Contributions
Abstract: EP1627
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Ocrelizumab (OCR) is a recombinant, humanised, monoclonal antibody that selectively targets CD20+ B cells. OCR demonstrated superior efficacy in patients with relapsing multiple sclerosis (RMS; OPERA I/II [NCT01247324]/[NCT01412333]) versus interferon (IFN) β1a, and primary progressive multiple sclerosis (PPMS; ORATORIO [NCT01194570]) versus placebo. The proportions of patients with adverse events (AEs) or serious AEs (SAEs) were similar in the OCR, IFNβ1a or placebo groups. Pooled trial data indicated an imbalance in malignancies between the OCR and control arms, which was driven by a higher number of female breast cancer events in the OCR group. Further data are needed to characterise the long-term safety of OCR in the post-marketing setting.
Objective: To further assess and characterise the long-term safety profile, including malignancy and serious infections, in patients with MS using OCR in a real-world setting.
Methods: In VERISMO, a US Food and Drug Administration post-marketing requirement prospective, observational, cohort study of patients with MS from the US and Germany initiating OCR treatment, patients will be followed to determine the incidence rates of breast cancer and total malignancy. The European Medicines Agency post-authorisation safety study, MANUSCRIPT, is an international, longitudinal surveillance study of patients with MS initiating OCR treatment or exposed to other approved disease-modifying therapies, also investigating incidence rates of malignancies, serious infections and SAEs. Both VERISMO and MANUSCRIPT studies will incorporate safety data from the 3,000 patients (from approximately 250 neurological centres in Germany) included in the long-term prospective CONFIDENCE study. The CONFIDENCE study will characterise the safety and effectiveness of OCR in patients with RMS and PPMS newly treated with the drug in the real-world setting.
Results: The CONFIDENCE study has started; first patient in occurred in April 2018. The VERISMO and MANUSCRIPT studies will run for 7-10 years, evaluating the risks of malignancy, serious infections and SAEs from first exposure to OCR until the event, censoring, death, loss to follow-up or study end. An overview of the design of both post-marketing studies will be presented.
Conclusions: The post-marketing studies VERISMO and MANUSCRIPT will further characterise the safety profile of ocrelizumab in patients with MS newly exposed to the drug, with a focus on malignancy and serious infections.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Articulate Science, UK.
T. Ziemssen has received grants and personal fees from Biogen, Novartis, Sanofi, and Teva, and personal fees from Almirall, Bayer, F. Hoffmann-La Roche, and Merck.
H. Berthold is an employee of Roche Pharma AG
P. Dirks is an employee of Roche Pharma AG
J. Evershed is an employee of Roche Products Ltd.
K. Gunzenhauser is an employee and shareholder of F. Hoffmann-La Roche Ltd.
J. Leemhuis is an employee of Roche Pharma AG and shareholder of F. Hoffmann-La Roche Ltd.
B. Shi is an employee of F. Hoffmann-La Roche Ltd.
D. Stokmaier is an employee of F. Hoffmann-La Roche Ltd.
Q. Wang is an employee of F. Hoffmann-La Roche Ltd.
D. Wormser is an employee and shareholder of F. Hoffmann-La Roche Ltd.
Abstract: EP1627
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Ocrelizumab (OCR) is a recombinant, humanised, monoclonal antibody that selectively targets CD20+ B cells. OCR demonstrated superior efficacy in patients with relapsing multiple sclerosis (RMS; OPERA I/II [NCT01247324]/[NCT01412333]) versus interferon (IFN) β1a, and primary progressive multiple sclerosis (PPMS; ORATORIO [NCT01194570]) versus placebo. The proportions of patients with adverse events (AEs) or serious AEs (SAEs) were similar in the OCR, IFNβ1a or placebo groups. Pooled trial data indicated an imbalance in malignancies between the OCR and control arms, which was driven by a higher number of female breast cancer events in the OCR group. Further data are needed to characterise the long-term safety of OCR in the post-marketing setting.
Objective: To further assess and characterise the long-term safety profile, including malignancy and serious infections, in patients with MS using OCR in a real-world setting.
Methods: In VERISMO, a US Food and Drug Administration post-marketing requirement prospective, observational, cohort study of patients with MS from the US and Germany initiating OCR treatment, patients will be followed to determine the incidence rates of breast cancer and total malignancy. The European Medicines Agency post-authorisation safety study, MANUSCRIPT, is an international, longitudinal surveillance study of patients with MS initiating OCR treatment or exposed to other approved disease-modifying therapies, also investigating incidence rates of malignancies, serious infections and SAEs. Both VERISMO and MANUSCRIPT studies will incorporate safety data from the 3,000 patients (from approximately 250 neurological centres in Germany) included in the long-term prospective CONFIDENCE study. The CONFIDENCE study will characterise the safety and effectiveness of OCR in patients with RMS and PPMS newly treated with the drug in the real-world setting.
Results: The CONFIDENCE study has started; first patient in occurred in April 2018. The VERISMO and MANUSCRIPT studies will run for 7-10 years, evaluating the risks of malignancy, serious infections and SAEs from first exposure to OCR until the event, censoring, death, loss to follow-up or study end. An overview of the design of both post-marketing studies will be presented.
Conclusions: The post-marketing studies VERISMO and MANUSCRIPT will further characterise the safety profile of ocrelizumab in patients with MS newly exposed to the drug, with a focus on malignancy and serious infections.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Articulate Science, UK.
T. Ziemssen has received grants and personal fees from Biogen, Novartis, Sanofi, and Teva, and personal fees from Almirall, Bayer, F. Hoffmann-La Roche, and Merck.
H. Berthold is an employee of Roche Pharma AG
P. Dirks is an employee of Roche Pharma AG
J. Evershed is an employee of Roche Products Ltd.
K. Gunzenhauser is an employee and shareholder of F. Hoffmann-La Roche Ltd.
J. Leemhuis is an employee of Roche Pharma AG and shareholder of F. Hoffmann-La Roche Ltd.
B. Shi is an employee of F. Hoffmann-La Roche Ltd.
D. Stokmaier is an employee of F. Hoffmann-La Roche Ltd.
Q. Wang is an employee of F. Hoffmann-La Roche Ltd.
D. Wormser is an employee and shareholder of F. Hoffmann-La Roche Ltd.