INDICATION

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Explore the treatment possibilities for MAC lung disease with this Culture Conversion Experience in augmented reality—right here on your mobile device

MAC=Mycobacterium avium complex.

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Press button to show MAC infection in lungs

Organisms are representational and not to scale

MAC lung disease is a tenacious bacterial infection1

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of MAC lung disease patients experienced radiographic deterioration over a median follow-up period of 5 years1

Which initial treatments do you use for MAC lung disease?
Choose 3

Though standard therapies work for many patients, they don't always work, and the infection remains2,3

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In fact, nearly one-third of MAC patients will not convert on standard therapy alone by Month 62,3

But there may be a way to move refractory patients from culture positive to culture negative

But there may be a way to move refractory patients from culture positive to culture negative

See how adding ARIKAYCE may help refractory MAC patients achieve culture conversion after first-line therapy fails1

INDICATION

LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.

This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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References
  1. Gochi M, et al. BMJ Open. 2015;5(8):e008058. doi:10.1136/bmjopen-2015-008058.
  2. Jeong BH, et al. Am J Respir Crit Care Med. 2015;191(1):96-103.
  3. Moon SM, et al. Eur Respir J. 2019;53(5). doi:10.1183/13993003.01636-2018
Footnotes

*Refractory MAC lung disease is defined as MAC patients who did not convert after ≥6 months of standard therapy.1

†Standard therapy was composed of an antimycobacterial regimen of at least 2 antibiotics based on the 2007 ATS/IDSA Statement or respective local guidelines. These drugs may have included, but were not limited to, azithromycin, clarithromycin, clofazimine, ethambutol, ethionamide, rifabutin, and rifampicin.2,4-6

‡The CONVERT trial is referred to as “Trial 1” in the full Prescribing Information.

§Culture conversion by Month 6 was a surrogate endpoint.1 Clinical benefit has not yet been established.

References
  1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed Incorporated; 2020.
  2. Griffith DE, et al. Am J Respir Crit Care Med. 2018;198(12):1559-1569.
  3. Griffith DE, et al. Published online ahead of print April 19, 2021. Chest. doi:10.1016/j.chest.2021.03.070.
  4. Griffith DE, et al; Online data supplement. Am J Respir Crit Care Med. 2018;198(12)(suppl):E1-E28. Accesseds June 4, 2021. https:
    //www.atsjournals.org/doi/suppl
    /10.1164/rccm.201807-1318OC/
    suppl_file/griffith_data_supplement.pdf.
  5. Data on file. Insmed Incorporated. Bridgewater, NJ.
  6. Griffith DE, et al. Am J Respir Crit Care Med. 2007;175(4):367-416
CONVERT‡ study design1,2

OVERVIEW: The efficacy and safety of ARIKAYCE + standard therapy vs standard therapy alone were evaluated in an open-label, randomized (2:1), multicenter, global, Phase 3 trial of 336 adult patients with refractory MAC lung disease.

Primary endpoint1,2

Patients who culture converted by Month 6. Patients needed to achieve their first negative culture by Month 4 to meet the primary endpoint.§ Culture conversion was defined as 3 consecutive monthly negative sputum cultures. The study design required 2 or 3 negative sputum samples per month for 3 consecutive months to confirm culture conversion.

Secondary endpoints2,3

Patients who remained culture converted 12 months after initial conversion and 3 months after treatment ended, along with change from baseline in 6MWT and SGRQ.

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Footnote

Reference:
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