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MabThera (rituximab) is now licensed as the first and only treatment for two potentially life-threatening auto-immune diseases, GPA and MPA, which result in the inflammation and damage of small blood vessels and frequently involve multiple organs. The two diseases affect over 13,000 people in the UK and are characterised by the decaying inflammation of specific areas of tissue in the body that, if not treated, can lead to organ damage, organ failure and even death.
MabThera, which selectively targets CD20, a cell surface marker that is expressed on certain B cells and leads to B cell depletion, has been shown to offer similar efficacy to the chemotherapy agent cyclophosphamide. In a subset of patients with relapsing disease, it has been shown to offer greater efficacy.
MabThera is licensed in combination with glucocorticoids, a type of steroid, to induce remission in adult patients with severe, active GPA or MPA. The licence is based on data, which compared MabThera versus cyclophosphamide and found that treatment with MabThera provided effective induction of complete remission at 6-months in 64% of patients vs. 53% with cyclophosphamide (p=0.09). Achieving complete remission is important for patients, as it means that their disease is kept at bay.
"This licence is much welcomed news for patients suffering from these rare diseases. GPA and MPA can strike suddenly and have a serious impact on a person's life and overall health, with the likelihood of relapse high," said Dr. David Jayne, Consultant in Nephrology and Vasculitis at Addenbrookes Hospital. "In the management of these two conditions, remission and keeping patients from relapsing is the goal of treatment. MabThera, as the first and only licensed treatment for these debilitating conditions, not only means that more patients will have an additional treatment option, but will also have a chance of achieving remission or getting patients back into remission when their disease has relapsed."
The rate of relapse is higher in patients with GPA compared to those with MPA, with up to 50% of GPA patients relapsing within 5 years and each episode carries a high risk of organ damage. Data have shown that treatment with MabThera is more efficacious than a cyclophosphamide-based regimen to induce remission among those with relapsing disease, 67% vs. 42% respectively (p=0.01).
MabThera has an established safety profile across a number of disease areas, as demonstrated in over 3.5 million patient exposures, 14,000 patient years, of up to ten years duration with up to 19 courses of treatment in clinical trials, The most common adverse reactions reported in clinical studies were upper respiratory tract infections, urinary tract infections, infusion related reactions and headaches.GPA and MPA in the UK:
RAVE enrolled 197 ANCA positive GPA and MPA patients (newly diagnosed or relapsing), who were randomised to either MabThera 375mg/m2 of body surface area intravenously (IV) once weekly for 4 weeks plus daily cyclophosphamide-placebo, or MabThera-placebo IV plus daily cyclophosphamide 2mg/kg. Those with severe renal disease or severe alveolar haemorrhage were excluded. The primary endpoint was remission, defined as BVAS/GPA of 0 and successful oral steroid withdrawal at month . Groups were matched for disease severity, subtype, organ involvement and ANCA type and approximately 50% in each group had relapsing disease. Remission rates were comparable in the two treatment arms, with 64% in the MabThera arm and 53% of the control arm reaching the primary endpoint (p=0.09). In a planned subgroup analysis, the MabThera-based regime (67%) was more efficacious than the cyclophosphamide-based regimen (42%) for inducing remission of relapsing disease (P=0.01).About MabThera
 NHS Commissioning Board Clinical Commissioning Policy: Rituximab for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis. Reference : NHSCB/ A13/P/a – April 2013
 Stone John H et al. Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis. The New England Journal of Medicine, Vol.363; 221-232, July 2010
 Van Vollenhoven RF, et al. Ann Rheum Dis 2012; 71(Suppl 3): 195 and poster number 459 at ACR 2012
 Roche data on file RXUKDONF00294, February 2013
 Summary of Product Characteristics. MabThera 100mg and 500mg concentrate for solution for infusion. http://www.medicines.org.uk/emc/medicine/2570/SPC/Mabthera+100mg+and+500mg+concentrate+for+solution+for+infusion [last accessed June 2013]
Roche Products Ltd
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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