Steve Cimino

A new study has found that, although the Affordable Care Act (ACA) increased health insurance coverage in states that expanded their Medicaid program, the expansion did not translate into improved access to care or decreased preventable hospitalizations of patients with systemic lupus erythematosus (SLE).

juststock/gettyimages

“Our findings emphasize the importance of addressing systemic problems with American healthcare delivery at multiple levels,” wrote Elizabeth A. Brown, PhD, of the Medical University of South Carolina, Charleston, and her coauthors. The study was published in Arthritis Care & Research.

To examine the effects of the ACA’s Medicaid expansion on lupus patients when it was implemented Jan. 1, 2014, the researchers launched a retrospective, quasi‐experimental study using administrative data from eight states to compare eight quarterly time points in the 2 years prior to implementation against seven quarterly time points in the 2 years after implementation. Four states expanded Medicaid under the ACA – Arizona, Kentucky, New Jersey, and New York – and four of them did not – Florida, Georgia, South Carolina, and Wisconsin.

During the study period, there were 204,150 lupus hospitalizations across all eight states during the 15 quarters, 53% of which occurred in the four states that did not expand Medicaid. Although the investigators’ base model found that the probability of a preventable hospitalization did not increase over time (odds ratio, 1.004; 95% confidence interval, 0.996-1.013), the four expansion states had significantly higher odds of having preventable hospitalizations in the final adjusted model (OR, 1.302; 95% CI, 1.119-1.515).

Variables that contributed to higher odds of a preventable hospitalization included age: Lupus patients who were 55-64 years old had considerably higher odds for preventable lupus hospitalizations than did patients who were 20-34 years old (OR, 1.488; 95% CI, 1.415-1.564). In addition, those with a median household income under $42,000 had higher odds of hospitalization when compared with those making over $68,000 (OR, 1.138; 95% CI, 1.415-1.564), as did those on Medicaid compared with those on private insurance (OR, 1.298; 95% CI, 1.238-1.361).

The authors acknowledged their study’s limitations, including relying on potential coding errors within administrative data. In addition, they were unable to factor in Medicaid marketing, enrollment strategies, or other related actions undertaken in each of the eight states.

The study was partially supported by the South Carolina Clinical & Translational Research Institute via a National Center for Advancing Translational Sciences grant. The authors reported no conflicts of interest.

SOURCE: Brown EA et al. Arthritis Care Res. 2019 Sept 28. doi: 10.1002/acr.24080

A new study has found that, although the Affordable Care Act (ACA) increased health insurance coverage in states that expanded their Medicaid program, the expansion did not translate into improved access to care or decreased preventable hospitalizations of patients with systemic lupus erythematosus (SLE).

juststock/gettyimages

“Our findings emphasize the importance of addressing systemic problems with American healthcare delivery at multiple levels,” wrote Elizabeth A. Brown, PhD, of the Medical University of South Carolina, Charleston, and her coauthors. The study was published in Arthritis Care & Research.

To examine the effects of the ACA’s Medicaid expansion on lupus patients when it was implemented Jan. 1, 2014, the researchers launched a retrospective, quasi‐experimental study using administrative data from eight states to compare eight quarterly time points in the 2 years prior to implementation against seven quarterly time points in the 2 years after implementation. Four states expanded Medicaid under the ACA – Arizona, Kentucky, New Jersey, and New York – and four of them did not – Florida, Georgia, South Carolina, and Wisconsin.

During the study period, there were 204,150 lupus hospitalizations across all eight states during the 15 quarters, 53% of which occurred in the four states that did not expand Medicaid. Although the investigators’ base model found that the probability of a preventable hospitalization did not increase over time (odds ratio, 1.004; 95% confidence interval, 0.996-1.013), the four expansion states had significantly higher odds of having preventable hospitalizations in the final adjusted model (OR, 1.302; 95% CI, 1.119-1.515).

Variables that contributed to higher odds of a preventable hospitalization included age: Lupus patients who were 55-64 years old had considerably higher odds for preventable lupus hospitalizations than did patients who were 20-34 years old (OR, 1.488; 95% CI, 1.415-1.564). In addition, those with a median household income under $42,000 had higher odds of hospitalization when compared with those making over $68,000 (OR, 1.138; 95% CI, 1.415-1.564), as did those on Medicaid compared with those on private insurance (OR, 1.298; 95% CI, 1.238-1.361).

The authors acknowledged their study’s limitations, including relying on potential coding errors within administrative data. In addition, they were unable to factor in Medicaid marketing, enrollment strategies, or other related actions undertaken in each of the eight states.

The study was partially supported by the South Carolina Clinical & Translational Research Institute via a National Center for Advancing Translational Sciences grant. The authors reported no conflicts of interest.

SOURCE: Brown EA et al. Arthritis Care Res. 2019 Sept 28. doi: 10.1002/acr.24080

A new study has found that, although the Affordable Care Act (ACA) increased health insurance coverage in states that expanded their Medicaid program, the expansion did not translate into improved access to care or decreased preventable hospitalizations of patients with systemic lupus erythematosus (SLE).

juststock/gettyimages

“Our findings emphasize the importance of addressing systemic problems with American healthcare delivery at multiple levels,” wrote Elizabeth A. Brown, PhD, of the Medical University of South Carolina, Charleston, and her coauthors. The study was published in Arthritis Care & Research.

To examine the effects of the ACA’s Medicaid expansion on lupus patients when it was implemented Jan. 1, 2014, the researchers launched a retrospective, quasi‐experimental study using administrative data from eight states to compare eight quarterly time points in the 2 years prior to implementation against seven quarterly time points in the 2 years after implementation. Four states expanded Medicaid under the ACA – Arizona, Kentucky, New Jersey, and New York – and four of them did not – Florida, Georgia, South Carolina, and Wisconsin.

During the study period, there were 204,150 lupus hospitalizations across all eight states during the 15 quarters, 53% of which occurred in the four states that did not expand Medicaid. Although the investigators’ base model found that the probability of a preventable hospitalization did not increase over time (odds ratio, 1.004; 95% confidence interval, 0.996-1.013), the four expansion states had significantly higher odds of having preventable hospitalizations in the final adjusted model (OR, 1.302; 95% CI, 1.119-1.515).

Variables that contributed to higher odds of a preventable hospitalization included age: Lupus patients who were 55-64 years old had considerably higher odds for preventable lupus hospitalizations than did patients who were 20-34 years old (OR, 1.488; 95% CI, 1.415-1.564). In addition, those with a median household income under $42,000 had higher odds of hospitalization when compared with those making over $68,000 (OR, 1.138; 95% CI, 1.415-1.564), as did those on Medicaid compared with those on private insurance (OR, 1.298; 95% CI, 1.238-1.361).

The authors acknowledged their study’s limitations, including relying on potential coding errors within administrative data. In addition, they were unable to factor in Medicaid marketing, enrollment strategies, or other related actions undertaken in each of the eight states.

The study was partially supported by the South Carolina Clinical & Translational Research Institute via a National Center for Advancing Translational Sciences grant. The authors reported no conflicts of interest.

SOURCE: Brown EA et al. Arthritis Care Res. 2019 Sept 28. doi: 10.1002/acr.24080

A new study has found that ankylosing spondylitis (AS) and axial psoriatic arthritis (axPsA) may be different diseases with overlapping features rather than entities on the spectrum of the same disease, building on previous research by analyzing AS patients with and without psoriasis and including a longitudinal analysis.

lolostock/Thinkstock

“Our study suggests that axial PsA and AS with psoriasis seem to be two different diseases with different genetics, demographics, and disease expression,” wrote Joy Feld, MD, of the University of Toronto and coauthors. Their findings were published in Rheumatology.

To investigate the similarities and differences between axPsA and AS patients, the researchers compared two adult cohorts recruited from Toronto clinics. The first was made up of AS patients and divided into two groups: with psoriasis (n = 91) and without psoriasis (n = 675). The second was made up of PsA patients and divided into two groups: axPsA (n = 477) and peripheral PsA (n = 826).

In comparing AS patients with and without psoriasis to axPsA patients, AS patients had a younger age at diagnosis (28.7 years and 30.4 years vs. 35.6 years; P less than .001), were more often male (76% and 72% vs. 64%; P less than .001), and were more likely to be HLA-B27 positive (82% and 75% vs. 19%; P less than .001).

At baseline, AS patients had more back pain (90% and 92% vs. 21%; P less than .001) and worse back metrology (Bath Ankylosing Spondylitis Metrology Index [BASMI] of 3.1 and 2.3 vs. 1.9; P less than .001).

The mean follow-up periods in the axial and peripheral PsA groups were 12.6 and 6.7 years, respectively, whereas in the AS groups with and without psoriasis the periods were 5.4 and 3.5 years. Over time and after longitudinal analysis, axPsA patients had more tender and swollen joints than AS patients with and without psoriasis (5.2 vs. 1.5 and 0.9; P less than .001) while AS patients with and without psoriasis had a higher BASMI (2.9 and 2.2 vs. 1.8; P less than .001) and worse axial disease activity scores (4.1 and 3.9 vs. 3.5; P = .02) as measured by the Bath Ankylosing Spondylitis Disease Activity Index.

After univariate analysis, AS with psoriasis was found to be more associated with HLA-B27 (odds ratio, 16.37; 95% confidence interval, 8.89-30.13; P less than .0001), a higher adjusted mean BASMI (OR, 1.41; 95% CI, 1.21-1.63; P less than .0001), worse sacroiliitis (OR, 7.58; 95% CI, 3.68-15.59; P less than .0001), and greater use of biologics (OR, 1.25; 95% CI, 0.77-1; P = .37), compared with axPsA. A multivariate analysis produced similar findings, including the lack of association between AS and active arthritis (OR, 0.75; 95% CI, 0.64-0.86; P less than .0001).

The authors acknowledged their study’s limitations, including the fact that symptoms often dictate which of the two clinics patients will be referred to, which can ultimately define the diagnosis. “Patients with significant back symptoms are more likely to be referred to the AS clinic,” they wrote, “while patients with more prominent peripheral symptoms are more likely to be referred to the PsA clinic.” Patients with AS in the study were also required to have back pain or limitations in spinal range of motion, while PsA patients were accepted even if they were asymptomatic.

Finally, they noted that some milder cases of the two diseases may have been missed in the cohort recruiting process, although they added that mild cases were, in fact, “present in the cohort, which might improve the generalizability of this study to primary rheumatology clinics.”

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation, but this study received no specific funding to carry out the research. Dr. Feld reported being supported by a grant from Novartis. The authors reported no conflicts of interest.

SOURCE: Feld J et al. Rheumatology. 2019 Oct 8. doi: 10.1093/rheumatology/kez457.

A new study has found that ankylosing spondylitis (AS) and axial psoriatic arthritis (axPsA) may be different diseases with overlapping features rather than entities on the spectrum of the same disease, building on previous research by analyzing AS patients with and without psoriasis and including a longitudinal analysis.

lolostock/Thinkstock

“Our study suggests that axial PsA and AS with psoriasis seem to be two different diseases with different genetics, demographics, and disease expression,” wrote Joy Feld, MD, of the University of Toronto and coauthors. Their findings were published in Rheumatology.

To investigate the similarities and differences between axPsA and AS patients, the researchers compared two adult cohorts recruited from Toronto clinics. The first was made up of AS patients and divided into two groups: with psoriasis (n = 91) and without psoriasis (n = 675). The second was made up of PsA patients and divided into two groups: axPsA (n = 477) and peripheral PsA (n = 826).

In comparing AS patients with and without psoriasis to axPsA patients, AS patients had a younger age at diagnosis (28.7 years and 30.4 years vs. 35.6 years; P less than .001), were more often male (76% and 72% vs. 64%; P less than .001), and were more likely to be HLA-B27 positive (82% and 75% vs. 19%; P less than .001).

At baseline, AS patients had more back pain (90% and 92% vs. 21%; P less than .001) and worse back metrology (Bath Ankylosing Spondylitis Metrology Index [BASMI] of 3.1 and 2.3 vs. 1.9; P less than .001).

The mean follow-up periods in the axial and peripheral PsA groups were 12.6 and 6.7 years, respectively, whereas in the AS groups with and without psoriasis the periods were 5.4 and 3.5 years. Over time and after longitudinal analysis, axPsA patients had more tender and swollen joints than AS patients with and without psoriasis (5.2 vs. 1.5 and 0.9; P less than .001) while AS patients with and without psoriasis had a higher BASMI (2.9 and 2.2 vs. 1.8; P less than .001) and worse axial disease activity scores (4.1 and 3.9 vs. 3.5; P = .02) as measured by the Bath Ankylosing Spondylitis Disease Activity Index.

After univariate analysis, AS with psoriasis was found to be more associated with HLA-B27 (odds ratio, 16.37; 95% confidence interval, 8.89-30.13; P less than .0001), a higher adjusted mean BASMI (OR, 1.41; 95% CI, 1.21-1.63; P less than .0001), worse sacroiliitis (OR, 7.58; 95% CI, 3.68-15.59; P less than .0001), and greater use of biologics (OR, 1.25; 95% CI, 0.77-1; P = .37), compared with axPsA. A multivariate analysis produced similar findings, including the lack of association between AS and active arthritis (OR, 0.75; 95% CI, 0.64-0.86; P less than .0001).

The authors acknowledged their study’s limitations, including the fact that symptoms often dictate which of the two clinics patients will be referred to, which can ultimately define the diagnosis. “Patients with significant back symptoms are more likely to be referred to the AS clinic,” they wrote, “while patients with more prominent peripheral symptoms are more likely to be referred to the PsA clinic.” Patients with AS in the study were also required to have back pain or limitations in spinal range of motion, while PsA patients were accepted even if they were asymptomatic.

Finally, they noted that some milder cases of the two diseases may have been missed in the cohort recruiting process, although they added that mild cases were, in fact, “present in the cohort, which might improve the generalizability of this study to primary rheumatology clinics.”

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation, but this study received no specific funding to carry out the research. Dr. Feld reported being supported by a grant from Novartis. The authors reported no conflicts of interest.

SOURCE: Feld J et al. Rheumatology. 2019 Oct 8. doi: 10.1093/rheumatology/kez457.

A new study has found that ankylosing spondylitis (AS) and axial psoriatic arthritis (axPsA) may be different diseases with overlapping features rather than entities on the spectrum of the same disease, building on previous research by analyzing AS patients with and without psoriasis and including a longitudinal analysis.

lolostock/Thinkstock

“Our study suggests that axial PsA and AS with psoriasis seem to be two different diseases with different genetics, demographics, and disease expression,” wrote Joy Feld, MD, of the University of Toronto and coauthors. Their findings were published in Rheumatology.

To investigate the similarities and differences between axPsA and AS patients, the researchers compared two adult cohorts recruited from Toronto clinics. The first was made up of AS patients and divided into two groups: with psoriasis (n = 91) and without psoriasis (n = 675). The second was made up of PsA patients and divided into two groups: axPsA (n = 477) and peripheral PsA (n = 826).

In comparing AS patients with and without psoriasis to axPsA patients, AS patients had a younger age at diagnosis (28.7 years and 30.4 years vs. 35.6 years; P less than .001), were more often male (76% and 72% vs. 64%; P less than .001), and were more likely to be HLA-B27 positive (82% and 75% vs. 19%; P less than .001).

At baseline, AS patients had more back pain (90% and 92% vs. 21%; P less than .001) and worse back metrology (Bath Ankylosing Spondylitis Metrology Index [BASMI] of 3.1 and 2.3 vs. 1.9; P less than .001).

The mean follow-up periods in the axial and peripheral PsA groups were 12.6 and 6.7 years, respectively, whereas in the AS groups with and without psoriasis the periods were 5.4 and 3.5 years. Over time and after longitudinal analysis, axPsA patients had more tender and swollen joints than AS patients with and without psoriasis (5.2 vs. 1.5 and 0.9; P less than .001) while AS patients with and without psoriasis had a higher BASMI (2.9 and 2.2 vs. 1.8; P less than .001) and worse axial disease activity scores (4.1 and 3.9 vs. 3.5; P = .02) as measured by the Bath Ankylosing Spondylitis Disease Activity Index.

After univariate analysis, AS with psoriasis was found to be more associated with HLA-B27 (odds ratio, 16.37; 95% confidence interval, 8.89-30.13; P less than .0001), a higher adjusted mean BASMI (OR, 1.41; 95% CI, 1.21-1.63; P less than .0001), worse sacroiliitis (OR, 7.58; 95% CI, 3.68-15.59; P less than .0001), and greater use of biologics (OR, 1.25; 95% CI, 0.77-1; P = .37), compared with axPsA. A multivariate analysis produced similar findings, including the lack of association between AS and active arthritis (OR, 0.75; 95% CI, 0.64-0.86; P less than .0001).

The authors acknowledged their study’s limitations, including the fact that symptoms often dictate which of the two clinics patients will be referred to, which can ultimately define the diagnosis. “Patients with significant back symptoms are more likely to be referred to the AS clinic,” they wrote, “while patients with more prominent peripheral symptoms are more likely to be referred to the PsA clinic.” Patients with AS in the study were also required to have back pain or limitations in spinal range of motion, while PsA patients were accepted even if they were asymptomatic.

Finally, they noted that some milder cases of the two diseases may have been missed in the cohort recruiting process, although they added that mild cases were, in fact, “present in the cohort, which might improve the generalizability of this study to primary rheumatology clinics.”

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation, but this study received no specific funding to carry out the research. Dr. Feld reported being supported by a grant from Novartis. The authors reported no conflicts of interest.

SOURCE: Feld J et al. Rheumatology. 2019 Oct 8. doi: 10.1093/rheumatology/kez457.

A new study of children who were born with congenital heart disease (CHD) has found that they have increased odds of developing autism spectrum disorder.

“To our knowledge, this is the only study in which there has been a comparison between [autism spectrum disorder] and multiple CHD subtypes,” wrote Eric R. Sigmon, MD, of Emory University, Atlanta, and coauthors. “Our findings are consistent with previous studies of CHD developmental outcomes, which have shown an increased risk of developmental and academic delay after CHD diagnosis and treatment.” The study was published in Pediatrics.

To further investigate the association between CHD and autism, the researchers performed a case-control study using the Military Health System administrative database. They uncovered 8,760 cases of children with autism spectrum disorder and matched each one with three controls (n = 26,280). From that sample size, they identified 1,063 children with CHD: 401 in the autism spectrum disorder group and 662 in the control group.

Before analysis, children with autism spectrum disorder had an odds ratio of 1.85 of having any form of CHD, compared with controls (95% confidence interval, 1.63-2.10). After adjustment for covariates – including genetic syndromes, maternal age and morbidity, perinatal morbidity, and neonatal complications – the OR was 1.33 (95% CI, 1.16-1.52).

In the sensitivity analysis – which included only 593 children with CHD – the OR was a similar 1.32 (95% CI, 1.10-1.59).

Certain forms of CHD were more associated with autism spectrum disorder, including atrial septal defect (OR, 1.72; 95% CI, 1.07-2.74) and ventricular septal defect (OR, 1.65; 95% CI, 1.21-2.25). Left heart obstructive lesion was significantly associated with autism spectrum disorder after covariate adjustment (OR, 1.42; 95% CI, 1.04-1.93), but the finding was no longer significant in the sensitivity analysis.

The authors noted the potential limitations of their study, including the general weaknesses of administrative data, which they attempted to counter with the sensitive analysis. In addition, they recognized that children with either autism spectrum disorder or CHD “tend to present for care more frequently,” which could have created an ascertainment bias.

In an accompanying editorial, Johanna Calderon, PhD, David C. Bellinger, PhD, and Jane W. Newburger, MD, MPH, stated that more work needs to be done to further quantify the relationship between CHD and autism spectrum disorder (Pediatrics. 2019 Oct 10. doi: 10.1542/peds.2019-2752). The three authors – all affiliated with Boston Children’s Hospital and Harvard Medical School, also in Boston – reiterated the acknowledgment from Dr. Sigmon and coauthors that the “etiologic pathways that might explain” the link between the two remains unknown. They also noted their surprise that autism spectrum disorder risk appears to be increased in children with modestly severe forms of CHD, stating that this finding required additional investigation.

“Despite the strengths of this study,” they wrote, “it raises more questions than answers.”

The study was funded by the Congressional Directed Medical Research Programs Autism Research Award. The authors reported no conflicts of interest.

SOURCE: Sigmon ER at al. Pediatrics. 2019 Oct 10. doi: 10.1542/peds.2018-4114.

A new study of children who were born with congenital heart disease (CHD) has found that they have increased odds of developing autism spectrum disorder.

“To our knowledge, this is the only study in which there has been a comparison between [autism spectrum disorder] and multiple CHD subtypes,” wrote Eric R. Sigmon, MD, of Emory University, Atlanta, and coauthors. “Our findings are consistent with previous studies of CHD developmental outcomes, which have shown an increased risk of developmental and academic delay after CHD diagnosis and treatment.” The study was published in Pediatrics.

To further investigate the association between CHD and autism, the researchers performed a case-control study using the Military Health System administrative database. They uncovered 8,760 cases of children with autism spectrum disorder and matched each one with three controls (n = 26,280). From that sample size, they identified 1,063 children with CHD: 401 in the autism spectrum disorder group and 662 in the control group.

Before analysis, children with autism spectrum disorder had an odds ratio of 1.85 of having any form of CHD, compared with controls (95% confidence interval, 1.63-2.10). After adjustment for covariates – including genetic syndromes, maternal age and morbidity, perinatal morbidity, and neonatal complications – the OR was 1.33 (95% CI, 1.16-1.52).

In the sensitivity analysis – which included only 593 children with CHD – the OR was a similar 1.32 (95% CI, 1.10-1.59).

Certain forms of CHD were more associated with autism spectrum disorder, including atrial septal defect (OR, 1.72; 95% CI, 1.07-2.74) and ventricular septal defect (OR, 1.65; 95% CI, 1.21-2.25). Left heart obstructive lesion was significantly associated with autism spectrum disorder after covariate adjustment (OR, 1.42; 95% CI, 1.04-1.93), but the finding was no longer significant in the sensitivity analysis.

The authors noted the potential limitations of their study, including the general weaknesses of administrative data, which they attempted to counter with the sensitive analysis. In addition, they recognized that children with either autism spectrum disorder or CHD “tend to present for care more frequently,” which could have created an ascertainment bias.

In an accompanying editorial, Johanna Calderon, PhD, David C. Bellinger, PhD, and Jane W. Newburger, MD, MPH, stated that more work needs to be done to further quantify the relationship between CHD and autism spectrum disorder (Pediatrics. 2019 Oct 10. doi: 10.1542/peds.2019-2752). The three authors – all affiliated with Boston Children’s Hospital and Harvard Medical School, also in Boston – reiterated the acknowledgment from Dr. Sigmon and coauthors that the “etiologic pathways that might explain” the link between the two remains unknown. They also noted their surprise that autism spectrum disorder risk appears to be increased in children with modestly severe forms of CHD, stating that this finding required additional investigation.

“Despite the strengths of this study,” they wrote, “it raises more questions than answers.”

The study was funded by the Congressional Directed Medical Research Programs Autism Research Award. The authors reported no conflicts of interest.

SOURCE: Sigmon ER at al. Pediatrics. 2019 Oct 10. doi: 10.1542/peds.2018-4114.

A new study of children who were born with congenital heart disease (CHD) has found that they have increased odds of developing autism spectrum disorder.

“To our knowledge, this is the only study in which there has been a comparison between [autism spectrum disorder] and multiple CHD subtypes,” wrote Eric R. Sigmon, MD, of Emory University, Atlanta, and coauthors. “Our findings are consistent with previous studies of CHD developmental outcomes, which have shown an increased risk of developmental and academic delay after CHD diagnosis and treatment.” The study was published in Pediatrics.

To further investigate the association between CHD and autism, the researchers performed a case-control study using the Military Health System administrative database. They uncovered 8,760 cases of children with autism spectrum disorder and matched each one with three controls (n = 26,280). From that sample size, they identified 1,063 children with CHD: 401 in the autism spectrum disorder group and 662 in the control group.

Before analysis, children with autism spectrum disorder had an odds ratio of 1.85 of having any form of CHD, compared with controls (95% confidence interval, 1.63-2.10). After adjustment for covariates – including genetic syndromes, maternal age and morbidity, perinatal morbidity, and neonatal complications – the OR was 1.33 (95% CI, 1.16-1.52).

In the sensitivity analysis – which included only 593 children with CHD – the OR was a similar 1.32 (95% CI, 1.10-1.59).

Certain forms of CHD were more associated with autism spectrum disorder, including atrial septal defect (OR, 1.72; 95% CI, 1.07-2.74) and ventricular septal defect (OR, 1.65; 95% CI, 1.21-2.25). Left heart obstructive lesion was significantly associated with autism spectrum disorder after covariate adjustment (OR, 1.42; 95% CI, 1.04-1.93), but the finding was no longer significant in the sensitivity analysis.

The authors noted the potential limitations of their study, including the general weaknesses of administrative data, which they attempted to counter with the sensitive analysis. In addition, they recognized that children with either autism spectrum disorder or CHD “tend to present for care more frequently,” which could have created an ascertainment bias.

In an accompanying editorial, Johanna Calderon, PhD, David C. Bellinger, PhD, and Jane W. Newburger, MD, MPH, stated that more work needs to be done to further quantify the relationship between CHD and autism spectrum disorder (Pediatrics. 2019 Oct 10. doi: 10.1542/peds.2019-2752). The three authors – all affiliated with Boston Children’s Hospital and Harvard Medical School, also in Boston – reiterated the acknowledgment from Dr. Sigmon and coauthors that the “etiologic pathways that might explain” the link between the two remains unknown. They also noted their surprise that autism spectrum disorder risk appears to be increased in children with modestly severe forms of CHD, stating that this finding required additional investigation.

“Despite the strengths of this study,” they wrote, “it raises more questions than answers.”

The study was funded by the Congressional Directed Medical Research Programs Autism Research Award. The authors reported no conflicts of interest.

SOURCE: Sigmon ER at al. Pediatrics. 2019 Oct 10. doi: 10.1542/peds.2018-4114.

Despite theoretical preferences for either the anterior or the posterior approach to peroral endoscopic myotomy (POEM) in patients with achalasia, a new study has found no significant difference between the two in regard to clinical success or safety.

“Both approaches are equivalently safe when performed by experienced operators,” wrote Mouen A. Khashab, MD, of Johns Hopkins Medicine in Baltimore and coauthors, adding that the most notable difference was “closure was rated as easier during the posterior approach,” and fewer clips were needed. The study was published in Gastrointestinal Endoscopy.

To analyze and compare the efficacy of the two POEM approaches, the researchers conducted a multicenter controlled clinical trial of 150 patients with achalasia. They were randomized into two groups: those receiving POEM with the anterior approach (n = 73) or the posterior approach (n = 77). Of those patients, 148 received POEM and 138 completed 1-year follow-up. At 3, 6, and 12 months’ follow-up by phone call, patients were evaluated via outcomes that included Eckardt and dysphagia scores, quality of life scales, and gastroesophageal reflux disease questionnaire score.

Technical success was achieved in all 77 patients in the posterior group compared with 71 patients (97.3%) in the anterior group (P = .23). Both groups had a median length of hospital stay post procedure of 2 days. Adverse events occurred in seven patients (9%) in the posterior group and in eight patients (11%) in the anterior group (P = .703).

Though no significant differences were found between the two groups in time to perform mucosal incision, submucosal tunneling, myotomy, or closure, the median difficulty of closure in the posterior group was lower than in the anterior group (P = .002). In addition, fewer clips were needed during closure in the posterior approach.

After per-protocol analysis, clinical success at 1 year was achieved in 89% of patients in the posterior group (95% confidence interval, 81%-96%) and 90% of patients in the anterior group (95% CI, 82%-97%). At 1-year follow-up, both groups had an Eckardt score of 0 (P = .994) and their median gastroesophageal reflux disease score was 6 (P = .73). All patients who completed quality of life questionnaires reported improvements, with a median change in pain of 23 in the anterior group and 34 in the posterior group (P = .49). The posterior group also reported a greater median change in social functioning (50 vs. 38; P = .02).

The authors noted their study’s potential limitations, including relying on the Eckardt scoring system – one that was recently questioned in terms of validity – to determine clinical success. However, they also offered an argument in favor of clinical scoring because of “the importance of symptom improvement from the patient perspective.” Also, because of the lack of prestudy data comparing the anterior and posterior approaches, they chose 15% as the noninferiority margin for clinical efficacy, which could be regarded as a limitation as well.

Four of the authors reported potential conflicts of interest, including serving as consultants for various medical companies, serving on medical advisory boards, and receiving research support and personal fees. The other authors reported no conflicts of interest.

SOURCE: Khashab MA et al. Gastrointest Endosc. 2019 Aug 10. doi: 10.1016/j.gie.2019.07.034.

Despite theoretical preferences for either the anterior or the posterior approach to peroral endoscopic myotomy (POEM) in patients with achalasia, a new study has found no significant difference between the two in regard to clinical success or safety.

“Both approaches are equivalently safe when performed by experienced operators,” wrote Mouen A. Khashab, MD, of Johns Hopkins Medicine in Baltimore and coauthors, adding that the most notable difference was “closure was rated as easier during the posterior approach,” and fewer clips were needed. The study was published in Gastrointestinal Endoscopy.

To analyze and compare the efficacy of the two POEM approaches, the researchers conducted a multicenter controlled clinical trial of 150 patients with achalasia. They were randomized into two groups: those receiving POEM with the anterior approach (n = 73) or the posterior approach (n = 77). Of those patients, 148 received POEM and 138 completed 1-year follow-up. At 3, 6, and 12 months’ follow-up by phone call, patients were evaluated via outcomes that included Eckardt and dysphagia scores, quality of life scales, and gastroesophageal reflux disease questionnaire score.

Technical success was achieved in all 77 patients in the posterior group compared with 71 patients (97.3%) in the anterior group (P = .23). Both groups had a median length of hospital stay post procedure of 2 days. Adverse events occurred in seven patients (9%) in the posterior group and in eight patients (11%) in the anterior group (P = .703).

Though no significant differences were found between the two groups in time to perform mucosal incision, submucosal tunneling, myotomy, or closure, the median difficulty of closure in the posterior group was lower than in the anterior group (P = .002). In addition, fewer clips were needed during closure in the posterior approach.

After per-protocol analysis, clinical success at 1 year was achieved in 89% of patients in the posterior group (95% confidence interval, 81%-96%) and 90% of patients in the anterior group (95% CI, 82%-97%). At 1-year follow-up, both groups had an Eckardt score of 0 (P = .994) and their median gastroesophageal reflux disease score was 6 (P = .73). All patients who completed quality of life questionnaires reported improvements, with a median change in pain of 23 in the anterior group and 34 in the posterior group (P = .49). The posterior group also reported a greater median change in social functioning (50 vs. 38; P = .02).

The authors noted their study’s potential limitations, including relying on the Eckardt scoring system – one that was recently questioned in terms of validity – to determine clinical success. However, they also offered an argument in favor of clinical scoring because of “the importance of symptom improvement from the patient perspective.” Also, because of the lack of prestudy data comparing the anterior and posterior approaches, they chose 15% as the noninferiority margin for clinical efficacy, which could be regarded as a limitation as well.

Four of the authors reported potential conflicts of interest, including serving as consultants for various medical companies, serving on medical advisory boards, and receiving research support and personal fees. The other authors reported no conflicts of interest.

SOURCE: Khashab MA et al. Gastrointest Endosc. 2019 Aug 10. doi: 10.1016/j.gie.2019.07.034.

Despite theoretical preferences for either the anterior or the posterior approach to peroral endoscopic myotomy (POEM) in patients with achalasia, a new study has found no significant difference between the two in regard to clinical success or safety.

“Both approaches are equivalently safe when performed by experienced operators,” wrote Mouen A. Khashab, MD, of Johns Hopkins Medicine in Baltimore and coauthors, adding that the most notable difference was “closure was rated as easier during the posterior approach,” and fewer clips were needed. The study was published in Gastrointestinal Endoscopy.

To analyze and compare the efficacy of the two POEM approaches, the researchers conducted a multicenter controlled clinical trial of 150 patients with achalasia. They were randomized into two groups: those receiving POEM with the anterior approach (n = 73) or the posterior approach (n = 77). Of those patients, 148 received POEM and 138 completed 1-year follow-up. At 3, 6, and 12 months’ follow-up by phone call, patients were evaluated via outcomes that included Eckardt and dysphagia scores, quality of life scales, and gastroesophageal reflux disease questionnaire score.

Technical success was achieved in all 77 patients in the posterior group compared with 71 patients (97.3%) in the anterior group (P = .23). Both groups had a median length of hospital stay post procedure of 2 days. Adverse events occurred in seven patients (9%) in the posterior group and in eight patients (11%) in the anterior group (P = .703).

Though no significant differences were found between the two groups in time to perform mucosal incision, submucosal tunneling, myotomy, or closure, the median difficulty of closure in the posterior group was lower than in the anterior group (P = .002). In addition, fewer clips were needed during closure in the posterior approach.

After per-protocol analysis, clinical success at 1 year was achieved in 89% of patients in the posterior group (95% confidence interval, 81%-96%) and 90% of patients in the anterior group (95% CI, 82%-97%). At 1-year follow-up, both groups had an Eckardt score of 0 (P = .994) and their median gastroesophageal reflux disease score was 6 (P = .73). All patients who completed quality of life questionnaires reported improvements, with a median change in pain of 23 in the anterior group and 34 in the posterior group (P = .49). The posterior group also reported a greater median change in social functioning (50 vs. 38; P = .02).

The authors noted their study’s potential limitations, including relying on the Eckardt scoring system – one that was recently questioned in terms of validity – to determine clinical success. However, they also offered an argument in favor of clinical scoring because of “the importance of symptom improvement from the patient perspective.” Also, because of the lack of prestudy data comparing the anterior and posterior approaches, they chose 15% as the noninferiority margin for clinical efficacy, which could be regarded as a limitation as well.

Four of the authors reported potential conflicts of interest, including serving as consultants for various medical companies, serving on medical advisory boards, and receiving research support and personal fees. The other authors reported no conflicts of interest.

SOURCE: Khashab MA et al. Gastrointest Endosc. 2019 Aug 10. doi: 10.1016/j.gie.2019.07.034.

Despite theoretical preferences for either the anterior or the posterior approach to peroral endoscopic myotomy (POEM) in patients with achalasia, a new study has found no significant difference between the two in regard to clinical success or safety.

“Both approaches are equivalently safe when performed by experienced operators,” wrote Mouen A. Khashab, MD, of Johns Hopkins Medicine in Baltimore and coauthors, adding that the most notable difference was “closure was rated as easier during the posterior approach,” and fewer clips were needed. The study was published in Gastrointestinal Endoscopy.

To analyze and compare the efficacy of the two POEM approaches, the researchers conducted a multicenter controlled clinical trial of 150 patients with achalasia. They were randomized into two groups: those receiving POEM with the anterior approach (n = 73) or the posterior approach (n = 77). Of those patients, 148 received POEM and 138 completed 1-year follow-up. At 3, 6, and 12 months’ follow-up by phone call, patients were evaluated via outcomes that included Eckardt and dysphagia scores, quality of life scales, and gastroesophageal reflux disease questionnaire score.

Technical success was achieved in all 77 patients in the posterior group compared with 71 patients (97.3%) in the anterior group (P = .23). Both groups had a median length of hospital stay post procedure of 2 days. Adverse events occurred in seven patients (9%) in the posterior group and in eight patients (11%) in the anterior group (P = .703).

Though no significant differences were found between the two groups in time to perform mucosal incision, submucosal tunneling, myotomy, or closure, the median difficulty of closure in the posterior group was lower than in the anterior group (P = .002). In addition, fewer clips were needed during closure in the posterior approach.

After per-protocol analysis, clinical success at 1 year was achieved in 89% of patients in the posterior group (95% confidence interval, 81%-96%) and 90% of patients in the anterior group (95% CI, 82%-97%). At 1-year follow-up, both groups had an Eckardt score of 0 (P = .994) and their median gastroesophageal reflux disease score was 6 (P = .73). All patients who completed quality of life questionnaires reported improvements, with a median change in pain of 23 in the anterior group and 34 in the posterior group (P = .49). The posterior group also reported a greater median change in social functioning (50 vs. 38; P = .02).

The authors noted their study’s potential limitations, including relying on the Eckardt scoring system – one that was recently questioned in terms of validity – to determine clinical success. However, they also offered an argument in favor of clinical scoring because of “the importance of symptom improvement from the patient perspective.” Also, because of the lack of prestudy data comparing the anterior and posterior approaches, they chose 15% as the noninferiority margin for clinical efficacy, which could be regarded as a limitation as well.

Four of the authors reported potential conflicts of interest, including serving as consultants for various medical companies, serving on medical advisory boards, and receiving research support and personal fees. The other authors reported no conflicts of interest.

SOURCE: Khashab MA et al. Gastrointest Endosc. 2019 Aug 10. doi: 10.1016/j.gie.2019.07.034.

The AGA Center for GI Innovation and Technology supports innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process. To learn more visit www.gastro.org/CIGT. 

Despite theoretical preferences for either the anterior or the posterior approach to peroral endoscopic myotomy (POEM) in patients with achalasia, a new study has found no significant difference between the two in regard to clinical success or safety.

“Both approaches are equivalently safe when performed by experienced operators,” wrote Mouen A. Khashab, MD, of Johns Hopkins Medicine in Baltimore and coauthors, adding that the most notable difference was “closure was rated as easier during the posterior approach,” and fewer clips were needed. The study was published in Gastrointestinal Endoscopy.

To analyze and compare the efficacy of the two POEM approaches, the researchers conducted a multicenter controlled clinical trial of 150 patients with achalasia. They were randomized into two groups: those receiving POEM with the anterior approach (n = 73) or the posterior approach (n = 77). Of those patients, 148 received POEM and 138 completed 1-year follow-up. At 3, 6, and 12 months’ follow-up by phone call, patients were evaluated via outcomes that included Eckardt and dysphagia scores, quality of life scales, and gastroesophageal reflux disease questionnaire score.

Technical success was achieved in all 77 patients in the posterior group compared with 71 patients (97.3%) in the anterior group (P = .23). Both groups had a median length of hospital stay post procedure of 2 days. Adverse events occurred in seven patients (9%) in the posterior group and in eight patients (11%) in the anterior group (P = .703).

Though no significant differences were found between the two groups in time to perform mucosal incision, submucosal tunneling, myotomy, or closure, the median difficulty of closure in the posterior group was lower than in the anterior group (P = .002). In addition, fewer clips were needed during closure in the posterior approach.

After per-protocol analysis, clinical success at 1 year was achieved in 89% of patients in the posterior group (95% confidence interval, 81%-96%) and 90% of patients in the anterior group (95% CI, 82%-97%). At 1-year follow-up, both groups had an Eckardt score of 0 (P = .994) and their median gastroesophageal reflux disease score was 6 (P = .73). All patients who completed quality of life questionnaires reported improvements, with a median change in pain of 23 in the anterior group and 34 in the posterior group (P = .49). The posterior group also reported a greater median change in social functioning (50 vs. 38; P = .02).

The authors noted their study’s potential limitations, including relying on the Eckardt scoring system – one that was recently questioned in terms of validity – to determine clinical success. However, they also offered an argument in favor of clinical scoring because of “the importance of symptom improvement from the patient perspective.” Also, because of the lack of prestudy data comparing the anterior and posterior approaches, they chose 15% as the noninferiority margin for clinical efficacy, which could be regarded as a limitation as well.

Four of the authors reported potential conflicts of interest, including serving as consultants for various medical companies, serving on medical advisory boards, and receiving research support and personal fees. The other authors reported no conflicts of interest.

SOURCE: Khashab MA et al. Gastrointest Endosc. 2019 Aug 10. doi: 10.1016/j.gie.2019.07.034.

The AGA Center for GI Innovation and Technology supports innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process. To learn more visit www.gastro.org/CIGT. 

Despite theoretical preferences for either the anterior or the posterior approach to peroral endoscopic myotomy (POEM) in patients with achalasia, a new study has found no significant difference between the two in regard to clinical success or safety.

“Both approaches are equivalently safe when performed by experienced operators,” wrote Mouen A. Khashab, MD, of Johns Hopkins Medicine in Baltimore and coauthors, adding that the most notable difference was “closure was rated as easier during the posterior approach,” and fewer clips were needed. The study was published in Gastrointestinal Endoscopy.

To analyze and compare the efficacy of the two POEM approaches, the researchers conducted a multicenter controlled clinical trial of 150 patients with achalasia. They were randomized into two groups: those receiving POEM with the anterior approach (n = 73) or the posterior approach (n = 77). Of those patients, 148 received POEM and 138 completed 1-year follow-up. At 3, 6, and 12 months’ follow-up by phone call, patients were evaluated via outcomes that included Eckardt and dysphagia scores, quality of life scales, and gastroesophageal reflux disease questionnaire score.

Technical success was achieved in all 77 patients in the posterior group compared with 71 patients (97.3%) in the anterior group (P = .23). Both groups had a median length of hospital stay post procedure of 2 days. Adverse events occurred in seven patients (9%) in the posterior group and in eight patients (11%) in the anterior group (P = .703).

Though no significant differences were found between the two groups in time to perform mucosal incision, submucosal tunneling, myotomy, or closure, the median difficulty of closure in the posterior group was lower than in the anterior group (P = .002). In addition, fewer clips were needed during closure in the posterior approach.

After per-protocol analysis, clinical success at 1 year was achieved in 89% of patients in the posterior group (95% confidence interval, 81%-96%) and 90% of patients in the anterior group (95% CI, 82%-97%). At 1-year follow-up, both groups had an Eckardt score of 0 (P = .994) and their median gastroesophageal reflux disease score was 6 (P = .73). All patients who completed quality of life questionnaires reported improvements, with a median change in pain of 23 in the anterior group and 34 in the posterior group (P = .49). The posterior group also reported a greater median change in social functioning (50 vs. 38; P = .02).

The authors noted their study’s potential limitations, including relying on the Eckardt scoring system – one that was recently questioned in terms of validity – to determine clinical success. However, they also offered an argument in favor of clinical scoring because of “the importance of symptom improvement from the patient perspective.” Also, because of the lack of prestudy data comparing the anterior and posterior approaches, they chose 15% as the noninferiority margin for clinical efficacy, which could be regarded as a limitation as well.

Four of the authors reported potential conflicts of interest, including serving as consultants for various medical companies, serving on medical advisory boards, and receiving research support and personal fees. The other authors reported no conflicts of interest.

SOURCE: Khashab MA et al. Gastrointest Endosc. 2019 Aug 10. doi: 10.1016/j.gie.2019.07.034.

The AGA Center for GI Innovation and Technology supports innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process. To learn more visit www.gastro.org/CIGT. 

Immune checkpoint inhibitor (ICI)–induced inflammatory arthritis (IA) can remain active months and even years after ending ICI therapy, according to a new study of long-term outcomes of immune-related adverse events published in Annals of the Rheumatic Diseases.

“This study is one of the largest longitudinal reports to date of patients with ICI-induced IA and the first to evaluate persistence of ICI-induced IA and identify influential factors on outcome,” wrote Tawnie J. Braaten, MD, and coauthors. “Continued clinical and translational investigation on larger longitudinal cohorts will allow for increased understanding of pathophysiology and determination of the best clinical care for patients with ICI-induced IA.”

Dr. Braaten conducted the study at Johns Hopkins University, Baltimore, when she was a postdoctoral fellow there, and she is now in the division of rheumatology at the University of Utah, Salt Lake City.

To determine how long IA can persist after patients cease ICI therapy, along with factors associated with its persistence, the researchers studied 60 patients who were referred to the Johns Hopkins Arthritis Center for IA caused by ICIs. The patients – 32 females and 28 males – had a median follow-up of 9 months after ICI cessation.

Of the 51 patients with 3-month follow-up data, 70.6% had active IA. Of the 41 patients with 6-month follow-up data, 48.8% had active IA. All told, 53.3% of patients had active IA at their last follow-up visit, which occurred anywhere from 1 to 24 months after stopping ICI therapy.

According to univariable analysis, arthritis was less likely to improve in patients with a longer duration of ICI exposure (hazard ratio, 0.93; 95% confidence interval, 0.87-0.99; P = .02), in patients receiving combination ICI therapy (HR, 0.29; 95% CI, 0.12-0.72; P = .008) and in patients with a history of other immune-related adverse events (HR, 0.61; 95% CI, 0.39-0.95; P = .03).

The authors acknowledged their study’s limitations, including a potential selection bias for symptomatic individuals and the possibility that persistent IA sufferers may have pursued follow-up for longer periods of time. In addition, they noted that some patients were omitted from analysis if they were on a blinded clinical trial or had been receiving an investigational immunotherapy agent.

The study was funded via a grant from Bristol-Myers Squibb, an arthritis fellowship award from AbbVie, and additional financial support from the Camille Julia Morgan Arthritis Research and Education Fund, the Jerome L. Greene Foundation, and the National Institutes of Health. The authors reported various conflicts of interest, including receiving honoraria, grants, and research funding from numerous pharmaceutical companies.

SOURCE: Braaten TJ et al. Ann Rheum Dis. 2019 Sep 20. doi: 10.1136/annrheumdis-2019-216109.

Immune checkpoint inhibitor (ICI)–induced inflammatory arthritis (IA) can remain active months and even years after ending ICI therapy, according to a new study of long-term outcomes of immune-related adverse events published in Annals of the Rheumatic Diseases.

“This study is one of the largest longitudinal reports to date of patients with ICI-induced IA and the first to evaluate persistence of ICI-induced IA and identify influential factors on outcome,” wrote Tawnie J. Braaten, MD, and coauthors. “Continued clinical and translational investigation on larger longitudinal cohorts will allow for increased understanding of pathophysiology and determination of the best clinical care for patients with ICI-induced IA.”

Dr. Braaten conducted the study at Johns Hopkins University, Baltimore, when she was a postdoctoral fellow there, and she is now in the division of rheumatology at the University of Utah, Salt Lake City.

To determine how long IA can persist after patients cease ICI therapy, along with factors associated with its persistence, the researchers studied 60 patients who were referred to the Johns Hopkins Arthritis Center for IA caused by ICIs. The patients – 32 females and 28 males – had a median follow-up of 9 months after ICI cessation.

Of the 51 patients with 3-month follow-up data, 70.6% had active IA. Of the 41 patients with 6-month follow-up data, 48.8% had active IA. All told, 53.3% of patients had active IA at their last follow-up visit, which occurred anywhere from 1 to 24 months after stopping ICI therapy.

According to univariable analysis, arthritis was less likely to improve in patients with a longer duration of ICI exposure (hazard ratio, 0.93; 95% confidence interval, 0.87-0.99; P = .02), in patients receiving combination ICI therapy (HR, 0.29; 95% CI, 0.12-0.72; P = .008) and in patients with a history of other immune-related adverse events (HR, 0.61; 95% CI, 0.39-0.95; P = .03).

The authors acknowledged their study’s limitations, including a potential selection bias for symptomatic individuals and the possibility that persistent IA sufferers may have pursued follow-up for longer periods of time. In addition, they noted that some patients were omitted from analysis if they were on a blinded clinical trial or had been receiving an investigational immunotherapy agent.

The study was funded via a grant from Bristol-Myers Squibb, an arthritis fellowship award from AbbVie, and additional financial support from the Camille Julia Morgan Arthritis Research and Education Fund, the Jerome L. Greene Foundation, and the National Institutes of Health. The authors reported various conflicts of interest, including receiving honoraria, grants, and research funding from numerous pharmaceutical companies.

SOURCE: Braaten TJ et al. Ann Rheum Dis. 2019 Sep 20. doi: 10.1136/annrheumdis-2019-216109.

Immune checkpoint inhibitor (ICI)–induced inflammatory arthritis (IA) can remain active months and even years after ending ICI therapy, according to a new study of long-term outcomes of immune-related adverse events published in Annals of the Rheumatic Diseases.

“This study is one of the largest longitudinal reports to date of patients with ICI-induced IA and the first to evaluate persistence of ICI-induced IA and identify influential factors on outcome,” wrote Tawnie J. Braaten, MD, and coauthors. “Continued clinical and translational investigation on larger longitudinal cohorts will allow for increased understanding of pathophysiology and determination of the best clinical care for patients with ICI-induced IA.”

Dr. Braaten conducted the study at Johns Hopkins University, Baltimore, when she was a postdoctoral fellow there, and she is now in the division of rheumatology at the University of Utah, Salt Lake City.

To determine how long IA can persist after patients cease ICI therapy, along with factors associated with its persistence, the researchers studied 60 patients who were referred to the Johns Hopkins Arthritis Center for IA caused by ICIs. The patients – 32 females and 28 males – had a median follow-up of 9 months after ICI cessation.

Of the 51 patients with 3-month follow-up data, 70.6% had active IA. Of the 41 patients with 6-month follow-up data, 48.8% had active IA. All told, 53.3% of patients had active IA at their last follow-up visit, which occurred anywhere from 1 to 24 months after stopping ICI therapy.

According to univariable analysis, arthritis was less likely to improve in patients with a longer duration of ICI exposure (hazard ratio, 0.93; 95% confidence interval, 0.87-0.99; P = .02), in patients receiving combination ICI therapy (HR, 0.29; 95% CI, 0.12-0.72; P = .008) and in patients with a history of other immune-related adverse events (HR, 0.61; 95% CI, 0.39-0.95; P = .03).

The authors acknowledged their study’s limitations, including a potential selection bias for symptomatic individuals and the possibility that persistent IA sufferers may have pursued follow-up for longer periods of time. In addition, they noted that some patients were omitted from analysis if they were on a blinded clinical trial or had been receiving an investigational immunotherapy agent.

The study was funded via a grant from Bristol-Myers Squibb, an arthritis fellowship award from AbbVie, and additional financial support from the Camille Julia Morgan Arthritis Research and Education Fund, the Jerome L. Greene Foundation, and the National Institutes of Health. The authors reported various conflicts of interest, including receiving honoraria, grants, and research funding from numerous pharmaceutical companies.

SOURCE: Braaten TJ et al. Ann Rheum Dis. 2019 Sep 20. doi: 10.1136/annrheumdis-2019-216109.

Researchers have found that patients with heart disease have an increased risk of hospitalization for severe cutaneous adverse reactions to allopurinol, with factors like chronic kidney disease and high initial dosage adding to that risk.

“Physicians who prescribe allopurinol should look for these risk factors so that they may consider initiating lower-dosage allopurinol and other precautions, which may prevent this rare but serious adverse reaction,” Chio Yokose, MD, of Massachusetts General Hospital in Boston and coauthors wrote in the Canadian Medical Association Journal.

To further investigate known associations between heart disease and severe cutaneous adverse reactions to allopurinol – including Stevens-Johnson syndrome and toxic epidermal necrolysis – the researchers used an administrative database known as Population Data BC to conduct a cohort study of allopurinol initiators in British Columbia between 1997 and 2015. Individuals with a history of severe cutaneous adverse reactions before starting allopurinol were excluded.

Of the 130,325 allopurinol users identified, 109 were hospitalized for allopurinol-associated severe cutaneous adverse reactions within 3 months of starting the drug. One in 655 allopurinol users with heart disease were admitted to the hospital for allopurinol-associated severe cutaneous adverse reaction (risk ratio = 1.53 per 1,000; 95% confidence interval, 1.10-2.06), compared with 1 in 1,548 allopurinol users without heart disease (risk ratio = 0.65 per 1,000; 95% CI, 0.50-0.82).

After multivariable analysis, other significant associations with hospital admission included chronic kidney disease (relative risk, 1.88; 95% CI, 1.17-3.02) and an initial allopurinol dosage greater than 100 mg/day (RR, 2.78; 95% CI, 1.75-4.43). In addition, patients with heart disease, chronic kidney disease, and an initial dosage greater than 100 mg/day had an 11-fold higher risk of hospital admission (RR, 11.13; 95% CI, 4.66-26.58).

The authors acknowledged their study’s limitations, including potential misclassification of reactions and comorbidities that can stem from a reliance on ICD codes. However, they also noted that “any misclassification is expected to be nondifferential” and bias results toward the null accordingly.

The study was funded by the Canadian Institutes of Health Research. One author reported receiving a grant from the National Institutes of Health and research support from AstraZeneca, along with consulting fees from Takeda, Selecta Biosciences, and Horizon. No other conflicts of interest were reported.

SOURCE: Yokose C et al. CMAJ. 2019 Sep 30. doi: 10.1503/cmaj.190339.

Researchers have found that patients with heart disease have an increased risk of hospitalization for severe cutaneous adverse reactions to allopurinol, with factors like chronic kidney disease and high initial dosage adding to that risk.

“Physicians who prescribe allopurinol should look for these risk factors so that they may consider initiating lower-dosage allopurinol and other precautions, which may prevent this rare but serious adverse reaction,” Chio Yokose, MD, of Massachusetts General Hospital in Boston and coauthors wrote in the Canadian Medical Association Journal.

To further investigate known associations between heart disease and severe cutaneous adverse reactions to allopurinol – including Stevens-Johnson syndrome and toxic epidermal necrolysis – the researchers used an administrative database known as Population Data BC to conduct a cohort study of allopurinol initiators in British Columbia between 1997 and 2015. Individuals with a history of severe cutaneous adverse reactions before starting allopurinol were excluded.

Of the 130,325 allopurinol users identified, 109 were hospitalized for allopurinol-associated severe cutaneous adverse reactions within 3 months of starting the drug. One in 655 allopurinol users with heart disease were admitted to the hospital for allopurinol-associated severe cutaneous adverse reaction (risk ratio = 1.53 per 1,000; 95% confidence interval, 1.10-2.06), compared with 1 in 1,548 allopurinol users without heart disease (risk ratio = 0.65 per 1,000; 95% CI, 0.50-0.82).

After multivariable analysis, other significant associations with hospital admission included chronic kidney disease (relative risk, 1.88; 95% CI, 1.17-3.02) and an initial allopurinol dosage greater than 100 mg/day (RR, 2.78; 95% CI, 1.75-4.43). In addition, patients with heart disease, chronic kidney disease, and an initial dosage greater than 100 mg/day had an 11-fold higher risk of hospital admission (RR, 11.13; 95% CI, 4.66-26.58).

The authors acknowledged their study’s limitations, including potential misclassification of reactions and comorbidities that can stem from a reliance on ICD codes. However, they also noted that “any misclassification is expected to be nondifferential” and bias results toward the null accordingly.

The study was funded by the Canadian Institutes of Health Research. One author reported receiving a grant from the National Institutes of Health and research support from AstraZeneca, along with consulting fees from Takeda, Selecta Biosciences, and Horizon. No other conflicts of interest were reported.

SOURCE: Yokose C et al. CMAJ. 2019 Sep 30. doi: 10.1503/cmaj.190339.

Researchers have found that patients with heart disease have an increased risk of hospitalization for severe cutaneous adverse reactions to allopurinol, with factors like chronic kidney disease and high initial dosage adding to that risk.

“Physicians who prescribe allopurinol should look for these risk factors so that they may consider initiating lower-dosage allopurinol and other precautions, which may prevent this rare but serious adverse reaction,” Chio Yokose, MD, of Massachusetts General Hospital in Boston and coauthors wrote in the Canadian Medical Association Journal.

To further investigate known associations between heart disease and severe cutaneous adverse reactions to allopurinol – including Stevens-Johnson syndrome and toxic epidermal necrolysis – the researchers used an administrative database known as Population Data BC to conduct a cohort study of allopurinol initiators in British Columbia between 1997 and 2015. Individuals with a history of severe cutaneous adverse reactions before starting allopurinol were excluded.

Of the 130,325 allopurinol users identified, 109 were hospitalized for allopurinol-associated severe cutaneous adverse reactions within 3 months of starting the drug. One in 655 allopurinol users with heart disease were admitted to the hospital for allopurinol-associated severe cutaneous adverse reaction (risk ratio = 1.53 per 1,000; 95% confidence interval, 1.10-2.06), compared with 1 in 1,548 allopurinol users without heart disease (risk ratio = 0.65 per 1,000; 95% CI, 0.50-0.82).

After multivariable analysis, other significant associations with hospital admission included chronic kidney disease (relative risk, 1.88; 95% CI, 1.17-3.02) and an initial allopurinol dosage greater than 100 mg/day (RR, 2.78; 95% CI, 1.75-4.43). In addition, patients with heart disease, chronic kidney disease, and an initial dosage greater than 100 mg/day had an 11-fold higher risk of hospital admission (RR, 11.13; 95% CI, 4.66-26.58).

The authors acknowledged their study’s limitations, including potential misclassification of reactions and comorbidities that can stem from a reliance on ICD codes. However, they also noted that “any misclassification is expected to be nondifferential” and bias results toward the null accordingly.

The study was funded by the Canadian Institutes of Health Research. One author reported receiving a grant from the National Institutes of Health and research support from AstraZeneca, along with consulting fees from Takeda, Selecta Biosciences, and Horizon. No other conflicts of interest were reported.

SOURCE: Yokose C et al. CMAJ. 2019 Sep 30. doi: 10.1503/cmaj.190339.

A study has found that administering tranexamic acid (TXA) to high-risk patients undergoing total joint arthroplasty (TJA) does not increase their odds of adverse outcomes.

“The inclusion of high-risk patients in our study increases the generalizability of our findings and is consistent with the previous studies that showed no increase in complications when TXA is administered to TJA patients,” wrote Steven B. Porter, MD, of the Mayo Clinic in Jacksonville, Fla., and coauthors. The study was published in the Journal of Arthroplasty.

To determine the safety of TXA in patients at risk for thrombotic complications, the researchers investigated 38,220 patients who underwent total knee or total hip arthroplasty between 2011 and 2017 at the Mayo Clinic. Of those patients, 20,501 (54%) patients received TXA during their operation and 17,719 (46%) did not. Overall, 8,877 were classified as “high-risk” cases, which meant they had one or more cardiovascular disease or thromboembolic event before surgery.

After multivariable analysis, high risk-patients who received TXA had no significant difference in adverse outcome odds, compared with high-risk patients who did not receive TXA (odds ratio, 1.00; 95% confidence interval, 0.85-1.18). After 90 days, high-risk patients who did not receive TXA were more likely than those who received TXA to experience deep vein thrombosis (2.3% vs 0.8%, P less than .001), pulmonary embolism (1.7% vs 1.0%, P less than .001), cerebrovascular accident (0.8% vs. 0.4%, P less than .001), or death (0.5% vs. 0.4%, P less than .001).

The authors noted their study’s limitations, including a higher baseline incidence of risk factors in high-risk patients who did not receive TXA, compared with high-risk patients who did, which could have led to that group being “self-selected” to not receive TXA. In addition, all medical histories and rates of complications were based on ICD codes, which may have been inaccurate and therefore led to mischaracterized risk or miscoded postoperative complications.

The study was funded by the Mayo Clinic’s Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. No conflicts of interest were reported.

SOURCE: Porter SB et al. J Arthroplasty. 2019 Aug 17. doi: 10.1016/j.arth.2019.08.015.

A study has found that administering tranexamic acid (TXA) to high-risk patients undergoing total joint arthroplasty (TJA) does not increase their odds of adverse outcomes.

“The inclusion of high-risk patients in our study increases the generalizability of our findings and is consistent with the previous studies that showed no increase in complications when TXA is administered to TJA patients,” wrote Steven B. Porter, MD, of the Mayo Clinic in Jacksonville, Fla., and coauthors. The study was published in the Journal of Arthroplasty.

To determine the safety of TXA in patients at risk for thrombotic complications, the researchers investigated 38,220 patients who underwent total knee or total hip arthroplasty between 2011 and 2017 at the Mayo Clinic. Of those patients, 20,501 (54%) patients received TXA during their operation and 17,719 (46%) did not. Overall, 8,877 were classified as “high-risk” cases, which meant they had one or more cardiovascular disease or thromboembolic event before surgery.

After multivariable analysis, high risk-patients who received TXA had no significant difference in adverse outcome odds, compared with high-risk patients who did not receive TXA (odds ratio, 1.00; 95% confidence interval, 0.85-1.18). After 90 days, high-risk patients who did not receive TXA were more likely than those who received TXA to experience deep vein thrombosis (2.3% vs 0.8%, P less than .001), pulmonary embolism (1.7% vs 1.0%, P less than .001), cerebrovascular accident (0.8% vs. 0.4%, P less than .001), or death (0.5% vs. 0.4%, P less than .001).

The authors noted their study’s limitations, including a higher baseline incidence of risk factors in high-risk patients who did not receive TXA, compared with high-risk patients who did, which could have led to that group being “self-selected” to not receive TXA. In addition, all medical histories and rates of complications were based on ICD codes, which may have been inaccurate and therefore led to mischaracterized risk or miscoded postoperative complications.

The study was funded by the Mayo Clinic’s Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. No conflicts of interest were reported.

SOURCE: Porter SB et al. J Arthroplasty. 2019 Aug 17. doi: 10.1016/j.arth.2019.08.015.

A study has found that administering tranexamic acid (TXA) to high-risk patients undergoing total joint arthroplasty (TJA) does not increase their odds of adverse outcomes.

“The inclusion of high-risk patients in our study increases the generalizability of our findings and is consistent with the previous studies that showed no increase in complications when TXA is administered to TJA patients,” wrote Steven B. Porter, MD, of the Mayo Clinic in Jacksonville, Fla., and coauthors. The study was published in the Journal of Arthroplasty.

To determine the safety of TXA in patients at risk for thrombotic complications, the researchers investigated 38,220 patients who underwent total knee or total hip arthroplasty between 2011 and 2017 at the Mayo Clinic. Of those patients, 20,501 (54%) patients received TXA during their operation and 17,719 (46%) did not. Overall, 8,877 were classified as “high-risk” cases, which meant they had one or more cardiovascular disease or thromboembolic event before surgery.

After multivariable analysis, high risk-patients who received TXA had no significant difference in adverse outcome odds, compared with high-risk patients who did not receive TXA (odds ratio, 1.00; 95% confidence interval, 0.85-1.18). After 90 days, high-risk patients who did not receive TXA were more likely than those who received TXA to experience deep vein thrombosis (2.3% vs 0.8%, P less than .001), pulmonary embolism (1.7% vs 1.0%, P less than .001), cerebrovascular accident (0.8% vs. 0.4%, P less than .001), or death (0.5% vs. 0.4%, P less than .001).

The authors noted their study’s limitations, including a higher baseline incidence of risk factors in high-risk patients who did not receive TXA, compared with high-risk patients who did, which could have led to that group being “self-selected” to not receive TXA. In addition, all medical histories and rates of complications were based on ICD codes, which may have been inaccurate and therefore led to mischaracterized risk or miscoded postoperative complications.

The study was funded by the Mayo Clinic’s Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. No conflicts of interest were reported.

SOURCE: Porter SB et al. J Arthroplasty. 2019 Aug 17. doi: 10.1016/j.arth.2019.08.015.

According to a study on patients undergoing revision knee replacement, a delay of more than 24 hours between hospital admission and total knee arthroplasty (TKA) for periprosthetic fracture (PPF) led to increased odds of complications such as surgical site and urinary tract infections.

gorodenkoff/iStock/Getty Images

“Although this association is an important finding, the confounding factors that cause delay to surgery must be elucidated in non-database studies,” wrote Venkat Boddapati, MD, of Columbia University Medical Center, New York, and coauthors. The study was published in Arthroplasty Today.

To assess the best time for revision TKA after PPF of the knee, the researchers analyzed data from 484 patients who underwent another TKA from 2005 to 2016. Of those patients, 377 (78%) had expedited surgery – defined as less than or equal to 24 hours from hospital admission – and 107 (22%) had non-expedited surgery. Non-expedited patients averaged 3.2 days from admission to surgery.

After multivariate analysis, non-expedited patients had more complications overall, compared with expedited patients (odds ratio 2.35, P = .037). They also had comparative increases in surgical site infections (OR 12.87, P = .029), urinary tract infections (OR 10.46, P = .048), non-home discharge (OR 4.27, P less than .001), and blood transfusions (OR 4.53, P less than .001). The two groups saw no statistical difference in mortality.

The authors noted their study’s limitations, including an inability to assess complications beyond 30 days after surgery, which may affect tracking longer-term outcomes such as mortality. In addition, they were only able to classify surgery as expedited or non-expedited based on when the patient was admitted to the hospital, not the time since their injury. Finally, they lacked “relevant variables that may have contributed to this analysis,” including the type of fracture and the revision implants used.

Three authors reported being paid consultants for, and receiving research support from, several medical companies. The others reported no conflicts of interest.

SOURCE: Boddapati V et al. Arthroplast Today. 2019 Sep 1. doi: 10.1016/j.artd.2019.05.002.

According to a study on patients undergoing revision knee replacement, a delay of more than 24 hours between hospital admission and total knee arthroplasty (TKA) for periprosthetic fracture (PPF) led to increased odds of complications such as surgical site and urinary tract infections.

gorodenkoff/iStock/Getty Images

“Although this association is an important finding, the confounding factors that cause delay to surgery must be elucidated in non-database studies,” wrote Venkat Boddapati, MD, of Columbia University Medical Center, New York, and coauthors. The study was published in Arthroplasty Today.

To assess the best time for revision TKA after PPF of the knee, the researchers analyzed data from 484 patients who underwent another TKA from 2005 to 2016. Of those patients, 377 (78%) had expedited surgery – defined as less than or equal to 24 hours from hospital admission – and 107 (22%) had non-expedited surgery. Non-expedited patients averaged 3.2 days from admission to surgery.

After multivariate analysis, non-expedited patients had more complications overall, compared with expedited patients (odds ratio 2.35, P = .037). They also had comparative increases in surgical site infections (OR 12.87, P = .029), urinary tract infections (OR 10.46, P = .048), non-home discharge (OR 4.27, P less than .001), and blood transfusions (OR 4.53, P less than .001). The two groups saw no statistical difference in mortality.

The authors noted their study’s limitations, including an inability to assess complications beyond 30 days after surgery, which may affect tracking longer-term outcomes such as mortality. In addition, they were only able to classify surgery as expedited or non-expedited based on when the patient was admitted to the hospital, not the time since their injury. Finally, they lacked “relevant variables that may have contributed to this analysis,” including the type of fracture and the revision implants used.

Three authors reported being paid consultants for, and receiving research support from, several medical companies. The others reported no conflicts of interest.

SOURCE: Boddapati V et al. Arthroplast Today. 2019 Sep 1. doi: 10.1016/j.artd.2019.05.002.

According to a study on patients undergoing revision knee replacement, a delay of more than 24 hours between hospital admission and total knee arthroplasty (TKA) for periprosthetic fracture (PPF) led to increased odds of complications such as surgical site and urinary tract infections.

gorodenkoff/iStock/Getty Images

“Although this association is an important finding, the confounding factors that cause delay to surgery must be elucidated in non-database studies,” wrote Venkat Boddapati, MD, of Columbia University Medical Center, New York, and coauthors. The study was published in Arthroplasty Today.

To assess the best time for revision TKA after PPF of the knee, the researchers analyzed data from 484 patients who underwent another TKA from 2005 to 2016. Of those patients, 377 (78%) had expedited surgery – defined as less than or equal to 24 hours from hospital admission – and 107 (22%) had non-expedited surgery. Non-expedited patients averaged 3.2 days from admission to surgery.

After multivariate analysis, non-expedited patients had more complications overall, compared with expedited patients (odds ratio 2.35, P = .037). They also had comparative increases in surgical site infections (OR 12.87, P = .029), urinary tract infections (OR 10.46, P = .048), non-home discharge (OR 4.27, P less than .001), and blood transfusions (OR 4.53, P less than .001). The two groups saw no statistical difference in mortality.

The authors noted their study’s limitations, including an inability to assess complications beyond 30 days after surgery, which may affect tracking longer-term outcomes such as mortality. In addition, they were only able to classify surgery as expedited or non-expedited based on when the patient was admitted to the hospital, not the time since their injury. Finally, they lacked “relevant variables that may have contributed to this analysis,” including the type of fracture and the revision implants used.

Three authors reported being paid consultants for, and receiving research support from, several medical companies. The others reported no conflicts of interest.

SOURCE: Boddapati V et al. Arthroplast Today. 2019 Sep 1. doi: 10.1016/j.artd.2019.05.002.

A new study has found that a group of four collagen metabolites are promising biomarkers for axial spondyloarthritis (axSpA) that could potentially distinguish patients without radiographic signs of disease and those with ankylosing spondylitis.

“This current study illustrates the potential of serological metabolites of tissue destruction as novel disease activity biomarkers in axSpA,” wrote Markéta Hušáková, PhD, of the Institute of Rheumatology and Department of Rheumatology at First Faculty of Medicine Charles University in Prague and coauthors. The study was published in Scientific Reports.

To determine if certain collagen metabolites could indicate axSpA disease activity and distinguish nonradiographic axial spondyloarthritis (nr-axSpA) from ankylosing spondylitis (AS), the researchers examined 193 recently diagnosed axSpA patients and 100 asymptomatic controls. Of the 193 patients, 121 had nr-axSpA and 72 had AS.

The researchers found that four collagen metabolites occurred at significantly higher serum levels in both subtypes of axSpA patients, compared with controls: for C1M, a mean of 43.4 ng/mL for AS and 34.6 ng/mL for nr-axSpA versus 24.5 ng/mL for controls; for C2M, 0.35 and 0.36 versus 0.26; for C3M, 15.4 and 12.8 versus 7.8; and for C4M2, 27.8 and 22.4 versus 15.2. Mean serum levels of C1M, C3M, and C4M2 were significantly higher in AS patients when compared with nr-axSpA patients. Of the four collagen metabolites, C3M was the best for differentiating between axSpA patients and asymptomatic controls (area under receiver operator characteristics curve, 0.95; specificity, 92.0; sensitivity, 83.4) and between nr-axSpA patients and controls (AUC, 0.93; specificity, 80.0; sensitivity, 92.6) and AS patients (AUC, 0.98; specificity, 92.0; sensitivity, 91.7).

The authors acknowledged their study’s limitations, including the inability to investigate changes in biomarker levels and disease activity over time. In addition, there was a lack of clinical information about cardiovascular or other systemic complications, as well as no clinical or radiographic examination of the asymptomatic individuals, which could have revealed factors influencing their metabolite levels.

Two of the authors acknowledged being employees of fibrosis biomarker developer Nordic Bioscience; another researcher acknowledged being a stockholder. No additional conflicts of interest were reported.

SOURCE: Hušáková M et al. Sci Rep. 2019 Aug 2. doi: 10.1038/s41598-019-47502-z.

A new study has found that a group of four collagen metabolites are promising biomarkers for axial spondyloarthritis (axSpA) that could potentially distinguish patients without radiographic signs of disease and those with ankylosing spondylitis.

“This current study illustrates the potential of serological metabolites of tissue destruction as novel disease activity biomarkers in axSpA,” wrote Markéta Hušáková, PhD, of the Institute of Rheumatology and Department of Rheumatology at First Faculty of Medicine Charles University in Prague and coauthors. The study was published in Scientific Reports.

To determine if certain collagen metabolites could indicate axSpA disease activity and distinguish nonradiographic axial spondyloarthritis (nr-axSpA) from ankylosing spondylitis (AS), the researchers examined 193 recently diagnosed axSpA patients and 100 asymptomatic controls. Of the 193 patients, 121 had nr-axSpA and 72 had AS.

The researchers found that four collagen metabolites occurred at significantly higher serum levels in both subtypes of axSpA patients, compared with controls: for C1M, a mean of 43.4 ng/mL for AS and 34.6 ng/mL for nr-axSpA versus 24.5 ng/mL for controls; for C2M, 0.35 and 0.36 versus 0.26; for C3M, 15.4 and 12.8 versus 7.8; and for C4M2, 27.8 and 22.4 versus 15.2. Mean serum levels of C1M, C3M, and C4M2 were significantly higher in AS patients when compared with nr-axSpA patients. Of the four collagen metabolites, C3M was the best for differentiating between axSpA patients and asymptomatic controls (area under receiver operator characteristics curve, 0.95; specificity, 92.0; sensitivity, 83.4) and between nr-axSpA patients and controls (AUC, 0.93; specificity, 80.0; sensitivity, 92.6) and AS patients (AUC, 0.98; specificity, 92.0; sensitivity, 91.7).

The authors acknowledged their study’s limitations, including the inability to investigate changes in biomarker levels and disease activity over time. In addition, there was a lack of clinical information about cardiovascular or other systemic complications, as well as no clinical or radiographic examination of the asymptomatic individuals, which could have revealed factors influencing their metabolite levels.

Two of the authors acknowledged being employees of fibrosis biomarker developer Nordic Bioscience; another researcher acknowledged being a stockholder. No additional conflicts of interest were reported.

SOURCE: Hušáková M et al. Sci Rep. 2019 Aug 2. doi: 10.1038/s41598-019-47502-z.

A new study has found that a group of four collagen metabolites are promising biomarkers for axial spondyloarthritis (axSpA) that could potentially distinguish patients without radiographic signs of disease and those with ankylosing spondylitis.

“This current study illustrates the potential of serological metabolites of tissue destruction as novel disease activity biomarkers in axSpA,” wrote Markéta Hušáková, PhD, of the Institute of Rheumatology and Department of Rheumatology at First Faculty of Medicine Charles University in Prague and coauthors. The study was published in Scientific Reports.

To determine if certain collagen metabolites could indicate axSpA disease activity and distinguish nonradiographic axial spondyloarthritis (nr-axSpA) from ankylosing spondylitis (AS), the researchers examined 193 recently diagnosed axSpA patients and 100 asymptomatic controls. Of the 193 patients, 121 had nr-axSpA and 72 had AS.

The researchers found that four collagen metabolites occurred at significantly higher serum levels in both subtypes of axSpA patients, compared with controls: for C1M, a mean of 43.4 ng/mL for AS and 34.6 ng/mL for nr-axSpA versus 24.5 ng/mL for controls; for C2M, 0.35 and 0.36 versus 0.26; for C3M, 15.4 and 12.8 versus 7.8; and for C4M2, 27.8 and 22.4 versus 15.2. Mean serum levels of C1M, C3M, and C4M2 were significantly higher in AS patients when compared with nr-axSpA patients. Of the four collagen metabolites, C3M was the best for differentiating between axSpA patients and asymptomatic controls (area under receiver operator characteristics curve, 0.95; specificity, 92.0; sensitivity, 83.4) and between nr-axSpA patients and controls (AUC, 0.93; specificity, 80.0; sensitivity, 92.6) and AS patients (AUC, 0.98; specificity, 92.0; sensitivity, 91.7).

The authors acknowledged their study’s limitations, including the inability to investigate changes in biomarker levels and disease activity over time. In addition, there was a lack of clinical information about cardiovascular or other systemic complications, as well as no clinical or radiographic examination of the asymptomatic individuals, which could have revealed factors influencing their metabolite levels.

Two of the authors acknowledged being employees of fibrosis biomarker developer Nordic Bioscience; another researcher acknowledged being a stockholder. No additional conflicts of interest were reported.

SOURCE: Hušáková M et al. Sci Rep. 2019 Aug 2. doi: 10.1038/s41598-019-47502-z.