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Anakinra Provides Long-Term Relief For Rheumatoid Arthritis Patients

The long-term benefits in treatment of active rheumatoid arthritis (RA) have been supported in a study for the European Group Of Clinical Investigators.

In this study, the clinical benefits of daily self-administered subcutaneous injections of this human recombinant interleukin-one receptor antagonist were maintained for up to 48 weeks, and the drug was well-tolerated over 76 weeks.

Efficacy and safety of anakinra were previously shown in a 24-week double blind placebo controlled evaluation in 472 patients with active RA.

Of 345 patients completing that study, 309 continued in this 52-week, multicentre, double blind extension phase led by Dr George Nuki from the University of Edinburgh, Edinburgh, Scotland.

The patients received injections of 30 mg, 75 mg or 150 mg anakinra once daily.

Efficacy for the first 24 weeks of the extension (48 weeks total therapy) was assessed via the American College of Rheumatology composite score, its components and radiographs of the hands and wrists.

Safety was assessed in all 472 patients for the entire 52-week extension (76 weeks total exposure).

Overall, 218 patients completed the extension phase. Of the 91 patients who withdrew prematurely, 46 did so because of adverse events and 26 because of lack of efficacy.

Among those completing the study, improvement level was maintained for 48 weeks, with ACR20 response 51 percent at week 24 and 46 percent at week 48. This was consistent across all dose groups.

Durability of response to the drug was further illustrated in an evaluation of the sustained ACR20 response, which was similar in the first (36 percent) and second (42 percent) 24-week periods.

At week 48, ACR50 and ACR70 responses were shown in, respectively, 18 percent and three percent of patients who continued on anakinra (all dose groups) and in, respectively, 20 percent and one percent of patients originally on placebo and then randomised to all doses of the drug.

Anakinra was well tolerated for 76 weeks, with the only apparent treatment-related side effects being skin reactions at the injection site.

Extended therapy did not appear to be linked with decreased tolerance or any increase in number of withdrawals or incidence of clinical complications, the researchers note.
Arthritis & Rheumatism 2002; Vol.46, No.11, Pp: 2838-2846. "Long-term safety and maintenance of clinical improvement following treatment with anakinra (recombinant human interleukin-1 receptor antagonist) in patients with rheumatoid arthritis: Extension phase of a randomized, double-blind, placebo-controlled trial"

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