ocrelizumab Results from the OPERA I and OPERA II phase III studies G Giovannoni D L Arnold A BarOr G Comi H P Hartung E Havrdova L Kappos F Lublin K Selmaj A ID: 619765
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Slide1
NEDA epoch analysis of patients with relapsing multiple sclerosis treated with ocrelizumab: Results from the OPERA I and OPERA II, phase III studies
G
Giovannoni
, D L Arnold, A Bar-Or, G
Comi
, H P
Hartung
, E
Havrdova
, L
Kappos
, F Lublin, K
Selmaj
, A
Traboulsee
, S
Belachew
, J Han, L Julian, S L HauserSlide2
BackgroundNo Evidence of Disease Activity (NEDA) is a composite measure of the absence of detectable clinical and magnetic resonance imaging (MRI) disease activity in relapsing multiple sclerosis (RMS). However, analyses of NEDA using a re-baseline approach may more closely reflect the effects of disease-modifying treatments. Slide3
Background (cont’d)Ocrelizumab
(600 mg), which demonstrated a robust effect on MRI activity at 8 weeks in a Phase II study of MS patients, was evaluated for NEDA from baseline and following re-
baselining
at the time of first MRI (Week 24).Slide4
ObjectiveTo assess the effect of
ocrelizumab
on the proportion of patients with NEDA by epoch in the pooled OPERA I and II studies. Slide5
MethodsIn OPERA I and II, patients were
randomized
1:1 to receive
600 mg
ocrelizumab
every 24 weeks or IFNβ‐1a 44 µg three-times weekly for 96 weeks.
NEDA
[defined as the absence of protocol-defined relapses, 12-week confirmed disability progression (CDP), new/enlarging T2 lesions and T1 gadolinium-enhancing lesions] was assessed in the overall intent-to-treat population over the controlled treatment phase (baseline to 96 weeks).
Further
analyses evaluated the proportion of patients with NEDA from baseline to Week 48 versus from Week 48 to Week 96, and from baseline to Week 24 versus from Week 24 to Week 96. Brain MRI was undertaken at baseline and at Weeks 24, 48 and 96. Slide6
ResultsIn pooled analyses of OPERA I and II, the proportion of patients with NEDA was increased by 75% with
ocrelizumab
compared with IFNβ-1a over 96 weeks (47.7%
versus
27.1
%,
P
<0.0001
).
Compared
with IFNβ-1a, the proportion of patients with NEDA was 57% higher with
ocrelizumab
from baseline to Week 48 (53.5%
versus 34%
) and 47% higher from Week 48 to Week 96 (85.9%
versus
58.6%; both
P
<0.0001
). Slide7
Results (cont’d)Compared with IFNβ-1a, the proportion of patients with NEDA was 36% higher with
ocrelizumab
from baseline to Week 24 (58.3% versus 42.8%) and 76% higher from Week 24 to Week 96 (75.5% versus 42.9%; both
P
<0.0001).
In the
ocrelizumab
and IFNβ-1a groups, respectively, 79.8% versus 44.4% of patients with evidence of disease activity during Weeks 0-48 achieved NEDA during Weeks 48-96 (relative increase with
ocrelizumab
: 84%;
P
<0.0001). Slide8
ConclusionsA higher proportion of patients reached NEDA at first MRI at Week 24 with
ocrelizumab
versus IFNβ-1a. After re-
baselining
, from Week 24 to 96
ocrelizumab
treatment further increased the proportion of patients reaching NEDA status by 76%, relative to IFNβ-1a.