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Delamanid Improves Outcomes and Reduces Mortality for Multidrug-Resistant Tuberculosis

Vija Skripconoka, Manfred Danilovits, Lea Pehme, Tarmo Tomson, Girts Skenders, Tiina Kummik, Andra Cirule, Vaira Leimane, Anu Kurve, Klavdia Levina, Lawrence J. Geiter, Davide Manissero, Charles D. Wells
European Respiratory Journal 2012; DOI: 10.1183/09031936.00125812
Vija Skripconoka
*Riga East University Hospital – Centre of Tuberculosis and Lung Diseases, Latvia
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Manfred Danilovits
#Tartu University Clinics, Lung Hospital, Estonia
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Lea Pehme
#Tartu University Clinics, Lung Hospital, Estonia
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Tarmo Tomson
¶North Estonian Medical Centre Foundation, Centre of Pulmonology, Tallinn, Estonia
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Girts Skenders
*Riga East University Hospital – Centre of Tuberculosis and Lung Diseases, Latvia
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Tiina Kummik
#Tartu University Clinics, Lung Hospital, Estonia
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Andra Cirule
*Riga East University Hospital – Centre of Tuberculosis and Lung Diseases, Latvia
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Vaira Leimane
*Riga East University Hospital – Centre of Tuberculosis and Lung Diseases, Latvia
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Anu Kurve
¶North Estonian Medical Centre Foundation, Centre of Pulmonology, Tallinn, Estonia
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Klavdia Levina
¶North Estonian Medical Centre Foundation, Centre of Pulmonology, Tallinn, Estonia
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Lawrence J. Geiter
+Otsuka Pharmaceutical Development and Commercialization, Rockville, MD, USA
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Davide Manissero
§Otsuka SA, Geneva, Switzerland
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Charles D. Wells
+Otsuka Pharmaceutical Development and Commercialization, Rockville, MD, USA
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  • For correspondence: Charles.Wells@otsuka-us.com
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Abstract

Multidrug-resistant and extensively drug-resistant tuberculosis are associated with worse treatment outcomes for patients, including higher mortality, than for drug sensitive tuberculosis. Delamanid (OPC-67683) is a novel anti-tuberculosis medication with demonstrated activity against multidrug-resistant disease.

Patients who participated in the previously reported randomised, placebo-controlled trial of delamanid and the subsequent open-label extension trial were eligible to participate in a 24-month observational study designed to capture treatment outcomes. Treatment outcomes, as assessed by clinicians and defined by the World Health Organization, were categorized as favourable and unfavourable outcomes. Delamanid treatment groups were combined for analysis, based on their duration of treatment. In all, 421/481 patients (87.5%) from the original randomised, controlled trial were followed and assessed.

Favourable outcomes were observed in 143/192 patients (74.5%) who received delamanid ≥6 months, compared to 126/229 patients (55.0%) who received delamanid for ≤2 months. Mortality was reduced to 1.0% among those receiving long-term delamanid, versus short-term/no delamanid (8.3%), p<0.001. Treatment benefit was also seen among patients with extensively drug-resistant disease.

This analysis suggests that treatment with delamanid for 6 months in combination with an optimized background regimen can improve outcomes and reduce mortality among patients with both multidrug-resistant and extensively drug-resistant tuberculosis.

  • Extensively drug-resistant
  • mycobacterium
  • pulmonary infection
  • treatment outcomes
  • ERS

ERJ Open articles are open access and distributed under the terms of the (Creative Commons Attribution Licence 3.0)

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Delamanid Improves Outcomes and Reduces Mortality for Multidrug-Resistant Tuberculosis
Vija Skripconoka, Manfred Danilovits, Lea Pehme, Tarmo Tomson, Girts Skenders, Tiina Kummik, Andra Cirule, Vaira Leimane, Anu Kurve, Klavdia Levina, Lawrence J. Geiter, Davide Manissero, Charles D. Wells
European Respiratory Journal Jan 2012, erj01258-2012; DOI: 10.1183/09031936.00125812

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Delamanid Improves Outcomes and Reduces Mortality for Multidrug-Resistant Tuberculosis
Vija Skripconoka, Manfred Danilovits, Lea Pehme, Tarmo Tomson, Girts Skenders, Tiina Kummik, Andra Cirule, Vaira Leimane, Anu Kurve, Klavdia Levina, Lawrence J. Geiter, Davide Manissero, Charles D. Wells
European Respiratory Journal Jan 2012, erj01258-2012; DOI: 10.1183/09031936.00125812
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