WHEN ADULTS WITH MAC LUNG DISEASE REMAINED CULTURE POSITIVE AFTER 6 MONTHS OF MULTIDRUG THERAPY,*
ARIKAYCE helped patients get converted and stay converted1-3

Only patients on ARIKAYCE + multidrug therapy for 12 months after conversion stayed culture negative after all treatment ended.1,3
Primary and Secondary ChartsPrimary and Secondary ChartsPrimary and Secondary Charts

aPercentage comparison.
bP<0.0001.

aPercentage comparison.
bP<0.0001.

aPercentage comparison.
bP<0.0001.

cNot significant.
dP<0.002 vs multidrug therapy.
eP<0.0001.

fPercentage of patients remaining culture negative 12 months off all treatment was an exploratory endpoint likely reflecting the natural history of the disease.3

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

Only patients on ARIKAYCE + multidrug therapy for 12 months after conversion stayed culture negative after all treatment ended1,3
In the CONVERT trial, the endpoints of the change from baseline in 6MWT distance and SGRQ did not demonstrate clinical benefit at Month 6.1

CONVERT study design

The efficacy and safety of ARIKAYCE + multidrug therapy vs multidrug 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.1,2

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 endpoints/responder analysis2,3

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

Patient selection in the CONVERT trial

Key inclusion criteria4

  • MAC lung disease documented by at least 2 positive cultures (≥1 positive culture within 6 months prior to screening and 1 positive culture at screening with cultures obtained ≥1 month apart)
  • Did not respond to active therapy for ≥6 months. Treatment was either ongoing or had been stopped no more than 12 months before the screening visit
  • Evidence of underlying lung disease, such as nodular bronchiectasis and/or fibrocavitary disease by chest radiography or CT

Key exclusion criteria4

  • Cystic fibrosis
  • MAC lung disease resistant to amikacin (as identified by MIC susceptibility >64 μg/mL)
  • Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 1 year before screening or anticipated during study period
  • Acquired and primary immunodeficiency syndrome (eg, HIV-positive patients regardless of CD4 counts)

Key baseline patient characteristics in the CONVERT trial2,5

Key baseline patient characteristics in the convert trial
Key baseline patient characteristics in the convert trial
Parameter ARIKAYCE + multidrug therapy (n=224)
n (%)
multidrug therapy alone (n=112)
n (%)
Gender
Female 165 (73.7) 68 (60.7)
Male 59 (26.3) 44 (39.3)
Underlying lung disease
Bronchiectasis only 146 (65.2) 64 (57.1)
COPD‡ 29 (12.9) 19 (17.0)
COPD‡ and bronchiectasis 22 (9.8) 18 (16.1)
multidrug therapy prior to enrollment
On treatment 201 (89.7) 101 (90.2)
Off treatment for at least 3 months 23 (10.3) 11 (9.8)

See real patient experiences with ARIKAYCE

Patients have been compensated.

WHEN ADULTS WITH MAC LUNG DISEASE REMAIN CULTURE POSITIVE AFTER 6 MONTHS OF MULTIDRUG THERAPY,

NTM Treatment Guidelines strongly recommend the addition of ARIKAYCE1,6

Start multidrug treatment

At diagnosis, initiate a 3-drug regimen, especially for MAC patients with positive AFB sputum smears and/or cavitary lung disease.6

Add ARIKAYCE at 6 months

Guidelines strongly recommend adding ARIKAYCE if patients remain culture positive after 6 months of multidrug therapy.6

Keep patients on therapy

Guidelines recommend continuing MAC treatment for 12 months after culture conversion.6
Footnotes

*Multidrug 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.2,4,5,7

The CONVERT trial is referred to as "Trial 1" in the full Prescribing Information.

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

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

||COPD was derived from the medical history data.2

In patients with macrolide-susceptible MAC pulmonary disease.6

#There was up to a 10-week window between screening and baseline during which time some patients may have achieved their first negative sputum culture. At the time of enrollment, 89.9% (302/336) of patients were either on a guideline-based regimen for MAC, or off guideline-based therapy for MAC for less than 3 months.1,4,5

6MWT=6-minute walk test; AFB=acid-fast bacilli; ATS=American Thoracic Society; CT=computed tomography; HIV=human immunodeficiency virus; IDSA=Infectious Diseases Society of America; ITT-intent to treat; MIC=minimum inhibitory concentration; NTM=nontuberculous mycobacteria; SGRQ=St George's Respiratory Questionnaire.

References:
1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed Incorporated; 2023. 2. Griffith DE, Eagle G, Thomson R, et al; CONVERT Study Group. 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. Griffith DE, Thomson R, Flume PA, et al. Amikacin liposome inhalation suspension for refractory Mycobacterium avium complex lung disease: sustainability and durability of culture conversion and safety of long-term exposure. Chest. 2021;160(3):831-842. 4. Griffith DE, Eagle G, Thomson R, et al; CONVERT Study Group. 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 March 3, 2023. 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. Daley CL, Iaccarino JM, Lange C, et al. Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline. Clin Infect Dis. 2020;71(4):e1-e36. 7. 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.
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