Melinta Therapeutics Publishes Findings from Orbactiv® (oritavancin) Real-World Registry Demonstrating Efficacy and Safety Consistent with Phase 3 SOLO Program
Orbactiv is approved in the
In the retrospective, observational registry, data was recorded from 112 patients who received a single dose of Orbactiv at eight healthcare sites for presumed skin and soft tissue infections are summarized in the publication. Clinical success was observed in 103 of 111 evaluable patients (92.8%). This clinical success rate is nearly identical to the 92.6% observed in the pooled Phase 3 SOLO studies that formed the basis of the Orbactiv marketing approval.
More individuals in the real-world registry than in SOLO presented with comorbidities such as obesity and diabetes that are typically associated with poor treatment outcome. In addition, 71% of patients in CHROME received prior antibiotic therapy for their infections, compared to only 20% in the SOLO studies. Four patients (3.6%) were hospitalized when their primary infection failed to improve or recurred within 28 days following Orbactiv administration.
Safety was evaluable in all 112 patients. Five (4.5%) patients experienced at least one adverse event probably or likely related to Orbactiv; no drug-related serious adverse events (SAEs) were reported. Of the 48 confirmed gram-positive pathogens recovered, 77.1% were caused by Staphylococcus aureus, the majority of which were multi-drug resistant (78.4%).
“These real-world results provide valuable insight into the real-world clinical use of Orbactiv,” said
CHROME is a multicenter, multiyear, retrospective observational study to characterize the demographics and outcomes of adult patients who have received Orbactiv for the treatment of infections due to presumed or confirmed gram-positive bacteria and to describe the associated clinical and microbiologic outcomes and safety.
Some of the limitations of a registry such as CHROME include the retrospective, noncomparative, unblinded, and nonrandomized nature of the data from a limited number of sites. Assessment of efficacy was based on a subjective assessment extracted from the medical record by the investigators. The rates of treatment emergent adverse events in this study was much lower than those seen in the SOLO trials, and in some cases the severity of the treatment emergent adverse events (TEAEs) experienced was different. Although there was a difference in the incidence of adverse events (AEs) in CHROME vs. SOLO, the types of AEs seen were consistent with those seen in SOLO. The AEs observed in this smaller patient population are not necessarily representative of what may be seen with treatment with oritavancin.
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For More Information:
1 Redell M et, al; A Real-world Patient Registry for Oritavancin Demonstrates Efficacy and Safety Consistent with the Phase 3 SOLO Program, 2018 Open Forum Infectious Diseases, June; 5(6)
Source: Melinta Therapeutics