Postlethwaite AE et al. (2008) A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease. Arthritis Rheum 58: 1810–1822

Previous studies have demonstrated that orally administered bovine autoantigens can induce immune tolerance and improve symptoms in patients with autoimmune diseases. In a multicenter, double-blind trial, Postlethwaite et al. compared 500 µg per day oral bovine type I collagen with daily placebo in patients with diffuse cutaneous systemic sclerosis (dcSSc) of less than 10 years duration.

The improvement in modified Rodnan skin thickness score (MRSS) from baseline was similar in patients who received collagen (n = 83) and in those who received placebo (n = 85), at both the end of the 12-month treatment period and at the 15-month follow-up. In a secondary analysis restricted to patients with early-phase dcSSc (≤3 years duration), there was no difference between the groups. In patients with late-phase dcSSc (3–10 years duration), however, individuals who received collagen showed a significantly greater improvement in MRSS at 15 months than did those who received placebo (P = 0.0063). There was a correlation between improvement in MRSS at 15 months and improvement in pain and global assessment of health in patients with late-phase disease. A similar number of adverse events occurred in the two treatment groups.

The authors conclude that 12 months' treatment with oral bovine type I collagen has a delayed, beneficial effect in patients with dcSSc of 3–10 years duration; however, this treatment effect was established in secondary analyses and needs to be confirmed in further clinical trials.