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ProvidenceMS

The old phrase, “we are what we eat”, may actually be true. Diet may influ-ence the development of multiple sclerosis, as well as the progression of the disease. So, currently, several studies, including a study at our MS center, are evaluating the role of the microbiome. The microbiome is composed of over a trillion microbes which include bacteria, viruses, fungi, and parasites which may influence our ability to process nutri-ents, metabolize food, and participate in regulating our immune system. In addi-tion, a growing number of studies have suggested that the gut may influence the brain as well as vice versa. This is frequently referred to the gut-brain axis.

Changes in the composition of the gut microbiome may play a role in obesity,

diabetes, gastric disorders, and autoim-mune conditions, including multiple sclerosis. However, these conditions may also cause a change in the microbiome. So numerous studies are being conduct-ed to determine how the microbiome may influence our health.

The immune system is overactive in multiple sclerosis which is characterized by a predominance of pro-inflammatory immune responses. So, it is possible that a depletion or an abundance of certain bacteria in the gut may influence the immune system.

Diet can influence the microbiome although recent evidence suggests this change may be temporary. Obesity, smoking, certain viruses, and vitamin D may play a role. In addition, genetics

potentially may influence the microbiome.

Several studies have identified that patients with multiple sclerosis have higher concentrations of certain types of bacteria compared to patients without multiple sclerosis. Also, the lack of certain types of bacteria may increase the risk of further relapses. For example, a study in California with 17 children with multiple sclerosis indicated that an absence or depletion of Fusobacteria was associated with a 70% risk of an early relapse. In addition, studies have indicated that disease modifying therapy could potentially positively influence the microbiome, resulting in fewer relapses and less disease progression. Our current study, in conjunction with a MS Center in Seattle, evaluates the change in the microbiome in patients who are starting dimethyl fumarate (Tecfidera).

In summary, more research needs to be conducted to determine if changes in bacteria influence the development of multiple sclerosis as well as the its clinical course, or if the disease itself plays a role in the composition of the microbiome. n

FALL/WINTER NEWSLETTER 2017 | ISSUE #4

We Are What We Eat?

I N T H I S I S S U E

2 | Interview with Meghan Romba, M.D.

4 | Focus on MS Symptom Management

7 | Enrolling Clinical Studies

11 | Our Program & Our Providers

12 | News & Events

2 | Fall/Winter 2017, Issue #4 | Providence MS Newsletter

Today, I had the

opportunity to inter-

view Meghan Romba,

M.D. who is our

new provider at the

Providence MS Center.

Where did you complete your training?After finishing medical school at Univer-sity of Illinois, I completed my neurol-ogy residency at University of Washing-ton in Seattle, WA. Given my interest in multiple sclerosis, I went on to complete a neuroimmunology/multiple sclerosis fellowship at Johns Hopkins University Hospital sponsored by the National MS Society from 2016-2017.

Why did you choose to move to Portland?I chose Portland because I wanted to join the MS Center at Providence. I was inspired by the clinic’s multidisci-plinary approach to providing patient-centered care and their commitment to research. It is an honor to be joining the MS Center and I look forward to the opportunity to provide MS care in the Portland-area.

How did you become interested in multiple sclerosis?I was motivated to choose MS as a subspecialty based on my clinical experience in residency. It was rewarding to see patients recover from

an MS exacerbation, help with their symptom management, and partner with them in choosing a disease modifying therapy so they could maintain their quality of life as best as possible.

What is one piece of advice you would like to give to patients with MS?Keeping a positive attitude is key and making sure to surround yourself with a supportive team, including family, friends, and healthcare staff who will encourage and motivate you.

What is one piece of advice you would like to give to caretakers?My advice to caregivers is to make sure you are taking time out for yourself throughout the week, whether that is to exercise, attend your own doctor’s appointments, etc. When a caregiver’s needs are taken care of, the loved one you are caring for will also benefit.

What do you like to do outside of work?Spending time with family, gardening, and vegetarian cooking.

What do you think will be the next major advance in MS treatment?I am hoping over the next 10 years we will see further advancements in the treatment options available for primary progressive MS and also the develop-ment of remyelinating agents.

Who would you invite to your dream dinner party (alive or dead)?Amelia Earhart, to ask about her flying adventures and of course the mystery of her disappearance.

What has been the highlight of your career?The highlight of my medical career is knowing that I made a difference in patients’ lives. Whether it was helping with a diagnosis, getting them the treat-ment they required, helping improve challenging symptoms, or just listening when needed.

What life experience has taught or changed you the most?Prior to entering medicine, I was a caretaker for a woman living with a neurodegenerative condition known as Huntington’s disease. This experience was very humbling and allowed me to see medicine from the standpoint of a caregiver rather than a provider. I am grateful for this time in my life as I think it helped shaped me into the person and physician I am today. n

Providence Brain and Spine Institute | Team Member Spotlight

Interview with Meghan Romba, M.D. Interview by Kyle Smoot, M.D.

Meghan Romba, M.D.

We are extremely fortunate to have Dr. Romba as part of our team at the Providence MS Center. Please feel free to contact your health care provider or call our office if you have questions.

Fall/Winter 2017, Issue #4 | Providence MS Newsletter | 3

MS Walk and Bike Ride

On a beautiful evening in July, the

MS Center team came together

to celebrate our recent successes

especially in the last year. The team

continues to play a role in the

community as we continue to

participate in the MS Walk and

Bike Ride. Both Drs. Cohan and

Kresa-Reahl are on the National

Multiple Sclerosis (Oregon

Chapter) board. n

Presentation Publication

Several presentations have been

accepted at major neurology meetings

including both the American Academy

Neurology meeting (AAN) and the

European Committee for Treatment

and Research in Multiple Sclerosis

meeting (ECTRIMS). In addition,

original research conducted at

our MS Center on tolerability and

effectiveness of Tecfidera was

accepted for publication in the

Multiple Sclerosis Journal. n

Best Wishes Bobbi Lee

Lastly, we said good-bye to Bobbi Lee.

Bobbi Lee worked at Providence for

5 years, and she was a valuable

member of our team. In addition, she

helped establish our monthly support

group. While working full-time and

raising 3 children, she returned to

school to become a nurse practitioner.

So, in July, she joined Cascade

Physicians in Tualatin. Our team will

miss her tremendously. n

Clinic News

Bikers (l-r): Dr. Kyle Smoot, Gary Huffman (Biogen), Dr. Vitalie Lupu, and Leah Gaedeke, NP completed the MS Century Ride on Aug 4th

Bottom right (l-r): Leah Gaedeke, NP, Dr. Kyle Smoot, Dr. Stanley Cohan and Dr. Kiren Kresa-Reahl


How does MS affect the bladder?Normal bladder function requires an intact “nerve circuit” which involves the brain, the spinal cord, the bladder itself, and the muscle which “clamps” the bladder neck shut to prevent leakage. In MS, the most common problem happens when MS attacks the spinal cord, disrupting the communica-tion back and forth between the bladder and the brain. This disconnection hampers the bladder’s ability to tell the brain when it is full, or can interrupt the brain’s ability to signal the bladder to release urine. This ‘disconnect’ causes the typical symptoms patients experience, including bladder urgency, frequency, hesitancy, and incontinence.

Which type of bladder problem do I have?The two broad categories of bladder problems in MS include failure to store urine, and failure to empty urine. Failure to store urine happens when the normal signals from the brain through the spinal cord to the bladder are interrupted, causing the bladder to become “spastic” (stiff or inflexible), holding very little urine before having the urge to release it. Patients with this type of bladder dysfunction have to void small amounts very often, and when they do get the urge to void, it can come on suddenly and intensely. Because of urgency, patients often find themselves keeping track of all the bathrooms in an area when they go out in public. While urinary frequency can be annoying during the day, it can be especially disruptive at

Focus on MS Symptom Management:

MS Urinary Health UpdateWritten by Kiren Kresa-Reahl, M.D.

Bladder dysfunction is one of the most common and challenging symptoms in MS, affecting up to 80% of patients1. Beyond being an anxiety-causing issue in social situations, MS bladder dysfunction can put patients at risk for potentially serious urinary infections as well. Below are some updates for the latest in urinary health treatments for MS patients.

night, since having to get up to void multiple times causes sleep deprivation, which then causes worsened fatigue the next day.

Failure to empty urine happens when the muscle which keeps the bladder outlet closed goes into spasm. This makes it difficult to open the bladder outlet fully to release urine. Patients with this type of dysfunction complain of urinary hesitancy, which is feeling the urge to void but then having trouble getting the urine stream started. This slowed urine stream sometimes causes the bladder to empty only partly during a void, also known as urinary retention. When the bladder inappropriately holds urine, bacteria have a chance to get into the bladder and grow out of control, leading to potentially serious urinary tract infections. Infections in the bladder cause pain or burning with urination known as dysuria (dys=”bad”). Other symptoms of urinary tract infection include changes in the color, odor, or clarity of the urine itself. The danger from these UTIs occurs when the infection becomes severe enough for bacteria to enter the bloodstream (urosepsis).

Although the two types of bladder problems seem very differ-ent, there can sometimes be overlap in the symptoms (e.g. patients with urinary retention can experience

What can I do to promote good bladder health in general?While each patient’s treatment must be individualized with their physician, some general tips to help bladder function include avoiding caffeine or certain spicy foods which can irritate the bladder lining, keeping well-hydrated (which seems counter-intuitive, but which is important to keep the bladder

flushed out so bacteria don’t settle in) and sometimes using foods or supplements to make the urine more acidic, and so less hospitable for bacterial growth.

What medications can be prescribed to help bladder function?Medications to help relax the bladder muscle and treat urinary urgency (spastic bladder) include oxybutynin (Ditropan), tolterodine (Detrol), solfenacin (Vesicare), fesoterodine

(Toviaz), and propantheline2. As a group, they can cause side effects such as confusion, dry mouth, dry eyes, and constipation. Some newer medications which are not as notorious for those side effects include trospium (Sanctura) and darifenacin (Enablex).

urinary frequency or urgency), so it is not always easy to decide what is going wrong based on symptoms alone. In these situations, testing called urodynamics can be performed by a Urologist to determine whether the problem is in the bladder itself, the muscle which closes the bladder opening, a combination of the two, or something else entirely (like weakness of the pelvic floor muscles from childbirth which causes urinary dribbling with coughing or sneezing). Fortunately, once the type of bladder dysfunction is diagnosed, there are many treatments available to help.


Focus on MS Symptom Management | MS Urinary Health Update, continued

…to help bladder function include avoiding caffeine or certain spicy foods which can irritate

the bladder lining, keeping well-hydrated…


Focus on MS Symptom Management | MS Urinary Health Update, continued

Treatment for ‘failure to empty’ bladder dysfunction focuses on relaxing the clamping muscle at the base of the bladder. This group of medications includes tamsulosin (Flomax), doxazo-

sin (Cardura), terazosin (Hytrin). As a group, they can cause side effects such as light-headedness on standing or dizziness.

What about non-drug treatments for bladder dysfunction?Non-medication treatments for MS bladder dysfunction include injections of Botox (botulinum toxin), which causes muscle relaxation. For patients with ‘failure to store’ issues, Botox is injected directly into the walls of the bladder, causing them to relax and allow more urine to fill the bladder before it signals to void. On the other hand, for people with ‘failure to empty’ problems, it is also injected into the bladder ‘clamp’ muscle at the base of the bladder, to loosen the tight muscle and allow the bladder outlet to open fully during voids.

If symptoms fail to improve with botulinum toxin, Urologists can implant special electrical wires which attach to the blad-der wall and connect to an implanted device called a bladder

stimulator. The bladder stimulator electrically signals the blad-der to contract (void) at the appropriate time of the patient’s choosing. Having the ability to control exactly when to void enables patients to feel more confident when they are out in public places. Lastly, patients who have difficulty getting

the urinary stream started can be trained how to use urinary

catheters, which are inserted into the bladder to fully drain it several times a day. If that is impractical (if a patient has hand weakness or incoordination from their MS for instance), the bladder can be drained permanently with the use of a supra-pubic catheter or indwelling Foley catheter. Unfortunately, these catheters can be associated with urinary tract infections, because bacteria can move up the tubing and invade the bladder.

What can be done to reduce overnight voiding (nocturia)?Some tips to avoid having to get up at night to void include limiting liquids after dinner, and if that doesn’t work, patients can be tried on desmopressin, which reduces the production of urine.

In summaryThere are multiple types of bladder dysfunction in MS patients, so pursuing a correct diagnosis for which type you have can allow your providers to decide which medication or surgical option is best for you. With good bladder habits (such as avoiding caffeine and avoiding drinking liquids after dinner) and the right medication, urinary problems in MS can go from being a major obstacle to a minor inconvenience. n

References:

1. National MS Society website, bladder problems in MShttp://www.nationalmssociety.org/Symptoms-Diagnosis/MS- Symptoms/Bladder-Dysfunction

2. Frohman TC, Castro W, Shah A, et al. Symptomatic therapyin multiple sclerosis. Ther Adv Neurol Disord 2011; 4:83.

To sign up or learn more about the registry, visit us at: www.pacificnwms.org Phone: (503) 216-1022 Email: [email protected]


Clinical Studies | Enrollment

Study Title: Pacific Northwest Multiple Sclerosis Registry

Objective: The purpose is to measure MS prevalence in the Pacific Northwest and to create a database for ongoing

epidemiological and health services research

Sponsor: Providence Health & Services

Principal Investigator: Stanley Cohan, M.D., Ph.D. Project Manager: Tamela Stuchiner

Study Title: Providence Ocrelizumab Patient Registry

Objective: The goal of this registry is to collect information from patients receiving ocrelizumab for the treatment of MS to

assess its long-term utilization, safety, tolerability and efficacy.


Principal Investigator: Kyle Smoot, M.D. Study Coordinator: Lois Grote

Study Title: Measurement of Relaxin in the Serum and Cerebrospinal Fluid of Subjects With and Without the Relapsing Form of Multiple Sclerosis

Objective: This study will evaluate relaxin (RLX) levels in patients with multiple sclerosis.


Principal Investigator: Stanley Cohan, M.D., Ph.D. Site Study Coordinator: Hannah Voss

Study Title: The Effect of ACTH (Acthar®) on Measures of Chronic Fatigue in Patients with Relapsing Multiple Sclerosis

Objective: The purpose is to study the effect of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are

experiencing chronic fatigue.


Principal Investigator: Stanley Cohan, M.D., Ph.D. Site Coordinator: Lynette Currie

Site Principal Investigator: Walter Carlini, M.D., Ph.D. (Medford, OR) Study Coordinator: Kari Jaasko (Medford, OR)


Clinical Studies | Enrollment, continued

Study Title: Evaluating The Efficacy And Safety Of Transitioning Patients From Natalizumab To Ocrelizumab

Objective: The purpose is to study the effect of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who

are experiencing chronic fatigue.


Site Principal Investigator: Kyle Smoot, M.D. Study Coordinator: Genevieve Leineweber

Study Title: Long-term, Prospective, Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy

Objective: The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of Multiple

Sclerosis, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the

incidence of selected safety-related outcomes and to further monitor the overall safety profile of fingolimod under

conditions of routine medical practice.

Sponsor: Novartis Pharmaceuticals

Site Principal Investigator: Stanley Cohan, M.D., Ph.D. Study Coordinator: Lynette Currie

Site Principal Investigator: Walter Carlini, M.D., Ph.D. (Medford, Or) Study Coordinator: Kari Jaasko (Medford, OR)

Study Title: A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)

Objective: The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion

of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched

from treatment with natalizumab to daclizumab due to safety concerns.

Sponsor: Biogen Idec

Site Principal Investigator: Kiren Kresa-Reahl, M.D. Study Coordinator: Eli Edwards

Study Title: Measuring the Impact of Tecfidera on the Gut Microbiota: Does a Change in the Gut Flora Correlate With Gastrointestinal Disturbances Following Therapy Initiation?

Objective: The primary objectives of this study are to determine whether a measureable change in bacterial species

representation follows the institution of DMF (Tecfidera); to determine whether a specific pattern of change in the



microbiota phylotype with DMF therapy correlates to onset and severity of gastrointestinal disturbances (heartburn, nausea,

flatulence, and diarrhea); to determine whether any instability of microbiota phylotype representation persists following the

institution of DMF or whether stabilization relates to resolution of gastrointestinal disturbances; and to determine whether

there is a correlation between a pre-existing functional bowel disorder and development or severity of gastrointestinal

disturbances and of peripheral eosinophilia.

Sponsor: Evergreen Health

Site Principal Investigator: Kyle Smoot, M.D. Study Coordinator: Lynette Currie

Study Title: A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in Multiple Sclerosis

Objective: Peginterferon-beta-1a (PEG) is an approved treatment for relapsing forms of MS that may cause injection

related erythema. This is a randomized controlled cross-over trial of superficial hot and cold modalities to reduce injection

site erythema caused by PEG.

Sponsor: Evergreen Health

Site Principal Investigator: Kyle Smoot, M.D. Study Coordinator: Eli Edwards

Study Title: Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study

Objective: The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients

suffering from progressive multiple sclerosis and especially those with gait impairment.

Sponsor: MedDay Pharmaceuticals

Site Principal Investigator: Kyle Smoot, M.D. Study Coordinator: Emily Moher

Study Title: A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

Objective: The purpose of this study is to compare the efficacy and safety of ofatumumab administered subcutaneously

every 4 weeks.


Site Principal Investigator: Stanley Cohan, M.D., Ph.D. Study Coordinator: Genevieve Leineweber


Stanley Cohan, M.D., Ph.D., Director and

Principal Investigator

Kiren Kresa-Reahl, M.D., Principal Investigator

Kyle Smoot, M.D., Principal Investigator

Walter Carlini, M.D., Ph.D., Principal Investigator

(Medford)

Leah Gaedeke, FNP, Sub-Investigator

Chiayi Chen, RN, Ph.D., Program Director

Tiffany Gervasi, MPH, CCRP, Supervisor

Kristen Reid, RN, BS, Supervisor

Lois Grote, RN, Data Coordinator

Tamela Stuchiner, MA, Program Manager

Kari Jaasko, CCRC, Clinical Trials Coordinator

(Medford)

Arlena Cummings, CCRP, Clinical Trials Coordinator

Lynette Currie, MA, Clinical Trials Coordinator

Emily Johnson, MA, Clinical Trials Coordinator

Genevieve Leineweber, Clinical Trials Coordinator

Emily Moher, MPH, Clinical Trials Coordinator

Eli Edwards, Senior Research Assistant

Hillary Frey, Senior Research Assistant

Robin Kintner, Senior Research Assistant

Hannah Voss, CCRP, Senior Research Assistant

Jessie Wallace, Clinical Research Assistant

For more information on clinical trials and research, visit us at oregon.providence.org/our-services/c/clinical-trials-brain or clinicaltrials.gov

Study Title: A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)

Objective: The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events,

including but not limited to infections, hepatic events, malignancies, and renal events, and of adverse events leading to

treatment discontinuation in patients with MS treated with dimethyl fumarate.


Site Principal Investigator: Walter Carlini, M.D., Ph.D. (Medford, OR) Study Coordinator: Kari Jaasko (Medford, OR)


Clinical Research | Team


Providence Multiple Sclerosis Center Providence Multiple Sclerosis Center, the only center of its kind in Oregon, is the state’s leading care provider for people with MS. Our medical director, Stanley Cohan, M.D., Ph.D., was an investigator in the original, pivotal trial of beta inter-feron 1-A, one of the key medications for treating multiple sclerosis. He continues to play a leading role in MS research and founded the Pacific Northwest Multiple Sclerosis Registry Project, which will be used to help advance treatment of multiple sclerosis.

Our goal at Providence Multiple Sclerosis Center is to provide persistent, proactive, focused treatment that minimizes the effects of MS on your life. Patients benefit from comprehensive services that may include medication therapy, physical

rehabilitation, counseling and other support. In addition, patients have access to the newest therapies through regional and international clinical trials.

Services:

• Highly advanced diagnostics

• Personalized treatment plans

• Attentive use of medications

• Rehabilitation with therapists whospecialize in MS care

• Continence treatment for bladderand bowel dysfunction

• Emotional support andpsychological counseling

• Opportunities to receive investigationalmedicines through clinical trials

• Close coordination with your primarycare physician

• The Pacific Northwest MultipleSclerosis Registry Project, a databasecreated for epidemiological andhealth services research

• An MS Network that allows physiciansto collaborate on MS treatments

Our Providence Multiple Sclerosis Center team specializes in:

• Comprehensive MS care• Neurology• Neuro-ophthalmology• Neurotology (for ear disorders)• Nursing• Physical therapy

• MS research

Clinicians:

Stanley Cohan, M.D., Ph.D., Neurologist; medical director of Providence Multiple Sclerosis Center

Kiren Kresa-Reahl, M.D., Neurologist

Meghan Romba, M.D., Neurologist

Kyle Smoot, M.D., Neurologist

Leah Gaedeke, FNP, Multiple Sclerosis Nurse Practitioner

Nurses:

Brittany Hannon, RN, Patient Care Coordinator

Sam Brighton, RN, Clinical Case Manager

Sarah Hogue, RN

The Providence Multiple Sclerosis Center’s research is supported by generous donations from friends in the community. If you are interested in learning more about supporting the center’s work, please contact Joel Kelly, Director of Development, at (503) 216-2198.

Available on our Web site at providence.org/brain:

• Physician directory: Get contactinformation for all Providence Brainand Spine Institute physicians.

• Upcoming events: Providenceoffers educational events through-out the year. Check our onlinecalendar to view upcoming topics.

• Clinical trials: Find out about mul-tiple clinical trials for investigationaltreatments for MS, as wellas other clinical trials availablethrough Providence.

• Support groups: Get details onsupport groups in Oregon.

• Additional resources: Our web-site offers the latest information onavailable programs and services;educational toolkits; and links totrusted sources of information.

News & Events:Multiple Sclerosis 101 (New Patient Program)

Thursday, Nov.16th, 2017 • 6-7:30 PM

Providence St. Vincent Medical Center, Brain and Spine Institute Conference Room

9135 SW Barnes Rd, Ste 363 Portland, OR 97225

Multiple Sclerosis 101 is ideal for newly diagnosed patients and their family members. Dr. Kyle Smoot will review the basics of multiple sclerosis including treatment options for the relapsing forms of the disease. Complimentary dinner will be provided.

Space is limited, RSVP is required.

To register, please call Shirley at (503) 216-1038

O U R M I S S I O NAs people of Providence, we reveal God’s love for all, especially the poor and vulnerable, through our compassionate service.

O U R C O R E V A L U E SRespect, Compassion, Justice, Excellence, Stewardship

P R O V I D E N C E M U L T I P L E S C L E R O S I S C E N T E R9135 SW Barnes Road, Suite 461 Portland, OR 97225 (503) 216-1150

providence.org/ms

Dr. Kyle Smoot is accepting patients on the East Side

Dr. Kyle Smoot is now offering patient appointments every Friday on the East side.

Providence Neurological Specialties-East 5050 NE Hoyt Street, Suite 615 Portland, OR 97213 (503) 215-8580

Providence Multiple Sclerosis Center

9135 SW Barnes Road, Suite 461 Portland, OR 97225

http://oregon.providence.org/our-services/p/providence-multiple-sclerosis-center

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