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RoACTEMRA: New Hope for Children With Systemic Juvenile Idiopathic Arthritis

Basel, Switzerland, June 18, 2010 (ots/PRNewswire)

Roche (SIX: RO,
ROG; OTCQX: RHHBY) (http://www.roche.com/investors.htm) today
announced that new data being presented at the European League
Against Rheumatism (EULAR) congress demonstrates that RoACTEMRA
(known as ACTEMRA outside Europe) is highly effective in improving
the signs and symptoms of systemic Juvenile Idiopathic Arthritis
(sJIA), a severe childhood arthritis, where there are no currently
licensed treatments. RoACTEMRA is also well tolerated in children
with sJIA having a safety profile similar to adults with RA.
Data from the phase III TENDER study[1] showed that, following
three months' treatment with RoACTEMRA, 85 percent of patients
achieved 30 percent improvement (JIA ACR30[1]) in the signs and
symptoms of sJIA and absence of fever, a primary characteristic of
sJIA, compared to 24 percent of patients receiving placebo. Further
data showed 70 percent achieved JIA ACR70 and 37 percent achieved
ACR90. In addition to the significant improvement in JIA ACR response
nearly two thirds were free of rash after three months.
"There is a critical need for new therapies for children
suffering from the debilitating and life-threatening effects of sJIA,
and these data represent an exciting breakthrough," commented Hal
Barron, M.D, Head of Global Development and Chief Medical Officer for
Roche. "RoACTEMRA's striking efficacy confirms a major advance in the
treatment of this disease. It promises to have a significant impact
in the life of these young children."
sJIA is characterised by chronic arthritis accompanied by
intermittent fever, skin rash, anaemia, enlargement of the liver
and/or spleen and inflammation of the lining of the heart and/or
lungs.[2] The peak age of onset of sJIA is between 18 months and two
years[3],[4] although persistence of the disease into adulthood does
occur.
Its disease course is variable and in the most severe cases, up
to two thirds of patients have chronic and persistent arthritis and
approximately half of these will develop significant
disability.[5],[6] It has the worst long term prognosis of all
childhood arthritis subtypes, accounting for almost two-thirds of all
deaths among children with arthritis, with an overall mortality rate
estimated to be between two to four percent.[7] There are no approved
therapies for sJIA and current treatment consists of high dose
corticosteroids to control systemic symptoms. However, these do not
improve the long-term prognosis and their use is accompanied by
severe side effects.[2]
The TENDER study findings reflect previous Japanese
studies[8],[9] which demonstrated that RoACTEMRA is well tolerated
and effective in children with sJIA who could not tolerate, or showed
inadequate response to systemic corticosteroids and
immunosuppressants. No new major safety signals were observed and the
adverse event profile was similar to adult RA studies and as expected
for this patient population.
RoACTEMRA inhibits the activity of interleukin-6 (IL-6), a
contributor to the major features of sJIA including chronic synovial
inflammation, articular cartilage damage, fever, anaemia, growth
impairment and osteoporosis.[10] Commenting on IL-6 as a treatment
approach, Hal Barron said: "RoACTEMRA's efficacy in treating these
symptoms provides further evidence of the pivotal role of IL-6 in
mediating joint inflammation and the detrimental systemic effects of
chronic inflammatory diseases."
RoACTEMRA is already approved in the EU, US and other countries
for adult RA, a disease also associated with elevated levels of IL-6
and systemic symptoms such as fatigue, anaemia and fever. Studies in
RA have demonstrated RoACTEMRA's strong efficacy and safety, with
consistently high remission rates across all patient types[11] and
inhibition of structural joint damage.[12] In addition it is the only
product to have proven superiority to methotrexate in monotherapy in
ACR20, ACR50 and ACR70 responses at six months, in adult RA.[13]
About the TENDER Study
The TENDER study is an international study, including
approximately 70 centres in 20 countries. The study aimed to assess
efficacy for signs and symptoms and short term safety of RoACTEMRA
versus placebo in 112 patients with active sJIA. Additional aims were
efficacy for the common systemic features of sJIA, steroid reduction,
other concomitant drug reductions, safety with chronic administration
and biomarkers.
In this randomised study, patients received RoACTEMRA 8 mg/kg (if
weight Is greater than or equal to 30 kg) and 12 mg/kg (if weight <
30 kg), every 2 weeks versus placebo infusions for 12 weeks. Patients
were also given the option to enroll for long-term, open label
follow-up. The study was performed in close collaboration with the
PRINTO (Paediatric Rheumatology International Trials Organisation)
and PRCSG (Paediatric Rheumatology Collaborative Study) groups.
About RoACTEMRA/ACTEMRA
RoACTEMRA/ACTEMRA is the result of research collaboration by
Chugai and is also being co-developed globally with Chugai.
RoACTEMRA/ACTEMRA is the first humanised interleukin-6 (IL-6)
receptor-inhibiting monoclonal antibody. An extensive clinical
development programme of five Phase III trials was designed to
evaluate clinical findings of RoACTEMRA/ACTEMRA, all of which met
their primary endpoints. RoACTEMRA/ACTEMRA was first approved in
Japan, and launched by Chugai in June 2005 as a therapy for
Castleman's disease; in April 2008, additional indications for
rheumatoid arthritis (RA), polyarticular juvenile idiopathic
arthritis and systemic-onset juvenile idiopathic arthritis were also
approved in Japan. RoACTEMRA/ACTEMRA was approved in the European
Union in January 2009 for the treatment of RA in patients who have
either responded inadequately to, or who were intolerant to, previous
therapy with one or more disease modifying anti-rheumatic drugs
(DMARDs) or tumour necrosis factor (TNF) inhibitors. It is also
approved for use in several other countries, including India, Brazil,
Switzerland, and Australia. RoACTEMRA/ACTEMRA was most recently
(January 2010) approved in the United States for the treatment of
adult patients with moderately to severely active RA who have had an
inadequate response to one or more TNF inhibitors.
The overall safety profile of RoACTEMRA/ACTEMRA is consistent
across all global clinical studies. The serious adverse events
reported in RoACTEMRA/ACTEMRA clinical studies include serious
infections, gastrointestinal perforations and hypersensitivity
reactions including anaphylaxis. The most common adverse events
reported in clinical studies were upper respiratory tract infection,
nasopharyngitis, headache, hypertension and increased ALT. Increases
in liver enzymes (ALT and AST) were seen in some patients; these
increases were generally mild and reversible, with no evidence of
hepatic injuries or any observed impact on liver function. Laboratory
changes, including increases in lipids (total cholesterol, LDL, HDL,
triglycerides) and decreases in neutrophils and platelets, were seen
in some patients without association with clinical outcomes.
Treatments that suppress the immune system, such as
RoACTEMRA/ACTEMRA, may cause an increase in the risk of malignancies.
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, virology,
inflammation, metabolism and CNS. Roche is also the world leader in
in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer
in diabetes management. Roche's personalised healthcare strategy aims
at providing medicines and diagnostic tools that enable tangible
improvements in the health, quality of life and survival of patients.
In 2009, Roche had over 80'000 employees worldwide and invested
almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1
billion Swiss francs. Genentech, United States, is a wholly owned
member of the Roche Group. Roche has a majority stake in Chugai
Pharmaceutical, Japan. For more information: http://www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
[1] JIA ACR30 response is defined as 3 of the 6 core components
improving (from the Baseline assessments) by greater than or equal to
30%, with no more than 1 of the remaining components worsening by >
30%. Core components include Physician global assessment of disease
activity VAS; Parent/patient global assessment of overall well-being
VAS; Number of joints with active arthritis; Number of joints with
limitation of movement; Erythrocyte Sedimentation Rate (ESR);
Functional ability - Childhood Health Assessment Questionnaire (CHAQ)
[1] Efficacy and safety of tocilizumab in patients with systemic
Juvenile Idiopathic Arthritis (sJIA): 12-week data from the phase 3
tender trial. Abstract presented on 18th June 2010 at EULAR
[2] Woo, P. Systemic juvenile rheumatoid arthritis: diagnosis,
management, and outcome. Nature Clinical Practice: Rheumatology.
2006. 2:1
[3] Symmons DP et al. Pediatric rheumatology in the United
Kingdom: data from the British Paediatric Rheumatology Group National
Diagnostic Register. J Rheumatology 1996: 23: 1975-1980
[4] Fishman D et al. The effect of novel polymorphisms in the
interleukin-6 (IL-6) gene on IL-6 transcription and plasma IL-6
levels, and an association with systemic-onset juvenile chronic
arthritis. J Clin Invest 1998: 102: 1369-1376
[5] Lomater C, Gerloni V, Gattinara M, Mazotti J, Cimaz R,
Fantini F. et al. Systemic onset juvenile idiopathic arthritis: a
retrospective study of 80 consecutive patients followed for 10 years.
J Rheumatol. 2000;27:491- 96.
[6] Prieur AM, Bremard-Oury C, Griscelli C, Mozziconacci P.
Prognosis of the systemic forms of juvenile chronic arthritis.
Apropos of 100 cases. Arch Fr Pediatr. 1984;41:91-7.
[7] Cassidy JT, et al. Juvenile rheumatoid arthritis. Cassidy JT,
Petty RE, eds. Textbook of pediatric rheumatology 2001:218-322
[8] Yokota, S. et al. Efficacy and safety of tocilizumab in
patients with systemic-onset juvenile idiopathic arthritis: a
randomised, double-blind, placebo-controlled, withdrawal phase III
trial. The Lancet 2008; 371: 998-1006
[9] Yokota, S. et al. Therapeutic efficacy of humanized
recombinant anti-interleukin-6 receptor antibody in children with
systemic-onset juvenile idiopathic arthritis. Arthritis & Rheumatism
2005; 52: 818-825
[10] Benedetti F. Inflammatory cytokines in the pathogenesis and
treatment of systemic juvenile idiopathic arthritis. Pediatric
Rheumatology Online Journal. 2005. Vol 3: 2
[11] Long-term efficacy of tocilizumab in rheumatoid arthritis
for up to 3.5 years. Smolen J et al. Oral presentation at ACR, 18th
October 2009
[12] LITHE: Tocilizumab inhibits radiographic progression and
improves physical function in rheumatoid arthritis (RA) patients
(Pts) at 2 years with increasing clinical efficacy over time.
Fleischmann, R et al. Oral presentation at ACR, 18th October 2009
[13] Jones G et al. Comparison of tocilizumab monotherapy versus
methotrexate monotherapy in patients with moderate to severe
rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010: 69:
88-96. Originally published online March 17, 2009. doi:
10.1136/ard.2008.105197
Additional information:
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Contact:

CONTACT: Roche Group Media Relations: Phone: +41-61-688 8888 /
e-mail:basel.mediaoffice@roche.com - Alexander Klauser (Head) -
Martina Rupp -Claudia Schmitt - Nina Schwab-Hautzinger

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