WHEN ADULTS WITH MAC LUNG DISEASE REMAINED CULTURE POSITIVE AFTER 6 MONTHS OF MULTIDRUG THERAPY,*ARIKAYCE helped patients get converted and stay converted1-3
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
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
||ARIKAYCE + multidrug therapy (n=224)
|multidrug therapy alone (n=112)
|Underlying lung disease
|COPD‡ and bronchiectasis
|multidrug therapy prior to enrollment
|Off treatment for at least 3 months
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 treatmentAt 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 monthsGuidelines strongly recommend adding ARIKAYCE if patients remain culture positive after 6 months of multidrug therapy.6Guidelines recommend continuing MAC treatment for 12 months after culture conversion.6
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;
MIC=minimum inhibitory concentration; NTM=nontuberculous mycobacteria; SGRQ=St George's Respiratory Questionnaire.
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.