Close
close
May 11th, 2004

New Study Confirms Efficacy & Safety of Octagam

A study published this week in the prestigious Journal of Clinical Immunology demonstrates that Octagam® 5% is efficacious and well tolerated in subjects with primary immunodeficiency diseases (PID).

On behalf of The Octagam Study Group, the authors, Prof. Hans D Ochs (University of Washington, Seattle) and Paul J Pinciaro (Primaryimmune Services Inc., Maryland), reported the results of this pivotal open-label, multicentre US trial.*

The study was designed to demonstrate that Octagam® meets the minimal efficacy requirement of the U.S. Food and Drug Administration (FDA), namely that treatment should result in one or less serious infection/subject/year and also to confirm the safety of Octagam®.

46 subjects, including 11 under the age of 15, with well-defined PID received a total of 694 infusions of Octagam® (either 400-600 mg/kg every 28 days or 300-450 mg/kg every 21 days) over a period of 12 months. The number of serious infections/subject/year was 0.1 - significantly lower than the FDA benchmark of <1.0.

The half-life of total IgG was 41 days.

Secondary efficacy endpoints involving patient productivity and healthcare utilisation showed that the average number of work or school days missed. Days spent in hospital and visits to an emergency room or physician during the year long study were very low (5.5 days, 0.4 days and 2.1 visits respectively).

Adverse events potentially related to Octagam® occurred in 5% of infusions. The majority of these were mild or moderate, such as headache, nausea and fever.
Safety profiile
"We were gratified to observe that the safety profile of Octagam established by the US trial mirrors actual European clinical experience with the product over a much larger group of patients and a longer time frame.” Wolfgang Frenzel MD, International Medical Director, Octapharma AG

The adverse event data correlates well with the much larger post-marketing surveillance experience in Europe.  The ongoing German, multicentre pharmacovigilance study, which started in 1995, currently includes data on >4,700 patients who collectively have received >66,000 infusions of Octagam®.
Overall the incidence of adverse events has been <0.5%, with fewer than 0.03% classified as serious.

Ochs and Pinciaro conclude from the US PID study that Octagam® meets the FDA minimal requirement for efficacy. Additionally, Octagam® had a half life comparable with published data, and was well tolerated.

For further information on this study please click here
(Please note that clicking on this link will take you outside of the Octapharma web site)

*Octagam® is not yet approved in the United States.


© Octapharma AG, 2004