Convenient new treatment option for rheumatoid arthritis sufferers offers patient freedom and control of disease

May 19 2014

A new subcutaneous formulation of RoActemra® (tocilizumab) has today been launched providing thousands of UK rheumatoid arthritis (RA) patients with a potentially life-changing treatment option.¹ Patients 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 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. RoActemra provides an important treatment option for the third of RA patients that cannot tolerate MTX, as they are almost four times more likely to achieve disease remission from RoActemra (tocilizumab) without MTX, or monotherapy, compared to patients taking the most widely prescribed anti TNF, Humira (adalimumab) without MTX, or monotherapy (39.9% vs 10.5%).²

“Today’s news marks a meaningful step in the management of this chronic condition, of which patient choice is extremely significant,” said Professor Ernest Choy, Professor of Rheumatology, Cardiff Institute of Infection & Immunity. “The versatility that RoActemra now offers is extremely valuable to this patient population who are already burdened with this consuming disease, not to mention the freeing up of precious consulting time for clinicians. Looking to the future, patients and clinicians will work together to make those all-important treatment decisions; RoActemra will be a key player in allowing patients better control of their disease.”

This positive news was based on data from the phase III SUMMACTA and BREVACTA studies.^3,4 SUMMACTA showed that the efficacy and tolerability of subcutaneous RoActemra was comparable with the intravenous formulation.³ In addition, long-term efficacy and reduced progression of joint damage over 48 weeks was demonstrated compared to placebo in the BREVACTA study.⁴ 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 a debilitating condition which can dominate the lives of sufferers and their families,” said Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society. “We welcome this new option which provides greater flexibility and choice for people with RA giving them the freedom to carry on with their day–to-day lives.”

RA is a chronic, progressive and disabling disease which affects over 690,000 adults in the UK⁵ and the incidence is rising.⁶ The disease often starts during the prime of a person’s working life, between the age of 35 and 45 and around 50% of people with RA will be unable to work within ten years due to disability⁷. It is essential that patients aim for achieving disease remission or their lowest possible disease state, as even if they are not suffering disease symptoms, long-term joint damage may be occurring, which can result in the need for joint replacement surgeries, an increased chance of deformities or perhaps even becoming wheelchair bound.^8,9

RoActemra is licenced for intravenous use every four weeks and the subcutaneous formulation is administered once a week via a pre-filled syringe.¹ 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.¹

RA in the UK Facts and Figures

• RA is an incurable, painful and debilitating auto-immune disease where the body attacks itself, most noticeably in the joints¹⁰
• RA often starts during the prime of a person’s working life, between the age of 35 and 45¹¹
• Around 50% of people with RA will be unable to work within ten years due to disability⁷
• The total direct and indirect cost of RA in the UK is estimated at up to £4.75bn per year¹²
• 690,000 people are currently estimated to have RA in the UK⁵
• Approximately 1/3 of patients treated with a biologic therapy cannot tolerate MTX due to side effects²
• Achieving remission is the ultimate goal in RA treatment¹³

References

1. RoActemra (tocilizumab) Summary of Product Characteristics. Available at: http://www.medicines.org.uk/. Accessed May 2014.
2. Gabay C et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. The Lancet 2013; 381:1541-1550
3. Burmester G et al. A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis 2013; 0:1–6. doi:10.1136/annrheumdis-2013-203523.
4. Kivitz A et al. A Randomized, Double-Blind, Parallel-Group Study of the Safety and Efficacy of Tocilizumab Subcutaneous Versus Placebo in Combination With Traditional DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis (BREVACTA). ACR, November 2012
5. NRAS. What is RA? http://www.nras.org.uk/what-is-ra--what-is-ra--295. Accessed April 2014
6. Arthritis Research UK. http://www.arthritisresearchuk.org/arthritis-information/data-and-statistics/rheumatoid-arthritis.aspx. Accessed April 2014
7. National Institute for Health and Clinical Excellence. Rheumatoid arthritis: the management and treatment of rheumatoid arthritis in adults. http://www.nice.org.uk/nicemedia/live/11653/37807/37807.pdf. Accessed April 2014
8. Svensson B, et al. Sustained remission over eight years retards joint damage in rheumatoid arthritis: experiences from the barfot study. Ann Rheum Dis 2010;69(Suppl3):503
9. Kinnunen-Tiippana et al. Impact of early radiographic remission on the 15-year radiographic outcome in patients with rheumatoid arthritis. Scandinavian Journal of Rheumatology 2011;40:236-268
10. National Audit Office. Services for people with rheumatoid arthritis. July 2009
11. National Audit Office. Services for people with rheumatoid arthritis. International Comparisons 2009
12. National Institute for Health and Clinical Excellence. CG79 Rheumatoid arthritis: the management of rheumatoid arthritis in adults. February 2009. http://guidance.nice.org.uk/CG79 [last accessed April 2014]
13. Sesin CA and Bingham CO III. Remission in rheumatoid arthritis: wishful thinking or clinical reality? Semin Arthritis Rheum. 2005 Dec;35(3):185-96