ACTEMRA Monotherapy Improves Symptoms of Rheumatoid Arthritis

Author: Genentech
Published: 2011/11/07 - Updated: 2022/06/10
Contents: Summary - Definition - Introduction - Main - Related

Synopsis: Data from Phase III clinical trials in rheumatoid arthritis patients who received ACTEMRA (tocilizumab) as monotherapy and those who received ACTEMRA plus antirheumatic drug (DMARD), including methotrexate (MTX). Rheumatoid arthritis (RA) is a chronic, progressive inflammatory disease of the joints and surrounding tissues associated with intense pain, irreversible joint destruction, and systemic complications. Joint damage often begins early in the condition and can lead to permanent disability; therefore, inhibiting structural damage to the joints is a critical measure of the effectiveness of an RA treatment. ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for treating adult patients with moderately to severely active RA. They have had an inadequate response to one or more tumor necrosis factors (TNF) antagonist therapies.

Introduction

ACT-RAY is a Phase IIIb, double-blind, two-year study designed to evaluate the clinical efficacy and safety profile of ACTEMRA monotherapy versus ACTEMRA 8 mg/kg plus MTX in 556 patients with moderate to severe Rheumatoid arthritis (RA) who had an inadequate response to MTX.

Main Digest

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced data from two large, Phase III clinical trials that assessed the efficacy and safety profile at 24 weeks in rheumatoid arthritis (RA) patients who received ACTEMRA (tocilizumab) as a monotherapy as well as those who received ACTEMRA plus a disease-modifying antirheumatic drug (DMARD), including methotrexate (MTX).

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures, and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for treating adult patients with moderately to severely active RA. They have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. The extensive ACTEMRA clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, ACTEMRA is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.

RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues associated with intense pain, irreversible joint destruction, and systemic complications. Joint damage often begins early in the disease and can lead to permanent disability; therefore, inhibiting structural damage to the joints is a critical measure of the effectiveness of an RA treatment.

"Data presented at this year's ACR meeting add to our broad knowledge of ACTEMRA and provide physicians with additional information to consider when selecting a medicine for their patients," said Hal Barron, M.D., chief medical officer, and head, Global Product Development. "Importantly, the data suggest that monotherapy with ACTEMRA was a viable alternative to combination therapy for these patients."

ACT-RAY Study - Abstract #2628

ACT-RAY is a Phase IIIb, double-blind, two-year study designed to evaluate the clinical efficacy and safety profile of ACTEMRA monotherapy versus ACTEMRA 8 mg/kg plus MTX in 556 patients with moderate to severe RA who had an inadequate response to MTX.

Efficacy parameters at week 24 include reduction in signs and symptoms by DAS28 scores, a measure of disease activity in RA patients, and x-rays that determined progression of structural damage as measured by Genant-modified Sharp Score (GSS).

Of the 512 patients analyzed at week 24, 34.8 percent of patients who received monotherapy achieved a DAS28 score at 24 weeks compared to 40.4 percent (p=0.19) of the combination group. Additionally, there were no significant radiographic differences, as measured by total GSS score, between patients on monotherapy (0.08) compared to patients receiving MTX plus ACTEMRA (0.22, p=0.3304).

At week 24, rates of serious adverse events (SAEs) were comparable among patients on monotherapy (5.8 percent) to those who received ACTEMRA plus MTX (6.1 percent).

The most common SAEs were infections with seven events in each group.

ACT-STAR Study - Abstracts #2213 and #427

The U.S.-based, open-label, randomized ACT-STAR clinical practice study (abstract #2213) was designed to evaluate the safety profile, tolerability, and efficacy of ACTEMRA monotherapy or ACTEMRA in combination with non-biologic DMARDs over 24 weeks in 883 patients with moderate to severe RA who had exhibited inadequate clinical response on their current non-biologic or biologic DMARDs.

The primary endpoint was the number and percentage of patients who had SAEs during 24 weeks of treatment among patients who received ACTEMRA alone (8 mg/kg) or two different doses (4 mg/kg and 8 mg/kg) of ACTEMRA plus a DMARD.

At week 24, rates of SAEs were comparable among patients on monotherapy (5.8 percent) to those who were randomized to 4 mg/kg (8 percent) or 8 mg/kg (8.4 percent) of ACTEMRA plus a DMARD.

The most common SAEs were serious infections with similar percentages of patients in each group: monotherapy (2.9 percent); 4/8 mg/kg (includes patients that increased dose from 4 mg/kg to 8 mg/kg at and after week eight) of ACTEMRA plus a DMARD (3.6 percent); 8 mg/kg of ACTEMRA plus a DMARD (3.9 percent).

A subset analysis of the ACT-STAR study (abstract #427) evaluated the safety profile, tolerability, and efficacy of ACTEMRA monotherapy or ACTEMRA in combination with non-biologic DMARDs over 24 weeks in 552 patients with moderate to severe RA who exhibited an inadequate clinical response to at least one tumor necrosis factor (TNF) blocker.

The rate of SAEs among patients taking a concomitant DMARD was comparable (7.4 percent in the 4 mg/kg group and 7.9 percent in the 8 mg/kg group) but lower in those taking ACTEMRA alone (4.6 percent).

The most common SAEs were infections.

Additionally, the study showed efficacy rates, as measured by a DAS28 score of less than 2.6, were similar between groups: monotherapy group (15.7 percent); 4/8 mg/kg group (17.6 percent); 8 mg/kg group (22.8 percent).

Additionally, an analysis of pooled data from five pivotal Phase III clinical trials (OPTION, TOWARD, RADIATE, AMBITION, and LITHE) and their respective long-term extension studies examined the long-term safety profile of ACTEMRA in more than 4,000 patients. It showed stable rates of SAEs, serious infections, and cardiovascular events with continued exposure over the study period.

The most common SAEs were infections (4.6 per 100 patient-years).

Long-Term Safety Data - Abstract #2217

An analysis of pooled data from multiple clinical trials as well as long-term extension studies - OPTION, TOWARD, RADIATE, AMBITION, LITHE, GROWTH95, and GROWTH96 - revealed that rates of SAEs, serious infections, and cardiovascular events remained stable in more than 4,000 patients who received ACTEMRA throughout more than three and a half years.

The most common SAEs were infections (4.6 per 100 patient-years; 95 percent CI: 4.3, 5.0). The SAE rate was 14.7 per 100 patients (95 percent CI: 14.0, 15.4).

Attribution/Source(s):

This quality-reviewed publication titled ACTEMRA Monotherapy Improves Symptoms of Rheumatoid Arthritis was selected for publishing by Disabled World's editors due to its relevance to the disability community. While the content may have been edited for style, clarity, or brevity, it was originally authored by Genentech and published 2011/11/07 (Edit Update: 2022/06/10). For further details or clarifications, you can contact Genentech directly at gene.com Disabled World does not provide any warranties or endorsements related to this article.

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