Key clinical point: After adjustment for hyperlipidemia, the risk of developing rheumatoid arthritis (RA) was not higher among statin users than nonusers.

Major finding: After adjusting for hyperlipidemia, the risk of developing RA was not higher among former users of statins (adjusted odds ratio [aOR] 1.03; 95% CI 0.96-1.10) and was slightly lower among current users (aOR 0.87; 95% CI 0.81-0.93) than nonusers.

Study details: This was a nationwide case-control study of 16,363 patients with RA and a similar number of matched control participants.

Disclosures: The National Institutes of Health, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Institute on Aging funded this work. None of the authors declared any conflict of interest.

Source: Peterson MN et al. Arthritis Res Ther. 2021 (Sep 18):23:244. doi: 10.1186/s13075-021-02617-5.

Key clinical point: After adjustment for hyperlipidemia, the risk of developing rheumatoid arthritis (RA) was not higher among statin users than nonusers.

Major finding: After adjusting for hyperlipidemia, the risk of developing RA was not higher among former users of statins (adjusted odds ratio [aOR] 1.03; 95% CI 0.96-1.10) and was slightly lower among current users (aOR 0.87; 95% CI 0.81-0.93) than nonusers.

Study details: This was a nationwide case-control study of 16,363 patients with RA and a similar number of matched control participants.

Disclosures: The National Institutes of Health, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Institute on Aging funded this work. None of the authors declared any conflict of interest.

Source: Peterson MN et al. Arthritis Res Ther. 2021 (Sep 18):23:244. doi: 10.1186/s13075-021-02617-5.

Key clinical point: After adjustment for hyperlipidemia, the risk of developing rheumatoid arthritis (RA) was not higher among statin users than nonusers.

Major finding: After adjusting for hyperlipidemia, the risk of developing RA was not higher among former users of statins (adjusted odds ratio [aOR] 1.03; 95% CI 0.96-1.10) and was slightly lower among current users (aOR 0.87; 95% CI 0.81-0.93) than nonusers.

Study details: This was a nationwide case-control study of 16,363 patients with RA and a similar number of matched control participants.

Disclosures: The National Institutes of Health, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Institute on Aging funded this work. None of the authors declared any conflict of interest.

Source: Peterson MN et al. Arthritis Res Ther. 2021 (Sep 18):23:244. doi: 10.1186/s13075-021-02617-5.

Key clinical point: A switch from adalimumab (ADL), sourced from the European Union (ADL-EU), to ADL biosimilar PF-06410293 (ADL-PF) had no effect on long-term treatment efficacy and safety in patients with active rheumatoid arthritis (RA).

Major finding: The American College of Rheumatology 20 response rate was sustained and similar in patients maintained on ADL-PF and those who switched from ADL-EU to ADL-PF at weeks 26 and 52 (52 weeks: 88.4%, 88.2%, and 87.6%, respectively; 78 weeks: 83.4%, 85.8%, and 84.3%, respectively). From weeks 52-78, the incidence of treatment-related adverse events was 42.6%, 37.0%, and 50.8% for the biosimilar, week 26 switch, and week 52 switch groups, respectively.

Study details: Findings are from an analysis of 597 patients with RA and an inadequate response to methotrexate who continued ADL-PF treatment throughout 78 weeks or switched from ADL-EU to ADL-PF at week 26 or 52 in the phase 3 REFLECTIONS B538-02 trial.

Disclosures: The study was sponsored by Pfizer. Five authors reported being employees and shareholders of Pfizer, and two reported receiving grants/support and consulting fees from several sources.

Source: Fleischmann RM. Arthritis Res Ther. 2021(Sep 25);23:248. doi: 10.1186/s13075-021-02626-4.

Key clinical point: A switch from adalimumab (ADL), sourced from the European Union (ADL-EU), to ADL biosimilar PF-06410293 (ADL-PF) had no effect on long-term treatment efficacy and safety in patients with active rheumatoid arthritis (RA).

Major finding: The American College of Rheumatology 20 response rate was sustained and similar in patients maintained on ADL-PF and those who switched from ADL-EU to ADL-PF at weeks 26 and 52 (52 weeks: 88.4%, 88.2%, and 87.6%, respectively; 78 weeks: 83.4%, 85.8%, and 84.3%, respectively). From weeks 52-78, the incidence of treatment-related adverse events was 42.6%, 37.0%, and 50.8% for the biosimilar, week 26 switch, and week 52 switch groups, respectively.

Study details: Findings are from an analysis of 597 patients with RA and an inadequate response to methotrexate who continued ADL-PF treatment throughout 78 weeks or switched from ADL-EU to ADL-PF at week 26 or 52 in the phase 3 REFLECTIONS B538-02 trial.

Disclosures: The study was sponsored by Pfizer. Five authors reported being employees and shareholders of Pfizer, and two reported receiving grants/support and consulting fees from several sources.

Source: Fleischmann RM. Arthritis Res Ther. 2021(Sep 25);23:248. doi: 10.1186/s13075-021-02626-4.

Key clinical point: A switch from adalimumab (ADL), sourced from the European Union (ADL-EU), to ADL biosimilar PF-06410293 (ADL-PF) had no effect on long-term treatment efficacy and safety in patients with active rheumatoid arthritis (RA).

Major finding: The American College of Rheumatology 20 response rate was sustained and similar in patients maintained on ADL-PF and those who switched from ADL-EU to ADL-PF at weeks 26 and 52 (52 weeks: 88.4%, 88.2%, and 87.6%, respectively; 78 weeks: 83.4%, 85.8%, and 84.3%, respectively). From weeks 52-78, the incidence of treatment-related adverse events was 42.6%, 37.0%, and 50.8% for the biosimilar, week 26 switch, and week 52 switch groups, respectively.

Study details: Findings are from an analysis of 597 patients with RA and an inadequate response to methotrexate who continued ADL-PF treatment throughout 78 weeks or switched from ADL-EU to ADL-PF at week 26 or 52 in the phase 3 REFLECTIONS B538-02 trial.

Disclosures: The study was sponsored by Pfizer. Five authors reported being employees and shareholders of Pfizer, and two reported receiving grants/support and consulting fees from several sources.

Source: Fleischmann RM. Arthritis Res Ther. 2021(Sep 25);23:248. doi: 10.1186/s13075-021-02626-4.

Key clinical point: The prevalence of low lean mass and sarcopenic obesity was significantly higher in patients with rheumatoid arthritis (RA) than the general reference population.

Major finding: Patients with RA compared to reference populations from NHANES and HealthABC had a greater prevalence of low lean mass (14.2% vs. 10.0% and 7.0%, respectively; all P < .001) and sarcopenic obesity (12.6% vs. 4.5% and 4.0%, respectively; all P < .001), with both associated with worse Health Assessment Questionnaire scores, suggesting worse disability (P < .001).

Study details: The findings came from the analysis of 113, 190, and 141 patients with RA from the University of Pennsylvania, Events in RA study, and University of San Francisco cohorts, respectively, compared with reference populations from NHANES and HealthABC.

Disclosures: This work was supported by a VA Clinical Science Research and Development Award, the National Institutes of Health, the University of Pennsylvania Clinical and Translational Research Center, among others. JF Bater declared receiving consulting fees from Bristol Myers Squibb, Gilead, and Pfizer.

Source: Baker JF et al. Rheumatology (Oxford). 2021 Sep 24. doi: 10.1093/rheumatology/keab710.

Key clinical point: The prevalence of low lean mass and sarcopenic obesity was significantly higher in patients with rheumatoid arthritis (RA) than the general reference population.

Major finding: Patients with RA compared to reference populations from NHANES and HealthABC had a greater prevalence of low lean mass (14.2% vs. 10.0% and 7.0%, respectively; all P < .001) and sarcopenic obesity (12.6% vs. 4.5% and 4.0%, respectively; all P < .001), with both associated with worse Health Assessment Questionnaire scores, suggesting worse disability (P < .001).

Study details: The findings came from the analysis of 113, 190, and 141 patients with RA from the University of Pennsylvania, Events in RA study, and University of San Francisco cohorts, respectively, compared with reference populations from NHANES and HealthABC.

Disclosures: This work was supported by a VA Clinical Science Research and Development Award, the National Institutes of Health, the University of Pennsylvania Clinical and Translational Research Center, among others. JF Bater declared receiving consulting fees from Bristol Myers Squibb, Gilead, and Pfizer.

Source: Baker JF et al. Rheumatology (Oxford). 2021 Sep 24. doi: 10.1093/rheumatology/keab710.

Key clinical point: The prevalence of low lean mass and sarcopenic obesity was significantly higher in patients with rheumatoid arthritis (RA) than the general reference population.

Major finding: Patients with RA compared to reference populations from NHANES and HealthABC had a greater prevalence of low lean mass (14.2% vs. 10.0% and 7.0%, respectively; all P < .001) and sarcopenic obesity (12.6% vs. 4.5% and 4.0%, respectively; all P < .001), with both associated with worse Health Assessment Questionnaire scores, suggesting worse disability (P < .001).

Study details: The findings came from the analysis of 113, 190, and 141 patients with RA from the University of Pennsylvania, Events in RA study, and University of San Francisco cohorts, respectively, compared with reference populations from NHANES and HealthABC.

Disclosures: This work was supported by a VA Clinical Science Research and Development Award, the National Institutes of Health, the University of Pennsylvania Clinical and Translational Research Center, among others. JF Bater declared receiving consulting fees from Bristol Myers Squibb, Gilead, and Pfizer.

Source: Baker JF et al. Rheumatology (Oxford). 2021 Sep 24. doi: 10.1093/rheumatology/keab710.

Motor imagery (MI) is a useful tool in the management of multiple sclerosis (MS), with the potential to improve balance, walking, and even cognitive function and mental health. It’s a technique that many think of as the realm of professional athletes, who use it to help mentally prepare for physical activity. But the underlying mechanism has broad applicability, even in patients with MS who have disability.

The method recruits and employs motor-related areas within the brain, which suggests that it has functional equivalence to carrying out the rehearsed movement. The mental chronometry is also similar between imagined and executed actions, said Barbara Seebacher, PhD, who discussed MI during a presentation at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

MI involves mentally rehearsing movements, and so requires working memory. The patient must also have the fundamental ability to carry out the action, so it isn’t much use having nonambulatory patients imagine themselves walking. “The mental representations need to be available,” said Dr. Seebacher, a researcher at Medical University of Innsbruck in Austria.

During MI, individuals may imagine themselves from a first- or third-person view. The experience may be visual, as in picturing oneself moving, or kinesthetic, as in imagining the feeling of movement. There can be implicit components, such as imagining a projection of the speed and distance of an approaching car, and explicit, such as imagining the personal movement of walking across the street.

The use of MI in MS rehabilitation is a relatively new development, with no reports before 2010. One early, uncontrolled study found improvements in fatigue and quality of life when MI was combined with physical practice in 20 patients. Another study published in 2012 found that MS patients had worse MI accuracy and temporal organization than that of healthy controls, and that MI accuracy was associated with cognitive impairment.

A study in 2012 used visual and rhythmic cues combined with MI, and compared results when those cues were present or absent during MI. The cues produced much better results. Dr. Seebacher’s group has used rhythmic, auditory-cued MI of walking in people with MS. Approaches included music cueing, music and verbal cueing, metronome and verbal cueing, and no cue MI. “We found significant effects after all of these approaches, but the greatest effects were shown after music and verbally-cued MI practice,” said Dr. Seebacher.

MI ability appears to be impaired by longer MS disease duration, more severe disability, depression and anxiety, and cognitive fatigue. “All of this contributes to timing deficits in performing mental movements and to deficits in the spatial organization of imagined movements,” said Dr. Seebacher.

In contrast, studies have shown that MI training improves dynamic balance, walking, perceived walking ability, balance, confidence, cognition, fatigue, anxiety and depression, quality of life, and health-related quality of life.

Rehabilitation specialists can help patients achieve success with MI by letting them select their preferred perspective, first or third person, at least during initial sessions. Patients can also be given the choice to use a more dexterous, more often-used body part, at least in initial MI sessions. External rhythmic, audio, or visual cuing can be offered.

Dr. Seebacher has developed an initial framework for helping patients to improve their MI ability. This includes assessing rhythmicity of single imagined movements to help ensure that MI and movements are functionally equivalent. Another step is to incorporate movements that are meaningful to the patients, to help ensure that they are emotionally engaged with the exercise. Research conducted primarily in stroke patients has shown that embedding physical practice into MI, or adding physical movement to MI, can enhance sensory feedback.

Motor learning principles from neurorehabilitation also apply to MI, such as beginning with simple tasks and progressing to more complex tasks, as well as use of blocked practice before turning to random practice. “All this should help our patients to perform MI more easily and to gain a greater benefit,” said Dr. Seebacher.

The potential of MI piqued the interest of comoderator Hanneke Hulst, PhD, assistant professor of neurology at Amsterdam University Medical Center, during the Q&A session. “It’s actually very intriguing and interesting,” she said, and then asked Dr. Seebacher how difficult MI is to implement in a rehabilitation program, especially for someone who isn’t a rehabilitation specialist.

Dr. Seebacher responded that it can be difficult, especially because patients and therapists usually aren’t familiar with MI. “Whenever I explain MI to patients, I compare it with athletes, because everybody knows that athletes use mental training, together with their physical training. And this is something patients can identify themselves with,” said Dr. Seebacher. It’s also vital that the patient has preserved cognitive function, and is open to a new therapeutic approach. “If somebody just wants to act the same way that they did all the time, it may not be useful for these patients,” said Dr. Seebacher.

MI is also useful for patients who have difficulty with physical training, for example following relapses, or for those who are at greater risk of falling.

Dr. Seebacher has no relevant financial disclosures. Dr. Hulst has consulted with or served on the scientific advisory boards of Biogen, Celgene, Genzyme, Merck, and Roche.

Motor imagery (MI) is a useful tool in the management of multiple sclerosis (MS), with the potential to improve balance, walking, and even cognitive function and mental health. It’s a technique that many think of as the realm of professional athletes, who use it to help mentally prepare for physical activity. But the underlying mechanism has broad applicability, even in patients with MS who have disability.

The method recruits and employs motor-related areas within the brain, which suggests that it has functional equivalence to carrying out the rehearsed movement. The mental chronometry is also similar between imagined and executed actions, said Barbara Seebacher, PhD, who discussed MI during a presentation at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

MI involves mentally rehearsing movements, and so requires working memory. The patient must also have the fundamental ability to carry out the action, so it isn’t much use having nonambulatory patients imagine themselves walking. “The mental representations need to be available,” said Dr. Seebacher, a researcher at Medical University of Innsbruck in Austria.

During MI, individuals may imagine themselves from a first- or third-person view. The experience may be visual, as in picturing oneself moving, or kinesthetic, as in imagining the feeling of movement. There can be implicit components, such as imagining a projection of the speed and distance of an approaching car, and explicit, such as imagining the personal movement of walking across the street.

The use of MI in MS rehabilitation is a relatively new development, with no reports before 2010. One early, uncontrolled study found improvements in fatigue and quality of life when MI was combined with physical practice in 20 patients. Another study published in 2012 found that MS patients had worse MI accuracy and temporal organization than that of healthy controls, and that MI accuracy was associated with cognitive impairment.

A study in 2012 used visual and rhythmic cues combined with MI, and compared results when those cues were present or absent during MI. The cues produced much better results. Dr. Seebacher’s group has used rhythmic, auditory-cued MI of walking in people with MS. Approaches included music cueing, music and verbal cueing, metronome and verbal cueing, and no cue MI. “We found significant effects after all of these approaches, but the greatest effects were shown after music and verbally-cued MI practice,” said Dr. Seebacher.

MI ability appears to be impaired by longer MS disease duration, more severe disability, depression and anxiety, and cognitive fatigue. “All of this contributes to timing deficits in performing mental movements and to deficits in the spatial organization of imagined movements,” said Dr. Seebacher.

In contrast, studies have shown that MI training improves dynamic balance, walking, perceived walking ability, balance, confidence, cognition, fatigue, anxiety and depression, quality of life, and health-related quality of life.

Rehabilitation specialists can help patients achieve success with MI by letting them select their preferred perspective, first or third person, at least during initial sessions. Patients can also be given the choice to use a more dexterous, more often-used body part, at least in initial MI sessions. External rhythmic, audio, or visual cuing can be offered.

Dr. Seebacher has developed an initial framework for helping patients to improve their MI ability. This includes assessing rhythmicity of single imagined movements to help ensure that MI and movements are functionally equivalent. Another step is to incorporate movements that are meaningful to the patients, to help ensure that they are emotionally engaged with the exercise. Research conducted primarily in stroke patients has shown that embedding physical practice into MI, or adding physical movement to MI, can enhance sensory feedback.

Motor learning principles from neurorehabilitation also apply to MI, such as beginning with simple tasks and progressing to more complex tasks, as well as use of blocked practice before turning to random practice. “All this should help our patients to perform MI more easily and to gain a greater benefit,” said Dr. Seebacher.

The potential of MI piqued the interest of comoderator Hanneke Hulst, PhD, assistant professor of neurology at Amsterdam University Medical Center, during the Q&A session. “It’s actually very intriguing and interesting,” she said, and then asked Dr. Seebacher how difficult MI is to implement in a rehabilitation program, especially for someone who isn’t a rehabilitation specialist.

Dr. Seebacher responded that it can be difficult, especially because patients and therapists usually aren’t familiar with MI. “Whenever I explain MI to patients, I compare it with athletes, because everybody knows that athletes use mental training, together with their physical training. And this is something patients can identify themselves with,” said Dr. Seebacher. It’s also vital that the patient has preserved cognitive function, and is open to a new therapeutic approach. “If somebody just wants to act the same way that they did all the time, it may not be useful for these patients,” said Dr. Seebacher.

MI is also useful for patients who have difficulty with physical training, for example following relapses, or for those who are at greater risk of falling.

Dr. Seebacher has no relevant financial disclosures. Dr. Hulst has consulted with or served on the scientific advisory boards of Biogen, Celgene, Genzyme, Merck, and Roche.

Motor imagery (MI) is a useful tool in the management of multiple sclerosis (MS), with the potential to improve balance, walking, and even cognitive function and mental health. It’s a technique that many think of as the realm of professional athletes, who use it to help mentally prepare for physical activity. But the underlying mechanism has broad applicability, even in patients with MS who have disability.

The method recruits and employs motor-related areas within the brain, which suggests that it has functional equivalence to carrying out the rehearsed movement. The mental chronometry is also similar between imagined and executed actions, said Barbara Seebacher, PhD, who discussed MI during a presentation at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

MI involves mentally rehearsing movements, and so requires working memory. The patient must also have the fundamental ability to carry out the action, so it isn’t much use having nonambulatory patients imagine themselves walking. “The mental representations need to be available,” said Dr. Seebacher, a researcher at Medical University of Innsbruck in Austria.

During MI, individuals may imagine themselves from a first- or third-person view. The experience may be visual, as in picturing oneself moving, or kinesthetic, as in imagining the feeling of movement. There can be implicit components, such as imagining a projection of the speed and distance of an approaching car, and explicit, such as imagining the personal movement of walking across the street.

The use of MI in MS rehabilitation is a relatively new development, with no reports before 2010. One early, uncontrolled study found improvements in fatigue and quality of life when MI was combined with physical practice in 20 patients. Another study published in 2012 found that MS patients had worse MI accuracy and temporal organization than that of healthy controls, and that MI accuracy was associated with cognitive impairment.

A study in 2012 used visual and rhythmic cues combined with MI, and compared results when those cues were present or absent during MI. The cues produced much better results. Dr. Seebacher’s group has used rhythmic, auditory-cued MI of walking in people with MS. Approaches included music cueing, music and verbal cueing, metronome and verbal cueing, and no cue MI. “We found significant effects after all of these approaches, but the greatest effects were shown after music and verbally-cued MI practice,” said Dr. Seebacher.

MI ability appears to be impaired by longer MS disease duration, more severe disability, depression and anxiety, and cognitive fatigue. “All of this contributes to timing deficits in performing mental movements and to deficits in the spatial organization of imagined movements,” said Dr. Seebacher.

In contrast, studies have shown that MI training improves dynamic balance, walking, perceived walking ability, balance, confidence, cognition, fatigue, anxiety and depression, quality of life, and health-related quality of life.

Rehabilitation specialists can help patients achieve success with MI by letting them select their preferred perspective, first or third person, at least during initial sessions. Patients can also be given the choice to use a more dexterous, more often-used body part, at least in initial MI sessions. External rhythmic, audio, or visual cuing can be offered.

Dr. Seebacher has developed an initial framework for helping patients to improve their MI ability. This includes assessing rhythmicity of single imagined movements to help ensure that MI and movements are functionally equivalent. Another step is to incorporate movements that are meaningful to the patients, to help ensure that they are emotionally engaged with the exercise. Research conducted primarily in stroke patients has shown that embedding physical practice into MI, or adding physical movement to MI, can enhance sensory feedback.

Motor learning principles from neurorehabilitation also apply to MI, such as beginning with simple tasks and progressing to more complex tasks, as well as use of blocked practice before turning to random practice. “All this should help our patients to perform MI more easily and to gain a greater benefit,” said Dr. Seebacher.

The potential of MI piqued the interest of comoderator Hanneke Hulst, PhD, assistant professor of neurology at Amsterdam University Medical Center, during the Q&A session. “It’s actually very intriguing and interesting,” she said, and then asked Dr. Seebacher how difficult MI is to implement in a rehabilitation program, especially for someone who isn’t a rehabilitation specialist.

Dr. Seebacher responded that it can be difficult, especially because patients and therapists usually aren’t familiar with MI. “Whenever I explain MI to patients, I compare it with athletes, because everybody knows that athletes use mental training, together with their physical training. And this is something patients can identify themselves with,” said Dr. Seebacher. It’s also vital that the patient has preserved cognitive function, and is open to a new therapeutic approach. “If somebody just wants to act the same way that they did all the time, it may not be useful for these patients,” said Dr. Seebacher.

MI is also useful for patients who have difficulty with physical training, for example following relapses, or for those who are at greater risk of falling.

Dr. Seebacher has no relevant financial disclosures. Dr. Hulst has consulted with or served on the scientific advisory boards of Biogen, Celgene, Genzyme, Merck, and Roche.

Low androgen levels appear to be linked to the development of posttransplantation diabetes mellitus (PTDM) in male kidney transplant recipients, new research suggests.

London_England/Thinkstock

Among 243 men who did not have diabetes prior to undergoing kidney transplantation, levels of both dihydrotestosterone (DHT) and testosterone were inversely related to the risk for developing diabetes the next 5 years.

“These results suggest that androgen insufficiency could play a role in the frequent deterioration of the glucose metabolism after kidney transplantation,” Suzanne P. Stam and colleagues wrote in Diabetes Care.

However, “our study has unfortunately no direct clinical findings as it was of an observational nature,” Ms. Stam told this news organization. “As a result, we can say that we have observed an association and have not established a causal relationship. So based on our study alone there is not a reason to start screening for low androgen values.”

Previous data have suggested that failure of pancreatic beta cell secretion of insulin plays a role in PTDM. In addition, DHT appears to act on the androgen receptor in pancreatic beta cells to enhance insulin secretion, while testosterone deficiency has been shown to play a role in the development of type 2 diabetes in aging males and in men receiving androgen-deprivation therapy. And, randomized clinical trials have found favorable metabolic effects of testosterone replacement therapy in hypogonadal men with type 2 diabetes.

The current post hoc analysis of a prospective single-center cohort study is the first longitudinal epidemiological investigation of the role of androgens in PTDM in kidney transplant recipients. The subjects, all men, had functioning grafts for at least a year posttransplantation. Androgen levels were assessed by liquid chromatography–tandem mass spectrometry.

At a median follow-up duration of 5.3 years, 28 (11.5%) of the men had developed PTDM. By DHT tertile, the proportions developing diabetes were 19% (15) for the lowest, 12% (10) for the middle, and 4% (3) for men with the highest DHT tertile (P = .008). A similar relationship was seen with tertiles of testosterone, with 17% (14), 14% (11), and 4% (3) developing diabetes in the lowest, middle, and highest tertiles, respectively (P = .01).

In unadjusted analysis, every doubling of DHT was linked to a 27% increased risk for PTDM (P < .001). The association remained significant after adjustments for age, estimated glomerular filtration rate, time between transplantation and baseline, body mass index, high sensitivity C-reactive protein, medication use, and baseline hemoglobin A1c (all P < .001). Similar results were found with total testosterone.

Ms. Stam, of the division of nephrology at the University Medical Center Groningen, the Netherlands, noted in an interview that, in the Netherlands, about 15% of those with kidney failure have preexisting diabetes, compared with about 50% in other western countries, including the United States.

She said that her team is currently working on a study to investigate the association between androgens and the development of PTDM in female kidney transplant recipients.

The study was funded by the TransplantLines Food and Nutrition Biobank and Cohort Study, Top Institute Food and Nutrition, and partly by the European Union’s Horizon 2020 research and innovation program. Ms. Stam and the other authors have no further disclosures.

Low androgen levels appear to be linked to the development of posttransplantation diabetes mellitus (PTDM) in male kidney transplant recipients, new research suggests.

London_England/Thinkstock

Among 243 men who did not have diabetes prior to undergoing kidney transplantation, levels of both dihydrotestosterone (DHT) and testosterone were inversely related to the risk for developing diabetes the next 5 years.

“These results suggest that androgen insufficiency could play a role in the frequent deterioration of the glucose metabolism after kidney transplantation,” Suzanne P. Stam and colleagues wrote in Diabetes Care.

However, “our study has unfortunately no direct clinical findings as it was of an observational nature,” Ms. Stam told this news organization. “As a result, we can say that we have observed an association and have not established a causal relationship. So based on our study alone there is not a reason to start screening for low androgen values.”

Previous data have suggested that failure of pancreatic beta cell secretion of insulin plays a role in PTDM. In addition, DHT appears to act on the androgen receptor in pancreatic beta cells to enhance insulin secretion, while testosterone deficiency has been shown to play a role in the development of type 2 diabetes in aging males and in men receiving androgen-deprivation therapy. And, randomized clinical trials have found favorable metabolic effects of testosterone replacement therapy in hypogonadal men with type 2 diabetes.

The current post hoc analysis of a prospective single-center cohort study is the first longitudinal epidemiological investigation of the role of androgens in PTDM in kidney transplant recipients. The subjects, all men, had functioning grafts for at least a year posttransplantation. Androgen levels were assessed by liquid chromatography–tandem mass spectrometry.

At a median follow-up duration of 5.3 years, 28 (11.5%) of the men had developed PTDM. By DHT tertile, the proportions developing diabetes were 19% (15) for the lowest, 12% (10) for the middle, and 4% (3) for men with the highest DHT tertile (P = .008). A similar relationship was seen with tertiles of testosterone, with 17% (14), 14% (11), and 4% (3) developing diabetes in the lowest, middle, and highest tertiles, respectively (P = .01).

In unadjusted analysis, every doubling of DHT was linked to a 27% increased risk for PTDM (P < .001). The association remained significant after adjustments for age, estimated glomerular filtration rate, time between transplantation and baseline, body mass index, high sensitivity C-reactive protein, medication use, and baseline hemoglobin A1c (all P < .001). Similar results were found with total testosterone.

Ms. Stam, of the division of nephrology at the University Medical Center Groningen, the Netherlands, noted in an interview that, in the Netherlands, about 15% of those with kidney failure have preexisting diabetes, compared with about 50% in other western countries, including the United States.

She said that her team is currently working on a study to investigate the association between androgens and the development of PTDM in female kidney transplant recipients.

The study was funded by the TransplantLines Food and Nutrition Biobank and Cohort Study, Top Institute Food and Nutrition, and partly by the European Union’s Horizon 2020 research and innovation program. Ms. Stam and the other authors have no further disclosures.

Low androgen levels appear to be linked to the development of posttransplantation diabetes mellitus (PTDM) in male kidney transplant recipients, new research suggests.

London_England/Thinkstock

Among 243 men who did not have diabetes prior to undergoing kidney transplantation, levels of both dihydrotestosterone (DHT) and testosterone were inversely related to the risk for developing diabetes the next 5 years.

“These results suggest that androgen insufficiency could play a role in the frequent deterioration of the glucose metabolism after kidney transplantation,” Suzanne P. Stam and colleagues wrote in Diabetes Care.

However, “our study has unfortunately no direct clinical findings as it was of an observational nature,” Ms. Stam told this news organization. “As a result, we can say that we have observed an association and have not established a causal relationship. So based on our study alone there is not a reason to start screening for low androgen values.”

Previous data have suggested that failure of pancreatic beta cell secretion of insulin plays a role in PTDM. In addition, DHT appears to act on the androgen receptor in pancreatic beta cells to enhance insulin secretion, while testosterone deficiency has been shown to play a role in the development of type 2 diabetes in aging males and in men receiving androgen-deprivation therapy. And, randomized clinical trials have found favorable metabolic effects of testosterone replacement therapy in hypogonadal men with type 2 diabetes.

The current post hoc analysis of a prospective single-center cohort study is the first longitudinal epidemiological investigation of the role of androgens in PTDM in kidney transplant recipients. The subjects, all men, had functioning grafts for at least a year posttransplantation. Androgen levels were assessed by liquid chromatography–tandem mass spectrometry.

At a median follow-up duration of 5.3 years, 28 (11.5%) of the men had developed PTDM. By DHT tertile, the proportions developing diabetes were 19% (15) for the lowest, 12% (10) for the middle, and 4% (3) for men with the highest DHT tertile (P = .008). A similar relationship was seen with tertiles of testosterone, with 17% (14), 14% (11), and 4% (3) developing diabetes in the lowest, middle, and highest tertiles, respectively (P = .01).

In unadjusted analysis, every doubling of DHT was linked to a 27% increased risk for PTDM (P < .001). The association remained significant after adjustments for age, estimated glomerular filtration rate, time between transplantation and baseline, body mass index, high sensitivity C-reactive protein, medication use, and baseline hemoglobin A1c (all P < .001). Similar results were found with total testosterone.

Ms. Stam, of the division of nephrology at the University Medical Center Groningen, the Netherlands, noted in an interview that, in the Netherlands, about 15% of those with kidney failure have preexisting diabetes, compared with about 50% in other western countries, including the United States.

She said that her team is currently working on a study to investigate the association between androgens and the development of PTDM in female kidney transplant recipients.

The study was funded by the TransplantLines Food and Nutrition Biobank and Cohort Study, Top Institute Food and Nutrition, and partly by the European Union’s Horizon 2020 research and innovation program. Ms. Stam and the other authors have no further disclosures.

When the COVID-19 pandemic temporarily shuttered in-patient visits to a multispecialty practice in the San Francisco Bay Area in March of 2019, Olga Afanasiev, MD, PhD, and her colleagues saw an opportunity to create a new teledermatology workflow.

“Before COVID, we had zero use of teledermatology,” Dr. Afanasiev, a dermatologist at the practice, said during the annual meeting of the Pacific Dermatologic Association. “We didn’t do photography other than the required pre-biopsy photographs, and minimal evaluation of home photos, in response to the patients who say, ‘Wait, doc. Let me pull out my phone and show my photographs.”

During the very first days of the pandemic, in order to accommodate urgent patient requests, she and her colleagues used cloud services for patients to submit photos for concerning skin conditions or lesions, which were then discussed over commonly available video platforms. But they quickly realized that this would not work long-term so within two months, they created an electronic health record–integrated workflow that they are still using, she said.

Here’s how it works. If the patient request is deemed nonacute or does not require a full-body skin exam, the scheduling team offers that patient a store-and-video evaluation (SAVe) or an in-person visit. If a SAVe visit is requested, the patient is required to submit a photograph of his or her condition, then a medical assistant checks for the presence and quality of up to nine patient-submitted photos and contacts the patient if additional photos are required.

Immediately before the encounter, a medical assistant calls the patient to ensure video connectivity and performs a brief intake history. The patient and physician then connect via a video-capable platform – most commonly Vidyo, which is integrated with EPIC. After the visit, the provider notifies the scheduling team if any additional in-person or virtual follow up is required.

In a half day of practice, Dr. Afanasiev sees about 20 patients via video visits scheduled every 15 minutes. On a recent day, 55% of visits were related to acne and 10% were related to a mole check, which usually resulted in recommendation for biopsy. Most (70%) were existing patients, while 30% were new.

“There is no store-and-forward option at this time, meaning that patients can’t just submit a photo without a visit,” she said. “In addition, part of our consent is, if you don’t show up to your scheduled video visit, your photos will not be reviewed. The photos are linked to the video visit and uploaded to the patient’s chart. The rooming workflow is very similar to in clinic, except you’re at home and the medical assistant is remote.”

In an article recently published in the Journal of the American Academy of Dermatology, Dr. Afanasiev and her colleagues described their experience with this photo plus video teledermatology – SAVe – workflow between March 16, 2020, and Aug. 31, 2020. The researchers analyzed 74,411 dermatology cases encountered by 89 providers who cared for 46,024 patients during that time frame. Most of the encounters (79%) were in-person, while the remaining 21% were digital in nature – SAVe in 89% of cases, followed by telephone/message encounters.

At the initial peak of the COVID-19 pandemic in April 2020, SAVe encounters increased to 72% of all encounters from 0% prior to March 16, 2020, and were sustained at 12% when the clinic reopened in the summer of 2020. Over the study period, the clinic’s incorporation of SAVe increased care access to patients located in 731 unique ZIP codes in and near California. “We also have been able to retain many patients within our system,” Dr. Afanasiev said. “We have a large proportion of patients that require 2-3 hours of travel time to get to our clinic, so virtual visits allowed for increased rural access. It also allowed for flexibility for patients and providers.”

The new workflow also led to faster access to care. The time from referral to an in-person evaluation fell from an average of 56 days in 2019 to average of 27 days in 2020, while the wait time for a virtual visit was just 14 days in 2020. “We were able to see a diverse number of diagnostic categories with both in-person and virtual care, most commonly rashes, acne, dermal growths, and pigmentary disorders,” she said.

For clinicians interested in incorporating a SAVe-like system into their workflow, Dr. Afanasiev advises them to think seriously about consent. “You want to make sure patients understand what they’re getting themselves into,” she said. “You want to make sure they know that some diagnoses cannot be adequately addressed by teledermatology.” Photo quality is also important, she said. “Video quality is not good enough for most of our diagnoses, so photos are an important part of this evaluation. In this day and age, patients are actually pretty good photographers most of the time.”

SDI Productions/E+

She urges practices to carefully think about how they allow patients to submit photos, especially if photographs are not attached to a billable visit.

In her opinion, a good teledermatology platform should have trained support staff with the ability for patients to send photos prior to their visit, and should be safe, secure, and HIPAA compliant. It should also be app and browser compatible and have high resolution and low downtime.

“Into the future, I think it’s important to maintain teledermatology within our clinical practice, especially for remote monitoring of chronic skin diseases,” Dr. Afanasiev said. “Oftentimes we schedule 3- or 6-month follow-ups but often those do not correspond to the patients’ disease flare. They may have had an eczema or psoriatic flare 3 weeks prior, but we see them in clinic with clear skin, which makes it hard to judge how to tailor our treatment. It will also be important for us to understand the safety and security and legal implications of these new practice styles.”

She also referred to technological advances, which she said “will dovetail well with teledermatology, including robust at-home and commercial 3D virtual capture technology, machine learning algorithms for improved photos, and virtual biopsy technology.”

Dr. Afanasiev is a member of the American Academy of Dermatology Teledermatology Task Force. She had no relevant disclosures.
 

[email protected]

When the COVID-19 pandemic temporarily shuttered in-patient visits to a multispecialty practice in the San Francisco Bay Area in March of 2019, Olga Afanasiev, MD, PhD, and her colleagues saw an opportunity to create a new teledermatology workflow.

“Before COVID, we had zero use of teledermatology,” Dr. Afanasiev, a dermatologist at the practice, said during the annual meeting of the Pacific Dermatologic Association. “We didn’t do photography other than the required pre-biopsy photographs, and minimal evaluation of home photos, in response to the patients who say, ‘Wait, doc. Let me pull out my phone and show my photographs.”

During the very first days of the pandemic, in order to accommodate urgent patient requests, she and her colleagues used cloud services for patients to submit photos for concerning skin conditions or lesions, which were then discussed over commonly available video platforms. But they quickly realized that this would not work long-term so within two months, they created an electronic health record–integrated workflow that they are still using, she said.

Here’s how it works. If the patient request is deemed nonacute or does not require a full-body skin exam, the scheduling team offers that patient a store-and-video evaluation (SAVe) or an in-person visit. If a SAVe visit is requested, the patient is required to submit a photograph of his or her condition, then a medical assistant checks for the presence and quality of up to nine patient-submitted photos and contacts the patient if additional photos are required.

Immediately before the encounter, a medical assistant calls the patient to ensure video connectivity and performs a brief intake history. The patient and physician then connect via a video-capable platform – most commonly Vidyo, which is integrated with EPIC. After the visit, the provider notifies the scheduling team if any additional in-person or virtual follow up is required.

In a half day of practice, Dr. Afanasiev sees about 20 patients via video visits scheduled every 15 minutes. On a recent day, 55% of visits were related to acne and 10% were related to a mole check, which usually resulted in recommendation for biopsy. Most (70%) were existing patients, while 30% were new.

“There is no store-and-forward option at this time, meaning that patients can’t just submit a photo without a visit,” she said. “In addition, part of our consent is, if you don’t show up to your scheduled video visit, your photos will not be reviewed. The photos are linked to the video visit and uploaded to the patient’s chart. The rooming workflow is very similar to in clinic, except you’re at home and the medical assistant is remote.”

In an article recently published in the Journal of the American Academy of Dermatology, Dr. Afanasiev and her colleagues described their experience with this photo plus video teledermatology – SAVe – workflow between March 16, 2020, and Aug. 31, 2020. The researchers analyzed 74,411 dermatology cases encountered by 89 providers who cared for 46,024 patients during that time frame. Most of the encounters (79%) were in-person, while the remaining 21% were digital in nature – SAVe in 89% of cases, followed by telephone/message encounters.

At the initial peak of the COVID-19 pandemic in April 2020, SAVe encounters increased to 72% of all encounters from 0% prior to March 16, 2020, and were sustained at 12% when the clinic reopened in the summer of 2020. Over the study period, the clinic’s incorporation of SAVe increased care access to patients located in 731 unique ZIP codes in and near California. “We also have been able to retain many patients within our system,” Dr. Afanasiev said. “We have a large proportion of patients that require 2-3 hours of travel time to get to our clinic, so virtual visits allowed for increased rural access. It also allowed for flexibility for patients and providers.”

The new workflow also led to faster access to care. The time from referral to an in-person evaluation fell from an average of 56 days in 2019 to average of 27 days in 2020, while the wait time for a virtual visit was just 14 days in 2020. “We were able to see a diverse number of diagnostic categories with both in-person and virtual care, most commonly rashes, acne, dermal growths, and pigmentary disorders,” she said.

For clinicians interested in incorporating a SAVe-like system into their workflow, Dr. Afanasiev advises them to think seriously about consent. “You want to make sure patients understand what they’re getting themselves into,” she said. “You want to make sure they know that some diagnoses cannot be adequately addressed by teledermatology.” Photo quality is also important, she said. “Video quality is not good enough for most of our diagnoses, so photos are an important part of this evaluation. In this day and age, patients are actually pretty good photographers most of the time.”

SDI Productions/E+

She urges practices to carefully think about how they allow patients to submit photos, especially if photographs are not attached to a billable visit.

In her opinion, a good teledermatology platform should have trained support staff with the ability for patients to send photos prior to their visit, and should be safe, secure, and HIPAA compliant. It should also be app and browser compatible and have high resolution and low downtime.

“Into the future, I think it’s important to maintain teledermatology within our clinical practice, especially for remote monitoring of chronic skin diseases,” Dr. Afanasiev said. “Oftentimes we schedule 3- or 6-month follow-ups but often those do not correspond to the patients’ disease flare. They may have had an eczema or psoriatic flare 3 weeks prior, but we see them in clinic with clear skin, which makes it hard to judge how to tailor our treatment. It will also be important for us to understand the safety and security and legal implications of these new practice styles.”

She also referred to technological advances, which she said “will dovetail well with teledermatology, including robust at-home and commercial 3D virtual capture technology, machine learning algorithms for improved photos, and virtual biopsy technology.”

Dr. Afanasiev is a member of the American Academy of Dermatology Teledermatology Task Force. She had no relevant disclosures.
 

[email protected]

When the COVID-19 pandemic temporarily shuttered in-patient visits to a multispecialty practice in the San Francisco Bay Area in March of 2019, Olga Afanasiev, MD, PhD, and her colleagues saw an opportunity to create a new teledermatology workflow.

“Before COVID, we had zero use of teledermatology,” Dr. Afanasiev, a dermatologist at the practice, said during the annual meeting of the Pacific Dermatologic Association. “We didn’t do photography other than the required pre-biopsy photographs, and minimal evaluation of home photos, in response to the patients who say, ‘Wait, doc. Let me pull out my phone and show my photographs.”

During the very first days of the pandemic, in order to accommodate urgent patient requests, she and her colleagues used cloud services for patients to submit photos for concerning skin conditions or lesions, which were then discussed over commonly available video platforms. But they quickly realized that this would not work long-term so within two months, they created an electronic health record–integrated workflow that they are still using, she said.

Here’s how it works. If the patient request is deemed nonacute or does not require a full-body skin exam, the scheduling team offers that patient a store-and-video evaluation (SAVe) or an in-person visit. If a SAVe visit is requested, the patient is required to submit a photograph of his or her condition, then a medical assistant checks for the presence and quality of up to nine patient-submitted photos and contacts the patient if additional photos are required.

Immediately before the encounter, a medical assistant calls the patient to ensure video connectivity and performs a brief intake history. The patient and physician then connect via a video-capable platform – most commonly Vidyo, which is integrated with EPIC. After the visit, the provider notifies the scheduling team if any additional in-person or virtual follow up is required.

In a half day of practice, Dr. Afanasiev sees about 20 patients via video visits scheduled every 15 minutes. On a recent day, 55% of visits were related to acne and 10% were related to a mole check, which usually resulted in recommendation for biopsy. Most (70%) were existing patients, while 30% were new.

“There is no store-and-forward option at this time, meaning that patients can’t just submit a photo without a visit,” she said. “In addition, part of our consent is, if you don’t show up to your scheduled video visit, your photos will not be reviewed. The photos are linked to the video visit and uploaded to the patient’s chart. The rooming workflow is very similar to in clinic, except you’re at home and the medical assistant is remote.”

In an article recently published in the Journal of the American Academy of Dermatology, Dr. Afanasiev and her colleagues described their experience with this photo plus video teledermatology – SAVe – workflow between March 16, 2020, and Aug. 31, 2020. The researchers analyzed 74,411 dermatology cases encountered by 89 providers who cared for 46,024 patients during that time frame. Most of the encounters (79%) were in-person, while the remaining 21% were digital in nature – SAVe in 89% of cases, followed by telephone/message encounters.

At the initial peak of the COVID-19 pandemic in April 2020, SAVe encounters increased to 72% of all encounters from 0% prior to March 16, 2020, and were sustained at 12% when the clinic reopened in the summer of 2020. Over the study period, the clinic’s incorporation of SAVe increased care access to patients located in 731 unique ZIP codes in and near California. “We also have been able to retain many patients within our system,” Dr. Afanasiev said. “We have a large proportion of patients that require 2-3 hours of travel time to get to our clinic, so virtual visits allowed for increased rural access. It also allowed for flexibility for patients and providers.”

The new workflow also led to faster access to care. The time from referral to an in-person evaluation fell from an average of 56 days in 2019 to average of 27 days in 2020, while the wait time for a virtual visit was just 14 days in 2020. “We were able to see a diverse number of diagnostic categories with both in-person and virtual care, most commonly rashes, acne, dermal growths, and pigmentary disorders,” she said.

For clinicians interested in incorporating a SAVe-like system into their workflow, Dr. Afanasiev advises them to think seriously about consent. “You want to make sure patients understand what they’re getting themselves into,” she said. “You want to make sure they know that some diagnoses cannot be adequately addressed by teledermatology.” Photo quality is also important, she said. “Video quality is not good enough for most of our diagnoses, so photos are an important part of this evaluation. In this day and age, patients are actually pretty good photographers most of the time.”

SDI Productions/E+

She urges practices to carefully think about how they allow patients to submit photos, especially if photographs are not attached to a billable visit.

In her opinion, a good teledermatology platform should have trained support staff with the ability for patients to send photos prior to their visit, and should be safe, secure, and HIPAA compliant. It should also be app and browser compatible and have high resolution and low downtime.

“Into the future, I think it’s important to maintain teledermatology within our clinical practice, especially for remote monitoring of chronic skin diseases,” Dr. Afanasiev said. “Oftentimes we schedule 3- or 6-month follow-ups but often those do not correspond to the patients’ disease flare. They may have had an eczema or psoriatic flare 3 weeks prior, but we see them in clinic with clear skin, which makes it hard to judge how to tailor our treatment. It will also be important for us to understand the safety and security and legal implications of these new practice styles.”

She also referred to technological advances, which she said “will dovetail well with teledermatology, including robust at-home and commercial 3D virtual capture technology, machine learning algorithms for improved photos, and virtual biopsy technology.”

Dr. Afanasiev is a member of the American Academy of Dermatology Teledermatology Task Force. She had no relevant disclosures.
 

[email protected]

Though once regarded with suspicion, exercise as a therapy for multiple sclerosis (MS) has gained traction in recent years, and has the potential to counter the physical effects often seen among patients, as well as reduce risk of progression.

That was the key message of a talk given by Ulrik Dalgas, PhD, professor of exercise biology at Aarhus University in Denmark, who spoke at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Rethinking the role of exercise

It used to be thought that exercise could worsen disease, but case studies in the 1960s suggested some beneficial effects. The first interventional studies were published in the 1990s. A 2008 special issue of Multiple Sclerosis Journal declared exercise safe for people with MS. Research has continued to evolve, “and now we are actually at a stage where some of us have started to believe that exercise is a medicine in multiple sclerosis,” said Dr. Dalgas, who outlined that view in a 2019 review paper.

In the early phase of MS, before the onset of a significant decline in brain volume or increase in disability, there are already measurable physical deficits. Dr. Dalgas showed data from an unpublished study from his group, which looked at 48 patients who had been diagnosed in the previous 2 years, at an average 10 months after diagnosis. “Already at this very early stage of the disease, we can actually observe impairments or deficits in walking, different walking outcome measures here between 10 and up to more than 30%, depending on the walking outcome,” said Dr. Dalgas. Similar deficits appeared in physical activity and maximum rate of oxygen consumption (VO₂ max).

Animal studies suggest that exercise could improve matters at this stage. In a model of experimental autoimmune encephalomyelitis, animals allowed the opportunity to exercise had lower levels of clinical disability throughout the model disease course. That has led some to examine a “prehabilitation” approach to early MS – a term borrowed from orthopedics. “We try to prevent rather than to treat symptoms, or build reserve capacity rather than restore capacity,” said Dr. Dalgas.

Some work in this area has been done in human patients, but a review found that none of more than 70 published studies looked at patients within 5 years of onset. “That left kind of an unstudied early phase,” said Dr. Dalgas.

In the mid-phase of MS, when brain volume loss increases and mobility and other problems increase, exercise has proved to counteract some of these issues. “What we are now trying to do is figure out what are the best exercise modalities for treating different symptoms,” said Dr. Dalgas.

Resistance and aerobic training have predictable, positive effects on strength and VO₂ max, but one study showed that the two modes of exercise had similar positive impacts on short and long walks, as well as fatigue, despite the fact that they have very different physiological effects.

Other studies have looked at the impact of exercise on the diseases itself. One recent study examined aerobic exercise versus a wait-list group. Gray matter volume remained stable in the exercise group, but dropped in the wait-list group, suggesting a possible protective effect .

In the later, more severe phase of MS, more specialized equipment is needed to ensure safety during exercise. A pilot study by Dr. Dalgas’ group in individuals with Expanded Disability Status Scores (EDSS) scores between 6.5 and 8 found that upper body exercise improved VO₂ peak score in five out of six patients. “Even at this later stage of the disease, it seems that people can still have important improvements in health and performance markers,” said Dr. Dalgas.

A review of numerous studies found that exercise had a positive effect on quality of life, and the gains were not affected by baseline disability, disease duration, or exercise type. The study shows that “it’s never too late to improve your life through exercise,” said Dr. Dalgas.
 

Next steps

Challenges remain for the field. “We still need to figure out how long-term adherence is best secured in these patients, and then we really need to look further into how to provide exercise in the best possible way in severe and elderly patients,” said Dr. Dalgas.

During the Q&A session following the presentation, Dr. Dalgas was asked for advice on how to get a patient with MS started with exercise. “We normally recommend that people should find a physical therapist or sports scientist who has expertise in this field to help with getting started. If you start out wrong you can get into problems, so having the right expertise at hand is a good way to start. Then shortly afterward they will be more independent to do the exercise,” said Dr. Dalgas.

Alan Thompson, MD, who moderated the session, brought up the concept of cognitive reserve in MS, which posits that positive life experience builds up the capacity and efficiency of neural networks, which in turn act as a sort of buffer against later cognitive decline due to aging and illness. “Can you build up your exercises in a way that has a meaningful impact in delaying the onset of confirmed disability or progression?” asked Dr. Thompson, professor of clinical neurology and neurorehabilitation at University College London.

Dr. Dalgas said that there are studies that suggest this may be true, with MS diagnoses occurring later in patients who are physically active. “You can interpret that as some kind of delayed onset of the disease.”

For more information, Dr. Dalgas suggested recently published recommendations for exercise in MS patients.

Dr. Dalgas disclosed ties with Biogen Idec, Merck Serono, Sanofi Aventis, Almirall, Novartis, Bayer Schering, and Sanofi Genzyme. Dr. Thompson has no relevant financial disclosures.

Though once regarded with suspicion, exercise as a therapy for multiple sclerosis (MS) has gained traction in recent years, and has the potential to counter the physical effects often seen among patients, as well as reduce risk of progression.

That was the key message of a talk given by Ulrik Dalgas, PhD, professor of exercise biology at Aarhus University in Denmark, who spoke at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Rethinking the role of exercise

It used to be thought that exercise could worsen disease, but case studies in the 1960s suggested some beneficial effects. The first interventional studies were published in the 1990s. A 2008 special issue of Multiple Sclerosis Journal declared exercise safe for people with MS. Research has continued to evolve, “and now we are actually at a stage where some of us have started to believe that exercise is a medicine in multiple sclerosis,” said Dr. Dalgas, who outlined that view in a 2019 review paper.

In the early phase of MS, before the onset of a significant decline in brain volume or increase in disability, there are already measurable physical deficits. Dr. Dalgas showed data from an unpublished study from his group, which looked at 48 patients who had been diagnosed in the previous 2 years, at an average 10 months after diagnosis. “Already at this very early stage of the disease, we can actually observe impairments or deficits in walking, different walking outcome measures here between 10 and up to more than 30%, depending on the walking outcome,” said Dr. Dalgas. Similar deficits appeared in physical activity and maximum rate of oxygen consumption (VO₂ max).

Animal studies suggest that exercise could improve matters at this stage. In a model of experimental autoimmune encephalomyelitis, animals allowed the opportunity to exercise had lower levels of clinical disability throughout the model disease course. That has led some to examine a “prehabilitation” approach to early MS – a term borrowed from orthopedics. “We try to prevent rather than to treat symptoms, or build reserve capacity rather than restore capacity,” said Dr. Dalgas.

Some work in this area has been done in human patients, but a review found that none of more than 70 published studies looked at patients within 5 years of onset. “That left kind of an unstudied early phase,” said Dr. Dalgas.

In the mid-phase of MS, when brain volume loss increases and mobility and other problems increase, exercise has proved to counteract some of these issues. “What we are now trying to do is figure out what are the best exercise modalities for treating different symptoms,” said Dr. Dalgas.

Resistance and aerobic training have predictable, positive effects on strength and VO₂ max, but one study showed that the two modes of exercise had similar positive impacts on short and long walks, as well as fatigue, despite the fact that they have very different physiological effects.

Other studies have looked at the impact of exercise on the diseases itself. One recent study examined aerobic exercise versus a wait-list group. Gray matter volume remained stable in the exercise group, but dropped in the wait-list group, suggesting a possible protective effect .

In the later, more severe phase of MS, more specialized equipment is needed to ensure safety during exercise. A pilot study by Dr. Dalgas’ group in individuals with Expanded Disability Status Scores (EDSS) scores between 6.5 and 8 found that upper body exercise improved VO₂ peak score in five out of six patients. “Even at this later stage of the disease, it seems that people can still have important improvements in health and performance markers,” said Dr. Dalgas.

A review of numerous studies found that exercise had a positive effect on quality of life, and the gains were not affected by baseline disability, disease duration, or exercise type. The study shows that “it’s never too late to improve your life through exercise,” said Dr. Dalgas.
 

Next steps

Challenges remain for the field. “We still need to figure out how long-term adherence is best secured in these patients, and then we really need to look further into how to provide exercise in the best possible way in severe and elderly patients,” said Dr. Dalgas.

During the Q&A session following the presentation, Dr. Dalgas was asked for advice on how to get a patient with MS started with exercise. “We normally recommend that people should find a physical therapist or sports scientist who has expertise in this field to help with getting started. If you start out wrong you can get into problems, so having the right expertise at hand is a good way to start. Then shortly afterward they will be more independent to do the exercise,” said Dr. Dalgas.

Alan Thompson, MD, who moderated the session, brought up the concept of cognitive reserve in MS, which posits that positive life experience builds up the capacity and efficiency of neural networks, which in turn act as a sort of buffer against later cognitive decline due to aging and illness. “Can you build up your exercises in a way that has a meaningful impact in delaying the onset of confirmed disability or progression?” asked Dr. Thompson, professor of clinical neurology and neurorehabilitation at University College London.

Dr. Dalgas said that there are studies that suggest this may be true, with MS diagnoses occurring later in patients who are physically active. “You can interpret that as some kind of delayed onset of the disease.”

For more information, Dr. Dalgas suggested recently published recommendations for exercise in MS patients.

Dr. Dalgas disclosed ties with Biogen Idec, Merck Serono, Sanofi Aventis, Almirall, Novartis, Bayer Schering, and Sanofi Genzyme. Dr. Thompson has no relevant financial disclosures.

Though once regarded with suspicion, exercise as a therapy for multiple sclerosis (MS) has gained traction in recent years, and has the potential to counter the physical effects often seen among patients, as well as reduce risk of progression.

That was the key message of a talk given by Ulrik Dalgas, PhD, professor of exercise biology at Aarhus University in Denmark, who spoke at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Rethinking the role of exercise

It used to be thought that exercise could worsen disease, but case studies in the 1960s suggested some beneficial effects. The first interventional studies were published in the 1990s. A 2008 special issue of Multiple Sclerosis Journal declared exercise safe for people with MS. Research has continued to evolve, “and now we are actually at a stage where some of us have started to believe that exercise is a medicine in multiple sclerosis,” said Dr. Dalgas, who outlined that view in a 2019 review paper.

In the early phase of MS, before the onset of a significant decline in brain volume or increase in disability, there are already measurable physical deficits. Dr. Dalgas showed data from an unpublished study from his group, which looked at 48 patients who had been diagnosed in the previous 2 years, at an average 10 months after diagnosis. “Already at this very early stage of the disease, we can actually observe impairments or deficits in walking, different walking outcome measures here between 10 and up to more than 30%, depending on the walking outcome,” said Dr. Dalgas. Similar deficits appeared in physical activity and maximum rate of oxygen consumption (VO₂ max).

Animal studies suggest that exercise could improve matters at this stage. In a model of experimental autoimmune encephalomyelitis, animals allowed the opportunity to exercise had lower levels of clinical disability throughout the model disease course. That has led some to examine a “prehabilitation” approach to early MS – a term borrowed from orthopedics. “We try to prevent rather than to treat symptoms, or build reserve capacity rather than restore capacity,” said Dr. Dalgas.

Some work in this area has been done in human patients, but a review found that none of more than 70 published studies looked at patients within 5 years of onset. “That left kind of an unstudied early phase,” said Dr. Dalgas.

In the mid-phase of MS, when brain volume loss increases and mobility and other problems increase, exercise has proved to counteract some of these issues. “What we are now trying to do is figure out what are the best exercise modalities for treating different symptoms,” said Dr. Dalgas.

Resistance and aerobic training have predictable, positive effects on strength and VO₂ max, but one study showed that the two modes of exercise had similar positive impacts on short and long walks, as well as fatigue, despite the fact that they have very different physiological effects.

Other studies have looked at the impact of exercise on the diseases itself. One recent study examined aerobic exercise versus a wait-list group. Gray matter volume remained stable in the exercise group, but dropped in the wait-list group, suggesting a possible protective effect .

In the later, more severe phase of MS, more specialized equipment is needed to ensure safety during exercise. A pilot study by Dr. Dalgas’ group in individuals with Expanded Disability Status Scores (EDSS) scores between 6.5 and 8 found that upper body exercise improved VO₂ peak score in five out of six patients. “Even at this later stage of the disease, it seems that people can still have important improvements in health and performance markers,” said Dr. Dalgas.

A review of numerous studies found that exercise had a positive effect on quality of life, and the gains were not affected by baseline disability, disease duration, or exercise type. The study shows that “it’s never too late to improve your life through exercise,” said Dr. Dalgas.
 

Next steps

Challenges remain for the field. “We still need to figure out how long-term adherence is best secured in these patients, and then we really need to look further into how to provide exercise in the best possible way in severe and elderly patients,” said Dr. Dalgas.

During the Q&A session following the presentation, Dr. Dalgas was asked for advice on how to get a patient with MS started with exercise. “We normally recommend that people should find a physical therapist or sports scientist who has expertise in this field to help with getting started. If you start out wrong you can get into problems, so having the right expertise at hand is a good way to start. Then shortly afterward they will be more independent to do the exercise,” said Dr. Dalgas.

Alan Thompson, MD, who moderated the session, brought up the concept of cognitive reserve in MS, which posits that positive life experience builds up the capacity and efficiency of neural networks, which in turn act as a sort of buffer against later cognitive decline due to aging and illness. “Can you build up your exercises in a way that has a meaningful impact in delaying the onset of confirmed disability or progression?” asked Dr. Thompson, professor of clinical neurology and neurorehabilitation at University College London.

Dr. Dalgas said that there are studies that suggest this may be true, with MS diagnoses occurring later in patients who are physically active. “You can interpret that as some kind of delayed onset of the disease.”

For more information, Dr. Dalgas suggested recently published recommendations for exercise in MS patients.

Dr. Dalgas disclosed ties with Biogen Idec, Merck Serono, Sanofi Aventis, Almirall, Novartis, Bayer Schering, and Sanofi Genzyme. Dr. Thompson has no relevant financial disclosures.

COVID-19 vaccination rates vary dramatically by astrological sign, with Leos at the top of the list and Scorpios at the bottom, according to The Salt Lake Tribune.

The Salt Lake County Health Department calculated the rates based on anonymous birth dates from the county’s vaccination data and then compared those figures to national estimates for the overall population represented by each sign.

“Now that Mercury is not in retrograde, we’re just going to leave this here … (and yes, this is based on data),” the Health Department wrote in a Twitter post on Tuesday.

“The COVID-19 vaccine is backed by science and is no way influenced by horoscopes,” the department continued. “But come on Scorpios!”

According to the graphic, 70% of those with the Leo sign are fully vaccinated, followed by Aquarius at 67%, and Aries and Sagittarius both at 59%. The other signs range from 58% to 50%, in descending order: Cancer, Taurus, Gemini, Libra, Pisces, Capricorn, and Virgo. Scorpio sits at the bottom of the list, with 46% fully vaccinated.

Notably, three of the top four signs are elemental fire signs, The Salt Lake Tribune noted.

“We are overachievers,” Jeff Eason, an Aries and the department’s bureau manager of population health and informatics, who did the analysis, told the newspaper.

The Health Department’s post sparked positive and negative feedback across social media, with some musing about their own sign’s inclinations and others scoffing at astrology altogether.

“What we’re really doing is finding new and different ways to keep our community talking about vaccination when there is significant message fatigue around this topic,” the department wrote in the comments.

The range of vaccination rates was startlingly wide, Mr. Eason told The Salt Lake Tribune. But he noted that the difference “could all come down to denominators.”

Each sign’s vaccination rate was ranked almost exactly inverse to its share of the overall population, the newspaper reported. Scorpios and Virgos make up 9.4% and 9.3% of the U.S. population, respectively, as compared with 7.1% for Leos and 6.3% for Aquarians.

If the 12 astrological signs were more evenly distributed in Salt Lake County than nationally, Mr. Eason said, the range of vaccinations rates wouldn’t be as wide as the analysis shows.

“Obviously, it’s not super scientific because we are talking astrology,” Nicholas Rupp, a spokesman for the health department and a vaccinated Scorpio, told the newspaper.

Still, health department officials wanted to do the analysis as a fun way to start conversations and promote vaccinations. About 59% of Salt Lake County residents are fully vaccinated, and about 54% of Utah residents are fully vaccinated.

“We do have message fatigue around vaccines,” Mr. Rupp said.

A version of this article first appeared on WebMD.com.

COVID-19 vaccination rates vary dramatically by astrological sign, with Leos at the top of the list and Scorpios at the bottom, according to The Salt Lake Tribune.

The Salt Lake County Health Department calculated the rates based on anonymous birth dates from the county’s vaccination data and then compared those figures to national estimates for the overall population represented by each sign.

“Now that Mercury is not in retrograde, we’re just going to leave this here … (and yes, this is based on data),” the Health Department wrote in a Twitter post on Tuesday.

“The COVID-19 vaccine is backed by science and is no way influenced by horoscopes,” the department continued. “But come on Scorpios!”

According to the graphic, 70% of those with the Leo sign are fully vaccinated, followed by Aquarius at 67%, and Aries and Sagittarius both at 59%. The other signs range from 58% to 50%, in descending order: Cancer, Taurus, Gemini, Libra, Pisces, Capricorn, and Virgo. Scorpio sits at the bottom of the list, with 46% fully vaccinated.

Notably, three of the top four signs are elemental fire signs, The Salt Lake Tribune noted.

“We are overachievers,” Jeff Eason, an Aries and the department’s bureau manager of population health and informatics, who did the analysis, told the newspaper.

The Health Department’s post sparked positive and negative feedback across social media, with some musing about their own sign’s inclinations and others scoffing at astrology altogether.

“What we’re really doing is finding new and different ways to keep our community talking about vaccination when there is significant message fatigue around this topic,” the department wrote in the comments.

The range of vaccination rates was startlingly wide, Mr. Eason told The Salt Lake Tribune. But he noted that the difference “could all come down to denominators.”

Each sign’s vaccination rate was ranked almost exactly inverse to its share of the overall population, the newspaper reported. Scorpios and Virgos make up 9.4% and 9.3% of the U.S. population, respectively, as compared with 7.1% for Leos and 6.3% for Aquarians.

If the 12 astrological signs were more evenly distributed in Salt Lake County than nationally, Mr. Eason said, the range of vaccinations rates wouldn’t be as wide as the analysis shows.

“Obviously, it’s not super scientific because we are talking astrology,” Nicholas Rupp, a spokesman for the health department and a vaccinated Scorpio, told the newspaper.

Still, health department officials wanted to do the analysis as a fun way to start conversations and promote vaccinations. About 59% of Salt Lake County residents are fully vaccinated, and about 54% of Utah residents are fully vaccinated.

“We do have message fatigue around vaccines,” Mr. Rupp said.

A version of this article first appeared on WebMD.com.

COVID-19 vaccination rates vary dramatically by astrological sign, with Leos at the top of the list and Scorpios at the bottom, according to The Salt Lake Tribune.

The Salt Lake County Health Department calculated the rates based on anonymous birth dates from the county’s vaccination data and then compared those figures to national estimates for the overall population represented by each sign.

“Now that Mercury is not in retrograde, we’re just going to leave this here … (and yes, this is based on data),” the Health Department wrote in a Twitter post on Tuesday.

“The COVID-19 vaccine is backed by science and is no way influenced by horoscopes,” the department continued. “But come on Scorpios!”

According to the graphic, 70% of those with the Leo sign are fully vaccinated, followed by Aquarius at 67%, and Aries and Sagittarius both at 59%. The other signs range from 58% to 50%, in descending order: Cancer, Taurus, Gemini, Libra, Pisces, Capricorn, and Virgo. Scorpio sits at the bottom of the list, with 46% fully vaccinated.

Notably, three of the top four signs are elemental fire signs, The Salt Lake Tribune noted.

“We are overachievers,” Jeff Eason, an Aries and the department’s bureau manager of population health and informatics, who did the analysis, told the newspaper.

The Health Department’s post sparked positive and negative feedback across social media, with some musing about their own sign’s inclinations and others scoffing at astrology altogether.

“What we’re really doing is finding new and different ways to keep our community talking about vaccination when there is significant message fatigue around this topic,” the department wrote in the comments.

The range of vaccination rates was startlingly wide, Mr. Eason told The Salt Lake Tribune. But he noted that the difference “could all come down to denominators.”

Each sign’s vaccination rate was ranked almost exactly inverse to its share of the overall population, the newspaper reported. Scorpios and Virgos make up 9.4% and 9.3% of the U.S. population, respectively, as compared with 7.1% for Leos and 6.3% for Aquarians.

If the 12 astrological signs were more evenly distributed in Salt Lake County than nationally, Mr. Eason said, the range of vaccinations rates wouldn’t be as wide as the analysis shows.

“Obviously, it’s not super scientific because we are talking astrology,” Nicholas Rupp, a spokesman for the health department and a vaccinated Scorpio, told the newspaper.

Still, health department officials wanted to do the analysis as a fun way to start conversations and promote vaccinations. About 59% of Salt Lake County residents are fully vaccinated, and about 54% of Utah residents are fully vaccinated.

“We do have message fatigue around vaccines,” Mr. Rupp said.

A version of this article first appeared on WebMD.com.

The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.

Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.

“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.

The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.

The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.

Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.

“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”

The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.

Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.

The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.

In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.

The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.

Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.

A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.

“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.

Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.

A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.

ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.

Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.

“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.

The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.

The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.

Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.

“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”

The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.

Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.

The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.

In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.

The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.

Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.

A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.

“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.

Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.

A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.

ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.

Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.

“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.

The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.

The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.

Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.

“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”

The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.

Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.

The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.

In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.

The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.

Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.

A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.

“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.

Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.

A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.

ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.

Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.

The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.

According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”

For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.

During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.

These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.

A version of this article first appeared on Medscape.com.

The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.

Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.

The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.

According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”

For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.

During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.

These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.

A version of this article first appeared on Medscape.com.

The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.

Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.

The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.

According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”

For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.

During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.

These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.

A version of this article first appeared on Medscape.com.