Effects of Kineret monotherapy on joint damage in patients with RA

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J Rheumatol. 2004 Jun;31(6):1103-11.

Effects of anakinra monotherapy on joint damage in patients with

rheumatoid arthritis. Extension of a 24-week randomized,

placebo-controlled trial.

Bresnihan B, Newmark R, Robbins S, Genant HK.

Department of Rheumatology, St. s University Hospital, Dublin,

Ireland.

OBJECTIVE: To determine the effects of treatment on the radiologic

manifestations of joint damage in patients with rheumatoid arthritis

(RA) who participated in a 24-week extension study of a randomized,

placebo-controlled clinical trial of anakinra, a recombinant human

interleukin 1 receptor antagonist. METHODS: The patients had entered a

24-week, randomized, double-blind, placebo-controlled study. Anakinra

was self-administered by subcutaneous injection of 30, 75, or 150

mg/day. Upon completion of the placebo-controlled phase, the patients

entering the extension study who had received placebo were randomized to

one of the 3 treatment dosages for a further 24 weeks, and the patients

who had been initially randomized to one of the 3 anakinra dosages

continued to receive the same dosage. Radiographs of the hands were

obtained at baseline and at 24 and 48 weeks. The radiographs were

evaluated using a modified Sharp method. RESULTS: A total of 472

patients were recruited. The mean change in the total modified Sharp

score of 178 patients who completed 48 weeks treatment, including all

dosages, was significantly less than the change observed in 58 patients

who received placebo for 24 weeks and anakinra for 24 weeks (p = 0.015).

A significant reduction in the change of the total modified Sharp score

was observed in the patients who received anakinra 75 and 150 mg/day.

The total modified Sharp score was reduced significantly more during the

second 24-week treatment period, compared to the first (p < 0.001).

Significant reductions in the second 24-week period were observed

following anakinra 75 mg/day (p = 0.006) and 150 mg/day (p = 0.008).

CONCLUSION: Patients with RA who received anakinra for 48 weeks

demonstrated significant slowing of radiographic joint damage. The

treatment effect observed after the first 24-week period appeared to

increase when anakinra was continued for 48 weeks.

PMID: 15170922

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