MDedge Rheumatology

Key clinical point: The incidence rates of major adverse cardiovascular events (MACE) were similar in patients with psoriatic arthritis (PsA) and rheumatoid arthritis (RA), suggesting that both inflammatory disorders share a common atherogenic mechanism.

Major finding: After a total of 119,571 patient-years of follow-up, 6.7% of patients with RA or PsA developed MACE for the first time. The rates of MACE incidence (adjusted incidence rate ratio 0.96; P  =  .767) and MACE-free survival (P  =  .987) were comparable between patients with PsA and RA. Higher time-varying erythrocyte sedimentation rate, C-reactive protein levels, and exposure to glucocorticoids increased the risk for MACE in both patients with PsA and RA (all P < .05).

Study details: This population based retrospective cohort study included 13,905 patients with PsA (n  =  1672) or RA (n  =  12,233) who did not have any previous history of MACE.

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

Source: Meng H, Lam SH, So H, Tam LS. Incidence and risk factors of major cardiovascular events in rheumatoid arthritis and psoriatic arthritis: A population-based cohort study. Semin Arthritis Rheum. 2024;65:152416 (Feb 17). Source

Key clinical point: The incidence rates of major adverse cardiovascular events (MACE) were similar in patients with psoriatic arthritis (PsA) and rheumatoid arthritis (RA), suggesting that both inflammatory disorders share a common atherogenic mechanism.

Major finding: After a total of 119,571 patient-years of follow-up, 6.7% of patients with RA or PsA developed MACE for the first time. The rates of MACE incidence (adjusted incidence rate ratio 0.96; P  =  .767) and MACE-free survival (P  =  .987) were comparable between patients with PsA and RA. Higher time-varying erythrocyte sedimentation rate, C-reactive protein levels, and exposure to glucocorticoids increased the risk for MACE in both patients with PsA and RA (all P < .05).

Study details: This population based retrospective cohort study included 13,905 patients with PsA (n  =  1672) or RA (n  =  12,233) who did not have any previous history of MACE.

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

Source: Meng H, Lam SH, So H, Tam LS. Incidence and risk factors of major cardiovascular events in rheumatoid arthritis and psoriatic arthritis: A population-based cohort study. Semin Arthritis Rheum. 2024;65:152416 (Feb 17). Source

Key clinical point: The incidence rates of major adverse cardiovascular events (MACE) were similar in patients with psoriatic arthritis (PsA) and rheumatoid arthritis (RA), suggesting that both inflammatory disorders share a common atherogenic mechanism.

Major finding: After a total of 119,571 patient-years of follow-up, 6.7% of patients with RA or PsA developed MACE for the first time. The rates of MACE incidence (adjusted incidence rate ratio 0.96; P  =  .767) and MACE-free survival (P  =  .987) were comparable between patients with PsA and RA. Higher time-varying erythrocyte sedimentation rate, C-reactive protein levels, and exposure to glucocorticoids increased the risk for MACE in both patients with PsA and RA (all P < .05).

Study details: This population based retrospective cohort study included 13,905 patients with PsA (n  =  1672) or RA (n  =  12,233) who did not have any previous history of MACE.

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

Source: Meng H, Lam SH, So H, Tam LS. Incidence and risk factors of major cardiovascular events in rheumatoid arthritis and psoriatic arthritis: A population-based cohort study. Semin Arthritis Rheum. 2024;65:152416 (Feb 17). Source

Key clinical point: Ixekizumab was more effective than adalimumab in resolving distal interphalangeal (DIP) joint tenderness, swelling, and adjacent nail psoriasis in patients with psoriatic arthritis (PsA) and DIP joint involvement who nearly invariably had adjacent nail psoriasis.

Major finding: More than 96% of patients with PsA and simultaneous DIP joint involvement reported adjacent nail psoriasis in at least one digit in the finger unit. Ixekizumab vs adalimumab led to greater improvements in DIP involvement and adjacent nail psoriasis as early as week 12 (38.8% vs 28.4%; P < .0001), with improvements sustained up to week 52 (64.9% vs 57.5%; P  =  .0055).

Study details: This post hoc analysis of the SPIRIT-H2H study included 354 patients with PsA who had simultaneous DIP joint involvement and adjacent nail psoriasis and were randomly assigned to receive ixekizumab or adalimumab.

Disclosures: This study was supported by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company. The other authors reported ties with various sources, including Eli Lilly and Company.

Source: McGonagle D, Kavanaugh A, McInnes IB, et al. Association of the clinical components in the distal interphalangeal joint synovio-entheseal complex and subsequent response to ixekizumab or adalimumab in psoriatic arthritis. Rheumatology (Oxford). 2024 (Feb 10). doi: 10.1093/rheumatology/keae060 Source

Key clinical point: Ixekizumab was more effective than adalimumab in resolving distal interphalangeal (DIP) joint tenderness, swelling, and adjacent nail psoriasis in patients with psoriatic arthritis (PsA) and DIP joint involvement who nearly invariably had adjacent nail psoriasis.

Major finding: More than 96% of patients with PsA and simultaneous DIP joint involvement reported adjacent nail psoriasis in at least one digit in the finger unit. Ixekizumab vs adalimumab led to greater improvements in DIP involvement and adjacent nail psoriasis as early as week 12 (38.8% vs 28.4%; P < .0001), with improvements sustained up to week 52 (64.9% vs 57.5%; P  =  .0055).

Study details: This post hoc analysis of the SPIRIT-H2H study included 354 patients with PsA who had simultaneous DIP joint involvement and adjacent nail psoriasis and were randomly assigned to receive ixekizumab or adalimumab.

Disclosures: This study was supported by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company. The other authors reported ties with various sources, including Eli Lilly and Company.

Source: McGonagle D, Kavanaugh A, McInnes IB, et al. Association of the clinical components in the distal interphalangeal joint synovio-entheseal complex and subsequent response to ixekizumab or adalimumab in psoriatic arthritis. Rheumatology (Oxford). 2024 (Feb 10). doi: 10.1093/rheumatology/keae060 Source

Key clinical point: Ixekizumab was more effective than adalimumab in resolving distal interphalangeal (DIP) joint tenderness, swelling, and adjacent nail psoriasis in patients with psoriatic arthritis (PsA) and DIP joint involvement who nearly invariably had adjacent nail psoriasis.

Major finding: More than 96% of patients with PsA and simultaneous DIP joint involvement reported adjacent nail psoriasis in at least one digit in the finger unit. Ixekizumab vs adalimumab led to greater improvements in DIP involvement and adjacent nail psoriasis as early as week 12 (38.8% vs 28.4%; P < .0001), with improvements sustained up to week 52 (64.9% vs 57.5%; P  =  .0055).

Study details: This post hoc analysis of the SPIRIT-H2H study included 354 patients with PsA who had simultaneous DIP joint involvement and adjacent nail psoriasis and were randomly assigned to receive ixekizumab or adalimumab.

Disclosures: This study was supported by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company. The other authors reported ties with various sources, including Eli Lilly and Company.

Source: McGonagle D, Kavanaugh A, McInnes IB, et al. Association of the clinical components in the distal interphalangeal joint synovio-entheseal complex and subsequent response to ixekizumab or adalimumab in psoriatic arthritis. Rheumatology (Oxford). 2024 (Feb 10). doi: 10.1093/rheumatology/keae060 Source

Medtronic Neurosurgery has recalled Duet External Drainage and Monitoring System (EDMS) catheter tubing because the catheter may disconnect from the patient line stopcock connectors.

If this happens, potential harm to patients may include infections, cerebrospinal fluid (CSF) leakage, overdrainage of CSF, and abnormality of the ventricles. Uncontrolled overdrainage of CSF could lead to neurological injury or death if the disconnection is undetected.

The Food and Drug Administration has identified this as a Class I recall — the most serious type — due to the risk for serious injury or death. To date, there have been 26 reported injuries and no deaths related to this issue. 

The recall includes 45,176 devices distributed in the United States between May 3, 2021, and January 9, 2024, with model numbers 46913, 46914, 46915, 46916, and 46917.

The Duet EDMS is used for temporary CSF drainage or sampling in patients who have surgery for open descending thoracic aortic aneurysm (TAA) or descending thoraco-abdominal aortic aneurysm (TAAA) or patients who have TAA/TAAA repair surgery and develop symptoms such as paraplegia.

Medtronic has sent an urgent medical device recall letter to all affected customers asking them to identify, quarantine, and return any unused recalled products. 

Customers are also advised to check all Duet EDMS components for damage and ensure that all connections are secure and leak-free. 

If a patient is currently connected to an impacted Duet EDMS and a leak or disconnection is detected, the device should be changed to a new alternative device utilizing a sterile technique. 

It is not recommended that a Duet system device that is connected to a patient and working as intended be removed or replaced.

Customers in the United States with questions about this recall should contact Medtronic at 1-800-874-5797.

A version of this article appeared on Medscape.com.

Medtronic Neurosurgery has recalled Duet External Drainage and Monitoring System (EDMS) catheter tubing because the catheter may disconnect from the patient line stopcock connectors.

If this happens, potential harm to patients may include infections, cerebrospinal fluid (CSF) leakage, overdrainage of CSF, and abnormality of the ventricles. Uncontrolled overdrainage of CSF could lead to neurological injury or death if the disconnection is undetected.

The Food and Drug Administration has identified this as a Class I recall — the most serious type — due to the risk for serious injury or death. To date, there have been 26 reported injuries and no deaths related to this issue. 

The recall includes 45,176 devices distributed in the United States between May 3, 2021, and January 9, 2024, with model numbers 46913, 46914, 46915, 46916, and 46917.

The Duet EDMS is used for temporary CSF drainage or sampling in patients who have surgery for open descending thoracic aortic aneurysm (TAA) or descending thoraco-abdominal aortic aneurysm (TAAA) or patients who have TAA/TAAA repair surgery and develop symptoms such as paraplegia.

Medtronic has sent an urgent medical device recall letter to all affected customers asking them to identify, quarantine, and return any unused recalled products. 

Customers are also advised to check all Duet EDMS components for damage and ensure that all connections are secure and leak-free. 

If a patient is currently connected to an impacted Duet EDMS and a leak or disconnection is detected, the device should be changed to a new alternative device utilizing a sterile technique. 

It is not recommended that a Duet system device that is connected to a patient and working as intended be removed or replaced.

Customers in the United States with questions about this recall should contact Medtronic at 1-800-874-5797.

A version of this article appeared on Medscape.com.

Medtronic Neurosurgery has recalled Duet External Drainage and Monitoring System (EDMS) catheter tubing because the catheter may disconnect from the patient line stopcock connectors.

If this happens, potential harm to patients may include infections, cerebrospinal fluid (CSF) leakage, overdrainage of CSF, and abnormality of the ventricles. Uncontrolled overdrainage of CSF could lead to neurological injury or death if the disconnection is undetected.

The Food and Drug Administration has identified this as a Class I recall — the most serious type — due to the risk for serious injury or death. To date, there have been 26 reported injuries and no deaths related to this issue. 

The recall includes 45,176 devices distributed in the United States between May 3, 2021, and January 9, 2024, with model numbers 46913, 46914, 46915, 46916, and 46917.

The Duet EDMS is used for temporary CSF drainage or sampling in patients who have surgery for open descending thoracic aortic aneurysm (TAA) or descending thoraco-abdominal aortic aneurysm (TAAA) or patients who have TAA/TAAA repair surgery and develop symptoms such as paraplegia.

Medtronic has sent an urgent medical device recall letter to all affected customers asking them to identify, quarantine, and return any unused recalled products. 

Customers are also advised to check all Duet EDMS components for damage and ensure that all connections are secure and leak-free. 

If a patient is currently connected to an impacted Duet EDMS and a leak or disconnection is detected, the device should be changed to a new alternative device utilizing a sterile technique. 

It is not recommended that a Duet system device that is connected to a patient and working as intended be removed or replaced.

Customers in the United States with questions about this recall should contact Medtronic at 1-800-874-5797.

A version of this article appeared on Medscape.com.

The rheumatologist of the future will see patients who have been assessed and triaged with artificial intelligence utilizing data from remote kiosk-placed ultrasound scanners and physician-directed algorithms. Practices will be broadly fueled by AI, which will screen charts, produce notes, handle prior authorizations and insurance issues, aid in earlier diagnoses, find patients for clinical trials, and maybe even suggest the next best therapy for individual patients.

Such is the future envisioned by Alvin F. Wells, MD, PhD, and John J. Cush, MD, who discussed the current and forthcoming reach of AI — and their own uses of it — at the 2024 Rheumatology Winter Clinical Symposium.

“We’re not at the stage where ChatGPT and AI can tell us what the next best therapy is, but we’re getting there,” said Dr. Cush, a rheumatologist based in Dallas and executive director of RheumNow.com. For now, he said, “AI affords us a truly big-time increase in efficiency. It helps you deal with your time constraints in managing information overload and task overload.”

Bruce Jancin/MDedge News

At a time when “PubMed doubles every 73 days ... and it’s getting harder and harder to stay abreast,” for example, new applications such as Scite, SciSpace, and Consensus can help curate, focus, and analyze the literature to match one’s own clinical interests. Such review tools are “just now getting into play and are evolving,” Dr. Cush said, noting that many but not all of them are based on ChatGPT, OpenAI’s chatbot that had a over 100 million users by January 2023 — just over a month after its version 3.5 was released.

For Dr. Wells, a rheumatologist and Midwest Region director in the department of rheumatology for the Advocate Health Medical Group in Franklin, Wisconsin, clinician-developed algorithms are helping his group assess patients — often remotely — and triage them to be seen fairly immediately by a rheumatologist versus in 4-6 weeks or in several months. “You can use AI to guide your access,” he said.

A patient “with a family history of RA, sed rate above 50, and osteopenia on x-rays” would be seen within a week, for example, while “another patient who’s had a [positive] ANA with no other symptoms, and maybe a family history, might be seen in 4-6 weeks,” said Dr. Wells, sharing his belief that “there is not a shortage of rheumatologists, [but a] shortage of using rheumatologists efficiently.”

Dr. Wells

AI for Improving Workflow

Current and future advances will enrich the intersection of AI and virtual medicine and improve outcomes and the rheumatologist-patient interaction, Dr. Wells said, pointing to research presented at the American College of Rheumatology (ACR) 2023 annual meeting on the use of computer vision technology for remotely assessing disease activity in rheumatoid arthritis (RA).

In the proof-of-concept “MeFisto” study, 28 patients with RA used an app that enabled computer vision inference of hand motion data. Upon recording, an algorithm tracked the mean degree change of joint angle on flexion and the mean time to maximal flexion for each joint.

The researchers found a strong correlation between flexion of the distal interphalangeal (DIP) joint and the Disease Activity Score in 28 joints, the Swollen Hand Joint Count, and the Tender Hand Joint Count. DIP flexion was found to be a significant predictor of low disease activity/remission and high disease activity, the researchers reported in their abstract.

“This blows you away — that a single camera on [one’s] smartphone can look at the manipulation of a hand … and that AI can tell me, there’s a chance this might be an inflammatory arthritis,” said Dr. Wells, noting that researchers are also developing ways to detect joint swelling in RA by AI.

AI can also be used for remote ultrasound scanning in RA, as evidenced by use of the ARTHUR system in Europe, he said. Developed by the Danish company ROPCA, the ARTHUR technology (Rheumatoid Arthritis Ultrasound Robot) interacts directly with the patient who has new joint pain or established RA to capture ultrasound images in grayscale and color flow of 11 joints per hand. AI analyzes the images and creates a report for the specialist.

“They’re trying to get a foothold in the US,” Dr. Wells said, sharing his prediction that similar technology will someday be seen not only in pharmacies but also — in support of equitable access — in locations such as grocery stores. “Again,” he said, “nothing will replace us. I’m taking all [such] information and saying, who needs to be seen in 7 days and who can wait.”
 

AI for Writing, for Improving Practice and Patient Care

To manage his “task overload,” Dr. Cush uses ChatGPT for jobs such as first drafts of articles and making PowerPoint slides. It must be used cautiously for medical writing, however, as inaccuracies and false data/fabricated information — some of which has been coined AI “hallucinations” — are not uncommon.

“It’s very good at manuscript drafts, at generating bibliographies … it can do systematic reviews, it can do network meta-analyses, and it can find trends and patterns that can very helpful when it comes to writing. But you have to know how it’s a tool, and how it can hurt you,” he said.

Researchers recently reported asking ChatGPT to write an editorial about “how AI may replace the rheumatologist in editorial writing,” Dr. Cush noted. ChatGPT was “very politically correct,” he quipped, because it wrote that AI is “a tool to help the rheumatologist, but not replace him.”

Publishers want to preserve human intelligence — critical thinking and the ability to interpret, for instance — and most of the top medical journals (those most often cited) have issued guidance on the use of generative AI. “One said AI can’t be attributed as an author because being an author carries with it accountability of the work, and AI can’t take responsibility,” Dr. Cush said. Journals also “are saying you can use AI but you have to be totally transparent about it … [how it’s used] has to be very well spelled out.”

In practice, chatbots can be used for summarizing medical records, drafting post-visit summaries, collecting patient feedback, reminding about vaccinations, and performing administrative functions. “It’s really limitless as to what chatbots can do,” Dr. Cush said. “The question is, [what is] really going to help you?”

Much of the research submitted for presentation at major rheumatology meetings over the years has had questionable real-world utility and value, he said. But in the future this will likely change. “Take the PsA [psoriatic arthritis] patient who hasn’t responded to methotrexate or apremilast [Otezla]. There are [so many] choices, and there really isn’t a clear one. Shouldn’t data guide us on whether an IL-23 is better than a JAK, or maybe a JAK preferred over a TNF for some reason?” Dr. Cush said. “That’s what we’re hoping will happen down the line.”

More realistic AI-guided clinical scenarios for now include the following: AI screens the chart of a 68-year-old with RA on methotrexate and etanercept who is following up, and retrieves pieces of history — an elevated C-reactive protein 3 months ago, for instance, and diverticulosis 5 years ago. “AI tells you, based on this, he may have active disease, and here are three medications covered by his insurance,” Dr. Wells said.

Or, in the case of a 58-year-old patient with RA who has scheduled a virtual follow-up visit after having been on methotrexate and hydroxychloroquine for 12 weeks, AI detects a low platelet count in her previsit labs and also sees that she received an MMR booster 5 weeks ago at a local CVS Minute Clinic. AI retrieves for the rheumatologist a review article about thrombocytopenic purpura after MMR vaccination.
 

AI for Drug Development, Clinical Trials

Dr. Cush is following with keen interest the integration of AI into the process of drug development, from drug discovery and biomarker evaluation to clinical trial efficiency and patient recruitment, as well as marketing. “A lot hasn’t been ‘rolled out’ or shown to us, but there’s a lot going on … everyone is investing,” he said. “The number one challenge is regulatory: How will the [Food and Drug Administration] handle AI-generated data sets or AI-generated or monitored trials?”

The FDA is working to ensure quality and utility of data and is rapidly “approving AI algorithms for use in medicine and healthcare,” he said.

AI’s ability to identify patients in populations can not only facilitate earlier diagnoses but can accelerate patient recruitment for clinical trials, Dr. Cush emphasized. He pointed to research presented at the ACR 2021 annual meeting in which a machine-learning algorithm was used with electronic health records in the United Kingdom to estimate the probability of a patient’s being diagnosed with axial spondyloarthritis (axSpA).

AI identified 89 best clinical predictors (out of 820 analyzed). When applying these predictors to the population, AI was able to differentiate patients with axSpA from healthy controls with a sensitivity of 75%, a specificity of 96%, and a positive predictive value of 81%. Such an application of AI “is ideal … It would make clinical trials more streamlined and productive,” he said.

The extent to which AI will lead to cost savings — in the pharmacology arena, for instance, or for Well’s medical group — is unknown, Dr. Cush and Dr. Wells said. And, of course, there are concerns about potential bias and abuse of AI. “The worry,” Dr. Cush said, “is, who’s watching?”

Dr. Wells disclosed that he has research support and has served as a member of advisory boards and/or speaker bureaus for 17 different pharmaceutical or medical technology companies. Dr. Cush disclosed relationships with AbbVie, Amgen, Bristol-Myers Squibb, Novartis, Sanofi, and UCB.

The rheumatologist of the future will see patients who have been assessed and triaged with artificial intelligence utilizing data from remote kiosk-placed ultrasound scanners and physician-directed algorithms. Practices will be broadly fueled by AI, which will screen charts, produce notes, handle prior authorizations and insurance issues, aid in earlier diagnoses, find patients for clinical trials, and maybe even suggest the next best therapy for individual patients.

Such is the future envisioned by Alvin F. Wells, MD, PhD, and John J. Cush, MD, who discussed the current and forthcoming reach of AI — and their own uses of it — at the 2024 Rheumatology Winter Clinical Symposium.

“We’re not at the stage where ChatGPT and AI can tell us what the next best therapy is, but we’re getting there,” said Dr. Cush, a rheumatologist based in Dallas and executive director of RheumNow.com. For now, he said, “AI affords us a truly big-time increase in efficiency. It helps you deal with your time constraints in managing information overload and task overload.”

Bruce Jancin/MDedge News

At a time when “PubMed doubles every 73 days ... and it’s getting harder and harder to stay abreast,” for example, new applications such as Scite, SciSpace, and Consensus can help curate, focus, and analyze the literature to match one’s own clinical interests. Such review tools are “just now getting into play and are evolving,” Dr. Cush said, noting that many but not all of them are based on ChatGPT, OpenAI’s chatbot that had a over 100 million users by January 2023 — just over a month after its version 3.5 was released.

For Dr. Wells, a rheumatologist and Midwest Region director in the department of rheumatology for the Advocate Health Medical Group in Franklin, Wisconsin, clinician-developed algorithms are helping his group assess patients — often remotely — and triage them to be seen fairly immediately by a rheumatologist versus in 4-6 weeks or in several months. “You can use AI to guide your access,” he said.

A patient “with a family history of RA, sed rate above 50, and osteopenia on x-rays” would be seen within a week, for example, while “another patient who’s had a [positive] ANA with no other symptoms, and maybe a family history, might be seen in 4-6 weeks,” said Dr. Wells, sharing his belief that “there is not a shortage of rheumatologists, [but a] shortage of using rheumatologists efficiently.”

Dr. Wells

AI for Improving Workflow

Current and future advances will enrich the intersection of AI and virtual medicine and improve outcomes and the rheumatologist-patient interaction, Dr. Wells said, pointing to research presented at the American College of Rheumatology (ACR) 2023 annual meeting on the use of computer vision technology for remotely assessing disease activity in rheumatoid arthritis (RA).

In the proof-of-concept “MeFisto” study, 28 patients with RA used an app that enabled computer vision inference of hand motion data. Upon recording, an algorithm tracked the mean degree change of joint angle on flexion and the mean time to maximal flexion for each joint.

The researchers found a strong correlation between flexion of the distal interphalangeal (DIP) joint and the Disease Activity Score in 28 joints, the Swollen Hand Joint Count, and the Tender Hand Joint Count. DIP flexion was found to be a significant predictor of low disease activity/remission and high disease activity, the researchers reported in their abstract.

“This blows you away — that a single camera on [one’s] smartphone can look at the manipulation of a hand … and that AI can tell me, there’s a chance this might be an inflammatory arthritis,” said Dr. Wells, noting that researchers are also developing ways to detect joint swelling in RA by AI.

AI can also be used for remote ultrasound scanning in RA, as evidenced by use of the ARTHUR system in Europe, he said. Developed by the Danish company ROPCA, the ARTHUR technology (Rheumatoid Arthritis Ultrasound Robot) interacts directly with the patient who has new joint pain or established RA to capture ultrasound images in grayscale and color flow of 11 joints per hand. AI analyzes the images and creates a report for the specialist.

“They’re trying to get a foothold in the US,” Dr. Wells said, sharing his prediction that similar technology will someday be seen not only in pharmacies but also — in support of equitable access — in locations such as grocery stores. “Again,” he said, “nothing will replace us. I’m taking all [such] information and saying, who needs to be seen in 7 days and who can wait.”
 

AI for Writing, for Improving Practice and Patient Care

To manage his “task overload,” Dr. Cush uses ChatGPT for jobs such as first drafts of articles and making PowerPoint slides. It must be used cautiously for medical writing, however, as inaccuracies and false data/fabricated information — some of which has been coined AI “hallucinations” — are not uncommon.

“It’s very good at manuscript drafts, at generating bibliographies … it can do systematic reviews, it can do network meta-analyses, and it can find trends and patterns that can very helpful when it comes to writing. But you have to know how it’s a tool, and how it can hurt you,” he said.

Researchers recently reported asking ChatGPT to write an editorial about “how AI may replace the rheumatologist in editorial writing,” Dr. Cush noted. ChatGPT was “very politically correct,” he quipped, because it wrote that AI is “a tool to help the rheumatologist, but not replace him.”

Publishers want to preserve human intelligence — critical thinking and the ability to interpret, for instance — and most of the top medical journals (those most often cited) have issued guidance on the use of generative AI. “One said AI can’t be attributed as an author because being an author carries with it accountability of the work, and AI can’t take responsibility,” Dr. Cush said. Journals also “are saying you can use AI but you have to be totally transparent about it … [how it’s used] has to be very well spelled out.”

In practice, chatbots can be used for summarizing medical records, drafting post-visit summaries, collecting patient feedback, reminding about vaccinations, and performing administrative functions. “It’s really limitless as to what chatbots can do,” Dr. Cush said. “The question is, [what is] really going to help you?”

Much of the research submitted for presentation at major rheumatology meetings over the years has had questionable real-world utility and value, he said. But in the future this will likely change. “Take the PsA [psoriatic arthritis] patient who hasn’t responded to methotrexate or apremilast [Otezla]. There are [so many] choices, and there really isn’t a clear one. Shouldn’t data guide us on whether an IL-23 is better than a JAK, or maybe a JAK preferred over a TNF for some reason?” Dr. Cush said. “That’s what we’re hoping will happen down the line.”

More realistic AI-guided clinical scenarios for now include the following: AI screens the chart of a 68-year-old with RA on methotrexate and etanercept who is following up, and retrieves pieces of history — an elevated C-reactive protein 3 months ago, for instance, and diverticulosis 5 years ago. “AI tells you, based on this, he may have active disease, and here are three medications covered by his insurance,” Dr. Wells said.

Or, in the case of a 58-year-old patient with RA who has scheduled a virtual follow-up visit after having been on methotrexate and hydroxychloroquine for 12 weeks, AI detects a low platelet count in her previsit labs and also sees that she received an MMR booster 5 weeks ago at a local CVS Minute Clinic. AI retrieves for the rheumatologist a review article about thrombocytopenic purpura after MMR vaccination.
 

AI for Drug Development, Clinical Trials

Dr. Cush is following with keen interest the integration of AI into the process of drug development, from drug discovery and biomarker evaluation to clinical trial efficiency and patient recruitment, as well as marketing. “A lot hasn’t been ‘rolled out’ or shown to us, but there’s a lot going on … everyone is investing,” he said. “The number one challenge is regulatory: How will the [Food and Drug Administration] handle AI-generated data sets or AI-generated or monitored trials?”

The FDA is working to ensure quality and utility of data and is rapidly “approving AI algorithms for use in medicine and healthcare,” he said.

AI’s ability to identify patients in populations can not only facilitate earlier diagnoses but can accelerate patient recruitment for clinical trials, Dr. Cush emphasized. He pointed to research presented at the ACR 2021 annual meeting in which a machine-learning algorithm was used with electronic health records in the United Kingdom to estimate the probability of a patient’s being diagnosed with axial spondyloarthritis (axSpA).

AI identified 89 best clinical predictors (out of 820 analyzed). When applying these predictors to the population, AI was able to differentiate patients with axSpA from healthy controls with a sensitivity of 75%, a specificity of 96%, and a positive predictive value of 81%. Such an application of AI “is ideal … It would make clinical trials more streamlined and productive,” he said.

The extent to which AI will lead to cost savings — in the pharmacology arena, for instance, or for Well’s medical group — is unknown, Dr. Cush and Dr. Wells said. And, of course, there are concerns about potential bias and abuse of AI. “The worry,” Dr. Cush said, “is, who’s watching?”

Dr. Wells disclosed that he has research support and has served as a member of advisory boards and/or speaker bureaus for 17 different pharmaceutical or medical technology companies. Dr. Cush disclosed relationships with AbbVie, Amgen, Bristol-Myers Squibb, Novartis, Sanofi, and UCB.

The rheumatologist of the future will see patients who have been assessed and triaged with artificial intelligence utilizing data from remote kiosk-placed ultrasound scanners and physician-directed algorithms. Practices will be broadly fueled by AI, which will screen charts, produce notes, handle prior authorizations and insurance issues, aid in earlier diagnoses, find patients for clinical trials, and maybe even suggest the next best therapy for individual patients.

Such is the future envisioned by Alvin F. Wells, MD, PhD, and John J. Cush, MD, who discussed the current and forthcoming reach of AI — and their own uses of it — at the 2024 Rheumatology Winter Clinical Symposium.

“We’re not at the stage where ChatGPT and AI can tell us what the next best therapy is, but we’re getting there,” said Dr. Cush, a rheumatologist based in Dallas and executive director of RheumNow.com. For now, he said, “AI affords us a truly big-time increase in efficiency. It helps you deal with your time constraints in managing information overload and task overload.”

Bruce Jancin/MDedge News

At a time when “PubMed doubles every 73 days ... and it’s getting harder and harder to stay abreast,” for example, new applications such as Scite, SciSpace, and Consensus can help curate, focus, and analyze the literature to match one’s own clinical interests. Such review tools are “just now getting into play and are evolving,” Dr. Cush said, noting that many but not all of them are based on ChatGPT, OpenAI’s chatbot that had a over 100 million users by January 2023 — just over a month after its version 3.5 was released.

For Dr. Wells, a rheumatologist and Midwest Region director in the department of rheumatology for the Advocate Health Medical Group in Franklin, Wisconsin, clinician-developed algorithms are helping his group assess patients — often remotely — and triage them to be seen fairly immediately by a rheumatologist versus in 4-6 weeks or in several months. “You can use AI to guide your access,” he said.

A patient “with a family history of RA, sed rate above 50, and osteopenia on x-rays” would be seen within a week, for example, while “another patient who’s had a [positive] ANA with no other symptoms, and maybe a family history, might be seen in 4-6 weeks,” said Dr. Wells, sharing his belief that “there is not a shortage of rheumatologists, [but a] shortage of using rheumatologists efficiently.”

Dr. Wells

AI for Improving Workflow

Current and future advances will enrich the intersection of AI and virtual medicine and improve outcomes and the rheumatologist-patient interaction, Dr. Wells said, pointing to research presented at the American College of Rheumatology (ACR) 2023 annual meeting on the use of computer vision technology for remotely assessing disease activity in rheumatoid arthritis (RA).

In the proof-of-concept “MeFisto” study, 28 patients with RA used an app that enabled computer vision inference of hand motion data. Upon recording, an algorithm tracked the mean degree change of joint angle on flexion and the mean time to maximal flexion for each joint.

The researchers found a strong correlation between flexion of the distal interphalangeal (DIP) joint and the Disease Activity Score in 28 joints, the Swollen Hand Joint Count, and the Tender Hand Joint Count. DIP flexion was found to be a significant predictor of low disease activity/remission and high disease activity, the researchers reported in their abstract.

“This blows you away — that a single camera on [one’s] smartphone can look at the manipulation of a hand … and that AI can tell me, there’s a chance this might be an inflammatory arthritis,” said Dr. Wells, noting that researchers are also developing ways to detect joint swelling in RA by AI.

AI can also be used for remote ultrasound scanning in RA, as evidenced by use of the ARTHUR system in Europe, he said. Developed by the Danish company ROPCA, the ARTHUR technology (Rheumatoid Arthritis Ultrasound Robot) interacts directly with the patient who has new joint pain or established RA to capture ultrasound images in grayscale and color flow of 11 joints per hand. AI analyzes the images and creates a report for the specialist.

“They’re trying to get a foothold in the US,” Dr. Wells said, sharing his prediction that similar technology will someday be seen not only in pharmacies but also — in support of equitable access — in locations such as grocery stores. “Again,” he said, “nothing will replace us. I’m taking all [such] information and saying, who needs to be seen in 7 days and who can wait.”
 

AI for Writing, for Improving Practice and Patient Care

To manage his “task overload,” Dr. Cush uses ChatGPT for jobs such as first drafts of articles and making PowerPoint slides. It must be used cautiously for medical writing, however, as inaccuracies and false data/fabricated information — some of which has been coined AI “hallucinations” — are not uncommon.

“It’s very good at manuscript drafts, at generating bibliographies … it can do systematic reviews, it can do network meta-analyses, and it can find trends and patterns that can very helpful when it comes to writing. But you have to know how it’s a tool, and how it can hurt you,” he said.

Researchers recently reported asking ChatGPT to write an editorial about “how AI may replace the rheumatologist in editorial writing,” Dr. Cush noted. ChatGPT was “very politically correct,” he quipped, because it wrote that AI is “a tool to help the rheumatologist, but not replace him.”

Publishers want to preserve human intelligence — critical thinking and the ability to interpret, for instance — and most of the top medical journals (those most often cited) have issued guidance on the use of generative AI. “One said AI can’t be attributed as an author because being an author carries with it accountability of the work, and AI can’t take responsibility,” Dr. Cush said. Journals also “are saying you can use AI but you have to be totally transparent about it … [how it’s used] has to be very well spelled out.”

In practice, chatbots can be used for summarizing medical records, drafting post-visit summaries, collecting patient feedback, reminding about vaccinations, and performing administrative functions. “It’s really limitless as to what chatbots can do,” Dr. Cush said. “The question is, [what is] really going to help you?”

Much of the research submitted for presentation at major rheumatology meetings over the years has had questionable real-world utility and value, he said. But in the future this will likely change. “Take the PsA [psoriatic arthritis] patient who hasn’t responded to methotrexate or apremilast [Otezla]. There are [so many] choices, and there really isn’t a clear one. Shouldn’t data guide us on whether an IL-23 is better than a JAK, or maybe a JAK preferred over a TNF for some reason?” Dr. Cush said. “That’s what we’re hoping will happen down the line.”

More realistic AI-guided clinical scenarios for now include the following: AI screens the chart of a 68-year-old with RA on methotrexate and etanercept who is following up, and retrieves pieces of history — an elevated C-reactive protein 3 months ago, for instance, and diverticulosis 5 years ago. “AI tells you, based on this, he may have active disease, and here are three medications covered by his insurance,” Dr. Wells said.

Or, in the case of a 58-year-old patient with RA who has scheduled a virtual follow-up visit after having been on methotrexate and hydroxychloroquine for 12 weeks, AI detects a low platelet count in her previsit labs and also sees that she received an MMR booster 5 weeks ago at a local CVS Minute Clinic. AI retrieves for the rheumatologist a review article about thrombocytopenic purpura after MMR vaccination.
 

AI for Drug Development, Clinical Trials

Dr. Cush is following with keen interest the integration of AI into the process of drug development, from drug discovery and biomarker evaluation to clinical trial efficiency and patient recruitment, as well as marketing. “A lot hasn’t been ‘rolled out’ or shown to us, but there’s a lot going on … everyone is investing,” he said. “The number one challenge is regulatory: How will the [Food and Drug Administration] handle AI-generated data sets or AI-generated or monitored trials?”

The FDA is working to ensure quality and utility of data and is rapidly “approving AI algorithms for use in medicine and healthcare,” he said.

AI’s ability to identify patients in populations can not only facilitate earlier diagnoses but can accelerate patient recruitment for clinical trials, Dr. Cush emphasized. He pointed to research presented at the ACR 2021 annual meeting in which a machine-learning algorithm was used with electronic health records in the United Kingdom to estimate the probability of a patient’s being diagnosed with axial spondyloarthritis (axSpA).

AI identified 89 best clinical predictors (out of 820 analyzed). When applying these predictors to the population, AI was able to differentiate patients with axSpA from healthy controls with a sensitivity of 75%, a specificity of 96%, and a positive predictive value of 81%. Such an application of AI “is ideal … It would make clinical trials more streamlined and productive,” he said.

The extent to which AI will lead to cost savings — in the pharmacology arena, for instance, or for Well’s medical group — is unknown, Dr. Cush and Dr. Wells said. And, of course, there are concerns about potential bias and abuse of AI. “The worry,” Dr. Cush said, “is, who’s watching?”

Dr. Wells disclosed that he has research support and has served as a member of advisory boards and/or speaker bureaus for 17 different pharmaceutical or medical technology companies. Dr. Cush disclosed relationships with AbbVie, Amgen, Bristol-Myers Squibb, Novartis, Sanofi, and UCB.

Patients diagnosed with rheumatoid arthritis (RA) and co-occurring anxiety or depression are less likely to achieve low disease activity (LDA) and better symptom control after 3 months of treatment, according to new research presented at the at the annual meeting of the Canadian Rheumatology Association.

The findings emphasized the importance of taking a multidisciplinary approach to RA treatment, said presenter Susan Bartlett, PhD, a professor in the Divisions of Clinical Epidemiology, Rheumatology, and Respiratory Epidemiology at McGill University in Montreal, Quebec, Canada.

McGill University

“In the absence of directly addressing anxiety and depression, people are not going to improve to the same extent we hope that they will,” she told this news organization.
 

Symptom Clusters in RA

In her research, presented on February 29, Dr. Bartlett explored how certain symptom clusters in RA predicted prognosis.

Symptom clusters are related symptoms that occur together and can be associated with worse outcomes than one symptom alone. Symptom science has been a growing interest in precision medicine, particularly for cancer, Dr. Bartlett noted, and this same approach could help pinpoint RA subtypes, disease trajectories, and personalized treatment.

In the study, Dr. Bartlett and colleagues used data from the Canadian Early Arthritis Cohort (CATCH), a multisite prospective research study following individuals with new-onset RA. They identified patients starting methotrexate (MTX) therapy who also had clinical and patient-reported outcome measures available. Individuals included in the analysis may have also been taking additional disease-modifying antirheumatic drugs beyond MTX.

Across the 310 selected individuals, researchers identified four key symptoms: Pain, fatigue, anxiety, and depression. Pain and fatigue were defined as physical symptoms, while anxiety and depression were classified as emotional symptoms. Results showed that the patients could be sorted into four distinct symptom clusters: Minimal symptoms (12%), mild physical and emotional symptoms (11%), moderate to severe pain and fatigue (40%), and moderate to severe physical and emotional symptoms (37%).

Researchers then followed patients during the first 6 months of treatment to evaluate if patients’ symptoms improved.

Symptom improvement mostly occurred during the first 3 months of treatment and remained consistent at 6 months. Overall, patients with moderate to severe emotional symptoms had a worse prognosis and were less likely to achieve milder symptoms than those who had only pain and fatigue or mild emotional symptoms. While 64% of patients in the moderate to severe physical symptoms group achieved minimal symptoms after 3 months of treatment, only 13% of patients with moderate to severe physical and emotional systems reported minimal symptoms during this same time frame.

The study builds on previous work that “suggests that there are different factors that we can identify around the time of diagnosis that point to how well a person is likely to respond,” Dr. Bartlett added. “What our work is showing pretty clearly [is that] the presence of anxiety and depression is one of those important markers.”
 

Patients With Depression Report Worse Disease Activity

In a related study, researchers from the University of Ottawa explored how depression in RA affected subjective and objective disease measures.

The study included patients from the Ottawa Rheumatology Comprehensive Treatment and Assessment (ORCHESTRA) clinic at The Ottawa Hospital, Ottawa, Ontario, Canada, which sees patients with inflammatory arthritis who are starting biologic therapy or switching to another biologic. The clinic is designed to take a more comprehensive approach to managing inflammatory arthritis, including addressing comorbidities such as cardiac disease, depression, and cancer. Patients seen at the clinic can opt to be included in the ORCHESTRA cohort to be a part of ongoing research.

From this cohort, researchers identified 98 patients with RA. At enrollment, patients were screened for depression using patient health questionnaire scores and asked about duration of morning stiffness and tender joint counts. Swollen joint counts, ultrasound, and clinical scores were used to evaluate disease activity.

In the study group, 47 patients had no depression, 21 patients had mild depression, and 30 patients had moderate to severe depression. Researchers found that subjective disease measures, including visual analog pain scale, health assessment questionnaire, and disease activity score in 28 joints were all higher in patients with depression; however, depression did not appear to affect objective disease measures, such as the Global OMERACT-EULAR Synovitis Score or Doppler scores.

While there is a known link between inflammation and depression, these findings suggest that depression is “a concomitant comorbidity just like cardiovascular disease, just like fibromyalgia, just like some other comorbidity that also needs to be addressed in its own right to improve the outcomes,” noted Elliot Hepworth, MD, a rheumatologist and ORCHESTRA clinic lead at The Ottawa Hospital, in an interview.

Dr. Hepworth presented the findings on March 1.

Dr. Elliot Hepworth

The data also suggested that patients with depression had poorer outcomes. For the 79 patients who had 3-month follow-up visit data, 43.9% of patients with no or mild depression achieved LDA and remission compared with 21.7% of patients with moderate to severe depression, though this difference was not statistically significant (P = .064). There was a similar trend for the 39 patients with 6-month follow-up data: Only 20% of patients with moderate to severe depression had reached LDA and remission compared with 37.9% of patients with no or mild depression (P = .445). The researchers noted this could be an issue with a smaller sample size.

“Every time more patients get added we approach closer to significance,” Dr. Hepworth added.
 

Some Disagreement, Same Takeaway

Commenting on the Ottawa study, Dr. Bartlett was skeptical of the conclusion that depression may not directly influence disease activity. “There’s just too much good evidence these days that [depression] very much coexists with worse disease activity,” she said. “It is not in the person’s head.”

Dr. Hepworth added that patient-reported outcomes are important for clinicians to address during treatment.

“There’s the tender joints, there’s the pain, there’s the fatigue, there’s the patient global assessment, which are subjective,” he said, “but that does not mean that they are not important. Those are important to the patient: That is how they’re living their life, and that is how they’re experiencing their disease.”

This is why efforts to treat depression in patients with RA such as cognitive behavioral therapy are so important, he said, to which Dr. Bartlett agreed.

“A comprehensive approach is required, which includes addressing depression,” she said. Otherwise, data show “that people just never make it to remission.”

The studies looked at different patient populations but ultimately complement each other, added Sibel Aydin, MD, a professor of medicine in the Division of Rheumatology at the University of Ottawa, Ottawa, Ontario, Canada, and senior author of the Ottawa study.

Dr. Sibel Aydin

“Two different cohorts with different patient populations still reached the same result,” she said. “If you don’t address the emotional aspect, you are not going to achieve the good outcomes.”

“It’s remarkable when you have two independent researchers coming to the same conclusion without ever talking to each other,” added Dr. Hepworth. “That really shows that this is something that’s pervasive, and it’s not just within our patient population.”

CATCH is funded by unrestricted research grants from programs with Pfizer, AbbVie, Roche, Sandoz, Fresenius Kabi, Organon, Viatris, JAMP, and Celltrion. Dr. Bartlett is president of the PROMIS Health Organization. She is a member of speakers bureaus or has consulted for Pfizer, Sandoz, Merck, Janssen, and Organon. Dr. Hepworth and Dr. Aydin declared no conflicts of interest.

A version of this article appeared on Medscape.com .

Patients diagnosed with rheumatoid arthritis (RA) and co-occurring anxiety or depression are less likely to achieve low disease activity (LDA) and better symptom control after 3 months of treatment, according to new research presented at the at the annual meeting of the Canadian Rheumatology Association.

The findings emphasized the importance of taking a multidisciplinary approach to RA treatment, said presenter Susan Bartlett, PhD, a professor in the Divisions of Clinical Epidemiology, Rheumatology, and Respiratory Epidemiology at McGill University in Montreal, Quebec, Canada.

McGill University

“In the absence of directly addressing anxiety and depression, people are not going to improve to the same extent we hope that they will,” she told this news organization.
 

Symptom Clusters in RA

In her research, presented on February 29, Dr. Bartlett explored how certain symptom clusters in RA predicted prognosis.

Symptom clusters are related symptoms that occur together and can be associated with worse outcomes than one symptom alone. Symptom science has been a growing interest in precision medicine, particularly for cancer, Dr. Bartlett noted, and this same approach could help pinpoint RA subtypes, disease trajectories, and personalized treatment.

In the study, Dr. Bartlett and colleagues used data from the Canadian Early Arthritis Cohort (CATCH), a multisite prospective research study following individuals with new-onset RA. They identified patients starting methotrexate (MTX) therapy who also had clinical and patient-reported outcome measures available. Individuals included in the analysis may have also been taking additional disease-modifying antirheumatic drugs beyond MTX.

Across the 310 selected individuals, researchers identified four key symptoms: Pain, fatigue, anxiety, and depression. Pain and fatigue were defined as physical symptoms, while anxiety and depression were classified as emotional symptoms. Results showed that the patients could be sorted into four distinct symptom clusters: Minimal symptoms (12%), mild physical and emotional symptoms (11%), moderate to severe pain and fatigue (40%), and moderate to severe physical and emotional symptoms (37%).

Researchers then followed patients during the first 6 months of treatment to evaluate if patients’ symptoms improved.

Symptom improvement mostly occurred during the first 3 months of treatment and remained consistent at 6 months. Overall, patients with moderate to severe emotional symptoms had a worse prognosis and were less likely to achieve milder symptoms than those who had only pain and fatigue or mild emotional symptoms. While 64% of patients in the moderate to severe physical symptoms group achieved minimal symptoms after 3 months of treatment, only 13% of patients with moderate to severe physical and emotional systems reported minimal symptoms during this same time frame.

The study builds on previous work that “suggests that there are different factors that we can identify around the time of diagnosis that point to how well a person is likely to respond,” Dr. Bartlett added. “What our work is showing pretty clearly [is that] the presence of anxiety and depression is one of those important markers.”
 

Patients With Depression Report Worse Disease Activity

In a related study, researchers from the University of Ottawa explored how depression in RA affected subjective and objective disease measures.

The study included patients from the Ottawa Rheumatology Comprehensive Treatment and Assessment (ORCHESTRA) clinic at The Ottawa Hospital, Ottawa, Ontario, Canada, which sees patients with inflammatory arthritis who are starting biologic therapy or switching to another biologic. The clinic is designed to take a more comprehensive approach to managing inflammatory arthritis, including addressing comorbidities such as cardiac disease, depression, and cancer. Patients seen at the clinic can opt to be included in the ORCHESTRA cohort to be a part of ongoing research.

From this cohort, researchers identified 98 patients with RA. At enrollment, patients were screened for depression using patient health questionnaire scores and asked about duration of morning stiffness and tender joint counts. Swollen joint counts, ultrasound, and clinical scores were used to evaluate disease activity.

In the study group, 47 patients had no depression, 21 patients had mild depression, and 30 patients had moderate to severe depression. Researchers found that subjective disease measures, including visual analog pain scale, health assessment questionnaire, and disease activity score in 28 joints were all higher in patients with depression; however, depression did not appear to affect objective disease measures, such as the Global OMERACT-EULAR Synovitis Score or Doppler scores.

While there is a known link between inflammation and depression, these findings suggest that depression is “a concomitant comorbidity just like cardiovascular disease, just like fibromyalgia, just like some other comorbidity that also needs to be addressed in its own right to improve the outcomes,” noted Elliot Hepworth, MD, a rheumatologist and ORCHESTRA clinic lead at The Ottawa Hospital, in an interview.

Dr. Hepworth presented the findings on March 1.

Dr. Elliot Hepworth

The data also suggested that patients with depression had poorer outcomes. For the 79 patients who had 3-month follow-up visit data, 43.9% of patients with no or mild depression achieved LDA and remission compared with 21.7% of patients with moderate to severe depression, though this difference was not statistically significant (P = .064). There was a similar trend for the 39 patients with 6-month follow-up data: Only 20% of patients with moderate to severe depression had reached LDA and remission compared with 37.9% of patients with no or mild depression (P = .445). The researchers noted this could be an issue with a smaller sample size.

“Every time more patients get added we approach closer to significance,” Dr. Hepworth added.
 

Some Disagreement, Same Takeaway

Commenting on the Ottawa study, Dr. Bartlett was skeptical of the conclusion that depression may not directly influence disease activity. “There’s just too much good evidence these days that [depression] very much coexists with worse disease activity,” she said. “It is not in the person’s head.”

Dr. Hepworth added that patient-reported outcomes are important for clinicians to address during treatment.

“There’s the tender joints, there’s the pain, there’s the fatigue, there’s the patient global assessment, which are subjective,” he said, “but that does not mean that they are not important. Those are important to the patient: That is how they’re living their life, and that is how they’re experiencing their disease.”

This is why efforts to treat depression in patients with RA such as cognitive behavioral therapy are so important, he said, to which Dr. Bartlett agreed.

“A comprehensive approach is required, which includes addressing depression,” she said. Otherwise, data show “that people just never make it to remission.”

The studies looked at different patient populations but ultimately complement each other, added Sibel Aydin, MD, a professor of medicine in the Division of Rheumatology at the University of Ottawa, Ottawa, Ontario, Canada, and senior author of the Ottawa study.

Dr. Sibel Aydin

“Two different cohorts with different patient populations still reached the same result,” she said. “If you don’t address the emotional aspect, you are not going to achieve the good outcomes.”

“It’s remarkable when you have two independent researchers coming to the same conclusion without ever talking to each other,” added Dr. Hepworth. “That really shows that this is something that’s pervasive, and it’s not just within our patient population.”

CATCH is funded by unrestricted research grants from programs with Pfizer, AbbVie, Roche, Sandoz, Fresenius Kabi, Organon, Viatris, JAMP, and Celltrion. Dr. Bartlett is president of the PROMIS Health Organization. She is a member of speakers bureaus or has consulted for Pfizer, Sandoz, Merck, Janssen, and Organon. Dr. Hepworth and Dr. Aydin declared no conflicts of interest.

A version of this article appeared on Medscape.com .

Patients diagnosed with rheumatoid arthritis (RA) and co-occurring anxiety or depression are less likely to achieve low disease activity (LDA) and better symptom control after 3 months of treatment, according to new research presented at the at the annual meeting of the Canadian Rheumatology Association.

The findings emphasized the importance of taking a multidisciplinary approach to RA treatment, said presenter Susan Bartlett, PhD, a professor in the Divisions of Clinical Epidemiology, Rheumatology, and Respiratory Epidemiology at McGill University in Montreal, Quebec, Canada.

McGill University

“In the absence of directly addressing anxiety and depression, people are not going to improve to the same extent we hope that they will,” she told this news organization.
 

Symptom Clusters in RA

In her research, presented on February 29, Dr. Bartlett explored how certain symptom clusters in RA predicted prognosis.

Symptom clusters are related symptoms that occur together and can be associated with worse outcomes than one symptom alone. Symptom science has been a growing interest in precision medicine, particularly for cancer, Dr. Bartlett noted, and this same approach could help pinpoint RA subtypes, disease trajectories, and personalized treatment.

In the study, Dr. Bartlett and colleagues used data from the Canadian Early Arthritis Cohort (CATCH), a multisite prospective research study following individuals with new-onset RA. They identified patients starting methotrexate (MTX) therapy who also had clinical and patient-reported outcome measures available. Individuals included in the analysis may have also been taking additional disease-modifying antirheumatic drugs beyond MTX.

Across the 310 selected individuals, researchers identified four key symptoms: Pain, fatigue, anxiety, and depression. Pain and fatigue were defined as physical symptoms, while anxiety and depression were classified as emotional symptoms. Results showed that the patients could be sorted into four distinct symptom clusters: Minimal symptoms (12%), mild physical and emotional symptoms (11%), moderate to severe pain and fatigue (40%), and moderate to severe physical and emotional symptoms (37%).

Researchers then followed patients during the first 6 months of treatment to evaluate if patients’ symptoms improved.

Symptom improvement mostly occurred during the first 3 months of treatment and remained consistent at 6 months. Overall, patients with moderate to severe emotional symptoms had a worse prognosis and were less likely to achieve milder symptoms than those who had only pain and fatigue or mild emotional symptoms. While 64% of patients in the moderate to severe physical symptoms group achieved minimal symptoms after 3 months of treatment, only 13% of patients with moderate to severe physical and emotional systems reported minimal symptoms during this same time frame.

The study builds on previous work that “suggests that there are different factors that we can identify around the time of diagnosis that point to how well a person is likely to respond,” Dr. Bartlett added. “What our work is showing pretty clearly [is that] the presence of anxiety and depression is one of those important markers.”
 

Patients With Depression Report Worse Disease Activity

In a related study, researchers from the University of Ottawa explored how depression in RA affected subjective and objective disease measures.

The study included patients from the Ottawa Rheumatology Comprehensive Treatment and Assessment (ORCHESTRA) clinic at The Ottawa Hospital, Ottawa, Ontario, Canada, which sees patients with inflammatory arthritis who are starting biologic therapy or switching to another biologic. The clinic is designed to take a more comprehensive approach to managing inflammatory arthritis, including addressing comorbidities such as cardiac disease, depression, and cancer. Patients seen at the clinic can opt to be included in the ORCHESTRA cohort to be a part of ongoing research.

From this cohort, researchers identified 98 patients with RA. At enrollment, patients were screened for depression using patient health questionnaire scores and asked about duration of morning stiffness and tender joint counts. Swollen joint counts, ultrasound, and clinical scores were used to evaluate disease activity.

In the study group, 47 patients had no depression, 21 patients had mild depression, and 30 patients had moderate to severe depression. Researchers found that subjective disease measures, including visual analog pain scale, health assessment questionnaire, and disease activity score in 28 joints were all higher in patients with depression; however, depression did not appear to affect objective disease measures, such as the Global OMERACT-EULAR Synovitis Score or Doppler scores.

While there is a known link between inflammation and depression, these findings suggest that depression is “a concomitant comorbidity just like cardiovascular disease, just like fibromyalgia, just like some other comorbidity that also needs to be addressed in its own right to improve the outcomes,” noted Elliot Hepworth, MD, a rheumatologist and ORCHESTRA clinic lead at The Ottawa Hospital, in an interview.

Dr. Hepworth presented the findings on March 1.

Dr. Elliot Hepworth

The data also suggested that patients with depression had poorer outcomes. For the 79 patients who had 3-month follow-up visit data, 43.9% of patients with no or mild depression achieved LDA and remission compared with 21.7% of patients with moderate to severe depression, though this difference was not statistically significant (P = .064). There was a similar trend for the 39 patients with 6-month follow-up data: Only 20% of patients with moderate to severe depression had reached LDA and remission compared with 37.9% of patients with no or mild depression (P = .445). The researchers noted this could be an issue with a smaller sample size.

“Every time more patients get added we approach closer to significance,” Dr. Hepworth added.
 

Some Disagreement, Same Takeaway

Commenting on the Ottawa study, Dr. Bartlett was skeptical of the conclusion that depression may not directly influence disease activity. “There’s just too much good evidence these days that [depression] very much coexists with worse disease activity,” she said. “It is not in the person’s head.”

Dr. Hepworth added that patient-reported outcomes are important for clinicians to address during treatment.

“There’s the tender joints, there’s the pain, there’s the fatigue, there’s the patient global assessment, which are subjective,” he said, “but that does not mean that they are not important. Those are important to the patient: That is how they’re living their life, and that is how they’re experiencing their disease.”

This is why efforts to treat depression in patients with RA such as cognitive behavioral therapy are so important, he said, to which Dr. Bartlett agreed.

“A comprehensive approach is required, which includes addressing depression,” she said. Otherwise, data show “that people just never make it to remission.”

The studies looked at different patient populations but ultimately complement each other, added Sibel Aydin, MD, a professor of medicine in the Division of Rheumatology at the University of Ottawa, Ottawa, Ontario, Canada, and senior author of the Ottawa study.

Dr. Sibel Aydin

“Two different cohorts with different patient populations still reached the same result,” she said. “If you don’t address the emotional aspect, you are not going to achieve the good outcomes.”

“It’s remarkable when you have two independent researchers coming to the same conclusion without ever talking to each other,” added Dr. Hepworth. “That really shows that this is something that’s pervasive, and it’s not just within our patient population.”

CATCH is funded by unrestricted research grants from programs with Pfizer, AbbVie, Roche, Sandoz, Fresenius Kabi, Organon, Viatris, JAMP, and Celltrion. Dr. Bartlett is president of the PROMIS Health Organization. She is a member of speakers bureaus or has consulted for Pfizer, Sandoz, Merck, Janssen, and Organon. Dr. Hepworth and Dr. Aydin declared no conflicts of interest.

A version of this article appeared on Medscape.com .

TOPLINE:

Tapering glucocorticoids (GCs) does not increase the risk for flare in modified serologically active clinically quiescent (mSACQ) patients with systemic lupus erythematosus (SLE) with a low daily exposure to GC.

METHODOLOGY:

• Previous research has indicated that SACQ SLE is associated with an increased risk for flare after low-dose GC withdrawal.
• Researchers assessed the risk for flare and damage accrual after tapering GCs in mSACQ patients with SLE.
• They used data from the Asia Pacific Lupus Collaboration (APLC) to study 1850 patients (mean age, 40 years; 91.6% women) who met the criteria for SLE, including the definition of mSACQ at least once during observation and being followed up for 2 years after the first mSACQ visit.
• mSACQ was defined as a condition with serological activity but without clinical activity managed with ≤ 7.5 mg/d of -equivalent GCs, regardless of duration.
• The primary outcome was disease flare (both severe and overall) on the basis of the SELENA-SLEDAI flare index definitions.

TAKEAWAY:

• A total of 742 patients experienced an overall flare, 271 experienced a severe flare, and 180 experienced damage accrual.
• Reducing the prednisolone-equivalent GC dosage by 1 mg/d did not increase the risk for an overall (P = .27) or severe (P = .11) flare in patients initially on prednisolone-equivalent GC dosages of 0-7.5 mg/d.
• Antimalarial use decreased the risk for overall (hazard ratio [HR], 0.78; P = .002) and severe (HR, 0.59; P < .001) flares, and immunosuppressant use decreased the risk for severe flares (HR, 0.77; P = .043) but not overall flares.
• Reducing the GC dosage by 1 mg/d reduced the risk for damage accrual by 4% in patients who started taking prednisolone at a dose > 5 but ≤ 7.5 mg/d (P = .007).

IN PRACTICE:

“Cautious tapering of GCs is a feasible option for mSACQ-SLE with low daily exposure to GCs (≤ 7.5 mg/d of prednisolone-equivalent) and can reduce GC burden,” wrote the authors.

SOURCE:

The study, led by Yasuhiro Katsumata, Division of Rheumatology, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The data were collected retrospectively. A short follow-up duration might have prevented the demonstration of clear benefits in terms of damage accrual among patients receiving < 5 mg of GCs. Moreover, the findings may have limited generalizability as the majority of patients had Asian ancestry.

DISCLOSURES:

This work was supported by grants and funding from AstraZeneca, Bristol-Myers Squibb, Eli Lily, Janssen, Merck Serono, UCB, GlaxoSmithKline, Australia, and others to APLC. Some of the authors declared receiving honoraria, consulting fees, research grants, and research support from various sources.

A version of this article appeared on Medscape.com.

TOPLINE:

Tapering glucocorticoids (GCs) does not increase the risk for flare in modified serologically active clinically quiescent (mSACQ) patients with systemic lupus erythematosus (SLE) with a low daily exposure to GC.

METHODOLOGY:

• Previous research has indicated that SACQ SLE is associated with an increased risk for flare after low-dose GC withdrawal.
• Researchers assessed the risk for flare and damage accrual after tapering GCs in mSACQ patients with SLE.
• They used data from the Asia Pacific Lupus Collaboration (APLC) to study 1850 patients (mean age, 40 years; 91.6% women) who met the criteria for SLE, including the definition of mSACQ at least once during observation and being followed up for 2 years after the first mSACQ visit.
• mSACQ was defined as a condition with serological activity but without clinical activity managed with ≤ 7.5 mg/d of -equivalent GCs, regardless of duration.
• The primary outcome was disease flare (both severe and overall) on the basis of the SELENA-SLEDAI flare index definitions.

TAKEAWAY:

• A total of 742 patients experienced an overall flare, 271 experienced a severe flare, and 180 experienced damage accrual.
• Reducing the prednisolone-equivalent GC dosage by 1 mg/d did not increase the risk for an overall (P = .27) or severe (P = .11) flare in patients initially on prednisolone-equivalent GC dosages of 0-7.5 mg/d.
• Antimalarial use decreased the risk for overall (hazard ratio [HR], 0.78; P = .002) and severe (HR, 0.59; P < .001) flares, and immunosuppressant use decreased the risk for severe flares (HR, 0.77; P = .043) but not overall flares.
• Reducing the GC dosage by 1 mg/d reduced the risk for damage accrual by 4% in patients who started taking prednisolone at a dose > 5 but ≤ 7.5 mg/d (P = .007).

IN PRACTICE:

“Cautious tapering of GCs is a feasible option for mSACQ-SLE with low daily exposure to GCs (≤ 7.5 mg/d of prednisolone-equivalent) and can reduce GC burden,” wrote the authors.

SOURCE:

The study, led by Yasuhiro Katsumata, Division of Rheumatology, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The data were collected retrospectively. A short follow-up duration might have prevented the demonstration of clear benefits in terms of damage accrual among patients receiving < 5 mg of GCs. Moreover, the findings may have limited generalizability as the majority of patients had Asian ancestry.

DISCLOSURES:

This work was supported by grants and funding from AstraZeneca, Bristol-Myers Squibb, Eli Lily, Janssen, Merck Serono, UCB, GlaxoSmithKline, Australia, and others to APLC. Some of the authors declared receiving honoraria, consulting fees, research grants, and research support from various sources.

A version of this article appeared on Medscape.com.

TOPLINE:

Tapering glucocorticoids (GCs) does not increase the risk for flare in modified serologically active clinically quiescent (mSACQ) patients with systemic lupus erythematosus (SLE) with a low daily exposure to GC.

METHODOLOGY:

• Previous research has indicated that SACQ SLE is associated with an increased risk for flare after low-dose GC withdrawal.
• Researchers assessed the risk for flare and damage accrual after tapering GCs in mSACQ patients with SLE.
• They used data from the Asia Pacific Lupus Collaboration (APLC) to study 1850 patients (mean age, 40 years; 91.6% women) who met the criteria for SLE, including the definition of mSACQ at least once during observation and being followed up for 2 years after the first mSACQ visit.
• mSACQ was defined as a condition with serological activity but without clinical activity managed with ≤ 7.5 mg/d of -equivalent GCs, regardless of duration.
• The primary outcome was disease flare (both severe and overall) on the basis of the SELENA-SLEDAI flare index definitions.

TAKEAWAY:

• A total of 742 patients experienced an overall flare, 271 experienced a severe flare, and 180 experienced damage accrual.
• Reducing the prednisolone-equivalent GC dosage by 1 mg/d did not increase the risk for an overall (P = .27) or severe (P = .11) flare in patients initially on prednisolone-equivalent GC dosages of 0-7.5 mg/d.
• Antimalarial use decreased the risk for overall (hazard ratio [HR], 0.78; P = .002) and severe (HR, 0.59; P < .001) flares, and immunosuppressant use decreased the risk for severe flares (HR, 0.77; P = .043) but not overall flares.
• Reducing the GC dosage by 1 mg/d reduced the risk for damage accrual by 4% in patients who started taking prednisolone at a dose > 5 but ≤ 7.5 mg/d (P = .007).

IN PRACTICE:

“Cautious tapering of GCs is a feasible option for mSACQ-SLE with low daily exposure to GCs (≤ 7.5 mg/d of prednisolone-equivalent) and can reduce GC burden,” wrote the authors.

SOURCE:

The study, led by Yasuhiro Katsumata, Division of Rheumatology, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan, was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The data were collected retrospectively. A short follow-up duration might have prevented the demonstration of clear benefits in terms of damage accrual among patients receiving < 5 mg of GCs. Moreover, the findings may have limited generalizability as the majority of patients had Asian ancestry.

DISCLOSURES:

This work was supported by grants and funding from AstraZeneca, Bristol-Myers Squibb, Eli Lily, Janssen, Merck Serono, UCB, GlaxoSmithKline, Australia, and others to APLC. Some of the authors declared receiving honoraria, consulting fees, research grants, and research support from various sources.

A version of this article appeared on Medscape.com.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

A new drug-device combo aimed at detecting residual cancer in real time during lumpectomy is one step closer to gaining federal approval, but some physicians aren’t convinced the technology is safe — or effective enough — to start using on patients.

A majority of the US Food and Drug Administration’s Medical Imaging Drugs Advisory Committee (MIDAC) on March 5 voted in support of LUMISIGHT’s (pegulicianine) benefit-risk profile.

LUMISIGHT is an optical imaging agent used in combination with Lumicell Direct Visualization System (DVS), a fluorescence-guided imaging system. The technology, developed by Lumicell Inc., helps surgeons identify cancer that may remain in the breast after they’ve completed the main resection of tissue.

Following MIDAC’s positive vote, the FDA will move on to reviewing Lumicell’s new drug application for LUMISIGHT and its premarket approval application for Lumicell DVS.

“We are proud of the efforts and look forward to the next steps as we work with the FDA to finalize the approval process so that women with breast cancer can access the therapy,” Jorge Ferrer, PhD, Lumicell’s chief scientific officer, said in an interview.

However, Freya Schnabel, MD, professor of surgery and director of breast surgery at NYU Perlmutter Cancer Center, said there are some “real concerns” with the technology. She expressed surprise at MIDAC’s overall favorable vote.

In a recently published study, she noted that the use of pegulicianine fluorescence-guided surgery (pFGS) did not meet the prespecified threshold for sensitivity.

“It did meet thresholds for removal of residual tumor and specificity — but this is still basically a negative study, and a low sensitivity raises concerns regarding false negative readings,” she said in an interview. “I’m surprised [the committee] is supportive in light of this result. Also, the technique is logistically challenging, as patients need to be injected 2 to 6 hours before their surgeries, very challenging timing for patients having ambulatory procedures.”

The study, published in the April 2023 NEJM Evidence, analyzed 357 patients who received 1.0 mg/kg intravenous pegulicianine followed by lumpectomy. Tumor left behind after standard lumpectomy was removed in 27 of 357 patients through use of pFGS. Of the 27, 22 patients had cavity orientations deemed “negative” on standard margin evaluation, according to the study. A margin is described as negative or clean when there are no further cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. Second surgeries were avoided by pFGS in 9 of 62 patients with positive margins, the analysis found.

On per-margin analysis, pFGS specificity was 85.2%, and sensitivity was 49.3%. While the sensitivity endpoint missed the lower boundary of the 95% confidence interval, the LUM system exceeded the specificity endpoint of 60% with a point estimate of 86%, and an accuracy of 84% for imaging residual cancer in the lumpectomy cavity, coinvestigator E. Shelley Hwang, MD, MPH, said during the MIDAC meeting.

“The pivotal study was an adequate and well-controlled study demonstrating the effectiveness of the LUM system to detect residual cancer in the lumpectomy cavity, following the standard of care procedure,” she said. “These results also demonstrate clinical benefit that improves the current standard of care. This is the first and only imaging system that provides results in the lumpectomy cavity in real time, allowing surgeons to use this information at the time of the initial procedure.”

Is the Technology Safe?

Pegulicianine is an imaging agent that contains a fluorescent dye. The agent is given to patients as a 3-minute intravenous infusion 2 to 6 hours before surgery.

After removal of the main tumor specimen, the surgeon inserts a handheld probe into the breast cavity and in combination with the detection software, searches for residual cancer that may have been left behind, Dr. Ferrer explained during the MIDAC meeting.

If the software identifies areas suspicious for residual cancer, those areas display in red on an overhead screen. The surgeon then takes a targeted shave to resect the suspicious tissue. Once the tissue has been removed, the surgeon can rescan the cavity with the probe to ensure a more complete resection has been performed. Use of the LUM system typically takes surgeons less than 7 minutes to use, Dr. Ferrer said.

In the study, a total of 406 patients received the intravenous pegulicianine, but 14 patients were withdrawn before randomization. After a standard lumpectomy procedure, 357 patients were assigned to the pFGS group and 35 patients to the control group.

Of the 406 patients, pegulicianine administration was stopped for adverse events in 6 patients (1.5%). Two patients had grade 3 serious adverse events related to pegulicianine; one had hypersensitivity, and one had an anaphylactic reaction. The other four pegulicianine-related adverse events included allergic reaction, milder hypersensitivity, nausea, and pegulicianine extravasation.

Dr. Schnabel said these reactions are worrisome. While any effort to reduce the need for patients to have more than one surgery to complete a breast conserving approach would be a “real advance,” Dr. Schnabel said she would not feel comfortable using pFGS in her own practice if approved by the FDA as is.

“This is clearly a major issue in terms of incorporating this technique into practice,” she said. “I could go on, but in light of the above, I’m surprised that [the committee] is supportive. I would hope for some refinement of the technique to reduce the risks to patients and improve the results before I’d consider utilizing this approach.”

During the MIDAC meeting, Dr. Ferrer said the company takes the safety events seriously and has developed mitigation strategies to further reduce the risk of patient hypersensitivity. These strategies include: clear labeling that informs users of anaphylaxis risk, incorporating a new section into the device training program to address warnings and precautions, an enhanced pharmacovigilance program to closely track and report hypersensitivity events, and a postmarket study to access the incidence rate and risk of such events in a broader population.

Several MIDAC members raised questions about the adverse reactions observed and about the safety of the technology.

David B. Hackney, MD, a neuroradiologist at Beth Israel Deaconess Medical Center in Boston, questioned the recommendation that patients only be monitored for 15 minutes after the injection.

“Since you don’t have enough data to know how long after injection reactions could occur, why not keep them under monitoring until after the surgery is over?” he said.

Barbara Smith, MD, PhD, lead investigator of the study, explained that per the protocol, there would be frequent monitoring, with a nurse at bedside, and patients would be monitored after injection, on their way to the procedure, and afterward.

She suggested, during the meeting, that more intense monitoring early in the process would be beneficial as that is when investigators observed side effects believed to be attributed to LUMISIGHT.

MIDAC member Kimberly E. Applegate, MD, a retired radiology professor, asked about the learning curve for surgeons and how long it generally takes for physicians to become familiar with the system.

Coinvestigator Kelly Hunt, MD, explained that all surgeons who participated in the trial completed a training program.

“Certainly, there’s a learning curve anytime we introduce new technology in the operating room,” she said. “Surgeons said it usually takes about three procedures before they’re comfortable with the system, including the camera and the software.”

During a presentation period by FDA officials, Anil Rajpal, MD, MPH, FDA, Deputy Division Director for Safety, said it’s important that prescribing information for LUMISIGHT communicate the risk of anaphylaxis and other hypersensitivity reactions, the need to monitor patients, and the need for the appropriate available personnel, medications, and equipment.

“This would be done by warnings and precautions and a boxed warning,” he said. “Note, that [such warnings] would only communicate the risks, it would not further characterize the risk.”
 

Committee Expresses Support

During a subsequent vote among committee members, most expressed support for the technology and its benefits. Sixteen members voted in support, one abstained, and two voted against the benefit-risk profile.

Andrea Richardson, MD, PhD, professor of pathology at Johns Hopkins in Baltimore, said she voted yes because the incremental benefits of avoiding additional surgeries outweigh the small risk of anaphylaxis.

Henry Royal, MD, MIDAC chair and professor of radiology at Washington University School of Medicine in St. Louis, agreed.

“Even though the benefit of this is on average, quite small, the benefit to the woman who has positive margins that’s converted to negative margins because of use of [LUMISIGHT] is really quite great,” he said. “The risk from this procedure is certainly very manageable.”

Harold J. Burstein, MD, PhD, a professor of medicine at Harvard Medical School and oncologist at Dana-Farber Cancer Institute in Boston, voted against the benefit-risk profile. He said the technology merits more research and that he does not believe it was proven the technology reduces the risk of reoperation.

“I think it’s a great technology,” he said. “I would like to see a well-conducted, randomized, phase III study with the endpoint of reoperation,” he said. “That would really prove the usefulness and benefit of the intervention in my mind.”

Chengjie Xiong, PhD, professor of biostatistics at Washington University School of Medicine in St. Louis, chose to abstain from voting because he said there was not enough data.

The FDA will now complete its review of Lumicell’s new drug application for LUMISIGHT and review of its premarket approval application for Lumicell DVS. The FDA review team has 6-10 months to make a decision. As part of the process, the FDA will evaluate clinical data, travel to clinical study sites to conduct inspections, and assemble a final action package for a senior FDA official to make a final decision.

If deemed safe and effective, the FDA will then work with Lumicell on developing and refining prescribing information.

Dr. Ferrer said his team expects to receive FDA approval in the coming weeks and will continue to work collaboratively with the FDA to expedite approval where possible.

The purpose of the MIDAC is to review and evaluate data about the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and make appropriate recommendations to the FDA Commissioner.

A new drug-device combo aimed at detecting residual cancer in real time during lumpectomy is one step closer to gaining federal approval, but some physicians aren’t convinced the technology is safe — or effective enough — to start using on patients.

A majority of the US Food and Drug Administration’s Medical Imaging Drugs Advisory Committee (MIDAC) on March 5 voted in support of LUMISIGHT’s (pegulicianine) benefit-risk profile.

LUMISIGHT is an optical imaging agent used in combination with Lumicell Direct Visualization System (DVS), a fluorescence-guided imaging system. The technology, developed by Lumicell Inc., helps surgeons identify cancer that may remain in the breast after they’ve completed the main resection of tissue.

Following MIDAC’s positive vote, the FDA will move on to reviewing Lumicell’s new drug application for LUMISIGHT and its premarket approval application for Lumicell DVS.

“We are proud of the efforts and look forward to the next steps as we work with the FDA to finalize the approval process so that women with breast cancer can access the therapy,” Jorge Ferrer, PhD, Lumicell’s chief scientific officer, said in an interview.

However, Freya Schnabel, MD, professor of surgery and director of breast surgery at NYU Perlmutter Cancer Center, said there are some “real concerns” with the technology. She expressed surprise at MIDAC’s overall favorable vote.

In a recently published study, she noted that the use of pegulicianine fluorescence-guided surgery (pFGS) did not meet the prespecified threshold for sensitivity.

“It did meet thresholds for removal of residual tumor and specificity — but this is still basically a negative study, and a low sensitivity raises concerns regarding false negative readings,” she said in an interview. “I’m surprised [the committee] is supportive in light of this result. Also, the technique is logistically challenging, as patients need to be injected 2 to 6 hours before their surgeries, very challenging timing for patients having ambulatory procedures.”

The study, published in the April 2023 NEJM Evidence, analyzed 357 patients who received 1.0 mg/kg intravenous pegulicianine followed by lumpectomy. Tumor left behind after standard lumpectomy was removed in 27 of 357 patients through use of pFGS. Of the 27, 22 patients had cavity orientations deemed “negative” on standard margin evaluation, according to the study. A margin is described as negative or clean when there are no further cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. Second surgeries were avoided by pFGS in 9 of 62 patients with positive margins, the analysis found.

On per-margin analysis, pFGS specificity was 85.2%, and sensitivity was 49.3%. While the sensitivity endpoint missed the lower boundary of the 95% confidence interval, the LUM system exceeded the specificity endpoint of 60% with a point estimate of 86%, and an accuracy of 84% for imaging residual cancer in the lumpectomy cavity, coinvestigator E. Shelley Hwang, MD, MPH, said during the MIDAC meeting.

“The pivotal study was an adequate and well-controlled study demonstrating the effectiveness of the LUM system to detect residual cancer in the lumpectomy cavity, following the standard of care procedure,” she said. “These results also demonstrate clinical benefit that improves the current standard of care. This is the first and only imaging system that provides results in the lumpectomy cavity in real time, allowing surgeons to use this information at the time of the initial procedure.”

Is the Technology Safe?

Pegulicianine is an imaging agent that contains a fluorescent dye. The agent is given to patients as a 3-minute intravenous infusion 2 to 6 hours before surgery.

After removal of the main tumor specimen, the surgeon inserts a handheld probe into the breast cavity and in combination with the detection software, searches for residual cancer that may have been left behind, Dr. Ferrer explained during the MIDAC meeting.

If the software identifies areas suspicious for residual cancer, those areas display in red on an overhead screen. The surgeon then takes a targeted shave to resect the suspicious tissue. Once the tissue has been removed, the surgeon can rescan the cavity with the probe to ensure a more complete resection has been performed. Use of the LUM system typically takes surgeons less than 7 minutes to use, Dr. Ferrer said.

In the study, a total of 406 patients received the intravenous pegulicianine, but 14 patients were withdrawn before randomization. After a standard lumpectomy procedure, 357 patients were assigned to the pFGS group and 35 patients to the control group.

Of the 406 patients, pegulicianine administration was stopped for adverse events in 6 patients (1.5%). Two patients had grade 3 serious adverse events related to pegulicianine; one had hypersensitivity, and one had an anaphylactic reaction. The other four pegulicianine-related adverse events included allergic reaction, milder hypersensitivity, nausea, and pegulicianine extravasation.

Dr. Schnabel said these reactions are worrisome. While any effort to reduce the need for patients to have more than one surgery to complete a breast conserving approach would be a “real advance,” Dr. Schnabel said she would not feel comfortable using pFGS in her own practice if approved by the FDA as is.

“This is clearly a major issue in terms of incorporating this technique into practice,” she said. “I could go on, but in light of the above, I’m surprised that [the committee] is supportive. I would hope for some refinement of the technique to reduce the risks to patients and improve the results before I’d consider utilizing this approach.”

During the MIDAC meeting, Dr. Ferrer said the company takes the safety events seriously and has developed mitigation strategies to further reduce the risk of patient hypersensitivity. These strategies include: clear labeling that informs users of anaphylaxis risk, incorporating a new section into the device training program to address warnings and precautions, an enhanced pharmacovigilance program to closely track and report hypersensitivity events, and a postmarket study to access the incidence rate and risk of such events in a broader population.

Several MIDAC members raised questions about the adverse reactions observed and about the safety of the technology.

David B. Hackney, MD, a neuroradiologist at Beth Israel Deaconess Medical Center in Boston, questioned the recommendation that patients only be monitored for 15 minutes after the injection.

“Since you don’t have enough data to know how long after injection reactions could occur, why not keep them under monitoring until after the surgery is over?” he said.

Barbara Smith, MD, PhD, lead investigator of the study, explained that per the protocol, there would be frequent monitoring, with a nurse at bedside, and patients would be monitored after injection, on their way to the procedure, and afterward.

She suggested, during the meeting, that more intense monitoring early in the process would be beneficial as that is when investigators observed side effects believed to be attributed to LUMISIGHT.

MIDAC member Kimberly E. Applegate, MD, a retired radiology professor, asked about the learning curve for surgeons and how long it generally takes for physicians to become familiar with the system.

Coinvestigator Kelly Hunt, MD, explained that all surgeons who participated in the trial completed a training program.

“Certainly, there’s a learning curve anytime we introduce new technology in the operating room,” she said. “Surgeons said it usually takes about three procedures before they’re comfortable with the system, including the camera and the software.”

During a presentation period by FDA officials, Anil Rajpal, MD, MPH, FDA, Deputy Division Director for Safety, said it’s important that prescribing information for LUMISIGHT communicate the risk of anaphylaxis and other hypersensitivity reactions, the need to monitor patients, and the need for the appropriate available personnel, medications, and equipment.

“This would be done by warnings and precautions and a boxed warning,” he said. “Note, that [such warnings] would only communicate the risks, it would not further characterize the risk.”
 

Committee Expresses Support

During a subsequent vote among committee members, most expressed support for the technology and its benefits. Sixteen members voted in support, one abstained, and two voted against the benefit-risk profile.

Andrea Richardson, MD, PhD, professor of pathology at Johns Hopkins in Baltimore, said she voted yes because the incremental benefits of avoiding additional surgeries outweigh the small risk of anaphylaxis.

Henry Royal, MD, MIDAC chair and professor of radiology at Washington University School of Medicine in St. Louis, agreed.

“Even though the benefit of this is on average, quite small, the benefit to the woman who has positive margins that’s converted to negative margins because of use of [LUMISIGHT] is really quite great,” he said. “The risk from this procedure is certainly very manageable.”

Harold J. Burstein, MD, PhD, a professor of medicine at Harvard Medical School and oncologist at Dana-Farber Cancer Institute in Boston, voted against the benefit-risk profile. He said the technology merits more research and that he does not believe it was proven the technology reduces the risk of reoperation.

“I think it’s a great technology,” he said. “I would like to see a well-conducted, randomized, phase III study with the endpoint of reoperation,” he said. “That would really prove the usefulness and benefit of the intervention in my mind.”

Chengjie Xiong, PhD, professor of biostatistics at Washington University School of Medicine in St. Louis, chose to abstain from voting because he said there was not enough data.

The FDA will now complete its review of Lumicell’s new drug application for LUMISIGHT and review of its premarket approval application for Lumicell DVS. The FDA review team has 6-10 months to make a decision. As part of the process, the FDA will evaluate clinical data, travel to clinical study sites to conduct inspections, and assemble a final action package for a senior FDA official to make a final decision.

If deemed safe and effective, the FDA will then work with Lumicell on developing and refining prescribing information.

Dr. Ferrer said his team expects to receive FDA approval in the coming weeks and will continue to work collaboratively with the FDA to expedite approval where possible.

The purpose of the MIDAC is to review and evaluate data about the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and make appropriate recommendations to the FDA Commissioner.

A new drug-device combo aimed at detecting residual cancer in real time during lumpectomy is one step closer to gaining federal approval, but some physicians aren’t convinced the technology is safe — or effective enough — to start using on patients.

A majority of the US Food and Drug Administration’s Medical Imaging Drugs Advisory Committee (MIDAC) on March 5 voted in support of LUMISIGHT’s (pegulicianine) benefit-risk profile.

LUMISIGHT is an optical imaging agent used in combination with Lumicell Direct Visualization System (DVS), a fluorescence-guided imaging system. The technology, developed by Lumicell Inc., helps surgeons identify cancer that may remain in the breast after they’ve completed the main resection of tissue.

Following MIDAC’s positive vote, the FDA will move on to reviewing Lumicell’s new drug application for LUMISIGHT and its premarket approval application for Lumicell DVS.

“We are proud of the efforts and look forward to the next steps as we work with the FDA to finalize the approval process so that women with breast cancer can access the therapy,” Jorge Ferrer, PhD, Lumicell’s chief scientific officer, said in an interview.

However, Freya Schnabel, MD, professor of surgery and director of breast surgery at NYU Perlmutter Cancer Center, said there are some “real concerns” with the technology. She expressed surprise at MIDAC’s overall favorable vote.

In a recently published study, she noted that the use of pegulicianine fluorescence-guided surgery (pFGS) did not meet the prespecified threshold for sensitivity.

“It did meet thresholds for removal of residual tumor and specificity — but this is still basically a negative study, and a low sensitivity raises concerns regarding false negative readings,” she said in an interview. “I’m surprised [the committee] is supportive in light of this result. Also, the technique is logistically challenging, as patients need to be injected 2 to 6 hours before their surgeries, very challenging timing for patients having ambulatory procedures.”

The study, published in the April 2023 NEJM Evidence, analyzed 357 patients who received 1.0 mg/kg intravenous pegulicianine followed by lumpectomy. Tumor left behind after standard lumpectomy was removed in 27 of 357 patients through use of pFGS. Of the 27, 22 patients had cavity orientations deemed “negative” on standard margin evaluation, according to the study. A margin is described as negative or clean when there are no further cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. Second surgeries were avoided by pFGS in 9 of 62 patients with positive margins, the analysis found.

On per-margin analysis, pFGS specificity was 85.2%, and sensitivity was 49.3%. While the sensitivity endpoint missed the lower boundary of the 95% confidence interval, the LUM system exceeded the specificity endpoint of 60% with a point estimate of 86%, and an accuracy of 84% for imaging residual cancer in the lumpectomy cavity, coinvestigator E. Shelley Hwang, MD, MPH, said during the MIDAC meeting.

“The pivotal study was an adequate and well-controlled study demonstrating the effectiveness of the LUM system to detect residual cancer in the lumpectomy cavity, following the standard of care procedure,” she said. “These results also demonstrate clinical benefit that improves the current standard of care. This is the first and only imaging system that provides results in the lumpectomy cavity in real time, allowing surgeons to use this information at the time of the initial procedure.”

Is the Technology Safe?

Pegulicianine is an imaging agent that contains a fluorescent dye. The agent is given to patients as a 3-minute intravenous infusion 2 to 6 hours before surgery.

After removal of the main tumor specimen, the surgeon inserts a handheld probe into the breast cavity and in combination with the detection software, searches for residual cancer that may have been left behind, Dr. Ferrer explained during the MIDAC meeting.

If the software identifies areas suspicious for residual cancer, those areas display in red on an overhead screen. The surgeon then takes a targeted shave to resect the suspicious tissue. Once the tissue has been removed, the surgeon can rescan the cavity with the probe to ensure a more complete resection has been performed. Use of the LUM system typically takes surgeons less than 7 minutes to use, Dr. Ferrer said.

In the study, a total of 406 patients received the intravenous pegulicianine, but 14 patients were withdrawn before randomization. After a standard lumpectomy procedure, 357 patients were assigned to the pFGS group and 35 patients to the control group.

Of the 406 patients, pegulicianine administration was stopped for adverse events in 6 patients (1.5%). Two patients had grade 3 serious adverse events related to pegulicianine; one had hypersensitivity, and one had an anaphylactic reaction. The other four pegulicianine-related adverse events included allergic reaction, milder hypersensitivity, nausea, and pegulicianine extravasation.

Dr. Schnabel said these reactions are worrisome. While any effort to reduce the need for patients to have more than one surgery to complete a breast conserving approach would be a “real advance,” Dr. Schnabel said she would not feel comfortable using pFGS in her own practice if approved by the FDA as is.

“This is clearly a major issue in terms of incorporating this technique into practice,” she said. “I could go on, but in light of the above, I’m surprised that [the committee] is supportive. I would hope for some refinement of the technique to reduce the risks to patients and improve the results before I’d consider utilizing this approach.”

During the MIDAC meeting, Dr. Ferrer said the company takes the safety events seriously and has developed mitigation strategies to further reduce the risk of patient hypersensitivity. These strategies include: clear labeling that informs users of anaphylaxis risk, incorporating a new section into the device training program to address warnings and precautions, an enhanced pharmacovigilance program to closely track and report hypersensitivity events, and a postmarket study to access the incidence rate and risk of such events in a broader population.

Several MIDAC members raised questions about the adverse reactions observed and about the safety of the technology.

David B. Hackney, MD, a neuroradiologist at Beth Israel Deaconess Medical Center in Boston, questioned the recommendation that patients only be monitored for 15 minutes after the injection.

“Since you don’t have enough data to know how long after injection reactions could occur, why not keep them under monitoring until after the surgery is over?” he said.

Barbara Smith, MD, PhD, lead investigator of the study, explained that per the protocol, there would be frequent monitoring, with a nurse at bedside, and patients would be monitored after injection, on their way to the procedure, and afterward.

She suggested, during the meeting, that more intense monitoring early in the process would be beneficial as that is when investigators observed side effects believed to be attributed to LUMISIGHT.

MIDAC member Kimberly E. Applegate, MD, a retired radiology professor, asked about the learning curve for surgeons and how long it generally takes for physicians to become familiar with the system.

Coinvestigator Kelly Hunt, MD, explained that all surgeons who participated in the trial completed a training program.

“Certainly, there’s a learning curve anytime we introduce new technology in the operating room,” she said. “Surgeons said it usually takes about three procedures before they’re comfortable with the system, including the camera and the software.”

During a presentation period by FDA officials, Anil Rajpal, MD, MPH, FDA, Deputy Division Director for Safety, said it’s important that prescribing information for LUMISIGHT communicate the risk of anaphylaxis and other hypersensitivity reactions, the need to monitor patients, and the need for the appropriate available personnel, medications, and equipment.

“This would be done by warnings and precautions and a boxed warning,” he said. “Note, that [such warnings] would only communicate the risks, it would not further characterize the risk.”
 

Committee Expresses Support

During a subsequent vote among committee members, most expressed support for the technology and its benefits. Sixteen members voted in support, one abstained, and two voted against the benefit-risk profile.

Andrea Richardson, MD, PhD, professor of pathology at Johns Hopkins in Baltimore, said she voted yes because the incremental benefits of avoiding additional surgeries outweigh the small risk of anaphylaxis.

Henry Royal, MD, MIDAC chair and professor of radiology at Washington University School of Medicine in St. Louis, agreed.

“Even though the benefit of this is on average, quite small, the benefit to the woman who has positive margins that’s converted to negative margins because of use of [LUMISIGHT] is really quite great,” he said. “The risk from this procedure is certainly very manageable.”

Harold J. Burstein, MD, PhD, a professor of medicine at Harvard Medical School and oncologist at Dana-Farber Cancer Institute in Boston, voted against the benefit-risk profile. He said the technology merits more research and that he does not believe it was proven the technology reduces the risk of reoperation.

“I think it’s a great technology,” he said. “I would like to see a well-conducted, randomized, phase III study with the endpoint of reoperation,” he said. “That would really prove the usefulness and benefit of the intervention in my mind.”

Chengjie Xiong, PhD, professor of biostatistics at Washington University School of Medicine in St. Louis, chose to abstain from voting because he said there was not enough data.

The FDA will now complete its review of Lumicell’s new drug application for LUMISIGHT and review of its premarket approval application for Lumicell DVS. The FDA review team has 6-10 months to make a decision. As part of the process, the FDA will evaluate clinical data, travel to clinical study sites to conduct inspections, and assemble a final action package for a senior FDA official to make a final decision.

If deemed safe and effective, the FDA will then work with Lumicell on developing and refining prescribing information.

Dr. Ferrer said his team expects to receive FDA approval in the coming weeks and will continue to work collaboratively with the FDA to expedite approval where possible.

The purpose of the MIDAC is to review and evaluate data about the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and make appropriate recommendations to the FDA Commissioner.

The US Food and Drug Administration (FDA) has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from a phase 2b clinical trial. Mind Medicine (MindMed) Inc is developing the treatment — MM120 (lysergide d-tartrate).

In a news release, the company reports that a single oral dose of MM120 met its key secondary endpoint, maintaining “clinically and statistically significant” reductions in Hamilton Anxiety Scale (HAM-A) score, compared with placebo, at 12 weeks with a 65% clinical response rate and 48% clinical remission rate.

The company previously announced statistically significant improvements on the HAM-A compared with placebo at 4 weeks, which was the trial’s primary endpoint.

“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California, San Diego, and director of the Kadima Neuropsychiatry Institute in La Jolla, California, said in the news release.

“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials,” Dr. Feifel added.

MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.

MM120 100 µg — the dose that demonstrated optimal clinical activity — produced a 7.7-point improvement over placebo at week 12 (P < .003; Cohen’s d = 0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.

Also at week 12, Clinical Global Impressions–Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (P < .004), the company reported.

Improvement was noted as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between 4 and 12 weeks.

MM120 was generally well-tolerated with most adverse events rated as mild to moderate and transient and occurred on the day of administration day, in line with the expected acute effects of the study drug.

The most common adverse events on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis, and hyperhidrosis.

The company plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024 and start phase 3 testing in the second half of 2024.

“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” Robert Barrow, director and CEO of MindMed said in the release.

The primary data analyses from the trial will be presented at the American Psychiatric Association (APA) annual meeting in May.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from a phase 2b clinical trial. Mind Medicine (MindMed) Inc is developing the treatment — MM120 (lysergide d-tartrate).

In a news release, the company reports that a single oral dose of MM120 met its key secondary endpoint, maintaining “clinically and statistically significant” reductions in Hamilton Anxiety Scale (HAM-A) score, compared with placebo, at 12 weeks with a 65% clinical response rate and 48% clinical remission rate.

The company previously announced statistically significant improvements on the HAM-A compared with placebo at 4 weeks, which was the trial’s primary endpoint.

“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California, San Diego, and director of the Kadima Neuropsychiatry Institute in La Jolla, California, said in the news release.

“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials,” Dr. Feifel added.

MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.

MM120 100 µg — the dose that demonstrated optimal clinical activity — produced a 7.7-point improvement over placebo at week 12 (P < .003; Cohen’s d = 0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.

Also at week 12, Clinical Global Impressions–Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (P < .004), the company reported.

Improvement was noted as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between 4 and 12 weeks.

MM120 was generally well-tolerated with most adverse events rated as mild to moderate and transient and occurred on the day of administration day, in line with the expected acute effects of the study drug.

The most common adverse events on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis, and hyperhidrosis.

The company plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024 and start phase 3 testing in the second half of 2024.

“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” Robert Barrow, director and CEO of MindMed said in the release.

The primary data analyses from the trial will be presented at the American Psychiatric Association (APA) annual meeting in May.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from a phase 2b clinical trial. Mind Medicine (MindMed) Inc is developing the treatment — MM120 (lysergide d-tartrate).

In a news release, the company reports that a single oral dose of MM120 met its key secondary endpoint, maintaining “clinically and statistically significant” reductions in Hamilton Anxiety Scale (HAM-A) score, compared with placebo, at 12 weeks with a 65% clinical response rate and 48% clinical remission rate.

The company previously announced statistically significant improvements on the HAM-A compared with placebo at 4 weeks, which was the trial’s primary endpoint.

“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California, San Diego, and director of the Kadima Neuropsychiatry Institute in La Jolla, California, said in the news release.

“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials,” Dr. Feifel added.

MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.

MM120 100 µg — the dose that demonstrated optimal clinical activity — produced a 7.7-point improvement over placebo at week 12 (P < .003; Cohen’s d = 0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.

Also at week 12, Clinical Global Impressions–Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (P < .004), the company reported.

Improvement was noted as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between 4 and 12 weeks.

MM120 was generally well-tolerated with most adverse events rated as mild to moderate and transient and occurred on the day of administration day, in line with the expected acute effects of the study drug.

The most common adverse events on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis, and hyperhidrosis.

The company plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024 and start phase 3 testing in the second half of 2024.

“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” Robert Barrow, director and CEO of MindMed said in the release.

The primary data analyses from the trial will be presented at the American Psychiatric Association (APA) annual meeting in May.

A version of this article appeared on Medscape.com.

Sulfites, present in foods, drinks, pharmaceuticals, and personal care products, have been named the “Allergen of the Year” for 2024 by the American Contact Dermatitis Society (ACDS).

Sulfites are currently not found in most screening patch test series, so may be missed as a relevant contact allergen, Donald V. Belsito, MD, emeritus professor in the Department of Dermatology at Columbia University, New York City, said in his presentation on the Allergen of the Year on March 7 at the annual meeting of the American Contact Dermatitis Society in San Diego. Sulfites, he noted, are distinct from sulfates, and the groups do not cross-react with each other.

FabrikaCr/iStock/Getty Images Plus

Sodium disulfite, an inorganic compound, belongs to a group of sulfiting agents, which contain the sulfite ion SO₃²⁻ and include ammonium sulfite, potassium sulfite, and sodium sulfite, Dr. Belsito said. Sulfites function as antioxidants and preservatives in a range of products including food and beverages, personal care products, and pharmaceuticals.

The type of sulfite allergy diagnosed by patch testing is type IV hypersensitivity or delayed-type hypersensitivity, where patients present with pruritic, red, scaling macules, papulovesicles, and patches, Dr. Belsito told this news organization. “It is not the type I, immediate hypersensitivity that causes hives and, in some cases, anaphylaxis,” he said. Sulfites also can cause these side effects, so correct labeling of food and beverages is important, he noted.

Some common nonoccupational sulfite sources include hair coloring and bleach products, hairspray, tanning lotions, makeup, sunscreens, and deodorants, Dr. Belsito said in his presentation. Medications including topical antifungals, topical corticosteroids, and nasal solutions can be culprits, as can water in swimming pools, he noted.

In occupational settings, sulfites may be present not only in food and drink products but also can be used in production of products, such as those used for sterilization during beer and wine fermentation, Dr. Belsito said. Other potential occupational sources of sulfite exposure include healthcare settings and textile, chemical, rubber, and pharmaceutical manufacturing.

High-sulfite food products (> 100 ppm) to be aware of include dried fruit (raisins and prunes are exceptions), bottled lemon or lime juice (but not frozen products), wine, molasses, grape juice (white, or white, pink, and red sparkling), and pickled cocktail onions, Dr. Belsito said.

“Like other contact allergens, the clinical presentation correlates with exposure,” he added. A study by the North American Contact Dermatitis Group (NACDG) found that 28.8% of patients positive for sulfite allergy on patch testing presented with facial dermatitis, which was not only related to cosmetics and medications used on the face but also from products, such as shampoo, used on the scalp that dripped onto the face. “The scalp is relatively resistant to the expression of contact allergy and may not be involved at all,” he said.

According to the NACDG study, the hands were the second most common site of dermatitis associated with sulfites (20.5%) followed by generalized distribution (13.6%). These sites are to be expected, given the sources of food and beverage, personal care products, and occupational materials, Dr. Belsito said.

“Eczematous dermatitis of the lips is also common in patients with ingested food sources of sulfites,” he said.

Systemic contact dermatitis to sulfites has been documented following oral, rectal, and parental exposure, Dr. Belsito told this news organization. “Systemic dermatitis may present as a scattered/generalized dermatitis, symmetrical drug-related intertriginous and flexural exanthema (also referred to as baboon syndrome), or erythroderma,” he said.
 

How to Spot Sulfite Allergies

The exclusion of sulfites from most patch test series means that sulfite allergy diagnoses are often missed, despite the wide range of potential exposures, Dr. Belsito said.

“Most cases of allergic contact dermatitis occur at the site of application of the allergen,” he noted. Depending on the location of the dermatitis, a detailed history of exposures that includes cosmetics and topical medications, work-related materials, and foods and beverages might suggest a sulfite allergy, he said.

Given the range of potential clinical presentations and the many and varied exposures to sulfites, Dr. Belsito’s best tip for clinicians is to routinely screen for them and evaluate the many avenues of exposure if a patch test is positive, he said.

For now, he said he does not think additional research is needed on sulfites as allergens; instead, sulfites, such as sodium metabisulfite/sodium disulfite, should be included in all clinicians’ baseline screening series, he said.

The Allergen of the Year was also recently announced in the journal Dermatitis. Authors Samuel F. Ekstein, MS, and Erin M. Warshaw, MD, from the Department of Dermatology, Park Nicollet Health Services, Minneapolis, Minnesota, noted that the ACDS hoped to raise awareness of sulfites as a “significant allergen” and called for their increased inclusion in screening patch test series.

Patients identified with sulfite allergies can find alternative products on the ACDS CAMP (Contact Allergen Management Program) website, Dr. Warshaw said in an interview.

She also highlighted some examples of sulfites as allergens in healthcare settings in particular. She described one patient who presented with dermatitis at the site of three previous hand orthopedic procedures.

“Although surgical cleansers were suspected, the patient reacted to sodium metabisulfite. Review of the operating room contactants confirmed sulfites as preservatives in an injectable anesthetic and antibiotic used for wound irrigation,” she said. Another patient who had been treated for recurrent otitis externa and seborrheic dermatitis was found to be allergic to sulfites in an otic antibiotic suspension as well as in a ketoconazole cream product, she added.

In the paper, Dr. Warshaw and Mr. Ekstein called for the addition of sulfites to the test series. Although the NACDG added sodium metabisulfite to the series in 2017, sulfites are not part of the American Contact Dermatitis Core Series, they wrote. Sodium metabisulfite, they said, was added to the European baseline standard series after review of the 2019-2020 patch test reactivity and clinical relevance data.

The ACDS meeting is held every year the day before the annual meeting of the American Academy of Dermatology.

Dr. Belsito and Dr. Warshaw had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Sulfites, present in foods, drinks, pharmaceuticals, and personal care products, have been named the “Allergen of the Year” for 2024 by the American Contact Dermatitis Society (ACDS).

Sulfites are currently not found in most screening patch test series, so may be missed as a relevant contact allergen, Donald V. Belsito, MD, emeritus professor in the Department of Dermatology at Columbia University, New York City, said in his presentation on the Allergen of the Year on March 7 at the annual meeting of the American Contact Dermatitis Society in San Diego. Sulfites, he noted, are distinct from sulfates, and the groups do not cross-react with each other.

FabrikaCr/iStock/Getty Images Plus

Sodium disulfite, an inorganic compound, belongs to a group of sulfiting agents, which contain the sulfite ion SO₃²⁻ and include ammonium sulfite, potassium sulfite, and sodium sulfite, Dr. Belsito said. Sulfites function as antioxidants and preservatives in a range of products including food and beverages, personal care products, and pharmaceuticals.

The type of sulfite allergy diagnosed by patch testing is type IV hypersensitivity or delayed-type hypersensitivity, where patients present with pruritic, red, scaling macules, papulovesicles, and patches, Dr. Belsito told this news organization. “It is not the type I, immediate hypersensitivity that causes hives and, in some cases, anaphylaxis,” he said. Sulfites also can cause these side effects, so correct labeling of food and beverages is important, he noted.

Some common nonoccupational sulfite sources include hair coloring and bleach products, hairspray, tanning lotions, makeup, sunscreens, and deodorants, Dr. Belsito said in his presentation. Medications including topical antifungals, topical corticosteroids, and nasal solutions can be culprits, as can water in swimming pools, he noted.

In occupational settings, sulfites may be present not only in food and drink products but also can be used in production of products, such as those used for sterilization during beer and wine fermentation, Dr. Belsito said. Other potential occupational sources of sulfite exposure include healthcare settings and textile, chemical, rubber, and pharmaceutical manufacturing.

High-sulfite food products (> 100 ppm) to be aware of include dried fruit (raisins and prunes are exceptions), bottled lemon or lime juice (but not frozen products), wine, molasses, grape juice (white, or white, pink, and red sparkling), and pickled cocktail onions, Dr. Belsito said.

“Like other contact allergens, the clinical presentation correlates with exposure,” he added. A study by the North American Contact Dermatitis Group (NACDG) found that 28.8% of patients positive for sulfite allergy on patch testing presented with facial dermatitis, which was not only related to cosmetics and medications used on the face but also from products, such as shampoo, used on the scalp that dripped onto the face. “The scalp is relatively resistant to the expression of contact allergy and may not be involved at all,” he said.

According to the NACDG study, the hands were the second most common site of dermatitis associated with sulfites (20.5%) followed by generalized distribution (13.6%). These sites are to be expected, given the sources of food and beverage, personal care products, and occupational materials, Dr. Belsito said.

“Eczematous dermatitis of the lips is also common in patients with ingested food sources of sulfites,” he said.

Systemic contact dermatitis to sulfites has been documented following oral, rectal, and parental exposure, Dr. Belsito told this news organization. “Systemic dermatitis may present as a scattered/generalized dermatitis, symmetrical drug-related intertriginous and flexural exanthema (also referred to as baboon syndrome), or erythroderma,” he said.
 

How to Spot Sulfite Allergies

The exclusion of sulfites from most patch test series means that sulfite allergy diagnoses are often missed, despite the wide range of potential exposures, Dr. Belsito said.

“Most cases of allergic contact dermatitis occur at the site of application of the allergen,” he noted. Depending on the location of the dermatitis, a detailed history of exposures that includes cosmetics and topical medications, work-related materials, and foods and beverages might suggest a sulfite allergy, he said.

Given the range of potential clinical presentations and the many and varied exposures to sulfites, Dr. Belsito’s best tip for clinicians is to routinely screen for them and evaluate the many avenues of exposure if a patch test is positive, he said.

For now, he said he does not think additional research is needed on sulfites as allergens; instead, sulfites, such as sodium metabisulfite/sodium disulfite, should be included in all clinicians’ baseline screening series, he said.

The Allergen of the Year was also recently announced in the journal Dermatitis. Authors Samuel F. Ekstein, MS, and Erin M. Warshaw, MD, from the Department of Dermatology, Park Nicollet Health Services, Minneapolis, Minnesota, noted that the ACDS hoped to raise awareness of sulfites as a “significant allergen” and called for their increased inclusion in screening patch test series.

Patients identified with sulfite allergies can find alternative products on the ACDS CAMP (Contact Allergen Management Program) website, Dr. Warshaw said in an interview.

She also highlighted some examples of sulfites as allergens in healthcare settings in particular. She described one patient who presented with dermatitis at the site of three previous hand orthopedic procedures.

“Although surgical cleansers were suspected, the patient reacted to sodium metabisulfite. Review of the operating room contactants confirmed sulfites as preservatives in an injectable anesthetic and antibiotic used for wound irrigation,” she said. Another patient who had been treated for recurrent otitis externa and seborrheic dermatitis was found to be allergic to sulfites in an otic antibiotic suspension as well as in a ketoconazole cream product, she added.

In the paper, Dr. Warshaw and Mr. Ekstein called for the addition of sulfites to the test series. Although the NACDG added sodium metabisulfite to the series in 2017, sulfites are not part of the American Contact Dermatitis Core Series, they wrote. Sodium metabisulfite, they said, was added to the European baseline standard series after review of the 2019-2020 patch test reactivity and clinical relevance data.

The ACDS meeting is held every year the day before the annual meeting of the American Academy of Dermatology.

Dr. Belsito and Dr. Warshaw had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Sulfites, present in foods, drinks, pharmaceuticals, and personal care products, have been named the “Allergen of the Year” for 2024 by the American Contact Dermatitis Society (ACDS).

Sulfites are currently not found in most screening patch test series, so may be missed as a relevant contact allergen, Donald V. Belsito, MD, emeritus professor in the Department of Dermatology at Columbia University, New York City, said in his presentation on the Allergen of the Year on March 7 at the annual meeting of the American Contact Dermatitis Society in San Diego. Sulfites, he noted, are distinct from sulfates, and the groups do not cross-react with each other.

FabrikaCr/iStock/Getty Images Plus

Sodium disulfite, an inorganic compound, belongs to a group of sulfiting agents, which contain the sulfite ion SO₃²⁻ and include ammonium sulfite, potassium sulfite, and sodium sulfite, Dr. Belsito said. Sulfites function as antioxidants and preservatives in a range of products including food and beverages, personal care products, and pharmaceuticals.

The type of sulfite allergy diagnosed by patch testing is type IV hypersensitivity or delayed-type hypersensitivity, where patients present with pruritic, red, scaling macules, papulovesicles, and patches, Dr. Belsito told this news organization. “It is not the type I, immediate hypersensitivity that causes hives and, in some cases, anaphylaxis,” he said. Sulfites also can cause these side effects, so correct labeling of food and beverages is important, he noted.

Some common nonoccupational sulfite sources include hair coloring and bleach products, hairspray, tanning lotions, makeup, sunscreens, and deodorants, Dr. Belsito said in his presentation. Medications including topical antifungals, topical corticosteroids, and nasal solutions can be culprits, as can water in swimming pools, he noted.

In occupational settings, sulfites may be present not only in food and drink products but also can be used in production of products, such as those used for sterilization during beer and wine fermentation, Dr. Belsito said. Other potential occupational sources of sulfite exposure include healthcare settings and textile, chemical, rubber, and pharmaceutical manufacturing.

High-sulfite food products (> 100 ppm) to be aware of include dried fruit (raisins and prunes are exceptions), bottled lemon or lime juice (but not frozen products), wine, molasses, grape juice (white, or white, pink, and red sparkling), and pickled cocktail onions, Dr. Belsito said.

“Like other contact allergens, the clinical presentation correlates with exposure,” he added. A study by the North American Contact Dermatitis Group (NACDG) found that 28.8% of patients positive for sulfite allergy on patch testing presented with facial dermatitis, which was not only related to cosmetics and medications used on the face but also from products, such as shampoo, used on the scalp that dripped onto the face. “The scalp is relatively resistant to the expression of contact allergy and may not be involved at all,” he said.

According to the NACDG study, the hands were the second most common site of dermatitis associated with sulfites (20.5%) followed by generalized distribution (13.6%). These sites are to be expected, given the sources of food and beverage, personal care products, and occupational materials, Dr. Belsito said.

“Eczematous dermatitis of the lips is also common in patients with ingested food sources of sulfites,” he said.

Systemic contact dermatitis to sulfites has been documented following oral, rectal, and parental exposure, Dr. Belsito told this news organization. “Systemic dermatitis may present as a scattered/generalized dermatitis, symmetrical drug-related intertriginous and flexural exanthema (also referred to as baboon syndrome), or erythroderma,” he said.
 

How to Spot Sulfite Allergies

The exclusion of sulfites from most patch test series means that sulfite allergy diagnoses are often missed, despite the wide range of potential exposures, Dr. Belsito said.

“Most cases of allergic contact dermatitis occur at the site of application of the allergen,” he noted. Depending on the location of the dermatitis, a detailed history of exposures that includes cosmetics and topical medications, work-related materials, and foods and beverages might suggest a sulfite allergy, he said.

Given the range of potential clinical presentations and the many and varied exposures to sulfites, Dr. Belsito’s best tip for clinicians is to routinely screen for them and evaluate the many avenues of exposure if a patch test is positive, he said.

For now, he said he does not think additional research is needed on sulfites as allergens; instead, sulfites, such as sodium metabisulfite/sodium disulfite, should be included in all clinicians’ baseline screening series, he said.

The Allergen of the Year was also recently announced in the journal Dermatitis. Authors Samuel F. Ekstein, MS, and Erin M. Warshaw, MD, from the Department of Dermatology, Park Nicollet Health Services, Minneapolis, Minnesota, noted that the ACDS hoped to raise awareness of sulfites as a “significant allergen” and called for their increased inclusion in screening patch test series.

Patients identified with sulfite allergies can find alternative products on the ACDS CAMP (Contact Allergen Management Program) website, Dr. Warshaw said in an interview.

She also highlighted some examples of sulfites as allergens in healthcare settings in particular. She described one patient who presented with dermatitis at the site of three previous hand orthopedic procedures.

“Although surgical cleansers were suspected, the patient reacted to sodium metabisulfite. Review of the operating room contactants confirmed sulfites as preservatives in an injectable anesthetic and antibiotic used for wound irrigation,” she said. Another patient who had been treated for recurrent otitis externa and seborrheic dermatitis was found to be allergic to sulfites in an otic antibiotic suspension as well as in a ketoconazole cream product, she added.

In the paper, Dr. Warshaw and Mr. Ekstein called for the addition of sulfites to the test series. Although the NACDG added sodium metabisulfite to the series in 2017, sulfites are not part of the American Contact Dermatitis Core Series, they wrote. Sodium metabisulfite, they said, was added to the European baseline standard series after review of the 2019-2020 patch test reactivity and clinical relevance data.

The ACDS meeting is held every year the day before the annual meeting of the American Academy of Dermatology.

Dr. Belsito and Dr. Warshaw had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.