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Octagam 10% Approved for Adult Dermatomyositis Credit: Octapharma. The Food and Drug Administration (FDA) has approved Octagam ® 10% (immune globulin intravenous [human]) for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease. The approval was based on data from the prospective, double-blind, randomized, placebo-controlled phase 3 ProDERM study (ClinicalTrials.gov Identifier: NCT02728752), which evaluated the efficacy and safety of Octagam 10% in 95 adults with dermatomyositis. Patients were randomly assigned to receive either Octagam 10% or placebo intravenously (IV) every 4 weeks during the initial 16 week period, followed by a 24-week open-label extension phase during which all patients received Octagam 10% every 4 weeks. The primary endpoint was the proportion of responders at week 16, defined as a patient with an increase of at least 20 points on the Total Improvement Score (TIS).

Octapharma octagamRohit aggarwalUniversity of pittsburgh school medicineDrug administrationOctapharma united states incAutoimmunity centerTotal improvement scoreCutaneous dermatomyositis disease areaSeverity indexMedical directorPittsburgh schoolAccessed julyபல்கலைக்கழகம் ஆஃப் பிட்ஸ்பர்க் பள்ளி மருந்துமொத்தம் முன்னேற்றம் மதிப்பெண்தீவிரம் குறியீட்டுமருத்துவ இயக்குனர்