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Comorbidities May Influence MS Treatment Decisions













MS is a chronic disease of the CNS.5 Beginning in the 1990s, disease-modifying therapies (DMTs) were introduced that advanced management of MS, resulting in reduced rates of both relapse and disability progression.5 Today, 13 DMTs are available to treat relapsing MS: seven self-injectable drugs, three intravenous agents, and three oral compounds. Drug monographs for these agents can be found here.

The three oral disease-modifying drugs—fingolimod, teriflunomide, and dimethyl fumarate—all were approved in the past decade and have an efficacy at least equivalent to established injectable drugs.1 Due to serious safety risks, including liver injury and immune conditions, the recently approved long-acting self-injectable, daclizumab (Zinbryta) should generally only be used in patients with an inadequate response to two or more MS drugs. According to the US Food and Drug Administration, the agent “is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.”4 Due to substantial safety concerns, the three intravenous drugs—mitoxantrone, natalizumab (Tysabri), and alemtuzumab (Lemtrada)—are restricted to treating aggressive forms of MS1.

As with other chronic diseases, comorbidities are common in individuals with MS, which can adversely affect health outcomes. What's little known, however, is whether such comorbidities delay initiation or affect initial selection of a DMT.5

One of the first studies to examine comorbidity and treatment decisions in patients with MS hypothesized that the presence of comorbidities would reduce DMT use and influence choice of DMT for those with MS.5 Comorbidities of interest included the physical (diabetes, hypertension, hyperlipidemia, ischemic heart disease, chronic lung disease, and epilepsy), and the mental (anxiety, depression, bipolar disorder).

The Canadian Institutes of Health Research Team in the Epidemiology and Impact of Comorbidity on Multiple Sclerosis study included 10,698 persons with incident MS, half of whom had 1 or more comorbidities. Mean age at index date was 43.1 years. The reference group was 1995/1996–1999; others were 1989–1994, 2000–2004, 2005–2010/2012. The analysis focused on first-line injectable DMTs, since oral DMTs were not approved.5

The investigators found that after the index date, 3,170 people (29.6%) initiated a DMT. Those more likely to initiate treatment were female and younger. Results also showed that the likelihood of initiating a DMT for MS decreased as the total number of comorbidities increased. Specifically, comorbid anxiety and ischemic heart disease were both associated with reduced DMT initiation. What was interesting is the investigators found that compared to patients without depression at the index date, those with depression were 13% more likely to initiate a DMT (adjusted hazard ratio 1.13; 95% confidence interval 1.00-1.27; P=0.05).5

These findings are “consistent with other chronic diseases such as cancer and diabetes, in which increasing comorbidity burden delays treatment initiation,” the investigative team reported.5

One reason for such delays may be that for both clinicians and patients, having multiple chronic conditions results not only in competing demands on time, but may act as barriers to access and treatment decisions. Another reason may be related to a delay in MS diagnosis due to the presence of comorbidity, as has been seen in other chronic diseases, such as rheumatoid arthritis and cancer.5

The potential number of concurrent drug therapies are likely to affect both a patient's and a clinician's decision as to whether to initiate another agent. This may be related to the perception that a specific treatment may offer fewer benefits when multiple chronic conditions are affecting a patients' health.5 Finally, because clinical trials often exclude those with comorbidities, the efficacy, safety, or tolerability of DMTs in patients with MS and comorbidities are not fully understood.2

A second study conducted by the Canadian team that examined sex differences in comorbidity at MS diagnosis included 23,382 incident MS cases and 116,638 age-, sex-, and geographically matched controls.2 The investigators estimated the prevalence of hypertension, diabetes, hyperlipidemia, heart disease, chronic lung disease, epilepsy, fibromyalgia, inflammatory bowel disease, depression, anxiety, bipolar disorder, and schizophrenia at MS diagnosis and compared the MS and control populations.


Debra Hughes, MS
June 09, 2016
Comorbidities May Influence MS Treatment Decisions
Today, 13 DMTs are available to treat relapsing MS
Today, 13 DMTs are available to treat relapsing MS
Multiple sclerosis (MS) is a chronic disease of the CNS.5 Beginning in the 1990s, disease-modifying therapies (DMTs) were introduced that advanced management of MS, resulting in reduced rates of both relapse and disability progression.5 Today, 13 DMTs are available to treat relapsing MS: seven self-injectable drugs, three intravenous agents, and three oral compounds. Drug monographs for these agents can be found here.

The three oral disease-modifying drugs—fingolimod, teriflunomide, and dimethyl fumarate—all were approved in the past decade and have an efficacy at least equivalent to established injectable drugs.1 Due to serious safety risks, including liver injury and immune conditions, the recently approved long-acting self-injectable, daclizumab (Zinbryta) should generally only be used in patients with an inadequate response to two or more MS drugs. According to the US Food and Drug Administration, the agent “is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.”4 Due to substantial safety concerns, the three intravenous drugs—mitoxantrone, natalizumab (Tysabri), and alemtuzumab (Lemtrada)—are restricted to treating aggressive forms of MS1.

As with other chronic diseases, comorbidities are common in individuals with MS, which can adversely affect health outcomes. What's little known, however, is whether such comorbidities delay initiation or affect initial selection of a DMT.5

One of the first studies to examine comorbidity and treatment decisions in patients with MS hypothesized that the presence of comorbidities would reduce DMT use and influence choice of DMT for those with MS.5 Comorbidities of interest included the physical (diabetes, hypertension, hyperlipidemia, ischemic heart disease, chronic lung disease, and epilepsy), and the mental (anxiety, depression, bipolar disorder).

The Canadian Institutes of Health Research Team in the Epidemiology and Impact of Comorbidity on Multiple Sclerosis study included 10,698 persons with incident MS, half of whom had 1 or more comorbidities. Mean age at index date was 43.1 years. The reference group was 1995/1996–1999; others were 1989–1994, 2000–2004, 2005–2010/2012. The analysis focused on first-line injectable DMTs, since oral DMTs were not approved.5

The investigators found that after the index date, 3,170 people (29.6%) initiated a DMT. Those more likely to initiate treatment were female and younger. Results also showed that the likelihood of initiating a DMT for MS decreased as the total number of comorbidities increased. Specifically, comorbid anxiety and ischemic heart disease were both associated with reduced DMT initiation. What was interesting is the investigators found that compared to patients without depression at the index date, those with depression were 13% more likely to initiate a DMT (adjusted hazard ratio 1.13; 95% confidence interval 1.00-1.27; P=0.05).5

These findings are “consistent with other chronic diseases such as cancer and diabetes, in which increasing comorbidity burden delays treatment initiation,” the investigative team reported.5

One reason for such delays may be that for both clinicians and patients, having multiple chronic conditions results not only in competing demands on time, but may act as barriers to access and treatment decisions. Another reason may be related to a delay in MS diagnosis due to the presence of comorbidity, as has been seen in other chronic diseases, such as rheumatoid arthritis and cancer.5

The potential number of concurrent drug therapies are likely to affect both a patient's and a clinician's decision as to whether to initiate another agent. This may be related to the perception that a specific treatment may offer fewer benefits when multiple chronic conditions are affecting a patients' health.5 Finally, because clinical trials often exclude those with comorbidities, the efficacy, safety, or tolerability of DMTs in patients with MS and comorbidities are not fully understood.2

A second study conducted by the Canadian team that examined sex differences in comorbidity at MS diagnosis included 23,382 incident MS cases and 116,638 age-, sex-, and geographically matched controls.2 The investigators estimated the prevalence of hypertension, diabetes, hyperlipidemia, heart disease, chronic lung disease, epilepsy, fibromyalgia, inflammatory bowel disease, depression, anxiety, bipolar disorder, and schizophrenia at MS diagnosis and compared the MS and control populations.

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Among those with MS, 71.9% were female. The most prevalent comorbidity was depression, in 19.1%. With the exception of hyperlipidemia, all of the physical and psychiatric comorbidities were more common among those who had MS versus the matched population. Consistent with known associations of known comorbidity in the general population, the “burden of comorbidity was higher with increasing age at diagnosis,” they reported.2

The highest rate ratios for physical comorbidities were seen for fibromyalgia, inflammatory bowel disease, and epilepsy. In both the MS and matched control population, depression, anxiety, and fibromyalgia were more common among women and ischemic heart disease was more common among men.2

Among women with MS, they found a disproportionately higher prevalence of chronic lung disease than men with MS; in contrast, men with MS had a disproportionately higher prevalence of hypertension, diabetes, and epilepsy as well as all of the psychiatric comorbidities studied (depression, anxiety, bipolar disorder, and schizophrenia) than did women with MS.2

The investigators noted that since depression and anxiety adversely affect health-related quality of life, adherence to treatment, and risk of hospitalization, “these comorbidities deserve particular clinical attention from the time of diagnosis, and support the need for studies aimed at improved diagnosis and management of these conditions.”2

To select an appropriate drug for patients newly diagnosed with MS, clinicians should consider a patient's views, requirements, and potential adherence difficulties, including an anxiety disorder that may mean they decline treatment due to needle phobia or fear of adverse effects.5 Any psychological aspects that may potentially affect treatment adherence should be considered, including coping strategies.3

For those who are currently prescribed a DMT, the clinician should determine patient satisfaction with that agent, including effect on symptoms of MS, adverse effects, and treatment adherence. Those who have been regularly self-injecting interferons and glatiramer acetate long-term may be dissatisfied with mode of administration, resulting in limited adherence.1 For such patients, an oral agent may be attractive and potentially enhance adherence.3 Patients who wish to become pregnant should not be prescribed teriflunomide.1

Story Source: The above story is based on materials provided by MPR
Note: Materials may be edited for content and length


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