Effect of ocrelizumab vs that of interferon beta-1a on visual outcomes in patients with relapsing multiple sclerosis in the OPERA studies
ECTRIMS Online Library. Balcer L. 10/27/17; 202550; 192
Laura Balcer
Laura Balcer
Contributions
Abstract

Abstract: 192

Type: Oral

Abstract Category: Therapy - disease modifying - 30 Tools for detecting therapeutic response

Background: Visual impairment is a common clinical manifestation of multiple sclerosis (MS). Low-contrast letter acuity (LCLA) measures can detect reduced visual function even in the absence of a clinically evident episode of optic neuritis.
Objective: To determine the impact of ocrelizumab (OCR) on LCLA in the pooled OPERA I and II studies.
Methods: Binocular LCLA testing (1.25% and 2.5% contrast) was conducted at baseline (BL) and every 12 weeks until Week 96. The pooled OPERA intention-to-treat (ITT) population (OCR: n=827; interferon beta-1a [IFN β-1a]: n=829) and the subgroup of patients with visual impairment (defined as visual Functional System Score ≥1) at BL (OCR: n=375; IFN β-1a: n=373) were evaluated. The change from BL in the number of letters identified correctly on LCLA testing was assessed using a mixed-effect model of repeated measures. Improvement was defined as a ≥5-, ≥7- or ≥10-letter increase on the Sloan LCL chart confirmed after 12 weeks; a 7-letter change is considered the minimal clinically important difference for this test. The cumulative probability of confirmed improvement was estimated by Kaplan-Meier analysis; the hazard ratio (HR) was calculated using a Cox proportional hazard regression model.
Results: The mean change from BL in the number of letters identified correctly on LCLA testing at 2.5% contrast was significantly improved with OCR vs IFN β-1a at Week 96 in the ITT population (OCR: 1.355; IFN β-1a: 0.012; p=0.03) and in the subgroup of patients with visual impairment at BL (OCR: 3.440; IFN β-1a: -0.470; p< 0.001). The relative increase in cumulative probability of ≥7-letter improvement at 2.5% contrast confirmed after 12 weeks with OCR vs IFN β-1a was 19% (31.7% vs 26.6%; HR=1.190; p=0.078) in the ITT population and 54% (36.3% vs 25.5%; HR=1.538; p=0.003) in the subgroup of patients with visual impairment at BL. Similar trends were observed with OCR vs IFN β-1a at ≥5- and ≥10-letter thresholds. Additional analyses will include change from BL in the number of letters identified correctly, by confirmed improvement status, and the proportion of patients with 12-week confirmed visual improvement at ≥5 of 7 visits. Results of LCLA testing at 1.25% contrast will also be presented.
Conclusions: Ocrelizumab was associated with an improvement in visual outcomes as assessed by LCLA testing in patients with relapsing MS, particularly in those with visual impairment at BL, compared with IFN β-1a.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Health Interactions, USA, and Articulate Science, UK.
L. Balcer has received consulting fees from Biogen.
S. L. Hauser serves on the board of trustees for Neurona and on scientific advisory boards for Annexon, Symbiotix and Bionure; 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, has received research support and payments that were used exclusively for research support for Prof Kappos' activities as principal investigator and member or chair of planning and steering committees or advisory boards for trials sponsored by Actelion, Addex, Almirall, Bayer HealthCare Pharmaceuticals, CSL Behring, Genentech, Inc., GeNeuro SA, Genzyme, Merck Serono, Mitsubishi Pharma, Novartis, Octapharma, Ono Pharmaceutical, Pfizer, Receptos, F. Hoffmann-La Roche Ltd, Sanofi, Santhera, Siemens, Teva, UCB and XenoPort; license fees for Neurostatus products; and research grants from the Swiss Multiple Sclerosis Society, Swiss National Research Foundation, European Union, Gianni Rubatto Foundation, Novartis Research Foundation and Roche Research Foundation.
L. Leocani has received honoraria for consulting services or speaking activities and travel or research support from Almirall, Biogen, Merck KGaA, Novartis and F. Hoffmann-La Roche Ltd.
S. Saidha has received consulting fees from Medical Logix for the development of continuing medical education programs in neurology, consulting fees from Axon Advisors LLC, educational grant support from Novartis and Teva Neurosciences, and speaking honoraria from the National Association of Managed Care Physicians, Family Medicine Foundation of West Virginia and Advanced Studies in Medicine; served on scientific advisory boards for Biogen, Genzyme, Genentech, Inc. and Novartis; received research support from Genentech, Inc. and the National Multiple Sclerosis Society; received support from the Race to Erase MS foundation; and serves on the working committee of the International Multiple Sclerosis Visual System (IMSVISUAL) Consortium.
L. Julian is an employee and shareholder of Genentech, Inc.
J. Han is an employee and shareholder of Genentech, Inc.
G. Comi in the past year, has received compensation for consulting services from Roche, Novartis, Teva, Sanofi, Genzyme, Merck, EXCEMED, Almirall, Chugai, Receptos and Forward Pharma and compensation for speaking activities from Roche, Novartis, Teva, Sanofi, Genzyme, Merck, EXCEMED, Almirall and Receptos.

Abstract: 192

Type: Oral

Abstract Category: Therapy - disease modifying - 30 Tools for detecting therapeutic response

Background: Visual impairment is a common clinical manifestation of multiple sclerosis (MS). Low-contrast letter acuity (LCLA) measures can detect reduced visual function even in the absence of a clinically evident episode of optic neuritis.
Objective: To determine the impact of ocrelizumab (OCR) on LCLA in the pooled OPERA I and II studies.
Methods: Binocular LCLA testing (1.25% and 2.5% contrast) was conducted at baseline (BL) and every 12 weeks until Week 96. The pooled OPERA intention-to-treat (ITT) population (OCR: n=827; interferon beta-1a [IFN β-1a]: n=829) and the subgroup of patients with visual impairment (defined as visual Functional System Score ≥1) at BL (OCR: n=375; IFN β-1a: n=373) were evaluated. The change from BL in the number of letters identified correctly on LCLA testing was assessed using a mixed-effect model of repeated measures. Improvement was defined as a ≥5-, ≥7- or ≥10-letter increase on the Sloan LCL chart confirmed after 12 weeks; a 7-letter change is considered the minimal clinically important difference for this test. The cumulative probability of confirmed improvement was estimated by Kaplan-Meier analysis; the hazard ratio (HR) was calculated using a Cox proportional hazard regression model.
Results: The mean change from BL in the number of letters identified correctly on LCLA testing at 2.5% contrast was significantly improved with OCR vs IFN β-1a at Week 96 in the ITT population (OCR: 1.355; IFN β-1a: 0.012; p=0.03) and in the subgroup of patients with visual impairment at BL (OCR: 3.440; IFN β-1a: -0.470; p< 0.001). The relative increase in cumulative probability of ≥7-letter improvement at 2.5% contrast confirmed after 12 weeks with OCR vs IFN β-1a was 19% (31.7% vs 26.6%; HR=1.190; p=0.078) in the ITT population and 54% (36.3% vs 25.5%; HR=1.538; p=0.003) in the subgroup of patients with visual impairment at BL. Similar trends were observed with OCR vs IFN β-1a at ≥5- and ≥10-letter thresholds. Additional analyses will include change from BL in the number of letters identified correctly, by confirmed improvement status, and the proportion of patients with 12-week confirmed visual improvement at ≥5 of 7 visits. Results of LCLA testing at 1.25% contrast will also be presented.
Conclusions: Ocrelizumab was associated with an improvement in visual outcomes as assessed by LCLA testing in patients with relapsing MS, particularly in those with visual impairment at BL, compared with IFN β-1a.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Health Interactions, USA, and Articulate Science, UK.
L. Balcer has received consulting fees from Biogen.
S. L. Hauser serves on the board of trustees for Neurona and on scientific advisory boards for Annexon, Symbiotix and Bionure; 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, has received research support and payments that were used exclusively for research support for Prof Kappos' activities as principal investigator and member or chair of planning and steering committees or advisory boards for trials sponsored by Actelion, Addex, Almirall, Bayer HealthCare Pharmaceuticals, CSL Behring, Genentech, Inc., GeNeuro SA, Genzyme, Merck Serono, Mitsubishi Pharma, Novartis, Octapharma, Ono Pharmaceutical, Pfizer, Receptos, F. Hoffmann-La Roche Ltd, Sanofi, Santhera, Siemens, Teva, UCB and XenoPort; license fees for Neurostatus products; and research grants from the Swiss Multiple Sclerosis Society, Swiss National Research Foundation, European Union, Gianni Rubatto Foundation, Novartis Research Foundation and Roche Research Foundation.
L. Leocani has received honoraria for consulting services or speaking activities and travel or research support from Almirall, Biogen, Merck KGaA, Novartis and F. Hoffmann-La Roche Ltd.
S. Saidha has received consulting fees from Medical Logix for the development of continuing medical education programs in neurology, consulting fees from Axon Advisors LLC, educational grant support from Novartis and Teva Neurosciences, and speaking honoraria from the National Association of Managed Care Physicians, Family Medicine Foundation of West Virginia and Advanced Studies in Medicine; served on scientific advisory boards for Biogen, Genzyme, Genentech, Inc. and Novartis; received research support from Genentech, Inc. and the National Multiple Sclerosis Society; received support from the Race to Erase MS foundation; and serves on the working committee of the International Multiple Sclerosis Visual System (IMSVISUAL) Consortium.
L. Julian is an employee and shareholder of Genentech, Inc.
J. Han is an employee and shareholder of Genentech, Inc.
G. Comi in the past year, has received compensation for consulting services from Roche, Novartis, Teva, Sanofi, Genzyme, Merck, EXCEMED, Almirall, Chugai, Receptos and Forward Pharma and compensation for speaking activities from Roche, Novartis, Teva, Sanofi, Genzyme, Merck, EXCEMED, Almirall and Receptos.

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