MabThera® (rituximab) approved as the first and only licensed treatment for severe forms of Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
Today the National Institute for Health and Care Excellence (NICE) 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 over 13,000 people in the UK and are characterised by the breaking down of specific areas of tissue in the body that, if not treated, can lead to organ damage, organ failure and even death.
“The decision from NICE marks a major step forward in the treatment of these two potentially deadly diseases. The availability of MabThera for patients in England and Wales provides us with great hope for the future management of these diseases,” said Dr. David Jayne, Consultant in Nephrology and Vasculitis at Addenbrookes Hospital. “GPA and MPA are debilitating conditions which carry a high likelihood of relapse and, if left untreated, are fatal in the majority of patients. MabThera is the first and only licensed treatment option to provide patients with a greater chance of achieving remission in patients whose disease has relapsed.”
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 comparing 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. The rate of relapse is higher in patients with GPA compared to those with MPA, with up to 50% of GPA patients relapsing within five 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).
NICE has recommended MabThera, in combination with glucocorticoids, as a treatment option for patients with severe active GPA or MPA who are unable to take cyclophosphamide due to exceeding the recommended cumulative dose whereby side effects often become unmanageable, there are concerns regarding cyclophosphamide’s effect on fertility, or the disease has remained active despite receiving the standard treatment regime.
John Mills, Chairman of Vasculitis UK added; “We are delighted that NICE has made the right decision for patients in England and Wales, particularly those who cannot tolerate the standard treatment regime, allowing patients access to the biggest breakthrough in the treatment of vasculitis for forty years. Until today, patients have been treated with chemotherapy and for those who didn’t respond to treatment, death and permanent disability was a possibility. MabThera offers patients an additional treatment option which can significantly increase the chance of reaching remission.”
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.