Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced data from two phase III studies using RoActemra in patients with rheumatoid arthritis (RA): the long-term extension (LTE) follow up of the AMBITION study demonstrated long-term efficacy of RoActemra without methotrexate (MTX); and the FUNCTION study showed the clinical benefits of the medicine, alone or in combination with MTX, when used to treat patients with early RA.(1,2) These studies are being presented at the 2013 European League Against Rheumatism (EULAR) Congress.
Results from the AMBITION LTE study showed that long-term treatment with RoActemra alone (monotherapy) showed long-term efficacy in people with RA who, at the time of entering the study, had never received MTX or had not received it in the preceding six months.(1) High remission rates and improvements in disease activity lasted up to 4.6 years. This was shown in people who achieved a 50% reduction in their swollen and tender joints at week 24 and who continued treatment with RoActemra without MTX.(1)
The FUNCTION study explored treatment with RoActemra alone or in combination with MTX in people with early RA who had not previously been treated with MTX, a setting in which biologics, such as RoActemra, are not commonly used.(3) The study showed that RoActemra (8mg/kg) when used with or without MTX was superior to MTX alone in achieving disease remission in people at week 24 (as measured by DAS28<2.6).(2)
“These data show that people with rheumatoid arthritis experienced meaningful clinical improvement when treated with RoActemra in the early stage of RA as well as in more advanced stages of the disease,” said Hal Barron, MD, chief medical officer and head, Global Product Development. “People who were treated with this medicine as monotherapy over a long period of time maintained relief from RA joint swelling and pain.”
RA is an autoimmune disease estimated to affect up to 70 million people worldwide, including children.(4) Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.(5) RA patients are often treated with a number of medicines, combining protein-based biologic therapies with MTX, the most common disease-modifying anti-rheumatic drug (DMARD).(3,6)
Biologic therapies, like RoActemra, are used to help people affected by RA to control symptoms of the disease, slow RA progression and prevent joint damage.(7) Approximately one in three patients treated with a biologic treatment receive it as monotherapy, largely due to them not being able to take MTX.(8–11)
Among the more than 35 RoActemra abstracts being presented at EULAR 2013, data from the LITHE study and pooled data from RoActemra registrational and post-approval studies show sustained benefits from its long-term use in patients with moderate to severe RA.(12,13) The data also suggest that the long-term safety profile is consistent with that observed in previous trials.(13)
RoActemra therapy has an established safety profile as demonstrated in over 125,691 patient years. 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.(14)
A copy of the Summary of Product Characteristics is available at:
- Jones G, et al. Long-term efficacy and safety of tocilizumab (TCZ) monotherapy in patients with Rheumatoid Arthritis previously methotrexate naïve or MTX free for 6 months prior to study start. Poster presentation at EULAR, 2013.
- Burmester G, et al. Tocilizumab (TCZ) in combination and monotherapy versus methotrexate (MTX) in MTX-naïve patients (pts) with early rheumatoid arthritis (RA): Clinical and radiographic outcomes from a randomized, placebo-controlled trial. Oral presentation at EULAR, 2013
- Smolen J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological diseasemodifying antirheumatic drugs. Ann Rheum Dis 2010;69:964–75
- World Health Organisation. Chronic rheumatic conditions. http://www.who.int/chp/topics/rheumatic/en/ (Last accessed May 2013)
- Patient UK.Rheumatoid arthritis. http://www.patient.co.uk/health/rheumatoid-arthritis (Last accessed May 2013)
- Saag K, et al. American College of Rheumatology 2008 recommandations for the use of nonbiologic and biologic diseasemodifying. Arthritis & Rheumatism, 2008;59;6;762–784
- NRAS. Methorexate in Rheumatoid Arthritis. Available at: www.nras.org.uk
- Yazici Y, et al. Bulletin of the NYU Hospital for Joint Diseases 2008;66(2):77-85
- Soliman M, et al. Ann Rheum Dis 2011;70:583–589
- Listing J, et al. Arthritis Research & Therapy 2006, 8:R66
- Askling J, et al. Ann Rheum Dis 2007;66:1339–1344
- Kremer JM, et al. LITHE: tocilizumab inhibits radiographic progression and improves physical function in patients with RA at 5 years with maintenance of clinical efficacy over time. Poster presentation at EULAR, 2013
- Genovese MC, et al. Long-term safety of tocilizumab in patients with rheumatoid arthritis following a mean treatment duration of 3.9 years. Poster presentation at EULAR, 2013
- RoActemra® (tocilizumab) Summary of Product Characteristics. Roche Registration Limited. May 2013.