Two “Great Debates” at this year’s annual meeting of the American College of Rheumatology in San Diego will center on important, but completely separate, issues in rheumatology: whether it is safe to switch to a biosimilar and the relevance of curricular milestones in rheumatology training.

At 2:30 p.m. on Sunday, Nov. 5, a session titled “Biosimilars ... To Switch or Not to Switch? That Is the Question“ will pit Jonathan Kay, MD, against Roy Fleischmann, MD, to try to sway the audience to their point of view in the face of a small evidence base about the consequences of switching.

Dr. Kay, the Timothy S. and Elaine L. Peterson Chair in Rheumatology and professor of medicine at the University of Massachusetts, Worcester, where he directs clinical research in the division of rheumatology, will discuss and defend the usefulness of biosimilars for rheumatoid arthritis in his presentation, “The Data Supports That It Is Safe, Effective and Cost-Effective to Switch to a Biosimilar.” He has been greatly involved in clinical research on the development of biosimilars to treat rheumatic diseases in recent years.

In his presentation, “The Data Is Not Convincing. One Study Cannot Be Generalized to All Indications, and Some Studies Suggest That It Is Not Safe, Not Effective and Not Cost-Effective to Switch All Patients (YET) to a Biosimilar,” Dr. Fleischmann will discuss and defend the position that biosimilars are not yet well-enough researched to confidently allow switching. Dr. Fleischmann is clinical professor in the department of internal medicine at the University of Texas Southwestern Medical Center, Dallas.

At 7:30 a.m. on Monday, Nov. 6, two clinician-educators will advocate for opposing opinions in “The Great (Educational) Debate: Milestones: Meaningful vs. Millstone.” The debate will focus on the relative merits of the Accreditation Council for Graduate Medical Education’s Next Accreditation System, which in 2013 led to a paradigm shift in how training programs approach curriculum development, and how both trainees and their programs are assessed.

Calvin Brown, MD, professor of medicine in the division of rheumatology and director of the rheumatology training program at Northwestern University, Chicago, will describe the reported and perceived benefits of the milestones, while Simon Helfgott, MD, of Brigham and Women’s Hospital, Boston, will summarize the arguments that underlie the call for radical change in the milestones system of evaluation

[email protected]

Two “Great Debates” at this year’s annual meeting of the American College of Rheumatology in San Diego will center on important, but completely separate, issues in rheumatology: whether it is safe to switch to a biosimilar and the relevance of curricular milestones in rheumatology training.

At 2:30 p.m. on Sunday, Nov. 5, a session titled “Biosimilars ... To Switch or Not to Switch? That Is the Question“ will pit Jonathan Kay, MD, against Roy Fleischmann, MD, to try to sway the audience to their point of view in the face of a small evidence base about the consequences of switching.

Dr. Kay, the Timothy S. and Elaine L. Peterson Chair in Rheumatology and professor of medicine at the University of Massachusetts, Worcester, where he directs clinical research in the division of rheumatology, will discuss and defend the usefulness of biosimilars for rheumatoid arthritis in his presentation, “The Data Supports That It Is Safe, Effective and Cost-Effective to Switch to a Biosimilar.” He has been greatly involved in clinical research on the development of biosimilars to treat rheumatic diseases in recent years.

In his presentation, “The Data Is Not Convincing. One Study Cannot Be Generalized to All Indications, and Some Studies Suggest That It Is Not Safe, Not Effective and Not Cost-Effective to Switch All Patients (YET) to a Biosimilar,” Dr. Fleischmann will discuss and defend the position that biosimilars are not yet well-enough researched to confidently allow switching. Dr. Fleischmann is clinical professor in the department of internal medicine at the University of Texas Southwestern Medical Center, Dallas.

At 7:30 a.m. on Monday, Nov. 6, two clinician-educators will advocate for opposing opinions in “The Great (Educational) Debate: Milestones: Meaningful vs. Millstone.” The debate will focus on the relative merits of the Accreditation Council for Graduate Medical Education’s Next Accreditation System, which in 2013 led to a paradigm shift in how training programs approach curriculum development, and how both trainees and their programs are assessed.

Calvin Brown, MD, professor of medicine in the division of rheumatology and director of the rheumatology training program at Northwestern University, Chicago, will describe the reported and perceived benefits of the milestones, while Simon Helfgott, MD, of Brigham and Women’s Hospital, Boston, will summarize the arguments that underlie the call for radical change in the milestones system of evaluation

[email protected]

Two “Great Debates” at this year’s annual meeting of the American College of Rheumatology in San Diego will center on important, but completely separate, issues in rheumatology: whether it is safe to switch to a biosimilar and the relevance of curricular milestones in rheumatology training.

At 2:30 p.m. on Sunday, Nov. 5, a session titled “Biosimilars ... To Switch or Not to Switch? That Is the Question“ will pit Jonathan Kay, MD, against Roy Fleischmann, MD, to try to sway the audience to their point of view in the face of a small evidence base about the consequences of switching.

Dr. Kay, the Timothy S. and Elaine L. Peterson Chair in Rheumatology and professor of medicine at the University of Massachusetts, Worcester, where he directs clinical research in the division of rheumatology, will discuss and defend the usefulness of biosimilars for rheumatoid arthritis in his presentation, “The Data Supports That It Is Safe, Effective and Cost-Effective to Switch to a Biosimilar.” He has been greatly involved in clinical research on the development of biosimilars to treat rheumatic diseases in recent years.

In his presentation, “The Data Is Not Convincing. One Study Cannot Be Generalized to All Indications, and Some Studies Suggest That It Is Not Safe, Not Effective and Not Cost-Effective to Switch All Patients (YET) to a Biosimilar,” Dr. Fleischmann will discuss and defend the position that biosimilars are not yet well-enough researched to confidently allow switching. Dr. Fleischmann is clinical professor in the department of internal medicine at the University of Texas Southwestern Medical Center, Dallas.

At 7:30 a.m. on Monday, Nov. 6, two clinician-educators will advocate for opposing opinions in “The Great (Educational) Debate: Milestones: Meaningful vs. Millstone.” The debate will focus on the relative merits of the Accreditation Council for Graduate Medical Education’s Next Accreditation System, which in 2013 led to a paradigm shift in how training programs approach curriculum development, and how both trainees and their programs are assessed.

Calvin Brown, MD, professor of medicine in the division of rheumatology and director of the rheumatology training program at Northwestern University, Chicago, will describe the reported and perceived benefits of the milestones, while Simon Helfgott, MD, of Brigham and Women’s Hospital, Boston, will summarize the arguments that underlie the call for radical change in the milestones system of evaluation

[email protected]

An electromyographic biofeedback program significantly improved abdominothoracic muscle control and abdominal distension compared with placebo in a randomized trial of patients fulfilling Rome III criteria for functional intestinal disorders.

Sensations of abdominal distension improved by 56% with biofeedback (standard deviation, 1%) versus 13% (SD, 8%) with placebo, wrote Elizabeth Barba, MD, of University Hospital Vall d’Hebron in Barcelona, and her associates. The study was published in the December issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.06.052). Biofeedback also led to a doubling of anterior wall muscle activity (101%; SD, 10%) compared with a 4% (SD, 2%) improvement with placebo. Finally, biofeedback lowered intercostal muscle activity by a mean of 45% (SD, 3%) compared with 5% (SD, 2%) with placebo (all P values less than .001).

“Biofeedback in this trial was applied using a complex technique that provided effective guidance to patients and allowed close control of the mechanistic effects of the intervention on postural tone,” the researchers noted. “Having proved the [efficacy] of this treatment, the next steps are to develop and then to properly validate a simpler technique for widespread application.”

Episodic abdominal distension is a primary reason for visiting gastroenterology clinics. Patients typically experience an objective, visible increase in girth with no detectable cause, although they often have irritable bowel syndrome, functional dyspepsia, or both. Past work has linked abdominal distension with increased diaphragmatic tone and ventral protrusion and decreased muscle tone of the abdominal wall, the researchers noted.

Therefore, they developed an electromyography (EMG) biofeedback program to help patients learn to correct abdominothoracic muscular dystony. The trial comprised 48 patients (47 women and 1 man) ranging in age from 21 to 74 years. During each 30-minute session, patients sat upright in a quiet room while EMG recorded the activity of the intercostal muscles, anterior abdominal wall (external oblique, upper rectus, lower rectus, and internal oblique muscles), and diaphragm. Patients reported their sensation of abdominal distension on a visual rating scale ranging from 0 (no distension) to 6 (extreme distension). Those in the intervention group watched the EMG readout and were taught to reduce their intercostal and diaphragm activity while increasing the activity of the anterior abdominal muscles. Three training sessions occurred over 10 days and patients performed similar exercises at home for 5 minutes before each meal. Patients in the placebo group underwent the same instrumental interventions but did not watch the EMG recording, received no instructions about muscle control, and were given oral simethicone.

Symptoms associated with abdominal distension lessened by 57% (SD, 9%) in the biofeedback group and by 23% (4%) in the placebo group (P = .02). Treatment outcomes did not vary based on symptoms and there were no adverse effects of treatment, the researchers said. Furthermore, 19 patients in the placebo group who did not improve underwent biofeedback training and experienced benefits similar to those of the original intervention group. Sensations of abdominal distension and associated symptoms improved significantly immediately after biofeedback compared with baseline and continued to improve significantly over 6 months of follow-up.

The researchers described the complexity of the intervention, which, they acknowledged, would need to be simplified before it could be deployed widely. They measured the activity of the external oblique, upper rectus, lower rectus, and internal oblique muscles with bipolar leads, and recorded intercostal muscle activity by placing a monopolar electrode at the second intercostal space on the right midclavicular line, with a ground electrode over the central sternum. To verify correct placement, they recorded EMG responses to a Valsalva maneuver and a deep inhalation. They measured diaphragmatic activity by mounting electrodes on a polyvinyl tube, performing nasal intubation, and positioning the electrodes across the diaphragmatic hiatus under fluoroscopic control.

Funders included the Spanish Ministry of Economy and Competitiveness and the Instituto de Salud Carlos III. The researchers reported having no conflicts of interest.

An electromyographic biofeedback program significantly improved abdominothoracic muscle control and abdominal distension compared with placebo in a randomized trial of patients fulfilling Rome III criteria for functional intestinal disorders.

Sensations of abdominal distension improved by 56% with biofeedback (standard deviation, 1%) versus 13% (SD, 8%) with placebo, wrote Elizabeth Barba, MD, of University Hospital Vall d’Hebron in Barcelona, and her associates. The study was published in the December issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.06.052). Biofeedback also led to a doubling of anterior wall muscle activity (101%; SD, 10%) compared with a 4% (SD, 2%) improvement with placebo. Finally, biofeedback lowered intercostal muscle activity by a mean of 45% (SD, 3%) compared with 5% (SD, 2%) with placebo (all P values less than .001).

“Biofeedback in this trial was applied using a complex technique that provided effective guidance to patients and allowed close control of the mechanistic effects of the intervention on postural tone,” the researchers noted. “Having proved the [efficacy] of this treatment, the next steps are to develop and then to properly validate a simpler technique for widespread application.”

Episodic abdominal distension is a primary reason for visiting gastroenterology clinics. Patients typically experience an objective, visible increase in girth with no detectable cause, although they often have irritable bowel syndrome, functional dyspepsia, or both. Past work has linked abdominal distension with increased diaphragmatic tone and ventral protrusion and decreased muscle tone of the abdominal wall, the researchers noted.

Therefore, they developed an electromyography (EMG) biofeedback program to help patients learn to correct abdominothoracic muscular dystony. The trial comprised 48 patients (47 women and 1 man) ranging in age from 21 to 74 years. During each 30-minute session, patients sat upright in a quiet room while EMG recorded the activity of the intercostal muscles, anterior abdominal wall (external oblique, upper rectus, lower rectus, and internal oblique muscles), and diaphragm. Patients reported their sensation of abdominal distension on a visual rating scale ranging from 0 (no distension) to 6 (extreme distension). Those in the intervention group watched the EMG readout and were taught to reduce their intercostal and diaphragm activity while increasing the activity of the anterior abdominal muscles. Three training sessions occurred over 10 days and patients performed similar exercises at home for 5 minutes before each meal. Patients in the placebo group underwent the same instrumental interventions but did not watch the EMG recording, received no instructions about muscle control, and were given oral simethicone.

Symptoms associated with abdominal distension lessened by 57% (SD, 9%) in the biofeedback group and by 23% (4%) in the placebo group (P = .02). Treatment outcomes did not vary based on symptoms and there were no adverse effects of treatment, the researchers said. Furthermore, 19 patients in the placebo group who did not improve underwent biofeedback training and experienced benefits similar to those of the original intervention group. Sensations of abdominal distension and associated symptoms improved significantly immediately after biofeedback compared with baseline and continued to improve significantly over 6 months of follow-up.

The researchers described the complexity of the intervention, which, they acknowledged, would need to be simplified before it could be deployed widely. They measured the activity of the external oblique, upper rectus, lower rectus, and internal oblique muscles with bipolar leads, and recorded intercostal muscle activity by placing a monopolar electrode at the second intercostal space on the right midclavicular line, with a ground electrode over the central sternum. To verify correct placement, they recorded EMG responses to a Valsalva maneuver and a deep inhalation. They measured diaphragmatic activity by mounting electrodes on a polyvinyl tube, performing nasal intubation, and positioning the electrodes across the diaphragmatic hiatus under fluoroscopic control.

Funders included the Spanish Ministry of Economy and Competitiveness and the Instituto de Salud Carlos III. The researchers reported having no conflicts of interest.

An electromyographic biofeedback program significantly improved abdominothoracic muscle control and abdominal distension compared with placebo in a randomized trial of patients fulfilling Rome III criteria for functional intestinal disorders.

Sensations of abdominal distension improved by 56% with biofeedback (standard deviation, 1%) versus 13% (SD, 8%) with placebo, wrote Elizabeth Barba, MD, of University Hospital Vall d’Hebron in Barcelona, and her associates. The study was published in the December issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.06.052). Biofeedback also led to a doubling of anterior wall muscle activity (101%; SD, 10%) compared with a 4% (SD, 2%) improvement with placebo. Finally, biofeedback lowered intercostal muscle activity by a mean of 45% (SD, 3%) compared with 5% (SD, 2%) with placebo (all P values less than .001).

“Biofeedback in this trial was applied using a complex technique that provided effective guidance to patients and allowed close control of the mechanistic effects of the intervention on postural tone,” the researchers noted. “Having proved the [efficacy] of this treatment, the next steps are to develop and then to properly validate a simpler technique for widespread application.”

Episodic abdominal distension is a primary reason for visiting gastroenterology clinics. Patients typically experience an objective, visible increase in girth with no detectable cause, although they often have irritable bowel syndrome, functional dyspepsia, or both. Past work has linked abdominal distension with increased diaphragmatic tone and ventral protrusion and decreased muscle tone of the abdominal wall, the researchers noted.

Therefore, they developed an electromyography (EMG) biofeedback program to help patients learn to correct abdominothoracic muscular dystony. The trial comprised 48 patients (47 women and 1 man) ranging in age from 21 to 74 years. During each 30-minute session, patients sat upright in a quiet room while EMG recorded the activity of the intercostal muscles, anterior abdominal wall (external oblique, upper rectus, lower rectus, and internal oblique muscles), and diaphragm. Patients reported their sensation of abdominal distension on a visual rating scale ranging from 0 (no distension) to 6 (extreme distension). Those in the intervention group watched the EMG readout and were taught to reduce their intercostal and diaphragm activity while increasing the activity of the anterior abdominal muscles. Three training sessions occurred over 10 days and patients performed similar exercises at home for 5 minutes before each meal. Patients in the placebo group underwent the same instrumental interventions but did not watch the EMG recording, received no instructions about muscle control, and were given oral simethicone.

Symptoms associated with abdominal distension lessened by 57% (SD, 9%) in the biofeedback group and by 23% (4%) in the placebo group (P = .02). Treatment outcomes did not vary based on symptoms and there were no adverse effects of treatment, the researchers said. Furthermore, 19 patients in the placebo group who did not improve underwent biofeedback training and experienced benefits similar to those of the original intervention group. Sensations of abdominal distension and associated symptoms improved significantly immediately after biofeedback compared with baseline and continued to improve significantly over 6 months of follow-up.

The researchers described the complexity of the intervention, which, they acknowledged, would need to be simplified before it could be deployed widely. They measured the activity of the external oblique, upper rectus, lower rectus, and internal oblique muscles with bipolar leads, and recorded intercostal muscle activity by placing a monopolar electrode at the second intercostal space on the right midclavicular line, with a ground electrode over the central sternum. To verify correct placement, they recorded EMG responses to a Valsalva maneuver and a deep inhalation. They measured diaphragmatic activity by mounting electrodes on a polyvinyl tube, performing nasal intubation, and positioning the electrodes across the diaphragmatic hiatus under fluoroscopic control.

Funders included the Spanish Ministry of Economy and Competitiveness and the Instituto de Salud Carlos III. The researchers reported having no conflicts of interest.

My leadership experience was limited when I became department chair 6 years ago. Recognizing the deficit immediately, I began reading self-help and leadership books, sought training in coaching techniques, and have attended innumerable leadership courses. I still have a lot to learn, but I am a lot more comfortable with my leadership skills than I was. Since I am often asked for advice with regard to advancing into administrative leadership positions, I want to share what I have learned with others.

In one of my previous columns, I reviewed the concept of drama triangles and introduced structural tension as a model for addressing and breaking them. The structural tension model is attributed to Robert Fritz and is presented in Figure 1. I have found this model very helpful for coaching toward desired change.

Kelly, the supervisor/manager/director/chairman, expects all physicians to carry a heavy clinical load while also conducting research, writing papers, and securing as many grants as possible. Of course, the expected clinical load encroaches on the time required for academic pursuits. Tension increases among the faculty as the clinical load prohibits academic work resulting in unmet expectations for Kelly and dissatisfaction and disengagement for everyone else. A staff meeting is called to address the worsening workplace environment.

Since Kelly is at a loss, the administrator, Pat, offers to run the meeting in an attempt to address the problem. Pat asks the assembled team to describe the ideal state, or desired result, for the department. Eagerly, the participants begin to list the components of their ideal state including error-free scheduling, adequate staffing, an efficient electronic medical record, uninterrupted administrative time, sufficient research support, and several other important requirements to successfully meet department expectations.

Next, Pat asks the staff to list the current state. Once again, the participants are more than happy to call out the current situation as they see it, including patients arriving without records, slow rooming times, add-on appointments outside clinic schedules, poor statistical support, and several other impediments to optimal efficiency.

For more reading: Fritz R, “The Path of Least Resistance” (New York: Random House, 1984).

My leadership experience was limited when I became department chair 6 years ago. Recognizing the deficit immediately, I began reading self-help and leadership books, sought training in coaching techniques, and have attended innumerable leadership courses. I still have a lot to learn, but I am a lot more comfortable with my leadership skills than I was. Since I am often asked for advice with regard to advancing into administrative leadership positions, I want to share what I have learned with others.

In one of my previous columns, I reviewed the concept of drama triangles and introduced structural tension as a model for addressing and breaking them. The structural tension model is attributed to Robert Fritz and is presented in Figure 1. I have found this model very helpful for coaching toward desired change.

Kelly, the supervisor/manager/director/chairman, expects all physicians to carry a heavy clinical load while also conducting research, writing papers, and securing as many grants as possible. Of course, the expected clinical load encroaches on the time required for academic pursuits. Tension increases among the faculty as the clinical load prohibits academic work resulting in unmet expectations for Kelly and dissatisfaction and disengagement for everyone else. A staff meeting is called to address the worsening workplace environment.

Since Kelly is at a loss, the administrator, Pat, offers to run the meeting in an attempt to address the problem. Pat asks the assembled team to describe the ideal state, or desired result, for the department. Eagerly, the participants begin to list the components of their ideal state including error-free scheduling, adequate staffing, an efficient electronic medical record, uninterrupted administrative time, sufficient research support, and several other important requirements to successfully meet department expectations.

Next, Pat asks the staff to list the current state. Once again, the participants are more than happy to call out the current situation as they see it, including patients arriving without records, slow rooming times, add-on appointments outside clinic schedules, poor statistical support, and several other impediments to optimal efficiency.

For more reading: Fritz R, “The Path of Least Resistance” (New York: Random House, 1984).

My leadership experience was limited when I became department chair 6 years ago. Recognizing the deficit immediately, I began reading self-help and leadership books, sought training in coaching techniques, and have attended innumerable leadership courses. I still have a lot to learn, but I am a lot more comfortable with my leadership skills than I was. Since I am often asked for advice with regard to advancing into administrative leadership positions, I want to share what I have learned with others.

In one of my previous columns, I reviewed the concept of drama triangles and introduced structural tension as a model for addressing and breaking them. The structural tension model is attributed to Robert Fritz and is presented in Figure 1. I have found this model very helpful for coaching toward desired change.

Kelly, the supervisor/manager/director/chairman, expects all physicians to carry a heavy clinical load while also conducting research, writing papers, and securing as many grants as possible. Of course, the expected clinical load encroaches on the time required for academic pursuits. Tension increases among the faculty as the clinical load prohibits academic work resulting in unmet expectations for Kelly and dissatisfaction and disengagement for everyone else. A staff meeting is called to address the worsening workplace environment.

Since Kelly is at a loss, the administrator, Pat, offers to run the meeting in an attempt to address the problem. Pat asks the assembled team to describe the ideal state, or desired result, for the department. Eagerly, the participants begin to list the components of their ideal state including error-free scheduling, adequate staffing, an efficient electronic medical record, uninterrupted administrative time, sufficient research support, and several other important requirements to successfully meet department expectations.

Next, Pat asks the staff to list the current state. Once again, the participants are more than happy to call out the current situation as they see it, including patients arriving without records, slow rooming times, add-on appointments outside clinic schedules, poor statistical support, and several other impediments to optimal efficiency.

For more reading: Fritz R, “The Path of Least Resistance” (New York: Random House, 1984).

NEW ORLEANS – In 2001, a patient at the Menninger Clinic, Houston, asked whether her husband could be with her during ECT treatments, so she’d feel safer.

He declined, but then she told her care team “the fact that you would allow that makes me feel entirely safe now,” recalled M. Justin Coffey, MD, medical director of Menninger’s Center for Brain Stimulation.

“She made her request partly in jest, but it was a great idea,” he said. Fast-forward 16 years, and it’s now standard practice at Menninger for patients to invite loved ones to ECT sessions. Sometimes they pick family members, other times a neighbor or even a pastor.

“One of the most powerful benefits we’ve seen is that the loved ones observing the treatment become thoroughly underwhelmed by what they see,” not much more than the patient under anesthesia. “At the same time, they are incredibly impressed by the expertise and competence of the team. They become ambassadors against stigma; I’ve got family members and patients now that join me in workshops talking about why ECT should be [used] more,” Dr. Coffey said at the American Psychiatric Association’s Institute on Psychiatric Services.

[email protected]

NEW ORLEANS – In 2001, a patient at the Menninger Clinic, Houston, asked whether her husband could be with her during ECT treatments, so she’d feel safer.

He declined, but then she told her care team “the fact that you would allow that makes me feel entirely safe now,” recalled M. Justin Coffey, MD, medical director of Menninger’s Center for Brain Stimulation.

“She made her request partly in jest, but it was a great idea,” he said. Fast-forward 16 years, and it’s now standard practice at Menninger for patients to invite loved ones to ECT sessions. Sometimes they pick family members, other times a neighbor or even a pastor.

“One of the most powerful benefits we’ve seen is that the loved ones observing the treatment become thoroughly underwhelmed by what they see,” not much more than the patient under anesthesia. “At the same time, they are incredibly impressed by the expertise and competence of the team. They become ambassadors against stigma; I’ve got family members and patients now that join me in workshops talking about why ECT should be [used] more,” Dr. Coffey said at the American Psychiatric Association’s Institute on Psychiatric Services.

[email protected]

NEW ORLEANS – In 2001, a patient at the Menninger Clinic, Houston, asked whether her husband could be with her during ECT treatments, so she’d feel safer.

He declined, but then she told her care team “the fact that you would allow that makes me feel entirely safe now,” recalled M. Justin Coffey, MD, medical director of Menninger’s Center for Brain Stimulation.

“She made her request partly in jest, but it was a great idea,” he said. Fast-forward 16 years, and it’s now standard practice at Menninger for patients to invite loved ones to ECT sessions. Sometimes they pick family members, other times a neighbor or even a pastor.

“One of the most powerful benefits we’ve seen is that the loved ones observing the treatment become thoroughly underwhelmed by what they see,” not much more than the patient under anesthesia. “At the same time, they are incredibly impressed by the expertise and competence of the team. They become ambassadors against stigma; I’ve got family members and patients now that join me in workshops talking about why ECT should be [used] more,” Dr. Coffey said at the American Psychiatric Association’s Institute on Psychiatric Services.

[email protected]

SAN DIEGO – The selective dopamine and norepinephrine reuptake inhibitor solriamfetol is effective in reducing sleepiness in patients with narcolepsy, according to results of a phase 3 study.

At 150-mg and 300-mg doses, the drug had statistically significant effects on objective and subjective measures.

There are wake-promoting drugs available, such as amphetamine-related drugs that are often used off label, but addiction liability is a concern. The nonamphetamine modafinil has been approved by the Food and Drug Administration since 1998.

Jazz Pharmaceuticals is in the process of submitting solriamfetol for FDA evaluation. If approved, the drug will add to the options available for narcolepsy patients. “All of the available drugs have some limitations. Some have more abuse liability than others. Some have more robust wake-promoting properties than others. We haven’t done any head-to-head comparisons, so I can’t tell you how we will stack up,” Philip Jochelson, MD, said in an interview. Dr. Jochelson is vice president of clinical development at Jazz Pharmaceuticals and presented the results of the study at a poster session at the annual meeting of the American Neurological Association.

An earlier study showed the drug had less abuse potential than the schedule IV stimulant phentermine. That’s not surprising given the drug’s mechanism of action, Dr. Jochelson said. Amphetamine-based drugs stimulate dopamine release, which can prompt a dopamine surge that people equate with a high, he said. Solriamfetol also affects dopamine, but it is a reuptake inhibitor, so it doesn’t produce a surge.

If the drug gains approval, it remains to be seen how it will be classified on the Drug Enforcement Agency Controlled Substance scale. “Where it will fall in that spectrum is speculative at this point,” said Dr. Jochelson.

In the current study, 236 adults (aged 18-75 years) with type 1 narcolepsy were randomized to once-daily placebo, 75 mg solriamfetol, 150 mg solriamfetol, or 300 mg solriamfetol; 27.1% of patients in the 300-mg group discontinued, compared with 7.3% in the 150-mg group, 16.9% in the 75-mg group, and 10.3% in the placebo group. The mean change from baseline on the Maintenance of Wakefulness Test was statistically significant in the 300-mg group (12.3 minutes vs. 2.1 minutes for placebo, P less than .0001) and the 150-mg group (9.8 minutes vs. 2.1 minutes, P less than .0001) but not the 75-mg group (4.7 minutes vs. 2.1 minutes).

The drug also outperformed placebo at week 12 on the Epworth Sleepiness Scale. The mean change in the 300-mg group was –6.4 vs. –1.6 for placebo (P less than .001), –5.4 in the 150-mg group (P less than .0001), and –3.8 in the 75-mg group (P less than .05).

By both Maintenance of Wakefulness Test and Epworth Sleepiness Scale measures, the 150-mg and 300-mg solriamfetol groups had statistically significant differences as early as week 1.

The drug had some adverse effects, which were expected based on its pharmacologic profile. These included increases in headache (5.1% with placebo, 10.2% with 75 mg, 23.7% with 150 mg, 30.5% with 300 mg), nausea (1.7% for placebo, 5.1% for 75 mg, 10.2% for 150 mg, 16.9% for 300 mg), anxiety (1.7% with placebo, 1.7% with 75 mg, 5.1% with 150 mg, 8.5% with 300 mg), and insomnia (0% for placebo, 3.4% for 75 mg, 0% for 150 mg, 5.1% for 300 mg). Other adverse events occurring in at least 5% of patients were decreased appetite, nasopharyngitis, and dry mouth.

The study was funded by Jazz Pharmaceuticals. Dr. Jochelson is an employee of Jazz.

[email protected]

SAN DIEGO – The selective dopamine and norepinephrine reuptake inhibitor solriamfetol is effective in reducing sleepiness in patients with narcolepsy, according to results of a phase 3 study.

At 150-mg and 300-mg doses, the drug had statistically significant effects on objective and subjective measures.

There are wake-promoting drugs available, such as amphetamine-related drugs that are often used off label, but addiction liability is a concern. The nonamphetamine modafinil has been approved by the Food and Drug Administration since 1998.

Jazz Pharmaceuticals is in the process of submitting solriamfetol for FDA evaluation. If approved, the drug will add to the options available for narcolepsy patients. “All of the available drugs have some limitations. Some have more abuse liability than others. Some have more robust wake-promoting properties than others. We haven’t done any head-to-head comparisons, so I can’t tell you how we will stack up,” Philip Jochelson, MD, said in an interview. Dr. Jochelson is vice president of clinical development at Jazz Pharmaceuticals and presented the results of the study at a poster session at the annual meeting of the American Neurological Association.

An earlier study showed the drug had less abuse potential than the schedule IV stimulant phentermine. That’s not surprising given the drug’s mechanism of action, Dr. Jochelson said. Amphetamine-based drugs stimulate dopamine release, which can prompt a dopamine surge that people equate with a high, he said. Solriamfetol also affects dopamine, but it is a reuptake inhibitor, so it doesn’t produce a surge.

If the drug gains approval, it remains to be seen how it will be classified on the Drug Enforcement Agency Controlled Substance scale. “Where it will fall in that spectrum is speculative at this point,” said Dr. Jochelson.

In the current study, 236 adults (aged 18-75 years) with type 1 narcolepsy were randomized to once-daily placebo, 75 mg solriamfetol, 150 mg solriamfetol, or 300 mg solriamfetol; 27.1% of patients in the 300-mg group discontinued, compared with 7.3% in the 150-mg group, 16.9% in the 75-mg group, and 10.3% in the placebo group. The mean change from baseline on the Maintenance of Wakefulness Test was statistically significant in the 300-mg group (12.3 minutes vs. 2.1 minutes for placebo, P less than .0001) and the 150-mg group (9.8 minutes vs. 2.1 minutes, P less than .0001) but not the 75-mg group (4.7 minutes vs. 2.1 minutes).

The drug also outperformed placebo at week 12 on the Epworth Sleepiness Scale. The mean change in the 300-mg group was –6.4 vs. –1.6 for placebo (P less than .001), –5.4 in the 150-mg group (P less than .0001), and –3.8 in the 75-mg group (P less than .05).

By both Maintenance of Wakefulness Test and Epworth Sleepiness Scale measures, the 150-mg and 300-mg solriamfetol groups had statistically significant differences as early as week 1.

The drug had some adverse effects, which were expected based on its pharmacologic profile. These included increases in headache (5.1% with placebo, 10.2% with 75 mg, 23.7% with 150 mg, 30.5% with 300 mg), nausea (1.7% for placebo, 5.1% for 75 mg, 10.2% for 150 mg, 16.9% for 300 mg), anxiety (1.7% with placebo, 1.7% with 75 mg, 5.1% with 150 mg, 8.5% with 300 mg), and insomnia (0% for placebo, 3.4% for 75 mg, 0% for 150 mg, 5.1% for 300 mg). Other adverse events occurring in at least 5% of patients were decreased appetite, nasopharyngitis, and dry mouth.

The study was funded by Jazz Pharmaceuticals. Dr. Jochelson is an employee of Jazz.

[email protected]

SAN DIEGO – The selective dopamine and norepinephrine reuptake inhibitor solriamfetol is effective in reducing sleepiness in patients with narcolepsy, according to results of a phase 3 study.

At 150-mg and 300-mg doses, the drug had statistically significant effects on objective and subjective measures.

There are wake-promoting drugs available, such as amphetamine-related drugs that are often used off label, but addiction liability is a concern. The nonamphetamine modafinil has been approved by the Food and Drug Administration since 1998.

Jazz Pharmaceuticals is in the process of submitting solriamfetol for FDA evaluation. If approved, the drug will add to the options available for narcolepsy patients. “All of the available drugs have some limitations. Some have more abuse liability than others. Some have more robust wake-promoting properties than others. We haven’t done any head-to-head comparisons, so I can’t tell you how we will stack up,” Philip Jochelson, MD, said in an interview. Dr. Jochelson is vice president of clinical development at Jazz Pharmaceuticals and presented the results of the study at a poster session at the annual meeting of the American Neurological Association.

An earlier study showed the drug had less abuse potential than the schedule IV stimulant phentermine. That’s not surprising given the drug’s mechanism of action, Dr. Jochelson said. Amphetamine-based drugs stimulate dopamine release, which can prompt a dopamine surge that people equate with a high, he said. Solriamfetol also affects dopamine, but it is a reuptake inhibitor, so it doesn’t produce a surge.

If the drug gains approval, it remains to be seen how it will be classified on the Drug Enforcement Agency Controlled Substance scale. “Where it will fall in that spectrum is speculative at this point,” said Dr. Jochelson.

In the current study, 236 adults (aged 18-75 years) with type 1 narcolepsy were randomized to once-daily placebo, 75 mg solriamfetol, 150 mg solriamfetol, or 300 mg solriamfetol; 27.1% of patients in the 300-mg group discontinued, compared with 7.3% in the 150-mg group, 16.9% in the 75-mg group, and 10.3% in the placebo group. The mean change from baseline on the Maintenance of Wakefulness Test was statistically significant in the 300-mg group (12.3 minutes vs. 2.1 minutes for placebo, P less than .0001) and the 150-mg group (9.8 minutes vs. 2.1 minutes, P less than .0001) but not the 75-mg group (4.7 minutes vs. 2.1 minutes).

The drug also outperformed placebo at week 12 on the Epworth Sleepiness Scale. The mean change in the 300-mg group was –6.4 vs. –1.6 for placebo (P less than .001), –5.4 in the 150-mg group (P less than .0001), and –3.8 in the 75-mg group (P less than .05).

By both Maintenance of Wakefulness Test and Epworth Sleepiness Scale measures, the 150-mg and 300-mg solriamfetol groups had statistically significant differences as early as week 1.

The drug had some adverse effects, which were expected based on its pharmacologic profile. These included increases in headache (5.1% with placebo, 10.2% with 75 mg, 23.7% with 150 mg, 30.5% with 300 mg), nausea (1.7% for placebo, 5.1% for 75 mg, 10.2% for 150 mg, 16.9% for 300 mg), anxiety (1.7% with placebo, 1.7% with 75 mg, 5.1% with 150 mg, 8.5% with 300 mg), and insomnia (0% for placebo, 3.4% for 75 mg, 0% for 150 mg, 5.1% for 300 mg). Other adverse events occurring in at least 5% of patients were decreased appetite, nasopharyngitis, and dry mouth.

The study was funded by Jazz Pharmaceuticals. Dr. Jochelson is an employee of Jazz.

[email protected]

ORLANDO – A single treatment with a suspension of allogeneic expanded adipose-derived mesenchymal stem cells, or Cx601, promotes long-term combined remission of complex perianal fistulas in patients with Crohn’s disease, according to 52-week results from the phase 3 ADMIRE CD trial.

Combined remission – a stringent endpoint consisting of closure of all treated external openings that were draining at baseline and of an absence of collections more than 2 cm of treated perianal fistulas as confirmed by blinded central MRI – was achieved in 56.3% of 103 treated patients, compared with 38.6% of 101 patients who received placebo (P = .010), Daniel C. Baumgart, MD, reported at the World Congress of Gastroenterology at ACG 2017.

This parallel-group, double-blind, multicenter study included patients who had draining, treatment-refractory, complex perianal fistulas and inactive or mildly active luminal Crohn’s disease (Crohn’s Disease Activity Index scores of 220 or less) at baseline. Those randomized to the Cx601 group received a single intralesional injection of 120 million expanded adipose-derived stem cells and standard of care. Those in the control arm received a placebo injection plus standard of care, said Dr. Baumgart of Charité Medical School, which is affiliated with both Humboldt University in Berlin and the Free University of Berlin.

Prior to receiving treatment or placebo, the patients underwent fistula curettage and, if indicated, seton placement and subsequent removal, he noted, adding that baseline concomitant medications, including immunosuppressants and anti–tumor necrosis factors, were continued without dose or regimen modification and that antibiotics were allowed for up to 4 weeks.

The 52-week findings were evaluated in the modified intention-to-treat population of patients who were randomized, were treated, and had at least one postbaseline efficacy assessment (61.8% of the study population). These findings showed that Cx601 is associated with even better outcomes at 1 year than those reported at 24 weeks; those prior results, published in The Lancet in July 2016, showed combined remission rates in the modified intention-to-treat population of 51% vs. 36% for placebo.

Furthermore, 75% of treated patients who achieved combined remission at 24 weeks maintained that remission at 52 weeks, compared with 55.9% of those in the placebo group (P = .052), Dr. Baumgart said.

Sensitivity analyses in this long-term assessment supported the long-term effectiveness of Cx601 over that of the control treatment, which provided evidence on the robustness of its advantage, he said, noting that safety results were also encouraging.

“The safety profile was similar to week 24; there were no new safety signals there at all,” he said.

The findings are of note because existing therapies for complex perianal fistulas in Crohn’s disease are often ineffective, he said, adding that fistulas occur in up to 50% of Crohn’s disease patients and that 70%-80% are complex and difficult to treat. Most are refractory to conventional anti–tumor necrosis factor therapies, and 60%-70% of patients relapse, he explained.

“If we’re honest, very few medications have been properly studied,” he said, adding that fistula patients often are excluded from industry trials.

“So [the ADMIRE CD trial] is new, design-wise, and has addressed a true medical need,” he said.

He attributed the good placebo response in this trial to the ongoing standard of care treatment in both groups, as well as to the team approach to care used in the trial. He also noted that a number of questions regarding the use of Cx601 remain to be answered, including the when the ideal retreatment time point should be, whether the treatment can be used for rectovaginal fistulas, and which patients should not receive treatment.

“So there is a lot to learn still, but I think it’s a revolutionary step forward, compared to what we have today, due to the trial design, which I think is robust, and also the encouraging outcomes,” he said.

The ADMIRE CD trial was sponsored by TiGenix SAU. Dr. Baumgart has received consulting fees and nonfinancial support from AbbVie, Biogen, and BMS.

[email protected]

ORLANDO – A single treatment with a suspension of allogeneic expanded adipose-derived mesenchymal stem cells, or Cx601, promotes long-term combined remission of complex perianal fistulas in patients with Crohn’s disease, according to 52-week results from the phase 3 ADMIRE CD trial.

Combined remission – a stringent endpoint consisting of closure of all treated external openings that were draining at baseline and of an absence of collections more than 2 cm of treated perianal fistulas as confirmed by blinded central MRI – was achieved in 56.3% of 103 treated patients, compared with 38.6% of 101 patients who received placebo (P = .010), Daniel C. Baumgart, MD, reported at the World Congress of Gastroenterology at ACG 2017.

This parallel-group, double-blind, multicenter study included patients who had draining, treatment-refractory, complex perianal fistulas and inactive or mildly active luminal Crohn’s disease (Crohn’s Disease Activity Index scores of 220 or less) at baseline. Those randomized to the Cx601 group received a single intralesional injection of 120 million expanded adipose-derived stem cells and standard of care. Those in the control arm received a placebo injection plus standard of care, said Dr. Baumgart of Charité Medical School, which is affiliated with both Humboldt University in Berlin and the Free University of Berlin.

Prior to receiving treatment or placebo, the patients underwent fistula curettage and, if indicated, seton placement and subsequent removal, he noted, adding that baseline concomitant medications, including immunosuppressants and anti–tumor necrosis factors, were continued without dose or regimen modification and that antibiotics were allowed for up to 4 weeks.

The 52-week findings were evaluated in the modified intention-to-treat population of patients who were randomized, were treated, and had at least one postbaseline efficacy assessment (61.8% of the study population). These findings showed that Cx601 is associated with even better outcomes at 1 year than those reported at 24 weeks; those prior results, published in The Lancet in July 2016, showed combined remission rates in the modified intention-to-treat population of 51% vs. 36% for placebo.

Furthermore, 75% of treated patients who achieved combined remission at 24 weeks maintained that remission at 52 weeks, compared with 55.9% of those in the placebo group (P = .052), Dr. Baumgart said.

Sensitivity analyses in this long-term assessment supported the long-term effectiveness of Cx601 over that of the control treatment, which provided evidence on the robustness of its advantage, he said, noting that safety results were also encouraging.

“The safety profile was similar to week 24; there were no new safety signals there at all,” he said.

The findings are of note because existing therapies for complex perianal fistulas in Crohn’s disease are often ineffective, he said, adding that fistulas occur in up to 50% of Crohn’s disease patients and that 70%-80% are complex and difficult to treat. Most are refractory to conventional anti–tumor necrosis factor therapies, and 60%-70% of patients relapse, he explained.

“If we’re honest, very few medications have been properly studied,” he said, adding that fistula patients often are excluded from industry trials.

“So [the ADMIRE CD trial] is new, design-wise, and has addressed a true medical need,” he said.

He attributed the good placebo response in this trial to the ongoing standard of care treatment in both groups, as well as to the team approach to care used in the trial. He also noted that a number of questions regarding the use of Cx601 remain to be answered, including the when the ideal retreatment time point should be, whether the treatment can be used for rectovaginal fistulas, and which patients should not receive treatment.

“So there is a lot to learn still, but I think it’s a revolutionary step forward, compared to what we have today, due to the trial design, which I think is robust, and also the encouraging outcomes,” he said.

The ADMIRE CD trial was sponsored by TiGenix SAU. Dr. Baumgart has received consulting fees and nonfinancial support from AbbVie, Biogen, and BMS.

[email protected]

ORLANDO – A single treatment with a suspension of allogeneic expanded adipose-derived mesenchymal stem cells, or Cx601, promotes long-term combined remission of complex perianal fistulas in patients with Crohn’s disease, according to 52-week results from the phase 3 ADMIRE CD trial.

Combined remission – a stringent endpoint consisting of closure of all treated external openings that were draining at baseline and of an absence of collections more than 2 cm of treated perianal fistulas as confirmed by blinded central MRI – was achieved in 56.3% of 103 treated patients, compared with 38.6% of 101 patients who received placebo (P = .010), Daniel C. Baumgart, MD, reported at the World Congress of Gastroenterology at ACG 2017.

This parallel-group, double-blind, multicenter study included patients who had draining, treatment-refractory, complex perianal fistulas and inactive or mildly active luminal Crohn’s disease (Crohn’s Disease Activity Index scores of 220 or less) at baseline. Those randomized to the Cx601 group received a single intralesional injection of 120 million expanded adipose-derived stem cells and standard of care. Those in the control arm received a placebo injection plus standard of care, said Dr. Baumgart of Charité Medical School, which is affiliated with both Humboldt University in Berlin and the Free University of Berlin.

Prior to receiving treatment or placebo, the patients underwent fistula curettage and, if indicated, seton placement and subsequent removal, he noted, adding that baseline concomitant medications, including immunosuppressants and anti–tumor necrosis factors, were continued without dose or regimen modification and that antibiotics were allowed for up to 4 weeks.

The 52-week findings were evaluated in the modified intention-to-treat population of patients who were randomized, were treated, and had at least one postbaseline efficacy assessment (61.8% of the study population). These findings showed that Cx601 is associated with even better outcomes at 1 year than those reported at 24 weeks; those prior results, published in The Lancet in July 2016, showed combined remission rates in the modified intention-to-treat population of 51% vs. 36% for placebo.

Furthermore, 75% of treated patients who achieved combined remission at 24 weeks maintained that remission at 52 weeks, compared with 55.9% of those in the placebo group (P = .052), Dr. Baumgart said.

Sensitivity analyses in this long-term assessment supported the long-term effectiveness of Cx601 over that of the control treatment, which provided evidence on the robustness of its advantage, he said, noting that safety results were also encouraging.

“The safety profile was similar to week 24; there were no new safety signals there at all,” he said.

The findings are of note because existing therapies for complex perianal fistulas in Crohn’s disease are often ineffective, he said, adding that fistulas occur in up to 50% of Crohn’s disease patients and that 70%-80% are complex and difficult to treat. Most are refractory to conventional anti–tumor necrosis factor therapies, and 60%-70% of patients relapse, he explained.

“If we’re honest, very few medications have been properly studied,” he said, adding that fistula patients often are excluded from industry trials.

“So [the ADMIRE CD trial] is new, design-wise, and has addressed a true medical need,” he said.

He attributed the good placebo response in this trial to the ongoing standard of care treatment in both groups, as well as to the team approach to care used in the trial. He also noted that a number of questions regarding the use of Cx601 remain to be answered, including the when the ideal retreatment time point should be, whether the treatment can be used for rectovaginal fistulas, and which patients should not receive treatment.

“So there is a lot to learn still, but I think it’s a revolutionary step forward, compared to what we have today, due to the trial design, which I think is robust, and also the encouraging outcomes,” he said.

The ADMIRE CD trial was sponsored by TiGenix SAU. Dr. Baumgart has received consulting fees and nonfinancial support from AbbVie, Biogen, and BMS.

[email protected]

You Have Lowered Length of Stay. Congratulations: You’re Fired.

For several decades, providers working within hospitals have had incentives to reduce stay durations and keep patient flow tip-top. Diagnosis Related Group (DRG)–based and capitated payments expedited that shift.

Accompanying the change, physicians became more aware of the potential repercussions of sicker and quicker discharges. They began to monitor their care and, as best as possible, use what measures they could as a proxy for quality (readmissions and hospital-acquired conditions). Providers balanced the harms of a continued stay with the benefits of added days, not to mention the need for cost savings.

Read the full post at hospitalleader.org.
 

Also on The Hospital Leader …

• Why 7 On/7 Off Doesn’t Meet the Needs of Long-Stay Hospital Patients by Lauren Doctoroff, MD, FHM
• Is It Time for Health Policy M&Ms? by Chris Moriates, MD
• George Carlin Predicts Hospital Planning Strategy by Jordan Messler, MD, SFHM
• Many Paths to a Richer Job by Leslie Flores, MHA, MPH, SFHM
• A New Face for Online Modules by Chris Moriates, MD

You Have Lowered Length of Stay. Congratulations: You’re Fired.

For several decades, providers working within hospitals have had incentives to reduce stay durations and keep patient flow tip-top. Diagnosis Related Group (DRG)–based and capitated payments expedited that shift.

Accompanying the change, physicians became more aware of the potential repercussions of sicker and quicker discharges. They began to monitor their care and, as best as possible, use what measures they could as a proxy for quality (readmissions and hospital-acquired conditions). Providers balanced the harms of a continued stay with the benefits of added days, not to mention the need for cost savings.

Read the full post at hospitalleader.org.
 

Also on The Hospital Leader …

• Why 7 On/7 Off Doesn’t Meet the Needs of Long-Stay Hospital Patients by Lauren Doctoroff, MD, FHM
• Is It Time for Health Policy M&Ms? by Chris Moriates, MD
• George Carlin Predicts Hospital Planning Strategy by Jordan Messler, MD, SFHM
• Many Paths to a Richer Job by Leslie Flores, MHA, MPH, SFHM
• A New Face for Online Modules by Chris Moriates, MD

You Have Lowered Length of Stay. Congratulations: You’re Fired.

For several decades, providers working within hospitals have had incentives to reduce stay durations and keep patient flow tip-top. Diagnosis Related Group (DRG)–based and capitated payments expedited that shift.

Accompanying the change, physicians became more aware of the potential repercussions of sicker and quicker discharges. They began to monitor their care and, as best as possible, use what measures they could as a proxy for quality (readmissions and hospital-acquired conditions). Providers balanced the harms of a continued stay with the benefits of added days, not to mention the need for cost savings.

Read the full post at hospitalleader.org.
 

Also on The Hospital Leader …

• Why 7 On/7 Off Doesn’t Meet the Needs of Long-Stay Hospital Patients by Lauren Doctoroff, MD, FHM
• Is It Time for Health Policy M&Ms? by Chris Moriates, MD
• George Carlin Predicts Hospital Planning Strategy by Jordan Messler, MD, SFHM
• Many Paths to a Richer Job by Leslie Flores, MHA, MPH, SFHM
• A New Face for Online Modules by Chris Moriates, MD

New data confirm cladribine’s efficacy as a treatment for relapsing-remitting multiple sclerosis (MS), according to results published online ahead of print August 1 in Multiple Sclerosis Journal. The drug’s effect on relapses is comparable to that of fingolimod, and its effect on disability accumulation is comparable to those of interferon β and fingolimod. Compared with interferon, fingolimod, and natalizumab, cladribine may be associated with superior recovery from disability.

A phase III trial demonstrated that, compared with placebo, cladribine reduced relapse rate and increased the likelihood of remaining free from three-month confirmed disability progression in patients with relapsing-remitting MS. The European Medicines Agency approved the therapy in August 2017. Cladribine’s potential position in the treatment landscape is unclear, however, because no direct comparisons of cladribine with other MS therapies are available.

An Analysis of Matched Cohorts

Tomas Kalincik, MD, PhD, Professor of Medicine at Royal Melbourne Hospital in Australia, and colleagues conducted a propensity score–matched analysis of observational data from MSBase, including patients from the Australian Cladribine Product Familiarization Program, to compare the effectiveness of cladribine to that of interferon β, fingolimod, and natalizumab. Eligible participants had relapsing-remitting MS, received one of the study medications as monotherapy for one or more years, and had no prior exposure to alemtuzumab, mitoxantrone, rituximab, or hematopoietic stem cell transplantation.

Patients received 3.5 mg/kg of oral cladribine, 44 μg of subcutaneous interferon β-1a three times weekly, 0.5 mg/day of oral fingolimod, or 300 μg of IV natalizumab every four weeks. Data were recorded during routine clinical practice. The primary end points were the proportion of patients free from relapses, disability accumulation, and disability improvement while on study therapy.

Cladribine Was Associated With Superior Disability Improvement

The researchers included 37 patients treated with cladribine, 1,940 patients treated with interferon β, 1,892 patients treated with fingolimod, and 1,410 patients treated with natalizumab in their analysis. The investigators noted only small differences in baseline characteristics between the matched cohorts.

Compared with participants receiving interferon β, patients receiving cladribine were less likely to have a relapse during the first year of treatment (hazard ratio [HR], 0.6). The proportion of relapse-free patients was 86% in the cladribine group and 70% in the interferon β group. The probability of disability accumulation was similar for these drugs (HR, 0.41), but the cladribine group was more likely to have disability improvement (HR, 15).

The proportion of relapse-free patients at one year was 79% in the cladribine and fingolimod groups, and cumulative hazards of a relapse did not differ between the two groups (HR, 1.2). The probability of disability accumulation was similar for cladribine and fingolimod (HR, 1.8), but the probability of disability improvement was greater for cladribine (HR, 3.9).

The probability of relapse was higher with cladribine than with natalizumab (HR, 1.8), but the proportions of relapse-free patients at the end of year one were 80% and 81%, respectively. The probability of disability accumulation was greater in the cladribine group than in the natalizumab group (HR, 2.5). The probability of disability improvement was greater among patients receiving cladribine than among those receiving natalizumab (HR, 4). Sensitivity analyses largely confirmed the results of the primary analyses.

“Six-month confirmed improvement of disability was observed in 10%–20% of the cladribine cohort during the first year, which was superior to all three comparator therapies. This [finding] is of interest in the context of the comparison to natalizumab, which is known to be associated with a marked improvement in disability early after its commencement,” said Dr. Kalincik and colleagues. “Improvement in disability in a cohort with this profile is unexpected.”

The study’s main limitation is the small size of the cladribine cohort, said the authors. Another limitation is the brief duration of follow-up for the cladribine group, which precludes conclusions about long-term outcomes. Nevertheless, the comparative effectiveness results “represent timely information about the role of cladribine in the management of MS,” Dr. Kalincik concluded.

—Erik Greb

Suggested Reading

Kalincik T, Jokubaitis V, Spelman T, et al. Cladribine versus fingolimod, natalizumab and interferon β for multiple sclerosis. Mult Scler. 2017 Aug 1 [Epub ahead of print].

New data confirm cladribine’s efficacy as a treatment for relapsing-remitting multiple sclerosis (MS), according to results published online ahead of print August 1 in Multiple Sclerosis Journal. The drug’s effect on relapses is comparable to that of fingolimod, and its effect on disability accumulation is comparable to those of interferon β and fingolimod. Compared with interferon, fingolimod, and natalizumab, cladribine may be associated with superior recovery from disability.

A phase III trial demonstrated that, compared with placebo, cladribine reduced relapse rate and increased the likelihood of remaining free from three-month confirmed disability progression in patients with relapsing-remitting MS. The European Medicines Agency approved the therapy in August 2017. Cladribine’s potential position in the treatment landscape is unclear, however, because no direct comparisons of cladribine with other MS therapies are available.

An Analysis of Matched Cohorts

Tomas Kalincik, MD, PhD, Professor of Medicine at Royal Melbourne Hospital in Australia, and colleagues conducted a propensity score–matched analysis of observational data from MSBase, including patients from the Australian Cladribine Product Familiarization Program, to compare the effectiveness of cladribine to that of interferon β, fingolimod, and natalizumab. Eligible participants had relapsing-remitting MS, received one of the study medications as monotherapy for one or more years, and had no prior exposure to alemtuzumab, mitoxantrone, rituximab, or hematopoietic stem cell transplantation.

Patients received 3.5 mg/kg of oral cladribine, 44 μg of subcutaneous interferon β-1a three times weekly, 0.5 mg/day of oral fingolimod, or 300 μg of IV natalizumab every four weeks. Data were recorded during routine clinical practice. The primary end points were the proportion of patients free from relapses, disability accumulation, and disability improvement while on study therapy.

Cladribine Was Associated With Superior Disability Improvement

The researchers included 37 patients treated with cladribine, 1,940 patients treated with interferon β, 1,892 patients treated with fingolimod, and 1,410 patients treated with natalizumab in their analysis. The investigators noted only small differences in baseline characteristics between the matched cohorts.

Compared with participants receiving interferon β, patients receiving cladribine were less likely to have a relapse during the first year of treatment (hazard ratio [HR], 0.6). The proportion of relapse-free patients was 86% in the cladribine group and 70% in the interferon β group. The probability of disability accumulation was similar for these drugs (HR, 0.41), but the cladribine group was more likely to have disability improvement (HR, 15).

The proportion of relapse-free patients at one year was 79% in the cladribine and fingolimod groups, and cumulative hazards of a relapse did not differ between the two groups (HR, 1.2). The probability of disability accumulation was similar for cladribine and fingolimod (HR, 1.8), but the probability of disability improvement was greater for cladribine (HR, 3.9).

The probability of relapse was higher with cladribine than with natalizumab (HR, 1.8), but the proportions of relapse-free patients at the end of year one were 80% and 81%, respectively. The probability of disability accumulation was greater in the cladribine group than in the natalizumab group (HR, 2.5). The probability of disability improvement was greater among patients receiving cladribine than among those receiving natalizumab (HR, 4). Sensitivity analyses largely confirmed the results of the primary analyses.

“Six-month confirmed improvement of disability was observed in 10%–20% of the cladribine cohort during the first year, which was superior to all three comparator therapies. This [finding] is of interest in the context of the comparison to natalizumab, which is known to be associated with a marked improvement in disability early after its commencement,” said Dr. Kalincik and colleagues. “Improvement in disability in a cohort with this profile is unexpected.”

The study’s main limitation is the small size of the cladribine cohort, said the authors. Another limitation is the brief duration of follow-up for the cladribine group, which precludes conclusions about long-term outcomes. Nevertheless, the comparative effectiveness results “represent timely information about the role of cladribine in the management of MS,” Dr. Kalincik concluded.

—Erik Greb

Suggested Reading

Kalincik T, Jokubaitis V, Spelman T, et al. Cladribine versus fingolimod, natalizumab and interferon β for multiple sclerosis. Mult Scler. 2017 Aug 1 [Epub ahead of print].

New data confirm cladribine’s efficacy as a treatment for relapsing-remitting multiple sclerosis (MS), according to results published online ahead of print August 1 in Multiple Sclerosis Journal. The drug’s effect on relapses is comparable to that of fingolimod, and its effect on disability accumulation is comparable to those of interferon β and fingolimod. Compared with interferon, fingolimod, and natalizumab, cladribine may be associated with superior recovery from disability.

A phase III trial demonstrated that, compared with placebo, cladribine reduced relapse rate and increased the likelihood of remaining free from three-month confirmed disability progression in patients with relapsing-remitting MS. The European Medicines Agency approved the therapy in August 2017. Cladribine’s potential position in the treatment landscape is unclear, however, because no direct comparisons of cladribine with other MS therapies are available.

An Analysis of Matched Cohorts

Tomas Kalincik, MD, PhD, Professor of Medicine at Royal Melbourne Hospital in Australia, and colleagues conducted a propensity score–matched analysis of observational data from MSBase, including patients from the Australian Cladribine Product Familiarization Program, to compare the effectiveness of cladribine to that of interferon β, fingolimod, and natalizumab. Eligible participants had relapsing-remitting MS, received one of the study medications as monotherapy for one or more years, and had no prior exposure to alemtuzumab, mitoxantrone, rituximab, or hematopoietic stem cell transplantation.

Patients received 3.5 mg/kg of oral cladribine, 44 μg of subcutaneous interferon β-1a three times weekly, 0.5 mg/day of oral fingolimod, or 300 μg of IV natalizumab every four weeks. Data were recorded during routine clinical practice. The primary end points were the proportion of patients free from relapses, disability accumulation, and disability improvement while on study therapy.

Cladribine Was Associated With Superior Disability Improvement

The researchers included 37 patients treated with cladribine, 1,940 patients treated with interferon β, 1,892 patients treated with fingolimod, and 1,410 patients treated with natalizumab in their analysis. The investigators noted only small differences in baseline characteristics between the matched cohorts.

Compared with participants receiving interferon β, patients receiving cladribine were less likely to have a relapse during the first year of treatment (hazard ratio [HR], 0.6). The proportion of relapse-free patients was 86% in the cladribine group and 70% in the interferon β group. The probability of disability accumulation was similar for these drugs (HR, 0.41), but the cladribine group was more likely to have disability improvement (HR, 15).

The proportion of relapse-free patients at one year was 79% in the cladribine and fingolimod groups, and cumulative hazards of a relapse did not differ between the two groups (HR, 1.2). The probability of disability accumulation was similar for cladribine and fingolimod (HR, 1.8), but the probability of disability improvement was greater for cladribine (HR, 3.9).

The probability of relapse was higher with cladribine than with natalizumab (HR, 1.8), but the proportions of relapse-free patients at the end of year one were 80% and 81%, respectively. The probability of disability accumulation was greater in the cladribine group than in the natalizumab group (HR, 2.5). The probability of disability improvement was greater among patients receiving cladribine than among those receiving natalizumab (HR, 4). Sensitivity analyses largely confirmed the results of the primary analyses.

“Six-month confirmed improvement of disability was observed in 10%–20% of the cladribine cohort during the first year, which was superior to all three comparator therapies. This [finding] is of interest in the context of the comparison to natalizumab, which is known to be associated with a marked improvement in disability early after its commencement,” said Dr. Kalincik and colleagues. “Improvement in disability in a cohort with this profile is unexpected.”

The study’s main limitation is the small size of the cladribine cohort, said the authors. Another limitation is the brief duration of follow-up for the cladribine group, which precludes conclusions about long-term outcomes. Nevertheless, the comparative effectiveness results “represent timely information about the role of cladribine in the management of MS,” Dr. Kalincik concluded.

—Erik Greb

Suggested Reading

Kalincik T, Jokubaitis V, Spelman T, et al. Cladribine versus fingolimod, natalizumab and interferon β for multiple sclerosis. Mult Scler. 2017 Aug 1 [Epub ahead of print].

SAN DIEGO – Researchers say that they’ve developed an easy and inexpensive way to instantly track divergences in thinking by faculty and students as they ponder cases presented in Mortality and Morbidity (M&M) conferences. They’ve already produced an intriguing early finding: Interns and junior residents hew more closely than do their elders to estimates provided by a surgical risk calculator.

The research has the potential to shed light on problems in the much-maligned M&M, says study leader Ira Leeds, MD, of Johns Hopkins University, Baltimore. He presented the study findings at the annual Clinical Congress of the American College of Surgeons.

SAN DIEGO – Researchers say that they’ve developed an easy and inexpensive way to instantly track divergences in thinking by faculty and students as they ponder cases presented in Mortality and Morbidity (M&M) conferences. They’ve already produced an intriguing early finding: Interns and junior residents hew more closely than do their elders to estimates provided by a surgical risk calculator.

The research has the potential to shed light on problems in the much-maligned M&M, says study leader Ira Leeds, MD, of Johns Hopkins University, Baltimore. He presented the study findings at the annual Clinical Congress of the American College of Surgeons.

SAN DIEGO – Researchers say that they’ve developed an easy and inexpensive way to instantly track divergences in thinking by faculty and students as they ponder cases presented in Mortality and Morbidity (M&M) conferences. They’ve already produced an intriguing early finding: Interns and junior residents hew more closely than do their elders to estimates provided by a surgical risk calculator.

The research has the potential to shed light on problems in the much-maligned M&M, says study leader Ira Leeds, MD, of Johns Hopkins University, Baltimore. He presented the study findings at the annual Clinical Congress of the American College of Surgeons.

SAN DIEGO – The DiaRem score was effective in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy, results from a single-center study showed.

Developed by clinicians at Geisinger Clinic, the DiaRem is a simple score that helps predict remission of type 2 diabetes in severely obese subjects with metabolic syndrome who undergo Roux-en-Y gastric bypass surgery (Lancet Diabetes Endocrinol 2014;2[1]:38-45). The DiaRem score spans from 0 to 22 and is divided into five groups corresponding to five probability ranges for type 2 diabetes remission: 0-2 (88%-99%), 3-7 (64%-88%), 8-12 (23%-49%), 13-17 (11%-33%), 18-22 (2%-16%). In an effort to assess the feasibility of using the DiaRem score to predict remission of type 2 diabetes after laparoscopic sleeve gastrectomy, Raul J. Rosenthal, MD, FACS, and his associates conducted a 4-year retrospective review of 162 patients at the Cleveland Clinic Florida, Weston. “This is the first report that uses the DiaRem score for similar subjects that underwent sleeve gastrectomy instead,” Dr. Rosenthal said in an interview in advance of the annual clinical congress of the American College of Surgeons.

[email protected]

SAN DIEGO – The DiaRem score was effective in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy, results from a single-center study showed.

Developed by clinicians at Geisinger Clinic, the DiaRem is a simple score that helps predict remission of type 2 diabetes in severely obese subjects with metabolic syndrome who undergo Roux-en-Y gastric bypass surgery (Lancet Diabetes Endocrinol 2014;2[1]:38-45). The DiaRem score spans from 0 to 22 and is divided into five groups corresponding to five probability ranges for type 2 diabetes remission: 0-2 (88%-99%), 3-7 (64%-88%), 8-12 (23%-49%), 13-17 (11%-33%), 18-22 (2%-16%). In an effort to assess the feasibility of using the DiaRem score to predict remission of type 2 diabetes after laparoscopic sleeve gastrectomy, Raul J. Rosenthal, MD, FACS, and his associates conducted a 4-year retrospective review of 162 patients at the Cleveland Clinic Florida, Weston. “This is the first report that uses the DiaRem score for similar subjects that underwent sleeve gastrectomy instead,” Dr. Rosenthal said in an interview in advance of the annual clinical congress of the American College of Surgeons.

[email protected]

SAN DIEGO – The DiaRem score was effective in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy, results from a single-center study showed.

Developed by clinicians at Geisinger Clinic, the DiaRem is a simple score that helps predict remission of type 2 diabetes in severely obese subjects with metabolic syndrome who undergo Roux-en-Y gastric bypass surgery (Lancet Diabetes Endocrinol 2014;2[1]:38-45). The DiaRem score spans from 0 to 22 and is divided into five groups corresponding to five probability ranges for type 2 diabetes remission: 0-2 (88%-99%), 3-7 (64%-88%), 8-12 (23%-49%), 13-17 (11%-33%), 18-22 (2%-16%). In an effort to assess the feasibility of using the DiaRem score to predict remission of type 2 diabetes after laparoscopic sleeve gastrectomy, Raul J. Rosenthal, MD, FACS, and his associates conducted a 4-year retrospective review of 162 patients at the Cleveland Clinic Florida, Weston. “This is the first report that uses the DiaRem score for similar subjects that underwent sleeve gastrectomy instead,” Dr. Rosenthal said in an interview in advance of the annual clinical congress of the American College of Surgeons.

[email protected]