Contributions
Abstract: P590
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: The efficacy and safety of ocrelizumab (OCR) in relapsing multiple sclerosis (RMS) were demonstrated in the 96-week double-blind control period of OPERA I and OPERA II (NCT01247324; NCT01412333), and results for the 2-year follow-up of the pooled OPERA I and OPERA II open-label extension (OLE) period have previously been reported (Hauser SL, et al. AAN 2018; Abstract P1.366).
Objective: To assess the efficacy of switching to or maintaining OCR therapy on clinical measures of disease activity and progression after 3 years of follow-up in the OLE period of the OPERA I and OPERA II Phase III trials in RMS.
Methods: At the start of the OLE period, patients continued OCR (OCR-OCR) or were switched from interferon (IFN) β-1a to OCR (IFN-OCR). Adjusted annualised relapse rate (ARR), time to onset of 24-week confirmed disability progression (CDP24) and change in adjusted mean Expanded Disability Status Scale (EDSS) score from baseline were analysed.
Results: Overall, 88.6% of patients who entered the OLE completed OLE Year 3. Among IFN-OCR patients, ARR decreased from 0.20 in the year pre-switch to 0.10, 0.08 and 0.07 at Years 1, 2 and 3 post-switch (p< 0.001, Year 1 vs pre-switch; p=0.31, Year 1 vs Year 2; p=0.56, Year 2 vs Year 3). OCR-OCR continuers maintained the low ARR through the year pre-OLE and the 3 years of the OLE period (0.13, 0.11, 0.08 and 0.07). OCR-OCR continuers versus IFN-OCR switchers had lower proportions of patients with CDP24 in the year pre-switch and Years 1, 2 and 3 of the OLE period (7.7%/12.0%, 10.1%/15.6%, 13.9%/18.1% and 16.1%/21.3%; p< 0.05, all difference comparisons). Changes in mean EDSS scores from baseline in OCR-OCR continuers versus IFN-OCR switchers will also be presented.
Conclusions: Switching from IFN to ocrelizumab after 2 years at the start of the OLE period was associated with a rapid reduction in ARR. Both OCR-OCR as well as IFN-OCR patients maintained their robust reduction in ARR through the 3-year follow-up of the OLE period. After 5 years of follow-up, the proportion of patients with disability progression was lower in patients who initiated ocrelizumab treatment earlier (OCR-OCR), compared to patients who received initial IFN treatment (IFN-OCR switchers), showing that patients who initiated ocrelizumab 2 years earlier accrued significant and sustained reductions in disability progression compared to patients switching from IFN.
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.
B. Brochet has received research support from Bayer, Merck, Genzyme, Biogen, Novartis, Roche, Actelion, MedDay and Teva, and has consulting agreements with Novartis and Biogen.
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. T. Naismith reports financial relationships with Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech Inc., Genzyme, Novartis and Teva.
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.
M. Manfrini is an employee of F. Hoffmann-La Roche Ltd.
M. Garas is an employee and shareholder of F. Hoffmann-La Roche Ltd.
P. Villoslada is an employee of Genentech, Inc. and shareholder of F. Hoffmann-La Roche Ltd.
F. Model is an employee of F. Hoffmann-La Roche Ltd.
S. Hubeaux is an employee and shareholder of F. Hoffmann-La Roche Ltd.
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.
Abstract: P590
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: The efficacy and safety of ocrelizumab (OCR) in relapsing multiple sclerosis (RMS) were demonstrated in the 96-week double-blind control period of OPERA I and OPERA II (NCT01247324; NCT01412333), and results for the 2-year follow-up of the pooled OPERA I and OPERA II open-label extension (OLE) period have previously been reported (Hauser SL, et al. AAN 2018; Abstract P1.366).
Objective: To assess the efficacy of switching to or maintaining OCR therapy on clinical measures of disease activity and progression after 3 years of follow-up in the OLE period of the OPERA I and OPERA II Phase III trials in RMS.
Methods: At the start of the OLE period, patients continued OCR (OCR-OCR) or were switched from interferon (IFN) β-1a to OCR (IFN-OCR). Adjusted annualised relapse rate (ARR), time to onset of 24-week confirmed disability progression (CDP24) and change in adjusted mean Expanded Disability Status Scale (EDSS) score from baseline were analysed.
Results: Overall, 88.6% of patients who entered the OLE completed OLE Year 3. Among IFN-OCR patients, ARR decreased from 0.20 in the year pre-switch to 0.10, 0.08 and 0.07 at Years 1, 2 and 3 post-switch (p< 0.001, Year 1 vs pre-switch; p=0.31, Year 1 vs Year 2; p=0.56, Year 2 vs Year 3). OCR-OCR continuers maintained the low ARR through the year pre-OLE and the 3 years of the OLE period (0.13, 0.11, 0.08 and 0.07). OCR-OCR continuers versus IFN-OCR switchers had lower proportions of patients with CDP24 in the year pre-switch and Years 1, 2 and 3 of the OLE period (7.7%/12.0%, 10.1%/15.6%, 13.9%/18.1% and 16.1%/21.3%; p< 0.05, all difference comparisons). Changes in mean EDSS scores from baseline in OCR-OCR continuers versus IFN-OCR switchers will also be presented.
Conclusions: Switching from IFN to ocrelizumab after 2 years at the start of the OLE period was associated with a rapid reduction in ARR. Both OCR-OCR as well as IFN-OCR patients maintained their robust reduction in ARR through the 3-year follow-up of the OLE period. After 5 years of follow-up, the proportion of patients with disability progression was lower in patients who initiated ocrelizumab treatment earlier (OCR-OCR), compared to patients who received initial IFN treatment (IFN-OCR switchers), showing that patients who initiated ocrelizumab 2 years earlier accrued significant and sustained reductions in disability progression compared to patients switching from IFN.
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.
B. Brochet has received research support from Bayer, Merck, Genzyme, Biogen, Novartis, Roche, Actelion, MedDay and Teva, and has consulting agreements with Novartis and Biogen.
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. T. Naismith reports financial relationships with Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech Inc., Genzyme, Novartis and Teva.
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.
M. Manfrini is an employee of F. Hoffmann-La Roche Ltd.
M. Garas is an employee and shareholder of F. Hoffmann-La Roche Ltd.
P. Villoslada is an employee of Genentech, Inc. and shareholder of F. Hoffmann-La Roche Ltd.
F. Model is an employee of F. Hoffmann-La Roche Ltd.
S. Hubeaux is an employee and shareholder of F. Hoffmann-La Roche Ltd.
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.