SEATTLE – Management of multiple sclerosis (MS) relapse consists of 3 main steps: timely and careful evaluation; treatment, if necessary; and assessment of treatment response, according to an algorithm presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Acute clinical relapses are a defining feature of MS with highly variable symptoms and potentially disabling effects,” said first author Amy Perrin Ross, APN, an MS certified nurse at Loyola University Chicago in Maywood, Ill., and coauthors. “Although clinicians have several management options for MS relapses, including several therapeutic interventions or observation, these options vary in terms of clinical evidence of efficacy, safety, cost, and tolerability. No consensus statements currently exist to help clinicians approach patients with acute MS relapse.”

To offer an algorithm for the management of MS relapses based on evidence and clinical experience, a work group of MS clinicians reviewed published literature on MS relapses and shared their clinical experiences managing relapses. They sought to develop a standardized and optimized approach to management.

The group reached consensus on an iterative management algorithm that consists of evaluation of symptoms to distinguish an MS relapse from a pseudorelapse; treatment, if necessary; and assessment of treatment response.

“Timely and careful evaluation of new symptoms in patients with MS is paramount, and distinguishing an MS relapse from a pseudorelapse is essential,” the authors said. “This evaluation is primarily clinical, and imaging findings may not be necessary for confirmation.”

Corticosteroid therapy is the mainstay of MS relapse management. For patients who cannot tolerate corticosteroids or in whom corticosteroids have been ineffective, clinicians may consider adrenocorticotropic hormone (ACTH). In patients with fulminant demyelination, plasma exchange therapy may be considered. In mild cases, observation may be reasonable, the authors said.

The group recommends that, between 3 and 5 weeks after the initial evaluation, a clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire should be undertaken.

If a patient’s response to treatment has been suboptimal – that is, symptoms have worsened despite treatment or there has been a lack of functional recovery – “reevaluation of the relapse and treatment with an alternative option should be considered,” they said.

The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
 

jremaly@mdedge.com

SEATTLE – Management of multiple sclerosis (MS) relapse consists of 3 main steps: timely and careful evaluation; treatment, if necessary; and assessment of treatment response, according to an algorithm presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Acute clinical relapses are a defining feature of MS with highly variable symptoms and potentially disabling effects,” said first author Amy Perrin Ross, APN, an MS certified nurse at Loyola University Chicago in Maywood, Ill., and coauthors. “Although clinicians have several management options for MS relapses, including several therapeutic interventions or observation, these options vary in terms of clinical evidence of efficacy, safety, cost, and tolerability. No consensus statements currently exist to help clinicians approach patients with acute MS relapse.”

To offer an algorithm for the management of MS relapses based on evidence and clinical experience, a work group of MS clinicians reviewed published literature on MS relapses and shared their clinical experiences managing relapses. They sought to develop a standardized and optimized approach to management.

The group reached consensus on an iterative management algorithm that consists of evaluation of symptoms to distinguish an MS relapse from a pseudorelapse; treatment, if necessary; and assessment of treatment response.

“Timely and careful evaluation of new symptoms in patients with MS is paramount, and distinguishing an MS relapse from a pseudorelapse is essential,” the authors said. “This evaluation is primarily clinical, and imaging findings may not be necessary for confirmation.”

Corticosteroid therapy is the mainstay of MS relapse management. For patients who cannot tolerate corticosteroids or in whom corticosteroids have been ineffective, clinicians may consider adrenocorticotropic hormone (ACTH). In patients with fulminant demyelination, plasma exchange therapy may be considered. In mild cases, observation may be reasonable, the authors said.

The group recommends that, between 3 and 5 weeks after the initial evaluation, a clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire should be undertaken.

If a patient’s response to treatment has been suboptimal – that is, symptoms have worsened despite treatment or there has been a lack of functional recovery – “reevaluation of the relapse and treatment with an alternative option should be considered,” they said.

The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
 

jremaly@mdedge.com

SEATTLE – Management of multiple sclerosis (MS) relapse consists of 3 main steps: timely and careful evaluation; treatment, if necessary; and assessment of treatment response, according to an algorithm presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Acute clinical relapses are a defining feature of MS with highly variable symptoms and potentially disabling effects,” said first author Amy Perrin Ross, APN, an MS certified nurse at Loyola University Chicago in Maywood, Ill., and coauthors. “Although clinicians have several management options for MS relapses, including several therapeutic interventions or observation, these options vary in terms of clinical evidence of efficacy, safety, cost, and tolerability. No consensus statements currently exist to help clinicians approach patients with acute MS relapse.”

To offer an algorithm for the management of MS relapses based on evidence and clinical experience, a work group of MS clinicians reviewed published literature on MS relapses and shared their clinical experiences managing relapses. They sought to develop a standardized and optimized approach to management.

The group reached consensus on an iterative management algorithm that consists of evaluation of symptoms to distinguish an MS relapse from a pseudorelapse; treatment, if necessary; and assessment of treatment response.

“Timely and careful evaluation of new symptoms in patients with MS is paramount, and distinguishing an MS relapse from a pseudorelapse is essential,” the authors said. “This evaluation is primarily clinical, and imaging findings may not be necessary for confirmation.”

Corticosteroid therapy is the mainstay of MS relapse management. For patients who cannot tolerate corticosteroids or in whom corticosteroids have been ineffective, clinicians may consider adrenocorticotropic hormone (ACTH). In patients with fulminant demyelination, plasma exchange therapy may be considered. In mild cases, observation may be reasonable, the authors said.

The group recommends that, between 3 and 5 weeks after the initial evaluation, a clinical reassessment using a tool such as the Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire should be undertaken.

If a patient’s response to treatment has been suboptimal – that is, symptoms have worsened despite treatment or there has been a lack of functional recovery – “reevaluation of the relapse and treatment with an alternative option should be considered,” they said.

The work group did not receive funding. The authors disclosed financial ties with various pharmaceutical companies.
 

jremaly@mdedge.com

Question: Dr. X incorrectly informs his patient Y that he is HIV negative, when in fact he had tested positive. As a result, treatment was delayed for a year. In the meantime, Y infects his sexual partner Z, who is not Dr. X’s patient, and whom the doctor has never met. In a negligence lawsuit by Z against Dr. X, which of the following is best?

A. Legal duty is used as a filter to control the tide of litigation and to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”

B. Duty of care arises from the doctor-patient relationship and is usually owed to the patient and no one else.

C. Even if Dr. X were negligent, Z must first establish that the doctor owes her a duty of due care.

D. As a nonpatient “third party,” Z has the burden of convincing the court that she was a known, foreseeable victim of a serious condition and was in a special relationship.

E. All correct.

Answer: E. The law requires that a professional acts reasonably with the knowledge, skill, and judgment ordinarily possessed by fellow members in good standing. For the medical profession, this duty of due care springs from the doctor-patient relationship, and is generally owed to the patient and to no one else. Allowing individuals outside the relationship, i.e., nonpatient third parties, a cause of action against the provider will unwisely expand the sphere of medical liability. Besides, an expansive view of legal duty may lead the provider to breach confidentiality or invite intrusive and/or irrelevant inquiries into a patient’s personal matters. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries. Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class” as famously articulated in the 1928 Plasgraf case.¹

Still, a health care provider can sometimes be found liable to one other than his or her immediate patient, notwithstanding the absence of a provider-patient relationship with that person. One such class of claims deals with communicable diseases. In Bradshaw v. Daniel,² the Supreme Court of Tennessee held that a physician has a duty to inform a patient’s immediate family of the risk of an infectious disease such as Rocky Mountain spotted fever, although the condition itself is not contagious without a vector. In Shepard v. Redford Community Hospital,³ a lower court found no physician-patient relationship between the doctor and the patient’s son who died after contracting meningitis from his mother, who had the disease first, but was not warned of the risk of spreading it to family members. The appellate court reversed, finding liability and holding that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son.

A nonpatient can sue providers who have failed to advise their patients of the sexual transmissibility of conditions such as AIDS or hepatitis B. In DiMarco v. Lynch Homes-Chester County Inc.,⁴ the Supreme Court of Pennsylvania found liability where the physician’s failure to advise his patient to abstain from sexual activity for an appropriate period of time led to the sexual partner acquiring hepatitis B. The Court used a “foreseeable orbit of risk of harm” argument, stating: “If a third person is in that class of persons whose health is likely to be threatened by the patient … [she] has a cause of action … because the physician should recognize that the services rendered to the patient are necessary for the protection of the third person.” And in Reisner v. Regents of the University of California,⁵ a 12-year-old girl became infected with HIV after receiving tainted blood, but the defendant did not disclose the information in a timely manner. She died of AIDS at age seventeen, but not before infecting her sexual partner, who was the plaintiff in the case. The court held that a physician fulfills his duty only after he warns the patient of the risk to others, and that the lack of knowledge of the third party’s identity was immaterial.

Liability may be more likely in jurisdictions that impose a statutory duty on physicians to inform, counsel, or warn their patients or inform health authorities of conditions such as AIDS. California allows the attending physician to disclose to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer.”⁶ Although this statutory disclosure is permissive rather than mandatory, it may prove persuasive in any court’s deliberation over the “no-duty” defense argument.

A recent case⁷ presents an interesting fact-situation on the duty issue. Dr. CC incorrectly told his patient that he tested negative for a sexually transmissible disease (herpes), when in fact he had tested positive. His girlfriend, who was not Dr. CC’s patient, became infected and filed suit. The trial court dismissed, ruling that the doctor owed no duty to the girlfriend, because she was not his patient and therefore she had no “legally cognizable claim.” Connecticut’s highest court has recently heard oral arguments on appeal, and its decision is pending.

The AMA has filed an amicus brief in support of Dr. CC.⁸ It argues that Connecticut’s precedent mitigates against expansion of a provider’s duty to nonpatients and raises public policy concerns such as impact on malpractice insurance rates, patient care, and the ethics of patient confidentiality. The brief concluded that it was “… nearly impossible to articulate a bright-line rule of foreseeability … when, like here, the class of persons potentially exposed to injury from such care is so broad and cannot be readily identifiable at the time care is rendered.”

References

1. Palsgraf v. Long Island Railroad Co., 248 N.Y. 339, 162 N.E. 99 (1928).

2. Bradshaw v. Daniel, 854 S.W.2d 865 (Tenn. 1993).

3. Shepard v. Redford Community Hospital, 390 N.W.2d 239 (Mich. App. 1986).

4. DiMarco v. Lynch Homes-Chester County Inc., 583 A 2d 422 (Penn. 1990).

5. Reisner v. Regents of the University of California, 37 Cal Rptr 2d 518 (Cal App 2 Dist., 1995).

6. California Health & Safety Code §121015 (a).

7. Doe v. Cochran, 62 Conn L Rptr 33, 2016 (S.C. #19879).

8. What duties do physicians owe to non-patients? AMA News. 2018 Jul 13.
 

Dr. Tan is Emeritus Professor of Medicine and former Adjunct Professor of Law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

Question: Dr. X incorrectly informs his patient Y that he is HIV negative, when in fact he had tested positive. As a result, treatment was delayed for a year. In the meantime, Y infects his sexual partner Z, who is not Dr. X’s patient, and whom the doctor has never met. In a negligence lawsuit by Z against Dr. X, which of the following is best?

A. Legal duty is used as a filter to control the tide of litigation and to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”

B. Duty of care arises from the doctor-patient relationship and is usually owed to the patient and no one else.

C. Even if Dr. X were negligent, Z must first establish that the doctor owes her a duty of due care.

D. As a nonpatient “third party,” Z has the burden of convincing the court that she was a known, foreseeable victim of a serious condition and was in a special relationship.

E. All correct.

Answer: E. The law requires that a professional acts reasonably with the knowledge, skill, and judgment ordinarily possessed by fellow members in good standing. For the medical profession, this duty of due care springs from the doctor-patient relationship, and is generally owed to the patient and to no one else. Allowing individuals outside the relationship, i.e., nonpatient third parties, a cause of action against the provider will unwisely expand the sphere of medical liability. Besides, an expansive view of legal duty may lead the provider to breach confidentiality or invite intrusive and/or irrelevant inquiries into a patient’s personal matters. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries. Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class” as famously articulated in the 1928 Plasgraf case.¹

Still, a health care provider can sometimes be found liable to one other than his or her immediate patient, notwithstanding the absence of a provider-patient relationship with that person. One such class of claims deals with communicable diseases. In Bradshaw v. Daniel,² the Supreme Court of Tennessee held that a physician has a duty to inform a patient’s immediate family of the risk of an infectious disease such as Rocky Mountain spotted fever, although the condition itself is not contagious without a vector. In Shepard v. Redford Community Hospital,³ a lower court found no physician-patient relationship between the doctor and the patient’s son who died after contracting meningitis from his mother, who had the disease first, but was not warned of the risk of spreading it to family members. The appellate court reversed, finding liability and holding that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son.

A nonpatient can sue providers who have failed to advise their patients of the sexual transmissibility of conditions such as AIDS or hepatitis B. In DiMarco v. Lynch Homes-Chester County Inc.,⁴ the Supreme Court of Pennsylvania found liability where the physician’s failure to advise his patient to abstain from sexual activity for an appropriate period of time led to the sexual partner acquiring hepatitis B. The Court used a “foreseeable orbit of risk of harm” argument, stating: “If a third person is in that class of persons whose health is likely to be threatened by the patient … [she] has a cause of action … because the physician should recognize that the services rendered to the patient are necessary for the protection of the third person.” And in Reisner v. Regents of the University of California,⁵ a 12-year-old girl became infected with HIV after receiving tainted blood, but the defendant did not disclose the information in a timely manner. She died of AIDS at age seventeen, but not before infecting her sexual partner, who was the plaintiff in the case. The court held that a physician fulfills his duty only after he warns the patient of the risk to others, and that the lack of knowledge of the third party’s identity was immaterial.

Liability may be more likely in jurisdictions that impose a statutory duty on physicians to inform, counsel, or warn their patients or inform health authorities of conditions such as AIDS. California allows the attending physician to disclose to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer.”⁶ Although this statutory disclosure is permissive rather than mandatory, it may prove persuasive in any court’s deliberation over the “no-duty” defense argument.

A recent case⁷ presents an interesting fact-situation on the duty issue. Dr. CC incorrectly told his patient that he tested negative for a sexually transmissible disease (herpes), when in fact he had tested positive. His girlfriend, who was not Dr. CC’s patient, became infected and filed suit. The trial court dismissed, ruling that the doctor owed no duty to the girlfriend, because she was not his patient and therefore she had no “legally cognizable claim.” Connecticut’s highest court has recently heard oral arguments on appeal, and its decision is pending.

The AMA has filed an amicus brief in support of Dr. CC.⁸ It argues that Connecticut’s precedent mitigates against expansion of a provider’s duty to nonpatients and raises public policy concerns such as impact on malpractice insurance rates, patient care, and the ethics of patient confidentiality. The brief concluded that it was “… nearly impossible to articulate a bright-line rule of foreseeability … when, like here, the class of persons potentially exposed to injury from such care is so broad and cannot be readily identifiable at the time care is rendered.”

References

1. Palsgraf v. Long Island Railroad Co., 248 N.Y. 339, 162 N.E. 99 (1928).

2. Bradshaw v. Daniel, 854 S.W.2d 865 (Tenn. 1993).

3. Shepard v. Redford Community Hospital, 390 N.W.2d 239 (Mich. App. 1986).

4. DiMarco v. Lynch Homes-Chester County Inc., 583 A 2d 422 (Penn. 1990).

5. Reisner v. Regents of the University of California, 37 Cal Rptr 2d 518 (Cal App 2 Dist., 1995).

6. California Health & Safety Code §121015 (a).

7. Doe v. Cochran, 62 Conn L Rptr 33, 2016 (S.C. #19879).

8. What duties do physicians owe to non-patients? AMA News. 2018 Jul 13.
 

Dr. Tan is Emeritus Professor of Medicine and former Adjunct Professor of Law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

Question: Dr. X incorrectly informs his patient Y that he is HIV negative, when in fact he had tested positive. As a result, treatment was delayed for a year. In the meantime, Y infects his sexual partner Z, who is not Dr. X’s patient, and whom the doctor has never met. In a negligence lawsuit by Z against Dr. X, which of the following is best?

A. Legal duty is used as a filter to control the tide of litigation and to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”

B. Duty of care arises from the doctor-patient relationship and is usually owed to the patient and no one else.

C. Even if Dr. X were negligent, Z must first establish that the doctor owes her a duty of due care.

D. As a nonpatient “third party,” Z has the burden of convincing the court that she was a known, foreseeable victim of a serious condition and was in a special relationship.

E. All correct.

Answer: E. The law requires that a professional acts reasonably with the knowledge, skill, and judgment ordinarily possessed by fellow members in good standing. For the medical profession, this duty of due care springs from the doctor-patient relationship, and is generally owed to the patient and to no one else. Allowing individuals outside the relationship, i.e., nonpatient third parties, a cause of action against the provider will unwisely expand the sphere of medical liability. Besides, an expansive view of legal duty may lead the provider to breach confidentiality or invite intrusive and/or irrelevant inquiries into a patient’s personal matters. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries. Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class” as famously articulated in the 1928 Plasgraf case.¹

Still, a health care provider can sometimes be found liable to one other than his or her immediate patient, notwithstanding the absence of a provider-patient relationship with that person. One such class of claims deals with communicable diseases. In Bradshaw v. Daniel,² the Supreme Court of Tennessee held that a physician has a duty to inform a patient’s immediate family of the risk of an infectious disease such as Rocky Mountain spotted fever, although the condition itself is not contagious without a vector. In Shepard v. Redford Community Hospital,³ a lower court found no physician-patient relationship between the doctor and the patient’s son who died after contracting meningitis from his mother, who had the disease first, but was not warned of the risk of spreading it to family members. The appellate court reversed, finding liability and holding that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son.

A nonpatient can sue providers who have failed to advise their patients of the sexual transmissibility of conditions such as AIDS or hepatitis B. In DiMarco v. Lynch Homes-Chester County Inc.,⁴ the Supreme Court of Pennsylvania found liability where the physician’s failure to advise his patient to abstain from sexual activity for an appropriate period of time led to the sexual partner acquiring hepatitis B. The Court used a “foreseeable orbit of risk of harm” argument, stating: “If a third person is in that class of persons whose health is likely to be threatened by the patient … [she] has a cause of action … because the physician should recognize that the services rendered to the patient are necessary for the protection of the third person.” And in Reisner v. Regents of the University of California,⁵ a 12-year-old girl became infected with HIV after receiving tainted blood, but the defendant did not disclose the information in a timely manner. She died of AIDS at age seventeen, but not before infecting her sexual partner, who was the plaintiff in the case. The court held that a physician fulfills his duty only after he warns the patient of the risk to others, and that the lack of knowledge of the third party’s identity was immaterial.

Liability may be more likely in jurisdictions that impose a statutory duty on physicians to inform, counsel, or warn their patients or inform health authorities of conditions such as AIDS. California allows the attending physician to disclose to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer.”⁶ Although this statutory disclosure is permissive rather than mandatory, it may prove persuasive in any court’s deliberation over the “no-duty” defense argument.

A recent case⁷ presents an interesting fact-situation on the duty issue. Dr. CC incorrectly told his patient that he tested negative for a sexually transmissible disease (herpes), when in fact he had tested positive. His girlfriend, who was not Dr. CC’s patient, became infected and filed suit. The trial court dismissed, ruling that the doctor owed no duty to the girlfriend, because she was not his patient and therefore she had no “legally cognizable claim.” Connecticut’s highest court has recently heard oral arguments on appeal, and its decision is pending.

The AMA has filed an amicus brief in support of Dr. CC.⁸ It argues that Connecticut’s precedent mitigates against expansion of a provider’s duty to nonpatients and raises public policy concerns such as impact on malpractice insurance rates, patient care, and the ethics of patient confidentiality. The brief concluded that it was “… nearly impossible to articulate a bright-line rule of foreseeability … when, like here, the class of persons potentially exposed to injury from such care is so broad and cannot be readily identifiable at the time care is rendered.”

References

1. Palsgraf v. Long Island Railroad Co., 248 N.Y. 339, 162 N.E. 99 (1928).

2. Bradshaw v. Daniel, 854 S.W.2d 865 (Tenn. 1993).

3. Shepard v. Redford Community Hospital, 390 N.W.2d 239 (Mich. App. 1986).

4. DiMarco v. Lynch Homes-Chester County Inc., 583 A 2d 422 (Penn. 1990).

5. Reisner v. Regents of the University of California, 37 Cal Rptr 2d 518 (Cal App 2 Dist., 1995).

6. California Health & Safety Code §121015 (a).

7. Doe v. Cochran, 62 Conn L Rptr 33, 2016 (S.C. #19879).

8. What duties do physicians owe to non-patients? AMA News. 2018 Jul 13.
 

Dr. Tan is Emeritus Professor of Medicine and former Adjunct Professor of Law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

SEATTLE – A 0.5-mg/day dose of fingolimod reduces disease activity in multiple sclerosis to a greater extent than 20 mg/day of glatiramer acetate, according to a controlled, head-to-head study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Investigations that directly compare the efficacy and safety of disease-modifying therapies can provide valuable information that influences treatment decisions in clinical practice. Phase 3 clinical trials indicated that oral fingolimod (0.5 mg/day) is more effective than placebo and interferon beta-1a in patients with multiple sclerosis (MS). However, how fingolimod compares with glatiramer acetate is unclear.

Bruce A. C. Cree, MD, PhD, clinical research director of the Multiple Sclerosis Center at the University of California, San Francisco, and colleagues sought to compare the efficacy of once-daily 0.5 mg and 0.25 mg oral fingolimod with that of once-daily 20 mg subcutaneous injections of glatiramer acetate in reducing disease activity over 12 months in patients with relapsing remitting MS. They conducted the phase 3b, multicenter, rater- and dose-blinded ASSESS study. Dr. Cree and colleagues randomized 352 eligible patients to 0.5 mg/day of oral fingolimod, 370 patients to 0.25 mg/day of oral fingolimod, and 342 patients to 20 mg/day of subcutaneous glatiramer acetate. They examined the potential superiority of each fingolimod dose to glatiramer acetate separately, starting with the higher dose. The primary endpoint was the change in annualized relapse rate, and the secondary endpoints were MRI measures of disease activity at 12 months. Finally, the investigators evaluated safety and tolerability.

A total of 859 patients (80.7%) completed the study. Over 12 months, the annualized relapse rate was 0.153 for the 0.5 mg fingolimod group and 0.258 for the glatiramer acetate group (relative reduction, 40.7%). The 0.25-mg dose of fingolimod achieved a numerical RR of 14.6%, but this result was not statistically significant. Compared with glatiramer acetate, the 0.5-mg and 0.25-mg doses of fingolimod significantly reduced the mean number of new or newly enlarged T2 lesions (RR, 54.4% and 42.1%, respectively) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses).

The adverse events that participants reported for both doses of fingolimod were consistent with the treatment’s known safety profile. More discontinuations were reported with glatiramer acetate than with fingolimod. These events mainly resulted from injection-related adverse events, consent withdrawal, and unsatisfactory therapeutic effects. Dr. Cree and colleagues plan to report the results of additional cognitive and functional system evaluations, including the Symbol Digit Modalities Test and the MS Functional Composite, later this year.

The study was not supported by outside funding. Dr. Cree reported receiving consulting fees from AbbVie, Akili, Biogen, EMD Serono, and Novartis.

egreb@mdedge.com

SEATTLE – A 0.5-mg/day dose of fingolimod reduces disease activity in multiple sclerosis to a greater extent than 20 mg/day of glatiramer acetate, according to a controlled, head-to-head study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Investigations that directly compare the efficacy and safety of disease-modifying therapies can provide valuable information that influences treatment decisions in clinical practice. Phase 3 clinical trials indicated that oral fingolimod (0.5 mg/day) is more effective than placebo and interferon beta-1a in patients with multiple sclerosis (MS). However, how fingolimod compares with glatiramer acetate is unclear.

Bruce A. C. Cree, MD, PhD, clinical research director of the Multiple Sclerosis Center at the University of California, San Francisco, and colleagues sought to compare the efficacy of once-daily 0.5 mg and 0.25 mg oral fingolimod with that of once-daily 20 mg subcutaneous injections of glatiramer acetate in reducing disease activity over 12 months in patients with relapsing remitting MS. They conducted the phase 3b, multicenter, rater- and dose-blinded ASSESS study. Dr. Cree and colleagues randomized 352 eligible patients to 0.5 mg/day of oral fingolimod, 370 patients to 0.25 mg/day of oral fingolimod, and 342 patients to 20 mg/day of subcutaneous glatiramer acetate. They examined the potential superiority of each fingolimod dose to glatiramer acetate separately, starting with the higher dose. The primary endpoint was the change in annualized relapse rate, and the secondary endpoints were MRI measures of disease activity at 12 months. Finally, the investigators evaluated safety and tolerability.

A total of 859 patients (80.7%) completed the study. Over 12 months, the annualized relapse rate was 0.153 for the 0.5 mg fingolimod group and 0.258 for the glatiramer acetate group (relative reduction, 40.7%). The 0.25-mg dose of fingolimod achieved a numerical RR of 14.6%, but this result was not statistically significant. Compared with glatiramer acetate, the 0.5-mg and 0.25-mg doses of fingolimod significantly reduced the mean number of new or newly enlarged T2 lesions (RR, 54.4% and 42.1%, respectively) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses).

The adverse events that participants reported for both doses of fingolimod were consistent with the treatment’s known safety profile. More discontinuations were reported with glatiramer acetate than with fingolimod. These events mainly resulted from injection-related adverse events, consent withdrawal, and unsatisfactory therapeutic effects. Dr. Cree and colleagues plan to report the results of additional cognitive and functional system evaluations, including the Symbol Digit Modalities Test and the MS Functional Composite, later this year.

The study was not supported by outside funding. Dr. Cree reported receiving consulting fees from AbbVie, Akili, Biogen, EMD Serono, and Novartis.

egreb@mdedge.com

SEATTLE – A 0.5-mg/day dose of fingolimod reduces disease activity in multiple sclerosis to a greater extent than 20 mg/day of glatiramer acetate, according to a controlled, head-to-head study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Investigations that directly compare the efficacy and safety of disease-modifying therapies can provide valuable information that influences treatment decisions in clinical practice. Phase 3 clinical trials indicated that oral fingolimod (0.5 mg/day) is more effective than placebo and interferon beta-1a in patients with multiple sclerosis (MS). However, how fingolimod compares with glatiramer acetate is unclear.

Bruce A. C. Cree, MD, PhD, clinical research director of the Multiple Sclerosis Center at the University of California, San Francisco, and colleagues sought to compare the efficacy of once-daily 0.5 mg and 0.25 mg oral fingolimod with that of once-daily 20 mg subcutaneous injections of glatiramer acetate in reducing disease activity over 12 months in patients with relapsing remitting MS. They conducted the phase 3b, multicenter, rater- and dose-blinded ASSESS study. Dr. Cree and colleagues randomized 352 eligible patients to 0.5 mg/day of oral fingolimod, 370 patients to 0.25 mg/day of oral fingolimod, and 342 patients to 20 mg/day of subcutaneous glatiramer acetate. They examined the potential superiority of each fingolimod dose to glatiramer acetate separately, starting with the higher dose. The primary endpoint was the change in annualized relapse rate, and the secondary endpoints were MRI measures of disease activity at 12 months. Finally, the investigators evaluated safety and tolerability.

A total of 859 patients (80.7%) completed the study. Over 12 months, the annualized relapse rate was 0.153 for the 0.5 mg fingolimod group and 0.258 for the glatiramer acetate group (relative reduction, 40.7%). The 0.25-mg dose of fingolimod achieved a numerical RR of 14.6%, but this result was not statistically significant. Compared with glatiramer acetate, the 0.5-mg and 0.25-mg doses of fingolimod significantly reduced the mean number of new or newly enlarged T2 lesions (RR, 54.4% and 42.1%, respectively) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses).

The adverse events that participants reported for both doses of fingolimod were consistent with the treatment’s known safety profile. More discontinuations were reported with glatiramer acetate than with fingolimod. These events mainly resulted from injection-related adverse events, consent withdrawal, and unsatisfactory therapeutic effects. Dr. Cree and colleagues plan to report the results of additional cognitive and functional system evaluations, including the Symbol Digit Modalities Test and the MS Functional Composite, later this year.

The study was not supported by outside funding. Dr. Cree reported receiving consulting fees from AbbVie, Akili, Biogen, EMD Serono, and Novartis.

egreb@mdedge.com

SEATTLE – A small new study suggests that patients with multiple sclerosis (MS) who use cannabis in a hazardous way are more likely to suffer from symptoms of anxiety and depression, although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.

For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.

The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.

Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.

They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).

The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.

The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.

No study funding was reported and the authors report no relevant disclosures.

SEATTLE – A small new study suggests that patients with multiple sclerosis (MS) who use cannabis in a hazardous way are more likely to suffer from symptoms of anxiety and depression, although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.

For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.

The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.

Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.

They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).

The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.

The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.

No study funding was reported and the authors report no relevant disclosures.

SEATTLE – A small new study suggests that patients with multiple sclerosis (MS) who use cannabis in a hazardous way are more likely to suffer from symptoms of anxiety and depression, although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.

For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.

The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.

Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.

They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).

The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.

The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.

No study funding was reported and the authors report no relevant disclosures.

Seattle – Over 2 years of follow-up, approximately one-third of patients with multiple sclerosis (MS) have a lapse in oral therapy of 30 days or longer, and approximately half discontinue their index oral therapy, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These results indicate “poor adherence to currently available oral medications” and “may imply a need for treatments with dosing regimens that facilitate adherence,” said Jacqueline Nicholas, MD, MPH, a clinical neuroimmunologist at the Ohio MS Center in Columbus, and colleagues.

Research has found that lapses in MS treatment regimens and discontinuation of disease-modifying therapy are associated with an increased likelihood of relapse. Few studies, however, have examined lapses in oral therapy and discontinuation of oral treatments in patients with MS. To address this gap, Dr. Nicholas and colleagues conducted a retrospective administrative claims study using data from the IQVIA RWD Adjudicated Claims – USA database.

The researchers examined claims filed between July 1, 2012, and June 30, 2017. Eligible participants were aged 18-63 years and had two or more MS diagnosis claims (i.e., ICD-9-CM code: 340.xx and ICD-10-CM code: G35) between July 1, 2013, and June 30, 2015. Participants also had one or more once- or twice-daily oral disease-modifying drug (DMD) claims between July 1, 2013, and June 30, 2015; continuous eligibility with commercial insurance for 1 year before (i.e., baseline) and 2 years after (i.e., follow-up) oral DMD initiation; and no oral DMD use during baseline.

The investigators defined the longest lapse in therapy as the number of days between the lapsing of the supply of the prior prescription and the fulfillment of a new prescription (i.e., the period during which no DMD was available, based on medical or pharmacy claims). Discontinuation was defined as cessation of the oral DMD for a minimum of 60 days without reinitiation (i.e., discontinuing treatment or switching therapy).

In all, 4,193 patients met the eligibility criteria. The population’s mean age was 45.4 years, and 76.3% of the patients were female. The mean duration of the longest lapse was 35.6 days. The longest lapse was 0 to fewer than 15 days for 44.6% of patients, 15 to fewer than 30 days for 25.6% of patients, 30 to fewer than 45 days for 11.0% of patients, 45 to fewer than 60 days for 5.2% of patients, 60 to fewer than 75 days for 3.5% of patients, 75 to fewer than 90 days for 1.7% of patients, and 90 or more days for 8.3% of patients. In addition, 45.2% of patients discontinued oral DMD treatment, and the mean time to discontinuation was 249.0 days.

The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.

egreb@mdedge.com

SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.

Seattle – Over 2 years of follow-up, approximately one-third of patients with multiple sclerosis (MS) have a lapse in oral therapy of 30 days or longer, and approximately half discontinue their index oral therapy, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These results indicate “poor adherence to currently available oral medications” and “may imply a need for treatments with dosing regimens that facilitate adherence,” said Jacqueline Nicholas, MD, MPH, a clinical neuroimmunologist at the Ohio MS Center in Columbus, and colleagues.

Research has found that lapses in MS treatment regimens and discontinuation of disease-modifying therapy are associated with an increased likelihood of relapse. Few studies, however, have examined lapses in oral therapy and discontinuation of oral treatments in patients with MS. To address this gap, Dr. Nicholas and colleagues conducted a retrospective administrative claims study using data from the IQVIA RWD Adjudicated Claims – USA database.

The researchers examined claims filed between July 1, 2012, and June 30, 2017. Eligible participants were aged 18-63 years and had two or more MS diagnosis claims (i.e., ICD-9-CM code: 340.xx and ICD-10-CM code: G35) between July 1, 2013, and June 30, 2015. Participants also had one or more once- or twice-daily oral disease-modifying drug (DMD) claims between July 1, 2013, and June 30, 2015; continuous eligibility with commercial insurance for 1 year before (i.e., baseline) and 2 years after (i.e., follow-up) oral DMD initiation; and no oral DMD use during baseline.

The investigators defined the longest lapse in therapy as the number of days between the lapsing of the supply of the prior prescription and the fulfillment of a new prescription (i.e., the period during which no DMD was available, based on medical or pharmacy claims). Discontinuation was defined as cessation of the oral DMD for a minimum of 60 days without reinitiation (i.e., discontinuing treatment or switching therapy).

In all, 4,193 patients met the eligibility criteria. The population’s mean age was 45.4 years, and 76.3% of the patients were female. The mean duration of the longest lapse was 35.6 days. The longest lapse was 0 to fewer than 15 days for 44.6% of patients, 15 to fewer than 30 days for 25.6% of patients, 30 to fewer than 45 days for 11.0% of patients, 45 to fewer than 60 days for 5.2% of patients, 60 to fewer than 75 days for 3.5% of patients, 75 to fewer than 90 days for 1.7% of patients, and 90 or more days for 8.3% of patients. In addition, 45.2% of patients discontinued oral DMD treatment, and the mean time to discontinuation was 249.0 days.

The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.

egreb@mdedge.com

SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.

Seattle – Over 2 years of follow-up, approximately one-third of patients with multiple sclerosis (MS) have a lapse in oral therapy of 30 days or longer, and approximately half discontinue their index oral therapy, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. These results indicate “poor adherence to currently available oral medications” and “may imply a need for treatments with dosing regimens that facilitate adherence,” said Jacqueline Nicholas, MD, MPH, a clinical neuroimmunologist at the Ohio MS Center in Columbus, and colleagues.

Research has found that lapses in MS treatment regimens and discontinuation of disease-modifying therapy are associated with an increased likelihood of relapse. Few studies, however, have examined lapses in oral therapy and discontinuation of oral treatments in patients with MS. To address this gap, Dr. Nicholas and colleagues conducted a retrospective administrative claims study using data from the IQVIA RWD Adjudicated Claims – USA database.

The researchers examined claims filed between July 1, 2012, and June 30, 2017. Eligible participants were aged 18-63 years and had two or more MS diagnosis claims (i.e., ICD-9-CM code: 340.xx and ICD-10-CM code: G35) between July 1, 2013, and June 30, 2015. Participants also had one or more once- or twice-daily oral disease-modifying drug (DMD) claims between July 1, 2013, and June 30, 2015; continuous eligibility with commercial insurance for 1 year before (i.e., baseline) and 2 years after (i.e., follow-up) oral DMD initiation; and no oral DMD use during baseline.

The investigators defined the longest lapse in therapy as the number of days between the lapsing of the supply of the prior prescription and the fulfillment of a new prescription (i.e., the period during which no DMD was available, based on medical or pharmacy claims). Discontinuation was defined as cessation of the oral DMD for a minimum of 60 days without reinitiation (i.e., discontinuing treatment or switching therapy).

In all, 4,193 patients met the eligibility criteria. The population’s mean age was 45.4 years, and 76.3% of the patients were female. The mean duration of the longest lapse was 35.6 days. The longest lapse was 0 to fewer than 15 days for 44.6% of patients, 15 to fewer than 30 days for 25.6% of patients, 30 to fewer than 45 days for 11.0% of patients, 45 to fewer than 60 days for 5.2% of patients, 60 to fewer than 75 days for 3.5% of patients, 75 to fewer than 90 days for 1.7% of patients, and 90 or more days for 8.3% of patients. In addition, 45.2% of patients discontinued oral DMD treatment, and the mean time to discontinuation was 249.0 days.

The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.

egreb@mdedge.com

SOURCE: Nicholas J et al. CMSC 2019. Abstract DXT34.

SEATTLE – A regimen of twice-daily doses of extended-release arbaclofen appears to reduce spasticity effectively in patients with multiple sclerosis (MS), according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. The regimen is well tolerated.

Spasticity is common in MS, and the traditional treatment is oral baclofen, a GABA_B receptor agonist. Therapeutic doses of baclofen may cause side effects that decrease adherence, however. Arbaclofen is a more active R-enantiomer of baclofen, which is a racemic mixture. Arbaclofen extended-release (ER) tablets enable twice-daily administration, which reduces dosing frequency and may decrease the rate of adverse events.

Daniel Kantor, MD, a faculty member at Florida Atlantic University in Boca Raton, and colleagues conducted a multicenter, double-blind, parallel-group study to compare the efficacy and safety of arbaclofen ER with those of placebo and baclofen in patients with MS-related spasticity. They randomized adults in North America and Eastern Europe in equal groups to arbaclofen ER (20 mg b.i.d.), baclofen (20 mg q.i.d.), or placebo. The dose was titrated over 2 weeks, and participants subsequently entered a 12-week maintenance phase. The study’s two primary endpoints were the mean change in Total Numeric-Transformed Modified Ashworth Scale for the most affected limb (TNmAS-MAL) and Clinician Global Impression of Change (CGIC) from baseline through the maintenance period.

Dr. Kantor and colleagues randomized 341 patients in their study. Of this population, 57.5% had relapsing-remitting MS, 38.4% had secondary progressive MS, 2.6% had primary progressive MS, and 0.9% had progressive relapsing MS. Thirteen patients from one site were excluded from analysis after study completion when an audit found irregularities. The mean baseline TNmAS-MAL score was 7.93 in the arbaclofen ER group, 7.75 in the baclofen group, and 7.55 in the placebo group. At the end of the maintenance period, the mean decrease in TNmAS-MAL score was larger with arbaclofen ER than with placebo (least-squares mean [LSMean] −2.90 vs. −1.95). In addition, CGIC was significantly improved for arbaclofen ER, compared with placebo (LSMean 1.00 vs. 0.52).

Furthermore, the change in MS Spasticity Scale (MSSS-88) was greater in the arbaclofen ER group than in the placebo group (−30.1 vs. −16.7). Results on the TNmAS, CGIC, and MSSS-88 did not significantly differ between arbaclofen ER and baclofen. Drowsiness and dizziness were less common in the arbaclofen ER group than in the baclofen group. A total of 63 (57.3%) patients receiving arbaclofen ER, 82 (72.6%) receiving baclofen, and 59 (50.0%) receiving placebo reported treatment-emergent adverse events. The most common adverse events were somnolence, asthenia, and muscle weakness.

The study did not have funding support. Dr. Kantor reported having received consulting fees from AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech/Roche, Mylan, Novartis, Osmotica, and Sanofi Genzyme.

egreb@mdedge.com

SEATTLE – A regimen of twice-daily doses of extended-release arbaclofen appears to reduce spasticity effectively in patients with multiple sclerosis (MS), according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. The regimen is well tolerated.

Spasticity is common in MS, and the traditional treatment is oral baclofen, a GABA_B receptor agonist. Therapeutic doses of baclofen may cause side effects that decrease adherence, however. Arbaclofen is a more active R-enantiomer of baclofen, which is a racemic mixture. Arbaclofen extended-release (ER) tablets enable twice-daily administration, which reduces dosing frequency and may decrease the rate of adverse events.

Daniel Kantor, MD, a faculty member at Florida Atlantic University in Boca Raton, and colleagues conducted a multicenter, double-blind, parallel-group study to compare the efficacy and safety of arbaclofen ER with those of placebo and baclofen in patients with MS-related spasticity. They randomized adults in North America and Eastern Europe in equal groups to arbaclofen ER (20 mg b.i.d.), baclofen (20 mg q.i.d.), or placebo. The dose was titrated over 2 weeks, and participants subsequently entered a 12-week maintenance phase. The study’s two primary endpoints were the mean change in Total Numeric-Transformed Modified Ashworth Scale for the most affected limb (TNmAS-MAL) and Clinician Global Impression of Change (CGIC) from baseline through the maintenance period.

Dr. Kantor and colleagues randomized 341 patients in their study. Of this population, 57.5% had relapsing-remitting MS, 38.4% had secondary progressive MS, 2.6% had primary progressive MS, and 0.9% had progressive relapsing MS. Thirteen patients from one site were excluded from analysis after study completion when an audit found irregularities. The mean baseline TNmAS-MAL score was 7.93 in the arbaclofen ER group, 7.75 in the baclofen group, and 7.55 in the placebo group. At the end of the maintenance period, the mean decrease in TNmAS-MAL score was larger with arbaclofen ER than with placebo (least-squares mean [LSMean] −2.90 vs. −1.95). In addition, CGIC was significantly improved for arbaclofen ER, compared with placebo (LSMean 1.00 vs. 0.52).

Furthermore, the change in MS Spasticity Scale (MSSS-88) was greater in the arbaclofen ER group than in the placebo group (−30.1 vs. −16.7). Results on the TNmAS, CGIC, and MSSS-88 did not significantly differ between arbaclofen ER and baclofen. Drowsiness and dizziness were less common in the arbaclofen ER group than in the baclofen group. A total of 63 (57.3%) patients receiving arbaclofen ER, 82 (72.6%) receiving baclofen, and 59 (50.0%) receiving placebo reported treatment-emergent adverse events. The most common adverse events were somnolence, asthenia, and muscle weakness.

The study did not have funding support. Dr. Kantor reported having received consulting fees from AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech/Roche, Mylan, Novartis, Osmotica, and Sanofi Genzyme.

egreb@mdedge.com

SEATTLE – A regimen of twice-daily doses of extended-release arbaclofen appears to reduce spasticity effectively in patients with multiple sclerosis (MS), according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. The regimen is well tolerated.

Spasticity is common in MS, and the traditional treatment is oral baclofen, a GABA_B receptor agonist. Therapeutic doses of baclofen may cause side effects that decrease adherence, however. Arbaclofen is a more active R-enantiomer of baclofen, which is a racemic mixture. Arbaclofen extended-release (ER) tablets enable twice-daily administration, which reduces dosing frequency and may decrease the rate of adverse events.

Daniel Kantor, MD, a faculty member at Florida Atlantic University in Boca Raton, and colleagues conducted a multicenter, double-blind, parallel-group study to compare the efficacy and safety of arbaclofen ER with those of placebo and baclofen in patients with MS-related spasticity. They randomized adults in North America and Eastern Europe in equal groups to arbaclofen ER (20 mg b.i.d.), baclofen (20 mg q.i.d.), or placebo. The dose was titrated over 2 weeks, and participants subsequently entered a 12-week maintenance phase. The study’s two primary endpoints were the mean change in Total Numeric-Transformed Modified Ashworth Scale for the most affected limb (TNmAS-MAL) and Clinician Global Impression of Change (CGIC) from baseline through the maintenance period.

Dr. Kantor and colleagues randomized 341 patients in their study. Of this population, 57.5% had relapsing-remitting MS, 38.4% had secondary progressive MS, 2.6% had primary progressive MS, and 0.9% had progressive relapsing MS. Thirteen patients from one site were excluded from analysis after study completion when an audit found irregularities. The mean baseline TNmAS-MAL score was 7.93 in the arbaclofen ER group, 7.75 in the baclofen group, and 7.55 in the placebo group. At the end of the maintenance period, the mean decrease in TNmAS-MAL score was larger with arbaclofen ER than with placebo (least-squares mean [LSMean] −2.90 vs. −1.95). In addition, CGIC was significantly improved for arbaclofen ER, compared with placebo (LSMean 1.00 vs. 0.52).

Furthermore, the change in MS Spasticity Scale (MSSS-88) was greater in the arbaclofen ER group than in the placebo group (−30.1 vs. −16.7). Results on the TNmAS, CGIC, and MSSS-88 did not significantly differ between arbaclofen ER and baclofen. Drowsiness and dizziness were less common in the arbaclofen ER group than in the baclofen group. A total of 63 (57.3%) patients receiving arbaclofen ER, 82 (72.6%) receiving baclofen, and 59 (50.0%) receiving placebo reported treatment-emergent adverse events. The most common adverse events were somnolence, asthenia, and muscle weakness.

The study did not have funding support. Dr. Kantor reported having received consulting fees from AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech/Roche, Mylan, Novartis, Osmotica, and Sanofi Genzyme.

egreb@mdedge.com

Almost 30 years ago a young woman made an appointment to see me. I had just started my internal medicine practice and almost all the patients who saw me were new to me. I assumed she was establishing care with me. Her first words to me were “Hello Dr. Paauw, I would like to interview you to see if you will be a good fit as my doctor.” We talked for the 40-minute appointment time. I asked her about her health, her life, and what she wanted out of both. We shared with each other that we both were parents of young children. When the appointment was over, she said she would really like for me to be her doctor. She told me that the main thing she appreciated about me was that I listened, and that her previous physician never sat down at her appointments and often had his hand on the door handle for much of the visit. Physicians and patients both agree that compassionate care is essential for good patient care, yet about half of patients and 60% of doctors believe it is lacking in our medical system.¹

Remember the golden first minutes

When you step in the room and greet the patient, make sure the first few minutes are about connecting with a new patient or reconnecting with a patient who has visited your office in the past. I often start by asking the patient to give me an update on how they are doing. This lets me know what is important to them. I do not touch the computer until after this initial check-in.

Use the computer as a bond to strengthen your patient relationship

Many studies have shown patients find the computer gets between the doctor and patient. It is especially problematic if it breaks eye contact with the patient. People are less likely to share scary, sensitive, or embarrassing information if someone is looking at a computer and typing. As you look up tests, radiology reports, or consultant notes, let the patient in on what you are doing. Explain why you are searching in the record, and if it helps make an important point, show your findings to the patient. Offer to print out results, so they have something to carry with them.

Explain what you are looking for and what you find on the physical exam

Being a patient is scary. We all want reassurance that our fears are not true. When you find normal findings on exam, share those with the patient. Hearing “your heart sounds good, your pulses are strong” really helps patients. Explaining what we are doing when we examine is also helpful. Explain why you are feeling for lymph nodes in the neck, why we percuss the abdomen. Patients are often fascinated by getting a window into how we are thinking. I usually have medical students with me, which offers another avenue to explaining the how and why behind the exam. In asking and explaining to students, the patient is also taught why we do what we do.

Make sure that we cover what they are afraid of, not just what their symptom is

Patients come in not just to get symptom relief but to rest their mind from their fears of what it could be. I find it helpful to ask the patient what they think is the cause of the problem, or if they are worried about any specific diagnosis. With certain symptoms this is particularly important (for example, headaches, fatigue, or abdominal pain).

None of these suggestions are easy to do in busy, time-pressured clinic visits. I have found though that when patients feel cared about, listened to and can have their fears addressed they value our advice more, and less time is needed to negotiate the plan, as it has been developed together.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at fpnews@mdedge.com.

Reference

Lown BA et al. Health Aff (Millwood). 2011 Sep;30(9):1772-8.

Almost 30 years ago a young woman made an appointment to see me. I had just started my internal medicine practice and almost all the patients who saw me were new to me. I assumed she was establishing care with me. Her first words to me were “Hello Dr. Paauw, I would like to interview you to see if you will be a good fit as my doctor.” We talked for the 40-minute appointment time. I asked her about her health, her life, and what she wanted out of both. We shared with each other that we both were parents of young children. When the appointment was over, she said she would really like for me to be her doctor. She told me that the main thing she appreciated about me was that I listened, and that her previous physician never sat down at her appointments and often had his hand on the door handle for much of the visit. Physicians and patients both agree that compassionate care is essential for good patient care, yet about half of patients and 60% of doctors believe it is lacking in our medical system.¹

Remember the golden first minutes

When you step in the room and greet the patient, make sure the first few minutes are about connecting with a new patient or reconnecting with a patient who has visited your office in the past. I often start by asking the patient to give me an update on how they are doing. This lets me know what is important to them. I do not touch the computer until after this initial check-in.

Use the computer as a bond to strengthen your patient relationship

Many studies have shown patients find the computer gets between the doctor and patient. It is especially problematic if it breaks eye contact with the patient. People are less likely to share scary, sensitive, or embarrassing information if someone is looking at a computer and typing. As you look up tests, radiology reports, or consultant notes, let the patient in on what you are doing. Explain why you are searching in the record, and if it helps make an important point, show your findings to the patient. Offer to print out results, so they have something to carry with them.

Explain what you are looking for and what you find on the physical exam

Being a patient is scary. We all want reassurance that our fears are not true. When you find normal findings on exam, share those with the patient. Hearing “your heart sounds good, your pulses are strong” really helps patients. Explaining what we are doing when we examine is also helpful. Explain why you are feeling for lymph nodes in the neck, why we percuss the abdomen. Patients are often fascinated by getting a window into how we are thinking. I usually have medical students with me, which offers another avenue to explaining the how and why behind the exam. In asking and explaining to students, the patient is also taught why we do what we do.

Make sure that we cover what they are afraid of, not just what their symptom is

Patients come in not just to get symptom relief but to rest their mind from their fears of what it could be. I find it helpful to ask the patient what they think is the cause of the problem, or if they are worried about any specific diagnosis. With certain symptoms this is particularly important (for example, headaches, fatigue, or abdominal pain).

None of these suggestions are easy to do in busy, time-pressured clinic visits. I have found though that when patients feel cared about, listened to and can have their fears addressed they value our advice more, and less time is needed to negotiate the plan, as it has been developed together.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at fpnews@mdedge.com.

Reference

Lown BA et al. Health Aff (Millwood). 2011 Sep;30(9):1772-8.

Almost 30 years ago a young woman made an appointment to see me. I had just started my internal medicine practice and almost all the patients who saw me were new to me. I assumed she was establishing care with me. Her first words to me were “Hello Dr. Paauw, I would like to interview you to see if you will be a good fit as my doctor.” We talked for the 40-minute appointment time. I asked her about her health, her life, and what she wanted out of both. We shared with each other that we both were parents of young children. When the appointment was over, she said she would really like for me to be her doctor. She told me that the main thing she appreciated about me was that I listened, and that her previous physician never sat down at her appointments and often had his hand on the door handle for much of the visit. Physicians and patients both agree that compassionate care is essential for good patient care, yet about half of patients and 60% of doctors believe it is lacking in our medical system.¹

Remember the golden first minutes

When you step in the room and greet the patient, make sure the first few minutes are about connecting with a new patient or reconnecting with a patient who has visited your office in the past. I often start by asking the patient to give me an update on how they are doing. This lets me know what is important to them. I do not touch the computer until after this initial check-in.

Use the computer as a bond to strengthen your patient relationship

Many studies have shown patients find the computer gets between the doctor and patient. It is especially problematic if it breaks eye contact with the patient. People are less likely to share scary, sensitive, or embarrassing information if someone is looking at a computer and typing. As you look up tests, radiology reports, or consultant notes, let the patient in on what you are doing. Explain why you are searching in the record, and if it helps make an important point, show your findings to the patient. Offer to print out results, so they have something to carry with them.

Explain what you are looking for and what you find on the physical exam

Being a patient is scary. We all want reassurance that our fears are not true. When you find normal findings on exam, share those with the patient. Hearing “your heart sounds good, your pulses are strong” really helps patients. Explaining what we are doing when we examine is also helpful. Explain why you are feeling for lymph nodes in the neck, why we percuss the abdomen. Patients are often fascinated by getting a window into how we are thinking. I usually have medical students with me, which offers another avenue to explaining the how and why behind the exam. In asking and explaining to students, the patient is also taught why we do what we do.

Make sure that we cover what they are afraid of, not just what their symptom is

Patients come in not just to get symptom relief but to rest their mind from their fears of what it could be. I find it helpful to ask the patient what they think is the cause of the problem, or if they are worried about any specific diagnosis. With certain symptoms this is particularly important (for example, headaches, fatigue, or abdominal pain).

None of these suggestions are easy to do in busy, time-pressured clinic visits. I have found though that when patients feel cared about, listened to and can have their fears addressed they value our advice more, and less time is needed to negotiate the plan, as it has been developed together.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at fpnews@mdedge.com.

Reference

Lown BA et al. Health Aff (Millwood). 2011 Sep;30(9):1772-8.

Louisiana has joined a handful of other states in passing a so-called fetal heartbeat bill that would ban abortions as early as 6 weeks, about the time a heartbeat is usually detectable.

The legislation, which does not include an exception for rape or incest cases, passed by a 79-23 vote on May 29 in the Louisiana House. The bill does allow exceptions if the woman’s life is in danger, if the pregnancy poses risk of serious impairment to a woman’s body, of if the pregnancy is deemed medically futile. Democratic Gov. John Bel Edwards said he plans to sign the measure when it hits his desk.

“In 2015, I ran for governor as a pro-life candidate after serving as a pro-life legislator for 8 years,” Gov. Edwards said in a May 29 statement. “As governor, I have been true to my word and my beliefs on this issue. As I prepare to sign this bill, I call on the overwhelming bipartisan majority of legislators who voted for it to join me in continuing to build a better Louisiana that cares for the least among us and provides more opportunity for everyone.”

Six other states have enacted similar abortion bans: Alabama, Georgia, Kentucky, Mississippi, Missouri, and Ohio. While most of the laws bar abortions after a heartbeat is detected, Alabama’s measure prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.

A number of lawsuits have been filed against the bans, including a May 24 legal challenge against Alabama’s law by Planned Parenthood Federation of America and the American Civil Liberties Union (ACLU), and a May 15 legal challenge against Ohio’s law by the ACLU and Planned Parenthood of Greater Ohio.

The U.S. Supreme Court on May 28 upheld part of an Indiana law that requires burial or cremation of fetal remains after an abortion, but the justices declined to address the measure’s prohibition on abortions sought because of race, sex, or disability of the fetus.

Court analysts say it’s only a matter of time before the Supreme Court takes up one of the abortion ban cases, most likely the legal challenge against Alabama’s law. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh, and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe v. Wade, court watchers said.

agallegos@mdedge.com

Louisiana has joined a handful of other states in passing a so-called fetal heartbeat bill that would ban abortions as early as 6 weeks, about the time a heartbeat is usually detectable.

The legislation, which does not include an exception for rape or incest cases, passed by a 79-23 vote on May 29 in the Louisiana House. The bill does allow exceptions if the woman’s life is in danger, if the pregnancy poses risk of serious impairment to a woman’s body, of if the pregnancy is deemed medically futile. Democratic Gov. John Bel Edwards said he plans to sign the measure when it hits his desk.

“In 2015, I ran for governor as a pro-life candidate after serving as a pro-life legislator for 8 years,” Gov. Edwards said in a May 29 statement. “As governor, I have been true to my word and my beliefs on this issue. As I prepare to sign this bill, I call on the overwhelming bipartisan majority of legislators who voted for it to join me in continuing to build a better Louisiana that cares for the least among us and provides more opportunity for everyone.”

Six other states have enacted similar abortion bans: Alabama, Georgia, Kentucky, Mississippi, Missouri, and Ohio. While most of the laws bar abortions after a heartbeat is detected, Alabama’s measure prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.

A number of lawsuits have been filed against the bans, including a May 24 legal challenge against Alabama’s law by Planned Parenthood Federation of America and the American Civil Liberties Union (ACLU), and a May 15 legal challenge against Ohio’s law by the ACLU and Planned Parenthood of Greater Ohio.

The U.S. Supreme Court on May 28 upheld part of an Indiana law that requires burial or cremation of fetal remains after an abortion, but the justices declined to address the measure’s prohibition on abortions sought because of race, sex, or disability of the fetus.

Court analysts say it’s only a matter of time before the Supreme Court takes up one of the abortion ban cases, most likely the legal challenge against Alabama’s law. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh, and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe v. Wade, court watchers said.

agallegos@mdedge.com

Louisiana has joined a handful of other states in passing a so-called fetal heartbeat bill that would ban abortions as early as 6 weeks, about the time a heartbeat is usually detectable.

The legislation, which does not include an exception for rape or incest cases, passed by a 79-23 vote on May 29 in the Louisiana House. The bill does allow exceptions if the woman’s life is in danger, if the pregnancy poses risk of serious impairment to a woman’s body, of if the pregnancy is deemed medically futile. Democratic Gov. John Bel Edwards said he plans to sign the measure when it hits his desk.

“In 2015, I ran for governor as a pro-life candidate after serving as a pro-life legislator for 8 years,” Gov. Edwards said in a May 29 statement. “As governor, I have been true to my word and my beliefs on this issue. As I prepare to sign this bill, I call on the overwhelming bipartisan majority of legislators who voted for it to join me in continuing to build a better Louisiana that cares for the least among us and provides more opportunity for everyone.”

Six other states have enacted similar abortion bans: Alabama, Georgia, Kentucky, Mississippi, Missouri, and Ohio. While most of the laws bar abortions after a heartbeat is detected, Alabama’s measure prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.

A number of lawsuits have been filed against the bans, including a May 24 legal challenge against Alabama’s law by Planned Parenthood Federation of America and the American Civil Liberties Union (ACLU), and a May 15 legal challenge against Ohio’s law by the ACLU and Planned Parenthood of Greater Ohio.

The U.S. Supreme Court on May 28 upheld part of an Indiana law that requires burial or cremation of fetal remains after an abortion, but the justices declined to address the measure’s prohibition on abortions sought because of race, sex, or disability of the fetus.

Court analysts say it’s only a matter of time before the Supreme Court takes up one of the abortion ban cases, most likely the legal challenge against Alabama’s law. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh, and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe v. Wade, court watchers said.

agallegos@mdedge.com

DALLAS – Children with cystic fibrosis or asthma report sleep interruptions 1 or 2 nights a week caused by their symptoms, but nighttime use of technology may contribute more to sleep problems, according to a new study.

“Routinely addressing sleep concerns, sleep hygiene, and mental health is important in the care of pediatric patients with chronic illness,” concluded Lauren Greenawald, DO, and colleagues at the Alfred I. duPont Hospital for Children in Wilmington, Del. The researchers presented their findings on sleep quality and mental health of children with asthma or cystic fibrosis (CF) at the American Thoracic Society’s international conference.

Dr. Greenawald’s team screened 31 children (aged 7-17 years) with CF and 34 children with asthma for anxiety, depression, and ADHD. The researchers also assessed the children’s sleep hygiene, sleep quality, and physical and emotional symptoms. Instruments included the validated Pediatric Daytime Sleepiness Scale (PDSS), Pediatric Quality of Life Inventory, and Patient-Reported Outcomes Measurement Information System Pediatric Anxiety Survey, plus an investigator-designed survey about sleep habits.

Just over half the children with CF (52%) and 14% of children with asthma had mental health diagnoses (P less than .01). The same proportion of patients with CF (52%) and nearly a third of patients with asthma (30%) reported they often or always felt they needed more sleep based on the PDSS. Further, 42% of children with CF and 55% of children with asthma said their symptoms kept them awake 1-2 nights a week. Only 6% of asthma patients and no CF patients said their symptoms keep them awake often, 3-4 nights a week. Just over a third of children with CF (36%) and 46% of those with asthma thought they would sleep better if they didn’t have a medical condition.

Yet, for the vast majority of children, the sleeping problems did not appear to result from worry about their illness: 85% of those with CF and nearly all of those with asthma (97%) did not have trouble sleeping as a result of anxiety about their medical condition.

The researchers identified nighttime use of technology that may affect the children’s sleep in ways similar to that of the general population. Many of the participants – 68% of those with CF and 47% of those with asthma – reported texting or using social media or other technology an hour before going to bed. In addition, 55% of those with CF and 25% of those with asthma said they use their phone after the lights are out at least 5 nights a week. One in five of those with CF (20%) said they go to bed later than they planned at least 5 days a week because of social media or texting, though only 6% of those with asthma said the same.

Despite the children’s reports of inadequate sleep, very few – 3.2% of children with CF and 5.9% of children with asthma – reported feeling low daytime energy.

The use of child self-reporting in the presence of family members is a study limitation, including potentially introducing social desirability bias.

The research was funded by the Nemours Summer Undergraduate Research Program. The authors reported no disclosures.

SOURCE: Greenawald L et al. ATS 2019, Abstract A2788.

DALLAS – Children with cystic fibrosis or asthma report sleep interruptions 1 or 2 nights a week caused by their symptoms, but nighttime use of technology may contribute more to sleep problems, according to a new study.

“Routinely addressing sleep concerns, sleep hygiene, and mental health is important in the care of pediatric patients with chronic illness,” concluded Lauren Greenawald, DO, and colleagues at the Alfred I. duPont Hospital for Children in Wilmington, Del. The researchers presented their findings on sleep quality and mental health of children with asthma or cystic fibrosis (CF) at the American Thoracic Society’s international conference.

Dr. Greenawald’s team screened 31 children (aged 7-17 years) with CF and 34 children with asthma for anxiety, depression, and ADHD. The researchers also assessed the children’s sleep hygiene, sleep quality, and physical and emotional symptoms. Instruments included the validated Pediatric Daytime Sleepiness Scale (PDSS), Pediatric Quality of Life Inventory, and Patient-Reported Outcomes Measurement Information System Pediatric Anxiety Survey, plus an investigator-designed survey about sleep habits.

Just over half the children with CF (52%) and 14% of children with asthma had mental health diagnoses (P less than .01). The same proportion of patients with CF (52%) and nearly a third of patients with asthma (30%) reported they often or always felt they needed more sleep based on the PDSS. Further, 42% of children with CF and 55% of children with asthma said their symptoms kept them awake 1-2 nights a week. Only 6% of asthma patients and no CF patients said their symptoms keep them awake often, 3-4 nights a week. Just over a third of children with CF (36%) and 46% of those with asthma thought they would sleep better if they didn’t have a medical condition.

Yet, for the vast majority of children, the sleeping problems did not appear to result from worry about their illness: 85% of those with CF and nearly all of those with asthma (97%) did not have trouble sleeping as a result of anxiety about their medical condition.

The researchers identified nighttime use of technology that may affect the children’s sleep in ways similar to that of the general population. Many of the participants – 68% of those with CF and 47% of those with asthma – reported texting or using social media or other technology an hour before going to bed. In addition, 55% of those with CF and 25% of those with asthma said they use their phone after the lights are out at least 5 nights a week. One in five of those with CF (20%) said they go to bed later than they planned at least 5 days a week because of social media or texting, though only 6% of those with asthma said the same.

Despite the children’s reports of inadequate sleep, very few – 3.2% of children with CF and 5.9% of children with asthma – reported feeling low daytime energy.

The use of child self-reporting in the presence of family members is a study limitation, including potentially introducing social desirability bias.

The research was funded by the Nemours Summer Undergraduate Research Program. The authors reported no disclosures.

SOURCE: Greenawald L et al. ATS 2019, Abstract A2788.

DALLAS – Children with cystic fibrosis or asthma report sleep interruptions 1 or 2 nights a week caused by their symptoms, but nighttime use of technology may contribute more to sleep problems, according to a new study.

“Routinely addressing sleep concerns, sleep hygiene, and mental health is important in the care of pediatric patients with chronic illness,” concluded Lauren Greenawald, DO, and colleagues at the Alfred I. duPont Hospital for Children in Wilmington, Del. The researchers presented their findings on sleep quality and mental health of children with asthma or cystic fibrosis (CF) at the American Thoracic Society’s international conference.

Dr. Greenawald’s team screened 31 children (aged 7-17 years) with CF and 34 children with asthma for anxiety, depression, and ADHD. The researchers also assessed the children’s sleep hygiene, sleep quality, and physical and emotional symptoms. Instruments included the validated Pediatric Daytime Sleepiness Scale (PDSS), Pediatric Quality of Life Inventory, and Patient-Reported Outcomes Measurement Information System Pediatric Anxiety Survey, plus an investigator-designed survey about sleep habits.

Just over half the children with CF (52%) and 14% of children with asthma had mental health diagnoses (P less than .01). The same proportion of patients with CF (52%) and nearly a third of patients with asthma (30%) reported they often or always felt they needed more sleep based on the PDSS. Further, 42% of children with CF and 55% of children with asthma said their symptoms kept them awake 1-2 nights a week. Only 6% of asthma patients and no CF patients said their symptoms keep them awake often, 3-4 nights a week. Just over a third of children with CF (36%) and 46% of those with asthma thought they would sleep better if they didn’t have a medical condition.

Yet, for the vast majority of children, the sleeping problems did not appear to result from worry about their illness: 85% of those with CF and nearly all of those with asthma (97%) did not have trouble sleeping as a result of anxiety about their medical condition.

The researchers identified nighttime use of technology that may affect the children’s sleep in ways similar to that of the general population. Many of the participants – 68% of those with CF and 47% of those with asthma – reported texting or using social media or other technology an hour before going to bed. In addition, 55% of those with CF and 25% of those with asthma said they use their phone after the lights are out at least 5 nights a week. One in five of those with CF (20%) said they go to bed later than they planned at least 5 days a week because of social media or texting, though only 6% of those with asthma said the same.

Despite the children’s reports of inadequate sleep, very few – 3.2% of children with CF and 5.9% of children with asthma – reported feeling low daytime energy.

The use of child self-reporting in the presence of family members is a study limitation, including potentially introducing social desirability bias.

The research was funded by the Nemours Summer Undergraduate Research Program. The authors reported no disclosures.

SOURCE: Greenawald L et al. ATS 2019, Abstract A2788.

Key clinical point: Structural and functional network MRI measures predict long-term worsening in multiple sclerosis.

Major finding: The odds ratio of worsening for patients with abnormally high baseline resting state functional connectivity is 1.67.

Study details: A prospective imaging study of 233 patients with multiple sclerosis and 77 healthy controls.

Disclosures: Dr. Filippi has received research support from Biogen, Merck Serono, Novartis, Teva, and Roche.

Citation: Filippi M et al. AAN 2019, Abstract S49.004.

Key clinical point: Structural and functional network MRI measures predict long-term worsening in multiple sclerosis.

Major finding: The odds ratio of worsening for patients with abnormally high baseline resting state functional connectivity is 1.67.

Study details: A prospective imaging study of 233 patients with multiple sclerosis and 77 healthy controls.

Disclosures: Dr. Filippi has received research support from Biogen, Merck Serono, Novartis, Teva, and Roche.

Citation: Filippi M et al. AAN 2019, Abstract S49.004.

Key clinical point: Structural and functional network MRI measures predict long-term worsening in multiple sclerosis.

Major finding: The odds ratio of worsening for patients with abnormally high baseline resting state functional connectivity is 1.67.

Study details: A prospective imaging study of 233 patients with multiple sclerosis and 77 healthy controls.

Disclosures: Dr. Filippi has received research support from Biogen, Merck Serono, Novartis, Teva, and Roche.

Citation: Filippi M et al. AAN 2019, Abstract S49.004.