Ofatumumab Label

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Someone asked about the vaccination responses to ofatumumab. I said it may be in the label. I forgot the way to search it was using the trade name

Its here. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf

The data was less than anticipated. The label says

Vaccinations
Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation
until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to
initiation of KESIMPTA for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to initiation of
KESIMPTA for inactivated vaccines [see Warnings and Precautions (5.1)].

Vaccinations
Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of KESIMPTA for
live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to initiation of KESIMPTA for inactivated vaccines.
KESIMPTA may interfere with the effectiveness of inactivated vaccines.
The safety of immunization with live or live-attenuated vaccines following KESIMPTA therapy has not been studied.
Vaccination with live or live-attenuated vaccines is not recommended during treatment and after discontinuation until B cell repletion

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MouseDoctor

10 comments

  • Erm…isn’t this in any way alarming?! (Or am I stating the obvious?!)….you say :

    “Vaccination with live or live-attenuated vaccines is not recommended during treatment and after discontinuation until Bcell repletion”

    Isn’t that what the DMDS do ?
    Especially the newer ones?

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5876115/

    Er what happens if we want to, or are all forced or co-erced or made to have the vaccine for COVID-19 .?

    (And Isnt being susceptible to every virus going not a rough way to live btw Never mind the global pandemic) hmmm

    It’s a funny co- incidence that the old timers (the SPs primary progressive MS is it’s brutal sibling) who didn’t have access to these dmds; in a lot of cases have survived and thrived, regardless of their slowly progressive MS.

    The life they have enjoyed has negated the inconvenience, interruption and adaptations having to now be made
    What are we all doing here
    Making ourselves sick and vulnerable to killer viruses- all to hopefully stave off the inevitable, spending the best years of your life having treatments that are also used to save people’s lives

    Newsflash; we are all dying
    …(and Id rather die fighting than live on my knees)
    Making the very best of our youth and vitality and enthusiasm for life is surely more important than becoming a professional patient/guinea pig in the best years of your life

    Why treat what may not come as if it’s cancer
    Especially, especially in these viral times.
    The quest to find a cure should be the focus now
    I’m over the pharma

    ‘…Dear jk can u please, please fund a search for an actual CURE…(and use the people who are working at lightening speed on the vaccine for COVID and the Barts team obs…)
    Thanks for all your hardwork…just jumped down off my soapbox to draft a letter…

  • Erm…isn’t this in any way alarming?! (Or am I stating the obvious?!)….you say :

    “Vaccination with live or live-attenuated vaccines is not recommended during treatment and after discontinuation until Bcell repletion”

    Isn’t that what all of the DMDS do ?
    Especially the newer ones?

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5876115/

    Er what happens if we are all forced or co-erced or made to have the vaccine for COVID-19 .?

    And Isnt being susceptible to every virus going not a rough way to live btw (Never mind the global pandemic) hmmm
    It’s a funny co- incidence that the old timers (the SPs primary progressive MS is it’s brutal sibling) who didn’t have access to these dmds; in a lot of cases have survived and thrived, regardless
    of their slowly progressive MS.
    The life they have enjoyed has negated the inconvenience and interruption and adaptations having to now be made
    What are we all doing here ?!

    Making ourselves sick and vulnerable to killer viruses- all to hopefully stave off the inevitable, spending the best years of your life having treatments that are also used to save people’s lives
    Newsflash; we are all dying
    …(Id rather die fighting than live on my knees)
    Making the very best of our youth and vitality and enthusiasm for life is surely more important than becoming a professional patient in the best years of your life

    Why treat what may not come as if it’s cancer
    Especially, especially in these viral times.
    The quest to find a cure should be the focus now

    ‘…Dear jk can u please, please fund a search for an actual CURE…(and use the people who are working at lightening speed on the vaccine for COVID and the Barts team obs…)

    • The vaccine for COVID-19….currently there are lots of variants, the American variiant that is furthest ahead is not a live vaccine.

      • Fact is we just don’t know eh? I was just alarmed because it is likely that any vaccine will be to ‘save the world’ and therefore mandatory
        Apologies for the duplicated waffle, I did email and to ask for it to be removed…

  • Hi MD, a belated thanks for this post (I was the one who requested it). You confirmed what surprised me – the vaccine language in the label implies that a washout is needed for some (all?) of the Covid vaccines, but none of the materials describe what the observed washout period was in the trials. In comparison, the ocrelizumab label includes data on the washout period: “For B-cell counts, assays for CD19+ B-cells are used because the presence of OCREVUS interferes with the CD20 assay. Treatment with OCREVUS reduces CD19+ B-cell counts in blood by 14 days after infusion. In clinical studies, B-cell counts rose to above the lower limit of normal (LLN) or above baseline counts between infusions of OCREVUS at least one time in 0.3% to 4.1% of patients. In a clinical study of 51 patients, the median time for B-cell counts to return to either baseline or LLN was 72 weeks (range 27-175 weeks) after the last OCREVUS infusion. Within 2.5 years after the last infusion, B-cell counts rose to either baseline or LLN in 90% of patients. ” (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s020lbl.pdf)

    • They have taken the cautious views and so there maybe time to wait to get them or get them just before the next cycle of treatment for continous treatments fingolimodand CD20 are the most concernng

      • Hi MD – talked to my primary neuro last week and found out he’s involved with a trial to measure vaccine responsiveness for people on ofatumumab (focused on existing vaccines – e.g., shingles – not Covid). So it seems that the data for vaccine responsiveness + ofatumumab just doesn’t exist yet.

        • I know the trial is called

          Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)NCT03650114. The plan was to recruit 2000 people and the start date was 2018, so if they are desparate to know they can break the codes.because end date is 2028. There are 292 sites including 6 in UK including Royal London

      • Found a little more data that could be relevant to thinking about vaccine readiness while on anti-CD20 drugs…Reading one of your other posts referencing ofatumumab sent me to a paper that references data on the timeline for reconstitution for anti-CD20 drugs. Sounds like ofatumumab reconstitutes more quickly than Ocrevus (I think?), but it’s not clear to me if it was measured after comparable amounts of time on the drug (i.e., how many doses of ocrelizumab = 6 doses of ofatumumab?). What do you think?

        Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7405500/

        “Monthly subcutaneous treatment with ofatumumab takes a median of 49 weeks (range = 14–102 weeks) for CD19 B cell repletion after six 60‐mg cycles of treatment, and immature (CD19+, CD38+, CD10+) cells repopulate quickly [104]. This may have some merits for ofatumumab if the rapid repopulation of B cells can be confirmed with more prolonged usage, once ofatumumab is licenced to treat MS. Repopulation of B cell subsets following ocrelizumab has not been reported previously, but we report here the influence of ocrelizumab on B cell subsets from the Phase II open‐label extension study (Fig. 3a,b) [105]. It was found that CD4 and CD8 T cell numbers were relatively unaffected (Fig. 3a,b), even during active treatment (Fig. ​(Fig.3b).3b). CD19 B cell subsets, including memory (CD19+, CD27+, CD38low) B cells, are completely depleted during active treatment (Fig. ​(Fig.3b).3b). Even following cessation of treatment, CD19+ B cells remain low for 6–12 months after the last infusion (Fig. ​(Fig.3a).3a). It is evident, however, that the memory B cell pool remained depleted for much longer, at least 18 months (Fig. 3a,b), and probably even longer in many individuals [105]. This is consistent with the durability of relapse inhibition and adds further support to the view that cells within this subset are important in MS disease pathogenesis [2, 9]. However, there appeared to be some recovery of the naive (CD19+, CD21, IgD+, IgM+) B cell pool during this time (Fig. ​(Fig.3a),3a), suggesting the potential to generate new antibody responses which may be crucial to mount an immune response during infections and vaccinations. “

        • Good question for the 20mg dose they suggest it takes 40 weeks (6 months) to replete compared to 62 (3 doses) -72 (4 doses) week. So one imagines with time there may be slower repopulation but we have to see data.

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