Objective. To determine whether interferon beta (IFN-beta) therapy might ha
ve a beneficial effect on arthritis, we evaluated the effect of IFN-beta on
collagen type II-induced arthritis (CIA) in rhesus monkeys and conducted a
pilot study in patients with rheumatoid arthritis (RA).
Methods. Four rhesus monkeys with CIA-were treated with 10 x 10(6) U(MIU)/k
g mammalian cell-derived recombinant IFN-beta (Rebif(R); Ares-Serono) s.c.
daily for 1 week. Subsequently, 12 patients with active RA were treated for
12 weeks with purified natural fibroblast IFN-beta (Frone(R), Ares-Serono)
s.c. 3 times weekly at the following dosages: 6 MIU (n = 4), 12 MIU (n = 4
) and 18 MIU (n = 4).
Results. Rapid clinical improvement during IFN-beta therapy was observed in
three of the four rhesus monkeys with CIA. There was also a marked decreas
e in serum C-reactive protein (CRP) levels with a subsequent increase after
discontinuation of the treatment in all monkeys. The 10 RA patients who co
mpleted the study exhibited on average gradual improvement of tender and sw
ollen joint counts, patient's assessment of pain, and patient's and doctor'
s global assessment (all P < 0.05). The health assessment questionnaire and
serum CRP levels also tended to decrease, but this was not statistically s
ignificant; 40% of the patients fulfilled the ACR criteria for 20% improvem
ent, whereas none fulfilled the ACR criteria for 50% improvement 12 weeks a
fter initiation of treatment. There was no clear dose-response relationship
.
Conclusion. The data suggest that IFN-beta treatment has a beneficial effec
t on arthritis.