Hospital medicine has grown rapidly, with more than 50,000 hospitalists practicing nationally in 2016.¹ Despite the remarkable increase in academic hospital medicine faculty (AHMF), scholarly productivity remains underdeveloped. Prior evidence suggests peer-reviewed publications remain an important aspect of promotion in academic hospital medicine.² However, there are multiple barriers to robust scholarly productivity among AHMF, including inadequate mentorship,³ lack of protected scholarship time,⁴ and greater participation in nonclinical activities outside of peer-reviewed clinical research.⁵ Though research barriers have been described previously, the current state of scholarly productivity among AHMF has not been characterized. In this cross-sectional study, we describe the distribution of academic rank and scholarly output of a national sample of AHMF.

Study Design and Data Source

We performed a cross-sectional study of AHMF at the top 25 internal medicine residency programs as determined by Doximity.com as of February 1, 2020 (Appendix Table 1). Between March and August 2020, two authors (NS, MT) visited each residency program’s website, identified all faculty listed as members of the hospital medicine program, and extracted demographic data, including degrees, sex, residency, medical school, year of residency graduation, completion of chief residency, completion of fellowship, and rank. We categorized all academic titles into full professor, associate professor, assistant professor, and instructor/lecturer. Missing information was supplemented by searching state licensing websites and Doximity.com. Sex was validated using Genderize.io. We queried the Scopus database for each AHMF’s name and affiliated institution to extract publications, citations, and H-index (metric of productivity and impact, derived from the number of publications and their associated citations).⁶ We categorized medical schools by rank (top 25, top 50, or unranked), as defined by the 2020 US News Best Medical Schools, sorted by research⁷ and by location (United States, international Caribbean, and international non-Caribbean). We excluded programs without hospital medicine section/division webpages and AHMF with nonpromotion titles such as “adjunct professor” or “acting professor” or those with missing data that could not be identified using these methods.

Analysis

Summary statistics were generated using means with standard deviations and medians with interquartile ranges. We evaluated postresidency years 6 to 10 and 14 to 18 as conservative time frames for promotion to associate and full professor, respectively. These windows account for time spent for additional degrees, instructor years, and alternative career pathways. Demographic differences between academic ranks were determined using chi-square and Kruskal-Wallis analyses.  

Because promotion occurs sequentially, a proportional odds logistic regression model was used to evaluate the association of academic rank and H-index, number of years post residency, completion of chief residency, graduation from a top 25 medical school, and sex. Since not all programs have the instructor/lecturer rank, only assistant, associate, and full professors were included in this model. Significance was assessed with the likelihood ratio test. The proportional odds assumption was assessed using the score test. All adjusted odds ratios and their associated 95% confidence intervals were recorded. A two-tailed P value < .05 was considered significant for this study, and SAS version 9.4 (SAS Institute Inc) was used to conduct all analyses. This study was approved by the UT Southwestern Institutional Review Board.

Cohort Demographics

Of the top 25 internal medicine programs, 3 were excluded because they did not have websites that listed AHMF. Of the remaining 22 programs, we identified 1,829 AHMF. We excluded 166 AHMF because we could not identify title or year of residency graduation and 109 for having nonpromotion titles, leaving 1,554 AHMF (Appendix Figure). The cohort characteristics are described in Table 1.

Research Productivity

A total of 9,809 documents had been published by this cohort of academic hospitalists (Appendix Table 2). Overall mean (SD) and median (IQR) publications were 6.3 (24.3) and 0.0 (0.0-4.0), respectively. A total of 799 (51.4%) AHMF had no publications, 347 (22.3%) had one to three publications, 209 (13.4%) had 10 or more, and 39 (2.5%) had 50 or more. The median number of publications stratified by academic rank were 0.0 (IQR, 0.0-1.0) for instructors, 0.0 (IQR, 0.0-3.0) for assistant professors, 8.0 (IQR, 2.0-23.0) for associate professors, and 38.0 (IQR, 6.0-99.0) for full professors. Among men, 54.3% had published at least one manuscript, compared to 42.7% of women (P < .0001). The distribution of H-indices by years since residency graduation is shown in the Figure. The median number of documents published by faculty 6 to 10 years post residency was 1.0 (IQR, 0.0-4.0), with 46.8% of these faculty without a publication. For faculty 14 to 18 years post residency, the median number of documents was 3.0 (IQR, 0.0-11.0), with 30.1% of these faculty without a publication. Years post residency and academic rank were correlated with higher H-indices as well as more publications and citations (P < .0001).

Factors Associated With Academic Rank

Factors associated with rank are described in Appendix Table 3. In our multivariable ordinal regression model, H-index (adjusted odds ratio [aOR], 1.16 per single H-index point; 95% CI, 1.12-1.20), years post residency graduation (aOR, 1.14; 95% CI, 1.11-1.17), completion of chief residency (aOR, 2.46; 95% CI, 1.34-4.51), and graduation from a top 25 medical school (aOR, 2.10; 95% CI, 1.44-3.06) were associated with promotion.

In this cross-sectional analysis of more than 1,500 AHMF at the top 25 internal medicine residencies in the United States, 88.3% were instructors or assistant professors, while only 11.7% were associate or full professors. Furthermore, 51.4% were without a publication, and only 26.3% had published more than three manuscripts. Last, H-index, completion of a chief residency, years post residency, and graduation from a top 25 medical school were associated with higher academic rank.

Only 2.7% of the cohort were full professors, and 9.0% were associate professors. In comparison, academic cardiology faculty are 28.2% full professors and 22.9% associate professors.⁸ While the field of hospital medicine is relatively new, many faculty members had practiced for the expected duration of time for promotion consideration, with assistant professors or instructors constituting 89.9% of faculty at 6 to 10 years and 63.6% of faculty at 14 to 18 years post residency. We additionally observed a gender gap in publication history in hospital medicine, consistent with prior studies in hospital medicine that suggested gender disparities in scholarship.^9,10 Increased focus will be needed in the future to ensure opportunities for scholarship are equitable for all faculty in hospital medicine.

Our findings suggest that scholarly productivity in academic hospital medicine remains a challenge. Prior studies have reported that less than half of academic hospitalists have ever published, and fewer than one in eight have received research funding.^11,12 It is encouraging, however, that publications increase with time after residency. These data are consistent with the literature demonstrating a modest increase in hospitalists who had ever published, increasing from 43.0% in 2012 to 48.6% in 2020.¹² Despite these trends, however, some early-career academic hospitalists report ambivalence toward academic productivity and promotion.¹³ Whether this ambivalence is the source of low scholarship output or the outcome of insufficient mentorship and limited research success is uncertain. But these factors, combined with the pressures of clinical productivity, the existing lack of mentorship, and inadequate protected research time represent barriers to successful scholarship in academic hospital medicine.^3,14

Our study has several limitations. First, our inclusion criteria for the top 25 internal medicine residencies may have excluded hospital medicine divisions with substantial scholarly productivity. However, with 21 of the 25 programs listed on Doximity.com in the top 25 for internal medicine research funding, it is likely that our results overestimate scholarly productivity if compared to a complete, national cohort of AHMF.¹⁵ Second, our findings may not be generalizable to hospitalists who practice in nonacademic settings. Third, we were unable to account for differences in promotion criteria/tracks or scholarly output expectations between institutions. This limitation has been seen similarly in prior studies linking promotion and H-index.² Furthermore, our study does not capture promotion via other pathways that may not depend on scholarly output, such as hospital leadership roles. Last, as data were abstracted from academic center websites, it is possible that not all information was accurate or updated. However, we randomly reevaluated 25% of hospital division webpages 6 months after our initial data collection and noted that all had been updated with new faculty and academic ranks, suggesting our data were accurate.

These data highlight that research productivity and academic promotion remain challenges in academic hospital medicine. Future studies may examine topics that include understanding pathways and milestones to promotion, reducing disparities in scholarship, and improving mentorship, protected time, and research funding in academic hospital medicine.

Hospital medicine has grown rapidly, with more than 50,000 hospitalists practicing nationally in 2016.¹ Despite the remarkable increase in academic hospital medicine faculty (AHMF), scholarly productivity remains underdeveloped. Prior evidence suggests peer-reviewed publications remain an important aspect of promotion in academic hospital medicine.² However, there are multiple barriers to robust scholarly productivity among AHMF, including inadequate mentorship,³ lack of protected scholarship time,⁴ and greater participation in nonclinical activities outside of peer-reviewed clinical research.⁵ Though research barriers have been described previously, the current state of scholarly productivity among AHMF has not been characterized. In this cross-sectional study, we describe the distribution of academic rank and scholarly output of a national sample of AHMF.

Study Design and Data Source

We performed a cross-sectional study of AHMF at the top 25 internal medicine residency programs as determined by Doximity.com as of February 1, 2020 (Appendix Table 1). Between March and August 2020, two authors (NS, MT) visited each residency program’s website, identified all faculty listed as members of the hospital medicine program, and extracted demographic data, including degrees, sex, residency, medical school, year of residency graduation, completion of chief residency, completion of fellowship, and rank. We categorized all academic titles into full professor, associate professor, assistant professor, and instructor/lecturer. Missing information was supplemented by searching state licensing websites and Doximity.com. Sex was validated using Genderize.io. We queried the Scopus database for each AHMF’s name and affiliated institution to extract publications, citations, and H-index (metric of productivity and impact, derived from the number of publications and their associated citations).⁶ We categorized medical schools by rank (top 25, top 50, or unranked), as defined by the 2020 US News Best Medical Schools, sorted by research⁷ and by location (United States, international Caribbean, and international non-Caribbean). We excluded programs without hospital medicine section/division webpages and AHMF with nonpromotion titles such as “adjunct professor” or “acting professor” or those with missing data that could not be identified using these methods.

Analysis

Summary statistics were generated using means with standard deviations and medians with interquartile ranges. We evaluated postresidency years 6 to 10 and 14 to 18 as conservative time frames for promotion to associate and full professor, respectively. These windows account for time spent for additional degrees, instructor years, and alternative career pathways. Demographic differences between academic ranks were determined using chi-square and Kruskal-Wallis analyses.  

Because promotion occurs sequentially, a proportional odds logistic regression model was used to evaluate the association of academic rank and H-index, number of years post residency, completion of chief residency, graduation from a top 25 medical school, and sex. Since not all programs have the instructor/lecturer rank, only assistant, associate, and full professors were included in this model. Significance was assessed with the likelihood ratio test. The proportional odds assumption was assessed using the score test. All adjusted odds ratios and their associated 95% confidence intervals were recorded. A two-tailed P value < .05 was considered significant for this study, and SAS version 9.4 (SAS Institute Inc) was used to conduct all analyses. This study was approved by the UT Southwestern Institutional Review Board.

Cohort Demographics

Of the top 25 internal medicine programs, 3 were excluded because they did not have websites that listed AHMF. Of the remaining 22 programs, we identified 1,829 AHMF. We excluded 166 AHMF because we could not identify title or year of residency graduation and 109 for having nonpromotion titles, leaving 1,554 AHMF (Appendix Figure). The cohort characteristics are described in Table 1.

Research Productivity

A total of 9,809 documents had been published by this cohort of academic hospitalists (Appendix Table 2). Overall mean (SD) and median (IQR) publications were 6.3 (24.3) and 0.0 (0.0-4.0), respectively. A total of 799 (51.4%) AHMF had no publications, 347 (22.3%) had one to three publications, 209 (13.4%) had 10 or more, and 39 (2.5%) had 50 or more. The median number of publications stratified by academic rank were 0.0 (IQR, 0.0-1.0) for instructors, 0.0 (IQR, 0.0-3.0) for assistant professors, 8.0 (IQR, 2.0-23.0) for associate professors, and 38.0 (IQR, 6.0-99.0) for full professors. Among men, 54.3% had published at least one manuscript, compared to 42.7% of women (P < .0001). The distribution of H-indices by years since residency graduation is shown in the Figure. The median number of documents published by faculty 6 to 10 years post residency was 1.0 (IQR, 0.0-4.0), with 46.8% of these faculty without a publication. For faculty 14 to 18 years post residency, the median number of documents was 3.0 (IQR, 0.0-11.0), with 30.1% of these faculty without a publication. Years post residency and academic rank were correlated with higher H-indices as well as more publications and citations (P < .0001).

Factors Associated With Academic Rank

Factors associated with rank are described in Appendix Table 3. In our multivariable ordinal regression model, H-index (adjusted odds ratio [aOR], 1.16 per single H-index point; 95% CI, 1.12-1.20), years post residency graduation (aOR, 1.14; 95% CI, 1.11-1.17), completion of chief residency (aOR, 2.46; 95% CI, 1.34-4.51), and graduation from a top 25 medical school (aOR, 2.10; 95% CI, 1.44-3.06) were associated with promotion.

In this cross-sectional analysis of more than 1,500 AHMF at the top 25 internal medicine residencies in the United States, 88.3% were instructors or assistant professors, while only 11.7% were associate or full professors. Furthermore, 51.4% were without a publication, and only 26.3% had published more than three manuscripts. Last, H-index, completion of a chief residency, years post residency, and graduation from a top 25 medical school were associated with higher academic rank.

Only 2.7% of the cohort were full professors, and 9.0% were associate professors. In comparison, academic cardiology faculty are 28.2% full professors and 22.9% associate professors.⁸ While the field of hospital medicine is relatively new, many faculty members had practiced for the expected duration of time for promotion consideration, with assistant professors or instructors constituting 89.9% of faculty at 6 to 10 years and 63.6% of faculty at 14 to 18 years post residency. We additionally observed a gender gap in publication history in hospital medicine, consistent with prior studies in hospital medicine that suggested gender disparities in scholarship.^9,10 Increased focus will be needed in the future to ensure opportunities for scholarship are equitable for all faculty in hospital medicine.

Our findings suggest that scholarly productivity in academic hospital medicine remains a challenge. Prior studies have reported that less than half of academic hospitalists have ever published, and fewer than one in eight have received research funding.^11,12 It is encouraging, however, that publications increase with time after residency. These data are consistent with the literature demonstrating a modest increase in hospitalists who had ever published, increasing from 43.0% in 2012 to 48.6% in 2020.¹² Despite these trends, however, some early-career academic hospitalists report ambivalence toward academic productivity and promotion.¹³ Whether this ambivalence is the source of low scholarship output or the outcome of insufficient mentorship and limited research success is uncertain. But these factors, combined with the pressures of clinical productivity, the existing lack of mentorship, and inadequate protected research time represent barriers to successful scholarship in academic hospital medicine.^3,14

Our study has several limitations. First, our inclusion criteria for the top 25 internal medicine residencies may have excluded hospital medicine divisions with substantial scholarly productivity. However, with 21 of the 25 programs listed on Doximity.com in the top 25 for internal medicine research funding, it is likely that our results overestimate scholarly productivity if compared to a complete, national cohort of AHMF.¹⁵ Second, our findings may not be generalizable to hospitalists who practice in nonacademic settings. Third, we were unable to account for differences in promotion criteria/tracks or scholarly output expectations between institutions. This limitation has been seen similarly in prior studies linking promotion and H-index.² Furthermore, our study does not capture promotion via other pathways that may not depend on scholarly output, such as hospital leadership roles. Last, as data were abstracted from academic center websites, it is possible that not all information was accurate or updated. However, we randomly reevaluated 25% of hospital division webpages 6 months after our initial data collection and noted that all had been updated with new faculty and academic ranks, suggesting our data were accurate.

These data highlight that research productivity and academic promotion remain challenges in academic hospital medicine. Future studies may examine topics that include understanding pathways and milestones to promotion, reducing disparities in scholarship, and improving mentorship, protected time, and research funding in academic hospital medicine.

Hospital medicine has grown rapidly, with more than 50,000 hospitalists practicing nationally in 2016.¹ Despite the remarkable increase in academic hospital medicine faculty (AHMF), scholarly productivity remains underdeveloped. Prior evidence suggests peer-reviewed publications remain an important aspect of promotion in academic hospital medicine.² However, there are multiple barriers to robust scholarly productivity among AHMF, including inadequate mentorship,³ lack of protected scholarship time,⁴ and greater participation in nonclinical activities outside of peer-reviewed clinical research.⁵ Though research barriers have been described previously, the current state of scholarly productivity among AHMF has not been characterized. In this cross-sectional study, we describe the distribution of academic rank and scholarly output of a national sample of AHMF.

Study Design and Data Source

We performed a cross-sectional study of AHMF at the top 25 internal medicine residency programs as determined by Doximity.com as of February 1, 2020 (Appendix Table 1). Between March and August 2020, two authors (NS, MT) visited each residency program’s website, identified all faculty listed as members of the hospital medicine program, and extracted demographic data, including degrees, sex, residency, medical school, year of residency graduation, completion of chief residency, completion of fellowship, and rank. We categorized all academic titles into full professor, associate professor, assistant professor, and instructor/lecturer. Missing information was supplemented by searching state licensing websites and Doximity.com. Sex was validated using Genderize.io. We queried the Scopus database for each AHMF’s name and affiliated institution to extract publications, citations, and H-index (metric of productivity and impact, derived from the number of publications and their associated citations).⁶ We categorized medical schools by rank (top 25, top 50, or unranked), as defined by the 2020 US News Best Medical Schools, sorted by research⁷ and by location (United States, international Caribbean, and international non-Caribbean). We excluded programs without hospital medicine section/division webpages and AHMF with nonpromotion titles such as “adjunct professor” or “acting professor” or those with missing data that could not be identified using these methods.

Analysis

Summary statistics were generated using means with standard deviations and medians with interquartile ranges. We evaluated postresidency years 6 to 10 and 14 to 18 as conservative time frames for promotion to associate and full professor, respectively. These windows account for time spent for additional degrees, instructor years, and alternative career pathways. Demographic differences between academic ranks were determined using chi-square and Kruskal-Wallis analyses.  

Because promotion occurs sequentially, a proportional odds logistic regression model was used to evaluate the association of academic rank and H-index, number of years post residency, completion of chief residency, graduation from a top 25 medical school, and sex. Since not all programs have the instructor/lecturer rank, only assistant, associate, and full professors were included in this model. Significance was assessed with the likelihood ratio test. The proportional odds assumption was assessed using the score test. All adjusted odds ratios and their associated 95% confidence intervals were recorded. A two-tailed P value < .05 was considered significant for this study, and SAS version 9.4 (SAS Institute Inc) was used to conduct all analyses. This study was approved by the UT Southwestern Institutional Review Board.

Cohort Demographics

Of the top 25 internal medicine programs, 3 were excluded because they did not have websites that listed AHMF. Of the remaining 22 programs, we identified 1,829 AHMF. We excluded 166 AHMF because we could not identify title or year of residency graduation and 109 for having nonpromotion titles, leaving 1,554 AHMF (Appendix Figure). The cohort characteristics are described in Table 1.

Research Productivity

A total of 9,809 documents had been published by this cohort of academic hospitalists (Appendix Table 2). Overall mean (SD) and median (IQR) publications were 6.3 (24.3) and 0.0 (0.0-4.0), respectively. A total of 799 (51.4%) AHMF had no publications, 347 (22.3%) had one to three publications, 209 (13.4%) had 10 or more, and 39 (2.5%) had 50 or more. The median number of publications stratified by academic rank were 0.0 (IQR, 0.0-1.0) for instructors, 0.0 (IQR, 0.0-3.0) for assistant professors, 8.0 (IQR, 2.0-23.0) for associate professors, and 38.0 (IQR, 6.0-99.0) for full professors. Among men, 54.3% had published at least one manuscript, compared to 42.7% of women (P < .0001). The distribution of H-indices by years since residency graduation is shown in the Figure. The median number of documents published by faculty 6 to 10 years post residency was 1.0 (IQR, 0.0-4.0), with 46.8% of these faculty without a publication. For faculty 14 to 18 years post residency, the median number of documents was 3.0 (IQR, 0.0-11.0), with 30.1% of these faculty without a publication. Years post residency and academic rank were correlated with higher H-indices as well as more publications and citations (P < .0001).

Factors Associated With Academic Rank

Factors associated with rank are described in Appendix Table 3. In our multivariable ordinal regression model, H-index (adjusted odds ratio [aOR], 1.16 per single H-index point; 95% CI, 1.12-1.20), years post residency graduation (aOR, 1.14; 95% CI, 1.11-1.17), completion of chief residency (aOR, 2.46; 95% CI, 1.34-4.51), and graduation from a top 25 medical school (aOR, 2.10; 95% CI, 1.44-3.06) were associated with promotion.

In this cross-sectional analysis of more than 1,500 AHMF at the top 25 internal medicine residencies in the United States, 88.3% were instructors or assistant professors, while only 11.7% were associate or full professors. Furthermore, 51.4% were without a publication, and only 26.3% had published more than three manuscripts. Last, H-index, completion of a chief residency, years post residency, and graduation from a top 25 medical school were associated with higher academic rank.

Only 2.7% of the cohort were full professors, and 9.0% were associate professors. In comparison, academic cardiology faculty are 28.2% full professors and 22.9% associate professors.⁸ While the field of hospital medicine is relatively new, many faculty members had practiced for the expected duration of time for promotion consideration, with assistant professors or instructors constituting 89.9% of faculty at 6 to 10 years and 63.6% of faculty at 14 to 18 years post residency. We additionally observed a gender gap in publication history in hospital medicine, consistent with prior studies in hospital medicine that suggested gender disparities in scholarship.^9,10 Increased focus will be needed in the future to ensure opportunities for scholarship are equitable for all faculty in hospital medicine.

Our findings suggest that scholarly productivity in academic hospital medicine remains a challenge. Prior studies have reported that less than half of academic hospitalists have ever published, and fewer than one in eight have received research funding.^11,12 It is encouraging, however, that publications increase with time after residency. These data are consistent with the literature demonstrating a modest increase in hospitalists who had ever published, increasing from 43.0% in 2012 to 48.6% in 2020.¹² Despite these trends, however, some early-career academic hospitalists report ambivalence toward academic productivity and promotion.¹³ Whether this ambivalence is the source of low scholarship output or the outcome of insufficient mentorship and limited research success is uncertain. But these factors, combined with the pressures of clinical productivity, the existing lack of mentorship, and inadequate protected research time represent barriers to successful scholarship in academic hospital medicine.^3,14

Our study has several limitations. First, our inclusion criteria for the top 25 internal medicine residencies may have excluded hospital medicine divisions with substantial scholarly productivity. However, with 21 of the 25 programs listed on Doximity.com in the top 25 for internal medicine research funding, it is likely that our results overestimate scholarly productivity if compared to a complete, national cohort of AHMF.¹⁵ Second, our findings may not be generalizable to hospitalists who practice in nonacademic settings. Third, we were unable to account for differences in promotion criteria/tracks or scholarly output expectations between institutions. This limitation has been seen similarly in prior studies linking promotion and H-index.² Furthermore, our study does not capture promotion via other pathways that may not depend on scholarly output, such as hospital leadership roles. Last, as data were abstracted from academic center websites, it is possible that not all information was accurate or updated. However, we randomly reevaluated 25% of hospital division webpages 6 months after our initial data collection and noted that all had been updated with new faculty and academic ranks, suggesting our data were accurate.

These data highlight that research productivity and academic promotion remain challenges in academic hospital medicine. Future studies may examine topics that include understanding pathways and milestones to promotion, reducing disparities in scholarship, and improving mentorship, protected time, and research funding in academic hospital medicine.

Clinical scenario

An 83-year-old man is admitted with a hemiplegic cerebrovascular accident. He is found to have dysphagia, and a nasogastric feeding tube is placed. Over the next several days, his strength begins to recover, and he tolerates his tube feeding well. Discharge to a skilled nursing facility (SNF) for subacute rehabilitation is planned. His swallowing is showing signs of recovery; it has not recovered adequately but is expected to continue to improve such that he is predicted to be independent of tube feeding within 7-14 days. None of the facilities in the region are willing to admit a patient with a nasal feeding tube, despite the anticipated short duration. The patient is medically ready for discharge but is refusing the feeding gastrostomy. “Why would I want a hole in my stomach, if I’m only going to need it for 1-2 weeks and this tube in my nose is working fine and is comfortable?” he pleads with tears in his eyes.

Feeding dysphagic patients after stroke

Dysphagia, potentially leading to aspiration and/or pneumonia, is a common sequela of stroke – up to half of hospitalized patients are affected.¹ When oral intake is contraindicated, patients are often fed by nasogastric tube (NGT) or by surgically or endoscopically placed gastrostomy tube (GT). Without good justification based on outcomes, NGTs are traditionally used when the need for feeding is thought to be short term (<4 weeks) and GTs are used for long term (>4 weeks). However, in 2005, a large multicenter randomized control trial found that the majority of stroke patients with dysphagia that would resolve had resolution within 2-3 weeks. Moreover, outcomes were equivalent or better for patients fed with an NGT versus GT.

The authors concluded by recommending feeding via NGT for 2-3 weeks, after which conversion to GT can be considered if dysphagia persists.¹ Notably, the recommendation allows consideration, and no evidence-based guideline requires or recommends GT be placed based on duration of tube feed dependence. Currently, while nutrition and neurology authorities have adopted these recommendations,^2,3 many authors have noted poor adherence to this guideline, and many find that the median period between stroke and GT placement is 7 days rather than the recommended minimum of 14.^4,5,6 While ignorance can partially explain the lack of widespread compliance,⁶ the policies of posthospital facilities are another culprit. Increasingly, and for a variety of reasons unsupported by the literature, SNFs refuse NGT and require GT.^4,7,8,9

Ethical considerations

The four principles of medical ethics – autonomy, beneficence, nonmaleficence, and justice – can guide clinicians, patients, and family members in decision-making. In our case, by withholding needed and desired treatment (discharge to and treatment by a rehabilitation facility) the patient is being coerced to undergo a procedure he does not want, and clinicians participate in denying him autonomy. Further, given that the evidence, national guidelines, and in fact federal regulations indicate that his preferences are congruent with best practices, pressuring him to accept gastrostomy placement runs afoul of the principles of beneficence and nonmaleficence. Though the mechanism is unclear, early gastrostomy (<14-21 days) is associated with increased risk of death, worse functional outcomes, and a lower rate of return to oral feeding, as well as a significant procedure-specific complication rate.^1,10 By insisting on gastrostomy, we neither act in this patient’s best interests nor “do no harm.”

However, the medical system is complex. The clinician at the bedside can evaluate this scenario, review the national guidelines, discuss the procedure and risks with the patient and family, and conclude that the patient should be discharged with a nasal feeding tube. Nevertheless, if no facility is willing to accept him without a gastrostomy, our decision-making model – previously limited to our patient’s best interests alone – is forced to change. Despite our misgivings, we often conclude that the harm done by an early gastrostomy is outweighed by the harm of remaining unnecessarily in the acute hospital setting. We further worry about other patients lingering in the emergency department for lack of an inpatient bed and the possible – though unknowable – harm done to them.
 

Looking forward

It is an unfortunate fact that medical decision-making must often include factors unrelated to the patient’s best interests, with financial considerations and structural barriers frequently driving deviation from ideal care. Providers and patients navigate these decisions to their best abilities, making compromises when forced. However, with education and professional activism, providers can advocate for the elimination of barriers to providing medically sound and ethically appropriate care. In our experience, delay of gastrostomy placement, until discharge is imminent and planning for postdischarge care is initiated, has resulted in a decrease by half the fraction of patients with tracheostomies who had gastrostomies placed prior to discharge.¹¹ With aggressive outreach and education, we now have nursing homes willing to accept patients with NGTs.

Criteria for admission to discharge facilities can drive medical decision-making that is unethical and unsupported by evidence. Continued efforts to eliminate barriers to appropriate and ethical care have been successful and are encouraged.
 

Dr. Cowan is administrative chief resident in the department of surgery at Columbia University Irving Medical Center, New York. Dr. Seres is professor of medicine in the Institute of Human Nutrition and associate clinical ethicist at Columbia University Irving Medical Center. The authors have no conflicts of interest to disclose.

References

1. Dennis MS et al. Lancet. 2005 Feb 26-Mar 4;365(9461):764-72.

2. Powers W. et al. Stroke. 2018 Mar;49(3):e46-e110.

3. Burgos R et al. Clin Nutr. 2018 Feb;37(1):354-96.

4. Wilmskoetter J et al. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2694-700.

5. George BP et al. Stroke. 2017 Feb;48(2):420-7.

6. Fessler TA. et al. Surg Endosc. 2019 Dec;33(12):4089-97.

7. Burgermaster M et al. Nutr Clin Pract. 2016 Jun;31(3):342-8.

8. Moran C and O’Mahoney S. Curr Opin Gastroenterol. 2015 Mar;31(2):137-42.

9. Gomes CA et al. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD008096.

10. Joundi RA et al. Neurology. 2018 Feb 13;90(7):e544-52.

11. Bothra A et al. J Parenter Enteral Nutr. 2018 Feb;42(2):491.

Clinical scenario

An 83-year-old man is admitted with a hemiplegic cerebrovascular accident. He is found to have dysphagia, and a nasogastric feeding tube is placed. Over the next several days, his strength begins to recover, and he tolerates his tube feeding well. Discharge to a skilled nursing facility (SNF) for subacute rehabilitation is planned. His swallowing is showing signs of recovery; it has not recovered adequately but is expected to continue to improve such that he is predicted to be independent of tube feeding within 7-14 days. None of the facilities in the region are willing to admit a patient with a nasal feeding tube, despite the anticipated short duration. The patient is medically ready for discharge but is refusing the feeding gastrostomy. “Why would I want a hole in my stomach, if I’m only going to need it for 1-2 weeks and this tube in my nose is working fine and is comfortable?” he pleads with tears in his eyes.

Feeding dysphagic patients after stroke

Dysphagia, potentially leading to aspiration and/or pneumonia, is a common sequela of stroke – up to half of hospitalized patients are affected.¹ When oral intake is contraindicated, patients are often fed by nasogastric tube (NGT) or by surgically or endoscopically placed gastrostomy tube (GT). Without good justification based on outcomes, NGTs are traditionally used when the need for feeding is thought to be short term (<4 weeks) and GTs are used for long term (>4 weeks). However, in 2005, a large multicenter randomized control trial found that the majority of stroke patients with dysphagia that would resolve had resolution within 2-3 weeks. Moreover, outcomes were equivalent or better for patients fed with an NGT versus GT.

The authors concluded by recommending feeding via NGT for 2-3 weeks, after which conversion to GT can be considered if dysphagia persists.¹ Notably, the recommendation allows consideration, and no evidence-based guideline requires or recommends GT be placed based on duration of tube feed dependence. Currently, while nutrition and neurology authorities have adopted these recommendations,^2,3 many authors have noted poor adherence to this guideline, and many find that the median period between stroke and GT placement is 7 days rather than the recommended minimum of 14.^4,5,6 While ignorance can partially explain the lack of widespread compliance,⁶ the policies of posthospital facilities are another culprit. Increasingly, and for a variety of reasons unsupported by the literature, SNFs refuse NGT and require GT.^4,7,8,9

Ethical considerations

The four principles of medical ethics – autonomy, beneficence, nonmaleficence, and justice – can guide clinicians, patients, and family members in decision-making. In our case, by withholding needed and desired treatment (discharge to and treatment by a rehabilitation facility) the patient is being coerced to undergo a procedure he does not want, and clinicians participate in denying him autonomy. Further, given that the evidence, national guidelines, and in fact federal regulations indicate that his preferences are congruent with best practices, pressuring him to accept gastrostomy placement runs afoul of the principles of beneficence and nonmaleficence. Though the mechanism is unclear, early gastrostomy (<14-21 days) is associated with increased risk of death, worse functional outcomes, and a lower rate of return to oral feeding, as well as a significant procedure-specific complication rate.^1,10 By insisting on gastrostomy, we neither act in this patient’s best interests nor “do no harm.”

However, the medical system is complex. The clinician at the bedside can evaluate this scenario, review the national guidelines, discuss the procedure and risks with the patient and family, and conclude that the patient should be discharged with a nasal feeding tube. Nevertheless, if no facility is willing to accept him without a gastrostomy, our decision-making model – previously limited to our patient’s best interests alone – is forced to change. Despite our misgivings, we often conclude that the harm done by an early gastrostomy is outweighed by the harm of remaining unnecessarily in the acute hospital setting. We further worry about other patients lingering in the emergency department for lack of an inpatient bed and the possible – though unknowable – harm done to them.
 

Looking forward

It is an unfortunate fact that medical decision-making must often include factors unrelated to the patient’s best interests, with financial considerations and structural barriers frequently driving deviation from ideal care. Providers and patients navigate these decisions to their best abilities, making compromises when forced. However, with education and professional activism, providers can advocate for the elimination of barriers to providing medically sound and ethically appropriate care. In our experience, delay of gastrostomy placement, until discharge is imminent and planning for postdischarge care is initiated, has resulted in a decrease by half the fraction of patients with tracheostomies who had gastrostomies placed prior to discharge.¹¹ With aggressive outreach and education, we now have nursing homes willing to accept patients with NGTs.

Criteria for admission to discharge facilities can drive medical decision-making that is unethical and unsupported by evidence. Continued efforts to eliminate barriers to appropriate and ethical care have been successful and are encouraged.
 

Dr. Cowan is administrative chief resident in the department of surgery at Columbia University Irving Medical Center, New York. Dr. Seres is professor of medicine in the Institute of Human Nutrition and associate clinical ethicist at Columbia University Irving Medical Center. The authors have no conflicts of interest to disclose.

References

1. Dennis MS et al. Lancet. 2005 Feb 26-Mar 4;365(9461):764-72.

2. Powers W. et al. Stroke. 2018 Mar;49(3):e46-e110.

3. Burgos R et al. Clin Nutr. 2018 Feb;37(1):354-96.

4. Wilmskoetter J et al. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2694-700.

5. George BP et al. Stroke. 2017 Feb;48(2):420-7.

6. Fessler TA. et al. Surg Endosc. 2019 Dec;33(12):4089-97.

7. Burgermaster M et al. Nutr Clin Pract. 2016 Jun;31(3):342-8.

8. Moran C and O’Mahoney S. Curr Opin Gastroenterol. 2015 Mar;31(2):137-42.

9. Gomes CA et al. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD008096.

10. Joundi RA et al. Neurology. 2018 Feb 13;90(7):e544-52.

11. Bothra A et al. J Parenter Enteral Nutr. 2018 Feb;42(2):491.

Clinical scenario

An 83-year-old man is admitted with a hemiplegic cerebrovascular accident. He is found to have dysphagia, and a nasogastric feeding tube is placed. Over the next several days, his strength begins to recover, and he tolerates his tube feeding well. Discharge to a skilled nursing facility (SNF) for subacute rehabilitation is planned. His swallowing is showing signs of recovery; it has not recovered adequately but is expected to continue to improve such that he is predicted to be independent of tube feeding within 7-14 days. None of the facilities in the region are willing to admit a patient with a nasal feeding tube, despite the anticipated short duration. The patient is medically ready for discharge but is refusing the feeding gastrostomy. “Why would I want a hole in my stomach, if I’m only going to need it for 1-2 weeks and this tube in my nose is working fine and is comfortable?” he pleads with tears in his eyes.

Feeding dysphagic patients after stroke

Dysphagia, potentially leading to aspiration and/or pneumonia, is a common sequela of stroke – up to half of hospitalized patients are affected.¹ When oral intake is contraindicated, patients are often fed by nasogastric tube (NGT) or by surgically or endoscopically placed gastrostomy tube (GT). Without good justification based on outcomes, NGTs are traditionally used when the need for feeding is thought to be short term (<4 weeks) and GTs are used for long term (>4 weeks). However, in 2005, a large multicenter randomized control trial found that the majority of stroke patients with dysphagia that would resolve had resolution within 2-3 weeks. Moreover, outcomes were equivalent or better for patients fed with an NGT versus GT.

The authors concluded by recommending feeding via NGT for 2-3 weeks, after which conversion to GT can be considered if dysphagia persists.¹ Notably, the recommendation allows consideration, and no evidence-based guideline requires or recommends GT be placed based on duration of tube feed dependence. Currently, while nutrition and neurology authorities have adopted these recommendations,^2,3 many authors have noted poor adherence to this guideline, and many find that the median period between stroke and GT placement is 7 days rather than the recommended minimum of 14.^4,5,6 While ignorance can partially explain the lack of widespread compliance,⁶ the policies of posthospital facilities are another culprit. Increasingly, and for a variety of reasons unsupported by the literature, SNFs refuse NGT and require GT.^4,7,8,9

Ethical considerations

The four principles of medical ethics – autonomy, beneficence, nonmaleficence, and justice – can guide clinicians, patients, and family members in decision-making. In our case, by withholding needed and desired treatment (discharge to and treatment by a rehabilitation facility) the patient is being coerced to undergo a procedure he does not want, and clinicians participate in denying him autonomy. Further, given that the evidence, national guidelines, and in fact federal regulations indicate that his preferences are congruent with best practices, pressuring him to accept gastrostomy placement runs afoul of the principles of beneficence and nonmaleficence. Though the mechanism is unclear, early gastrostomy (<14-21 days) is associated with increased risk of death, worse functional outcomes, and a lower rate of return to oral feeding, as well as a significant procedure-specific complication rate.^1,10 By insisting on gastrostomy, we neither act in this patient’s best interests nor “do no harm.”

However, the medical system is complex. The clinician at the bedside can evaluate this scenario, review the national guidelines, discuss the procedure and risks with the patient and family, and conclude that the patient should be discharged with a nasal feeding tube. Nevertheless, if no facility is willing to accept him without a gastrostomy, our decision-making model – previously limited to our patient’s best interests alone – is forced to change. Despite our misgivings, we often conclude that the harm done by an early gastrostomy is outweighed by the harm of remaining unnecessarily in the acute hospital setting. We further worry about other patients lingering in the emergency department for lack of an inpatient bed and the possible – though unknowable – harm done to them.
 

Looking forward

It is an unfortunate fact that medical decision-making must often include factors unrelated to the patient’s best interests, with financial considerations and structural barriers frequently driving deviation from ideal care. Providers and patients navigate these decisions to their best abilities, making compromises when forced. However, with education and professional activism, providers can advocate for the elimination of barriers to providing medically sound and ethically appropriate care. In our experience, delay of gastrostomy placement, until discharge is imminent and planning for postdischarge care is initiated, has resulted in a decrease by half the fraction of patients with tracheostomies who had gastrostomies placed prior to discharge.¹¹ With aggressive outreach and education, we now have nursing homes willing to accept patients with NGTs.

Criteria for admission to discharge facilities can drive medical decision-making that is unethical and unsupported by evidence. Continued efforts to eliminate barriers to appropriate and ethical care have been successful and are encouraged.
 

Dr. Cowan is administrative chief resident in the department of surgery at Columbia University Irving Medical Center, New York. Dr. Seres is professor of medicine in the Institute of Human Nutrition and associate clinical ethicist at Columbia University Irving Medical Center. The authors have no conflicts of interest to disclose.

References

1. Dennis MS et al. Lancet. 2005 Feb 26-Mar 4;365(9461):764-72.

2. Powers W. et al. Stroke. 2018 Mar;49(3):e46-e110.

3. Burgos R et al. Clin Nutr. 2018 Feb;37(1):354-96.

4. Wilmskoetter J et al. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2694-700.

5. George BP et al. Stroke. 2017 Feb;48(2):420-7.

6. Fessler TA. et al. Surg Endosc. 2019 Dec;33(12):4089-97.

7. Burgermaster M et al. Nutr Clin Pract. 2016 Jun;31(3):342-8.

8. Moran C and O’Mahoney S. Curr Opin Gastroenterol. 2015 Mar;31(2):137-42.

9. Gomes CA et al. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD008096.

10. Joundi RA et al. Neurology. 2018 Feb 13;90(7):e544-52.

11. Bothra A et al. J Parenter Enteral Nutr. 2018 Feb;42(2):491.

Inpatient care utilization for hidradenitis suppurativa (HS) was higher for Black and Hispanic patients, compared with White patients, in an analysis of the 2012-2017 National Inpatient Sample.

The differences occurred despite Black and Hispanic patients being younger at the time of admission than White patients, and may reflect increased disease severity and management challenges in these patients with skin of color, Nishadh Sutaria, BS, a medical student at Tufts University, Boston, said at the annual Skin of Color Society symposium. “They may also reflect social inequities in access to dermatologists, with racial and ethnic minorities using inpatient services in lieu of outpatient care.”

Mr. Sutaria and coinvestigators, led by Shawn Kwatra, MD, of Johns Hopkins University, Baltimore, identified 8,040 HS admissions for White patients, 16,490 Black patients, and 2,405 for Hispanic patients during the 5-year period.

Black and Hispanic patients were significantly younger than White patients, with a mean age of 38.1 years and 35 years, respectively, compared with 42 years for White patients (P < .001 in each case). Compared with White patients, Black patients had more procedures (2.03 vs. 1.84, P = .006), a longer length of stay (5.82 days vs. 4.97 days, P = .001), and higher cost of care ($46,119 vs. $39,862, P = .010). Compared with White patients, Hispanic patients had higher cost of care ($52,334 vs. $39,862, P = .004).

“In these models, Black patients stayed almost a full day longer and accrued a charge of $8,000 more than White patients, and Hispanic patients stayed about a half-day longer and accrued a charge of almost $15,000 more than White patients,” Mr. Sutaria said.

In a multilinear regression analysis adjusting for age, sex, and insurance type, Black race correlated with more procedures, higher length of stay, and higher cost of care, and Hispanic ethnicity with more procedures and higher cost of care.

Prior research has shown that Black patients may be disproportionately affected by HS. A 2017 analysis of electronic health record data for tens of millions of patients nationally, for instance, showed an incidence of HS that was over 2.5 times greater in Blacks than Whites. And a recent analysis of electronic data in Wisconsin for patients with an HS diagnosis and 3 or more encounters for the disease showed that Blacks are more likely to have HS that is Hurley Stage 3, the most severe type.

Increased severity “has not been explicitly shown in Hispanic patients,” Dr. Kwatra said in an interview, “[but] there is a strong relationship between obesity/metabolic syndrome with HS. Because Hispanic patients have higher rates of obesity and metabolic syndrome, it’s [thought] that they may have more severe HS.”

HS patients with skin of color are underrepresented in clinical trials, he said. “Severe HS can be difficult to treat because there are few effective treatments,” he said, noting that adalimumab is the only Food and Drug Administration–approved therapy.

The National Inpatient Sample is a publicly available, all-payer inpatient care database developed for the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project.

Mr. Sutaria is a dermatology research fellow working under the guidance of Dr. Kwatra.

Inpatient care utilization for hidradenitis suppurativa (HS) was higher for Black and Hispanic patients, compared with White patients, in an analysis of the 2012-2017 National Inpatient Sample.

The differences occurred despite Black and Hispanic patients being younger at the time of admission than White patients, and may reflect increased disease severity and management challenges in these patients with skin of color, Nishadh Sutaria, BS, a medical student at Tufts University, Boston, said at the annual Skin of Color Society symposium. “They may also reflect social inequities in access to dermatologists, with racial and ethnic minorities using inpatient services in lieu of outpatient care.”

Mr. Sutaria and coinvestigators, led by Shawn Kwatra, MD, of Johns Hopkins University, Baltimore, identified 8,040 HS admissions for White patients, 16,490 Black patients, and 2,405 for Hispanic patients during the 5-year period.

Black and Hispanic patients were significantly younger than White patients, with a mean age of 38.1 years and 35 years, respectively, compared with 42 years for White patients (P < .001 in each case). Compared with White patients, Black patients had more procedures (2.03 vs. 1.84, P = .006), a longer length of stay (5.82 days vs. 4.97 days, P = .001), and higher cost of care ($46,119 vs. $39,862, P = .010). Compared with White patients, Hispanic patients had higher cost of care ($52,334 vs. $39,862, P = .004).

“In these models, Black patients stayed almost a full day longer and accrued a charge of $8,000 more than White patients, and Hispanic patients stayed about a half-day longer and accrued a charge of almost $15,000 more than White patients,” Mr. Sutaria said.

In a multilinear regression analysis adjusting for age, sex, and insurance type, Black race correlated with more procedures, higher length of stay, and higher cost of care, and Hispanic ethnicity with more procedures and higher cost of care.

Prior research has shown that Black patients may be disproportionately affected by HS. A 2017 analysis of electronic health record data for tens of millions of patients nationally, for instance, showed an incidence of HS that was over 2.5 times greater in Blacks than Whites. And a recent analysis of electronic data in Wisconsin for patients with an HS diagnosis and 3 or more encounters for the disease showed that Blacks are more likely to have HS that is Hurley Stage 3, the most severe type.

Increased severity “has not been explicitly shown in Hispanic patients,” Dr. Kwatra said in an interview, “[but] there is a strong relationship between obesity/metabolic syndrome with HS. Because Hispanic patients have higher rates of obesity and metabolic syndrome, it’s [thought] that they may have more severe HS.”

HS patients with skin of color are underrepresented in clinical trials, he said. “Severe HS can be difficult to treat because there are few effective treatments,” he said, noting that adalimumab is the only Food and Drug Administration–approved therapy.

The National Inpatient Sample is a publicly available, all-payer inpatient care database developed for the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project.

Mr. Sutaria is a dermatology research fellow working under the guidance of Dr. Kwatra.

Inpatient care utilization for hidradenitis suppurativa (HS) was higher for Black and Hispanic patients, compared with White patients, in an analysis of the 2012-2017 National Inpatient Sample.

The differences occurred despite Black and Hispanic patients being younger at the time of admission than White patients, and may reflect increased disease severity and management challenges in these patients with skin of color, Nishadh Sutaria, BS, a medical student at Tufts University, Boston, said at the annual Skin of Color Society symposium. “They may also reflect social inequities in access to dermatologists, with racial and ethnic minorities using inpatient services in lieu of outpatient care.”

Mr. Sutaria and coinvestigators, led by Shawn Kwatra, MD, of Johns Hopkins University, Baltimore, identified 8,040 HS admissions for White patients, 16,490 Black patients, and 2,405 for Hispanic patients during the 5-year period.

Black and Hispanic patients were significantly younger than White patients, with a mean age of 38.1 years and 35 years, respectively, compared with 42 years for White patients (P < .001 in each case). Compared with White patients, Black patients had more procedures (2.03 vs. 1.84, P = .006), a longer length of stay (5.82 days vs. 4.97 days, P = .001), and higher cost of care ($46,119 vs. $39,862, P = .010). Compared with White patients, Hispanic patients had higher cost of care ($52,334 vs. $39,862, P = .004).

“In these models, Black patients stayed almost a full day longer and accrued a charge of $8,000 more than White patients, and Hispanic patients stayed about a half-day longer and accrued a charge of almost $15,000 more than White patients,” Mr. Sutaria said.

In a multilinear regression analysis adjusting for age, sex, and insurance type, Black race correlated with more procedures, higher length of stay, and higher cost of care, and Hispanic ethnicity with more procedures and higher cost of care.

Prior research has shown that Black patients may be disproportionately affected by HS. A 2017 analysis of electronic health record data for tens of millions of patients nationally, for instance, showed an incidence of HS that was over 2.5 times greater in Blacks than Whites. And a recent analysis of electronic data in Wisconsin for patients with an HS diagnosis and 3 or more encounters for the disease showed that Blacks are more likely to have HS that is Hurley Stage 3, the most severe type.

Increased severity “has not been explicitly shown in Hispanic patients,” Dr. Kwatra said in an interview, “[but] there is a strong relationship between obesity/metabolic syndrome with HS. Because Hispanic patients have higher rates of obesity and metabolic syndrome, it’s [thought] that they may have more severe HS.”

HS patients with skin of color are underrepresented in clinical trials, he said. “Severe HS can be difficult to treat because there are few effective treatments,” he said, noting that adalimumab is the only Food and Drug Administration–approved therapy.

The National Inpatient Sample is a publicly available, all-payer inpatient care database developed for the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project.

Mr. Sutaria is a dermatology research fellow working under the guidance of Dr. Kwatra.

The results from three small studies of targeted therapy for rare brain tumors were “remarkable,” according to Jaishri Blakeley, MD, a neurology professor at Johns Hopkins Medicine, Baltimore, who discussed the studies after they were presented at the American Society of Clinical Oncology meeting.

Although most patients don’t have targetable mutations, molecular testing “is well worth the effort,” for those that do. “I think it’s fair to say that precision medicine” – well established in other tumor types – “is finally here in full force for neuro-oncology,” Dr. Blakeley said.
 

A promising start

Fifteen of 16 patients (94%) in one study had newly diagnosed and untreated papillary craniopharyngiomas (PCPs) that harbored BRAF V600E mutations, a common finding in PCPs, which have no effective medical treatment.

Tumors shrunk 68%-99% in 14 patients (93%) after treatment with the BRAF inhibitor vemurafenib plus the MEK inhibitor cobimetinib, which was included to stave off resistance to vemurafenib. The 24-month progression free survival was 93%.

The combination resulted in significant response in all patients who received at least one cycle of therapy, with a median 91% volume reduction. “Our study indicates that BRAF/MEK inhibitors could be a powerful tool in the treatment of previously untreated PCP, with the potential to avoid the morbidity associated with radiation and surgery,” concluded lead investigator and presenter Priscilla K. Brastianos, MD, associate professor of medicine at Mass General Cancer Center, Boston.

Thirty-three people in the second study had a mix of high and low grade gliomas or other CNS tumors positive for TRK gene fusions, a known oncogenic driver; the majority were children. They were treated with the TRK inhibitor larotrectinib after progressing on other systemic therapies.

The objective response rate was 30%, and the disease control rate was 73% at 24 weeks, with a median time to best response of 1.9 months. Tumors shrank in 82% of evaluable patients. Median progression-free survival was 18.3 months, and overall survival was not reached.

“These results support testing for TRK gene fusions for all patients with CNS tumors, especially if there is no known driver and especially in infants,” concluded lead investigator and presenter Sebastien Perreault, MD, a clinical assistant neurosciences professor at the University of Montreal.

The third study tested ALK inhibitors such as crizotinib in seven patients with adult-onset neuroblastoma, a rare and almost invariably fatal tumor known to be enriched for ALK mutations; the subjects were positive for them.

Their disease remained stable anywhere from 3.4 to 37.4 months. Median time to progression was 15.5 months, and median overall survival was 46.5 months.

ALK inhibitors “can be a well-tolerated options for treatment, improving time to progression. Development of resistance to one agent does not preclude use of other agents in the same drug class. ALK inhibitors should be considered when treating patients with this diagnosis,” said lead investigator and presenter Jessica Stiefel, MD, a pediatric hematology oncology fellow at Memorial Sloan Kettering Cancer Center, New York.
 

A ‘strong’ recommendation

The data “are great news” across the board. Targeted therapy applied to the right CNS tumor can have “dramatic” benefit for tumor control, Dr. Blakeley said.

But organizing molecular testing is not straightforward and requires strategies to balance “the use of precious resources, such as time money, and tissue,” with the potential benefit. Interpretation of testing results isn’t straightforward either, and is best handled by a molecular tumor board. Clinical pharmacists are also key to accessing expensive medications off label for CNS tumors.

Adverse events are also a consideration. Most of the subjects in the PCP study had grade 3/4 toxicity. Three patients in the ALK inhibitor study had to stop because of adverse events. Almost 40% on larotrectinib had grade 3 or 4 toxicity; nobody came off treatment, but a third had to skip doses.

Once an actionable mutation is identified, Dr. Blakeley’s “strong recommendation” is to enroll patients in a clinical trial that targets it, to take advantage the structure already in place to secure treatment, managed patients, and assess outcomes.

The National Cancer Institute’s MATCH trial is one of several options.

The BRAF/MEK inhibitor study was funded by Genentech and the National Institutes of Health. Dr. Brastianos had ties to numerous companies, including Pfizer, Lilly, and Merck. The TRK inhibitor study was funded by Bayer/Lilly. Dr. Perreault is a speaker and researcher for the company and has other ties. Dr. Blakeley is an adviser and/or researcher for a number of companies, including AbbVie, Astellas, BMS, and Exelixis. Dr. Stiefel didn’t have any disclosures, and didn’t report outside funding.

[email protected]

The results from three small studies of targeted therapy for rare brain tumors were “remarkable,” according to Jaishri Blakeley, MD, a neurology professor at Johns Hopkins Medicine, Baltimore, who discussed the studies after they were presented at the American Society of Clinical Oncology meeting.

Although most patients don’t have targetable mutations, molecular testing “is well worth the effort,” for those that do. “I think it’s fair to say that precision medicine” – well established in other tumor types – “is finally here in full force for neuro-oncology,” Dr. Blakeley said.
 

A promising start

Fifteen of 16 patients (94%) in one study had newly diagnosed and untreated papillary craniopharyngiomas (PCPs) that harbored BRAF V600E mutations, a common finding in PCPs, which have no effective medical treatment.

Tumors shrunk 68%-99% in 14 patients (93%) after treatment with the BRAF inhibitor vemurafenib plus the MEK inhibitor cobimetinib, which was included to stave off resistance to vemurafenib. The 24-month progression free survival was 93%.

The combination resulted in significant response in all patients who received at least one cycle of therapy, with a median 91% volume reduction. “Our study indicates that BRAF/MEK inhibitors could be a powerful tool in the treatment of previously untreated PCP, with the potential to avoid the morbidity associated with radiation and surgery,” concluded lead investigator and presenter Priscilla K. Brastianos, MD, associate professor of medicine at Mass General Cancer Center, Boston.

Thirty-three people in the second study had a mix of high and low grade gliomas or other CNS tumors positive for TRK gene fusions, a known oncogenic driver; the majority were children. They were treated with the TRK inhibitor larotrectinib after progressing on other systemic therapies.

The objective response rate was 30%, and the disease control rate was 73% at 24 weeks, with a median time to best response of 1.9 months. Tumors shrank in 82% of evaluable patients. Median progression-free survival was 18.3 months, and overall survival was not reached.

“These results support testing for TRK gene fusions for all patients with CNS tumors, especially if there is no known driver and especially in infants,” concluded lead investigator and presenter Sebastien Perreault, MD, a clinical assistant neurosciences professor at the University of Montreal.

The third study tested ALK inhibitors such as crizotinib in seven patients with adult-onset neuroblastoma, a rare and almost invariably fatal tumor known to be enriched for ALK mutations; the subjects were positive for them.

Their disease remained stable anywhere from 3.4 to 37.4 months. Median time to progression was 15.5 months, and median overall survival was 46.5 months.

ALK inhibitors “can be a well-tolerated options for treatment, improving time to progression. Development of resistance to one agent does not preclude use of other agents in the same drug class. ALK inhibitors should be considered when treating patients with this diagnosis,” said lead investigator and presenter Jessica Stiefel, MD, a pediatric hematology oncology fellow at Memorial Sloan Kettering Cancer Center, New York.
 

A ‘strong’ recommendation

The data “are great news” across the board. Targeted therapy applied to the right CNS tumor can have “dramatic” benefit for tumor control, Dr. Blakeley said.

But organizing molecular testing is not straightforward and requires strategies to balance “the use of precious resources, such as time money, and tissue,” with the potential benefit. Interpretation of testing results isn’t straightforward either, and is best handled by a molecular tumor board. Clinical pharmacists are also key to accessing expensive medications off label for CNS tumors.

Adverse events are also a consideration. Most of the subjects in the PCP study had grade 3/4 toxicity. Three patients in the ALK inhibitor study had to stop because of adverse events. Almost 40% on larotrectinib had grade 3 or 4 toxicity; nobody came off treatment, but a third had to skip doses.

Once an actionable mutation is identified, Dr. Blakeley’s “strong recommendation” is to enroll patients in a clinical trial that targets it, to take advantage the structure already in place to secure treatment, managed patients, and assess outcomes.

The National Cancer Institute’s MATCH trial is one of several options.

The BRAF/MEK inhibitor study was funded by Genentech and the National Institutes of Health. Dr. Brastianos had ties to numerous companies, including Pfizer, Lilly, and Merck. The TRK inhibitor study was funded by Bayer/Lilly. Dr. Perreault is a speaker and researcher for the company and has other ties. Dr. Blakeley is an adviser and/or researcher for a number of companies, including AbbVie, Astellas, BMS, and Exelixis. Dr. Stiefel didn’t have any disclosures, and didn’t report outside funding.

[email protected]

The results from three small studies of targeted therapy for rare brain tumors were “remarkable,” according to Jaishri Blakeley, MD, a neurology professor at Johns Hopkins Medicine, Baltimore, who discussed the studies after they were presented at the American Society of Clinical Oncology meeting.

Although most patients don’t have targetable mutations, molecular testing “is well worth the effort,” for those that do. “I think it’s fair to say that precision medicine” – well established in other tumor types – “is finally here in full force for neuro-oncology,” Dr. Blakeley said.
 

A promising start

Fifteen of 16 patients (94%) in one study had newly diagnosed and untreated papillary craniopharyngiomas (PCPs) that harbored BRAF V600E mutations, a common finding in PCPs, which have no effective medical treatment.

Tumors shrunk 68%-99% in 14 patients (93%) after treatment with the BRAF inhibitor vemurafenib plus the MEK inhibitor cobimetinib, which was included to stave off resistance to vemurafenib. The 24-month progression free survival was 93%.

The combination resulted in significant response in all patients who received at least one cycle of therapy, with a median 91% volume reduction. “Our study indicates that BRAF/MEK inhibitors could be a powerful tool in the treatment of previously untreated PCP, with the potential to avoid the morbidity associated with radiation and surgery,” concluded lead investigator and presenter Priscilla K. Brastianos, MD, associate professor of medicine at Mass General Cancer Center, Boston.

Thirty-three people in the second study had a mix of high and low grade gliomas or other CNS tumors positive for TRK gene fusions, a known oncogenic driver; the majority were children. They were treated with the TRK inhibitor larotrectinib after progressing on other systemic therapies.

The objective response rate was 30%, and the disease control rate was 73% at 24 weeks, with a median time to best response of 1.9 months. Tumors shrank in 82% of evaluable patients. Median progression-free survival was 18.3 months, and overall survival was not reached.

“These results support testing for TRK gene fusions for all patients with CNS tumors, especially if there is no known driver and especially in infants,” concluded lead investigator and presenter Sebastien Perreault, MD, a clinical assistant neurosciences professor at the University of Montreal.

The third study tested ALK inhibitors such as crizotinib in seven patients with adult-onset neuroblastoma, a rare and almost invariably fatal tumor known to be enriched for ALK mutations; the subjects were positive for them.

Their disease remained stable anywhere from 3.4 to 37.4 months. Median time to progression was 15.5 months, and median overall survival was 46.5 months.

ALK inhibitors “can be a well-tolerated options for treatment, improving time to progression. Development of resistance to one agent does not preclude use of other agents in the same drug class. ALK inhibitors should be considered when treating patients with this diagnosis,” said lead investigator and presenter Jessica Stiefel, MD, a pediatric hematology oncology fellow at Memorial Sloan Kettering Cancer Center, New York.
 

A ‘strong’ recommendation

The data “are great news” across the board. Targeted therapy applied to the right CNS tumor can have “dramatic” benefit for tumor control, Dr. Blakeley said.

But organizing molecular testing is not straightforward and requires strategies to balance “the use of precious resources, such as time money, and tissue,” with the potential benefit. Interpretation of testing results isn’t straightforward either, and is best handled by a molecular tumor board. Clinical pharmacists are also key to accessing expensive medications off label for CNS tumors.

Adverse events are also a consideration. Most of the subjects in the PCP study had grade 3/4 toxicity. Three patients in the ALK inhibitor study had to stop because of adverse events. Almost 40% on larotrectinib had grade 3 or 4 toxicity; nobody came off treatment, but a third had to skip doses.

Once an actionable mutation is identified, Dr. Blakeley’s “strong recommendation” is to enroll patients in a clinical trial that targets it, to take advantage the structure already in place to secure treatment, managed patients, and assess outcomes.

The National Cancer Institute’s MATCH trial is one of several options.

The BRAF/MEK inhibitor study was funded by Genentech and the National Institutes of Health. Dr. Brastianos had ties to numerous companies, including Pfizer, Lilly, and Merck. The TRK inhibitor study was funded by Bayer/Lilly. Dr. Perreault is a speaker and researcher for the company and has other ties. Dr. Blakeley is an adviser and/or researcher for a number of companies, including AbbVie, Astellas, BMS, and Exelixis. Dr. Stiefel didn’t have any disclosures, and didn’t report outside funding.

[email protected]

Patients with relapsed or refractory B-cell non-Hodgkin lymphomas who are not candidates for hematopoietic stem cell transplant have a generally poor prognosis and few treatment options, but an experimental combination of the antibody-drug conjugate naratuximab with rituximab showed promising efficacy and acceptable safety in these patients in a phase 2 trial.

Among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) the combination was associated with a 44.7% overall response rate, including 31.6% complete responses, and two-thirds of patients had responses lasting more than 12 months, reported Moshe Yair Levy, MD, from Texas Oncology–Baylor Charles A Sammons Cancer Center in Dallas.

“This is, in my viewpoint, very exciting therapy,” he said in a question-and-answer session following his presentation of the data in a late-breaking abstract session during the European Hematology Association annual congress. (Abstract LB1903).

Naratuximab emtansine is an investigational antibody-drug conjugate (ADC) consisting of a humanized monoclonal antibody against CD37, a surface marker on B lymphocytes that is highly expressed in non-Hodgkin lymphoma (NHL), conjugated to a cytotoxic derivative of maitansine.

CD37 is also an internalizable cell-surface antigen, making it an attractive candidate for an ADC approach.

In a phase 1 trial, naratuximab monotherapy showed a good safety profile and a 22% overall response rate, Dr. Levy noted.

“What they found is that, if you coadminister this ADC with rituximab, you’re actually going to get more internalization of the CD37 monoclonal, therefore more payload delivered to your target cells,” he said.

He reported results of a multicenter, adaptive phase 2 study of the combination in patients with DLBCL and other relapsed/refractory NHL.
 

DLBCL and others

The trial was divided into two parts, with the first consisting of a safety run-in phase with expansion in patients with confirmed diagnoses of relapsed/refractory NHL, including DLBCL, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma.

Patients with double- or triple-hit disease (with translocations in MYC plus either BCL2 and/or BCL6), bulky disease, or transformed lymphoma were eligible.

The second part consisted of two cohorts of patients with DLBCL treated with naratuximab and rituximab either weekly or every 3 weeks.

All patients in the study had received one to six prior lines of therapy, and had Eastern Cooperative Oncology Group performance status of 0-2. Patients with CNS lymphomas or prior anti-CD37 targeting therapy were excluded.

The safety population included 50 patients with DLBCL assigned to therapy every 3 weeks, 30 assigned to weekly therapy, and 20 patients with other NHL.
 

DLBCL efficacy

A total of 76 patients with DLBCL were evaluable for efficacy.

The ORR was 44% for patients in both the weekly and every 3 week cohorts, with 31.6% having complete responses.

Among 61 patients with nonbulky disease (longest diameter 7.5 cm or less), the ORR was 50.8%, and among 28 patients who had three or more prior lines of therapy the ORR was 46.4%, with 32.1% having a complete response.

Among responders followed for a median of 15 months, the median duration of response was not reached, and 66% had responses lasting beyond 12 months.

In the weekly dosing DLBCL cohort, 53.3% of patients discontinued treatment of both study drugs because of disease progression, as did 58% of those in the every 3 week cohort, and 30% of patients with other lymphomas. Only eight patients discontinued the combination because of treatment-emergent adverse events. Six patients had treatment-emergent adverse events leading to naratuximab dose reduction.

The most common grade 3 or 4 adverse events were neutropenia, leukopenia, lymphopenia and thrombocytopenias. Dr. Levy commented that the use of granulocyte colony-stimulating factor, which was not mandatory in the study, would likely have lowered the incidence of cytopenias.

There were 10 deaths during the study, 2 of which were considered to be treatment related, occurring in 1 patient each in the DLBCL dosing cohorts; 1 of the patients died from pneumonitis, and the other from left ventricular heart failure.

Other patients deaths were attributed to non–treatment-related cardiac arrest, acute renal failure, exacerbation of chronic heart failure, respiratory failure, multiorgan failure, lung infection, or colon adenocarcinoma.
 

Q 3 weeks suffices

In the question-and-answer session following the presentation, Kenny Lei, MD, from the Chinese University of Hong Kong asked Dr. Levy what the half-life of naratuximab is, and what was the investigator’s rationale for testing a weekly dosing schedule.

“I think the reason they checked the two different regimens, the Q week and the Q 3-week group, is that they noted that [naratuximab] was cleared relatively quickly, and they wanted to see whether or not, by giving Q weekly, when you get a continuous CD37 site occupancy if they would have a better outcome. But as you saw, in the groups there was really no clinically relevant difference in outcome,” Dr. Levy said.

Andrew Davies, MD, PhD, from the University of Southampton (England), asked whether the neutropenia seen in the study was related to myeloid expression of the target of from the off-target deconjugated payload.

“I don’t know that I necessarily have the answer to that,” Dr. Levy replied. “Remember there is the CD20 monoclonal rituximab which we know can cause neutropenia, as well as the CD37 and the target payload. I don’t know if we have enough information to attribute it to one specific component of the therapy,” he said.

The study was funded by Debiopharm International. Dr. Levy disclosed speaker activities for multiple companies, not including Debiopharm. Dr. Lei and Dr. Davies had no disclosures relevant to the study.

Patients with relapsed or refractory B-cell non-Hodgkin lymphomas who are not candidates for hematopoietic stem cell transplant have a generally poor prognosis and few treatment options, but an experimental combination of the antibody-drug conjugate naratuximab with rituximab showed promising efficacy and acceptable safety in these patients in a phase 2 trial.

Among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) the combination was associated with a 44.7% overall response rate, including 31.6% complete responses, and two-thirds of patients had responses lasting more than 12 months, reported Moshe Yair Levy, MD, from Texas Oncology–Baylor Charles A Sammons Cancer Center in Dallas.

“This is, in my viewpoint, very exciting therapy,” he said in a question-and-answer session following his presentation of the data in a late-breaking abstract session during the European Hematology Association annual congress. (Abstract LB1903).

Naratuximab emtansine is an investigational antibody-drug conjugate (ADC) consisting of a humanized monoclonal antibody against CD37, a surface marker on B lymphocytes that is highly expressed in non-Hodgkin lymphoma (NHL), conjugated to a cytotoxic derivative of maitansine.

CD37 is also an internalizable cell-surface antigen, making it an attractive candidate for an ADC approach.

In a phase 1 trial, naratuximab monotherapy showed a good safety profile and a 22% overall response rate, Dr. Levy noted.

“What they found is that, if you coadminister this ADC with rituximab, you’re actually going to get more internalization of the CD37 monoclonal, therefore more payload delivered to your target cells,” he said.

He reported results of a multicenter, adaptive phase 2 study of the combination in patients with DLBCL and other relapsed/refractory NHL.
 

DLBCL and others

The trial was divided into two parts, with the first consisting of a safety run-in phase with expansion in patients with confirmed diagnoses of relapsed/refractory NHL, including DLBCL, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma.

Patients with double- or triple-hit disease (with translocations in MYC plus either BCL2 and/or BCL6), bulky disease, or transformed lymphoma were eligible.

The second part consisted of two cohorts of patients with DLBCL treated with naratuximab and rituximab either weekly or every 3 weeks.

All patients in the study had received one to six prior lines of therapy, and had Eastern Cooperative Oncology Group performance status of 0-2. Patients with CNS lymphomas or prior anti-CD37 targeting therapy were excluded.

The safety population included 50 patients with DLBCL assigned to therapy every 3 weeks, 30 assigned to weekly therapy, and 20 patients with other NHL.
 

DLBCL efficacy

A total of 76 patients with DLBCL were evaluable for efficacy.

The ORR was 44% for patients in both the weekly and every 3 week cohorts, with 31.6% having complete responses.

Among 61 patients with nonbulky disease (longest diameter 7.5 cm or less), the ORR was 50.8%, and among 28 patients who had three or more prior lines of therapy the ORR was 46.4%, with 32.1% having a complete response.

Among responders followed for a median of 15 months, the median duration of response was not reached, and 66% had responses lasting beyond 12 months.

In the weekly dosing DLBCL cohort, 53.3% of patients discontinued treatment of both study drugs because of disease progression, as did 58% of those in the every 3 week cohort, and 30% of patients with other lymphomas. Only eight patients discontinued the combination because of treatment-emergent adverse events. Six patients had treatment-emergent adverse events leading to naratuximab dose reduction.

The most common grade 3 or 4 adverse events were neutropenia, leukopenia, lymphopenia and thrombocytopenias. Dr. Levy commented that the use of granulocyte colony-stimulating factor, which was not mandatory in the study, would likely have lowered the incidence of cytopenias.

There were 10 deaths during the study, 2 of which were considered to be treatment related, occurring in 1 patient each in the DLBCL dosing cohorts; 1 of the patients died from pneumonitis, and the other from left ventricular heart failure.

Other patients deaths were attributed to non–treatment-related cardiac arrest, acute renal failure, exacerbation of chronic heart failure, respiratory failure, multiorgan failure, lung infection, or colon adenocarcinoma.
 

Q 3 weeks suffices

In the question-and-answer session following the presentation, Kenny Lei, MD, from the Chinese University of Hong Kong asked Dr. Levy what the half-life of naratuximab is, and what was the investigator’s rationale for testing a weekly dosing schedule.

“I think the reason they checked the two different regimens, the Q week and the Q 3-week group, is that they noted that [naratuximab] was cleared relatively quickly, and they wanted to see whether or not, by giving Q weekly, when you get a continuous CD37 site occupancy if they would have a better outcome. But as you saw, in the groups there was really no clinically relevant difference in outcome,” Dr. Levy said.

Andrew Davies, MD, PhD, from the University of Southampton (England), asked whether the neutropenia seen in the study was related to myeloid expression of the target of from the off-target deconjugated payload.

“I don’t know that I necessarily have the answer to that,” Dr. Levy replied. “Remember there is the CD20 monoclonal rituximab which we know can cause neutropenia, as well as the CD37 and the target payload. I don’t know if we have enough information to attribute it to one specific component of the therapy,” he said.

The study was funded by Debiopharm International. Dr. Levy disclosed speaker activities for multiple companies, not including Debiopharm. Dr. Lei and Dr. Davies had no disclosures relevant to the study.

Patients with relapsed or refractory B-cell non-Hodgkin lymphomas who are not candidates for hematopoietic stem cell transplant have a generally poor prognosis and few treatment options, but an experimental combination of the antibody-drug conjugate naratuximab with rituximab showed promising efficacy and acceptable safety in these patients in a phase 2 trial.

Among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) the combination was associated with a 44.7% overall response rate, including 31.6% complete responses, and two-thirds of patients had responses lasting more than 12 months, reported Moshe Yair Levy, MD, from Texas Oncology–Baylor Charles A Sammons Cancer Center in Dallas.

“This is, in my viewpoint, very exciting therapy,” he said in a question-and-answer session following his presentation of the data in a late-breaking abstract session during the European Hematology Association annual congress. (Abstract LB1903).

Naratuximab emtansine is an investigational antibody-drug conjugate (ADC) consisting of a humanized monoclonal antibody against CD37, a surface marker on B lymphocytes that is highly expressed in non-Hodgkin lymphoma (NHL), conjugated to a cytotoxic derivative of maitansine.

CD37 is also an internalizable cell-surface antigen, making it an attractive candidate for an ADC approach.

In a phase 1 trial, naratuximab monotherapy showed a good safety profile and a 22% overall response rate, Dr. Levy noted.

“What they found is that, if you coadminister this ADC with rituximab, you’re actually going to get more internalization of the CD37 monoclonal, therefore more payload delivered to your target cells,” he said.

He reported results of a multicenter, adaptive phase 2 study of the combination in patients with DLBCL and other relapsed/refractory NHL.
 

DLBCL and others

The trial was divided into two parts, with the first consisting of a safety run-in phase with expansion in patients with confirmed diagnoses of relapsed/refractory NHL, including DLBCL, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma.

Patients with double- or triple-hit disease (with translocations in MYC plus either BCL2 and/or BCL6), bulky disease, or transformed lymphoma were eligible.

The second part consisted of two cohorts of patients with DLBCL treated with naratuximab and rituximab either weekly or every 3 weeks.

All patients in the study had received one to six prior lines of therapy, and had Eastern Cooperative Oncology Group performance status of 0-2. Patients with CNS lymphomas or prior anti-CD37 targeting therapy were excluded.

The safety population included 50 patients with DLBCL assigned to therapy every 3 weeks, 30 assigned to weekly therapy, and 20 patients with other NHL.
 

DLBCL efficacy

A total of 76 patients with DLBCL were evaluable for efficacy.

The ORR was 44% for patients in both the weekly and every 3 week cohorts, with 31.6% having complete responses.

Among 61 patients with nonbulky disease (longest diameter 7.5 cm or less), the ORR was 50.8%, and among 28 patients who had three or more prior lines of therapy the ORR was 46.4%, with 32.1% having a complete response.

Among responders followed for a median of 15 months, the median duration of response was not reached, and 66% had responses lasting beyond 12 months.

In the weekly dosing DLBCL cohort, 53.3% of patients discontinued treatment of both study drugs because of disease progression, as did 58% of those in the every 3 week cohort, and 30% of patients with other lymphomas. Only eight patients discontinued the combination because of treatment-emergent adverse events. Six patients had treatment-emergent adverse events leading to naratuximab dose reduction.

The most common grade 3 or 4 adverse events were neutropenia, leukopenia, lymphopenia and thrombocytopenias. Dr. Levy commented that the use of granulocyte colony-stimulating factor, which was not mandatory in the study, would likely have lowered the incidence of cytopenias.

There were 10 deaths during the study, 2 of which were considered to be treatment related, occurring in 1 patient each in the DLBCL dosing cohorts; 1 of the patients died from pneumonitis, and the other from left ventricular heart failure.

Other patients deaths were attributed to non–treatment-related cardiac arrest, acute renal failure, exacerbation of chronic heart failure, respiratory failure, multiorgan failure, lung infection, or colon adenocarcinoma.
 

Q 3 weeks suffices

In the question-and-answer session following the presentation, Kenny Lei, MD, from the Chinese University of Hong Kong asked Dr. Levy what the half-life of naratuximab is, and what was the investigator’s rationale for testing a weekly dosing schedule.

“I think the reason they checked the two different regimens, the Q week and the Q 3-week group, is that they noted that [naratuximab] was cleared relatively quickly, and they wanted to see whether or not, by giving Q weekly, when you get a continuous CD37 site occupancy if they would have a better outcome. But as you saw, in the groups there was really no clinically relevant difference in outcome,” Dr. Levy said.

Andrew Davies, MD, PhD, from the University of Southampton (England), asked whether the neutropenia seen in the study was related to myeloid expression of the target of from the off-target deconjugated payload.

“I don’t know that I necessarily have the answer to that,” Dr. Levy replied. “Remember there is the CD20 monoclonal rituximab which we know can cause neutropenia, as well as the CD37 and the target payload. I don’t know if we have enough information to attribute it to one specific component of the therapy,” he said.

The study was funded by Debiopharm International. Dr. Levy disclosed speaker activities for multiple companies, not including Debiopharm. Dr. Lei and Dr. Davies had no disclosures relevant to the study.

Secukinumab (Cosentyx), an interleukin-17A inhibitor, is effective and reasonably well tolerated for treatment of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in children and adolescents, according to a phase 3 trial presented at a late breaking abstracts session of the annual European Congress of Rheumatology.

On the primary outcome of time to flare, the curves for secukinumab and placebo separated almost immediately, with fewer than half the number of flares occurring in the experimental arm over the course of the study, according to Nicolino Ruperto, MD, senior research scientist at IRCCS Istituto Giannina Gaslini in Genoa, Italy.

The trial, called JUNIPERA, was conducted over 2 years and included an open-label treatment period (TP1) and then a randomized, placebo-controlled comparison (TP2). In TP1, 86 children were initiated on open-label secukinumab administered subcutaneously on weeks 1, 2, 3, 4, 8, and 12. The dose was 75 mg for children less than 50 kg and 150 kg for those heavier.
 

Average patient age was 13.1 years

Of these 86 children, 52 had ERA and 34 had JPsA. Disease duration of at least 6 months was required for entry. Patients up to the age of 18 years were permitted to enroll. The average age was 13.1 years. Most patients, two-thirds of whom were male, had received an immunomodulator prior to study entry.

At the end of TP1, 69.9% of patients had achieved 70% improvement in the Juvenile Idiopathic Arthritis American College of Rheumatology joint score (JIA ACR70). The 90.4% of patients who achieved JIA ACR30 were invited to enroll in TP2. A total of 75 patients did so.

At the end of TP2, response rates strongly favored secukinumab over placebo for JIA ACR30 (89.2% vs. 64.9%; P = .014) and JIA ACR70 (67.7% vs. 43.2%; P = .042). Higher but not statistically significant differences in response rates were seen for secukinumab over placebo for JIA ACR50 (78.4% vs. 62.2%; P = .152), JIA ACR90 (51.4% vs. 40.5%; P = .431) and JIA ACR100 (43.2% vs. 37.8%; P = .755).

During TP2, there were 10 flares in the group randomized to secukinumab versus 21 flares in the placebo group, translating by hazard ratio (HR) into a 72% risk reduction (HR, 0.28; P < .001).

Side effects similar to those in adults

The types and rates of serious adverse events were similar to those reported previously in adult patients, according to Dr. Ruperto. Although the rate of serious adverse events (14.6% vs. 10.6%) was only moderately higher in the experimental arm, more patients randomized to secukinumab than placebo discontinued therapy (13.2% vs. 6.3%) before the end of follow-up.

The side effects that occurred more commonly on secukinumab included gastrointestinal complaints, such as diarrhea (22.9% vs. 15.8%). Other adverse events occurring in more than 10% of patients included headache and nasopharyngitis, but most side effects were mild and resolved.

Although the proportion of patients with flare increased over time in both groups, Dr. Ruperto reported that protection against flares and relative improvement in clinical markers of disease activity relative to placebo “were sustained out to 2 years of follow-up.”

The submission of these data to regulatory agencies is anticipated. If secukinumab is given an indication for these forms of arthritis, it will join an indication for plaque psoriasis in children that was granted just a few days before these data were presented. The psoriasis indication is the only current use approved for children in the United States.
 

More biologics needed for JPsA

Additional biologics will be helpful for children with arthritis who are poorly controlled on available treatments, according to Natasha M. Ruth, MD, director of the division of pediatric rheumatology at the Medical University of South Carolina, Charleston. Dr. Ruth was senior author of a case study published 2 years ago in which secukinumab was used to control psoriatic arthritis and nail manifestations of psoriasis.

“It was a girl who had already failed to improve adequately to TNF inhibitors,” reported Dr. Ruth, who had said the child and her parent were very concerned about the nail appearance.

“The nail involvement completely resolved, so it was a very good result in a difficult situation,” Dr. Ruth explained. She said that the decision to try secukinumab was made collaboratively in a clinic in which dermatologists and rheumatologists at her institution work together on difficult cases.

“There is a need for more biologics with different mechanisms of action,” Dr. Ruth said. Based on her experience, secukinumab could be an important addition to treatment options.

Dr. Ruperto reported having financial relationships with more than 20 pharmaceutical companies, including Novartis, which provided financial support for this trial. Many coauthors had financial relationships with multiple companies, including Novartis, and some were employees of the company. Dr. Ruth reported having no potential conflicts of interest.

Secukinumab (Cosentyx), an interleukin-17A inhibitor, is effective and reasonably well tolerated for treatment of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in children and adolescents, according to a phase 3 trial presented at a late breaking abstracts session of the annual European Congress of Rheumatology.

On the primary outcome of time to flare, the curves for secukinumab and placebo separated almost immediately, with fewer than half the number of flares occurring in the experimental arm over the course of the study, according to Nicolino Ruperto, MD, senior research scientist at IRCCS Istituto Giannina Gaslini in Genoa, Italy.

The trial, called JUNIPERA, was conducted over 2 years and included an open-label treatment period (TP1) and then a randomized, placebo-controlled comparison (TP2). In TP1, 86 children were initiated on open-label secukinumab administered subcutaneously on weeks 1, 2, 3, 4, 8, and 12. The dose was 75 mg for children less than 50 kg and 150 kg for those heavier.
 

Average patient age was 13.1 years

Of these 86 children, 52 had ERA and 34 had JPsA. Disease duration of at least 6 months was required for entry. Patients up to the age of 18 years were permitted to enroll. The average age was 13.1 years. Most patients, two-thirds of whom were male, had received an immunomodulator prior to study entry.

At the end of TP1, 69.9% of patients had achieved 70% improvement in the Juvenile Idiopathic Arthritis American College of Rheumatology joint score (JIA ACR70). The 90.4% of patients who achieved JIA ACR30 were invited to enroll in TP2. A total of 75 patients did so.

At the end of TP2, response rates strongly favored secukinumab over placebo for JIA ACR30 (89.2% vs. 64.9%; P = .014) and JIA ACR70 (67.7% vs. 43.2%; P = .042). Higher but not statistically significant differences in response rates were seen for secukinumab over placebo for JIA ACR50 (78.4% vs. 62.2%; P = .152), JIA ACR90 (51.4% vs. 40.5%; P = .431) and JIA ACR100 (43.2% vs. 37.8%; P = .755).

During TP2, there were 10 flares in the group randomized to secukinumab versus 21 flares in the placebo group, translating by hazard ratio (HR) into a 72% risk reduction (HR, 0.28; P < .001).

Side effects similar to those in adults

The types and rates of serious adverse events were similar to those reported previously in adult patients, according to Dr. Ruperto. Although the rate of serious adverse events (14.6% vs. 10.6%) was only moderately higher in the experimental arm, more patients randomized to secukinumab than placebo discontinued therapy (13.2% vs. 6.3%) before the end of follow-up.

The side effects that occurred more commonly on secukinumab included gastrointestinal complaints, such as diarrhea (22.9% vs. 15.8%). Other adverse events occurring in more than 10% of patients included headache and nasopharyngitis, but most side effects were mild and resolved.

Although the proportion of patients with flare increased over time in both groups, Dr. Ruperto reported that protection against flares and relative improvement in clinical markers of disease activity relative to placebo “were sustained out to 2 years of follow-up.”

The submission of these data to regulatory agencies is anticipated. If secukinumab is given an indication for these forms of arthritis, it will join an indication for plaque psoriasis in children that was granted just a few days before these data were presented. The psoriasis indication is the only current use approved for children in the United States.
 

More biologics needed for JPsA

Additional biologics will be helpful for children with arthritis who are poorly controlled on available treatments, according to Natasha M. Ruth, MD, director of the division of pediatric rheumatology at the Medical University of South Carolina, Charleston. Dr. Ruth was senior author of a case study published 2 years ago in which secukinumab was used to control psoriatic arthritis and nail manifestations of psoriasis.

“It was a girl who had already failed to improve adequately to TNF inhibitors,” reported Dr. Ruth, who had said the child and her parent were very concerned about the nail appearance.

“The nail involvement completely resolved, so it was a very good result in a difficult situation,” Dr. Ruth explained. She said that the decision to try secukinumab was made collaboratively in a clinic in which dermatologists and rheumatologists at her institution work together on difficult cases.

“There is a need for more biologics with different mechanisms of action,” Dr. Ruth said. Based on her experience, secukinumab could be an important addition to treatment options.

Dr. Ruperto reported having financial relationships with more than 20 pharmaceutical companies, including Novartis, which provided financial support for this trial. Many coauthors had financial relationships with multiple companies, including Novartis, and some were employees of the company. Dr. Ruth reported having no potential conflicts of interest.

Secukinumab (Cosentyx), an interleukin-17A inhibitor, is effective and reasonably well tolerated for treatment of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in children and adolescents, according to a phase 3 trial presented at a late breaking abstracts session of the annual European Congress of Rheumatology.

On the primary outcome of time to flare, the curves for secukinumab and placebo separated almost immediately, with fewer than half the number of flares occurring in the experimental arm over the course of the study, according to Nicolino Ruperto, MD, senior research scientist at IRCCS Istituto Giannina Gaslini in Genoa, Italy.

The trial, called JUNIPERA, was conducted over 2 years and included an open-label treatment period (TP1) and then a randomized, placebo-controlled comparison (TP2). In TP1, 86 children were initiated on open-label secukinumab administered subcutaneously on weeks 1, 2, 3, 4, 8, and 12. The dose was 75 mg for children less than 50 kg and 150 kg for those heavier.
 

Average patient age was 13.1 years

Of these 86 children, 52 had ERA and 34 had JPsA. Disease duration of at least 6 months was required for entry. Patients up to the age of 18 years were permitted to enroll. The average age was 13.1 years. Most patients, two-thirds of whom were male, had received an immunomodulator prior to study entry.

At the end of TP1, 69.9% of patients had achieved 70% improvement in the Juvenile Idiopathic Arthritis American College of Rheumatology joint score (JIA ACR70). The 90.4% of patients who achieved JIA ACR30 were invited to enroll in TP2. A total of 75 patients did so.

At the end of TP2, response rates strongly favored secukinumab over placebo for JIA ACR30 (89.2% vs. 64.9%; P = .014) and JIA ACR70 (67.7% vs. 43.2%; P = .042). Higher but not statistically significant differences in response rates were seen for secukinumab over placebo for JIA ACR50 (78.4% vs. 62.2%; P = .152), JIA ACR90 (51.4% vs. 40.5%; P = .431) and JIA ACR100 (43.2% vs. 37.8%; P = .755).

During TP2, there were 10 flares in the group randomized to secukinumab versus 21 flares in the placebo group, translating by hazard ratio (HR) into a 72% risk reduction (HR, 0.28; P < .001).

Side effects similar to those in adults

The types and rates of serious adverse events were similar to those reported previously in adult patients, according to Dr. Ruperto. Although the rate of serious adverse events (14.6% vs. 10.6%) was only moderately higher in the experimental arm, more patients randomized to secukinumab than placebo discontinued therapy (13.2% vs. 6.3%) before the end of follow-up.

The side effects that occurred more commonly on secukinumab included gastrointestinal complaints, such as diarrhea (22.9% vs. 15.8%). Other adverse events occurring in more than 10% of patients included headache and nasopharyngitis, but most side effects were mild and resolved.

Although the proportion of patients with flare increased over time in both groups, Dr. Ruperto reported that protection against flares and relative improvement in clinical markers of disease activity relative to placebo “were sustained out to 2 years of follow-up.”

The submission of these data to regulatory agencies is anticipated. If secukinumab is given an indication for these forms of arthritis, it will join an indication for plaque psoriasis in children that was granted just a few days before these data were presented. The psoriasis indication is the only current use approved for children in the United States.
 

More biologics needed for JPsA

Additional biologics will be helpful for children with arthritis who are poorly controlled on available treatments, according to Natasha M. Ruth, MD, director of the division of pediatric rheumatology at the Medical University of South Carolina, Charleston. Dr. Ruth was senior author of a case study published 2 years ago in which secukinumab was used to control psoriatic arthritis and nail manifestations of psoriasis.

“It was a girl who had already failed to improve adequately to TNF inhibitors,” reported Dr. Ruth, who had said the child and her parent were very concerned about the nail appearance.

“The nail involvement completely resolved, so it was a very good result in a difficult situation,” Dr. Ruth explained. She said that the decision to try secukinumab was made collaboratively in a clinic in which dermatologists and rheumatologists at her institution work together on difficult cases.

“There is a need for more biologics with different mechanisms of action,” Dr. Ruth said. Based on her experience, secukinumab could be an important addition to treatment options.

Dr. Ruperto reported having financial relationships with more than 20 pharmaceutical companies, including Novartis, which provided financial support for this trial. Many coauthors had financial relationships with multiple companies, including Novartis, and some were employees of the company. Dr. Ruth reported having no potential conflicts of interest.

Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

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Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

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Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

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Key clinical point: Ustekinumab induced and maintained steroid-free clinical remission to 1 year in a significant proportion of children with extensive and treatment-refractory ulcerative colitis (UC).

Major finding: At week 52, 44% of children who received ustekinumab achieved steroid-free remission. This included 69% of those previously treated with antitumor necrosis factor (anti-TNF) only vs. 17% of those who previously failed vedolizumab (P = .008). No adverse events were reported.

Study details: Data come from an open-label prospective cohort study of 25 children with anti-TNF refractory UC who were treated with intravenous ustekinumab. All patients had failed prior infliximab therapy, whereas 12 patients also failed vedolizumab.

Disclosures: The study was funded by the Canadian Institutes of Health Research and Children's Intestinal and Liver Disease Foundation. Some of the authors reported serving as a consultant, speaker, advisory board member for and receiving speaker/consultation fees, honoraria, and/or research support from multiple sources.

Source: Dhaliwal J et al. Aliment Pharmacol Ther. 2021 Apr 28. doi: 10.1111/apt.16388.

Key clinical point: Ustekinumab induced and maintained steroid-free clinical remission to 1 year in a significant proportion of children with extensive and treatment-refractory ulcerative colitis (UC).

Major finding: At week 52, 44% of children who received ustekinumab achieved steroid-free remission. This included 69% of those previously treated with antitumor necrosis factor (anti-TNF) only vs. 17% of those who previously failed vedolizumab (P = .008). No adverse events were reported.

Study details: Data come from an open-label prospective cohort study of 25 children with anti-TNF refractory UC who were treated with intravenous ustekinumab. All patients had failed prior infliximab therapy, whereas 12 patients also failed vedolizumab.

Disclosures: The study was funded by the Canadian Institutes of Health Research and Children's Intestinal and Liver Disease Foundation. Some of the authors reported serving as a consultant, speaker, advisory board member for and receiving speaker/consultation fees, honoraria, and/or research support from multiple sources.

Source: Dhaliwal J et al. Aliment Pharmacol Ther. 2021 Apr 28. doi: 10.1111/apt.16388.

Key clinical point: Ustekinumab induced and maintained steroid-free clinical remission to 1 year in a significant proportion of children with extensive and treatment-refractory ulcerative colitis (UC).

Major finding: At week 52, 44% of children who received ustekinumab achieved steroid-free remission. This included 69% of those previously treated with antitumor necrosis factor (anti-TNF) only vs. 17% of those who previously failed vedolizumab (P = .008). No adverse events were reported.

Study details: Data come from an open-label prospective cohort study of 25 children with anti-TNF refractory UC who were treated with intravenous ustekinumab. All patients had failed prior infliximab therapy, whereas 12 patients also failed vedolizumab.

Disclosures: The study was funded by the Canadian Institutes of Health Research and Children's Intestinal and Liver Disease Foundation. Some of the authors reported serving as a consultant, speaker, advisory board member for and receiving speaker/consultation fees, honoraria, and/or research support from multiple sources.

Source: Dhaliwal J et al. Aliment Pharmacol Ther. 2021 Apr 28. doi: 10.1111/apt.16388.

Key clinical point: Sarcopenia is predictive of the clinical course and postoperative outcomes of acute severe ulcerative colitis (ASUC).

Major finding: Sarcopenia was an independent risk factor for intravenous corticosteroid failure (odds ratio [OR], 3.130; P = .001), colectomy after medical rescue therapy failure (OR, 3.401; P = .033), and postoperative complications after colectomy (OR, 4.157; P = .012).

Study details: Findings are from a retrospective cohort study of 233 patients with ASUC.

Disclosures: The work was supported by the National Natural Science Foundation of China and Zhejiang Provincial Natural Science Foundation. The authors declared no conflicts of interest.

Source: Ge X et al. Dig Liver Dis. 2021 Apr 29. doi: 10.1016/j.dld.2021.03.031.

Key clinical point: Sarcopenia is predictive of the clinical course and postoperative outcomes of acute severe ulcerative colitis (ASUC).

Major finding: Sarcopenia was an independent risk factor for intravenous corticosteroid failure (odds ratio [OR], 3.130; P = .001), colectomy after medical rescue therapy failure (OR, 3.401; P = .033), and postoperative complications after colectomy (OR, 4.157; P = .012).

Study details: Findings are from a retrospective cohort study of 233 patients with ASUC.

Disclosures: The work was supported by the National Natural Science Foundation of China and Zhejiang Provincial Natural Science Foundation. The authors declared no conflicts of interest.

Source: Ge X et al. Dig Liver Dis. 2021 Apr 29. doi: 10.1016/j.dld.2021.03.031.

Key clinical point: Sarcopenia is predictive of the clinical course and postoperative outcomes of acute severe ulcerative colitis (ASUC).

Major finding: Sarcopenia was an independent risk factor for intravenous corticosteroid failure (odds ratio [OR], 3.130; P = .001), colectomy after medical rescue therapy failure (OR, 3.401; P = .033), and postoperative complications after colectomy (OR, 4.157; P = .012).

Study details: Findings are from a retrospective cohort study of 233 patients with ASUC.

Disclosures: The work was supported by the National Natural Science Foundation of China and Zhejiang Provincial Natural Science Foundation. The authors declared no conflicts of interest.

Source: Ge X et al. Dig Liver Dis. 2021 Apr 29. doi: 10.1016/j.dld.2021.03.031.

Key clinical point: Inflammatory bowel disease (IBD) may be a risk factor for stroke.

Major finding: IBD was associated with an increased risk for stroke (odds ratio/relative risk [OR/RR], 1.21; P less than .001). Additionally, both Crohn's disease (OR/RR, 1.25; P less than .001) and ulcerative colitis (OR/RR, 1.09; P = .051) were associated with an increased risk for stroke.

Study details: Findings are from a meta-analysis of 9 studies involving 791,010 patients with IBD or stroke.

Disclosures: The study was supported by the General Project of Chongqing Natural Science Foundation and the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Chen Y et al. Brain Behav. 2021 May 7. doi: 10.1002/brb3.2159.

Key clinical point: Inflammatory bowel disease (IBD) may be a risk factor for stroke.

Major finding: IBD was associated with an increased risk for stroke (odds ratio/relative risk [OR/RR], 1.21; P less than .001). Additionally, both Crohn's disease (OR/RR, 1.25; P less than .001) and ulcerative colitis (OR/RR, 1.09; P = .051) were associated with an increased risk for stroke.

Study details: Findings are from a meta-analysis of 9 studies involving 791,010 patients with IBD or stroke.

Disclosures: The study was supported by the General Project of Chongqing Natural Science Foundation and the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Chen Y et al. Brain Behav. 2021 May 7. doi: 10.1002/brb3.2159.

Key clinical point: Inflammatory bowel disease (IBD) may be a risk factor for stroke.

Major finding: IBD was associated with an increased risk for stroke (odds ratio/relative risk [OR/RR], 1.21; P less than .001). Additionally, both Crohn's disease (OR/RR, 1.25; P less than .001) and ulcerative colitis (OR/RR, 1.09; P = .051) were associated with an increased risk for stroke.

Study details: Findings are from a meta-analysis of 9 studies involving 791,010 patients with IBD or stroke.

Disclosures: The study was supported by the General Project of Chongqing Natural Science Foundation and the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Chen Y et al. Brain Behav. 2021 May 7. doi: 10.1002/brb3.2159.