In adult patients with refractory MAC lung disease,
Over a 3-fold increase in rate of refractory* patients converting on ARIKAYCE + standard therapy by Month 6 AND more than half of those patients stayed converted for 15 months after initial conversion1-3

This means that patients who met this secondary endpoint could have had up to 24 to 36 negative sputum cultures In order to meet this secondary endpoint, patients needed to have 2 to 3 negative sputum samples at several time points throughout the CONVERT trial 0 0 patients continued to stay converted after 3 months off treatment 36 36 patients continued to stay converted after 3 months off treatment 3 3 patients stayed converted on treatment through 12 months after initial conversion 41 41 patients stayed converted on treatment through 12 months after initial conversion SECONDARY ENDPOINTS Patients who did not convert by Month 6 in either arm did not continue in the CONVERT trial and left the study by Month 8 10 10 patients converted by Month 6 65 65 patients converted by Month 6 PRIMARY ENDPOINT Culture conversion: Patients needed to achieve first negative culture by Month 4 to meet the primary endpoint 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 Start of CONVERT trial Months ARIKAYCE + STANDARD THERAPY = 224 PATIENTS 1-3 The CONVERT trial studied refractory MAC patients 8.9% of patients on standard therapy alone (n=10/112) converted by Month 6 - 1 29% of patients on ARIKAYCE + standard therapy (n=65/224) converted by Month 6
29% of patients on ARIKAYCE + standard therapy (n=65/224) converted by Month 6 8.9% of patients on standard therapy alone (n=10/112) converted by Month 6 - 1 This means that patients who met this secondary endpoint could have had up to 24 to 36 negative sputum cultures In order to meet this secondary endpoint, patients needed to have 2 to 3 negative sputum samples at several time points throughout the CONVERT trial 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 0 0 patients continued to stay converted after 3 months off treatment 36 36 patients continued to stay converted after 3 months off treatment SECONDARY ENDPOINT 3 3 patients stayed converted on treatment through 12 months after initial conversion 41 41 patients stayed converted on treatment through 12 months after initial conversion SECONDARY ENDPOINT Patients who did not convert by Month 6 in either arm did not continue in the CONVERT trial and left the study by Month 8 10 patients converted by Month 6 10 65 patients converted by Month 6 65 PRIMARY ENDPOINT Culture conversion: Patients needed to achieve first negative culture by Month 4 to meet the primary endpoint Months Start of CONVERT trial STANDARD THERAPY ALONE = 112 PATIENTS ARIKAYCE + STANDARD THERAPY = 224 PATIENTS The CONVERT trial studied refractory MAC patients 1-3

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

In the CONVERT trial, the endpoints of the change from baseline in 6MWT distance and the SGRQ did not demonstrate clinical benefit at Month 6.1

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.2-5

At baseline, the standard therapy included a macrolide (93.3%), a rifamycin (86.3%), or ethambutol (81.4%). Overall, 55.6% of patients were receiving a triple-drug standard therapy consisting of a macrolide, a rifamycin, and ethambutol.1

Checkmark in shield icon
Sputum culture results and true microbiologic status

A recently published analysis of sputum samples from the randomized, double-blind, placebo-controlled, Phase 2 trial (INS-112) of ARIKAYCE showed that negative sputum culture results for MAC isolates during treatment with amikacin reliably reflected the true microbiologic status of the patient. Culture results of sputum-containing Mycobacterium avium isolates were not influenced by the presence of amikacin.6

In addition, processing of sputum samples involves dilution and centrifugation, which separates the cellular material to be cultured from soluble elements, such as residual amikacin.1,6

Which patients in your practice could benefit from ARIKAYCE?

See patient types
Right arrow icon
Patient population icon

The CONVERT trial evaluated patients with refractory MAC lung disease.1

Learn more about this

patient population
Right arrow icon
Trial design icon

ARIKAYCE was evaluated in an open-label, randomized (2:1), multicenter, global, Phase 3 trial of 336 adult patients with refractory MAC lung disease who did not respond to treatment.1,2

6MWT=6-minute walk test; ATS=American Thoracic Society; IDSA=Infectious Diseases Society of America; MAC=Mycobacterium avium complex; SGRQ=St George's Respiratory Questionnaire.

References

  1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed Incorporated; 2020.
  2. Griffith DE, Eagle G, Thomson R, et al. Amikacin liposome inhalation suspension for treatment-refractory lung disease caused by Mycobacterium avium complex (CONVERT): a prospective, open-label, randomized study. Am J Respir Crit Care Med. 2018;198(12):1559-1569.
  3. Data on file. Insmed Incorporated. Bridgewater, NJ.
  4. Griffith DE, Aksamit T, Brown-Elliott BA, et al; ATS Mycobacterial Diseases Subcommittee. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007;175(4):367-416.
  5. Griffith DE, Eagle G, Thomson R, et al. Amikacin liposome inhalation suspension for treatment-refractory lung disease caused by Mycobacterium avium complex. Online data supplement. Am J Respir Crit Care Med. 2018;198(12)
    (suppl):E1-E28. Accessed October 16, 2020. https://www.atsjournals.org/doi/suppl/10.1164/rccm.201807-1318OC/suppl_file/griffith_data_supplement.pdf.
  6. Eagle G, Brown K, Floto RA. Examining the effect of residual amikacin on sputum culture for nontuberculous mycobacteria. Am J Respir Crit Care Med. 2018;197(2):267-269.