SMC Approves MabThera (Rituximab) for Patients Suffering from Potentially Fatal Forms of Vasculitis

The Scottish Medicines Consortium (SMC) has approved the use of MabThera 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 of specific areas of tissue in the body that, if not treated, can lead to organ damage, organ failure and even death.¹

“The SMC’s decision is very welcome news in Scotland and represents a major step-forward in the treatment of GPA and MPA. These auto-immune diseases are debilitating conditions which carry a high likelihood of relapse and, if left untreated, are fatal in the majority of patients. With the knowledge that MabThera is now accessible for Scottish patients we are equipped with an alternative treatment option which can heighten the chance of reaching remission, truly offering these patients new hope for the future.” commented Dr Lars Erwig, Professor of Nephrology and Honorary Consultant at the University of Aberdeen. 

MabThera is licensed in combination with glucocorticoids, a type of steroid, to induce remission in adult patients with severe, active GPA or MPA. The approval 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. The rate of relapse is higher in patients with GPA compared with 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

John Mills, Chairman of Vasculitis UK added: “We whole-heartedly welcome the news that Scottish patients now have routine access to this medicine, which is the most significant breakthrough in the treatment of vasculitis in forty years, bringing Scotland into line with the US and the EU. GPA and MPA can be deadly diseases, often leaving those who survive permanently disabled and previously, treatment has involved the use of chemotherapy. However, for those where this particular treatment did not work, there was no other treatment available. This targeted treatment offers an alternative and we urge the health bodies in the rest of the UK to grant access to this treatment in the near future.”

References

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

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