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Published on 29 October 2013

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RoActemra subcutaneous formulation

 

 

Roche and Chugai’s investigational RoActemra® (tocilizumab) subcutaneous formulation shows comparable long-term efficacy and tolerability to the intravenous formulation in rheumatoid arthritis
Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced that the long-term use of RoActemra (tocilizumab) subcutaneous (SC) formulation (49 weeks) has comparable efficacy to the use of intravenous (IV) formulation, according to the SUMMACTA study.(1) In addition, long-term efficacy and reduced progression of joint damage over 48 weeks was demonstrated in the BREVACTA study.(2)
Both SC phase-3 clinical trials also showed that the adverse event profile was consistent with previous findings.(1,2) These new data were released at the 2013 American College of Rheumatology Annual Meeting in San Diego, California.
“These data show that RoActemra can continue to deliver meaningful improvements for people living with rheumatoid arthritis over the long term regardless of how it is delivered,” said Professor Dr Gerd Burmester, Clinical Rheumatologist at the Charité Universitätsmedizin, Berlin. “The convenience of subcutaneous administration gives people with rheumatoid arthritis a time-saving treatment option of a self-administered injection, and may mean less time being treated and more time getting on with what matters to them.” 
Rheumatoid arthritis (RA) is an autoimmune disease estimated to affect up to 70 million people worldwide.(3) Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.(4) RA patients are often treated with a number of medicines, combining protein-based biologic therapies with methotrexate, the most common disease modifying antirheumatic drug (DMARD).(5,6,7)
Biologic therapies, like RoActemra, are used to help people affected by RA to control symptoms of the disease, slow RA progression and prevent further joint damage.(8) Approximately one in three patients treated with a biologic treatment, such as RoActemra, receive it as monotherapy, largely due to intolerance to methotrexate.(8–11)
In the BREVACTA study, the efficacy of RoActemra SC given every two weeks was maintained from week 24 to 48, in terms of the proportion of patients with ACR20/50/70* responses, in DAS28** remission and with a clinically meaningful improvement in physical function. Moreover, mean reduction in radiographic progression of structural joint damage was also maintained from week 24 to 48. The safety profile also remained stable with longer-term use to Week 48.
The SUMMACTA study demonstrated that efficacy rates for patients continuing on RoActemra SC given every week are maintained over 49 weeks and remain comparable to RoActemra IV, as shown at week 24. The week 49 cumulative safety profiles of patients on RoActemra SC were consistent with week 24 data and with RoActemra IV. The efficacy and safety profile of patients who switched from RoActemra IV to RoActemra SC and vice versa, was similar to patients who remained on RoActemra SC or RoActemra IV throughout the study with the exception of injection site reactions for SC.
About BREVACTA 
The BREVACTA study is a phase-3, randomised, multicenter, parallel-arm study investigating the efficacy and safety of SC RoActemra 162mg given every two weeks in patients with moderate to severe, active RA who had an inadequate response to DMARD therapy (21% of whom had failed an anti-TNF). The primary objective of the study was to assess efficacy and safety up to week 24. The secondary objective was to assess long-term efficacy and safety. Preliminary results from the study showed that after 24 weeks of treatment, RA patients who received RoActemra 162mg SC every two weeks were significantly more likely to have experienced at least a 20% improvement in the signs and symptoms of RA (including tender and swollen joint counts) than those given placebo injections (ACR20*). RoActemra SC demonstrated sustained ACR response rates and reduced progression of joint damage by week 48. There was no change in the adverse event profile for RoActemra SC compared to previous evaluations.
About SUMMACTA
The SUMMACTA study is a phase-3, randomised, multicentre, parallel-arm study investigating the efficacy and safety of RoActemra 162mg SC given weekly versus RoActemra 8mg/kg IV given every four weeks in patients with RA in combination with DMARD therapy. The primary objective of the study was to assess efficacy and safety at week 24. The secondary objective was to assess long-term efficacy and safety. Preliminary results showed that after 24 weeks of treatment, RA patients who received RoActemra 162mg SC every week were as likely to have experienced at least a 20% improvement in the signs and symptoms of RA (including tender and swollen joint counts) than those given RoActemra 8mg/kg IV every four weeks (ACR20§). RoActemra SC demonstrated sustained efficacy by week 49, comparable to RoActemra IV. The week 49 cumulative safety profile for RoActemra SC was consistent with the preliminary week 24 data and with IV RoActemra, with the exception of injection site reactions, which were lower in the IV group.
References
  1. Burmester GR et al. The Efficacy and Safety of Tocilizumab Subcutaneous Versus Tocilizumab Intravenous, in Combination With
  2. Kivitz A et al. The Safety and Efficacy of Tocilizumab Subcutaneous in Combination With Traditional DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis up to 48 Weeks (BREVACTA), ACR, October 2013. Traditional DMARDs in Patients With RA at 49 Weeks (SUMMACTA), ACR, October 2013.
  3. World Health Organisation. Chronic rheumatic conditions. http://www.who.int/chp/topics/rheumatic/en/ (Last accessed October 2013).
  4. Patient UK.Rheumatoid arthritis. http://www.patient.co.uk/health/rheumatoid-­‐arthritis (Last accessed October 2013).
  5. Smolen J, et al. EULAR Recommendations for the Management of Rheumatoid Arthritis with Synthetic and Biological Disease-­Modifying Antirheumatic drugs. Ann Rheum Dis 2010;69:964–975.
  6. Saag K, et al. American College of Rheumatology 2008 Recommendations for the Use of Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis. Arthritis & Rheumatism, 2008;59;6;762–784.
  7. NRAS. Methotrexate in Rheumatoid Arthritis. Available at: www.nras.org.uk (Last accessed October 2013).
  8. Yazici Y, et al. Bulletin of the NYU Hospital for Joint Diseases 2008;66(2):77-­‐85.
  9. Soliman M, et al. Ann Rheum Dis 2011;70:583–589.
  10. Listing J, et al. Arthritis Research & Therapy 2006, 8:R66.
  11.  Askling J, et al. Ann Rheum Dis 2007;66:1339–1344.


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