Contributions
Abstract: P1229
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Ongoing safety reporting is crucial to understanding the long-term benefit-risk profile of ocrelizumab in patients with multiple sclerosis (MS). The safety and efficacy of ocrelizumab have been characterised in one Phase II study in relapsing-remitting MS (RRMS; NCT00676715), two identical Phase III trials in relapsing MS (RMS; OPERA I/II [NCT01247324]/[NCT01412333]) and the Phase III trial in primary progressive MS (PPMS; ORATORIO [NCT01194570]) and their extensions.
Objective: To report ongoing safety evaluations from ocrelizumab clinical trials and open-label extension (OLE) periods up to February 2018, and report updated post-marketing data.
Methods: Safety outcomes were reported for all patients who received ocrelizumab during the controlled treatment and associated OLE periods of the Phase II and Phase III MS clinical trials, plus VELOCE, CHORDS, CASTING and OBOE (ocrelizumab all-exposure population). Long-term safety data will continue to be reported on a regular basis. The number of post-marketing patients exposed to ocrelizumab is based on estimated total number of vials sold, as well as US claims data.
Results: As of February 2018, 3,811 patients with MS received ocrelizumab, resulting in 10,919 patient years (PY) of exposure. Reported rates per 100 PY (95% confidence interval) were as follows: adverse events (AEs), 242 (239-245); serious AEs, 7.23 (6.73-7.75); infections, 74.5 (72.9-76.1); serious infections, 2.00 (1.74-2.28); and malignancy 0.45 (0.33-0.60). Updated post-marketing data will be presented.
Conclusions: The reported rates of events per 100 PY in the ocrelizumab MS all-exposure population continue to be generally consistent with those seen during the controlled treatment period in the RMS and PPMS populations.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Articulate Science, UK.
S. L. Hauser serves on the board of trustees for Neurona and on scientific advisory boards for Annexon, Bionure and Symbiotix, and has received travel reimbursement and writing assistance from F. Hoffmann-La Roche Ltd for CD20-related meetings and presentations.
L. Kappos' institution (University Hospital Basel) received in the last 3 years and used exclusively for research support at the Department: steering committee, advisory board and consultancy fees from Actelion, Alkermes, Almirall, Bayer, Biogen, Celgene/Receptos, df-mp, Excemed, GeNeuro SA, Genzyme, Japan Tobacco, Merck, Minoryx, Mitsubishi Pharma, Novartis, Roche, sanofi-aventis, Santhera, Teva, Vianex and royalties for Neurostatus-UHB products; the Research of the MS Center in Basel has been supported by grants from Bayer, Biogen, Novartis, the Swiss MS Society, the Swiss National Research Foundation, the European Union and Roche Research Foundations.
X. Montalban has received speaker honoraria and travel expense reimbursement for participation in scientific meetings, been a steering committee member of clinical trials or served on advisory boards of clinical trials for Actelion, Biogen, Celgene, Merck, Novartis, Oryzon, Roche, Sanofi-Genzyme and Teva Pharmaceutical.
R. Hughes is an employee of F. Hoffmann-La Roche Ltd.
H. Koendgen is an employee and shareholder of F. Hoffmann-La Roche Ltd.
J. McNamara is an employee of John McNamara Consulting Ltd.
A. Pradhan is an employee of Genentech, Inc.
D. Wormser is an employee and shareholder of F. Hoffmann-La Roche Ltd.
J. S. Wolinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie, Acetilon, Alkermes, Biogen, Bionest, Celgene, Clene Nanomedicine, EMD Serono, Forward Pharma A/S, GeNeuro, MedDay Pharmaceuticals, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, Sanofi Genzyme.; royalties are received for out-licensed monoclonal antibodies through UTHealth from Millipore Corporation.
Abstract: P1229
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Ongoing safety reporting is crucial to understanding the long-term benefit-risk profile of ocrelizumab in patients with multiple sclerosis (MS). The safety and efficacy of ocrelizumab have been characterised in one Phase II study in relapsing-remitting MS (RRMS; NCT00676715), two identical Phase III trials in relapsing MS (RMS; OPERA I/II [NCT01247324]/[NCT01412333]) and the Phase III trial in primary progressive MS (PPMS; ORATORIO [NCT01194570]) and their extensions.
Objective: To report ongoing safety evaluations from ocrelizumab clinical trials and open-label extension (OLE) periods up to February 2018, and report updated post-marketing data.
Methods: Safety outcomes were reported for all patients who received ocrelizumab during the controlled treatment and associated OLE periods of the Phase II and Phase III MS clinical trials, plus VELOCE, CHORDS, CASTING and OBOE (ocrelizumab all-exposure population). Long-term safety data will continue to be reported on a regular basis. The number of post-marketing patients exposed to ocrelizumab is based on estimated total number of vials sold, as well as US claims data.
Results: As of February 2018, 3,811 patients with MS received ocrelizumab, resulting in 10,919 patient years (PY) of exposure. Reported rates per 100 PY (95% confidence interval) were as follows: adverse events (AEs), 242 (239-245); serious AEs, 7.23 (6.73-7.75); infections, 74.5 (72.9-76.1); serious infections, 2.00 (1.74-2.28); and malignancy 0.45 (0.33-0.60). Updated post-marketing data will be presented.
Conclusions: The reported rates of events per 100 PY in the ocrelizumab MS all-exposure population continue to be generally consistent with those seen during the controlled treatment period in the RMS and PPMS populations.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Articulate Science, UK.
S. L. Hauser serves on the board of trustees for Neurona and on scientific advisory boards for Annexon, Bionure and Symbiotix, and has received travel reimbursement and writing assistance from F. Hoffmann-La Roche Ltd for CD20-related meetings and presentations.
L. Kappos' institution (University Hospital Basel) received in the last 3 years and used exclusively for research support at the Department: steering committee, advisory board and consultancy fees from Actelion, Alkermes, Almirall, Bayer, Biogen, Celgene/Receptos, df-mp, Excemed, GeNeuro SA, Genzyme, Japan Tobacco, Merck, Minoryx, Mitsubishi Pharma, Novartis, Roche, sanofi-aventis, Santhera, Teva, Vianex and royalties for Neurostatus-UHB products; the Research of the MS Center in Basel has been supported by grants from Bayer, Biogen, Novartis, the Swiss MS Society, the Swiss National Research Foundation, the European Union and Roche Research Foundations.
X. Montalban has received speaker honoraria and travel expense reimbursement for participation in scientific meetings, been a steering committee member of clinical trials or served on advisory boards of clinical trials for Actelion, Biogen, Celgene, Merck, Novartis, Oryzon, Roche, Sanofi-Genzyme and Teva Pharmaceutical.
R. Hughes is an employee of F. Hoffmann-La Roche Ltd.
H. Koendgen is an employee and shareholder of F. Hoffmann-La Roche Ltd.
J. McNamara is an employee of John McNamara Consulting Ltd.
A. Pradhan is an employee of Genentech, Inc.
D. Wormser is an employee and shareholder of F. Hoffmann-La Roche Ltd.
J. S. Wolinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie, Acetilon, Alkermes, Biogen, Bionest, Celgene, Clene Nanomedicine, EMD Serono, Forward Pharma A/S, GeNeuro, MedDay Pharmaceuticals, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, Sanofi Genzyme.; royalties are received for out-licensed monoclonal antibodies through UTHealth from Millipore Corporation.