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Kineret

Clinical Pharmacology
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Clinical Pharmacology

Kineret

Study 2 evaluated 419 patients with active RA who had received MTX for at least 6 months including a stable dose (15 to 25 mg/week) for at least 3 consecutive months prior to enrollment. Patients were randomized to receive placebo or one of five doses of kineret® SC daily for 12 to 24 weeks in addition to their stable doses of MTX.

Study 3 evaluated 472 patients with active RA and had similar inclusion criteria to study 1 except that these patients had received no DMARD for the previous 6 weeks or during the study.7 Patients were randomized to receive either Kineret® or placebo. Patients were DMARD-naive or had failed no more than 3 DMARDs.

Study 4 was a placebo-controlled, randomized trial designed to assess the safety of Kineret® in 1414 patients receiving a variety of concurrent medications for their RA including some DMARD therapies, as well as patients who were DMARD-free. The TNF blocking agents etanercept and infliximab were specifically excluded. Concurrent DMARDs included MTX, sulfasalazine, hydroxychloroquine, gold, penicillamine, leflunomide, and azathioprine. Unlike studies 1 , 2 and 3 , patients predisposed to infection due to a history of underlying disease such as pneumonia, asthma, controlled diabetes, and chronic obstructive pulmonary disease (COPD) were also enrolled (see ADVERSE REACTIONS: Infections).

In studies 1 2 and 3 , the improvement in signs and symptoms of RA was assessed using the American College of Rheumatology (ACR) response criteria (ACR20, ACR50, ACR70). In these studies, patients treated with Kineret® were more likely to achieve an ACR20 or higher magnitude of response (ACR50 and ACR70) than patients treated with placebo (Table 1). The treatment response rates did not differ based on gender or ethnic group. The results of the ACR component scores in study 1 are shown in Table 2.

Most clinical responses, both in patients receiving placebo and patients receiving Kineret® , occurred within 12 weeks of enrollment.


Table 1: Percent of Patients with ACR Responses in Studies 1 and 3

Study 1 (patients on MTX)

Study 3 (No DMARDs)



Response


Placebo
(n = 251)

Kineret®
100 mg/day
(n = 250)


Placebo
(n = 119)

Kineret®
75 mg/day
(n = 115)

Kineret®
150 mg/day
(n = 115)

ACR20

Month 3

24%

34%a

23%

33%

33%

Month 6

22%

38%c

27%

34%

43%a

ACR50

Month 3

6%

13%b

5%

10%

8%

Month 6

8%

17%b

8%

11%

19%a
Brand Name: Kineret
Generic Name: Anakinra
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