Real world patient profile and step up dosing process of early initiators of teclistamab for multiple myeloma in US hospitals An analysis using the Premier Healthcare Database summary

What is PACUPod: Oncology?

PACUPod is your trusted source for evidence-based insights tailored to advanced clinical pharmacists and physicians. Each episode dives into the latest primary literature, covering medication-focused studies across oncology, and many more. We break down study designs, highlight key findings, and objectively discuss clinical implications—without the hype—so you stay informed and ready to apply new evidence in practice. Whether you’re preparing for board certification or striving for excellence in patient care, PACUPod helps you make sense of the data, one study at a time.

Britany: Welcome back to PACULit, everyone. Today, we’re diving into a fascinating real-world study on teclistamab, a bispecific T-cell engager for relapsed or refractory multiple myeloma. Seth, it’s great to have you here to unpack this with me.

Seth: Thanks, Britany. I’m excited to discuss this. Teclistamab has been a game changer in RRMM, but understanding how it’s used outside clinical trials is crucial. The study by Tan and colleagues really sheds light on that.

Britany: Absolutely. Multiple myeloma remains incurable despite advances, and patients with relapsed or refractory disease have limited options. Teclistamab targets BCMA and CD3, engaging T cells to attack myeloma cells. But with this mechanism come risks like cytokine release syndrome, or CRS, and neurotoxicity, which require close monitoring.

Seth: Right, and the pivotal MajesTEC-1 trial demonstrated teclistamab’s efficacy and safety, but it enrolled younger, healthier patients under controlled conditions. So, the big question is: how does this translate to the real world, especially in older, more comorbid populations?

Britany: Exactly. That’s the knowledge gap this study aimed to fill. They used the Premier Healthcare Database, a large US hospital claims database, to analyze early initiators of teclistamab in routine clinical practice. They focused on the inpatient step-up dosing process, critical for mitigating CRS risk.

Seth: The step-up dosing, or SUD, is a gradual increase in teclistamab dose over several days, designed to reduce CRS severity by allowing the immune system to adjust.

Britany: Yes, typically a three-step process. The study looked at how hospitals implemented this in real life, including patient demographics, dosing schedules, and safety outcomes. Real-world patients tend to be older and have more comorbidities than trial participants.

Seth: That’s key. The study included adult RRMM patients initiating teclistamab from FDA approval through early post-marketing. They excluded those without complete dosing or hospitalization data, or those in clinical trials if identifiable. So, it’s a clean real-world cohort.

Britany: What stood out was the patient profile. The median age was notably higher than in MajesTEC-1, with many having cardiovascular and renal comorbidities. This reflects the typical US hospital population more accurately.

Seth: Absolutely. This makes the findings highly relevant for everyday practice. The study confirmed inpatient administration of step-up doses was common, likely due to the need for close monitoring during initial dosing.

Britany: Right, inpatient SUD allows rapid intervention if CRS or neurotoxicity occurs. The study reported CRS incidence consistent with MajesTEC-1, mostly low-grade and manageable with standard supportive care.

Seth: That’s reassuring. It suggests the safety profile observed in trials holds true in a broader, more complex population. Did the study mention how CRS was managed?

Britany: Yes, frequent use of tocilizumab and corticosteroids for CRS management was noted, aligning with established guidelines. Importantly, no unexpected safety signals emerged, and neurotoxicity events were rare.

Seth: That highlights the importance of institutional protocols for monitoring and managing adverse events during SUD. The study also emphasized resource utilization, noting longer hospital stays during step-up dosing.

Britany: Exactly. Hospitalization for SUD is resource-intensive but justified given the safety benefits. The study compared inpatient versus outpatient SUD practices internationally, noting variability.

Seth: I found that interesting. Some centers in Europe and Asia explore outpatient SUD with close monitoring, but US hospitals tend to favor inpatient administration, especially for older or comorbid patients.

Britany: That’s a critical clinical pearl. Patient selection for outpatient SUD requires careful consideration of comorbidities, social support, and access to emergency care. The study supports inpatient SUD as a safer default in many US settings.

Seth: Agreed. Another point is the lack of direct comparative studies between inpatient and outpatient SUD strategies—an evidence gap.

Britany: Yes, and the authors called for standardized protocols to optimize safety and resource use. Given teclistamab’s expanding use, this is timely.

Seth: Now, about drug interactions. Teclistamab’s T-cell activation means concomitant immunosuppressants could blunt efficacy or increase infection risk.

Britany: Right, many patients were on corticosteroids or other supportive meds. Clinicians must balance immunosuppression to manage CRS without compromising anti-myeloma activity.

Seth: That’s delicate. Also, renal impairment is common in MM patients. The study included patients with varying renal function; dosing wasn’t adjusted, aligning with current labeling.

Britany: Correct. No increased toxicity was observed in patients with renal comorbidities, which is encouraging. Still, vigilance is necessary given complex pharmacodynamics.

Seth: The study highlighted the importance of multidisciplinary teams—pharmacists, nurses, physicians—to manage dosing, monitoring, and adverse event mitigation effectively.

Britany: Clinical pharmacists play a vital role in educating patients and staff, ensuring adherence to step-up dosing schedules, and monitoring for drug interactions.

Seth: Regarding special populations, the study referenced elderly cohorts confirming favorable safety outcomes with teclistamab. This supports its use in older patients who often have limited options.

Britany: Absolutely. It’s encouraging to see real-world evidence backing safety and feasibility in vulnerable groups. International data from China and Korea showed broadly comparable safety profiles, suggesting generalizability.

Seth: That’s important globally. However, practice patterns differ, with some centers favoring outpatient administration or modified dosing schedules. These variations highlight the need for tailored approaches.

Britany: Indeed. The findings reinforce that while teclistamab is generally well tolerated, institutional protocols must adapt to local resources and patient populations.

Seth: To sum up, this study provides valuable insights into real-world teclistamab use, confirming inpatient step-up dosing as a safe, effective strategy for RRMM patients, especially older or comorbid ones.

Britany: Absolutely, Seth. It bridges the gap between trial data and everyday practice, helping clinicians optimize treatment delivery and patient safety.

Seth: And it underscores the need for ongoing research into outpatient SUD feasibility, predictors of severe CRS, and standardized management protocols.

Britany: Exactly. Any final clinical pearls?

Seth: First, always anticipate CRS during initial dosing and have tocilizumab readily available. Second, engage a multidisciplinary team early. Third, consider patient-specific factors like comorbidities and social support when deciding inpatient versus outpatient dosing.

Britany: Great takeaways. For me, real-world data like this study are invaluable for informing clinical workflows and resource planning, ensuring safe, effective care.

Seth: Couldn’t agree more. Thanks for the great discussion, Britany.

Britany: Thank you, Seth. And thanks to our listeners for tuning in. Stay ahead of the curve with PACULit, where clinical literature meets practical application. Until next time!