NEDA epoch analysis of patients with relapsing multiple sclerosis treated with ocrelizumab: Results from the OPERA I and OPERA II, phase III studies G.

Slides:

Advertisements

Similar presentations

Defining suboptimal response to MS treatment: MRI outcome

Advertisements

Guidelines for a standardized MRI protocol for MS:

Study Design 121 Relapsing-remitting MS patients randomized to –Stress Management Therapy MS active treatment* 16 individual sessions conducted over 24.

Dimethyl Fumarate and Peginterferon b-1a: New Insights Into the Pivotal Trials Pavan Bhargava, MD Johns Hopkins University School of Medicine, Baltimore,

Phase 1/2 Study of Weekly MLN9708, an Investigational Oral Proteasome Inhibitor, in Combination with Lenalidomide and Dexamethasone in Patients with Previously.

results from the phase III TRIBE trial

Original Article B-Cell Depletion with Rituximab in Relapsing- Remitting Multiple Sclerosis Stephen L. Hauser, M.D., Emmanuelle Waubant, M.D., Ph.D., Douglas.

FREEDOMS II TRIAL.

Daclizumab High-Yield Process in Relapsing-Remitting Multiple Sclerosis (SELECT): A Randomised, Double-blind, Placebo-controlled Trial Aaron E. Miller,

An Analysis of Monthly Surveillance 3T MRI in MS patients switched from long term natalizumab to teriflunomide in a controlled, prospective study K. Edwards,

Natalizumab use for neuropsychological deficits in relapsing multiple sclerosis K. Edwards, 1,2 W. Goodman, 1 1 MS Center of Northeastern New York (Latham,

Background to Adaptive Design Nigel Stallard Professor of Medical Statistics Director of Health Sciences Research Institute Warwick Medical School

© 2014 Direct One Communications, Inc. All rights reserved. 1 Natalizumab and Dimethyl Fumarate: A Fresh Take on Pivotal Trials and Reports from Ongoing.

A Randomized Placebo-Controlled Phase III Trial of Oral Laquinimod for Multiple Sclerosis Timothy L. Vollmer, MD Professor, Neurology and Neuroscience.

Journal Insights Into: Oral Therapy for MS-Related Walking Impairment Supplemental Slides.

Thrice-Weekly Glatiramer Acetate for Relapsing Forms of Multiple Sclerosis: Findings from the GALA Study Fred D. Lublin, MD Saunders Family Professor of.

Fred D. Lublin, M.D. Corinne Goldsmith Dickinson Center for Multiple Sclerosis Icahn School of Medicine at Mount Sinai New York, NY, USA.

Multiple Sclerosis (MS) a serious, chronic and debilitating disease What is MS? A disease of the brain and spinal cord.

Laquinimod, an Oral Product in Development for the Treatment of Relapsing Remitting Multiple Sclerosis Steve Glenski, PharmD Medical Affairs Teva Neuroscience.

Adjuvant autologous renal tumour cell vaccine and risk of tumour progression in patients with renal- cell carcinoma after radical nephrectomy: phase III,

Zinbryta ™ - daclizumab Manufacturer: Biogen, Inc. FDA Approval Date: May 27, 2016 Jenna W. Bartlett, PharmD Candidate.

Carrie M. Hersh, D.O., Robert Fox, M.D.

Brain imaging prior to lung cancer resection

Four Known Types of MS Clinically isolated syndrome (CIS)

Chen R et al. Proc ASH 2015;Abstract 518.

Applying the New Multiple Sclerosis Guidelines to Clinical Practice

Multiple sclerosis: Oral Therapies and Beyond

Between-subject variability

Copyright © 2010 American Medical Association. All rights reserved.

Martha Carvour, MD, PhD March 2, 2017

Tales from the Front Lynn Pezzullo, RPh

Dimopoulos MA et al. Proc ASH 2012;Abstract LBA-6.

Perspectives on Key MS Data From the Annual European MS Meeting

ATX-101 for reduction of submental fat: A phase III randomized controlled trial Shannon Humphrey, MD, Jonathan Sykes, MD, Jonathan Kantor, MD, MSCE, MA,

Alalia Berry, MD, William W. Busse, MD

ADI Disease International 7-10 March, 2012

Nat. Rev. Neurol. doi: /nrneurol

What Predicts Disability Progression in Multiple Sclerosis?

What’s the Big Deal About Brain Atrophy and Neurodegeneration in RRMS?

Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease Martin et al. Am J Nephrol 2017;45: (DOI:

Dr Jessica Jenkins Consultant Oncologist

ATX-101 for reduction of submental fat: A phase III randomized controlled trial Shannon Humphrey, MD, Jonathan Sykes, MD, Jonathan Kantor, MD, MSCE, MA,

Figure 3 Proportion of patients for whom NEDA

Novel Therapies for the Treatment of MS

Discussion and Concluding Remarks

Longitudinal Analysis Beyond effect size

Treating to Target in MS

Oral pentasa in the treatment of active Crohn’s disease: A meta-analysis of double- blind, placebo-controlled trials Stephen B Hanauer, Ulf Strömberg

Figure 1 Evolution of multiple sclerosis

Phase 2 Multicenter Study Results of Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Forms of Multiple.

Tales from the Front Lynn Pezzullo, RPh

The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): A phase II, randomized, double-blind study of sonidegib in patients.

Fig. 1. MAHALO clinical trial flowchart.

Modelled mean (SEM) observed forced vital capacity (FVC) volume change from baseline (mL) over time by dose intensity (>90%, ≤90%), based on actual dose.

LV5FU2-cisplatin followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: Preliminary results of a randomized phase III trial (FFCD.

1 Verstovsek S et al. Proc ASH 2012;Abstract Cervantes F et al.

In 507 follow-up images, only 1

Cetuximab with chemotherapy as 1st-line treatment for metastatic colorectal cancer: a meta-analysis of the CRYSTAL and OPUS studies according to KRAS.

Frequency of lesions detected using CNS imaging (computed tomography [CT] and magnetic resonance imaging [MRI]) on patients with baylisascariasis (see.

Secondary Progressive Multiple Sclerosis: What Do We Know and Where Are We Heading?

HAQ-DI change from baseline and proportion of patients achieving MCID after 24 weeks in patients treated with PBO, IXEQ4W or IXEQ2W alone or in combination.

Longitudinal Characterization of Cortical Lesion Development and Evolution in Multiple Sclerosis with 7.0-T MRI In patients with multiple sclerosis, 7.0-T.

Coiffier B et al. Proc ASH 2011;Abstract 265.

Nathaniel P Katz, MD Journal of Pain and Symptom Management

Efficacy of guselkumab in subpopulations of patients with moderate-to-severe plaque psoriasis: A pooled analysis of the Phase 3 VOYAGE 1 and VOYAGE.

Figure 2 Clinical data and variation of sNfL levels of patients 4–6 with ATZ-treated MS Clinical data and variation of sNfL levels of patients 4–6 with.

Evaluating the Efficacy and Safety of Transitioning Patients from Natalizumab to Ocrelizumab (OCTAVE) Kyle Smoot, MD, FAAN1, Kiren Kresa-Reahl, MD1, Pavle.

Axial magnetic resonance imaging (MRI) of a 30 year old man with relapsing remitting multiple sclerosis (MS) showing multiple periventricular lesions:

Impact of approaches for clinical and radiological monitoring on predicting of short-term and long-term disability outcomes in multiple sclerosis Brian.

Atrophied Brain T2 Lesion Volume at MRI Is Associated with Disability Progression and Conversion to Secondary Progressive Multiple Sclerosis The rate.

Presentation transcript:

NEDA epoch analysis of patients with relapsing multiple sclerosis treated with ocrelizumab: Results from the OPERA I and OPERA II, phase III studies G Giovannoni, D L Arnold, A Bar-Or, G Comi, H P Hartung, E Havrdova, L Kappos, F Lublin, K Selmaj, A Traboulsee, S Belachew, J Han, L Julian, S L Hauser

Background No Evidence of Disease Activity (NEDA) is a composite measure of the absence of detectable clinical and magnetic resonance imaging (MRI) disease activity in relapsing multiple sclerosis (RMS). However, analyses of NEDA using a re-baseline approach may more closely reflect the effects of disease-modifying treatments.

Background (cont’d) Ocrelizumab (600 mg), which demonstrated a robust effect on MRI activity at 8 weeks in a Phase II study of MS patients, was evaluated for NEDA from baseline and following re-baselining at the time of first MRI (Week 24).

Objective To assess the effect of ocrelizumab on the proportion of patients with NEDA by epoch in the pooled OPERA I and II studies.

Methods In OPERA I and II, patients were randomized 1:1 to receive 600 mg ocrelizumab every 24 weeks or IFNβ‐1a 44 µg three-times weekly for 96 weeks. NEDA [defined as the absence of protocol-defined relapses, 12-week confirmed disability progression (CDP), new/enlarging T2 lesions and T1 gadolinium-enhancing lesions] was assessed in the overall intent-to-treat population over the controlled treatment phase (baseline to 96 weeks). Further analyses evaluated the proportion of patients with NEDA from baseline to Week 48 versus from Week 48 to Week 96, and from baseline to Week 24 versus from Week 24 to Week 96. Brain MRI was undertaken at baseline and at Weeks 24, 48 and 96.

Results In pooled analyses of OPERA I and II, the proportion of patients with NEDA was increased by 75% with ocrelizumab compared with IFNβ-1a over 96 weeks (47.7% versus 27.1%, P<0.0001). Compared with IFNβ-1a, the proportion of patients with NEDA was 57% higher with ocrelizumab from baseline to Week 48 (53.5% versus 34%) and 47% higher from Week 48 to Week 96 (85.9% versus 58.6%; both P<0.0001).

Results (cont’d) Compared with IFNβ-1a, the proportion of patients with NEDA was 36% higher with ocrelizumab from baseline to Week 24 (58.3% versus 42.8%) and 76% higher from Week 24 to Week 96 (75.5% versus 42.9%; both P<0.0001). In the ocrelizumab and IFNβ-1a groups, respectively, 79.8% versus 44.4% of patients with evidence of disease activity during Weeks 0-48 achieved NEDA during Weeks 48-96 (relative increase with ocrelizumab: 84%; P<0.0001).

Conclusions A higher proportion of patients reached NEDA at first MRI at Week 24 with ocrelizumab versus IFNβ-1a. After re-baselining, from Week 24 to 96 ocrelizumab treatment further increased the proportion of patients reaching NEDA status by 76%, relative to IFNβ-1a.