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THUR 179 Ocrelizumab effect on neda in patient subgroups of opera I and opera II
  1. Turner Ben1,
  2. Papeix Caroline2,
  3. Cree Bruce3,
  4. Kappos Ludwig4,
  5. Montalban Xavier5,
  6. Wolinsky Jerry6,
  7. Buffels Regine7,
  8. Han Jian8,
  9. Hauser Stephen3
  1. 1Royal London Hospital, London
  2. 2Pitié-Salpêtrière Hospital, Paris, France
  3. 3University of California, San Francisco, CA, USA
  4. 4University Hospital Basel, Switzerland
  5. 5Division of Neurology, University of Toronto, Toronto, ON, Canada
  6. 6McGovern Medical School, UTHealth, Houston, TX, USA
  7. 7F. Hoffmann-La Roche Ltd, Basel, Switzerland
  8. 8Genentech, Inc., South San Francisco, CA, USA


Background In a pooled analysis of patients with relapsing multiple sclerosis in the Phase III OPERA I and OPERA II (NCT01247324/NCT014112333) studies, ocrelizumab increased the proportion of patients with no evidence of disease activity (NEDA) vs interferon β−1a (IFNβ1a); post hoc subgroup analyses are reported here.

Methods NEDA (no 12 week confirmed disability progression, relapse, new/enlarging T2 lesions or T1 gadolinium enhancing lesions) rates were compared by Cochran–Mantel–Haenszel test on the pooled modified intent-to-treat (mITT) population (ocrelizumab, n=761 [600 mg intravenously every 24 weeks]; IFNβ1a, n=759 [44 μg subcutaneously three times weekly]; excludes patients with NEDA discontinuing for reasons unrelated to efficacy).

Results Treatment benefit for NEDA in the mITT population with ocrelizumab vs IFNβ1a (47.7% vs 27.1%; p<0.001) was maintained across subgroups (ocrelizumab/IFNβ1a; p<0.001 unless stated): age (<40 years: 44.3%/22.6%; ≥40 years: 52.8%/33.7%), gender (male: 44.0%/22.2%; female: 49.7%/29.6%), prior [last 2 years] disease-modifying therapy (yes: 42.8%/23.9%; no: 49.5%/28.3%), prior relapses [last 12 months] (≤1: 49.2%/29.2%; ≥2: 44.2%/22.6%), baseline T1 Gd-enhancing lesions (none: 59.6%/38.8%; ≥1: 30.1%/10.2%) and baseline EDSS score (EDSS <2.5/<4.0: ocrelizumab 50.5%/50.3%, IFNβ1a 27.5%/26.4%; EDSS ≥2.5/≥4.0: ocrelizumab 46.0%/39.6%, IFNβ1a 26.9%/29.4% [NB: EDSS score ≥4: ocrelizumab/IFNβ1a p=0.043]).

Conclusions Subgroup analyses were consistent with those of the overall pooled population on maintaining NEDA status.

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