Patients Suffering from Potentially Fatal Forms of Vasculitis Could Benefit from First Ever Licensed Treatment

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 more than 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.¹

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.2 In a subset of patients with relapsing disease, it has been shown to offer greater efficacy.²

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 versus 53% with cyclophosphamide (p=0.09).² 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.¹ Data have shown that treatment with MabThera is more efficacious than a cyclophosphamide-based regimen to induce remission among those with relapsing disease, 67% versus 42% respectively (p=0.01).2

MabThera has an established safety profile across a number of disease areas, as demonstrated in more than 3.5 million patient exposures, 14,000 patient years, of up to 10 years duration with up to 19 courses of treatment in clinical trials.^3,4 The most common adverse reactions reported in clinical studies were upper respiratory tract infections, urinary tract infections, infusion related reactions and headaches.⁵

References

1. NHS Commissioning Board Clinical Commissioning Policy: Rituximab for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis. Reference : NHSCB/ A13/P/a – April 2013

2. J.H. Stone, et al., "Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis," The New England Journal of Medicine, Vol.363; 221-232, July 2010.

3. R.F. Van Vollenhoven, et al., Ann Rheum Dis 2012; 71(Suppl 3): 195 and poster number 459 at ACR 2012.

4. Roche data on file RXUKDONF00294, February 2013.

5. Summary of Product Characteristics. MabThera 100 mg and 500 mg concentrate for solution for infusion. www.medicines.org.uk/emc/medicine/2570/SPC/Mabthera+100mg+and+500mg+concentrate+for+solution+for+infusion [last accessed June 2013]