June Halper, MSCN, ANP, FAAN

1
Patient Considerations in Disease Management

• June Halper, MSCN, ANP, FAAN
• Executive Director
• Consortium of MS Centers
• Gimbel MS Center
• Teaneck, New Jersey
• Clyde Markowitz, MD
• Assistant Professor of Neurology
• Director, Multiple Sclerosis Center
• Hospital of the University of Pennsylvania
• Philadelphia, Pennsylvania

2
Initiation of Treatment with Disease-Modifying
Therapy (DMT)

• Immunomodulatory therapies for relapsing-remitting
  multiple sclerosis (RRMS) are most effective
  when started early in the disease course
• Initiation of treatment is recommended as soon as
  possible following a definite diagnosis of RRMS
• Patients who have had only one clinical event may
  be followed closely for signs of disease
  progression before beginning therapy
• Initiation of treatment should be preceded by a
  candid discussion with patients and their family
• To establish a therapeutic relationship of shared
  decision making
• To assess patients educational needs and
  treatment readiness
• To review the rationale for immunomodulatory
  therapy

3
Importance of Realistic Expectations and Informed
Decision Making

• Realistic expectations of therapy are critical to
  the success of long-term disease management of MS
• Patients should understand that the available
  DMTs are not curative, but can
• Reduce relapse frequency and severity
• Slow progression of disease
• Improve quality of life
• Natural history studies can be used to highlight
  the risks of delaying or not treating MS
• Patients decisions about their care should be
  based on appropriate and balanced information
• Patients should be taught to critically evaluate
  educational materials related to MS and its
  management

4
Diagnostic Tools to Support MS Diagnosis

• Cervical magnetic resonance imaging (MRI) is
  recommended, especially in patients with
  symptomatology referable to spinal cord lesions
• Cerebrospinal fluid analysis is recommended for
  most patients to solidify the diagnosis of RRMS
• Evoked potentials can also provide helpful
  confirmatory data

5
Treatment Selection

• Adherence to therapy is critical to achieving
  optimal clinical outcomes with the available MS
  DMTs
• The best DMT for an individual patient is the
  one that he or she is going to continue to take
• Potential barriers to adherence (eg, lifestyle
  issues) and other patient concerns (eg, fear of
  injections, specific side effect concerns) should
  be identified prior to initiation of therapy
• Selection of a specific treatment plan should
  involve a team approach and reflect mutual
  agreement

6
First-Line Disease-Modifying Therapies for RRMS

• Glatiramer acetate (Copaxone)
• Random polypeptide, subcutaneous (SC)
  administration, daily
• Interferon beta-1b (Betaseron)
• SC administration, every other day
• Interferon beta-1a (Avonex)
• Intramuscular (IM) administration, weekly
• Interferon beta-1a (Rebif)
• SC administration, 3x/per week

7
Additional Disease-Modifying Therapies for RRMS

• Natalizumab (Tysabri)
• Monoclonal antibody monthly IV infusion
• Use suspended in 2005 after 2 patients developed
  a rare and frequently fatal CNS disease,
  progressive multifocal encephalopathy
• FDA approved re-release in June 2006
• Mitoxantrone (Novantrone)
• Synthetic anthracenedione derivative approved for
  worsening RRMS or progressive MS, quarterly IV
  infusion
• Cardiotoxicity risk limits its cumulative dose

8
Which Treatment for Which Patient?

• Selection of one of the first-line DMTs should be
  individualized and based on specific disease,
  drug, and patient characteristics
• In patients with prominent disease activity,
  treatment with high-dose IFN ? is often
  recommended
• In patients with more typical disease activity,
  glatiramer acetate or IFN ?-1a IM are commonly
  recommended and may offer better tolerability
• In patients who are concerned about frequency of
  injections, once weekly IFN ?-1a IM may be a
  viable option
• If patients are concerned about flu-like
  symptoms, headache, increased spasticity, or
  liver toxicity issues, glatiramer acetate may be
  the most appropriate first-line therapy

9
Use of Natalizumab, Mitoxantrone

• Use of toxic compounds such as mitoxantrone in
  patients in early stages of MS is an area of
  concern
• It is not known whether risk of PML or other
  opportunistic infections following natalizumab
  therapy is restricted to immunosuppressed or
  combination therapy patients
• Use of these agents may be more appropriate in
  patients whose disease is unable to be managed
  with the available first-line therapies
• Clinicians and nurses must be familiar with the
  patient-oriented, legal, and financial
  considerations related to infusion therapy

10
Considerations in Making Changes to a Patients
Treatment Regimen

• Generally, therapies should be given an adequate
  trial
• (1 year) before changes to the initial
  treatment strategy are considered
• Patients who are stable and adherent to therapy
  should be strongly encouraged to continue with
  their current therapy
• If patients are experiencing problems with
  tolerability or adherence or demonstrating
  significant continued disease activity, switching
  to or adding a new or alternative treatment may
  be appropriate
• Changes to the treatment strategy, whether
  patient- or physician-driven, should be
  accompanied by an in-depth discussion of
  potential risks and benefits

11
Patient Advocacy and Resources

• MS nurses serve as advocates for patients on
  immunomodulatory therapy to ensure that they have
  
• adequate and timely access to treatment
• Recent changes in reimbursement have created
  significant challenges related to education and
  access for many patients
• MS nurses play a vital role in helping patients
  navigate the complex maze of issues related to
  their care and can direct patients to the
  available resources designed to assist patients

12
Summary

• The expanding range of medications available to
  treat MS and the increased emphasis on self-care
  have introduced new challenges for both the
  patient and the health care team
• The available DMTs promote the health and
  well-being of patients, but require a great deal
  of work
• Through their critical roles in establishing,
  continuing, and sustaining care, MS nurses
  support patients long-term adherence to therapy
  the key to success with the DMTs