What is secondary progressive MS and how is it treated?

WHAT IS SPMS?1-5

SPMS follows an initial relapsing-remitting course; it is characterized by disability accumulation, defined as a continuous worsening of neurological function, independent of relapses.

MAYZENT® is approved for active SPMS patients

SEE HOW MAYZENT CAN HELP YOUR PATIENTS Arrow
85%

of patients with MS are initially diagnosed with RRMS, according to NMSS

MOST
PATIENTS

with RRMS will eventually progress to SPMS, whether or not they're on treatment

Progression to SPMS may happen sooner than you think6

RRMS SPMS

Signs of progression may go unrecognized during the earlier stages of SPMS due to the subtle changes that occur between the onset of symptoms and a formal diagnosis6,7

How is active SPMS
identified?2

Active SPMS may be defined as SPMS in patients who have had a relapse
within the past 2 years

The clinical burden of SPMS increases as disability worsens8,9

8 FUNCTIONAL DOMAINS MEASURED BY THE EDSS

EDSS Bowel/Bladder Dysfunction EDSS Bowel/Bladder Dysfunction

Bowel/bladder dysfunction

EDSS Memory/Concentration Trouble EDSS Memory/Concentration Trouble

Trouble with memory or concentration

EDSS Weakness/Ambulation Problems EDSS Weakness/Ambulation Problems

Weakness or problems with ambulation

EDSS Numbness/Loss of Sensation EDSS Numbness/Loss of Sensation

Numbness or loss of sensation

EDSS Coordination Problems EDSS Coordination Problems

Problems with coordination

EDSS Speech/Swallowing Difficulty EDSS Speech/Swallowing Difficulty

Difficulty with speech or swallowing

EDSS Vision Problems EDSS Vision Problems

Vision problems

EDSS MS-Related Neurologic Findings EDSS MS-Related Neurologic Findings

Other neurologic findings related to MS

75%

of patients with MS showed signs of progression at EDSS ≤37*

70%

of patients with RRMS remained undiagnosed with SPMS until they began to walk with a cane6,9

75%

of patients with MS showed signs of progression at EDSS ≤37*

70%

of patients with RRMS remained undiagnosed with SPMS until they began to walk with a cane6,9

EDSS Discussion EDSS Discussion

A thorough discussion can make the difference

Talking to your patients and their care partners about the signs and symptoms of progression is crucial. Work with your patients by sharing resources to identify any changes in their symptoms.

Recognizing progression early on and taking action may help to delay the accumulation of disability.10

EDSS=Expanded Disability Status Scale; MS=multiple sclerosis; NMSS=National Multiple Sclerosis Society; RRMS=relapsing-remitting MS; SPMS=secondary progressive MS.

*In a natural history analysis of 824 attack-onset patients with MS.7

The percentage of patients who reached EDSS ≥6 at the time of SPMS diagnosis, from a review of 88 RRMS patients with long-term follow-up to observe the transition to SPMS.6

References: 1. NMSS — Types of MS. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed February 14, 2019. 2. Mayzent [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; March 2019. 3. Weinshenker BG, Bass B, Rice GP, et al. The natural history of multiple sclerosis: a geographically based study. I. clinical course and disability. Brain. 1989;112(pt 1):133-146. 4. Leray E, Yaouanq J, Le Page E, et al. Evidence for a two-stage disability progression in multiple sclerosis. Brain. 2010;133(7):1900-1913. doi:10.1093/brain/awq076. 5. Bsteh G, Ehling R, Lutterotti A, et al. Long term clinical prognostic factors in relapsing-remitting multiple sclerosis: insights from a 10-year observational study. PLoS One.2016;11(7):e0158978. doi:10.1371/journal.pone.0158978 6. Katz Sand I, Krieger S, Farrell C, Miller AE. Diagnostic uncertainty during the transition to secondary progressive multiple sclerosis. Mult Scler. 2014;20(12):1654-1657. 7. Kremenchutzky M, Rice GPA, Baskerville J, Wingerchuk DM, Ebers GC. The natural history of multiple sclerosis: a geographically based study 9: observations on the progressive phase of the disease. Brain. 2006;129:584-594. 8. Diagnosing SPMS. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Secondary-progressive-MS/Diagnosing-Secondary-progressive-MS. Accessed April 4, 2019. 9. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983;33(11):1444-1452. 10. Gross HJ, Watson C. Characteristics, burden of illness, and physical functioning of patients with relapsing-remitting and secondary progressive multiple sclerosis: a cross-sectional US survey. Neuropsychiatr Dis Treat. 2017;13:1349-1357.

Back to top

Indication and Important Safety Information

INDICATION

MAYZENT® (siponimod) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Patients with a CYP2C9*3/*3 genotype

  • In the last 6 months, experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure

  • Presence of Mobitz type II second-degree, third-degree atrioventricular block, or sick sinus syndrome, unless patient has a functioning pacemaker

INDICATION

MAYZENT® (siponimod) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Infections: MAYZENT may increase risk of infections with some that are serious in nature. Life-threatening and rare fatal infections have occurred.

Before starting MAYZENT, review a recent complete blood count (CBC) (ie, within 6 months or after discontinuation of prior therapy). Delay initiation of treatment in patients with severe active infections until resolved. Employ effective treatments and monitor patients with symptoms of infection while on therapy. Consider discontinuing treatment if patient develops a serious infection.

Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another sphingosine 1-phosphate (S1P) receptor modulator. Rare cases of CM have occurred with MAYZENT. If CM is suspected, MAYZENT should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.

No cases of progressive multifocal leukoencephalopathy (PML) were reported in MAYZENT clinical trials; however, they have been observed in patients treated with another sphingosine 1-phosphate (S1P) receptor modulator and other multiple sclerosis (MS) therapies. If PML is suspected, MAYZENT should be discontinued.

Cases of herpes viral infection, including one case of reactivation of varicella zoster virus leading to varicella zoster meningitis, have been reported. Patients without a confirmed history of varicella zoster virus (VZV) or without vaccination should be tested for antibodies before starting MAYZENT. If VZV antibodies are not present or detected, then VZV immunization is recommended and MAYZENT should be initiated 4 weeks after vaccination.

Use of live vaccines should be avoided while taking MAYZENT and for 4 weeks after stopping treatment.

Caution should be used when combining treatment (ie, anti-neoplastic, immune-modulating, or immunosuppressive therapies) due to additive immune system effects.

Macular Edema: In most cases, macular edema occurred within 4 months of therapy. Patients with history of uveitis or diabetes are at an increased risk. Before starting treatment, an ophthalmic evaluation of the fundus, including the macula, is recommended and at any time if there is a change in vision. The use of MAYZENT in patients with macular edema has not been evaluated; the potential risks and benefits to the individual patient should be considered.

Bradyarrhythmia and Atrioventricular Conduction Delays: Prior to initiation of MAYZENT, an ECG should be obtained to determine if preexisting cardiac conduction abnormalities are present. In all patients, a dose titration is recommended for initiation of MAYZENT treatment to help reduce cardiac effects.

MAYZENT was not studied in patients who had:

Reinitiation of treatment (initial dose titration, monitoring effects on heart rate and AV conduction [ie, ECG]) should apply if ≥4 consecutive daily doses are missed.

Respiratory Effects: MAYZENT may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy if clinically warranted.

Liver Injury: Elevation of transaminases may occur in patients taking MAYZENT. Before starting treatment, obtain liver transaminase and bilirubin levels. Closely monitor patients with severe hepatic impairment. Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes checked, and MAYZENT should be discontinued if significant liver injury is confirmed.

Increased Blood Pressure: Increase in systolic and diastolic pressure was observed about 1 month after initiation of treatment and persisted with continued treatment. During therapy, blood pressure should be monitored and managed appropriately.

Fetal Risk: Based on animal studies, MAYZENT may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during and for 10 days after stopping MAYZENT therapy.

Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a sphingosine 1-phosphate (S1P) receptor modulator. Such events have not been reported for patients treated with MAYZENT in clinical trials. If patients develop any unexpected neurological or psychiatric symptoms, a prompt evaluation should be considered. If PRES is suspected, MAYZENT should be discontinued.

Unintended Additive Immunosuppressive Effects From Prior Treatment or After Stopping MAYZENT: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects.

Initiating treatment with MAYZENT after treatment with alemtuzumab is not recommended.

After stopping MAYZENT therapy, siponimod remains in the blood for up to 10 days. Starting other therapies during this interval will result in concomitant exposure to siponimod.

Lymphocyte counts returned to the normal range in 90% of patients within 10 days of stopping therapy. However, residual pharmacodynamic effects, such as lowering effects on peripheral lymphocyte count, may persist for up to 3-4 weeks after the last dose. Use of immunosuppressants within this period may lead to an additive effect on the immune system, and therefore, caution should be applied 3-4 weeks after the last dose of MAYZENT.

Severe Increase in Disability After Stopping MAYZENT: Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of an S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping MAYZENT treatment, thus patients should be monitored upon discontinuation.

Most Common Adverse Reactions: Most common adverse reactions (>10%) are headache, hypertension, and transaminase increases.

Please click here for full Prescribing Information, including Medication Guide.