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Fresh Hope For Thousands Of Rheumatoid Arthritis (RA) Sufferers Who Cannot Tolerate The Most Common Treatment For This Debilitating Disease

Head to head data in The Lancet confirms RoActemra® (tocilizumab)  is superior to Humira® (adalimumab) in achieving disease remission when either is used without methotrexate (MTX)

Data published this week in The Lancet show that over 50% of  RA patients can achieve low disease activity or remission with RoActemra, compared to under 20% of those treated with the most widely prescribed anti-TNF Humira when neither drug is combined with methotrexate (51.5% vs. 19.8%, assessed by DAS28 ≤3.2*). The study exposed a wealth of data indicating the superiority of RoActemra over Humira, with almost four times as many patients achieving disease remission with RoActemra alone, compared to Humira alone (39.9% vs. 10.5%, assessed by DAS28 <2.6*) and almost twice as many patients achieve a 70% improvement in the signs and symptoms of their disease (32.5% vs. 17.9%, assessed by ACR70**).1

The study findings offer hope to RA patients that RoActemra without methotrexate is an efficacious treatment which can provide tight disease control to those who cannot tolerate methotrexate. RA patients are often treated with a number of medicines, combining methotrexate, the current standard of care for RA patients across the UK, with a biologic therapy. However, it is estimated that approximately one third of patients cannot tolerate methotrexate, due to the side effects including nausea and vomiting, diarrhoea, mouth ulcers, skin conditions, such as redness of the skin, itching and even hair loss.1, 2, 3, 4, 5, 6

RoActemra, which is directed at a different aspect of the immune response compared to other biologic treatments, targets the interleukin-6 (IL-6) receptor, which is one of the main causes of inflammation, fatigue, anaemia and joint damage in RA. By blocking IL-6 and disrupting the signalling pathway, it reduces the cascade of inflammation, supressing the systemic and local RA symptoms and preventing the progression of the disease in the joints and through-out the body. 7, 8

“RA is a progressive, debilitating disease which can have a serious impact on a person’s life and the side effects of treatment can further compound this, so these data are particularly relevant for those who cannot take methotrexate” said Professor John Isaacs, Consultant Rheumatologist and ADACTA Study Investigator. “Remission is the ultimate goal of treatment in RA because until a patient has reached this, further joint damage can occur. As the first study of its kind which shows the superiority of one RA therapy over another in the monotherapy setting, these data will be of great interest to physicians and patients alike” he commented.

It is essential that patients achieve disease remission, because even if they are not suffering disease symptoms, long-term joint damage is occurring, which can result in the need for joint replacement surgeries, an increased chance of deformities or perhaps even becoming wheelchair bound. 9, 10

RoActemra therapy has an established safety profile as demonstrated in over 125,691 patient years.11 The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, elevated blood pressure, and increased liver enzymes. The serious adverse reactions reported in clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis.12 Within the ADACTA study, the adverse event profile was comparable across RoActemra and Humira.1

* The Disease Activity Score (DAS)28 is a combined index that measures disease activity in patients with RA. It combines information from 28 tender and swollen joints (0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analogue scale. The level of disease activity is interpreted as low (DAS28 ≤3.2), moderate (DAS28 3.2-5.1) or high (DAS28>5.1). DAS28<2.6 corresponds to being in remission according to the criteria of the American College of Rheumatology

** ACR70 represents a 70% reduction in certain RA symptoms, including the number of tender and swollen joints, pain, patient’s and physician’s global assessments and certain laboratory markers

A copy of the Summary of Product Characteristics is available here.


1 Gabay C et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): results from a randomised, double-blind, controlled phase 4 trial. The Lancet 2013; 381

2Soliman M, et al. Impact of concomitant use of DMARDs on the persistence with anti-TNF therapies in patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis 2011;70:583-589

3 Pincus T, et al. Underestimation of the efficacy, effectiveness, tolerability, and safety of weekly low-dose methotrexate in information presented to physicians and patients. Clin Exp Rheumatol 2010; 28(Suppl. 61):S68-S79

4 Yazici Y, et al. Utilisation of biologic agents in rheumatoid arthritis in the United States: analysis of prescribing patterns in 16,752 newly diagnosed patients and patients new to biologic therapy. Bull NYU Hosp Jt Dis 2008; 66:77-85

5 NRAS Methotrexate in Rheumatoid Arthritis. (last accessed March 2013)

6 Methotrexate Summary of Product Characteristics. Hospira UK Ltd. February 2009

7 Choy E. Inhibiting interleukin-6 in rheumatoid arthritis. Curr Rheumatol Rep. 2008;10:413-417

8 Isaacs J. What is RoActemra (tocilizumab)? NRAS 2010. [last accessed March 2013]

9 Svensson B, et al. Sustained remission over eight years retards joint damage in rheumatoid arthritis: experiences from the barfot study. Ann Rheum Dis 2010;69(Suppl3):503

10 Kinnunen-Tiippana et al. Impact of early radiographic remission on the 15-year radiographic outcome in patients with rheumatoid arthritis. Scandinavian Journal of Rheumatology 2011;40:236-268

11 RoActemra Data on File – RXUKDONF00219. August 2012

12 RoActemra (tocilizumab) Summary of Product Characteristics. Roche Products Ltd. December 2012

13 National Audit Office. Services for people with rheumatoid arthritis. July 2009

14 National Audit Office. Services for people with rheumatoid arthritis. International Comparisons 2009

15 National Institute for Health and Clinical Excellence.CG79 Rheumatoid arthritis: the management of rheumatoid arthritis in adults. February 2009. [last accessed March 2013]

16 Roche Data on File RA Algorithm- RXUKDATA00058a. March 2011

17 Sesin CA and Bingham CO III. Remission in rheumatoid arthritis: wishful thinking or clinical reality? Semin Arthritis Rheum. 2005 Dec;35(3):185-96

Source: Roche in the UK