1838. Efficacy and Safety of Omadacycline in Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and High Body Mass Index or Type 2 Diabetes: A Subgroup Analysis from the OASIS Tria
Session: Poster Abstract Session: Clinical Study with New Antibiotics and Antifungals
Saturday, October 7, 2017
Room: Poster Hall CD
Posters
  • 87779 ProEd_ID Week OASIS BMI DM Pstr_7121 02OCT2017.pdf (350.8 kB)
  • Background:  Skin infections in overweight/obese patients or patients with diabetes mellitus (DM) are common and can be associated with poor outcomes. Omadacycline (OMC) is a first-in-class aminomethylcycline. Intravenous (IV)-to-once-daily oral OMC demonstrated non-inferiority to IV-to-twice-daily oral linezolid (LZD) in the phase 3 ABSSSI study, OASIS. Here, we report the efficacy and safety of OMC vs LZD in patients with high body mass index (BMI) or type 2 DM from OASIS in a post-hoc analysis.

    Methods:  655 adult patients were randomized 1:1 to OMC 100 mg IV q12h × 2 doses then 100 mg IV q24h, or to LZD 600 mg IV q12h. After ≥ 3 days’ IV therapy, patients could transition to oral OMC 300 mg q24h or oral LZD 600 mg q12h. Total treatment duration was 7-14 days. Primary endpoint was early clinical response (ECR) assessed at 48-72 hours in the modified intent to treat (mITT) population. Secondary endpoints were clinical response at post-treatment evaluation (PTE) in the mITT and clinically evaluable (CE) populations. Safety was assessed based on adverse events (AEs), vital signs, and laboratory tests. 228 patients had a normal BMI (BMI <25); 417 had a high BMI (BMI ≥25). Of those with a high BMI, 225 were overweight (25 ≤ BMI <30) and 192 were obese (BMI ≥30). 59 patients had a medical history of DM.

    Results:  ECR rates with OMC were similar for normal and high BMI patients. At PTE, OMC-treated patients showed higher clinical success vs LZD-treated patients across most subgroups. At PTE, OMC-treated DM patients showed higher clinical success vs LZD-treated DM patients. None of the OMC vs LZD differences were significant. Nausea and vomiting were less frequent in patients treated with OMC vs LZD across all subgroups studied.

    Conclusion:  IV-to-once-daily oral OMC was effective and well-tolerated for treating ABSSSI irrespective of BMI or DM status.

    Table 1: Clinical Success at ECR and PTE

    Clinical Success, %

    mITT at ECR

    mITT at PTE

    CE at PTE

    OMC

    LZD

    Difference (95% CI)

    OMC

    LZD

    Difference (95% CI)

    OMC

    LZD

    Difference (95% CI)

    Normal BMI

    84.7

    84.9

    –0.2
    (–9.7, 9.6)

    84.6

    84.0

    2.5
    (–6.9, 12.2)

    97.1

    94.2

    2.9
    (–3.3, 10.4)

    High BMI

    84.8

    85.9

    –1.0
    (–8.0, 6.0)

    85.9

    83.4

    2.4
    (–4.7, 9.6)

    95.8

    93.1

    2.7
    (–2.4, 8.0)

    Figure 1. Clinical Success at PTE in mITT Population

    Figure 2. Clinical Success at PTE in CE Population

    Mark Wilcox, MD1, Nancy Cure-Bolt, MD2, Surya Chitra, PhD, MBA3, Evan Tzanis, BA3 and Paul McGovern, MD3, (1)Healthcare Associated Infections Research Group, Leeds Teaching Hospitals NHS Trust and University of Leeds, Leeds, United Kingdom, (2)Paratek Pharmaceuticals, King of Prussia, PA, (3)Paratek Pharmaceuticals, Inc., King of Prussia, PA

    Disclosures:

    M. Wilcox, None

    N. Cure-Bolt, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    S. Chitra, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    E. Tzanis, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    P. McGovern, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 4th with the exception of research findings presented at the IDWeek press conferences.