RESEARCH - Therapeutic efficacy and safety of chaperonin 10 in patients with RA

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Lancet. 2006 Sep 2;368(9538):855-63.

Therapeutic efficacy and safety of chaperonin 10 in patients with rheumatoid

arthritis: a double-blind randomised trial.

Vanags D, B, B, Hall S, Nash P, A, Weiss J, Feeney

D.

CBio Ltd, Eight Mile Plains, Queensland, Australia.

BACKGROUND: Chaperonin 10 (heat shock protein 10, XToll) has

anti-inflammatory properties related to the inhibition of Toll-like receptor

signalling pathways. Our aim was to establish whether chaperonin 10 is safe

and effective in the treatment of rheumatoid arthritis. METHODS: In this

randomised, double-blind, multicentre study, 23 patients with moderate to

severe active rheumatoid arthritis receiving disease-modifying antirheumatic

drugs were randomly allocated to three treatment groups receiving

intravenous chaperonin 10 twice weekly for 12 weeks at doses of 5 mg (n=8),

7.5 mg (8), or 10 mg (7). The primary outcomes were change in disease

activity score (DAS28) and improvement of core disease measures (American

College of Rheumatology response score) from baseline to week 12. All

analyses were done by intention to treat. This study is registered with the

Australian Clinical Trials Registry, number ACTRNO12606000041550. FINDINGS:

Primary endpoint measures improved from day 14 in all groups and continued

to improve to day 84. By end of study, a 20% improvement of core disease

measures was seen in six (86%, 95% CI 43-100), a 50% improvement in four

(57%, 14-86), and a 70% improvement in two (29%, 0-57) patients given the

highest dose of chaperonin 10. Clinical remission (as defined by a DAS28

<2.6) was achieved in three (13%) of 23 patients. Three individuals dropped

out during the study: one in the 5 mg group (rheumatoid arthritis not

controlled), one in the 7.5 mg group (adverse event), and one in the 10 mg

group (lost to follow-up). The most common adverse events were exacerbation

of rheumatoid arthritis (both during and after the study) and upper

respiratory tract infection. Only one adverse event was judged to be of

severe intensity.

INTERPRETATION: Chaperonin 10 seems to be well tolerated and efficacious in

treatment of the symptoms of rheumatoid arthritis, at least in the short

term.

PMID: 16950363

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6950363

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