Cleveland Clinic Lou Ruvo Center for Brain Health

Author Of 2 Presentations

Clinical Trials Poster Presentation

P0222 - OLIKOS study design: exploring maintained ofatumumab efficacy in relapsing MS patients who transition from intravenous anti-CD20 therapy (ID 1757)

Speakers
Presentation Number
P0222
Presentation Topic
Clinical Trials

Abstract

Background

Depletion of B cells in patients with relapsing multiple sclerosis (RMS) using anti-CD20 monoclonal antibodies (mAbs) reduces annualized relapse rates and inflammatory lesion activity on magnetic resonance imaging, and delays time to confirmed disability worsening. Anti-CD20 mAbs ocrelizumab and rituximab are administered by intravenous infusion in clinic; ofatumumab is administered subcutaneously with a pre-filled syringe or autoinjector (AI) pen, facilitating self-administration. No outcome data exist relating to transition of patients treated with ocrelizumab or rituximab to ofatumumab.

Objectives

OLIKOS is a 12 month, prospective, single-arm, multicenter phase 3b study that will explore maintained efficacy of ofatumumab in patients with RMS who transition from intravenous anti-CD20 mAb therapy.

Methods

About 100 adults with RMS will be enrolled at 10-20 centers in the USA. Eligible patients will have been previously treated with 2-5 consecutive courses of intravenous ocrelizumab or rituximab (other anti-CD20 mAbs are excluded), with last dose 4-9 months before OLIKOS baseline. Other inclusion criteria are Expanded Disability Status Scale score 5.5 or lower at screening and CD19 B cells depleted to below 1% at baseline. Patients with suboptimal response to anti-CD20 therapy in the previous 6 months (relapse, ≥2 active gadolinium-enhancing [Gd+] lesions, any new/enlarging T2 lesions, clinical worsening), or who discontinued anti-CD20 therapy because of severe infusion-related reactions or recurrent infections, or with progressive disease, will be excluded. All participants will receive subcutaneous ofatumumab 20 mg administered by AI pen on Days 1, 7 and 14, then monthly in Months 1-12. The primary endpoint will be no change or a reduction in Gd+ lesion count at Month 12. Secondary endpoints will be participant retention and changes in immune biomarkers, treatment satisfaction, safety and tolerability at Months 6 and 12. There will be a 6 month interim analysis.

Results

The detailed study design will be presented. OLIKOS will complement the ofatumumab phase 3 program in RMS by generating maintained efficacy, retention and satisfaction data based on monthly subcutaneous drug delivery with the AI pen in patients previously treated with ocrelizumab or rituximab.

Conclusions

OLIKOS will provide important data on the maintained efficacy of ofatumumab in patients with RMS transitioning from intravenous anti-CD20 therapies.

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Observational Studies Poster Presentation

P0843 - Characteristics and clinical outcomes of older patients with MS treated with peginterferon beta-1a or intramuscular interferon beta-1a in MS PATHS (ID 792)

Speakers
Presentation Number
P0843
Presentation Topic
Observational Studies

Abstract

Background

Safety and effectiveness information for peginterferon beta-1a or intramuscular interferon (IM IFN) beta-1a in older patients (≥60 years [y]) with multiple sclerosis (MS) are limited. MS PATHS, an international network of MS centers, provides access to real-world (RW) data generated from a broad MS patient population.

Objectives

Evaluate the clinical outcomes of patients ≥60 y of age in MS PATHS treated with peginterferon beta-1a or IM IFN beta-1a.

Methods

Included patients were currently taking peginterferon beta-1a or IM IFN beta-1a or began taking either therapy at a follow-up visit, and had ≥1 follow-up clinical assessment as of November 2019. Assessments included Patient-Determined Disease Steps (PDDS), and Multiple Sclerosis Performance Test (MSPT) assessments, including Processing Speed Test (PST), Manual Dexterity Test (MDT), and Walking Speed Test (WST). Z-scores were based on normative data from 500 healthy volunteers.

Results

Analysis included 817 patients, of whom 218 (27%) were aged ≥60 y at baseline (BL). Follow-up times were similar for ≥60 y and <60 y patients (mean [SD] 1.35 [0.97] y and 1.27 [0.94] y, respectively). Older patients had higher BL PDDS score (mean [SD] 1.82 [2.14] vs 0.91 [1.48]) and higher rates of comorbidities including pain, cardiovascular, and dyslipidemia than younger patients. At BL, patients ≥60 y had significantly greater functional impairment than patients <60 y on MDT (Z-score mean [SD] -0.85 [1.79] vs -0.23 [1.56]) and WST (-1.66 [3.35] vs -0.52 [2.30]; both P<0.001), but not PST (-0.48 [1.00] vs. -0.37 [1.11]; P=0.197). Change from BL in PST, MDT or WST Z-scores at 6 months (mo), 1 y or 2 y was not significant for patients ≥60 y, whereas those <60 y showed significant improvement in PST at all 3 time points (mean change in Z-score 0.11–0.26; all P≤0.006) and in MDT at 1 and 2 y (mean change in Z-score 0.24 and 0.36; both P≤0.003). Approximately half of the ≥60-y and <60-y subgroups were relapse free at 6 mo (57% and 58%), 1 y (48% and 61%) and 2 y (49% and 60%).

Conclusions

In this RW study of patients with MS aged ≥60 or <60 y treated with peginterferon beta-1a or IM IFN beta-1a, younger patients had significantly improved PST and MDT ≥6 mo post-BL, and approximately equal proportions of patients in both age groups were relapse-free over 2 y. These results indicate that peginterferon beta-1a and IM IFN beta-1a may provide RW treatment benefits to patients with MS, including those aged 60 and above.

This study was supported by Biogen.

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Presenter Of 1 Presentation

Observational Studies Poster Presentation

P0843 - Characteristics and clinical outcomes of older patients with MS treated with peginterferon beta-1a or intramuscular interferon beta-1a in MS PATHS (ID 792)

Speakers
Presentation Number
P0843
Presentation Topic
Observational Studies

Abstract

Background

Safety and effectiveness information for peginterferon beta-1a or intramuscular interferon (IM IFN) beta-1a in older patients (≥60 years [y]) with multiple sclerosis (MS) are limited. MS PATHS, an international network of MS centers, provides access to real-world (RW) data generated from a broad MS patient population.

Objectives

Evaluate the clinical outcomes of patients ≥60 y of age in MS PATHS treated with peginterferon beta-1a or IM IFN beta-1a.

Methods

Included patients were currently taking peginterferon beta-1a or IM IFN beta-1a or began taking either therapy at a follow-up visit, and had ≥1 follow-up clinical assessment as of November 2019. Assessments included Patient-Determined Disease Steps (PDDS), and Multiple Sclerosis Performance Test (MSPT) assessments, including Processing Speed Test (PST), Manual Dexterity Test (MDT), and Walking Speed Test (WST). Z-scores were based on normative data from 500 healthy volunteers.

Results

Analysis included 817 patients, of whom 218 (27%) were aged ≥60 y at baseline (BL). Follow-up times were similar for ≥60 y and <60 y patients (mean [SD] 1.35 [0.97] y and 1.27 [0.94] y, respectively). Older patients had higher BL PDDS score (mean [SD] 1.82 [2.14] vs 0.91 [1.48]) and higher rates of comorbidities including pain, cardiovascular, and dyslipidemia than younger patients. At BL, patients ≥60 y had significantly greater functional impairment than patients <60 y on MDT (Z-score mean [SD] -0.85 [1.79] vs -0.23 [1.56]) and WST (-1.66 [3.35] vs -0.52 [2.30]; both P<0.001), but not PST (-0.48 [1.00] vs. -0.37 [1.11]; P=0.197). Change from BL in PST, MDT or WST Z-scores at 6 months (mo), 1 y or 2 y was not significant for patients ≥60 y, whereas those <60 y showed significant improvement in PST at all 3 time points (mean change in Z-score 0.11–0.26; all P≤0.006) and in MDT at 1 and 2 y (mean change in Z-score 0.24 and 0.36; both P≤0.003). Approximately half of the ≥60-y and <60-y subgroups were relapse free at 6 mo (57% and 58%), 1 y (48% and 61%) and 2 y (49% and 60%).

Conclusions

In this RW study of patients with MS aged ≥60 or <60 y treated with peginterferon beta-1a or IM IFN beta-1a, younger patients had significantly improved PST and MDT ≥6 mo post-BL, and approximately equal proportions of patients in both age groups were relapse-free over 2 y. These results indicate that peginterferon beta-1a and IM IFN beta-1a may provide RW treatment benefits to patients with MS, including those aged 60 and above.

This study was supported by Biogen.

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