Characterizing the Use of Ofatumumab in a Real World Setting

Proportion of doses not completed within three days of the expected date during initiation to be collected

Proportion of doses not completed within 3 days of the expected date during the first three months of maintenance to be collected

Proportion of doses not completed within three days of the expected date to be collected

Proportion of doses not completed within 14 days of the expected date to be collected

Proportion of participants with a treatment interruption of more than six months during maintenance to be collected.

Interruption is calculated as 6 doses not completed

Proportion of participants discontinued within three months of the intial dose to be collected

Proportion of participants discontinued within 12 months of the initial dose to be collected

Patient sub-groups will be compared to either other complementary sub-groups or the "all patients" cohort

This outcome measure will be measured for those patients who have MRI completed at approximately 18 months

This outcome measure will be measured for those patients who have MRI completed at approximately 18 months

The Work Productivity and Activity Impairment (WPAI) measures Four domain specific scores assessing work productivity and activity impairment (Absenteeism; Presenteeism; Mean work productivity; Activity impairment). Scores range from 0 to 100%. The four scores are expressed as impairment percentages with a higher score indicating less productivity and greater activity impairment.

It comprises of a short descriptive system questionnaire and a visual analogue scale (VAS). The questionnaire provides a simple descriptive profile of a respondents health state and the VAS provides an alternative way to elicit an individuals rating of their own overall current health. Scale is rated from 0 (worst imaginable health) to 100 (the best imaginable scale)

The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).

TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction .

Proportion of self administration as calculated by the number of self administered doses compared to the total number of doses over the total study time

Proportion of patients initiating ofatumumab who are treatment naïve relative to prior high efficacy therapy as defined in Australia as alemtuzumab, ocrelizumab, natalizumab and cladribine) and other non-high efficacy Disease Modifying Therapies (DMTs).

EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.

EDSS scores range between 0 and 10 in 0.5 unit increments. Scores increase when the severity of the disability increases

Measured by number of relapses over a period of approximately 12 months.

This will only be assessed where gadolinium is used as per Institution's usual practice. Otherwise, this will not be reported

Number of new or enlarging T2 lesions on MRI to be collected

The percent brain volume change analysis will be performed at 12 months follow up (either Month 12 (cf. Baseline) or Month 18 (cf. Month 6), via use of the SIENA method for atrophy analysis.