Breakthrough Treatment For Rheumatoid Arthritis Offers New Hope To Patients

Main Category: Arthritis / Rheumatology
Article Date: 28 May 2009 - 5:00 PDT

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Today's Irish launch of RoActemra, a new treatment for rheumatoid arthritis (RA) from Roche, is being hailed as a breakthrough in the fight against this incurable and often debilitating disease. RoActemra (tocilizumab) is the first medication of its kind developed for the treatment of RA and provides an innovative therapy option (1), which gives people with RA fast relief of RA signs and symptoms, such as pain. Also, people receiving RoActemra continue to benefit from increased relief during the course of treatment, with approximately half reaching remission (minimal signs and symptoms) by one year.

In a recent Irish survey* when asked how rheumatoid arthritis affects the lives of people with the condition, the majority of respondents cited pain as the most prominent feature (2). According to respondents nearly half (47%) of those with RA experience pain, with nearly all of these (94%) describing the pain as moderate or severe (2). When people living with RA were asked, nearly two-thirds (65%) cited pain as being the biggest affect of RA on their lives (2).

The arrival of RoActemra to Ireland has been favourably received by physicians and Arthritis Ireland alike, as there is still a huge unmet medical need in RA. According to the research, 78% of people with RA take medication for their condition, but a massive 95% of those still experience pain (2). "Rheumatoid arthritis is a chronic, progressive inflammatory disease of the joints and surrounding tissues that can cause intense pain, disability and irreversible joint destruction," commented Professor Douglas Veale, Consultant Rheumatologist, St Vincent's University Hospital, Dublin. "As the research shows, there is still a need for new treatment options in RA, so I welcome the arrival of RoActemra, which offers a new option for Irish physicians and patients alike."

A drug called methotrexate (MTX) is the current standard of care in treating RA and, until now, no biologic drug has been able to show superiority over MTX as measured by scores called ACR20, 50 and 70. These scores indicate 20, 50 and 70 percent improvement respectively in the signs and symptoms of RA, so for example, someone achieving an ACR70 score has seen a 70 percent improvement in their condition. RoActemra is the first and only biologic to demonstrate superiority over MTX in all three ACR scores at six months. RoActemra is licenced for use in combination with MTX or alone in patients intolerant to MTX. It works by blocking one of the most common chemical influencers, called IL-6, in the rheumatoid system. This widespread blocking causes improvement in a range of signs and symptoms in RA, such as reduced inflammation and fatigue. It also stops the disease from progressing, both in the joints and throughout the body.

There are estimated to be around 40,000 people with RA in Ireland (3) and this figure is on the rise. People of any age can develop RA, but it is most common between the ages of 30 and 50 years (4), with seven in ten of those diagnosed with RA having had to give up work as a consequence (3). The disease is more common in women, with an estimated 70% of those with RA being female (3). RA is an autoimmune disease, so-called because a person's immune system, which normally helps protect the body from infection and disease, attacks joint tissues for unknown reasons. It can affect many different joints; often resulting in pain, swelling, stiffness and loss of function in the joints.

Mr. John Church, Chief Executive of Arthritis Ireland, said: "Arthritis Ireland welcome the introduction of this new therapy, particularly as it shows strong results in achieving remission for RA patients, the ultimate goal for people with this often debilitating disease. Remission, which can be described as minimal disease activity, is the ultimate goal for people with RA."

RoActemra is licensed for the treatment of adults with moderate-to-severe active RA who have either responded inadequately to, or who were intolerant of, previous RA therapies. It can be used either in combination with methotrexate (MTX) or alone in patients who cannot tolerate MTX. It will be administered to suitable RA patients every four weeks in a hospital setting.

RA patients can access a new online resource on the condition at http://www.irishhealth.com/clin/ra. This website, developed by irishhealth.com and Arthritis Ireland, and supported by an unrestricted educational grant from Roche, offers advice on the management of RA both in terms of treatment and guidance on practical day-to-day issues. People who are concerned about rheumatoid arthritis can also contact Arthritis Ireland directly on their helpline: locall 1890 252 846 (10am-4pm Mon-Fri) or email: helpline@arthritisireland.ie

About RoActemra/Actemra

RoActemra (known as Actemra outside of the EU) is the result of a research collaboration between Roche and Chugai and the drug has been co-developed globally with Chugai. RoActemra is the first humanised interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development programme of five Phase III trials was designed to evaluate clinical findings of RoActemra. 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.

RoActemra is generally well tolerated. The overall safety profile of RoActemra is consistent across all global clinical studies. The serious adverse reactions reported in RoActemra clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse reactions reported in clinical studies 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 RoActemra, may cause an increase in the risk of malignancies.

To date, there is limited evidence that monotherapy with other treatments is superior to methotrexate, as neither etanercept nor adalimumab monotherapy were statistically superior to methotrexate in standard clinical efficacy parameters at 24 weeks in the ERA, TEMPO, and PREMIER trials (5-7).

References

1. Madhok et al. Annals of the Rheumatic Diseases. 1993; 52: 232-34.
2. Rheumatoid Arthritis, Findings from iReach Consumer Survey. April 2009.
3. Arthritis Ireland website. http://www.arthritisireland.ie
4. Arthritis Care, United Kingdom. http://www.arthritiscare.org.uk/AboutArthritis/Conditions/Rheumatoidarthritis
5. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van VR et al. Arthritis Rheum 2006;54:26-37.
6. Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC et al. N.Engl.J.Med. 2000;343:1586-1593.
7. Klareskog L, van der HD, de Jager JP, Gough A, Kalden J, Malaise M et al. Lancet 2004;363:675-681.

Source
Roche

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