#AAN2018 — Lemtrada Sustains Long-Term Benefits for RRMS Patients, TOPAZ Study Shows

#AAN2018 — Lemtrada Sustains Long-Term Benefits for RRMS Patients, TOPAZ Study Shows

Lemtrada (alemtuzumab) can sustain reduced activity and prevent progression of relapsing-remitting multiple sclerosis (RRMS) for more than seven years, clinical data from the CARE-MS extension trial shows.

Findings were recently presented in four poster presentations at the 2018 Annual Meeting of the American Academy of Neurology (AAN) in Los Angeles.

Lemtrada, marketed by Sanofi Genzyme, is an approved MS therapy that, according to its label, should generally be reserved for patients who have had an inadequate response to two or more other therapies. But the use of the word “generally” opens a window of opportunity “to use Lemtrada as a second-line therapy and potentially first-line therapy,” Barry Singer, MD, director of the MS Center for Innovations in Care at Missouri Baptist Medical Center, said in an email response to questions from Multiple Sclerosis News Today.

The treatment was initially tested in two pivotal clinical trials in comparison with a high-dose under-the-skin injection of Rebif (interferon beta-1a) in RRMS patients. Participants were either new to treatment (CARE-MS I, NCT00530348) or had not responded to prior therapies (CARE-MS II, NCT00548405).

During these trials, patients received 12 mg of Lemtrada for three or five consecutive days in two annual courses — at the beginning of the study and again one year later. After completing this treatment period, they had the opportunity to participate in a four-year extension study (NCT00930553) during which they could receive the therapy as needed to control their disease. Patients completing the extension could enroll in the five-year TOPAZ trial (NCT02255656) for further evaluation.

To date, 80% of the participants (299 patients) from CARE-MS I and 73% from CARE-MS II (317 patients) have completed seven years of long-term follow-up.

After completing two initial courses of Lemtrada, 59% of patients from CARE-MS I and 47% from CARE-MS II did not require additional treatment courses with Lemtrada or other disease-modifying therapies during the next six years. Two-thirds of  CARE-MS II patients who required a third Lemtrada course also experienced disability stabilization one year after the last treatment.

During the seven years of follow-up, reported annualized relapse rates remained low, and 37% of patients from CARE-MS 1 and 44% from CARE-MS II experienced confirmed improvements in disability. In fact, during this period, only 26% from CARE-MS 1 and 31% from CARE-MS II showed disability worsening.

The treatment also had a sustained effect on slowing brain volume loss by the seventh year, with a median yearly brain volume loss of 0.20% or less from the third to seventh year. This effect was found to be even better than that reported during the initial two years of treatment in the pivotal studies (0.59% in the first year and 0.25% in the second year in CARE-MS I, and 0.48% in year one and 0.22% in year two in CARE-MS II).

Additionally, evaluation by magnetic resonance imaging (MRI) showed no signs of disease activity during the seven years of follow-up.

“The extension study data being presented at AAN illustrate that more than two-thirds of patients did not experience confirmed disability worsening at year seven after initiating treatment with Lemtrada,” Singer said in a press release. “In addition, consistent effects were maintained over time across relapses and MRI outcomes including brain volume loss, even though the majority of patients did not receive any additional treatment over the prior six years.”

During the extension studies, the frequency of adverse events was similar to that reported during the pivotal studies. In seven years, three deaths occurred, none of which was considered to be treatment-related. Thyroid adverse events were reported to be more frequent by the third year, but declined thereafter.

As Singer noted, “the serious risks of Lemtrada, including serious infusion reactions, serious infections, thyroid disease, kidney disease, low platelets and potential malignancies, must always be discussed with the patient.”

All patients should also be carefully monitored on a monthly basis for four years after the last treatment course “to screen for autoimmune complications, including low platelet counts, thyroid disease, and kidney disease,” he said.

Lemtrada’s long-term effects were shared at the AAN annual meeting in these presentations:

Lemtrada is approved in more than 60 countries, and has additional marketing applications under review by regulatory authorities worldwide.

6 comments

  1. Shirley swanson says:

    Lemtrada for me, left me feeling ten years older than I am. I am now 76 and have been in neuro icu for falls resulting in subdural bleeds.
    I was jc positive before I started but did not get pml
    I’m twice as tired as I was before I started it. It appears to be a decision I am regretting but you never know until you roll the dice!

  2. Jason says:

    “The treatment also had a sustained effect on slowing brain volume loss by the seventh year, with a median yearly brain volume loss of 0.20% or less from the third to seventh year.”

    Hmmm…HSCT show an improvement.

    Good luck with your reduced loss though.

  3. Jason says:

    If you want this, fine; or, you want try HSCT. Here’s a list of providers:

    State of Illinois approved 2013
    State of Illinois approved 2013
    BCBS Federal Program approved 2013
    Care First BCBS approved 2013
    Cigna approved 2013
    Humana Military approved 2013
    BCBS Regence approved 2013
    Anthem BCBS approved 2013
    BCBS of Illinois approved 2013
    State of Texas overturned BCBS of Texas denial 2013
    PHCS United Health Group denial was overturned by independent review 2013
    Blue Cross Blue Shield Federal Employee Plan approved 2013
    BCBS of Oregon approved 2013
    Aetna approved 2013
    Blue Cross & Blue Shield of Kansas City approved 2013
    Medicare/Medical Mutual of Ohio approved 2013
    HealthAlliance (state of Illinois plan) approved 2013
    Humana approved 2014
    United Healthcare approved 2014
    Tricare Standard North Region (Health Net Federal) approved 2014
    Blue Cross & Blue Shield of Alabama approved 2014
    Cigna approved 2014

    Or you can leave the country (like me) and get it.

  4. Jason says:

    “#AAN2018 – Blood Stem Cell Transplant Superior to DMDs in Highly Active RRMS, MIST Trial Shows”
    Just curious, why are we using drugs?

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