Ofatumumab and PROMS


I understand oftatumumab is available from BartsHealth. You may have heard of the results from the ofatumumab phase III trial against teriflunomide. Here is some more information compared to placebo for 6 months

Kira JI, Nakahara J, Sazonov DV, Kurosawa T, Tsumiyama I, Willi R, Zalesak M, Pingili R, Häring DA, Ramanathan K, Kieseier BC, Merschhemke M, Su W, Saida T. Effect of ofatumumab versus placebo in relapsing multiple sclerosis patients from Japan and Russia: Phase 2 APOLITOS study. Mult Scler. 2021 Nov 17:13524585211055934. 

In the phase 3 ASCLEPIOS I and II trials, ofatumumab 20 mg subcutaneous (SC) every 4 weeks showed superior efficacy versus teriflunomide 14 mg oral once daily, Ofatumumab is approved in the United States, the European Union, and several other countries for the treatment of RMS in adults. Teriflunomide is not an approved disease-modifying therapy (DMT) for use in the MS population in Japan; therefore, patients from Japan were not able to participate in the global phase 3 ASCLEPIOS trials. The placebo-controlled phase 2 APOLITOS study was designed based on the recommendations from the Japanese Health Authority (Pharmaceuticals and Medical Devices Agency (PMDA)) and represents an ethnic bridging study to support the registration of ofatumumab for the treatment of RMS in Japan in conjunction with the ASCLEPIOS I/II trials.

Number of gadolinium enhancing lesions reduced by about 94% overall and the B cells count was observed on Day 2 in the ofatumumab group (3.0 cells/μL in Japan; 14.0 cells/μL in Russia) and further decreased to or below a limit of detection (LOD) of 1 cell/μL in both subgroups up to Week 24. In the placebo group in the Japanese and Russian subgroups, the CD19+ B-cell count remained unchanged during the double-blind treatment epoch. So ensure you have your jabs before starting ofatumumab.

COI Multiple

There are some other posts that many be of interest. We have said it is good to self monitor so you can see if there are changes and this may be useful in discussion with your neuro, but I can’t say much about how this would be viewed in clinic. Maybe some one will take take up the challenege

van Oirschot P, Heerings M, Wendrich K, den Teuling B, Dorssers F, van Ee R, Martens MB, Jongen PJ. A Two-Minute Walking Test With a Smartphone App for Persons With Multiple Sclerosis: Validation Study. JMIR Form Res. 2021 Nov 17;5(11):e29128. 

Background: Walking disturbances are a common dysfunction in persons with multiple sclerosis (MS). The 2-Minute Walking Test (2MWT) is widely used to quantify walking speed. We implemented a smartphone-based 2MWT (s2MWT) in MS sherpa, an app for persons with MS. When performing the s2MWT, users of the app are instructed to walk as fast as safely possible for 2 minutes in the open air, while the app records their movement and calculates the distance walked.

Objective: The aim of this study is to investigate the concurrent validity and test-retest reliability of the MS sherpa s2MWT.

Conclusions: The high correlation between s2MWT distance and the conventional 2MWT distance indicates a good concurrent validity. Similarly, high correlations underpin a good test-retest reliability of the s2MWT. We conclude that the s2MWT can be used to measure the distance that the persons with MS walk in 2 minutes outdoors near their home, from which both clinical studies and clinical practice can benefit.

However, rest assurred I will probably not be calling “you to to arms” discussing black swams or the carbon footprint of DMT.

It would be nice to discuss Do you want to do it?

Healy BC, Zurawski J, Chitnis T, Weiner HL, Glanz BI. Patient-reported outcomes associated with transition to secondary progressive multiple sclerosis. Qual Life Res. 2021 Nov 16. doi: 10.1007/s11136-021-03034-6.

Purpose: To investigate patient-reported outcome (PRO) measures in patients with relapsing-remitting multiple sclerosis (RRMS) who transition to secondary progressive multiple sclerosis (SPMS).

Conclusions: Patients in the period closely preceding transition from RRMS to SPMS have worse physical QOL and fatigue compared to subjects who remain RRMS.

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  • The 2MWT is new information to me. I was only aware of the 25m timed test. Are both used in the NHS? They should be easy enough to administer . The 2MWT may be tricker in a clinic setting if the patient can cover more than a corridor’s distance. Re: self testing, it would be useful. I’ll give it a go tomorrow, as I have the perfect place down the road. More importantly, what do the tests reveal about patients beyond the obvious measurement of time v distance? Slow, worse; faster, better. Is there improvement over time with DMT?

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