IN THIS ISSUE 2 | Interview with Chiayi Chen, RN, Ph.D. 3 | Caregivers: The Hidden Patient 4 | Flare vs Pseudo Flare- When is it real? 5 | Enrolling Clinical Studies 7 | Our Program & Our Providers 8 | News & Events Providence MS Daclizumab (Zinbryta) is currently being reviewed by the FDA, and ap- proval of this medication is expected later this year. is medication is given via a subcutaneous injection every 4 weeks. How Daclizumab works is unique compared to our other medi- cations. e medication is believed to influence a type of cell called natural killer (NK) cells which may play a role in regulating the immune system. In clinical trials, which our center participated in, the medication demonstrated a 45 percent reduction in relapses compared to interferon- ß1a (Avonex). In addition, there was significant reduction in the number of MRI changes. Of course, safety is extremely important, and there is the potential to experience side effects with any medication. In the clinical trials, some patients on Daclizumab developed a rash including eczema. In addition, elevations in liver enzymes were seen in a small percentage of people. So, possibly, patients who are on this medication may need frequent lab tests to monitor the liver. Ocrelizumab just completed clinical trials. is medication may not only be approved for patients with relaps- ing disease, but benefits were seen in a separate trial in patients with primary progressive multiple sclerosis. is would be the first medication approved for this form of MS. e medication is given through an IV every 6 months. A medication called Rituximab is very similar to Ocreli- zumab, but the infusions are better tolerated. However, a reaction to the medication at the time of the infusion is very common. In the relapsing trial, this medication reduced relapses by 46 percent compared to interferon- ß1a (Rebif ). In addition, almost all patients had no new activity on their follow up MRIs. Fortunately, there were no major safety concerns includ- ing risk of infection. However, it may be too early to tell. Hopefully, the medication will be approved in the Spring of 2017. n SPRING/SUMMER NEWSLETTER 2016 | ISSUE #1 Medication Update Currently, there are 12 medications available for the treatment of relapsing multiple sclerosis. By the end of 2017, there will be two new additional medications – Daclizumab and Ocrelizumab. Welcome to our inaugural issue of the Providence MS Newsletter. We plan on producing a newsletter twice year to provide updates in the field of Multiple Sclerosis. In addition, we will provide information on general wellness and introduce you to our staff who help make this a wonderful center.
Transcript
I n t h I s I s s u e
2 | Interview with Chiayi Chen, Rn, Ph.D.
3 | Caregivers: the hidden Patient
4 | Flare vs Pseudo Flare- When is it real?
5 | enrolling Clinical studies
7 | Our Program & Our Providers
8 | news & events
ProvidenceMs
Daclizumab (Zinbryta) is currently being reviewed by the FDA, and ap-proval of this medication is expected later this year. This medication is given via a subcutaneous injection every 4 weeks. How Daclizumab works is unique compared to our other medi-cations. The medication is believed to influence a type of cell called natural killer (NK) cells which may play a role in regulating the immune system. In clinical trials, which our center participated in, the medication demonstrated a 45 percent reduction in relapses compared to interferon-ß1a (Avonex). In addition, there was significant reduction in the number of MRI changes. Of course, safety is
extremely important, and there is the potential to experience side effects with any medication. In the clinical trials, some patients on Daclizumab developed a rash including eczema. In addition, elevations in liver enzymes were seen in a small percentage of people. So, possibly, patients who are on this medication may need frequent lab tests to monitor the liver.
Ocrelizumab just completed clinical trials. This medication may not only be approved for patients with relaps-ing disease, but benefits were seen in a separate trial in patients with primary progressive multiple sclerosis. This would be the first medication
approved for this form of MS. The medication is given through an IV every 6 months. A medication called Rituximab is very similar to Ocreli-zumab, but the infusions are better tolerated. However, a reaction to the medication at the time of the infusion is very common. In the relapsing trial, this medication reduced relapses by 46 percent compared to interferon-ß1a (Rebif ). In addition, almost all patients had no new activity on their follow up MRIs. Fortunately, there were no major safety concerns includ-ing risk of infection. However, it may be too early to tell. Hopefully, the medication will be approved in the Spring of 2017. n
Spring/SummernewSletter2016 | iSSue #1
Medication Update
Currently, there are 12 medications available for the treatment of relapsing multiple sclerosis. By the end of 2017, there will be two new additional medications – Daclizumab and Ocrelizumab.
Welcome to our inaugural issue of the Providence MS Newsletter. We plan on producing a newsletter twice year to provide updates in the field of Multiple Sclerosis. In addition, we will provide information on general wellness and introduce you to our staff who help make this a wonderful center.
2 | spring/summer 2016, Issue #1 | Providence Ms newsletter
Today, I was fortunate
to interview Dr. Chiayi
Chen as she is
extremely busy. She
is the program director
for clinical research at
both the Providence
Brain and Spine Institute (PBSI), and
Women and Children’s Program.
How long have you been at Providence?Over 8 years
What was your previous job prior to coming to Providence?I was working on my PhD at UCLA School of Nursing, with a focus on Health Services Research and during that time, I was involved in a number of NIH grants and worked as a research nurse at Cedars-Sinai Neurosurgical Institute on dendritic cell vaccine clinical trials for Gliobas-toma Multiforme (GBM).
How did you become interested in MS?My first job at Providence was a program manager, working with Dr. Cohan to establish the Pacific Northwest MS Registry, formally Oregon MS Registry.
Tell me more about the registry?Initially, the registry was started for patients in our clinic, but the regis-try has been expanded to the Pacific Northwest as a regional registry.
How many patients are in the registry?4700 patients, and 80 percent are from Oregon. We are planning to expand to all Providence ministries and affiliates and have representation from communities across the Pacific Northwest.
How is the registry conducted?There is now an online registration and survey. Information is collected at the time of registration and annually.
What information is collected?We collect demographics, MS history, MS treatments, initial and current MS symptoms, disability status, healthcare utilization, medication adherence, health behaviors, quality of life.
How is that information used?Several abstracts have been presented at major neurology meetings including the American Academy of Neurology, ECTRIMS and CMSC.
How many clinical trials are active at the PBSI?45 to 50 trials
Wow, that is a lot! How about for MS?15 to 20 trials. The remainder are for ALS, dementia and stroke.
Given the large number of trials, how many people are part of the research team?We have 15 dedicated research staff on the team. They are the number one factor to our success!
Well enough about work, what do you like to do outside of work?I enjoy gardening, yoga, and hiking. I also like sporting events, but only when my boys are participating. n
Providence Brain and spine Institute | team Member spotlight
Interview with Dr. Chiayi Chen Interview by Kyle smoot, M.D.
Dr. Chiayi Chen
I would like to thank Dr. Chen for taking the time to meet with me today. She is such a valuable member of our team. Without her, our research program would not be as successful.
In addition, she is a lovely person!
Caregivers: The Hidden Patient written by Sam Brighton, rn, BSn
spring/summer 2016, Issue #1 | Providence Ms newsletter | 3
Family Caregiver Support Programs: ORegOn | (855) 673-2372 WashIngtOn | (509) 766-2568
PROvIDenCe Ms CenteR | (503) 216-1057
Caring for a family member with a chronic condition such as Multiple sclerosis or dementia is a very important and rewarding role. at the same time, caregiving is a stressful role that impacts many areas of a caregiver’s life: work life, social life, physical health (such as high blood pressure), and mental health (such as depression).(1)
Caregivers who prioritize taking care of themselves are better able to provide quality care for longer periods of time when caring for a family member. There is a reason why the airline industry advises passengers to put on their own oxygen mask first before helping another passenger – if you lose oxygen and pass out, you cannot help the person sitting next to you. Like-wise, if you are overwhelmed with the demands of caregiving, without stress reduction strategies, you are vulnerable to burnout, and you put the quality of your care at risk.(2)
There is help! There is hope! Both Oregon and Washington operate Family Caregiver Support Programs which exist to support you in your caregiving role – they want to help you take care of yourself so you can continue caring for your loved one. They offer information and referrals,
education, support groups, counseling, and respite services.
Respite services provide a temporary break from caregiving so the caregiver can go to the store or their own medi-cal appointments, or reconnect with a hobby.(3) Respite services help the caregiver’s ability to manage stress and increase their quality of life.(4) Respite care makes the family stronger and protects the health and well-being of everyone involved.(3) Caregivers who use respite report less depression and feelings of burden and they report improvements in physical health problems.(5)
In Oregon, you may contact the state Family Caregiver Support Program to be connected to your local office. They can discuss costs and may be able to provide financial assistance for people who meet income requirements. Their
phone number is (855) 673-2372. In Washington, the phone number for the Family Caregiver Support Program is (509) 766-2568.
As always, if you have any questions about caregiver support programs or need assistance with anything that is getting in the way of your health and wellness, please call Sam Brighton, RN – the clinical case manager at the Providence MS Center – at (503) 216-1057. n
sources
1 – eifert, e., adams, R., Dudley, W., Perko, M. (2015). Family Caregiver Identity: a Literature Review. American Journal of Health Education, 46(6), 357-367.
2 – strawderman, M. (2015). Caregiver fatigue and the importance of respite. Virginia Nurses Today, 23(4) 8-11
3 – Link, g. (2015). the administration for community living: programs and initiatives providing family caregiver support. Generations, 39(4), 57-63.
5 – arksey, h, Jackson, K, Croucher, K, Weatherly, h, golder, s, hare, P, newbronner, e, and Baldwin, s, (2004). Review of respite services and short-term breaks for carers of people with dementia. national health service, service Delivery Organization, London.
Multiple Sclerosis (MS) is a chronic, progressive disease of the central nervous system (CNS). The central nervous system includes the brain, optic nerves, and spine. Early disease is often referred to as relapsing- remitting multiple sclerosis and is characterized by relapses or “flare ups” or “attacks” –which is caused by inflammation in the CNS – followed by periods of remission.
Sometimes individuals with multiple sclerosis experience pseudo-flares. The prefix, “pseudo” means “not real or genuine.” Although symptoms of a pseudo-flare may seem like a true flare, it is not. Symptoms of a pseudo-flare may include weakness, numbness, sensation changes, visual difficulties, tingling or dizziness. Pseudo-flares usually have a trigger such as heat, stress, or illness. Once the root cause is known, you can begin a care plan. For example, if you experience neurologi-cal symptoms during a vigorous work out, take the time to cool down and cool off. The symptoms will return to normal and not cause permanent damage. Investing in a cooling vest can help you maintain a low core temperature. The Multiple Sclerosis Association of America (MSAA) can be a great resource.
www.mymsaa.org/msaa-help/cooling Apply early!
If your symptoms persist past 24 hours, please call your neurologist or send a MyChart message (mychartor.org or download the MyChart app on your I-phone or Android). Ask your-self the following questions:
How long have you had your symptoms?
Are they brand new?
Have you recently been ill?
Do you have any signs or symptoms of a urinary tract infection?
Have you been emotionally or physically stressed?
Have you been over-doing it?
Have you been hydrating and getting enough sleep?
Communicating with your neurologist is key when it comes to differentiating a pseudo-flare vs a true MS flare. We are here to help! A “true” MS flare is when you have new neurological symptoms and your overall condition seems worse. These symptoms last for at least twenty four hours and you
may need a MRI and/or 3 to 5 days of a steroid infusion. n
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4 | spring/summer 2016, Issue #1 | Providence Ms newsletter
Flare vs Pseudo-flare - When is it Real?Written by Bobbi Lee Roth, Rn/Bsn & Kali Dailey, Rn
Join the Pacific Northwest Multiple Sclerosis Registry
the registry was developed by the providence mS Center in collaboration with the national mS Society - Oregon Chapter in 2007. to date, more than 4,500 participants have completed confidential surveys. the goal of the registry is to provide an accurate assessment of the number of individu-als living with mS in the northwest and to learn more about the course of the disease.
To sign up or learn more about the registry, visit us at: www.pacificnwms.org
Pacific NW MS Registry Teamtamela stuchiner, Research and Quality Program Manager
sarah Baump, Research assistant
trevor McKee, Data analyst
STUDY TITLE: a 12-month, randomized, rater- and dose-blinded study to compare the efficacy and safety of fingolimod 0.25 mg and 0.5 mg administered orally once daily with glatiramer acetate 20 mg administered subcutaneously once daily in patients with relapsing-remitting multiple sclerosis (assess)
SPONSOR: novartis Pharmaceuticals
SITE PRINCIPAL INVESTIGATOR: Kiren Kresa-Reahl, MD SITE CONTACT: tiffany gervasi
STUDY TITLE: the effect of aCth on Measures of Fatigue in Patients with Relapsing Multiple sclerosis
SPONSOR: Providence health & services
SITE PRINCIPAL INVESTIGATOR: stanley Cohan, MD, PhD & Walter Carlini, MD, PhD (Medford) SITE CONTACT: arlena georgeson & Kari Jaasko (Medford)
STUDY TITLE: Long-term, Prospective, Observational, Multinational, Parallel-cohort study Monitoring safety in Patients with Ms newly started with Fingolimod Once Daily or treated with another approved Disease-modifying therapy (Passage)
SPONSOR: novartis Pharmaceuticals
SITE PRINCIPAL INVESTIGATOR: stanley Cohan, MD, PhD & Walter Carlini, MD, PhD (Medford) SITE CONTACT: tiffany gervasi & Kari Jaasko (Medford)
STUDY TITLE: Measurement of Relaxin in the serum and Cerebrospinal Fluid of subjects With and Without the Relapsing Form of Multiple sclerosis (ReLaXIn)
SPONSOR: Providence health & services
SITE PRINCIPAL INVESTIGATOR: stanley Cohan, MD, PhD SITE CONTACT: hannah voss
STUDY TITLE: a Multicenter, Double-Blind, Placebo-Controlled study of Montelukast on gastrointestinal tolerability in Patients With Relapsing Forms of Multiple sclerosis Receiving tecfidera (Dimethyl Fumarate) Delayed-Release Capsules (MItIgate)
SPONSOR: Biogen Idec
SITE PRINCIPAL INVESTIGATOR: Kyle smoot, MD SITE CONTACT: arlena georgeson
Clinical studies | enrollment
spring/summer 2016, Issue #1 | Providence Ms newsletter | 5
STUDY TITLE: Plegridy (pegrinterferon β-1a) Real World effectiveness and safety Observational Program (POP)
SPONSOR: Biogen Idec
SITE PRINCIPAL INVESTIGATOR: Kiren Kresa-Reahl, MD & Walter Carlini, MD, PhD (Medford) SITE CONTACT: Jose archuleta & Kari Jaasko (Medford)
STUDY TITLE: a pilot study of warm and cold compress to reduce injection site erythema due to peginterferon-beta-1a in multiple sclerosis
SPONSOR: evergreen health
SITE PRINCIPAL INVESTIGATOR: Kyle smoot, MD SITE CONTACT: arlena georgeson
Clinical studies | enrollment, continued
Clinical Research | team
6 | spring/summer 2016, Issue #1 | Providence Ms newsletter
stanley Cohan, M.D., PhD, Director and Principal Investigator
Kiren Kresa-Reahl, M.D., Principal Investigator
Kyle smoot, M.D., Principal Investigator
Walter Carlini, M.D., PhD, Principal Investigator (Medford)
Kari Jaasko, CCRC, Clinical trials Coordinator (Medford)
sarah Jamieson, Clinical trials Coordinator
Dana Lassiter, CCRC, Clinical trials Coordinator
Chad Parks, CCRP, senior Research Coordinator
hillary Frey, Clinical Research assistant
hannah voss, 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
spring/summer 2016, Issue #1 | Providence Ms newsletter | 7
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 direc-tor, Stanley Cohan, M.D., Ph.D., was an investigator in the original, pivotal trial of beta interferon 1-A, one of the key medications for treating multiple sclerosis. He continues to play a lead-ing role in MS research and founded the Pacific Northwest Multiple Sclero-sis Registry Project, which will be used to help advance treatment of multiple sclerosis.
Our goal at Providence Multiple Sclerosis Center is to provide persis-tent, proactive, focused treatment that minimizes the effects of MS on your life. Patients benefit from comprehen-
sive services that may include medica-tion 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 who specialize in Ms care
• Continence treatment for bladder and bowel dysfunction
• emotional support and psychological counseling
• Opportunities to receive investigational medicines through clinical trials
• Close coordination with your primary care physician
• the Pacific northwest Multiple sclerosis Registry Project, a database created for epidemiological and health services research
• an Ms network that allows physicians to 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
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 contact
information for all Providence Brain and spine Institute physicians.
• Upcoming events: Providence of-fers educational events throughout the year. Check our online calendar to view upcoming topics.
• Clinical trials: Find out about mul-tiple clinical trials for investigational treatments for Ms, as well as other clinical trials available through Providence.
• Support groups: get details on support groups in Oregon.
• Additional resources: Our website offers the latest information on available programs and services; educational toolkits; and links to trusted sources of information.
News & Events:Dr. Kyle Smoot is accepting patients on the East Side
Dr. Kyle smoot is now offering patient appointments on Fridays, twice a month, on the east side of Portland.
Providence neurological specialties-east 5050 ne hoyt st., suite 315, Portland, OR 97213 503-215-8580
Providence Multiple Sclerosis Center is moving!
new clinic address, effective June 7: 9135 sW Barnes Road, suite 461, Portland, OR 97225
Bike MS: Willamette Valley
august 5-7, 2016 For more information, visit www.nationalmssociety.org/BikeMs
O u R M I s s I O n
As people of Providence, we reveal God’s love for all, especially the poor and vulnerable, through our compassionate service.
