The number of treatments released for MS has been growing steadily in the last 10 years. The American Academy of Neurology has issued guidelines to help with choice of treatment. One new feature of the guidelines is several recommendations that may cause a change in treatment from one medication to another in certain clinical settings--something there has been little consensus on in prior years.
Here's a summary, with italics for "must" (level A) recommendations and bolded text where potential treatment-changing recommendations are made (those are at the lesser "should" level, B):
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Starting DMT: Recommendations
Statement 1
Clinicians should
counsel people with newly diagnosed MS about specific treatment
options with DMT at a dedicated treatment visit (Level B).
Statement 2a
Clinicians must
ascertain and incorporate/review preferences in terms of safety,
route of administration, lifestyle, cost, efficacy, common adverse
effects (AEs), and tolerability in the choice of DMT in people with
MS being considered for DMT (Level A).
Statement 2b
Clinicians must
engage in an ongoing dialogue regarding treatment decisions
throughout the disease course with people with MS (Level A).
Statement 3a
Clinicians should
counsel people with MS that DMTs are prescribed to reduce relapses
and new MRI lesion activity. DMTs are not prescribed for symptom
improvement in people with MS (Level B).
Statement 3b
Clinicians must
counsel people with MS on DMTs to notify the clinicians of new or
worsening symptoms (Level A).
Statement 4
Clinicians should
evaluate readiness or reluctance to initiate DMT and counsel on its
importance in people with MS who are candidates to initiate DMT
(Level B).
Statement 5
Clinicians should
counsel about comorbid disease, adverse health behaviors, and
potential interactions of the DMT with concomitant medications when
people with MS initiate DMTs (Level B).
Statement 6a
Clinicians should
evaluate barriers to adherence to DMT in people with MS (Level B).
Statement 6b
Clinicians should
counsel on the importance of adherence to DMT when people with MS
initiate DMTs (Level B).
Statement 7a
Clinicians should
discuss the benefits and risks of DMTs for people with a single
clinical demyelinating event with 2 or more brain lesions that have
imaging characteristics consistent with MS (Level B).
Statement 7b
After discussing the
risks and benefits, clinicians should prescribe DMT to people with a
single clinical demyelinating event and 2 or more brain lesions
characteristic of MS who decide they want this therapy (Level B).
Statement 8
Clinicians may
recommend serial imaging at least annually for the first 5 years and
close follow-up rather than initiating DMT in people with CIS or
relapsing forms of MS who are not on DMT, have not had relapses in
the preceding 2 years, and do not have active new MRI lesion activity
on recent imaging (Level C).
Statement 9
Clinicians should
offer DMTs to people with relapsing forms of MS with recent clinical
relapses or MRI activity (Level B).
Statement 10a
Clinicians should
monitor for medication adherence, AEs, tolerability, safety, and
effectiveness of the therapy in people with MS on DMTs (Level B).
Statement 10b
Clinicians should
follow up either annually or according to medication-specific REMS in
people with MS on DMTs (Level B).
Statement 11
Clinicians should
monitor the reproductive plans of women with MS and counsel regarding
reproductive risks and use of birth control during DMT use in women
of childbearing potential who have MS (Level B).
Statement 12
Clinicians should
counsel men with MS on their reproductive plans regarding treatment
implications before initiating treatment with teriflunomide or
cyclophosphamide (Level B).
Statement 13
Because of the high
frequency of severe AEs, clinicians should not prescribe mitoxantrone
to people with MS unless the potential therapeutic benefits greatly
outweigh the risks (Level B).
Statement 14
Clinicians should
prescribe alemtuzumab, fingolimod, or natalizumab for people with MS
with highly active MS (Level B).
Statement 15a
Clinicians may
direct people with MS who are candidates for DMTs to support programs
(Level C).
Statement 15b
Clinicians may
recommend azathioprine or cladribine for people with relapsing forms
of MS who do not have access to approved DMTs (Level C).
Statement 16
Clinicians may
initiate natalizumab treatment in people with MS with positive
anti-JCV antibody indexes above 0.9 only when there is a reasonable
chance of benefit compared with the low but serious risk of PML
(Level C).
Statement 17
Clinicians should
offer ocrelizumab to people with PPMS who are likely to benefit from
this therapy unless there are risks of treatment that outweigh the
benefits (Level B).
Switching DMT: Recommendations
Statement 1a
Clinicians should
monitor MRI disease activity from the clinical onset of disease to
detect the accumulation of new lesions in order to inform treatment
decisions in people with MS using DMTs (Level B).
Statement 1b
Clinicians should
recognize that relapses or new MRI-detected lesions may develop after
initiation of a DMT and before the treatment becomes effective in
people with MS who are using DMTs (Level B).
Statement 1c
Clinicians should
discuss switching from one DMT to another in people with MS who have
been using a DMT long enough for the treatment to take full effect
and are adherent to their therapy when they experience 1 or more
relapses, 2 or more unequivocally new MRI-detected lesions, or
increased disability on examination, over a 1-year period of using a
DMT (Level B).
Statement 2
Clinicians should
evaluate the degree of disease activity, adherence, AE profiles, and
mechanism of action of DMTs when switching DMTs in people with MS
with breakthrough disease activity during DMT use (Level B).
Statement 3
Clinicians should
discuss a change to noninjectable or less frequently injectable DMTs
in people with MS who report intolerable discomfort with the
injections or in those who report injection fatigue on injectable
DMTs (Level B).
Statement 4a
Clinicians should
inquire about medication AEs with people with MS who are taking a DMT
and attempt to manage these AEs, as appropriate (Level B).
Statement 4b
Clinicians should
discuss a medication switch with people with MS for whom these AEs
negatively influence adherence (Level B).
Statement 5a
Clinicians should
monitor laboratory abnormalities found on requisite laboratory
surveillance (as outlined in the medication's package insert) in
people with MS who are using a DMT (Level B).
Statement 5b
Clinicians should
discuss switching DMT or reducing dosage or frequency (where there
are data on different doses [e.g., interferons, teriflunomide,
azathioprine]) when there are persistent laboratory abnormalities
(Level B).
Statement 6a
Clinicians should
counsel people with MS considering natalizumab, fingolimod,
rituximab, ocrelizumab, and dimethyl fumarate about the PML risk
associated with these agents (Level B).
Statement 6b
Clinicians should
discuss switching to a DMT with a lower PML risk with people with MS
taking natalizumab who are or become JCV antibody–positive,
especially with an index of above 0.9 while on therapy (Level B).
Statement 7a
Clinicians should
counsel that new DMTs without long-term safety data have an undefined
risk of malignancy and infection for people with MS starting or using
new DMTs (Level B).
Statement 7b
If a patient with
MS develops a malignancy while using a DMT, clinicians should
promptly discuss switching to an alternate DMT, especially for people
with MS using azathioprine, methotrexate, mycophenolate,
cyclophosphamide, fingolimod, teriflunomide, alemtuzumab, or dimethyl
fumarate (Level B).
Statement 7c
People with MS
with serious infections potentially linked to their DMT should switch
DMTs (does not pertain to PML management in people with MS using
DMT) (Level B).
Statement 8a
Clinicians should
check for natalizumab antibodies in people with MS who have infusion
reactions before subsequent infusions, or in people with MS who
experience breakthrough disease activity with natalizumab use (Level
B).
Statement 8b
Clinicians should
switch DMTs in people with MS who have persistent natalizumab
antibodies (Level B).
Statement 9a
Physicians must
counsel people with MS considering natalizumab discontinuation that
there is an increased risk of MS relapse or MRI-detected disease
activity within 6 months of discontinuation (Level A).
Statement 9b
Physicians and
people with MS choosing to switch from natalizumab to fingolimod
should initiate treatment within 8–12 weeks after natalizumab
discontinuation (for reasons other than pregnancy or pregnancy
planning) to diminish the return of disease activity (Level B).
Statement 10a
Clinicians should
counsel women to stop their DMT before conception for planned
pregnancies unless the risk of MS activity during pregnancy outweighs
the risk associated with the specific DMT during pregnancy (Level B).
Statement 10b
Clinicians should
discontinue DMTs during pregnancy if accidental exposure occurs,
unless the risk of MS activity during pregnancy outweighs the risk
associated with the specific DMT during pregnancy (Level B).
Statement 10c
Clinicians should
not initiate DMTs during pregnancy unless the risk of MS activity
during pregnancy outweighs the risk associated with the specific DMT
during pregnancy (Level B).
Stopping DMT: Recommendations
Statement 1a
In people with RRMS
who are stable on DMT and want to discontinue therapy, clinicians
should counsel people regarding the need for ongoing follow-up and
periodic reevaluation of the decision to discontinue DMT (Level B).
Statement 1b
Clinicians should
advocate that people with MS who are stable (that is, no relapses, no
disability progression, stable imaging) on DMT should continue their
current DMT unless the patient and physician decide a trial off
therapy is warranted (Level B).
Statement 2a
Clinicians should
assess the likelihood of future relapse in individuals with SPMS by
assessing patient age, disease duration, relapse history, and
MRI-detected activity (e.g., frequency, severity, time since most
recent relapse or gadolinium-enhanced lesion) (Level B).
Statement 2b
Clinicians may
advise discontinuation of DMT in people with SPMS who do not have
ongoing relapses (or gadolinium-enhanced lesions on MRI activity) and
have not been ambulatory (EDSS 7 or greater) for at least 2 years
(Level C).
Statement 3
Clinicians should
review the associated risks of continuing DMTs vs those of stopping
DMTs in people with CIS using DMTs who have not been diagnosed with
MS (Level B).
