Nplate ^® Increases Platelet Production and Sustains Platelet Counts

Nplate^® has been shown to increase and sustain platelet counts when administered regularly.¹

Nplate^® is given once a week for as long as your healthcare provider thinks is appropriate.

In the Nplate^® clinical trials, how many patients were treated?
Nplate^® was studied in two large clinical trials including over 120 patients. One trial studied patients who had already had their spleens removed, and the other trial studied patients who still had spleens.¹ 83% of the patients taking Nplate^® responded to treatment.²

For 6 months, patients received either Nplate^® therapy or placebo, and patients were allowed to stay on their original standard of care ITP medications (azathioprine, danazol, and/or corticosteroids). Patients also received rescue therapies (IVIG, corticosteroids, anti-D, or platelet transfusion) as needed to prevent or treat bleeding.¹

What is durable platelet response?

In the two 6-month trials, the primary goal of treatment with Nplate^® was something called "durable platelet response." A durable platelet response was defined as keeping platelet counts greater than or equal to 50,000 per microliter for at least 6 of the last 8 weeks of the 6-month study.¹

No one who received rescue therapies at any time during the 6-month trial could be considered to have a durable platelet response. Studying Nplate^® this way helped show how well Nplate^® worked by taking the effects of other ITP medications into account.¹ In the two trials:

• 61% (25/41) of Nplate^® patients who did not have a splenectomy met the goal, versus 5% (1/21) of placebo patients.^1,2
• 38% (16/42) of Nplate^® patients who have had a splenectomy met the goal, versus 0% (0/21) of placebo patients.^1,2

In the trials, if a patient in any given week had a platelet count of 50,000 per microliter or greater, that was called a "weekly platelet response." Platelet counts within 8 weeks of rescue medication were not included. If a patient had four or more weekly platelet responses, that patient was considered to have a "transient platelet response."

All the patients who had transient platelet responses and durable platelet responses were added together to obtain the "overall platelet response"¹:

• 88% (36/41) of Nplate^® patients, versus 14% (3/21) of placebo patients who did not have a splenectomy had an overall platelet response.^1,2
• 79% (33/42) of Nplate^® patients, versus 0% (0/21) of placebo patients who had a splenectomy had an overall platelet response.^1,2

Approximately 80% of patients from the two clinical trials enrolled in the extension study. Half of the patients in the extension study received Nplate^® for at least 60 weeks, and a few patients were on Nplate^® for as long as 96 weeks.¹ In this study, platelet counts were increased and sustained regardless of whether patients had received Nplate^® in the prior studies.¹

When did the patients in the clinical study see results?

In the two 6-month trials, the majority of patients experienced an increase in platelet counts in 1 week and achieved a platelet response (≥ 50,000 per microliter) after one to three doses, or after approximately 2 to 4 weeks.¹ Individual patient results may vary.

Why is platelet count >50,000 per microliter important?

Even when you are on therapy, platelet counts can vary somewhat from week to week, which is why trying to raise and sustain platelet counts to a level of at least 50,000 per microliter is often considered appropriate for an adult patient to reduce the risks for bleeding due to ITP. Remember, it is common for platelet counts to fluctuate, and small fluctuations do not mean that your treatment is not working. Your healthcare provider may work to keep your platelet counts at a level within a range sufficient to reduce the risk for bleeding, rather than trying to hit an exact platelet count.² Increasing and sustaining a platelet count is an important goal in treating ITP.