Roche Pharmaceuticals

MabThera Continues to Improve Patient Response in Rheumatoid Arthritis With Multiple Courses of Treatment

    Basel, Switzerland (ots/PRNewswire) -

    - MabThera Shown to be Effective and Well Tolerated Over the Long-Term

    A study(1) has shown that rheumatoid arthritis patients given multiple courses of MabThera experienced further improvements in their condition with each subsequent treatment course. The patients in the study all suffered from moderate to severe rheumatoid arthritis (RA) and had failed to respond adequately to another class of RA drug known as tumour necrosis factor (TNF) inhibitors, the most commonly prescribed first-line biologic therapy for RA. The continued response seen with MabThera is a particularly important outcome as it highlights durable efficacy over time.

    The impressive new data presented at the American College of Rheumatology (ACR) annual meeting in San Francisco show that MabThera continues to improve RA symptoms with each subsequent course of treatment, maximising patient response. The number of patients achieving remission from their disease doubled over three successive treatment courses with MabThera (Disease Activity Scores (DAS)(*) increased from 8.8% after the first course to 17.6% after the third course). Additionally, almost twice as many patients achieved a 70% reduction of their symptoms after their third course of treatment compared to their first course of treatment (increase in ACR70(i) response from 14% to 25.7%).

    "Prolonged treatment with MabThera clearly demonstrates an improvement in symptoms for patients with rheumatoid arthritis who do not respond adequately to TNF inhibitor therapy," said Professor Edward Keystone, Rheumatology Department at the University of Toronto, Canada. "These findings confirm that MabThera controls rheumatoid arthritis effectively, giving patients greater freedom from the disease with repeat courses of treatment."

    Long-term treatment with MabThera also shown to reduce joint damage

    MabThera's effectiveness over the long term is reinforced by further data presented at ACR which demonstrate that the drug continues to significantly inhibit the progression of joint damage caused by RA over a period of two years in those patients who do not respond to TNF inhibitor therapy(2). Damage to the structure of joints ultimately causes joint destruction and contributes to joint deformity and loss of mobility. The inhibition of structural damage is therefore a major goal of treatment. In patients who do not respond to TNF inhibitor therapy, MabThera is the first and only therapy to have demonstrated a reduction in joint structural damage.

    Data demonstrates long-term safety of MabThera

    Six-year follow-up data also presented at the ACR prove that MabThera continues to be well-tolerated over several courses of treatment. The safety profile of MabThera remained consistent with a low rate of adverse events and infections in 2578 patients, receiving multiple treatment courses. These results add to the wealth of data contributing to MabThera's safety profile with 5013 patient-years of follow-up now collected.(3)

    Commenting on the findings, Dr Ronald van Vollenhoven, Rheumatology Unit at Karolinska University Hospital, Sweden, said, "This data confirms that the excellent safety profile identified with MabThera in clinical trials after one course of therapy is maintained over multiple courses. This is very reassuring for physicians. Given that rheumatoid arthritis is a long-term condition, we want to ensure that treatments for patients are both effective and safe over an extended period of time."

    Editor's Notes

    About rheumatoid arthritis and MabThera

    Rheumatoid arthritis (RA) is an autoimmune disease characterized by inflammation that leads to stiff, swollen and painful joints. This ultimately results in irreversible joint damage and disability. MabThera selectively targets B cells and represents a new highly effective therapeutic approach for RA in addition to existing treatments such as disease-modifying anti-rheumatic drugs (DMARDs) and tumour necrosis factor (TNF) inhibitors.

    B cells are known to play a key role in the inflammation associated with RA. As the first and only selective B cell therapy available for the treatment of RA, MabThera represents a proven and truly different alternative for patients who have inadequate response or are not able to tolerate TNF inhibitor therapy. MabThera is the only RA treatment that has demonstrated the ability to preserve joint structure in this patient group and offers an unprecedented duration of response of at least six months with each course. Each course of MabThera also provides the opportunity of sustained or improved relief for patients from the signs and symptoms of their disease.

    MabThera is marketed in the US by Genentech and Biogen Idec under the brand name Rituxan(R).

    For a selection of broadcast footage clips relating to MabThera and rheumatoid arthritis please visit http://www.thenewsmarket.com/roche.

    To view and download high resolution stills and media materials please visit the MabThera Virtual Press Office at http://www.mabthera-ra.com

    All trademarks used or mentioned in this release are protected by law.

    References

    (1) Keystone, EC et al. Efficacy and safety of repeat treatment courses of rituximab (RTX) in RA patients with inadequate response to tumor necrosis factor inhibitors: long-term experience from the REFLEX study. ACR 2008.

    (2) Cohen S et al. Continued inhibition of structural damage in RA patients treated with rituximab at two years: REFLEX study. ACR, 2008.

    (3) van Vollenhoven, RF et al. Long-term safety of rituximab: 6-year follow-up of the RA clinical trials and re-treatment population. ACR 2008.

    ---------------------------------

    (*) DAS is a measurement score used to assess whether a patient shows an improvement in disease activity. DAS provides a number on a scale from 0 to 10 which indicates the current activity of the disease. Disease remission is defined as DAS<2.6.

    (i) The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example, a 20%, 50% or 70% level of reduction is represented as ACR20, ACR50 or ACR70. An ACR 70 response is exceptional for existing treatments and represents a significant improvement in a patient's condition.

      For further information, please contact:
      Roche
      Federico Maiardi
      Associate International Communications Manager
      Tel: +41-79-264-3978
      federico.maiardi@roche.com
      Cohn & Wolfe
      Rebecca Hibble
      Tel: +44-207-331-5318
      rebecca.hibble@cohnwolfe.com

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
For further information, please contact: Roche, Federico Maiardi,
Associate International Communications Manager, Tel: +41-79-264-3978,
federico.maiardi@roche.com; Cohn & Wolfe, Rebecca Hibble, Tel:
+44-207-331-5318, rebecca.hibble@cohnwolfe.com



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