We evaluated the efficacy and safety of orally administered bovine tracheal
type II collagen (CGII) in the treatment of rheumatoid arthritis (RA). Twe
nty RA patients received 0.5 mg/day of CGII for 12 weeks. Eighteen of them
had improvements in the clinical parameters studied (swollen and tender joi
nt counts, 15-m walking time, duration of morning stiffness, and physician'
s global assessment of disease activity). Anti-CGII antibodies were positiv
e in 57% and rheumatoid factor (RF) in 71% of the patients with, a short hi
story of RA ( less than or equal to2 years), whereas only 23% of those with
long histories (>2 years) presented autoantibodies to CGII and 38% had pos
itive RF. After the treatment, four patients showed reduced RF levels and a
ll those with detectable serum tumor necrosis factor alpha (TNF-alpha) expe
rienced its return to normal or levels below those at study entry. Although
a placebo effect cannot be discounted, the oral administration of bovine t
racheal CGII induced clinical benefits in 90% of the patients, without the
side effects usually associated with treatment. This is the first study sho
wing that feeding CGII can induce reductions in RF and TNF-alpha. The data
justify further controlled studies to assess the long-term efficacy of this
treatment approach.