Real-world data backs clinical safety profile of Enspryng for NMOSD
Study: Elderly or male patients more likely to experience severe problems
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Most documented safety issues reported during Enspryng (satralizumab-mwge) treatment for neuromyelitis optica spectrum disorder (NMOSD) in a real-world database have been consistent with the therapy’s reported safety profile in clinical trials, a study showed.
Simultaneous use of corticosteroids, a common anti-inflammatory treatment in NMOSD, was associated with higher rates of infections and liver damage, the data showed. Also, elderly or male patients were more likely to experience severe safety problems.
“This real-world study highlights clinically relevant safety signals of [Enspryng] in NMOSD, identifies vulnerable patient subgroups, and supports risk-adapted monitoring strategies in neurological practice,” the researchers wrote. “Early recognition of high-risk clinical events … may facilitate timely intervention and mitigate progression to life-threatening outcomes.”
The study, “Real-world safety of satralizumab in neuromyelitis optica spectrum disorder: a FAERS-based risk stratification study,” was published in the Journal of Neurology.
Enspryng blocks activity of key signaling molecule
NMOSD is a rare condition marked by damaging inflammation of the spinal cord and optic nerve, which relays signals between the eyes and the brain. This can cause symptoms such as muscle weakness and vision problems.
Enspryng is an injection therapy approved to treat NMOSD patients who test positive for the most common type of disease-driving self-reactive antibodies, those targeting the AQP4 protein. Chugai Pharmaceutical, a member of the Roche group, sells the therapy.
It works by blocking the activity of an inflammatory signaling molecule called interleukin-6 (IL-6). By blocking this molecule, the therapy suppresses the immune system, thereby dampening the inflammatory attack that drives NMOSD.
Data from clinical trials have shown that Enspryng is effective for reducing the risk of disease flares in people with NMOSD, but as with any medication, Enspryng carries safety risks. Most notably, due to its immunosuppressive effects, the therapy can increase the risk of infections. Enspryng can also cause liver damage, low immune cell counts, and allergic reactions in some patients.
Adverse events possibly tied to Enspryng include pneumonia, COVID-19
Seeking to learn more about Enspryng’s real-world safety profile, a team of researchers in China dug through the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS), which allows doctors to report suspected reactions to various drugs in real-world practice.
FAERS can be an important tool for identifying safety problems that weren’t detected in clinical testing. However, an important caveat is that doctors are by definition simply reporting adverse events that occurred in patients taking a given drug. As such, it’s impossible to definitively conclude whether the drug itself caused the safety issue or if other factors might be at play.
“Because [Enspryng] is currently approved almost exclusively for NMOSD, reports were interpreted within the clinical context of NMOSD, although indication information was not uniformly available in FAERS,” the researchers wrote.
The analysis, which covered 1,174 cases (79.56% women) and 3,028 associated reports of adverse events suspected to be related to Enspryng, showed that the most commonly reported issues were infections, such as urinary tract infections, pneumonia (a lung infection), and COVID-19. Reports of liver damage were also fairly common.
The team noted that these data were generally consistent with the therapy’s known safety profile from clinical trials.
“This first comprehensive real-world pharmacovigilance study of [Enspryng] confirms previously established safety signals related to infections and [liver] abnormalities,” the researchers wrote.
There were also some reports of adverse events not previously linked to Enspryng. For example, there were many reports of broken bones. The researchers stressed, however, that underlying NMOSD may increase the risk of broken bones due to factors such as reduced mobility.
Our findings emphasize the importance of individualized safety surveillance during long-term [Enspryng] therapy in NMOSD.
Statistical analyses indicated that patients who were taking Enspryng plus corticosteroids, often used to help manage acute attacks in NMOSD, were more likely to experience infections and liver damage than those on Enspryng alone.
Again, the researchers stressed that this isn’t necessarily a cause-and-effect relationship — patients who were taking corticosteroids likely had more severe underlying disease, which may have contributed to these differences.
Still, the team recommended that clinicians “carefully balance therapeutic benefits against potential risks when co-prescribing these agents, particularly during periods of increased infection exposure or in patients with pre-existing liver dysfunction.”
Additional statistical tests showed that severe issues were significantly more common in males, individuals older than 65, and those with certain co-occurring health issues, including fluid in the lungs, aspiration pneumonia (a type of lung infection), poor kidney function, and septic shock (a life-threatening immune response to infection). These findings can help guide personalized monitoring for patients taking Enspryng, the researchers noted.
“Our findings emphasize the importance of individualized safety surveillance during long-term [Enspryng] therapy in NMOSD,” the researchers wrote. “Clinically, these findings support a risk-adapted monitoring approach: elderly male patients and those developing early signs of [body-wide] infection or respiratory compromise warrant closer surveillance and timely intervention to prevent progression to catastrophic outcomes while maintaining therapeutic benefit.”
