SUMMARY

• Janssen does not recommend the use of CARVYKTI in a manner that is inconsistent with the approved labeling.
• Janakiram et al (2025)¹ presented a retrospective longitudinal cohort study evaluating healthcare resource utilization (HCRU) following CARVYKTI infusion in inpatient (IP) and outpatient (OP) settings using claims data from January 1, 2016 to June 30, 2024.

CLINICAL DATA: REAL-WORLD

Janakiram et al (2025)¹ presented a retrospective longitudinal cohort study evaluating HCRU following CARVYKTI infusion in both IP and OP settings.

Study Design/Methods

• The study utilized open claims data from the Komodo Research Database, covering the period from January 1, 2016 to June 30, 2024.
• The index date was defined as the date of CARVYKTI infusion on or after February 28, 2022 (date of CARVYKTI Food and Drug Administration [FDA] approval).
• The baseline period was defined as the 12-month period prior to the index date.
• The follow-up period was defined as the period from the index date to the earliest of 30 days after infusion, end of clinical activity, death, or end of data availability.
• Inclusion criteria (N=517)
  • CARVYKTI after ≥4 prior lines of therapy on or after February 28, 2022
  • ≥1 diagnosis for multiple myeloma (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM]: C90.0) on or prior to index date
  • ≥18 years of age as of index date
  • ≥12 months of clinical activity prior to index date
• Exclusion criteria (N=275)
  • ≥1 diagnosis of amyloidosis (ICD-10-CM: E85.x) prior to index date
  • Clinical trial participation on or prior to index date (ICD-10-CM: Z00.6; Healthcare Common Procedure Coding System [HCPCS]: S9988, S9990, S9991, S9992, S9994, S9996)
  • No claims for lymphodepleting therapy agents (ie, cyclophosphamide, fludarabine, or bendamustine) in the 14 days prior to or the 30 days after index date
• Endpoints: adverse events, related management strategies, 30-day mortality rate, and HCRU.

Results

Treatment Disposition, Baseline Demographics, and Disease Characteristics

• A total of 242 patients (IP, n=148; OP, n=94) were enrolled in the study. Patient characteristics and baseline demographics are presented in Table: Baseline Patient Demographic and Clinical Characteristics.

Adverse Events and Management Strategies

• Adverse events and management strategies in IP and OP cohorts are presented in Table: Adverse Events and Management Strategies After Infusion.

HCRU

• Details of hospitalization after CARVYKTI infusion in the IP and OP cohorts are presented in Tables: HCRU During the First 30 Days After Infusion: IP Cohort and HCRU During the First 30 Days After Infusion: OP Cohort.
• The mean number of hospitalization days in patients with ≥1 IP day over the first 30 days after CARVYKTI infusion was significantly higher for the IP cohort vs OP cohort (14.9 days [range, 1-30] vs 7.7 days [range, 1-26]; P<0.001). Hospitalization days are presented in Table: Mean Number of Hospitalization Days in Patients After Infusion With ≥1 IP Day.
• Hospitalization was not needed in 31.9% of patients (n=30) in the OP cohort within the first 30 days after CARVYKTI infusion.

Limitations

• The study was conducted using open claims; therefore, visits outside of the network may not be captured in the data.
• Although the study cohorts were relatively comparable, adjusted comparisons were not conducted; therefore, results may be affected by residual confounding.
• Risk of misclassification may exist due to possible inaccuracies in diagnosis, procedure, or drug codes, as well as differences in recording of these events between cohorts.

Literature Search

A literature search of Ovid MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 25 September 2025.