Study of subcutaneously administered interferon beta 1a in the treatment of patients with active RA

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Ann Rheum Dis. 2004 Jul 8 [Epub ahead of print]

A multicentre, randomised, double-blind, placebo controlled phase II

study of subcutaneously administered interferon beta 1a in the treatment

of patients with active rheumatoid arthritis.

Van Holten J, Pavelka K, Vencovsky J, Stahl H, Rozman B, Genovese M,

Kivitz AJ, Alvaro J, Nuki G, Furst D, Herrero-Beaumont G, McInnes I,

Musikic P, Tak PP.

Division of Clinical Immunology and Rheumatology Academic Medical

Center, Amsterdam, The Netherlands.

OBJECTIVE: To assess the efficacy of IFNbeta in combination with

methotrexate on clinical and radiological parameters in patients with

early active RA METHODS: Two hundred nine patients with active RA, who

were receiving methotrexate for at least 6 months, with a stable dose

for 4 weeks before study entry were randomized in a double-blind fashion

to receive: placebo (0.05ml or 0.5 ml), 2.2 mg (0.05 ml) or 44 mg (0.5

ml) of IFNbeta administered in subcutaneous injections three times

weekly for the duration of 24 weeks. The primary efficacy measure was a

change in radiological scores at week 24. The secondary endpoint was

defined as the proportion of patients who met the American College of

Rheumatology (ACR) 20% improvement criteria at the end of the study. In

addition, synovial biopsy specimens were obtained before and after

treatment from a subset of patients. Immunohistochemistry was used to

detect the presence of inflammatory cells and the results were measured

by digital image analysis. Furthermore, levels of collagen crosslinks in

urine were measured at different time points throughout the study.

RESULTS: Analysis of changes in radiological scores and clinical

parameters revealed no changes in the groups that received IFNbeta or

the placebo group, and no difference between groups. Microscopic

analysis of synovial tissue showed no significant change in the scores

for infiltration by inflammatory cells after IFNbeta treatment. In

addition, urinary levels of collagen crosslinks were unchanged between

the treatment groups.

CONCLUSION: At the doses tested, treatment with IFNbeta 3 times weekly

given in combination with methotrexate did not induce a clinical or

radiological effect in RA patients.

PMID: 15242865

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