Scottish Patients to Benefit from New, Convenient Treatment Option for Rheumatoid Arthritis

Today a new subcutaneous formulation of RoActemra (tocilizumab) has been accepted for use on the NHS in Scotland for the treatment of rheumatoid arthritis (RA). This announcement by the Scottish Medicines Consortium (SMC), which advises NHS Scotland on prescribing new treatments, means that patients receiving treatment with RoActemra can now be in control of where and when they have their treatment, giving them freedom to manage the condition convenient to their lifestyle, whether at hospital or at home. This is especially important for the vast number of patients in Scotland without easy access to their nearest hospital due to their rural or remote location.

RoActemra is the first anti IL-6 receptor inhibitor to be available as both subcutaneous and intravenous (IV) formulation, for both combination therapy with methotrexate (MTX) and for use without MTX for those patients who cannot or will not continue with MTX. It provides an important treatment option for the 20–40% of RA patients that experience incomplete responses and/or adverse events with MTX as, in an IV trial, it was shown that they are almost four times more likely to achieve disease remission from RoActemra (tocilizumab) without MTX compared to patients taking the most widely prescribed anti TNF, Humira (adalimumab) without MTX (39.9% vs 10.5%).

Commenting on the SMC decision, Professor Ernest Choy, Professor of Rheumatology, Cardiff Institute
of Infection & Immunity, remarked: “Today’s positive decision brings a valuable option in the management of this chronic condition for people with RA in Scotland, of which patient choice is extremely significant. The convenience of self-administration in a subcutaneous formulation not only benefits patients, giving them more choice and better control of their disease, but also improves costeffectiveness by freeing up capacity in Scottish hospitals.”

Today’s approval from the SMC was based on data from the phase III SUMMACTA and BREVACTA studies. SUMMACTA showed that the efficacy and tolerability of subcutaneous RoActemra was comparable with the intravenous formulation. In addition, long-term efficacy and reduced progression of joint damage over 48 weeks was demonstrated compared to placebo in the BREVACTA study. With comparable efficacy and tolerability to the intravenous formulation, the addition of the subcutaneous formulation provides clinicians and patients, particularly those unable to take MTX, with more flexibility to choose a treatment method that suits their needs.

“RA is an extremely debilitating disease that can affect every aspect of a person’s life,” said Sheila MacLeod, Scottish Ambassador at NRAS. “With the availability of this treatment option, sufferers in Scotland now have much needed flexibility and choice, giving them a better opportunity to remain active and get on with their lives as normally as possible.”

RoActemra is licenced for intravenous use every 4 weeks and the subcutaneous formulation is administered once a week via a pre-filled syringe. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, elevated blood pressure, and increased liver enzymes. The serious adverse reactions reported in clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis.