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S15 Ep44: Subcutaneous Isatuximab via On-Body Injector Has Noninferior Efficacy vs IV Delivery in Myeloma: With Sikander Ailawadhi, MD; and Beth Faiman, CNP, PhD

Jan 30, 2026
Sikander Ailawadhi, MD, a Mayo Clinic myeloma researcher, and Beth Faiman, CNP, PhD, a Cleveland Clinic hematology practitioner, talk about subcutaneous isatuximab delivered via an on-body injector. They cover trial design showing noninferior efficacy to IV, practical advantages like hands-free delivery and fewer reactions, body-weight considerations, home administration pilots, and implications for patient access and convenience.
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INSIGHT

OBI Matches IV Efficacy And PK

  • The ARACALIA trial showed subcutaneous isatuximab via an on-body injector (OBI) was noninferior to IV for efficacy and pharmacokinetics.
  • The OBI had >99% successful injections and similar safety compared with IV administration.
INSIGHT

Small-Gauge OBI Lowers Reaction Risk

  • The OBI uses a thin 30-gauge hidden needle for low-pressure, hands-free delivery.
  • Sub-Q OBI administration produced almost no infusion-related reactions compared with initial IV anti-CD38 infusions.
INSIGHT

Body Habitus Could Affect Sub-Q Absorption

  • Subcutaneous delivery raises concerns about variable absorption across body habitus versus IV's full bioavailability.
  • The study specifically evaluated how BMI extremes might affect drug levels and clinical outcomes.
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