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Mycobacterium abscessus

December 2024

Mycobacterium abscessus falls into a group of non-tuberculosis mycobacterium, further sub-classified as a rapid-growing mycobacterium. The prevalence of M. abscessus has been increasing over the last decade, with multi-drug resistance becoming more prevalent. [1] Even in the face of this, creating new antibiotics to battle this problem has not been a huge area of Infectious Disease (ID) pharmaceutical research. Due to the lack of new antibiotics in the field, we are limited to utilizing older drugs off-label or hard to acquire investigational therapies. In turn, this decreases access to appropriate therapy as the logistics and complicated resistance pattern testing require management by academic centers or large ID groups that are able to navigate the complex processes necessary to acquire and manage these medications. The critical need for appropriate management is underscored by high mortality rates, of 11.4% at five years and 50.6% at 15 years.[2] Guidelines suggesting treatment with at least three active antimicrobial agents, as well as the anticipated length of treatment course, increase the complexity of care.[3]

Treatment

Options for the treatment of M. abscessus include macrolides, carbapenems, cefoxitin, amikacin IV or inhaled, oxazolidinone, clofazimine, and tetracycline derivatives. When evaluating each of these options, many possible confounding factors need to be considered. Some factors to consider include the possibility of resistance development, the requirement for three or more effective concurrent antimicrobials, medication costs, the total duration of therapy, and the handling of medication adverse reactions.

Macrolides:

Clarithromycin Breakpoint (BP): <=2 mg/ml [4]

Dosing:          (Azithromycin): 250-500 mg daily or 500mg three times a week

Regimens with a macrolide backbone are preferred due to improved outcomes. [3] The two most frequently used options are clarithromycin and azithromycin. Traditionally, clarithromycin has been the preferred macrolide. However, this agent is difficult to tolerate long-term due to gastrointestinal upset, making it a difficult option.[5] Thus, the improved tolerability of azithromycin has supplanted clarithromycin as the macrolide of choice for the treatment of M. abscessus [3].

Although preferred, macrolides are frequently one of the first classes of antibiotics to be eliminated due to drug resistance. The erm gene is one of the most common mutations that confer resistance to the macrolide class. This resistance is inducible upon macrolide initiation, and determination of this gene takes time for the laboratory to report. [6] Guidelines do support maintaining the use of macrolide therapy in the presence of the erm gene with the knowledge that its function would be reduced to that of an adjunct immunomodulator and that it should not be considered part of the active antimicrobial treatment regimen. [3] Therefore, when utilizing a macrolide, a fourth agent should be employed.

Carbapenems:

Breakpoint: <=1 [7]

Dosing           (Imipenem): 1000mg every 8 hours (adjust based on renal function)

Imipenem is the only carbapenem with a considerable amount of data against M. abscessus.

Although recommended as a first-line agent against M. abscessus, the in vitro data is mixed. Some studies report resistance from 2% to 88% of isolates. [5,811]

In vitro, synergistic activity with other agents helps overcome this resistance and provides a rationale for better clinical outcomes. [12]

Although effective, imipenem proves to be limited in its utility due to being dosed intravenously multiple times daily in most patients. Patients are thus required to have an intravenous central line to receive this long-term, complicating treatment adherence.

Cefoxitin:

Breakpoint: <=16 [13]

Dosing:         8-12gm/day in 2-3 divided doses (adjust based on renal function)

Cefoxitin is part of the cephamycin class of drugs and is commonly a preferred initial agent to be chosen in patients with M. abscessus.

Research groups have found M. abscessus to be largely susceptible to cefoxitin. Rates of resistance are approximately 5-15%, depending on the testing method. [8,14] However, one group found dramatically higher resistance rates in patients who were also clarithromycin-resistant. Resistance rates to cefoxitin in this subgroup were over 50% [15].

Using a nude mouse model, Lerat et al. demonstrated a significant decrease in bacterial load at two and three months using cefoxitin as monotherapy or in combination with clarithromycin and amikacin over an untreated control group [16]

Cefoxitin suffers from the same issue as imipenem in that it is only available intravenously, and the dosing is two or three times daily, making long-term compliance problematic. One group supports the idea of a continuous infusion to ensure appropriate therapeutic levels, but this also makes ongoing compliance difficult. [17] This relegates cefoxitin to the initial phase of treatment and is a difficult choice for long-term therapy.

Oxazolidinone:

Breakpoint: No FDA approved BP; consider <=2 [7]

Dosing:       Linezolid: 600mg daily

                    Tedizolid: 200mg daily

There are two options in this class: linezolid and tedizolid.

Linezolid tends to have a very good resistance profile for M. abscessus. Resistance rates for isolates were less than 10% in one trial, 91 of 99 isolates were either susceptible or intermediate. [18]. 

Cheng et al. compared the effectiveness and safety of 164 patients versus a control group with M. abscessus pulmonary disease. Patients who received treatment regimens with a linezolid backbone had a shorter time to culture conversion and a higher rate with a shorter time to lung cavity closure compared to those who did not take linezolid. However, the rates of culture conversion were the same between both groups. [19]

A newer oxazolidinone tedizolid has also been evaluated as an option. Tedizolid has been shown to be up to 4-fold more potent against M. abscessus compared to linezolid [2022]. The clinical difference between this is unclear currently but represents another treatment option.

Since both agents are available orally, they represent good long-term options, although susceptibility testing for these agents is not always available. If done, susceptibility can likely be inferred from linezolid to tedizolid, though not all providers may be comfortable with this.[20]  The chronic use of these agents can be limited by the potential onset of myelosuppression or peripheral neuropathy.

Amikacin:

Breakpoint: Breakpoints: <=16 [4], consider <=64 for pulmonary when using Amikacin liposomal

Dosing:         10-15 mg/kg IV daily or 15-25mg/kg three times a week.

Final dosing based on peak and trough levels

Amikacin is available in two different formulations: intravenous and inhaled.

Multiple studies have shown intravenous amikacin to have good clinical efficacy with culture conversion rates of 44-67% [2325]. However, these studies have also shown multiple patient AEs while on therapy, specifically ototoxicity and nephrotoxicity. Some of these climbed to 14% of patients studied. [25,26]

Multiple dosing schemes for intravenous amikacin have been developed to limit toxicity while maintaining efficacy. Three-time weekly dosing in non-tuberculosis mycobacterium [27,28] has become common as this strategy could potentially reduce the incidence of renal toxicity. It is important to monitor peaks/troughs, although the levels of drug needed to maximize efficacy in M. abscessus are unknown. [29]

For those patients with strictly pulmonary disease, inhaled amikacin can be a less toxic option.

Amikacin liposomal inhalation suspension (ALIS) is a product that is FDA-approved for mycobacterium avium complex lung disease. Data showing this drug’s utility for M. abscessus is compelling. Culture conversion rates range from 44%-50% in this cohort of patients. [30,31] Even in salvage therapy, ALIS met statistically significant culture-negative improvement at days 84 & 168. [32]. Utilization of ALIS delivers a therapeutic dose of amikacin while limiting renal and otic toxicity by giving this directly at the site of infection. [30]

Another limitation is that since M. abscessus is off-label, getting insurance to cover this product is difficult and typically requires peer-to-peer and/or prior authorizations. To obtain ALIS, the provider must work through the drug company access program. Once approved, the product is inhaled daily through a specialized nebulizer. The nebulizer does require daily cleaning and maintenance, which may make this therapy unsuitable for some patients. Pending data to come regarding off-label three-times-weekly dosing may make this easier for patients to use.

Omadacyline:

Breakpoint: No FDA-approved breakpoint, consider <=1

Dosing: 300mg daily

This agent has become an increasingly important option for therapy due to its potent in vitro and in vivo activity and synergy with other agents. [33,34]. Since this product is available as an intravenous and an oral formulation, the transition to long-term therapy is simplified.

Typically, omadacycline MICs are not tested, but clinicians can use tigecycline as a surrogate, as strong correlation between tigecycline and omadacycline MICs has been shown. [35]

In vitro testing has shown synergy with multiple agents, such as reducing the MICs when given in combination. [33]

Multiple groups had success utilizing omadacycline as part of a treatment regimen. One group reported up to 80% clinical success at three months and 76% at 12 months [36].

A larger cohort of patients was studied with less success, but 44% of patients had at least one negative culture. However, this group had a high number of dropouts due to adverse events and the high cost of the agent. [34]

The current cost of omadacycline likely places limits on this agent as a treatment that we can be broadly provided to patients.

Occasionally, when the oral formulation cannot be financially covered through insurance due to the pharmacy benefit not approving it, the intravenous option through the medical benefit may allow more options. Additionally, as alluded to, the limitations of this agent mainly come back to insurance coverage. Since Omadacyline is off-label for NTM, insurance will typically only cover the medication if a peer-to-peer authorization is completed. Other provider labor-intensive options for these patients include an assistance company called “the assistance fund,” which provides financial coverage for patients with NTM. Compassionate plea assistance from the company is also available.

Clofazimine:

Breakpoint:  <=1 mcg/mL

Dosing: 50-100mg PO daily; final dosing based on tolerability

Clofazimine has become the cornerstone of salvage treatment for resistant M. abscessus; this is despite the difficulty in access to availability, owing to the investigational nature of the drug and the numerous potential side effects.

Clofazimine has exhibited both in vitro and synergistic activity against M. abscessus [3739], making it an effective add-on oral treatment option.

Culture conversion has been seen in 24%-50% of patients with treatment-refractory disease. [40,41].

Adverse effects that may be seen include brownish skin discoloration, ichthyosis, photosensitivity, QT prolongation, and GI intolerance. In real-world practice, QT prolongation can be mitigated by avoiding the concomitant use of other QT-prolonging medications. The most common side effect is GI intolerance, with some groups reporting over 60%. [41] To help manage this adverse effect, the medication is best taken with food.

Drug acquisition is difficult in that it can only be obtained through an investigational new drug (IND) process that has to go through the Food and Drug Administration (FDA). Once the FDA IND is given, you then have to submit this to both your investigational review board and to the Novartis-sponsored portal for distribution of the medication.

If you are planning to treat numerous M. abscessus patients, an expanded access program for NTM patients may be utilized through the FDA. Patients must meet specific inclusion/exclusion criteria to obtain the medication without the requirement for an IND.

Once clofazimine is obtained, all adverse events are required to be submitted to both the FDA and the IRB according to good clinical practice regulations.

Lastly, clofazimine breakpoints are also not definitive across every source of infection or every indication. It is important to know that synergistic MICs are reported by some labs, and these can be helpful in situations where you have individuals with elevated clofazimine MICs.

Conclusion

Due to the complexity of therapy and an extended duration of treatment, other options continue to be explored to improve overall outcomes.

Using bedaquiline, rifabutin, and new Blamab inhibitor antibiotics show some promise as additional agents.[4246]

Although one regimen is hard to routinely recommend, we do know that a macrolide-based regimen is preferred if that is a starting option. The debate on whether a macrolide should be used in situations where it is resistant is still ongoing. Things to consider when choosing a regimen including need for potentially chronic intravenous therapy, patient renal and hepatic function status, drug penetration into the site of infection, and oral tolerability.

Lastly, it is important to note that the recommended length of treatment is variable. Many centers consider treatment complete when the patient is culture-negative for 12 months. An answer to this duration question may be forthcoming when the FORMAT trial is completed. This study is designed to find the optimal regimen for the treatment of M. Abscessus [47].

References

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