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Roche (RHHBY)'s Investigational Roactemra Subcutaneous Formulation Shows Comparable Long-Term Efficacy and Tolerability to the Intravenous Formulation in Rheumatoid Arthritis


10/28/2013 8:43:11 AM

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October 26 2013 -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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 Prof.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 (MTX), the most common disease modifying antirheumatic drug (DMARD).5,6

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.7 Approximately one in three patients treated with a biologic treatment, such as RoActemra, receive it as monotherapy, largely due to intolerance to MTX.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 DAS** 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, randomized, multicenter, parallel-arm study investigating the efficacy and safety of SC RoActemra 162 mg 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 162 mg 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, randomized, multicenter, parallel-arm study investigating the efficacy and safety of ACTEMRA 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 162-mg 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 8 mg/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.

About RoActemra (tocilizumab)

RoActemra, known as ACTEMRA outside of Europe, is the first humanized interleukin-6 (IL-6) receptor agonist approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).12 The extensive RoActemra clinical development program included five phase-3 clinical studies and enrolled more than 4,000 people with RA in 41 countries. In addition, the phase-4 ADACTA study showed that monotherapy with ACTEMRA was superior to monotherapy with adalimumab in reducing signs and symptoms of RA in MTX-intolerant patients or patients for whom MTX treatment was considered ineffective or inappropriate.13 The overall safety profile of both medications was consistent with previously reported data.13

RoActemra is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older.

RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co. It has been approved in Japan since April 2005 for Castleman’s disease, followed by approvals for RA, SJIA and PJIA in 2008. RoActemra is approved for RA, SJIA and PJIA in the European Union and several other countries including the United States, China, India, Brazil, Switzerland and Australia.

* ACR20, ACR50, ACR70 represent the percentage of reduction (20%, 50%, 70%) in certain RA signs and symptoms and measures the number of tender and swollen joints, physical function, patient’s pain, patient’s and physician’s global assessments and certain laboratory markers.

** The Disease Activity Score (DAS)28 is a combined index that measures disease activity in patients with RA. It combines information from 28 tender and swollen joints (range 0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. The level of disease activity is interpreted as low (DAS28=3.2), moderate (3.25.1). DAS28<2.6 corresponds to being in remission according to the criteria of the American College of Rheumatology.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, ophthalmology, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over eight billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media Relations

Phone: +41 -61 688 8888 / e-mail: basel.mediaoffice@roche.com

- Alexander Klauser (Head)

- Silvia Dobry

- Daniel Grotzky

- Štepán Krácal

References

1Kivitz 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.

2Burmester GR et al. The Efficacy and Safety of Tocilizumab Subcutaneous Versus Tocilizumab Intravenous, in Combination With Traditional DMARDs in Patients With RA at 49 Weeks (SUMMACTA), ACR, October 2013.

3World Health Organisation. Chronic rheumatic conditions. http://www.who.int/chp/topics/rheumatic/en/ (Last accessed October 2013 2013).

4Patient UK.Rheumatoid arthritis. http://www.patient.co.uk/health/rheumatoid-arthritis (Last accessed October 2013).

5Smolen 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.

6Saag 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.

7NRAS. Methotrexate in Rheumatoid Arthritis. Available at: www.nras.org.uk (Last accessed October 2013).

8Yazici 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.

10Listing J, et al. Arthritis Research & Therapy 2006, 8:R66.

11Askling J, et al. Ann Rheum Dis 2007;66:1339–1344.

12RoACTEMRA® Summary of Product Characteristics. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000955/WC500054890.pdf (Last accessed October 2013).

13Gabay C, et al. The Lancet 2013. 381;9877:1541-1550.

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