Contributions
Abstract: P600
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Ocrelizumab (OCR), a humanised monoclonal antibody that selectively targets CD20+ B cells, is approved for the treatment of relapsing and primary progressive forms of multiple sclerosis (MS), and has also been studied in clinical trials for rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). As a large proportion of patients with MS are women of reproductive age, pregnancy outcomes in patients exposed to OCR is of importance. B-cell levels in neonates following maternal exposure to OCR have not been studied in clinical trials and the effect of OCR on the immune system of the newborn is unknown.
Objective: To provide an update of pregnancy outcomes in women treated with OCR during clinical trials and post marketing.
Methods: This analysis includes pregnancies in women with MS, RA and SLE in OCR clinical trials and from post-marketing sources (dose range 20 to 2000 mg) up to 31/03/2018. In the EU, women of childbearing potential are recommended to use contraception while receiving and for 12 months after last OCR infusion, while across trials, women of childbearing potential were required to use two methods of contraception and continue contraception for 48 weeks after the last OCR infusion or until B cells repleted, whichever was longer. An embryo/foetus was considered exposed to OCR in utero if the last infusion occurred within 3 months of conception or during pregnancy or if the date was unknown.
Results: As previously reported, between 2008 and 31/01/2017, 56 women randomised to OCR in clinical trials reported 58 pregnancies (25 MS, 11 SLE, 22 RA). This cumulative update provides approximately 14 months' additional data on pregnancies reported in clinical trials and from post-marketing sources up to 31/03/2018, and will review 108 pregnancies reported in 106 women (68 patients with MS, 7 patients in whom the OCR indication was not reported, and 31 patients with RA or SLE). Among the 68 pregnancies in patients with MS, 38 were considered to have foetal OCR exposure, 17 had no foetal OCR exposure, and 13 were not assessable for foetal OCR exposure. Preliminary outcomes of the 68 pregnancies include 20 ongoing at cutoff and 14 electively terminated or ended in spontaneous abortion or stillbirth.
Conclusions: The current update on pregnancy outcomes remains in line with previous reports. As the number of pregnancies is too small to draw firm conclusions on the effect of OCR on pregnancy outcomes, data will continue to be collected and assessed.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Articulate Science, UK.
S. Vukusic has received consulting and lecture fees, travel grants and research support from Bayer-Schering, Biogen Idec, F. Hoffmann-La Roche Ltd, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma.
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.
S. Wray has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, F. Hoffmann-La Roche Ltd and Genentech, Inc., Genzyme/Sanofi, Novartis and TG Therapeutics.
S. Bader-Weder is an employee of F. Hoffmann-La Roche Ltd.
R. Buffels is an employee of F. Hoffmann-La Roche Ltd.
D. Masterman is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd.
J. Napieralski is an employee of F. Hoffmann-La Roche Ltd.
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.
Abstract: P600
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Ocrelizumab (OCR), a humanised monoclonal antibody that selectively targets CD20+ B cells, is approved for the treatment of relapsing and primary progressive forms of multiple sclerosis (MS), and has also been studied in clinical trials for rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). As a large proportion of patients with MS are women of reproductive age, pregnancy outcomes in patients exposed to OCR is of importance. B-cell levels in neonates following maternal exposure to OCR have not been studied in clinical trials and the effect of OCR on the immune system of the newborn is unknown.
Objective: To provide an update of pregnancy outcomes in women treated with OCR during clinical trials and post marketing.
Methods: This analysis includes pregnancies in women with MS, RA and SLE in OCR clinical trials and from post-marketing sources (dose range 20 to 2000 mg) up to 31/03/2018. In the EU, women of childbearing potential are recommended to use contraception while receiving and for 12 months after last OCR infusion, while across trials, women of childbearing potential were required to use two methods of contraception and continue contraception for 48 weeks after the last OCR infusion or until B cells repleted, whichever was longer. An embryo/foetus was considered exposed to OCR in utero if the last infusion occurred within 3 months of conception or during pregnancy or if the date was unknown.
Results: As previously reported, between 2008 and 31/01/2017, 56 women randomised to OCR in clinical trials reported 58 pregnancies (25 MS, 11 SLE, 22 RA). This cumulative update provides approximately 14 months' additional data on pregnancies reported in clinical trials and from post-marketing sources up to 31/03/2018, and will review 108 pregnancies reported in 106 women (68 patients with MS, 7 patients in whom the OCR indication was not reported, and 31 patients with RA or SLE). Among the 68 pregnancies in patients with MS, 38 were considered to have foetal OCR exposure, 17 had no foetal OCR exposure, and 13 were not assessable for foetal OCR exposure. Preliminary outcomes of the 68 pregnancies include 20 ongoing at cutoff and 14 electively terminated or ended in spontaneous abortion or stillbirth.
Conclusions: The current update on pregnancy outcomes remains in line with previous reports. As the number of pregnancies is too small to draw firm conclusions on the effect of OCR on pregnancy outcomes, data will continue to be collected and assessed.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Articulate Science, UK.
S. Vukusic has received consulting and lecture fees, travel grants and research support from Bayer-Schering, Biogen Idec, F. Hoffmann-La Roche Ltd, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma.
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.
S. Wray has received honoraria and/or research funding from Actelion, Alkermes, Biogen, Celgene, EMD Serono, F. Hoffmann-La Roche Ltd and Genentech, Inc., Genzyme/Sanofi, Novartis and TG Therapeutics.
S. Bader-Weder is an employee of F. Hoffmann-La Roche Ltd.
R. Buffels is an employee of F. Hoffmann-La Roche Ltd.
D. Masterman is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd.
J. Napieralski is an employee of F. Hoffmann-La Roche Ltd.
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.