fragility fractures are similar in men and women. These include:

• Increasing age
• Low body mass index
• Excessive alcohol intake
• Current smoking
• Chronic corticosteroid use
• History of prior fractures, falls within the past year, cerebrovascular accident, and diabetes
• Hypogonadism

The process of updating the USPSTF recommendations can serve as a chance to expand public awareness about osteoporosis, as many men may not know to raise the question of their fracture risk during medical appointments, Dr. Davis said.

“Clinicians need to be aware of the risk factors and to be able to have conversations with men,” she said.

Dr. Davis also cautioned about the need to be aware of limitations with clinical risk assessment tools. In the draft recommendation statement, the USPSTF noted that some tools and approaches may be less likely to identify Black, Hispanic, and Asian people as high risk, and subsequently, clinicians may be less likely to offer treatment to them compared with White people of the same age, bone mineral density, and clinical risk profile.

Dr. Davis had no relevant financial relationships. Dr. Jain received research funding from the Amgen Foundation.
 

A version of this article appeared on Medscape.com.

An influential US panel may largely reaffirm its current recommendation in favor of screening older women to prevent osteoporotic fractures, while also repeating its call for more research to try to determine whether men would benefit from this kind of routine testing.

The US Preventive Services Task Force (USPSTF) on June 11 released a draft update of its recommendations on osteoporosis screening. The task force will accept comments on the draft through July 8. Federal law gives the USPSTF recommendations extra clout, requiring insurers to cover — without co-pay — services that get top marks “A” or “B” from the task force.

The task force intends to maintain a “B” recommendation on screening of older women, indicating that the evidence gathered to date suggests a moderate net benefit. But the draft includes a shift in the approach to this screening.

The USPSTF proposed saying that it recommends screening for osteoporosis in both women aged 65 years and older and postmenopausal women younger than 65 years who are at an increased risk for an osteoporotic fracture. The current recommendation, finalized in 2018, advises “screening for osteoporosis with bone measurement testing [emphasis added]” for these groups.

The proposed change in language — dropping the phrase “with bone measurement testing” — is intended to expand flexibility for clinicians, Esa Davis, MD, MPH, a member of USPSTF and a professor at the University of Maryland School of Medicine, Baltimore, told this news organization.

USPSTF

University of Chicago Medicine

Insufficient Evidence

The USPSTF’s “I” grade is different from a “D” grade, which is what the task force uses to recommend against the use of a service.

A “D” grade means the USPSTF says there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. (The USPSTF makes it easy to search online for grades given to preventive services, including those that got a “D.”)

The USPSTF is calling for more studies on the benefits and harms of screening for osteoporosis to prevent fractures and related morbidity and mortality in men.

“Men do get osteoporosis,” Dr. Davis said. “But unfortunately, the evidence isn’t there” to allow USPSTF to make a recommendation on screening approaches.

“Any man who has concerns about bone health should certainly talk to his clinician and figure out what is the best form of screening” he might want to do, she said.

There’s been a growing interest in the question of whether to screen men for osteoporosis and bone health. For example, Osteoporosis Canada last year updated a guideline to emphasize the need to assess older patients of both sexes for the risk for fractures. But the Canadian Task Force on Preventive Health Care in 2023 came to a conclusion in line with the USPSTF draft.

The Canadian task force recommended against routine screening in men, while adding that clinicians should be alert to changes in health that may indicate the patient has experienced or is at a higher risk for fragility fracture.
 

Risk Factors, Concerns About Tests

The USPSTF said that risk factors associated with fragility fractures are similar in men and women. These include:

• Increasing age
• Low body mass index
• Excessive alcohol intake
• Current smoking
• Chronic corticosteroid use
• History of prior fractures, falls within the past year, cerebrovascular accident, and diabetes
• Hypogonadism

The process of updating the USPSTF recommendations can serve as a chance to expand public awareness about osteoporosis, as many men may not know to raise the question of their fracture risk during medical appointments, Dr. Davis said.

“Clinicians need to be aware of the risk factors and to be able to have conversations with men,” she said.

Dr. Davis also cautioned about the need to be aware of limitations with clinical risk assessment tools. In the draft recommendation statement, the USPSTF noted that some tools and approaches may be less likely to identify Black, Hispanic, and Asian people as high risk, and subsequently, clinicians may be less likely to offer treatment to them compared with White people of the same age, bone mineral density, and clinical risk profile.

Dr. Davis had no relevant financial relationships. Dr. Jain received research funding from the Amgen Foundation.
 

A version of this article appeared on Medscape.com.

TOPLINE: 

Having more tender than swollen joints is linked to worse patient-reported outcomes (PROs), particularly in pain interference, social participation, and fatigue, in patients with rheumatoid arthritis (RA).

METHODOLOGY:

• In early RA, understanding the impact of tender-swollen joint differences (TSJDs) on PROs across multiple domains of health-related quality of life is important to customize personalized therapeutic strategies.
• This study evaluated the impact of TSJDs on PROs over 1 year in 547 patients (mean age, 56 years; 70% women; mean symptom duration, 5.3 months) with early RA across 18 centers in Canada between January 2016 and August 2022.
• TSJDs were assessed for 28 joints (six large and 22 small) at baseline and at 3-, 6-, and 12-month visits using the PRO Measurement Information System (PROMIS-29), covering seven domains of health. Higher PROMIS T-scores indicated better health outcomes.

TAKEAWAY: 

• A one-point increase of TSJD was significantly associated with worse PROMIS T-scores in physical function (adjusted regression coefficient [β], −0.27; 95% CI, −0.39 to −0.15) and social participation (β, −0.34; 95% CI, −0.50 to −0.19).
• A one-point increase in TSJD was also linked to worsened PROMIS symptoms in pain interference (β, 0.49), fatigue (β, 0.34), sleep problems (β, 0.29), anxiety (β, 0.23), and depression (β, 0.20).
• Large-joint TSJD was particularly associated with worse PROs than small-joint TSJD.
• The sensitivity analysis validated the reliability of the primary findings regarding the association between joint counts and PROs evaluated by PROMIS-29, even when accounting for C-reactive protein levels in various scenarios or assumptions.

IN PRACTICE:

“Patients with more tender than swollen joints may experience worsening of all seven domains of health, especially pain interference, social participation, and fatigue. Rheumatologists should be alerted to their patients with early RA having more tender than swollen joints, particularly in large joints,” the authors wrote.

SOURCE:

The study was led by Charis F. Meng, MD, Division of Rheumatology, Hospital for Special Surgery, New York. It was published online on May 1, 2024, in Journal of Clinical Rheumatology. 

LIMITATIONS:

The study was observational with missing data, which could have impacted the reliability of the results. Most participants were women and White individuals, which could restrict the generalizability of results. The absence of ultrasound for synovitis limited the clinical assessment of patients with RA for information beyond physical examination alone. 

DISCLOSURES: 

The study was supported and funded by the Inflammatory Arthritis Center and Division of Rheumatology at the Hospital for Special Surgery, New York. One author reported receiving funding from the National Institutes of Health.
 

A version of this article appeared on Medscape.com.

TOPLINE: 

Having more tender than swollen joints is linked to worse patient-reported outcomes (PROs), particularly in pain interference, social participation, and fatigue, in patients with rheumatoid arthritis (RA).

METHODOLOGY:

• In early RA, understanding the impact of tender-swollen joint differences (TSJDs) on PROs across multiple domains of health-related quality of life is important to customize personalized therapeutic strategies.
• This study evaluated the impact of TSJDs on PROs over 1 year in 547 patients (mean age, 56 years; 70% women; mean symptom duration, 5.3 months) with early RA across 18 centers in Canada between January 2016 and August 2022.
• TSJDs were assessed for 28 joints (six large and 22 small) at baseline and at 3-, 6-, and 12-month visits using the PRO Measurement Information System (PROMIS-29), covering seven domains of health. Higher PROMIS T-scores indicated better health outcomes.

TAKEAWAY: 

• A one-point increase of TSJD was significantly associated with worse PROMIS T-scores in physical function (adjusted regression coefficient [β], −0.27; 95% CI, −0.39 to −0.15) and social participation (β, −0.34; 95% CI, −0.50 to −0.19).
• A one-point increase in TSJD was also linked to worsened PROMIS symptoms in pain interference (β, 0.49), fatigue (β, 0.34), sleep problems (β, 0.29), anxiety (β, 0.23), and depression (β, 0.20).
• Large-joint TSJD was particularly associated with worse PROs than small-joint TSJD.
• The sensitivity analysis validated the reliability of the primary findings regarding the association between joint counts and PROs evaluated by PROMIS-29, even when accounting for C-reactive protein levels in various scenarios or assumptions.

IN PRACTICE:

“Patients with more tender than swollen joints may experience worsening of all seven domains of health, especially pain interference, social participation, and fatigue. Rheumatologists should be alerted to their patients with early RA having more tender than swollen joints, particularly in large joints,” the authors wrote.

SOURCE:

The study was led by Charis F. Meng, MD, Division of Rheumatology, Hospital for Special Surgery, New York. It was published online on May 1, 2024, in Journal of Clinical Rheumatology. 

LIMITATIONS:

The study was observational with missing data, which could have impacted the reliability of the results. Most participants were women and White individuals, which could restrict the generalizability of results. The absence of ultrasound for synovitis limited the clinical assessment of patients with RA for information beyond physical examination alone. 

DISCLOSURES: 

The study was supported and funded by the Inflammatory Arthritis Center and Division of Rheumatology at the Hospital for Special Surgery, New York. One author reported receiving funding from the National Institutes of Health.
 

A version of this article appeared on Medscape.com.

TOPLINE: 

Having more tender than swollen joints is linked to worse patient-reported outcomes (PROs), particularly in pain interference, social participation, and fatigue, in patients with rheumatoid arthritis (RA).

METHODOLOGY:

• In early RA, understanding the impact of tender-swollen joint differences (TSJDs) on PROs across multiple domains of health-related quality of life is important to customize personalized therapeutic strategies.
• This study evaluated the impact of TSJDs on PROs over 1 year in 547 patients (mean age, 56 years; 70% women; mean symptom duration, 5.3 months) with early RA across 18 centers in Canada between January 2016 and August 2022.
• TSJDs were assessed for 28 joints (six large and 22 small) at baseline and at 3-, 6-, and 12-month visits using the PRO Measurement Information System (PROMIS-29), covering seven domains of health. Higher PROMIS T-scores indicated better health outcomes.

TAKEAWAY: 

• A one-point increase of TSJD was significantly associated with worse PROMIS T-scores in physical function (adjusted regression coefficient [β], −0.27; 95% CI, −0.39 to −0.15) and social participation (β, −0.34; 95% CI, −0.50 to −0.19).
• A one-point increase in TSJD was also linked to worsened PROMIS symptoms in pain interference (β, 0.49), fatigue (β, 0.34), sleep problems (β, 0.29), anxiety (β, 0.23), and depression (β, 0.20).
• Large-joint TSJD was particularly associated with worse PROs than small-joint TSJD.
• The sensitivity analysis validated the reliability of the primary findings regarding the association between joint counts and PROs evaluated by PROMIS-29, even when accounting for C-reactive protein levels in various scenarios or assumptions.

IN PRACTICE:

“Patients with more tender than swollen joints may experience worsening of all seven domains of health, especially pain interference, social participation, and fatigue. Rheumatologists should be alerted to their patients with early RA having more tender than swollen joints, particularly in large joints,” the authors wrote.

SOURCE:

The study was led by Charis F. Meng, MD, Division of Rheumatology, Hospital for Special Surgery, New York. It was published online on May 1, 2024, in Journal of Clinical Rheumatology. 

LIMITATIONS:

The study was observational with missing data, which could have impacted the reliability of the results. Most participants were women and White individuals, which could restrict the generalizability of results. The absence of ultrasound for synovitis limited the clinical assessment of patients with RA for information beyond physical examination alone. 

DISCLOSURES: 

The study was supported and funded by the Inflammatory Arthritis Center and Division of Rheumatology at the Hospital for Special Surgery, New York. One author reported receiving funding from the National Institutes of Health.
 

A version of this article appeared on Medscape.com.

The European Alliance of Associations for Rheumatology (EULAR) 2024 European Congress of Rheumatology annual meeting is about to take place in Vienna, Austria. From June 12 to 15, some of the world’s leading researchers and clinicians will convene to present and learn about data on some of the new and innovative treatments for people with rheumatic and musculoskeletal diseases (RMDs) as well as to discuss how to use and optimize existing approaches. 

Ahead of the Congress, this news organization asked the Congress Committee’s Scientific Programme Chair Caroline Ospelt, MD, PhD, and Abstract Chair Christian Dejaco, MD, PhD, MBA, to discuss some of their highlights of this year’s meeting.
 

From Bench to Bedside

“For me, the beauty at EULAR is really that you have the latest on basic research, how this can be translated in clinical trials, and then the last step would be how EULAR recommends it to be used in clinical practice,” Dr. Ospelt, professor of experimental rheumatology at University Hospital Zurich, said in an interview.  

University Hospital Zurich

“So, if you go to EULAR continuously, you can actually follow the whole story of how novelty comes into clinical practice,” she added. 

In a separate interview, Dr. Dejaco, a consultant rheumatologist and associate professor at the Medical University of Graz in Austria, said: “There are several new drug trials that are going to be presented.” 

One of his highlights on the use of new drugs for the treatment of giant cell arteritis will be the phase 3 SELECT-GCA trial of the Janus kinase (JAK) inhibitor upadacitinib (LBA0001).

“It’s a trial that hopefully will lead to the approval of this drug in this indication,” Dr. Dejaco said.

EULAR

Late-Breaking Abstracts

Dr. Ospelt noted: “We had a lot of good late-breaking abstracts this year.” 

Some of these include: 

• Real-world data on the comparative effectiveness of five different classes of drugs used to treat psoriatic arthritis (PsA; LBA0002) 
• The 16-week results of a phase 2b/3 study with the novel interleukin (IL)–17A inhibitor izokibep in people with PsA (LBA0005)
• Data from the COSPIRIT-JIA trial on the efficacy and safety of ixekizumab (Taltz) in juvenile idiopathic arthritis (LBA0009)
• Phase 2 data on the safety and efficacy of the CD38-targeting monoclonal antibody daratumumab in systemic lupus erythematosus (LBA0007)
• Results of the phase 2 DAHLIAS study of the anti–neonatal Fc receptor monoclonal antibody nipocalimab in people with primary Sjögren disease (LBA0010) 
• Safety and immunogenicity data from a phase 1 study of an active anti–IL-6 immunotherapy in people with knee osteoarthritis (LBA0011)

The latter is “really interesting,” Dr. Ospelt said. As of now, there is no approved treatment for osteoarthritis, and there is no immunotherapy, “so this would be the first.” 

But it’s not just the late-breaker abstracts to look out for. Dr. Dejaco highlighted two abstracts that will be presented during the Abstract Plenary: 

• A phase 3 study of a new selective JAK1 inhibitor, SHR0302, in rheumatoid arthritis (OP0037)
• A multi-omics analysis and targeted gene-editing study in people with , which causes inflammatory and hematologic changes (OP0073)

Of the latter, he said, “this disease is still incompletely understood, and this abstract really helps to better understand the mechanisms underlying this disease.”
 

One to Watch: CAR T-Cell Therapy 

Dr. Ospelt said that the scientific program is about 80% clinical and 20% basic science overall. However, more sessions are being held jointly because data are starting to move from the bench to bedside. 

One of the basic science areas that has had “a real buzz” around it and is now producing results in the clinic is the use of chimeric antigen receptor (CAR) T cells. In one of the first, and perhaps aptly titled What Is New, or WIN, sessions of the congress, Georg Schett, MD, vice president of research at Friedrich-Alexander-Universität Erlangen-Nüremberg in Germany, will discuss the use of CAR T-cell therapy for inflammatory RMDs. There are also multiple abstract presentations on this topic. 

In-depth tissue analysis and prediction of treatment response is another interesting approach, Dr. Ospelt said. “I think that’s the way to go, that we come from the blood, we go into the tissue.” A “very nice” example of this approach will be presented during the Abstract Plenary session on Wednesday, June 12, looking at how synovial tissue macrophages may be able to give information on likely treatment response in treatment-naive rheumatoid arthritis (OP0062). There are also some further findings related to the tissue biopsy–driven treatment trial R4RA that are being presented at the meeting (OP0218, OP0242, and POS0351).
 

EULAR Highlighted Sessions

Among the highlighted sessions on the EULAR 2024 website is one on axial involvement in PsA and spondyloarthritis (SpA). 

“Axial involvement in psoriatic arthritis and peripheral involvement in axial spondyloarthritis is quite a hot topic at the moment,” Dr. Ospelt said. There are lots of questions: “How connected are they? How different are they? Do we need different treatment for axial involvement compared to peripheral involvement?” 

Another EULAR highlighted session is the 75th anniversary of glucocorticoid treatment, during which Past President of EULAR and Emeritus Professor of Rheumatology Josef S. Smolen, MD, will overview the “past, present, and future” of glucocorticoids in RMDs. Consultant rheumatologist Frank Buttgereit, MD, from the German Rheumatism Research Center in Berlin, will discuss the practicalities of using these drugs in clinical practice.

Dr. Dejaco noted: “Glucocorticoids have been one of the most important treatments for a very long time, and they’re still the most important treatment for the acute treatment of systemic inflammatory diseases.”

For a long time, there was no alternative to using steroids, he added, but steroid-sparing options now exist, and there will be data presented on a new type of drug that could potentially be used to control cortisol levels in the body (OP0335).
 

Recommendations and More

Dr. Ospelt and Dr. Dejaco both pointed out other sessions that are likely to be very popular, such as the first and second EULAR Recommendations sessions, a session on rheumatoid arthritis prevention, as well as the many presentations and sessions on digital health and nonpharmacologic interventions such as exercise. 

With over 5242 submitted abstracts, there is going to be no shortage of data being presented at EULAR 2024. Alongside the traditional abstract submission categories, this year there is a new clinical case reports category. 

“We had about 578 submissions for that category,” Dr. Dejaco said. There were 3315 abstracts submitted for the clinical research category, 812 for the basic and translational research category, 283 from health professionals in rheumatology, 152 from patient groups, and 102 in the field of pediatric rheumatology.
 

Join in On-Site, Watch on Demand 

EULAR 2024 reverts to an on-site–only meeting this year. Some of the more lighthearted yet educational elements of the program for those attending include the second edition of the EMEUNET Rheumatology Quiz and, new for this year, two escape rooms. These rooms will provide an interactive experience where small teams will have to solve rheumatologic conundrums in order to escape the room within the hour, Dr. Dejaco explained. There will also be a morning run on Friday, June 14. “It’s not a race, it’s simply to meet and run together,” Dr. Dejaco said. 

But if you cannot make the congress in person, the EULAR 2024 Livestream will be broadcasting throughout the congress. Anyone registered by June 30 will have on-demand access to the recorded content from June 17 until December 31, 2024. 

Abstracts for the meeting will be published as a supplement to Annals of the Rheumatic Diseases, the official journal of EULAR. 

Dr. Ospelt reported no relevant financial relationships. Dr. Dejaco has received consulting/speaker fees from AbbVie, Eli Lilly, Janssen, Sparrow, Novartis, Pfizer, Roche, Galapagos, and Sanofi.

A version of this article appeared on Medscape.com.

The European Alliance of Associations for Rheumatology (EULAR) 2024 European Congress of Rheumatology annual meeting is about to take place in Vienna, Austria. From June 12 to 15, some of the world’s leading researchers and clinicians will convene to present and learn about data on some of the new and innovative treatments for people with rheumatic and musculoskeletal diseases (RMDs) as well as to discuss how to use and optimize existing approaches. 

Ahead of the Congress, this news organization asked the Congress Committee’s Scientific Programme Chair Caroline Ospelt, MD, PhD, and Abstract Chair Christian Dejaco, MD, PhD, MBA, to discuss some of their highlights of this year’s meeting.
 

From Bench to Bedside

“For me, the beauty at EULAR is really that you have the latest on basic research, how this can be translated in clinical trials, and then the last step would be how EULAR recommends it to be used in clinical practice,” Dr. Ospelt, professor of experimental rheumatology at University Hospital Zurich, said in an interview.  

University Hospital Zurich

“So, if you go to EULAR continuously, you can actually follow the whole story of how novelty comes into clinical practice,” she added. 

In a separate interview, Dr. Dejaco, a consultant rheumatologist and associate professor at the Medical University of Graz in Austria, said: “There are several new drug trials that are going to be presented.” 

One of his highlights on the use of new drugs for the treatment of giant cell arteritis will be the phase 3 SELECT-GCA trial of the Janus kinase (JAK) inhibitor upadacitinib (LBA0001).

“It’s a trial that hopefully will lead to the approval of this drug in this indication,” Dr. Dejaco said.

EULAR

Late-Breaking Abstracts

Dr. Ospelt noted: “We had a lot of good late-breaking abstracts this year.” 

Some of these include: 

• Real-world data on the comparative effectiveness of five different classes of drugs used to treat psoriatic arthritis (PsA; LBA0002) 
• The 16-week results of a phase 2b/3 study with the novel interleukin (IL)–17A inhibitor izokibep in people with PsA (LBA0005)
• Data from the COSPIRIT-JIA trial on the efficacy and safety of ixekizumab (Taltz) in juvenile idiopathic arthritis (LBA0009)
• Phase 2 data on the safety and efficacy of the CD38-targeting monoclonal antibody daratumumab in systemic lupus erythematosus (LBA0007)
• Results of the phase 2 DAHLIAS study of the anti–neonatal Fc receptor monoclonal antibody nipocalimab in people with primary Sjögren disease (LBA0010) 
• Safety and immunogenicity data from a phase 1 study of an active anti–IL-6 immunotherapy in people with knee osteoarthritis (LBA0011)

The latter is “really interesting,” Dr. Ospelt said. As of now, there is no approved treatment for osteoarthritis, and there is no immunotherapy, “so this would be the first.” 

But it’s not just the late-breaker abstracts to look out for. Dr. Dejaco highlighted two abstracts that will be presented during the Abstract Plenary: 

• A phase 3 study of a new selective JAK1 inhibitor, SHR0302, in rheumatoid arthritis (OP0037)
• A multi-omics analysis and targeted gene-editing study in people with , which causes inflammatory and hematologic changes (OP0073)

Of the latter, he said, “this disease is still incompletely understood, and this abstract really helps to better understand the mechanisms underlying this disease.”
 

One to Watch: CAR T-Cell Therapy 

Dr. Ospelt said that the scientific program is about 80% clinical and 20% basic science overall. However, more sessions are being held jointly because data are starting to move from the bench to bedside. 

One of the basic science areas that has had “a real buzz” around it and is now producing results in the clinic is the use of chimeric antigen receptor (CAR) T cells. In one of the first, and perhaps aptly titled What Is New, or WIN, sessions of the congress, Georg Schett, MD, vice president of research at Friedrich-Alexander-Universität Erlangen-Nüremberg in Germany, will discuss the use of CAR T-cell therapy for inflammatory RMDs. There are also multiple abstract presentations on this topic. 

In-depth tissue analysis and prediction of treatment response is another interesting approach, Dr. Ospelt said. “I think that’s the way to go, that we come from the blood, we go into the tissue.” A “very nice” example of this approach will be presented during the Abstract Plenary session on Wednesday, June 12, looking at how synovial tissue macrophages may be able to give information on likely treatment response in treatment-naive rheumatoid arthritis (OP0062). There are also some further findings related to the tissue biopsy–driven treatment trial R4RA that are being presented at the meeting (OP0218, OP0242, and POS0351).
 

EULAR Highlighted Sessions

Among the highlighted sessions on the EULAR 2024 website is one on axial involvement in PsA and spondyloarthritis (SpA). 

“Axial involvement in psoriatic arthritis and peripheral involvement in axial spondyloarthritis is quite a hot topic at the moment,” Dr. Ospelt said. There are lots of questions: “How connected are they? How different are they? Do we need different treatment for axial involvement compared to peripheral involvement?” 

Another EULAR highlighted session is the 75th anniversary of glucocorticoid treatment, during which Past President of EULAR and Emeritus Professor of Rheumatology Josef S. Smolen, MD, will overview the “past, present, and future” of glucocorticoids in RMDs. Consultant rheumatologist Frank Buttgereit, MD, from the German Rheumatism Research Center in Berlin, will discuss the practicalities of using these drugs in clinical practice.

Dr. Dejaco noted: “Glucocorticoids have been one of the most important treatments for a very long time, and they’re still the most important treatment for the acute treatment of systemic inflammatory diseases.”

For a long time, there was no alternative to using steroids, he added, but steroid-sparing options now exist, and there will be data presented on a new type of drug that could potentially be used to control cortisol levels in the body (OP0335).
 

Recommendations and More

Dr. Ospelt and Dr. Dejaco both pointed out other sessions that are likely to be very popular, such as the first and second EULAR Recommendations sessions, a session on rheumatoid arthritis prevention, as well as the many presentations and sessions on digital health and nonpharmacologic interventions such as exercise. 

With over 5242 submitted abstracts, there is going to be no shortage of data being presented at EULAR 2024. Alongside the traditional abstract submission categories, this year there is a new clinical case reports category. 

“We had about 578 submissions for that category,” Dr. Dejaco said. There were 3315 abstracts submitted for the clinical research category, 812 for the basic and translational research category, 283 from health professionals in rheumatology, 152 from patient groups, and 102 in the field of pediatric rheumatology.
 

Join in On-Site, Watch on Demand 

EULAR 2024 reverts to an on-site–only meeting this year. Some of the more lighthearted yet educational elements of the program for those attending include the second edition of the EMEUNET Rheumatology Quiz and, new for this year, two escape rooms. These rooms will provide an interactive experience where small teams will have to solve rheumatologic conundrums in order to escape the room within the hour, Dr. Dejaco explained. There will also be a morning run on Friday, June 14. “It’s not a race, it’s simply to meet and run together,” Dr. Dejaco said. 

But if you cannot make the congress in person, the EULAR 2024 Livestream will be broadcasting throughout the congress. Anyone registered by June 30 will have on-demand access to the recorded content from June 17 until December 31, 2024. 

Abstracts for the meeting will be published as a supplement to Annals of the Rheumatic Diseases, the official journal of EULAR. 

Dr. Ospelt reported no relevant financial relationships. Dr. Dejaco has received consulting/speaker fees from AbbVie, Eli Lilly, Janssen, Sparrow, Novartis, Pfizer, Roche, Galapagos, and Sanofi.

A version of this article appeared on Medscape.com.

The European Alliance of Associations for Rheumatology (EULAR) 2024 European Congress of Rheumatology annual meeting is about to take place in Vienna, Austria. From June 12 to 15, some of the world’s leading researchers and clinicians will convene to present and learn about data on some of the new and innovative treatments for people with rheumatic and musculoskeletal diseases (RMDs) as well as to discuss how to use and optimize existing approaches. 

Ahead of the Congress, this news organization asked the Congress Committee’s Scientific Programme Chair Caroline Ospelt, MD, PhD, and Abstract Chair Christian Dejaco, MD, PhD, MBA, to discuss some of their highlights of this year’s meeting.
 

From Bench to Bedside

“For me, the beauty at EULAR is really that you have the latest on basic research, how this can be translated in clinical trials, and then the last step would be how EULAR recommends it to be used in clinical practice,” Dr. Ospelt, professor of experimental rheumatology at University Hospital Zurich, said in an interview.  

University Hospital Zurich

“So, if you go to EULAR continuously, you can actually follow the whole story of how novelty comes into clinical practice,” she added. 

In a separate interview, Dr. Dejaco, a consultant rheumatologist and associate professor at the Medical University of Graz in Austria, said: “There are several new drug trials that are going to be presented.” 

One of his highlights on the use of new drugs for the treatment of giant cell arteritis will be the phase 3 SELECT-GCA trial of the Janus kinase (JAK) inhibitor upadacitinib (LBA0001).

“It’s a trial that hopefully will lead to the approval of this drug in this indication,” Dr. Dejaco said.

EULAR

Late-Breaking Abstracts

Dr. Ospelt noted: “We had a lot of good late-breaking abstracts this year.” 

Some of these include: 

• Real-world data on the comparative effectiveness of five different classes of drugs used to treat psoriatic arthritis (PsA; LBA0002) 
• The 16-week results of a phase 2b/3 study with the novel interleukin (IL)–17A inhibitor izokibep in people with PsA (LBA0005)
• Data from the COSPIRIT-JIA trial on the efficacy and safety of ixekizumab (Taltz) in juvenile idiopathic arthritis (LBA0009)
• Phase 2 data on the safety and efficacy of the CD38-targeting monoclonal antibody daratumumab in systemic lupus erythematosus (LBA0007)
• Results of the phase 2 DAHLIAS study of the anti–neonatal Fc receptor monoclonal antibody nipocalimab in people with primary Sjögren disease (LBA0010) 
• Safety and immunogenicity data from a phase 1 study of an active anti–IL-6 immunotherapy in people with knee osteoarthritis (LBA0011)

The latter is “really interesting,” Dr. Ospelt said. As of now, there is no approved treatment for osteoarthritis, and there is no immunotherapy, “so this would be the first.” 

But it’s not just the late-breaker abstracts to look out for. Dr. Dejaco highlighted two abstracts that will be presented during the Abstract Plenary: 

• A phase 3 study of a new selective JAK1 inhibitor, SHR0302, in rheumatoid arthritis (OP0037)
• A multi-omics analysis and targeted gene-editing study in people with , which causes inflammatory and hematologic changes (OP0073)

Of the latter, he said, “this disease is still incompletely understood, and this abstract really helps to better understand the mechanisms underlying this disease.”
 

One to Watch: CAR T-Cell Therapy 

Dr. Ospelt said that the scientific program is about 80% clinical and 20% basic science overall. However, more sessions are being held jointly because data are starting to move from the bench to bedside. 

One of the basic science areas that has had “a real buzz” around it and is now producing results in the clinic is the use of chimeric antigen receptor (CAR) T cells. In one of the first, and perhaps aptly titled What Is New, or WIN, sessions of the congress, Georg Schett, MD, vice president of research at Friedrich-Alexander-Universität Erlangen-Nüremberg in Germany, will discuss the use of CAR T-cell therapy for inflammatory RMDs. There are also multiple abstract presentations on this topic. 

In-depth tissue analysis and prediction of treatment response is another interesting approach, Dr. Ospelt said. “I think that’s the way to go, that we come from the blood, we go into the tissue.” A “very nice” example of this approach will be presented during the Abstract Plenary session on Wednesday, June 12, looking at how synovial tissue macrophages may be able to give information on likely treatment response in treatment-naive rheumatoid arthritis (OP0062). There are also some further findings related to the tissue biopsy–driven treatment trial R4RA that are being presented at the meeting (OP0218, OP0242, and POS0351).
 

EULAR Highlighted Sessions

Among the highlighted sessions on the EULAR 2024 website is one on axial involvement in PsA and spondyloarthritis (SpA). 

“Axial involvement in psoriatic arthritis and peripheral involvement in axial spondyloarthritis is quite a hot topic at the moment,” Dr. Ospelt said. There are lots of questions: “How connected are they? How different are they? Do we need different treatment for axial involvement compared to peripheral involvement?” 

Another EULAR highlighted session is the 75th anniversary of glucocorticoid treatment, during which Past President of EULAR and Emeritus Professor of Rheumatology Josef S. Smolen, MD, will overview the “past, present, and future” of glucocorticoids in RMDs. Consultant rheumatologist Frank Buttgereit, MD, from the German Rheumatism Research Center in Berlin, will discuss the practicalities of using these drugs in clinical practice.

Dr. Dejaco noted: “Glucocorticoids have been one of the most important treatments for a very long time, and they’re still the most important treatment for the acute treatment of systemic inflammatory diseases.”

For a long time, there was no alternative to using steroids, he added, but steroid-sparing options now exist, and there will be data presented on a new type of drug that could potentially be used to control cortisol levels in the body (OP0335).
 

Recommendations and More

Dr. Ospelt and Dr. Dejaco both pointed out other sessions that are likely to be very popular, such as the first and second EULAR Recommendations sessions, a session on rheumatoid arthritis prevention, as well as the many presentations and sessions on digital health and nonpharmacologic interventions such as exercise. 

With over 5242 submitted abstracts, there is going to be no shortage of data being presented at EULAR 2024. Alongside the traditional abstract submission categories, this year there is a new clinical case reports category. 

“We had about 578 submissions for that category,” Dr. Dejaco said. There were 3315 abstracts submitted for the clinical research category, 812 for the basic and translational research category, 283 from health professionals in rheumatology, 152 from patient groups, and 102 in the field of pediatric rheumatology.
 

Join in On-Site, Watch on Demand 

EULAR 2024 reverts to an on-site–only meeting this year. Some of the more lighthearted yet educational elements of the program for those attending include the second edition of the EMEUNET Rheumatology Quiz and, new for this year, two escape rooms. These rooms will provide an interactive experience where small teams will have to solve rheumatologic conundrums in order to escape the room within the hour, Dr. Dejaco explained. There will also be a morning run on Friday, June 14. “It’s not a race, it’s simply to meet and run together,” Dr. Dejaco said. 

But if you cannot make the congress in person, the EULAR 2024 Livestream will be broadcasting throughout the congress. Anyone registered by June 30 will have on-demand access to the recorded content from June 17 until December 31, 2024. 

Abstracts for the meeting will be published as a supplement to Annals of the Rheumatic Diseases, the official journal of EULAR. 

Dr. Ospelt reported no relevant financial relationships. Dr. Dejaco has received consulting/speaker fees from AbbVie, Eli Lilly, Janssen, Sparrow, Novartis, Pfizer, Roche, Galapagos, and Sanofi.

A version of this article appeared on Medscape.com.