Research Shows ACTEMRA Improves Rheumatoid Arthritis

Introduction

New data shows ACTEMRA inhibits progression of joint destruction and improves physical function of patients with Rheumatoid Arthritis. The fifth phase III study also confirms a significant rate of disease remission in patients treated with ACTEMRA.

Main Digest

Roche announced that the innovative new therapy ACTEMRA (tocilizumab) can significantly inhibit structural damage to joints in patients with rheumatoid arthritis (RA) - this is a critical measure of effectiveness of an RA treatment. ACTEMRA was also found to improve the patients' physical function after one year of therapy and significantly increase the disease remission rate.

The results from the LITHE1 trial, presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Francisco, showed that:

A greater proportion of patients treated with ACTEMRA in combination with a commonly used RA drug called methotrexate (MTX) benefited from significant inhibition of structural damage during 12 months of therapy compared to patients treated with MTX alone. The outcome was determined by x-ray evidence of the progression of bone erosions and narrowing of joint spaces. This benefit is important to patients as damage to the joints caused by the disease leads to the disability and pain associated with RA.

ACTEMRA improved the patients' ability to perform normal daily activities, as assessed by the Health Assessment Questionnaire (HAQ)2, leading to a better quality of life.

Significantly more patients treated with ACTEMRA achieved remission than those treated with MTX alone (47% vs. 8%). The improvement in remission at one year reinforces the strong remission data seen at six months in four different ACTEMRA phase III trials across multiple RA patient populations.

"The outcome of this study is good news for RA patients as presently many either fail to achieve an adequate response or cannot tolerate therapies currently available," said William M. Burns, Head of the Roche Pharma Division. "New treatment options are needed, particularly those targeting different pathways to bring relief and inhibit joint damage in patients suffering from RA."

"The LITHE study demonstrated that treatment with ACTEMRA inhibited structural joint damage, which is a major cause of disability and loss of physical function for RA patients," said Joel Kremer, M.D., an investigator in the LITHE study and Director of Research at The Center for Rheumatology in Albany, New York. "It is critical to stop joint damage as quickly as possible to avoid joint deformity and help patients maintain their quality of life."

In the LITHE study, ACTEMRA was generally well tolerated, and the overall safety profile after 12 months of treatment was consistent with previously reported six-month trial data.

ACTEMRA is the first of a new drug class with a novel mechanism of action that brings new hope to RA patients. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody that works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.

*defined by the recognized measure DAS28<2.6

Rheumatoid Arthritis - A High Unmet Medical Need

Rheumatoid arthritis affects over 21 million people worldwide. It is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation distorts the joint and causes impaired function accompanied by pain, stiffness, and swelling, ultimately leading to irreversible joint destruction and disability. In addition, the systemic symptoms of RA include fatigue, anemia, and osteoporosis, which may contribute to shortening life expectancy by affecting major organ systems. After ten years, less than 50% of patients can continue to work or function normally daily.

LITHE Study

The LITHE study, a randomized, double-blind, placebo-controlled trial, evaluated the efficacy of TCZ plus MTX in preventing structural joint damage and improving physical function. LITHE is an international study, including 15 countries and 1196 patients with moderate to severe RA who had an inadequate response to MTX.

In this randomized study, patients received either ACTEMRA (4 mg/kg or 8 mg/kg, one infusion every four weeks) in combination with methotrexate or methotrexate alone. The results presented are from a planned 12-month analysis of a 2-year study. At 52 weeks, total Genant-modified Sharp Score change from baseline for the ACTEMRA 8mg + MTX, 4mg +MTX, and MTX alone groups were: 0.29, 0.34, and 1.1, respectively. The percentage of patients achieving no progression in total Genant-modified Sharp Score was 85%, 81%, and 67%.The HAQ-DI AUC change from baseline, adjusted mean scores were: -144.1, -128.4, and -58.1, respectively. DAS28 clinical remission (<2.6) was 47%, 30% and 8%.

ACTEMRA

ACTEMRA is the result of research collaboration by Chugai and is being co-developed globally with Chugai. ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development program of five Phase III trials was designed to evaluate the clinical findings of ACTEMRA. The five studies have reported meeting their primary endpoints. In Japan, ACTEMRA was launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis, and systemic-onset juvenile idiopathic arthritis were also approved in Japan.

ACTEMRA is generally well tolerated. The overall safety profile of ACTEMRA is consistent across all global clinical studies. The serious adverse reactions reported in ACTEMRA clinical studies include serious infections, gastrointestinal perforations, and hypersensitivity reactions, including anaphylaxis. Clinical studies reported the most common adverse reactions were upper respiratory tract infection, nasopharyngitis, headache, hypertension, and increased ALT. Increases in liver enzymes (ALT and AST) were seen in patients; these increases were generally mild and reversible, with no evidence of hepatic injuries. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in patients without association with clinical outcomes. Treatments that suppress the immune system, such as ACTEMRA, may cause an increase in the risk of malignancies.

Roche in Rheumatoid Arthritis

One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication.

Following the launch of MabThera (rituximab), several projects are in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. ACTEMRA is Roche's second novel medicine and is a humanized monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6. This protein plays a major role in the RA inflammation process. Additional projects creating a rich pipeline include compounds in Phase I, II, and III clinical trials. Notably, ocrelizumab, a humanized anti-CD20 antibody, has entered phase III development for RA.

References:

• 1) LITHE refers to the TociLIzumab safety and THE prevention of structural joint damage trial.
• 2) HAQ, or the Health Assessment Questionnaire Disability Index, is a patient self-report functional status (disability) measurement used to assess the patient's functional ability and discomfort during the past week. It is a commonly used instrument in many disease areas, including RA.

Attribution/Source(s):

This quality-reviewed publication was selected for publishing by the editors of Disabled World due to its significant relevance to the disability community. Originally authored by Roche, and published on 2009/01/03 (Edit Update: 2022/06/10), the content may have been edited for style, clarity, or brevity. For further details or clarifications, Roche can be contacted at roche.com. NOTE: Disabled World does not provide any warranties or endorsements related to this article.

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Cite This Page (APA): Roche. (2009, January 3 - Last revised: 2022, June 10). Research Shows ACTEMRA Improves Rheumatoid Arthritis. Disabled World. Retrieved September 7, 2024 from www.disabled-world.com/news/research/actemra.php

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