A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis

Proportion of patients with high serum neurofilament light (sNfL) levels within 24 months of observation

Description of perception, utility, frequency of serum neurofilament light (sNfL) measurements and clinical consequences initiated by the treating physician in clinical routine care setting

Proportion of patients demonstrating radiological (number of new/enlarging T2 lesions, number of Gadolinium-positive T1 lesions) and / or clinical activity (MS relapse, confirmed disability progression) at Baseline and throughout the study also in context with sNfL level.

Proportion of patients with NEDA at 12 and 24 months as compared to Baseline also in context with sNfL level.

NEDA is defined by no confirmed multiple sclerosis relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening.

Proportion of patients perceived as clinically stable depending on sNfL level

The Multiple Sclerosis Impact Scale version 2 will be used to assess health-related quality of life. MSIS-29 is a 29-item, self-administered questionnaire that includes two domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day-to-day life.

FSMC consists of 20 items (10 for cognitive fatigue [FSMCcog] and 10 for motor fatigue [FSMCmot]) with 1-5 points per item. The total possible score ranges from 20-100 points. A sum score of ≥43 is categorized as mild fatigue, ≥53 as moderate fatigue and ≥63 as severe fatigue.

This patient questionnaire is a generic multidimensional measure of health-related quality of life (EuroQol 1990). The five domains of mobility, ability to take care of oneself, everyday activities, pain/discomfort and anxiety/depression are considered. For each dimension, the most appropriate answer is selected from three given possibilities (1=no problem, 2=moderate problem, 3=big problem). In addition, the patient marks the current state of health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health).

Change in satisfaction scores and evaluation of improvement of patient-physician dialogue and Multiple Sclerosis patient management

The TSQM Version 1.4 comprises 14 items across four domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items) of the medication over the previous 2-3 weeks, or since the subject´s last use. With the exception of item 4 (presence of side effects; yes or no), all items have 5 or 7 responses, scored from 1 (least satisfied) to 5 or 7 (most satisfied). The 7-item scales had a non-neutral midpoint, such that there were more positive response options than negative response options, to allow precise information to be obtained at the upper end of the score distribution. Item scores are summarized to give four domain scores, which are in turn transformed to a scale of 0-100.

Reasons for and proportion of patients switching from current DMTs to ofatumumab depending on sNfL level

Proportion of missed ofatumumab doses within one year, defined as the difference between number of planned doses and number of administered doses.

Proportion of patients who continue to receive their initial treatment (ofatumumab or DMT category 1)

Reasons for and number of treatment interruptions and discontinuations.

Duration of treatment interruptions and discontinuations.

Patients with matching number of planned doses and number of administered doses within 1 year (eg, previous experience with sub-cutaneous therapy)