Early Natalizumab treatment

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No sooner has the dust from ProfGs survey settled. When you suggested that natalizumab first line may be a nice addition to UK MS treatment…..no sooner have we said ATTACKMS butDr.Foxy has come out with some data looking at early treatment with natalizumab….and guess what have low lesion numbers and disability is a good sign

Natalizumab in Early Relapsing-Remitting Multiple Sclerosis: A 4-Year, Open-Label Study.Perumal J, Balabanov R, Su R, Chang R, Balcer L, Galetta S, Campagnolo DI, Avila R, Lee L, Rutledge D, Fox RJ.Adv Ther. 2021 May 20. doi: 10.1007/s12325-021-01722-w.

Introduction: STRIVE was a 4-year, multicenter, observational, open-label, single-arm study of natalizumab treatment in anti-JC virus antibody-negative (JCV-negative) relapsing-remitting multiple sclerosis (RRMS) patients with disease duration ≤ 3 years. The objective of STRIVE was to examine no evidence of disease activity (NEDA) status and predictors of NEDA in natalizumab-treated patients with early RRMS.

Methods: Proportions of patients with NEDA were evaluated along with baseline predictors of NEDA, annualized relapse rate, 24-week confirmed disability worsening (CDW), magnetic resonance imaging assessments (T2 and gadolinium-enhancing lesions), and serious adverse events.

Results: In years 1 and 2, 56.1% (95% confidence interval [CI] 48.7-63.4%) and 73.6% (95% CI 66.2-80.2%) of patients (intent-to-treat population [N = 222]), respectively, achieved NEDA. In years 3 and 4, 84.6% (95% CI 78.0-89.9%) and 91.9% (95% CI 86.4-95.8%) of patients, respectively, achieved Clinical NEDA (no relapses or 24-week CDW). Baseline predictors of NEDA in year 4 were Expanded Disability Status Scale score ≤ 2.0 (odds ratio [OR] = 3.85 [95% CI 1.54-9.63]; p = 0.004) and T2 lesion volume > 4 cc (OR = 0.39 [95% CI 0.15-0.98]; p = 0.046), with the latter also predicting Clinical NEDA in year 4 (OR = 0.21 [95% CI 0.05-0.92]; p = 0.038). The cumulative probability of CDW at year 4 was 19.3%. Serious adverse events were reported in 11.3% of patients.

Conclusion: These results support the long-term safety and effectiveness of natalizumab. Baseline predictors of NEDA help to inform benefit-risk assessments of natalizumab treatment in JCV-negative patients with early RRMS.

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MouseDoctor

5 comments

  • I beg to disagree. Prof G can tell you why…he has my file.

    Let’s just rebrand it as (I) natalizumab buys you a few more years of freedoms from MS symptoms or (ii) natalizumab tricks you into a false sense of contentment.

    • Are you contesting safety or efficacy?
      “Let’s just rebrand it as …”. Could the same not be said for all DMTs, depending on who you are talking to? For some people HSCT and Alem are disappointing ultimately but for some not. Same with all the DMTs when you read personal experiences. At least that is what it seems like.

      • “natalizumab tricks you into a false sense of contentment.”

        He’s saying stopping relapses makes one think they’re cured but
        ms brain loss is happening all the while…

    • This worries me. I stared first line in my mid-forties and have no disability, but lots of lesions on brain/spine MRI. I was hoping this was good news.

      • Eh. One patient saying ‘but it didn’t work for me!’ shouldn’t worry you.

        A minority of the patients in the study got worse. The majority did not. I’m not even sure what Tony is disagreeing with here.

        I got Tysabri first line last year and so far it’s working nicely. Even if it just buys me ‘a few more years of freedom from symptoms’ that’s very significant.

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