EFFICACY OF INHALED ANTIBIOTICS IN CF PATIENTS WITH CHRONIC P. AERUGINOSA INFECTION- A NETWORK META-ANALYSIS

Author(s)

Janssen KJ*1;Higashi K1;Jansen J2;Doering G3;Elborn S4;Calado F5;Sagkriotis A5;Angyalosi G5, Balp MM5 1Mapi, Houten, Netherlands, 2Mapi, Boston, MA, USA, 3Tübingen University, Tübingen, Germany, 4Queens University Belfas, Belfast, United Kingdom, 5Novartis Pharma AG, Basel, Switzerland

OBJECTIVES: To compare the efficacy of tobramycin powder for inhalation (TIP) relative to tobramycin inhalation solution containing 300 mg/5ml of tobramycin (TIS-T) and 300mg/4ml of tobramycin (TIS-B), aztreonam lysine inhalation solution (AZLI), colistimethate sodium solution (colistin) and colistin inhalation powder (colistin-P) for cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection, by updating a systematic literature review (SLR) and network meta-analysis (NMA) with recently published evidence. METHODS: The updated SLR was conducted in Medline, Medline in Process, Embase and the Cochrane Library up to 2012. Individual study results were synthesized and indirectly compared with a Bayesian NMA. As some trials included naïve patients (previously not exposed to the treatment) in one arm, and previously exposed patients to the treatment in the other arm, the naïve and exposed arms were considered separate treatment-by-population groups in the network.  RESULTS: Three new trials were identified and analysed with eleven trials identified in the previous SLR. In naïve populations, TIP is expected to have similar efficacy as TIS-T, TIS-B, and AZLI (difference in % change in FEV1 predicted at week 4 respectively -1.97 (95% Credible Interval -11.84, 8.03), -2.38 (-12.71, 7.98), and 1.53 (-7.04, 10.00)). Compared to colistin-P, TIP is expected to have similar efficacy, however the point estimate is in favour of TIP (11.36 (-1.75, 24.31)).  In exposed populations, TIP is expected to have similar efficacy as TIS-T, TIS-B and colistin (respectively -0.78 (-7.65, 5.99), 0.01 (-10.42, 10.46), and -5.75 (-21.23, 9.89)). No data on naïve and exposed populations was available for colistin and colistin-P, respectively.  CONCLUSIONS: By conducting an alternative approach where the naïve and exposed arms were considered separate treatment-by-population groups, the full evidence base could be evaluated, including the data for the dry-powder colistimethate sodium inhaler. This will provide relevant information to support clinical decision making in CF.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PND7

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Neurological Disorders, Rare and Orphan Diseases

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