Kesimpta
101
101
MOA of Kesimpta
precise mechanism by which ofatumumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ofatumumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.
Primary endpoint outcome
reduction in annualized relapse rates: ofatumamab demonstrated significant reduction in the annualized relapse rate of 51% and 58% (both P<0.001) compared to teriflunomide
These DMT’s act via anti-inflammatory effects to modulate theimmune response and reduce the accumulation of immune cells in the CNS called immunomodulation
Copaxone, Avonex, Rebif, Techfidera, Aubagio
Hallmarks of RRMS
flare ups and remission. Relapses are a main feature in patients with RRMS and are defined as the occurrence of a new or worsening neurologic symptoms lasting more than 24 or 48 hours that are preceded by a period of at least 30 days of clinical stability or improvement
Manages the patient intake and treatment initiation processes as well as completes the Welcome and Coverage Determination calls
PAC - patient access coordinator at Covermymeds
The loading dose of Kesimpta
initial dosing of 20 mg by subcutaneous injection at Weeks 0, 1, and 2, followed by subsequent dosing of 20 mg by subcutaneous injection once monthly starting at Week 4
3 month and 6 month Confirmed Disability Progression in pooled analysis
ofatumumab 10.9% vs. 15% in the Aubagio group or six months ofatumumab 8.1% vs. 12% Aubagio group
These DMT’s Inhibit of egress of lymphocytes from lymph nodes
Mayzent, Gilenya, Zeposia
On this type of MRI “black holes”- lesions appear as persistently hypo-intense. This may be a sign of demyelination and axonal loss
T1 weighted
Completes Welcome Call ONLY for commercially insured patients enrolled in Bridge Program
PCC - patient care coordinator from Homescripts
Most common side effects of Kesimpta in clinical trials which occurred in at least 10% of patients
Injection related reactions, nasopharyngitis, headache, injection site reactions, upper respiratory infections, and urinary tract infections
rate of any adverse event in trials
83.6% ofatumumab, 84.2% Aubagio
This therapy binds to a4B1- integrinhampering movement of potentially damaging immune cells from the bloodstream, across the “blood-brain barrier” into the brain and spinal cord
Tysabri
The 6 score ranges of the EDSS are
o 0-2.5- no or minimal disability
o 3.0-5.5- moderate or severe disability, but person ambulatory
o 6.0 needs single device to walk and a score of 6.5 indicates that 2 walking devices are needed
o 7.0- indicates wheelchair most of the time
o 8.5-9.5- generally bedridden
o 10- died from MS
This person provides an overview of the patient program, helps patients understand treatment, and discusses adherence offerings. they can conduct virtual injection demonstration via video chat, if requested by the patient. They are the virtual single point of contact for patients throughout the adherence journey (outreach frequency based on patient needs and support surveys)
PSC- patient services coordinator, a Novartis contract employee
must be done before starting Kesimpta
Hepatitis B, quantitative serum immunoglobulins, no live vaccines 4 weeks prior, non live vaccines 2 weeks prior
Median time of patients in trials
1.6 years
These therapies activate the Nrf2 pathway in our cells. During inflammation, the body produces toxins that can cause oxidative stress on the cells. When this stress builds up, it can damage or even destroy healthy cells in different parts of the body, including the central nervous system (CNS).One way the body reacts to oxidative stress is through a pathway called Nrf2
Vumerity and Tecfidera
These type of images allows greater visualization of structures from CSF because CSF appears dark
FLAIR
This person builds advocacy and support for Novartis brand(s) among thought leaders • Utilizes approved materials to serve as the primary contact with key thought leaders • Will connect other relevant parts of the Novartis organization (eg, Marketing, Market Access, Medical Affairs) while maintaining compliance with guidelines on appropriate medical/commercial collaboration
• Responsible for coordination of national/regional conferences and peer-to-peer educational initiative
Thought Leader Liason
The most common cause of discontinuation in patients treated with KESIMPTA
(3.5%) low immunoglobulins
Number is sites in trials, number of countries, number of ofatumumab patients and number of Aubagio patients
385 sites in 37 countries , 946 ofatumumab patients, 936 Aubagio patients
This therapy is a humanized monoclonal antibody directed against the cell surface marker CD20, which is found on immature and mature B cells. When bound to B cells, ocrevus causes cell lysis and a reduction in circulating B cell counts.
Ocrevus
B cells role in MS
are thought to contribute to relapse in MS through antibody independent pro inflammatory mechanisms including the interaction with other immune cells in the periphery and their ability to recruit and activate T cells and myeloid cells in the CNS
This person provides education to providers and office staff on Novartis process and programs • Central point of contact for payer issues raised by PSCs, Case Managers, and field sales personnel • Collaborates compliantly with Sales, MS-AMs, and ADRA on updates and issues
Field Reimbursement Manager