Home > Neurology > EAN 2019 > Multiple Sclerosis > Randomised and observational studies comparing treatments

Randomised and observational studies comparing treatments

Presented by
Prof. Giancarlo Comi, Vita-Salute San Raffaele University, Italy
Conference
EAN 2019
Trial
Phase 3, SUNBEAM and RADIANCE
In two randomised phase 3 studies, SUNBEAM and RADIANCE, ozanimod reduced whole brain volume loss (BVL), cortical grey matter volume, and thalamic volume in relapsing MS patients compared with IFN-beta-1a [1]. In two other studies comparing MS treatments, there was no difference in long-term efficacy of IFN and azathioprine [2], while in another study resting state functional connectivity was significantly increased in both fingolimod- and natalizumab-treated relapsing-remitting MS patients [3].

In the SUNBEAM and RADIANCE studies, participants received oral ozanimod hydrochloride 1 or 0.5 mg/day or intramuscular IFN beta-1a 30 µg a week for ≥12 months (SUNBEAM; n=1,346) or 24 months (RADIANCE; n=1,313). The effects on the whole BVL were presented by Prof. Giancarlo Comi (Vita-Salute San Raffaele University, Italy) [1]. After 12 months in SUNBEAM, whole BVL was -0.61, -0.49, and -0.41 in the IFN-beta-1a, ozanimod 0.5 mg, and ozanimod 1 mg group, respectively (nominal P-values for ozanimod 0.5 mg and 1 mg: P=0.0092 and P<0.0001, respectively). After 24 months in RADIANCE, whole BVL was -0.94, -0.71, and -0.71 in the 3 respective groups (nominal P-values for ozanimod 0.5 mg and 1 mg: P=0.0002 and P<0.0001, respectively). Both ozanimod doses also reduced two prespecified exploratory endpoints vs IFN: cortical grey matter volume loss and thalamic volume loss.

In a single-centre study, the long-term efficacy of IFN (n=562) and azathioprine (n=373) in relapsing-remitting MS was retrospectively compared [2]. At 10 year follow-up, 50% of patients were free of any disability worsening and 25% were relapse-free, with no differences between IFN and azathioprine. Safety was also similar, but higher adherence in the azathioprine group suggests better tolerability of azathioprine.

In another study, longitudinal changes of resting state functional connectivity were evaluated in 50 relapsing-remitting MS patients treated with fingolimod (n=23) or natalizumab (n=27) over a period of 2 years [3]. Significant reduction of disease activity, stability of the EDSS score, and improvement of cognitive performance were found in both groups. Resting state functional connectivity significantly increased in the main large-scale functional networks in fingolimod- and natalizumab-treated groups, possibly reflecting a recovery from disease activity before treatment start and subsequent disease stability.

Two anti-CD20 monoclonal antibodies, one chimeric (rituximab; n=53) and one humanised (ocrelizumab; n=38) were compared [4]. B cell levels in the peripheral blood were equally decreased. However, CD4+ and CD8+ lymphocyte reduction was more pronounced in the ocrelizumab group. Patients treated with ocrelizumab presented with 10.6% more reduced overall lymphocyte count (P=0.030) and 8% more increased of CD4/CD8 ratio (P=0.042) after 1 month. After 3 months, patients treated with ocrelizumab presented with 15.2% more reduction of CD4+ lymphocytes (p=0.034).


    1. Arnold D, et al. EAN 2019, O1201.
    2. Mecchi C, et al. EAN 2019, O4110.
    3. Rocca MA, et al. EAN 2019, O4112.
    4. Nozzolillo A, et al. EAN 2019, EPO2227.

 



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