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Few Differences Seen in RA Pain Outcomes for JAK Inhibitors, Biologics
TOPLINE:
Janus kinase (JAK) inhibitors had a marginally superior effect on pain relief when compared with tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis (RA), particularly when used as monotherapy and in those previously treated with at least two biologic disease-modifying antirheumatic drugs (DMARDs), but their pain reduction effects were similar to those of non–TNF inhibitor biologic DMARDs.
METHODOLOGY:
- Researchers aimed to compare the effect of JAK inhibitors and each class of biologic DMARDs such as TNF inhibitors, rituximab, abatacept, and interleukin (IL)-6 inhibitors on pain in patients with RA in clinical practice.
- They included 8430 patients with RA who were initiated on either a JAK inhibitor (n = 1827), TNF inhibitor (n = 6422), IL-6 inhibitor (n = 887), abatacept (n = 1102), or rituximab (n = 1149) in 2017-2019.
- Differences in the change in pain, assessed using a visual analog scale (VAS; 0-100 mm), from baseline to 3 months were compared between the treatment arms.
- The proportion of patients who continued their initial treatment with low pain levels (VAS pain, < 20 mm) at 12 months was also evaluated.
- The comparisons of treatment responses between JAK inhibitors and biologic DMARDs were analyzed using multivariate linear regression, adjusted for patient characteristics, comorbidities, current co-medication, and previous treatment.
TAKEAWAY:
- Pain scores improved from baseline to 3 months in all the treatment arms, with mean changes ranging from −20.1 mm (95% CI, −23.1 to −17.2) for IL-6 inhibitors to −16.6 mm (95% CI, −19.1 to −14.0) for rituximab.
- At 3 months, JAK inhibitors reduced pain scores by 4.0 mm (95% CI, 1.7-6.3) more than TNF inhibitors and by 3.9 mm (95% CI, 0.9-6.9) more than rituximab; however, the change in pain was not significantly different on comparing JAK inhibitors with abatacept or IL-6 inhibitors.
- The superior pain-reducing effects of JAK inhibitors over those of TNF inhibitors were more prominent in those who were previously treated with at least two biologic DMARDs and when the treatments were used as monotherapy.
- At 12 months, 19.5% of the patients receiving JAK inhibitors continued their treatment and achieved low pain levels, with the corresponding proportions ranging from 17% to 26% for biologic DMARDs; JAK inhibitors were more effective in reducing pain than TNF inhibitors, although the difference was not statistically significant.
IN PRACTICE:
“JAK inhibitors yield slightly better pain outcomes than TNF inhibitors. The magnitude of these effects is unlikely to be clinically meaningful in unselected groups of patients with RA,” experts from Feinberg School of Medicine, Northwestern University, Chicago, wrote in an accompanying editorial. “Specific subgroups, such as those who have tried at least two DMARDs, may experience greater effects,” they added.
SOURCE:
The study was led by Anna Eberhard, MD, Department of Clinical Sciences, Lund University, Malmö, Sweden. It was published online on September 22, 2024, in Arthritis & Rheumatology.
LIMITATIONS:
The study had a significant amount of missing data, particularly for follow-up evaluations, which may have introduced bias. The majority of patients were treated using baricitinib, potentially limiting the generalizability to other JAK inhibitors. Residual confounding could not be excluded despite adjustments for multiple relevant patient characteristics.
DISCLOSURES:
This study was supported by grants from The Swedish Research Council, The Swedish Rheumatism Association, and Lund University. Some authors declared receiving consulting fees, payments or honoraria, or grants or having other ties with pharmaceutical companies and other sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Janus kinase (JAK) inhibitors had a marginally superior effect on pain relief when compared with tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis (RA), particularly when used as monotherapy and in those previously treated with at least two biologic disease-modifying antirheumatic drugs (DMARDs), but their pain reduction effects were similar to those of non–TNF inhibitor biologic DMARDs.
METHODOLOGY:
- Researchers aimed to compare the effect of JAK inhibitors and each class of biologic DMARDs such as TNF inhibitors, rituximab, abatacept, and interleukin (IL)-6 inhibitors on pain in patients with RA in clinical practice.
- They included 8430 patients with RA who were initiated on either a JAK inhibitor (n = 1827), TNF inhibitor (n = 6422), IL-6 inhibitor (n = 887), abatacept (n = 1102), or rituximab (n = 1149) in 2017-2019.
- Differences in the change in pain, assessed using a visual analog scale (VAS; 0-100 mm), from baseline to 3 months were compared between the treatment arms.
- The proportion of patients who continued their initial treatment with low pain levels (VAS pain, < 20 mm) at 12 months was also evaluated.
- The comparisons of treatment responses between JAK inhibitors and biologic DMARDs were analyzed using multivariate linear regression, adjusted for patient characteristics, comorbidities, current co-medication, and previous treatment.
TAKEAWAY:
- Pain scores improved from baseline to 3 months in all the treatment arms, with mean changes ranging from −20.1 mm (95% CI, −23.1 to −17.2) for IL-6 inhibitors to −16.6 mm (95% CI, −19.1 to −14.0) for rituximab.
- At 3 months, JAK inhibitors reduced pain scores by 4.0 mm (95% CI, 1.7-6.3) more than TNF inhibitors and by 3.9 mm (95% CI, 0.9-6.9) more than rituximab; however, the change in pain was not significantly different on comparing JAK inhibitors with abatacept or IL-6 inhibitors.
- The superior pain-reducing effects of JAK inhibitors over those of TNF inhibitors were more prominent in those who were previously treated with at least two biologic DMARDs and when the treatments were used as monotherapy.
- At 12 months, 19.5% of the patients receiving JAK inhibitors continued their treatment and achieved low pain levels, with the corresponding proportions ranging from 17% to 26% for biologic DMARDs; JAK inhibitors were more effective in reducing pain than TNF inhibitors, although the difference was not statistically significant.
IN PRACTICE:
“JAK inhibitors yield slightly better pain outcomes than TNF inhibitors. The magnitude of these effects is unlikely to be clinically meaningful in unselected groups of patients with RA,” experts from Feinberg School of Medicine, Northwestern University, Chicago, wrote in an accompanying editorial. “Specific subgroups, such as those who have tried at least two DMARDs, may experience greater effects,” they added.
SOURCE:
The study was led by Anna Eberhard, MD, Department of Clinical Sciences, Lund University, Malmö, Sweden. It was published online on September 22, 2024, in Arthritis & Rheumatology.
LIMITATIONS:
The study had a significant amount of missing data, particularly for follow-up evaluations, which may have introduced bias. The majority of patients were treated using baricitinib, potentially limiting the generalizability to other JAK inhibitors. Residual confounding could not be excluded despite adjustments for multiple relevant patient characteristics.
DISCLOSURES:
This study was supported by grants from The Swedish Research Council, The Swedish Rheumatism Association, and Lund University. Some authors declared receiving consulting fees, payments or honoraria, or grants or having other ties with pharmaceutical companies and other sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Janus kinase (JAK) inhibitors had a marginally superior effect on pain relief when compared with tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis (RA), particularly when used as monotherapy and in those previously treated with at least two biologic disease-modifying antirheumatic drugs (DMARDs), but their pain reduction effects were similar to those of non–TNF inhibitor biologic DMARDs.
METHODOLOGY:
- Researchers aimed to compare the effect of JAK inhibitors and each class of biologic DMARDs such as TNF inhibitors, rituximab, abatacept, and interleukin (IL)-6 inhibitors on pain in patients with RA in clinical practice.
- They included 8430 patients with RA who were initiated on either a JAK inhibitor (n = 1827), TNF inhibitor (n = 6422), IL-6 inhibitor (n = 887), abatacept (n = 1102), or rituximab (n = 1149) in 2017-2019.
- Differences in the change in pain, assessed using a visual analog scale (VAS; 0-100 mm), from baseline to 3 months were compared between the treatment arms.
- The proportion of patients who continued their initial treatment with low pain levels (VAS pain, < 20 mm) at 12 months was also evaluated.
- The comparisons of treatment responses between JAK inhibitors and biologic DMARDs were analyzed using multivariate linear regression, adjusted for patient characteristics, comorbidities, current co-medication, and previous treatment.
TAKEAWAY:
- Pain scores improved from baseline to 3 months in all the treatment arms, with mean changes ranging from −20.1 mm (95% CI, −23.1 to −17.2) for IL-6 inhibitors to −16.6 mm (95% CI, −19.1 to −14.0) for rituximab.
- At 3 months, JAK inhibitors reduced pain scores by 4.0 mm (95% CI, 1.7-6.3) more than TNF inhibitors and by 3.9 mm (95% CI, 0.9-6.9) more than rituximab; however, the change in pain was not significantly different on comparing JAK inhibitors with abatacept or IL-6 inhibitors.
- The superior pain-reducing effects of JAK inhibitors over those of TNF inhibitors were more prominent in those who were previously treated with at least two biologic DMARDs and when the treatments were used as monotherapy.
- At 12 months, 19.5% of the patients receiving JAK inhibitors continued their treatment and achieved low pain levels, with the corresponding proportions ranging from 17% to 26% for biologic DMARDs; JAK inhibitors were more effective in reducing pain than TNF inhibitors, although the difference was not statistically significant.
IN PRACTICE:
“JAK inhibitors yield slightly better pain outcomes than TNF inhibitors. The magnitude of these effects is unlikely to be clinically meaningful in unselected groups of patients with RA,” experts from Feinberg School of Medicine, Northwestern University, Chicago, wrote in an accompanying editorial. “Specific subgroups, such as those who have tried at least two DMARDs, may experience greater effects,” they added.
SOURCE:
The study was led by Anna Eberhard, MD, Department of Clinical Sciences, Lund University, Malmö, Sweden. It was published online on September 22, 2024, in Arthritis & Rheumatology.
LIMITATIONS:
The study had a significant amount of missing data, particularly for follow-up evaluations, which may have introduced bias. The majority of patients were treated using baricitinib, potentially limiting the generalizability to other JAK inhibitors. Residual confounding could not be excluded despite adjustments for multiple relevant patient characteristics.
DISCLOSURES:
This study was supported by grants from The Swedish Research Council, The Swedish Rheumatism Association, and Lund University. Some authors declared receiving consulting fees, payments or honoraria, or grants or having other ties with pharmaceutical companies and other sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Small Bowel Dysmotility Brings Challenges to Patients With Systemic Sclerosis
TOPLINE:
Patients with systemic sclerosis (SSc) who exhibit abnormal small bowel transit are more likely to be men, experience more severe cardiac involvement, have a higher mortality risk, and show fewer sicca symptoms.
METHODOLOGY:
- Researchers enrolled 130 patients with SSc having gastrointestinal (GI) symptoms (mean age at symptom onset, 56.8 years; 90% women; 81% White) seen at the Johns Hopkins Scleroderma Center, Baltimore, from October 2014 to May 2022.
- Clinical data and serum samples were longitudinally collected from all actively followed patients at the time of enrollment and every 6 months thereafter (median disease duration, 8.4 years).
- Participants underwent whole gut transit scintigraphy for the assessment of small bowel motility.
- A cross-sectional analysis compared the clinical features of patients with (n = 22; mean age at symptom onset, 61.4 years) and without (n = 108; mean age at symptom onset, 55.8 years) abnormal small bowel transit.
TAKEAWAY:
- Men with SSc (odds ratio [OR], 3.70; P = .038) and those with severe cardiac involvement (OR, 3.98; P = .035) were more likely to have abnormal small bowel transit.
- Sicca symptoms were negatively associated with abnormal small bowel transit in patients with SSc (adjusted OR, 0.28; P = .043).
- Patients with abnormal small bowel transit reported significantly worse (P = .028) and social functioning (P = .015) than those having a normal transit.
- A multivariate analysis showed that patients with abnormal small bowel transit had higher mortality than those with a normal transit (adjusted hazard ratio, 5.03; P = .005).
IN PRACTICE:
“Our findings improve our understanding of risk factors associated with abnormal small bowel transit in SSc patients and shed light on the lived experience of patients with this GI [gastrointestinal] complication,” the authors wrote. “Overall, these findings are important for patient risk stratification and monitoring and will help to identify a more homogeneous group of patients for future clinical and translational studies,” they added.
SOURCE:
The study was led by Jenice X. Cheah, MD, University of California, Los Angeles. It was published online on October 7, 2024, in Rheumatology.
LIMITATIONS:
The study may be subject to referral bias as it was conducted at a tertiary referral center, potentially including patients with a more severe disease status. Furthermore, this study was retrospective in nature, and whole gut transit studies were not conducted in all the patients seen at the referral center. Additionally, the cross-sectional design limited the ability to establish causality between the clinical features and abnormal small bowel transit.
DISCLOSURES:
The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Patients with systemic sclerosis (SSc) who exhibit abnormal small bowel transit are more likely to be men, experience more severe cardiac involvement, have a higher mortality risk, and show fewer sicca symptoms.
METHODOLOGY:
- Researchers enrolled 130 patients with SSc having gastrointestinal (GI) symptoms (mean age at symptom onset, 56.8 years; 90% women; 81% White) seen at the Johns Hopkins Scleroderma Center, Baltimore, from October 2014 to May 2022.
- Clinical data and serum samples were longitudinally collected from all actively followed patients at the time of enrollment and every 6 months thereafter (median disease duration, 8.4 years).
- Participants underwent whole gut transit scintigraphy for the assessment of small bowel motility.
- A cross-sectional analysis compared the clinical features of patients with (n = 22; mean age at symptom onset, 61.4 years) and without (n = 108; mean age at symptom onset, 55.8 years) abnormal small bowel transit.
TAKEAWAY:
- Men with SSc (odds ratio [OR], 3.70; P = .038) and those with severe cardiac involvement (OR, 3.98; P = .035) were more likely to have abnormal small bowel transit.
- Sicca symptoms were negatively associated with abnormal small bowel transit in patients with SSc (adjusted OR, 0.28; P = .043).
- Patients with abnormal small bowel transit reported significantly worse (P = .028) and social functioning (P = .015) than those having a normal transit.
- A multivariate analysis showed that patients with abnormal small bowel transit had higher mortality than those with a normal transit (adjusted hazard ratio, 5.03; P = .005).
IN PRACTICE:
“Our findings improve our understanding of risk factors associated with abnormal small bowel transit in SSc patients and shed light on the lived experience of patients with this GI [gastrointestinal] complication,” the authors wrote. “Overall, these findings are important for patient risk stratification and monitoring and will help to identify a more homogeneous group of patients for future clinical and translational studies,” they added.
SOURCE:
The study was led by Jenice X. Cheah, MD, University of California, Los Angeles. It was published online on October 7, 2024, in Rheumatology.
LIMITATIONS:
The study may be subject to referral bias as it was conducted at a tertiary referral center, potentially including patients with a more severe disease status. Furthermore, this study was retrospective in nature, and whole gut transit studies were not conducted in all the patients seen at the referral center. Additionally, the cross-sectional design limited the ability to establish causality between the clinical features and abnormal small bowel transit.
DISCLOSURES:
The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Patients with systemic sclerosis (SSc) who exhibit abnormal small bowel transit are more likely to be men, experience more severe cardiac involvement, have a higher mortality risk, and show fewer sicca symptoms.
METHODOLOGY:
- Researchers enrolled 130 patients with SSc having gastrointestinal (GI) symptoms (mean age at symptom onset, 56.8 years; 90% women; 81% White) seen at the Johns Hopkins Scleroderma Center, Baltimore, from October 2014 to May 2022.
- Clinical data and serum samples were longitudinally collected from all actively followed patients at the time of enrollment and every 6 months thereafter (median disease duration, 8.4 years).
- Participants underwent whole gut transit scintigraphy for the assessment of small bowel motility.
- A cross-sectional analysis compared the clinical features of patients with (n = 22; mean age at symptom onset, 61.4 years) and without (n = 108; mean age at symptom onset, 55.8 years) abnormal small bowel transit.
TAKEAWAY:
- Men with SSc (odds ratio [OR], 3.70; P = .038) and those with severe cardiac involvement (OR, 3.98; P = .035) were more likely to have abnormal small bowel transit.
- Sicca symptoms were negatively associated with abnormal small bowel transit in patients with SSc (adjusted OR, 0.28; P = .043).
- Patients with abnormal small bowel transit reported significantly worse (P = .028) and social functioning (P = .015) than those having a normal transit.
- A multivariate analysis showed that patients with abnormal small bowel transit had higher mortality than those with a normal transit (adjusted hazard ratio, 5.03; P = .005).
IN PRACTICE:
“Our findings improve our understanding of risk factors associated with abnormal small bowel transit in SSc patients and shed light on the lived experience of patients with this GI [gastrointestinal] complication,” the authors wrote. “Overall, these findings are important for patient risk stratification and monitoring and will help to identify a more homogeneous group of patients for future clinical and translational studies,” they added.
SOURCE:
The study was led by Jenice X. Cheah, MD, University of California, Los Angeles. It was published online on October 7, 2024, in Rheumatology.
LIMITATIONS:
The study may be subject to referral bias as it was conducted at a tertiary referral center, potentially including patients with a more severe disease status. Furthermore, this study was retrospective in nature, and whole gut transit studies were not conducted in all the patients seen at the referral center. Additionally, the cross-sectional design limited the ability to establish causality between the clinical features and abnormal small bowel transit.
DISCLOSURES:
The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Hospital Diagnostic Errors May Affect 7% of Patients
Diagnostic errors are common in hospitals and are largely preventable, according to a new observational study led by Anuj K. Dalal, MD, from the Division of General Internal Medicine at Brigham and Women’s Hospital and Harvard Medical School in Boston, published in BMJ Quality & Safety.
Dalal and his colleagues found that 1 in 14 general medicine patients (7%) suffer harm due to diagnostic errors, and up to 85% of these cases could be prevented.
Few Studies on Diagnostic Errors
The study found that adverse event surveillance in hospital underestimated the prevalence of harmful diagnostic errors.
“It is difficult to quantify and characterize diagnostic errors, which have been studied less than medication errors,” Micaela La Regina, MD, an internist and head of the Clinical Governance and Risk Management Unit at ASL 5 in La Spezia, Italy, told Univadis Italy. “Generally, it is estimated that around 50% of diagnostic errors are preventable, but the authors of this study went beyond simply observing the hospital admission period and followed their sample for 90 days after discharge. Their findings will need to be verified in other studies, but they seem convincing.”
The researchers in Boston selected a random sample of 675 hospital patients from a total of 9147 eligible cases who received general medical care between July 2019 and September 2021, excluding the peak of the COVID-19 pandemic (April-December 2020). They retrospectively reviewed the patients’ electronic health records using a structured method to evaluate the diagnostic process for potential errors and then estimated the impact and severity of any harm.
Cases sampled were those featuring transfer to intensive care more than 24 hours after admission (100% of 130 cases), death within 90 days of hospital admission or after discharge (38.5% of 141 cases), complex clinical problems without transfer to intensive care or death within 90 days of admission (7% of 298 cases), and 2.4% of 106 cases without high-risk criteria.
Each case was reviewed by two experts trained in the use of diagnostic error evaluation and research taxonomy, modified for acute care. Harm was classified as mild, moderate, severe, or fatal. The review assessed whether diagnostic error contributed to the harm and whether it was preventable. Cases with discrepancies or uncertainties regarding the diagnostic error or its impact were further examined by an expert panel.
Most Frequent Situations
Among all the cases examined, diagnostic errors were identified in 160 instances in 154 patients. The most frequent situations with diagnostic errors involved transfer to intensive care (54 cases), death within 90 days (34 cases), and complex clinical problems (52 cases). Diagnostic errors causing harm were found in 84 cases (82 patients), of which 37 (28.5%) occurred in those transferred to intensive care; 18 (13%) among patients who died within 90 days; 23 (8%) among patients with complex clinical issues; and 6 (6%) in low-risk cases.
The severity of harm was categorized as minor in 5 cases (6%), moderate in 36 (43%), major in 25 (30%), and fatal in 18 cases (21.5%). Overall, the researchers estimated that the proportion of harmful, preventable diagnostic errors with serious harm in general medicine patients was slightly more than 7%, 6%, and 1%, respectively.
Most Frequent Diagnoses
The most common diagnoses associated with diagnostic errors in the study included heart failure, acute kidney injury, sepsis, pneumonia, respiratory failure, altered mental state, abdominal pain, and hypoxemia. Dalal and colleagues emphasize the need for more attention to diagnostic error analysis, including the adoption of artificial intelligence–based tools for medical record screening.
“The technological approach, with alert-based systems, can certainly be helpful, but more attention must also be paid to continuous training and the well-being of healthcare workers. It is also crucial to encourage greater listening to caregivers and patients,” said La Regina. She noted that in the past, a focus on error prevention has often led to an increased workload and administrative burden on healthcare workers. However, the well-being of healthcare workers is key to ensuring patient safety.
“Countermeasures to reduce diagnostic errors require a multimodal approach, targeting professionals, the healthcare system, and organizational aspects, because even waiting lists are a critical factor,” she said. As a clinical risk expert, she recently proposed an adaptation of the value-based medicine formula in the International Journal for Quality in Health Care to include healthcare professionals’ care experience as one of the elements that contribute to determining high-value healthcare interventions. “Experiments are already underway to reimburse healthcare costs based on this formula, which also allows the assessment of the value of skills and expertise acquired by healthcare workers,” concluded La Regina.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Diagnostic errors are common in hospitals and are largely preventable, according to a new observational study led by Anuj K. Dalal, MD, from the Division of General Internal Medicine at Brigham and Women’s Hospital and Harvard Medical School in Boston, published in BMJ Quality & Safety.
Dalal and his colleagues found that 1 in 14 general medicine patients (7%) suffer harm due to diagnostic errors, and up to 85% of these cases could be prevented.
Few Studies on Diagnostic Errors
The study found that adverse event surveillance in hospital underestimated the prevalence of harmful diagnostic errors.
“It is difficult to quantify and characterize diagnostic errors, which have been studied less than medication errors,” Micaela La Regina, MD, an internist and head of the Clinical Governance and Risk Management Unit at ASL 5 in La Spezia, Italy, told Univadis Italy. “Generally, it is estimated that around 50% of diagnostic errors are preventable, but the authors of this study went beyond simply observing the hospital admission period and followed their sample for 90 days after discharge. Their findings will need to be verified in other studies, but they seem convincing.”
The researchers in Boston selected a random sample of 675 hospital patients from a total of 9147 eligible cases who received general medical care between July 2019 and September 2021, excluding the peak of the COVID-19 pandemic (April-December 2020). They retrospectively reviewed the patients’ electronic health records using a structured method to evaluate the diagnostic process for potential errors and then estimated the impact and severity of any harm.
Cases sampled were those featuring transfer to intensive care more than 24 hours after admission (100% of 130 cases), death within 90 days of hospital admission or after discharge (38.5% of 141 cases), complex clinical problems without transfer to intensive care or death within 90 days of admission (7% of 298 cases), and 2.4% of 106 cases without high-risk criteria.
Each case was reviewed by two experts trained in the use of diagnostic error evaluation and research taxonomy, modified for acute care. Harm was classified as mild, moderate, severe, or fatal. The review assessed whether diagnostic error contributed to the harm and whether it was preventable. Cases with discrepancies or uncertainties regarding the diagnostic error or its impact were further examined by an expert panel.
Most Frequent Situations
Among all the cases examined, diagnostic errors were identified in 160 instances in 154 patients. The most frequent situations with diagnostic errors involved transfer to intensive care (54 cases), death within 90 days (34 cases), and complex clinical problems (52 cases). Diagnostic errors causing harm were found in 84 cases (82 patients), of which 37 (28.5%) occurred in those transferred to intensive care; 18 (13%) among patients who died within 90 days; 23 (8%) among patients with complex clinical issues; and 6 (6%) in low-risk cases.
The severity of harm was categorized as minor in 5 cases (6%), moderate in 36 (43%), major in 25 (30%), and fatal in 18 cases (21.5%). Overall, the researchers estimated that the proportion of harmful, preventable diagnostic errors with serious harm in general medicine patients was slightly more than 7%, 6%, and 1%, respectively.
Most Frequent Diagnoses
The most common diagnoses associated with diagnostic errors in the study included heart failure, acute kidney injury, sepsis, pneumonia, respiratory failure, altered mental state, abdominal pain, and hypoxemia. Dalal and colleagues emphasize the need for more attention to diagnostic error analysis, including the adoption of artificial intelligence–based tools for medical record screening.
“The technological approach, with alert-based systems, can certainly be helpful, but more attention must also be paid to continuous training and the well-being of healthcare workers. It is also crucial to encourage greater listening to caregivers and patients,” said La Regina. She noted that in the past, a focus on error prevention has often led to an increased workload and administrative burden on healthcare workers. However, the well-being of healthcare workers is key to ensuring patient safety.
“Countermeasures to reduce diagnostic errors require a multimodal approach, targeting professionals, the healthcare system, and organizational aspects, because even waiting lists are a critical factor,” she said. As a clinical risk expert, she recently proposed an adaptation of the value-based medicine formula in the International Journal for Quality in Health Care to include healthcare professionals’ care experience as one of the elements that contribute to determining high-value healthcare interventions. “Experiments are already underway to reimburse healthcare costs based on this formula, which also allows the assessment of the value of skills and expertise acquired by healthcare workers,” concluded La Regina.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Diagnostic errors are common in hospitals and are largely preventable, according to a new observational study led by Anuj K. Dalal, MD, from the Division of General Internal Medicine at Brigham and Women’s Hospital and Harvard Medical School in Boston, published in BMJ Quality & Safety.
Dalal and his colleagues found that 1 in 14 general medicine patients (7%) suffer harm due to diagnostic errors, and up to 85% of these cases could be prevented.
Few Studies on Diagnostic Errors
The study found that adverse event surveillance in hospital underestimated the prevalence of harmful diagnostic errors.
“It is difficult to quantify and characterize diagnostic errors, which have been studied less than medication errors,” Micaela La Regina, MD, an internist and head of the Clinical Governance and Risk Management Unit at ASL 5 in La Spezia, Italy, told Univadis Italy. “Generally, it is estimated that around 50% of diagnostic errors are preventable, but the authors of this study went beyond simply observing the hospital admission period and followed their sample for 90 days after discharge. Their findings will need to be verified in other studies, but they seem convincing.”
The researchers in Boston selected a random sample of 675 hospital patients from a total of 9147 eligible cases who received general medical care between July 2019 and September 2021, excluding the peak of the COVID-19 pandemic (April-December 2020). They retrospectively reviewed the patients’ electronic health records using a structured method to evaluate the diagnostic process for potential errors and then estimated the impact and severity of any harm.
Cases sampled were those featuring transfer to intensive care more than 24 hours after admission (100% of 130 cases), death within 90 days of hospital admission or after discharge (38.5% of 141 cases), complex clinical problems without transfer to intensive care or death within 90 days of admission (7% of 298 cases), and 2.4% of 106 cases without high-risk criteria.
Each case was reviewed by two experts trained in the use of diagnostic error evaluation and research taxonomy, modified for acute care. Harm was classified as mild, moderate, severe, or fatal. The review assessed whether diagnostic error contributed to the harm and whether it was preventable. Cases with discrepancies or uncertainties regarding the diagnostic error or its impact were further examined by an expert panel.
Most Frequent Situations
Among all the cases examined, diagnostic errors were identified in 160 instances in 154 patients. The most frequent situations with diagnostic errors involved transfer to intensive care (54 cases), death within 90 days (34 cases), and complex clinical problems (52 cases). Diagnostic errors causing harm were found in 84 cases (82 patients), of which 37 (28.5%) occurred in those transferred to intensive care; 18 (13%) among patients who died within 90 days; 23 (8%) among patients with complex clinical issues; and 6 (6%) in low-risk cases.
The severity of harm was categorized as minor in 5 cases (6%), moderate in 36 (43%), major in 25 (30%), and fatal in 18 cases (21.5%). Overall, the researchers estimated that the proportion of harmful, preventable diagnostic errors with serious harm in general medicine patients was slightly more than 7%, 6%, and 1%, respectively.
Most Frequent Diagnoses
The most common diagnoses associated with diagnostic errors in the study included heart failure, acute kidney injury, sepsis, pneumonia, respiratory failure, altered mental state, abdominal pain, and hypoxemia. Dalal and colleagues emphasize the need for more attention to diagnostic error analysis, including the adoption of artificial intelligence–based tools for medical record screening.
“The technological approach, with alert-based systems, can certainly be helpful, but more attention must also be paid to continuous training and the well-being of healthcare workers. It is also crucial to encourage greater listening to caregivers and patients,” said La Regina. She noted that in the past, a focus on error prevention has often led to an increased workload and administrative burden on healthcare workers. However, the well-being of healthcare workers is key to ensuring patient safety.
“Countermeasures to reduce diagnostic errors require a multimodal approach, targeting professionals, the healthcare system, and organizational aspects, because even waiting lists are a critical factor,” she said. As a clinical risk expert, she recently proposed an adaptation of the value-based medicine formula in the International Journal for Quality in Health Care to include healthcare professionals’ care experience as one of the elements that contribute to determining high-value healthcare interventions. “Experiments are already underway to reimburse healthcare costs based on this formula, which also allows the assessment of the value of skills and expertise acquired by healthcare workers,” concluded La Regina.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Is It Possible To Treat Patients You Dislike?
This transcript has been edited for clarity.
What do we do if we don’t like patients? We take the Hippocratic Oath as young students in Glasgow. We do that just before our graduation ceremony; we hold our hands up and repeat the Hippocratic Oath: “First, do no harm,” and so on.
I can only think genuinely over a couple of times in which I’ve acted reflexively when a patient has done something awful. The couple of times it happened, it was just terrible racist comments to junior doctors who were with me. Extraordinarily dreadful things such as, “I don’t want to be touched by ...” or something of that sort.
Without really thinking about it, you react as a normal citizen and say, “That’s absolutely awful. Apologize immediately or leave the consultation room, and never ever come back again.”
I remember that it happened once in Glasgow and once when I was a young professor in Birmingham, and it’s just an automatic gut reaction. The patient got a fright, and I immediately apologized and groveled around. In that relationship, we hold all the power, don’t we? Rather than being gentle about it, I was genuinely angry because of these ridiculous comments.
Otherwise, I think most of the doctor-patient relationships are predicated on nonromantic love. I think patients want us to love them as one would a son, mother, father, or daughter, because if we do, then we will do better for them and we’ll pull out all the stops. “Placebo” means “I will please.” I think in the vast majority of cases, at least in our National Health Service (NHS), patients come with trust and a sense of wanting to build that relationship. That may be changing, but not for me.
What about putting the boot on the other foot? What if the patients don’t like us rather than vice versa? As part of our accreditation appraisal process, from time to time we have to take patient surveys as to whether the patients felt that, after they had been seen in a consultation, they were treated with dignity, the quality of information given was appropriate, and they were treated with kindness.
It’s an excellent exercise. Without bragging about it, patients objectively, according to these measures, appreciate the service that I give. It’s like getting five-star reviews on Trustpilot, or whatever these things are, that allow you to review car salesmen and so on. I have always had five-star reviews across the board.
That, again, I thought was just a feature of that relationship, of patients wanting to please. These are patients who had been treated, who were in the outpatient department, who were in the midst of battle. Still, the scores are very high. I speak to my colleagues and that’s not uniformly the case. Patients actually do use these feedback forms, I think in a positive rather than negative way, reflecting back on the way that they were treated.
It has caused some of my colleagues to think quite hard about their personal style and approach to patients. That sense of feedback is important.
What about losing trust? If that’s at the heart of everything that we do, then what would be an objective measure of losing trust? Again, in our healthcare system, it has been exceedingly unusual for a patient to request a second opinion. Now, that’s changing. The government is trying to change it. Leaders of the NHS are trying to change it so that patients feel assured that they can seek second opinions.
Again, in all the years I’ve been a cancer doctor, it has been incredibly infrequent that somebody has sought a second opinion after I’ve said something. That may be a measure of trust. Again, I’ve lived through an NHS in which seeking second opinions was something of a rarity.
I’d be really interested to see what you think. In your own sphere of healthcare practice, is it possible for us to look after patients that we don’t like, or should we be honest and say, “I don’t like you. Our relationship has broken down. I want you to be seen by a colleague,” or “I want you to be nursed by somebody else”?
Has that happened? Is that something that you think is common or may become more common? What about when trust breaks down the other way? Can you think of instances in which the relationship, for whatever reason, just didn’t work and the patient had to move on because of that loss of trust and what underpinned it? I’d be really interested to know.
I seek to be informed rather than the other way around. Can we truly look after patients that we don’t like or can we rise above it as Hippocrates might have done?
Thanks for listening, as always. For the time being, over and out.
Dr. Kerr, Professor, Nuffield Department of Clinical Laboratory Science, University of Oxford; Professor of Cancer Medicine, Oxford Cancer Centre, Oxford, United Kingdom, disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer HealthCare Pharmaceuticals, Genomic Health, Merck Serono, and Roche.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
What do we do if we don’t like patients? We take the Hippocratic Oath as young students in Glasgow. We do that just before our graduation ceremony; we hold our hands up and repeat the Hippocratic Oath: “First, do no harm,” and so on.
I can only think genuinely over a couple of times in which I’ve acted reflexively when a patient has done something awful. The couple of times it happened, it was just terrible racist comments to junior doctors who were with me. Extraordinarily dreadful things such as, “I don’t want to be touched by ...” or something of that sort.
Without really thinking about it, you react as a normal citizen and say, “That’s absolutely awful. Apologize immediately or leave the consultation room, and never ever come back again.”
I remember that it happened once in Glasgow and once when I was a young professor in Birmingham, and it’s just an automatic gut reaction. The patient got a fright, and I immediately apologized and groveled around. In that relationship, we hold all the power, don’t we? Rather than being gentle about it, I was genuinely angry because of these ridiculous comments.
Otherwise, I think most of the doctor-patient relationships are predicated on nonromantic love. I think patients want us to love them as one would a son, mother, father, or daughter, because if we do, then we will do better for them and we’ll pull out all the stops. “Placebo” means “I will please.” I think in the vast majority of cases, at least in our National Health Service (NHS), patients come with trust and a sense of wanting to build that relationship. That may be changing, but not for me.
What about putting the boot on the other foot? What if the patients don’t like us rather than vice versa? As part of our accreditation appraisal process, from time to time we have to take patient surveys as to whether the patients felt that, after they had been seen in a consultation, they were treated with dignity, the quality of information given was appropriate, and they were treated with kindness.
It’s an excellent exercise. Without bragging about it, patients objectively, according to these measures, appreciate the service that I give. It’s like getting five-star reviews on Trustpilot, or whatever these things are, that allow you to review car salesmen and so on. I have always had five-star reviews across the board.
That, again, I thought was just a feature of that relationship, of patients wanting to please. These are patients who had been treated, who were in the outpatient department, who were in the midst of battle. Still, the scores are very high. I speak to my colleagues and that’s not uniformly the case. Patients actually do use these feedback forms, I think in a positive rather than negative way, reflecting back on the way that they were treated.
It has caused some of my colleagues to think quite hard about their personal style and approach to patients. That sense of feedback is important.
What about losing trust? If that’s at the heart of everything that we do, then what would be an objective measure of losing trust? Again, in our healthcare system, it has been exceedingly unusual for a patient to request a second opinion. Now, that’s changing. The government is trying to change it. Leaders of the NHS are trying to change it so that patients feel assured that they can seek second opinions.
Again, in all the years I’ve been a cancer doctor, it has been incredibly infrequent that somebody has sought a second opinion after I’ve said something. That may be a measure of trust. Again, I’ve lived through an NHS in which seeking second opinions was something of a rarity.
I’d be really interested to see what you think. In your own sphere of healthcare practice, is it possible for us to look after patients that we don’t like, or should we be honest and say, “I don’t like you. Our relationship has broken down. I want you to be seen by a colleague,” or “I want you to be nursed by somebody else”?
Has that happened? Is that something that you think is common or may become more common? What about when trust breaks down the other way? Can you think of instances in which the relationship, for whatever reason, just didn’t work and the patient had to move on because of that loss of trust and what underpinned it? I’d be really interested to know.
I seek to be informed rather than the other way around. Can we truly look after patients that we don’t like or can we rise above it as Hippocrates might have done?
Thanks for listening, as always. For the time being, over and out.
Dr. Kerr, Professor, Nuffield Department of Clinical Laboratory Science, University of Oxford; Professor of Cancer Medicine, Oxford Cancer Centre, Oxford, United Kingdom, disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer HealthCare Pharmaceuticals, Genomic Health, Merck Serono, and Roche.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
What do we do if we don’t like patients? We take the Hippocratic Oath as young students in Glasgow. We do that just before our graduation ceremony; we hold our hands up and repeat the Hippocratic Oath: “First, do no harm,” and so on.
I can only think genuinely over a couple of times in which I’ve acted reflexively when a patient has done something awful. The couple of times it happened, it was just terrible racist comments to junior doctors who were with me. Extraordinarily dreadful things such as, “I don’t want to be touched by ...” or something of that sort.
Without really thinking about it, you react as a normal citizen and say, “That’s absolutely awful. Apologize immediately or leave the consultation room, and never ever come back again.”
I remember that it happened once in Glasgow and once when I was a young professor in Birmingham, and it’s just an automatic gut reaction. The patient got a fright, and I immediately apologized and groveled around. In that relationship, we hold all the power, don’t we? Rather than being gentle about it, I was genuinely angry because of these ridiculous comments.
Otherwise, I think most of the doctor-patient relationships are predicated on nonromantic love. I think patients want us to love them as one would a son, mother, father, or daughter, because if we do, then we will do better for them and we’ll pull out all the stops. “Placebo” means “I will please.” I think in the vast majority of cases, at least in our National Health Service (NHS), patients come with trust and a sense of wanting to build that relationship. That may be changing, but not for me.
What about putting the boot on the other foot? What if the patients don’t like us rather than vice versa? As part of our accreditation appraisal process, from time to time we have to take patient surveys as to whether the patients felt that, after they had been seen in a consultation, they were treated with dignity, the quality of information given was appropriate, and they were treated with kindness.
It’s an excellent exercise. Without bragging about it, patients objectively, according to these measures, appreciate the service that I give. It’s like getting five-star reviews on Trustpilot, or whatever these things are, that allow you to review car salesmen and so on. I have always had five-star reviews across the board.
That, again, I thought was just a feature of that relationship, of patients wanting to please. These are patients who had been treated, who were in the outpatient department, who were in the midst of battle. Still, the scores are very high. I speak to my colleagues and that’s not uniformly the case. Patients actually do use these feedback forms, I think in a positive rather than negative way, reflecting back on the way that they were treated.
It has caused some of my colleagues to think quite hard about their personal style and approach to patients. That sense of feedback is important.
What about losing trust? If that’s at the heart of everything that we do, then what would be an objective measure of losing trust? Again, in our healthcare system, it has been exceedingly unusual for a patient to request a second opinion. Now, that’s changing. The government is trying to change it. Leaders of the NHS are trying to change it so that patients feel assured that they can seek second opinions.
Again, in all the years I’ve been a cancer doctor, it has been incredibly infrequent that somebody has sought a second opinion after I’ve said something. That may be a measure of trust. Again, I’ve lived through an NHS in which seeking second opinions was something of a rarity.
I’d be really interested to see what you think. In your own sphere of healthcare practice, is it possible for us to look after patients that we don’t like, or should we be honest and say, “I don’t like you. Our relationship has broken down. I want you to be seen by a colleague,” or “I want you to be nursed by somebody else”?
Has that happened? Is that something that you think is common or may become more common? What about when trust breaks down the other way? Can you think of instances in which the relationship, for whatever reason, just didn’t work and the patient had to move on because of that loss of trust and what underpinned it? I’d be really interested to know.
I seek to be informed rather than the other way around. Can we truly look after patients that we don’t like or can we rise above it as Hippocrates might have done?
Thanks for listening, as always. For the time being, over and out.
Dr. Kerr, Professor, Nuffield Department of Clinical Laboratory Science, University of Oxford; Professor of Cancer Medicine, Oxford Cancer Centre, Oxford, United Kingdom, disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer HealthCare Pharmaceuticals, Genomic Health, Merck Serono, and Roche.
A version of this article appeared on Medscape.com.
Dactylitis Represents More Active and Severe PsA Phenotype
Key clinical point: The presence of clinical or subclinical dactylitis represented a more active and severe form of psoriatic arthritis (PsA), characterized by increased disease activity, swollen joint counts (SJCs), and tender joint counts (TJCs).
Major finding: PsA with dactylitis (clinical or subclinical) vs without dactylitis was associated with higher median disease activity index in PsA (DAPSA) scores (25.5 vs 16.1; P < .01), SJCs (4 vs 2; P < .001), and TJCs (4 vs 3; P < .01). PsA with subclinical dactylitis vs without dactylitis was associated with even higher DAPSA scores (27.2 vs 16.1; P < .05), SJCs (4.5 vs 2; P < .01), and TJCs (5 vs 3; P < .05).
Study details: This case-control study included 223 patients with PsA who were stratified on the basis of the presence of dactylitis (clinical or subclinical) or its absence at baseline.
Disclosures: This study was supported by the Youth Clinical Research Project of Peking University First Hospital and other sources. No conflicts of interest were reported.
Source: Song Z, Geng Y, Zhang X, Deng X, Zhang Z. Subclinical dactylitis represents a more active phenotype of psoriatic arthritis. Joint Bone Spine. Published online September 24, 2024. Source
Key clinical point: The presence of clinical or subclinical dactylitis represented a more active and severe form of psoriatic arthritis (PsA), characterized by increased disease activity, swollen joint counts (SJCs), and tender joint counts (TJCs).
Major finding: PsA with dactylitis (clinical or subclinical) vs without dactylitis was associated with higher median disease activity index in PsA (DAPSA) scores (25.5 vs 16.1; P < .01), SJCs (4 vs 2; P < .001), and TJCs (4 vs 3; P < .01). PsA with subclinical dactylitis vs without dactylitis was associated with even higher DAPSA scores (27.2 vs 16.1; P < .05), SJCs (4.5 vs 2; P < .01), and TJCs (5 vs 3; P < .05).
Study details: This case-control study included 223 patients with PsA who were stratified on the basis of the presence of dactylitis (clinical or subclinical) or its absence at baseline.
Disclosures: This study was supported by the Youth Clinical Research Project of Peking University First Hospital and other sources. No conflicts of interest were reported.
Source: Song Z, Geng Y, Zhang X, Deng X, Zhang Z. Subclinical dactylitis represents a more active phenotype of psoriatic arthritis. Joint Bone Spine. Published online September 24, 2024. Source
Key clinical point: The presence of clinical or subclinical dactylitis represented a more active and severe form of psoriatic arthritis (PsA), characterized by increased disease activity, swollen joint counts (SJCs), and tender joint counts (TJCs).
Major finding: PsA with dactylitis (clinical or subclinical) vs without dactylitis was associated with higher median disease activity index in PsA (DAPSA) scores (25.5 vs 16.1; P < .01), SJCs (4 vs 2; P < .001), and TJCs (4 vs 3; P < .01). PsA with subclinical dactylitis vs without dactylitis was associated with even higher DAPSA scores (27.2 vs 16.1; P < .05), SJCs (4.5 vs 2; P < .01), and TJCs (5 vs 3; P < .05).
Study details: This case-control study included 223 patients with PsA who were stratified on the basis of the presence of dactylitis (clinical or subclinical) or its absence at baseline.
Disclosures: This study was supported by the Youth Clinical Research Project of Peking University First Hospital and other sources. No conflicts of interest were reported.
Source: Song Z, Geng Y, Zhang X, Deng X, Zhang Z. Subclinical dactylitis represents a more active phenotype of psoriatic arthritis. Joint Bone Spine. Published online September 24, 2024. Source
Guselkumab Demonstrates Sustained Efficacy and Safety in PsA
Key clinical point: Guselkumab administered every 4 weeks (Q4W) or every 8 weeks (Q8W) yielded better clinical outcomes than placebo in patients with psoriatic arthritis (PsA), without any new safety concerns.
Major findings: At week 24, a higher proportion of patients receiving guselkumab Q4W (60%) and Q8W (51%) vs placebo (30%) achieved a ≥ 20% improvement in the American College of Rheumatology (ACR)20 response. The response rates increased through week 52 (69%-78) and were consistent at week 100 (76%-80%) across all the groups. Similar trends were observed for ACR50, with no new safety signals.
Study details: This post hoc analysis of the phase 3 trials DISCOVER-1 and DISCOVER-2 included 1002 biologic-naive patients with PsA who received 100 mg guselkumab Q4W, 100 mg guselkumab at weeks 0 and 4 and then Q8W, or placebo through week 24 with crossover to 100 mg guselkumab Q4W.
Disclosure: The study was sponsored by Janssen-Cilag Ltd. Four authors were employees of Johnson & Johnson. Several authors received research grants, consulting fees, or had ties with various sources.
Source: Mease P, Korotaeva T, Shesternya P, et al. Guselkumab in biologic-naïve patients with active psoriatic arthritis in Russia: A post hoc analysis of the DISCOVER-1 and -2 randomized clinical trials. Rheumatol Ther. Published online September 25, 2024. Source
Key clinical point: Guselkumab administered every 4 weeks (Q4W) or every 8 weeks (Q8W) yielded better clinical outcomes than placebo in patients with psoriatic arthritis (PsA), without any new safety concerns.
Major findings: At week 24, a higher proportion of patients receiving guselkumab Q4W (60%) and Q8W (51%) vs placebo (30%) achieved a ≥ 20% improvement in the American College of Rheumatology (ACR)20 response. The response rates increased through week 52 (69%-78) and were consistent at week 100 (76%-80%) across all the groups. Similar trends were observed for ACR50, with no new safety signals.
Study details: This post hoc analysis of the phase 3 trials DISCOVER-1 and DISCOVER-2 included 1002 biologic-naive patients with PsA who received 100 mg guselkumab Q4W, 100 mg guselkumab at weeks 0 and 4 and then Q8W, or placebo through week 24 with crossover to 100 mg guselkumab Q4W.
Disclosure: The study was sponsored by Janssen-Cilag Ltd. Four authors were employees of Johnson & Johnson. Several authors received research grants, consulting fees, or had ties with various sources.
Source: Mease P, Korotaeva T, Shesternya P, et al. Guselkumab in biologic-naïve patients with active psoriatic arthritis in Russia: A post hoc analysis of the DISCOVER-1 and -2 randomized clinical trials. Rheumatol Ther. Published online September 25, 2024. Source
Key clinical point: Guselkumab administered every 4 weeks (Q4W) or every 8 weeks (Q8W) yielded better clinical outcomes than placebo in patients with psoriatic arthritis (PsA), without any new safety concerns.
Major findings: At week 24, a higher proportion of patients receiving guselkumab Q4W (60%) and Q8W (51%) vs placebo (30%) achieved a ≥ 20% improvement in the American College of Rheumatology (ACR)20 response. The response rates increased through week 52 (69%-78) and were consistent at week 100 (76%-80%) across all the groups. Similar trends were observed for ACR50, with no new safety signals.
Study details: This post hoc analysis of the phase 3 trials DISCOVER-1 and DISCOVER-2 included 1002 biologic-naive patients with PsA who received 100 mg guselkumab Q4W, 100 mg guselkumab at weeks 0 and 4 and then Q8W, or placebo through week 24 with crossover to 100 mg guselkumab Q4W.
Disclosure: The study was sponsored by Janssen-Cilag Ltd. Four authors were employees of Johnson & Johnson. Several authors received research grants, consulting fees, or had ties with various sources.
Source: Mease P, Korotaeva T, Shesternya P, et al. Guselkumab in biologic-naïve patients with active psoriatic arthritis in Russia: A post hoc analysis of the DISCOVER-1 and -2 randomized clinical trials. Rheumatol Ther. Published online September 25, 2024. Source
Impact of Smoking on Treatment Outcomes of Tofacitinib in PsA
Key clinical point: In patients with psoriatic arthritis (PsA), tofacitinib demonstrated higher efficacy than placebo, regardless of smoking status; however, current or past smokers experienced increased rates of adverse events.
Major finding: At 3 months, 10 mg tofacitinib showed higher rates of a ≥ 50% improvement in the American College of Rheumatology response than placebo in current or past smokers (odds ratio [OR], 3.01; 95% CI, 1.43-6.33) and never smokers (OR, 6.53; 95% CI, 3.46-12.33). The incidence rates of treatment-emergent adverse events were higher in current or past smokers vs never smokers (adjusted incidence rate, 263.2 vs 208.9); 5 mg tofacitinib had comparable outcomes.
Study details: This post hoc analysis pooled data from phase 2 and 3 trials and a long-term extension study, involving 914 patients with PsA and 372 patients with ankylosing spondylitis who received tofacitinib (5 or 10 mg twice daily) or placebo, while considering their smoking status.
Disclosures: This study was sponsored by Pfizer. Four authors declared being current or former employees or shareholders of Pfizer. Other authors declared having ties with various sources.
Source: Ogdie A, Kristensen LE, Soriano ER, et al. Efficacy and safety of tofacitinib in patients with psoriatic arthritis or ankylosing spondylitis by cigarette smoking status. Rheumatol Ther. Published online September 25, 2024. Source
Key clinical point: In patients with psoriatic arthritis (PsA), tofacitinib demonstrated higher efficacy than placebo, regardless of smoking status; however, current or past smokers experienced increased rates of adverse events.
Major finding: At 3 months, 10 mg tofacitinib showed higher rates of a ≥ 50% improvement in the American College of Rheumatology response than placebo in current or past smokers (odds ratio [OR], 3.01; 95% CI, 1.43-6.33) and never smokers (OR, 6.53; 95% CI, 3.46-12.33). The incidence rates of treatment-emergent adverse events were higher in current or past smokers vs never smokers (adjusted incidence rate, 263.2 vs 208.9); 5 mg tofacitinib had comparable outcomes.
Study details: This post hoc analysis pooled data from phase 2 and 3 trials and a long-term extension study, involving 914 patients with PsA and 372 patients with ankylosing spondylitis who received tofacitinib (5 or 10 mg twice daily) or placebo, while considering their smoking status.
Disclosures: This study was sponsored by Pfizer. Four authors declared being current or former employees or shareholders of Pfizer. Other authors declared having ties with various sources.
Source: Ogdie A, Kristensen LE, Soriano ER, et al. Efficacy and safety of tofacitinib in patients with psoriatic arthritis or ankylosing spondylitis by cigarette smoking status. Rheumatol Ther. Published online September 25, 2024. Source
Key clinical point: In patients with psoriatic arthritis (PsA), tofacitinib demonstrated higher efficacy than placebo, regardless of smoking status; however, current or past smokers experienced increased rates of adverse events.
Major finding: At 3 months, 10 mg tofacitinib showed higher rates of a ≥ 50% improvement in the American College of Rheumatology response than placebo in current or past smokers (odds ratio [OR], 3.01; 95% CI, 1.43-6.33) and never smokers (OR, 6.53; 95% CI, 3.46-12.33). The incidence rates of treatment-emergent adverse events were higher in current or past smokers vs never smokers (adjusted incidence rate, 263.2 vs 208.9); 5 mg tofacitinib had comparable outcomes.
Study details: This post hoc analysis pooled data from phase 2 and 3 trials and a long-term extension study, involving 914 patients with PsA and 372 patients with ankylosing spondylitis who received tofacitinib (5 or 10 mg twice daily) or placebo, while considering their smoking status.
Disclosures: This study was sponsored by Pfizer. Four authors declared being current or former employees or shareholders of Pfizer. Other authors declared having ties with various sources.
Source: Ogdie A, Kristensen LE, Soriano ER, et al. Efficacy and safety of tofacitinib in patients with psoriatic arthritis or ankylosing spondylitis by cigarette smoking status. Rheumatol Ther. Published online September 25, 2024. Source
Intravenous Secukinumab Effective and Safe in PsA
Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous secukinumab every 4 weeks demonstrated rapid and sustained efficacy, along with a safety profile consistent with that of subcutaneous secukinumab.
Major finding: At week 16, intravenous secukinumab vs placebo significantly improved the American College of Rheumatology 50 response rate (31.4% vs 6.3%; adjusted P < .0001). Improvements were observed as early as week 4 (P < .0005) and were sustained through week 52, regardless of whether patients continued intravenous secukinumab (58.0%) or switched from placebo to intravenous secukinumab (64.0%). No new safety signals were reported.
Study details: In this phase 3 INVIGORATE-2 trial, 381 patients with active PsA and either plaque psoriasis or nail psoriasis were randomly assigned to receive intravenous secukinumab or placebo with crossover to intravenous secukinumab at week 16.
Disclosures: This study was supported by Novartis. Five authors declared being employees of and owning stocks in Novartis. Several authors declared having ties with various sources, including Novartis.
Source: Kivitz A, Sedova L, Churchill M, et al. Efficacy and safety of intravenous secukinumab for the treatment of active psoriatic arthritis: Results from the randomized, placebo-controlled phase III INVIGORATE-2 study. Arthritis Rheumatol. Published online September 19, 2024. Source
Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous secukinumab every 4 weeks demonstrated rapid and sustained efficacy, along with a safety profile consistent with that of subcutaneous secukinumab.
Major finding: At week 16, intravenous secukinumab vs placebo significantly improved the American College of Rheumatology 50 response rate (31.4% vs 6.3%; adjusted P < .0001). Improvements were observed as early as week 4 (P < .0005) and were sustained through week 52, regardless of whether patients continued intravenous secukinumab (58.0%) or switched from placebo to intravenous secukinumab (64.0%). No new safety signals were reported.
Study details: In this phase 3 INVIGORATE-2 trial, 381 patients with active PsA and either plaque psoriasis or nail psoriasis were randomly assigned to receive intravenous secukinumab or placebo with crossover to intravenous secukinumab at week 16.
Disclosures: This study was supported by Novartis. Five authors declared being employees of and owning stocks in Novartis. Several authors declared having ties with various sources, including Novartis.
Source: Kivitz A, Sedova L, Churchill M, et al. Efficacy and safety of intravenous secukinumab for the treatment of active psoriatic arthritis: Results from the randomized, placebo-controlled phase III INVIGORATE-2 study. Arthritis Rheumatol. Published online September 19, 2024. Source
Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous secukinumab every 4 weeks demonstrated rapid and sustained efficacy, along with a safety profile consistent with that of subcutaneous secukinumab.
Major finding: At week 16, intravenous secukinumab vs placebo significantly improved the American College of Rheumatology 50 response rate (31.4% vs 6.3%; adjusted P < .0001). Improvements were observed as early as week 4 (P < .0005) and were sustained through week 52, regardless of whether patients continued intravenous secukinumab (58.0%) or switched from placebo to intravenous secukinumab (64.0%). No new safety signals were reported.
Study details: In this phase 3 INVIGORATE-2 trial, 381 patients with active PsA and either plaque psoriasis or nail psoriasis were randomly assigned to receive intravenous secukinumab or placebo with crossover to intravenous secukinumab at week 16.
Disclosures: This study was supported by Novartis. Five authors declared being employees of and owning stocks in Novartis. Several authors declared having ties with various sources, including Novartis.
Source: Kivitz A, Sedova L, Churchill M, et al. Efficacy and safety of intravenous secukinumab for the treatment of active psoriatic arthritis: Results from the randomized, placebo-controlled phase III INVIGORATE-2 study. Arthritis Rheumatol. Published online September 19, 2024. Source
Guselkumab Shows Persistent Effects in PsA
Key clinical point: In biologic-naive patients with active psoriatic arthritis (PsA), guselkumab administered every 8 weeks (Q8W) led to consistent patient-level improvements in joint disease activity, which persisted for 2 years.
Major finding: Guselkumab maintained high rates of minimal clinically important improvements (MCII) in the clinical Disease Activity Index for PsA (cDAPSA; 94%-99%), with improvements of ≥ 5.7 from baseline through week 52 with a dosing of 100 mg guselkumab Q8W. Among those achieving MCII by week 24, maintenance rates were 69.2% for the cDAPSA and 89.0% for the Psoriatic Arthritis Disease Activity Score at 100 weeks post-achievement.
Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 248 biologic-naive patients with active PsA who received 100 mg guselkumab Q8W for 100 weeks.
Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors disclosed holding stock or stock options; receiving grants, payment, honoraria, or consulting fees; or having other ties with various sources, including Janssen.
Source: Mease PJ, Baraliakos X, Chandran V, et al. Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: Post hoc analysis of a 2-year, phase 3, randomized, controlled study. ACR Open Rheumatol. Published online October 4, 2024. Source
Key clinical point: In biologic-naive patients with active psoriatic arthritis (PsA), guselkumab administered every 8 weeks (Q8W) led to consistent patient-level improvements in joint disease activity, which persisted for 2 years.
Major finding: Guselkumab maintained high rates of minimal clinically important improvements (MCII) in the clinical Disease Activity Index for PsA (cDAPSA; 94%-99%), with improvements of ≥ 5.7 from baseline through week 52 with a dosing of 100 mg guselkumab Q8W. Among those achieving MCII by week 24, maintenance rates were 69.2% for the cDAPSA and 89.0% for the Psoriatic Arthritis Disease Activity Score at 100 weeks post-achievement.
Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 248 biologic-naive patients with active PsA who received 100 mg guselkumab Q8W for 100 weeks.
Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors disclosed holding stock or stock options; receiving grants, payment, honoraria, or consulting fees; or having other ties with various sources, including Janssen.
Source: Mease PJ, Baraliakos X, Chandran V, et al. Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: Post hoc analysis of a 2-year, phase 3, randomized, controlled study. ACR Open Rheumatol. Published online October 4, 2024. Source
Key clinical point: In biologic-naive patients with active psoriatic arthritis (PsA), guselkumab administered every 8 weeks (Q8W) led to consistent patient-level improvements in joint disease activity, which persisted for 2 years.
Major finding: Guselkumab maintained high rates of minimal clinically important improvements (MCII) in the clinical Disease Activity Index for PsA (cDAPSA; 94%-99%), with improvements of ≥ 5.7 from baseline through week 52 with a dosing of 100 mg guselkumab Q8W. Among those achieving MCII by week 24, maintenance rates were 69.2% for the cDAPSA and 89.0% for the Psoriatic Arthritis Disease Activity Score at 100 weeks post-achievement.
Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 248 biologic-naive patients with active PsA who received 100 mg guselkumab Q8W for 100 weeks.
Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors disclosed holding stock or stock options; receiving grants, payment, honoraria, or consulting fees; or having other ties with various sources, including Janssen.
Source: Mease PJ, Baraliakos X, Chandran V, et al. Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: Post hoc analysis of a 2-year, phase 3, randomized, controlled study. ACR Open Rheumatol. Published online October 4, 2024. Source
Secukinumab Promotes Long-Term Disease Control in PsA
Key clinical point: Secukinumab led to clinical improvements across all psoriatic arthritis (PsA) domains, achieving minimal disease activity and demonstrating a favorable 4-year safety profile in biologic-naive patients, those with previous treatment failure, and those with or without comorbidities.
Major finding: During the 48-month follow-up, secukinumab significantly reduced the proportion of patients with active tender joints, swollen joints, enthesitis, and dactylitis (all P < .01). Overall, 50% of patients achieved remission or low disease activity in PsA, with higher rates of minimal disease activity in biologic-naive vs non-naive patients (76.9% vs 66.2%; P < .01) and in those without comorbidities vs those with over three comorbidities (78.8% vs 48.7%; P < .001). Only 5.9% of patients discontinued treatment due to adverse events.
Study details: This 4-year prospective observational study included 685 patients with PsA who received secukinumab; 32.9% were biologic-naive and 74.2% had at least one comorbidity.
Disclosures: This study did not receive financial support from any pharmaceutical company. The authors declared no conflicts of interest.
Source: Ramonda R, Lorenzin M, Chimenti MS, et al. Four-year effectiveness, safety and drug retention rate of secukinumab in psoriatic arthritis: A real-life Italian multicenter cohort. Arthritis Res Ther. 2024;26:172. Source
Key clinical point: Secukinumab led to clinical improvements across all psoriatic arthritis (PsA) domains, achieving minimal disease activity and demonstrating a favorable 4-year safety profile in biologic-naive patients, those with previous treatment failure, and those with or without comorbidities.
Major finding: During the 48-month follow-up, secukinumab significantly reduced the proportion of patients with active tender joints, swollen joints, enthesitis, and dactylitis (all P < .01). Overall, 50% of patients achieved remission or low disease activity in PsA, with higher rates of minimal disease activity in biologic-naive vs non-naive patients (76.9% vs 66.2%; P < .01) and in those without comorbidities vs those with over three comorbidities (78.8% vs 48.7%; P < .001). Only 5.9% of patients discontinued treatment due to adverse events.
Study details: This 4-year prospective observational study included 685 patients with PsA who received secukinumab; 32.9% were biologic-naive and 74.2% had at least one comorbidity.
Disclosures: This study did not receive financial support from any pharmaceutical company. The authors declared no conflicts of interest.
Source: Ramonda R, Lorenzin M, Chimenti MS, et al. Four-year effectiveness, safety and drug retention rate of secukinumab in psoriatic arthritis: A real-life Italian multicenter cohort. Arthritis Res Ther. 2024;26:172. Source
Key clinical point: Secukinumab led to clinical improvements across all psoriatic arthritis (PsA) domains, achieving minimal disease activity and demonstrating a favorable 4-year safety profile in biologic-naive patients, those with previous treatment failure, and those with or without comorbidities.
Major finding: During the 48-month follow-up, secukinumab significantly reduced the proportion of patients with active tender joints, swollen joints, enthesitis, and dactylitis (all P < .01). Overall, 50% of patients achieved remission or low disease activity in PsA, with higher rates of minimal disease activity in biologic-naive vs non-naive patients (76.9% vs 66.2%; P < .01) and in those without comorbidities vs those with over three comorbidities (78.8% vs 48.7%; P < .001). Only 5.9% of patients discontinued treatment due to adverse events.
Study details: This 4-year prospective observational study included 685 patients with PsA who received secukinumab; 32.9% were biologic-naive and 74.2% had at least one comorbidity.
Disclosures: This study did not receive financial support from any pharmaceutical company. The authors declared no conflicts of interest.
Source: Ramonda R, Lorenzin M, Chimenti MS, et al. Four-year effectiveness, safety and drug retention rate of secukinumab in psoriatic arthritis: A real-life Italian multicenter cohort. Arthritis Res Ther. 2024;26:172. Source