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WED 187 Infections in ocrelizumab recipients from phase III studies
  1. Giovannoni Gavin1,
  2. Hartung Hans-Peter2,
  3. Comi Giancarlo3,
  4. de Seze Jérôme4,
  5. Hemmer Bernhard5,
  6. Kappos Ludwig6,
  7. Montalban Xavier7,
  8. Selmaj Krzysztof8,
  9. Mairon Nicole9,
  10. Wolinsky Jerry10
  1. 1Queen Mary University of London
  2. 2Medical Faculty, Heinrich-Heine University Düsseldorf, Germany
  3. 3University Vita-Salute San Raffaele, Milan, Italy
  4. 4University Hospital of Strasbourg, France
  5. 5Technische Universität München, Germany
  6. 6University Hospital Basel, Switzerland
  7. 7University of Toronto, Toronto, ON, Canada
  8. 8Medical University of Lodz, Poland
  9. 9F. Hoffmann-La Roche Ltd, Basel, Switzerland
  10. 10McGovern Medical School, UTHealth, Houston, TX, USA


Background Ocrelizumab Phase III study safety findings in relapsing (OPERA I/II [NCT01247324/NCT01412333]) and primary progressive multiple sclerosis (ORATORIO [NCT01194570]) were reported; infections and serious infections are reported here. Methods: Ocrelizumab patients received 600 mg intravenously every 24 weeks for 96 weeks (OPERA I/II) or ≥120 weeks (ORATORIO; 2 × 300 mg infusions 14 days apart every 24 weeks). Controls received interferon beta-1a 44 µg thrice weekly (IFNβ−1a; OPERA I/II) or placebo (ORATORIO). Infections were classified by MedDRA system organ class/preferred term.

Results Non-serious infection rates in ocrelizumab-treated patients in OPERA were 58.4% (pooled analysis) and ORATORIO 69.8%; comparators were IFNβ−1a 52.4% and placebo 67.8%. Most infections were mild-to-moderate. Common infections (≥10% in either group) reported more in ocrelizumab treated patients were upper respiratory tract infections and either nasopharyngitis (OPERA) or influenza (ORATORIO);<1% of ocrelizumab-treated patients withdrew due to non-serious infections. Serious infections occurred in 1.3% (OPERA) and 6.2% (ORATORIO) of ocrelizumab-treated patients; comparators were IFNβ−1a 2.9% and placebo 5.9%. No infection-related deaths occurred in ocrelizumabtreated patients in OPERA; two deaths occurred in ORATORIO (aspiration pneumonia and pneumonia [unrelated per investigator, related per sponsor]). No opportunistic infections were reported.

Conclusion Serious infection rates with ocrelizumab were numerically lower than with IFNβ−1a and similar compared with placebo.

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