This study was an uncontrolled, central registration system, open-label, multicenter observational study in patients using Kesimpta for the labeled indication.
This was a primary data collection-based special drug-use surveillance to be conducted in accordance with the GPSP ordinance. Observational period lasted 24 months from the start of treatment with Kesimpta.
Study Type
OBSERVATIONAL
Enrollment
367
Prospective observational cohort study. There was no treatment allocation.
Incidence of adverse events (AEs)
An adverse event (AE) is any untoward medical occurrence experienced by a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not related to the medicinal product(s).
Time frame: 24 months
Incidence of serious adverse events (SAEs)
A SAE is defined as an adverse event which: * Is fatal or life-threatening * Results in persistent or significant disability/incapacity * Constitutes a congenital anomaly/birth defect * Requires inpatient hospitalization or prolongation of existing hospitalization, unless hospitalization is for: * Routine treatment or monitoring of the indication under study, not associated with any deterioration in condition * Elective or pre-planned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of treatment with Kesimpta * Social reasons and respite care in the absence of any deterioration in the patient's general condition * Is medically significant, i.e., events that jeopardize the patient or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: 24 months
Incidence of adverse reactions
An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Kesimpta or whose causality is not recorded.
Time frame: 24 months
Physician's Global Assessment
The investigator comprehensively assessed the symptom changes in relapsing-remitting Multiple Sclerosis (MS) and active Secondary Progressive Multiple Sclerosis (SPMS), rating the changes as "very much improved", "improved", "unchanged", "worsening" or "not assessable" in comparison with the symptoms at the start of this drug, and record the results in the Case report forms (CRFs).
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Novartis Investigative Site
Ichinomiya, Aichi-ken, Japan
Novartis Investigative Site
Nagakute, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Tokoname, Aichi-ken, Japan
Novartis Investigative Site
Toyohashi, Aichi-ken, Japan
Novartis Investigative Site
Hachinohe, Aomori, Japan
Novartis Investigative Site
Hachinohe, Aomori, Japan
Novartis Investigative Site
Hirosaki, Aomori, Japan
...and 93 more locations
Time frame: month 12, month 24 (or at treatment discontinuation)
Confirmed disability worsening on Expanded Disability Status Scale (EDSS)
EDSS is a method of quantifying disability in multiple sclerosis (MS) and monitoring changes in the level of disability over time. The scale ranges from 0 (being normal neurological exam and no disability in any functional system) up to 10 (death due to MS). Confirmed disability worsening on EDSS continuing for ≥ 3 months and ≥ 6 months (3mCDW, 6mCDW)
Time frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)
Confirmed improvement on Expanded Disability Status Scale (EDSS)
EDSS is a method of quantifying disability in multiple sclerosis (MS) and monitoring changes in the level of disability over time. The scale ranges from 0 (being normal neurological exam and no disability in any functional system) up to 10 (death due to MS). Confirmed improvement on EDSS continuing for ≥ 6 months (6mCDI)
Time frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)
Number of gadolinium (Gd)-enhancing lesions on Magnetic Resonance Imaging (MRI)
The investigator recorded, in the Case report forms (CRFs), the numbers of gadolinium (Gd)-enhancing lesions on MRI
Time frame: Baseline, month 6, month 12, month 18, month 24 (or at discontinuation)
Annual relapse rate
Relapse: Occurrence of new neurological abnormalities or pre-existing neurological abnormalities in stable state or remission occurring at least 30 days after the occurrence of the previous clinical demyelination event that continues at least for 24 hours without pyrexia and infection.
Time frame: Up to 24 months
No Evidence of Disease Activity (NEDA-3)
NEDA-3 assessments: no relapse, no new/enlarged MRI lesion, no disability progression on EDSS
Time frame: month 12, month 24