Effects of daratumumab injection: A Synthesis of Findings from 13 Studies

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Original Abstract of the Article

Main Research Findings

Daratumumab is a monoclonal antibody targeting CD38, a protein expressed on the surface of multiple myeloma (MM) cells. 3 It is a key component in the treatment of both newly diagnosed and relapsed/refractory MM and AL amyloidosis. 3 Traditionally, daratumumab was administered intravenously (IV), requiring extended infusion times and associated with higher rates of infusion-related reactions (IRRs) compared to the subcutaneous (SC) formulation. 3 However, recent research has shown that subcutaneous administration of daratumumab is a safe and effective alternative to IV administration. 8 10 12 11 9 5 6 2 SC daratumumab provides similar or slightly higher trough concentrations (Ctrough) compared to IV daratumumab, with lower maximum concentrations and smaller peak-to-trough fluctuations. 8 11 This suggests that SC daratumumab is well-tolerated and achieves similar efficacy to IV daratumumab. 11 The non-inferiority of SC daratumumab to IV daratumumab has been confirmed in large clinical trials, such as the phase 3 COLUMBA study. 10 2 Additionally, SC daratumumab has been shown to significantly reduce the incidence of systemic reactions. 5 Furthermore, SC administration significantly reduces infusion chair time, resulting in less time spent in healthcare settings, a relevant practical consideration for patient care, especially during the COVID-19 pandemic. 3 2

Benefits and Risks

Benefits Summary

Subcutaneous administration of daratumumab offers several advantages over intravenous administration: reduced infusion times, less time spent in healthcare settings, fewer infusion-related reactions, and similar or slightly higher trough concentrations, leading to a potentially more stable drug level in the body. 3 8 11 9 6 2 These benefits translate to a less burdensome treatment experience for patients.

Risks Summary

While SC daratumumab is generally well-tolerated, potential risks include infusion reactions, although these are generally mild and less frequent compared to IV administration. 12 11 Some studies have reported a higher incidence of neutropenia in patients with lower body weight. 8 Therefore, careful monitoring is essential, especially for patients with pre-existing conditions.

Comparison of Studies

Similarities

The studies reviewed consistently show a reduced rate of infusion reactions with SC daratumumab compared to IV administration. 3 12 11 9 6 Furthermore, studies consistently highlight the reduced administration time associated with SC daratumumab. 3 10 9 6 2

Differences

Some differences exist in the findings regarding the pharmacokinetic profile of SC daratumumab. 8 11 While most studies suggest similar or improved drug exposure with SC administration, some report a higher incidence of neutropenia in patients with lower body weight. 8 These discrepancies may be due to variations in study design, patient populations, or other factors. 8 Further research is needed to fully understand these discrepancies.

Consistency and Contradictions

The majority of the research supports the conclusion that SC daratumumab is a safe and effective alternative to IV administration. 3 8 10 12 11 9 5 6 2 While there are some conflicting findings related to neutropenia in certain patient subgroups, further research is warranted to clarify these discrepancies. 8

Considerations for Real-World Application

SC daratumumab offers a less burdensome treatment option for patients with MM. 3 8 10 9 6 2 However, it is essential to consider the potential risk of neutropenia in certain patients, especially those with lower body weight. 8 Close monitoring and personalized treatment plans are crucial for optimizing patient outcomes.

Limitations of Current Research

The existing body of research on SC daratumumab is still relatively limited. 8 5 6 More studies are needed to explore the long-term safety and efficacy of SC daratumumab, especially in specific patient populations, such as those with low body weight or advanced age. 8 2 Research on optimal monitoring strategies for hypersensitivity reactions following SC daratumumab administration is also lacking. 5 Further research is needed to address these gaps in knowledge.

Future Research Directions

Future research on SC daratumumab should focus on addressing current limitations and expanding our understanding of this treatment approach. 8 5 6 This includes conducting long-term studies to evaluate safety and efficacy in various patient populations, investigating the role of SC daratumumab in combination therapy, and developing strategies for optimal monitoring and management of potential adverse events. 8 5 6 Furthermore, research on the optimal use of SC daratumumab in the ambulatory care setting would be valuable. 5

Conclusion

SC daratumumab has emerged as a promising alternative to IV administration for patients with MM, offering several advantages, including reduced infusion times, fewer infusion reactions, and similar or potentially improved efficacy. 3 8 10 12 11 9 5 6 2 However, the potential risk of neutropenia in certain patients, especially those with lower body weight, requires careful monitoring. 8 Further research is essential to fully elucidate the nuances of SC daratumumab and optimize its use for improved patient outcomes.

Literature analysis of 13 papers
Positive Content
12
Neutral Content
1
Negative Content
0
Article Type
3
0
0
2
13
1.

Comparison of the pharmacodynamic effects of deflazacort and prednisolone in healthy subjects.

Author: BabadjanovaG, AllolioB, VollmerM, ReinckeM, SchulteH M

Anti-inflammatory
Glucocorticoid
Adverse effects

The study focused on the equipotency ratio of deflazacort versus other glucocorticoids for the assumption of fewer adverse effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma.

Author: MateosMaria-Victoria, RigaudeauSophie, BasuSupratik, SpickaIvan, SchotsRik, WrobelTomasz, CookGordon, BeksacMeral, GriesKatharine S, KudvaAnupa, TrompBrenda, Van RampelberghRian, PeiHuiling, WroblewskiSusan, CarsonRobin, DelioukinaMaria, WhiteDarrell

Improved patient care
Reduced administration time

Intravenous daratumumab (DARA IV) plus bortezomib/melphalan/prednisone (ALCYONE) or lenalidomide/dexamethasone (Rd; MAIA) is more effective than standard treatments for transplant-ineligible newly diagnosed multiple myeloma. Patients can switch from DARA IV to subcutaneous daratumumab (DARA SC) while on daratumumab monotherapy in ALCYONE or daratumumab plus Rd in MAIA. DARA SC has been shown to be noninferior to DARA IV and reduces administration time, allowing patients to spend less time in healthcare settings.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Intra-articular delivery of full-length antibodies through the use of an in situ forming depot.

Author: Fayd'herbe De MaudaveAlexis, LeconetWilhem, ToupetKarine, ConstantinidesMichael, BossisGuillaume, de ToledoMarion, VialaretJérôme, HirtzChristophe, Lopez-NoriegaAdolfo, JorgensenChristian, NoëlDaniele, Louis-PlencePascale, GrizotSylvestre, VillalbaMartin

Autoimmune disease treatment
Cancer treatment

A local controlled-delivery approach using in situ forming depot technology effectively delivers monoclonal antibodies (mAbs) to targeted tissues, reducing off-target effects and enhancing efficacy. This approach demonstrates promise for local delivery of clinically relevant mAbs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

Transition from Intravenous to Subcutaneous Daratumumab Formulation in Clinical Practice.

Author: HamadehIssam S, MooreDonald C, MartinAllison, KarabinosAllison, HillHailey, NdiayeAmi, RobinsonJordan D, PaulBarry A, AtrashShebli, BhutaniManisha, VoorheesPeter M, UsmaniSaad Z

Multiple myeloma treatment

This review discusses best practices for the safe administration of subcutaneous daratumumab, an anti-CD38 monoclonal antibody used to treat multiple myeloma.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study.

Author: IidaShinsuke, IshikawaTakayuki, MinChang Ki, KimKihyun, YehSu Peng, UsmaniSaad Z, MateosMaria-Victoria, NahiHareth, HeuckChristoph, QinXiang, ParasrampuriaDolly A, GriesKatharine S, QiMing, BahlisNizar, ItoShigeki

Multiple myeloma treatment
Cytopenias

This subgroup analysis of Asian patients from the COLUMBA study showed that subcutaneous daratumumab (DARA SC) was comparable to intravenous daratumumab (DARA IV) in terms of efficacy, pharmacokinetic profile, safety, and patient-reported satisfaction.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Equivalence TrialA clinical trial designed to show that a new treatment is equivalent in efficacy/safety to an existing treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

8.

Exposure-Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients.

Author: LuoMan Melody, UsmaniSaad Z, MateosMaria-Victoria, NahiHareth, ChariAjai, San-MiguelJesus, TouzeauCyrille, SuzukiKenshi, KaiserMartin, CarsonRobin, HeuckChristoph, QiMing, ZhouHonghui, SunYu-Nien, ParasrampuriaDolly A

Similar efficacy and safety
Subcutaneous alternative
Higher risk in smaller patients
Neutropenia risk

This study reports population pharmacokinetic (PK) and exposure-response analyses of a novel subcutaneous formulation of daratumumab (DARA) using data from four clinical trials. The results support the DARA 1800-mg subcutaneous flat dose as an alternative to the approved intravenous DARA 16 mg/kg, with similar efficacy and safety profiles.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

An evaluation of subcutaneous daratumumab for the treatment of multiple myeloma.

Author: PaulBarry, AtrashShebli, BhutaniManisha, VoorheesPeter, HamadehIssam, UsmaniSaad Z

Decreased infusion times
Reduced infusion reactions

Daratumumab, a monoclonal antibody targeting CD38, has recently been approved for the treatment of multiple myeloma in both newly diagnosed and relapsed refractory settings. This review discusses the recent FDA approval of a subcutaneous formulation of daratumumab, which promises to decrease infusion times and infusion reactions in myeloma patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial.

Author: MateosMaria-Victoria, NahiHareth, LegiecWojciech, GrosickiSebastian, VorobyevVladimir, SpickaIvan, HungriaVania, KorenkovaSibirina, BahlisNizar, FlogegardMax, BladéJoan, MoreauPhilippe, KaiserMartin, IidaShinsuke, LaubachJacob, MagenHila, CavoMichele, HulinCyrille, WhiteDarrell, De StefanoValerio, ClemensPamela L, MastersonTara, LantzKristen, O'RourkeLisa, HeuckChristoph, QinXiang, ParasrampuriaDolly A, YuanZhilong, XuSteven, QiMing, UsmaniSaad Z

Myeloma treatment

This study (COLUMBA) evaluated the non-inferiority of subcutaneous daratumumab to intravenous daratumumab for the treatment of patients with multiple myeloma. Subcutaneous daratumumab is considered easier to administer and may cause fewer administration-related reactions.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

11.

Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma.

Author: UsmaniSaad Z, NahiHareth, MateosMaria-Victoria, van de DonkNiels W C J, ChariAjai, KaufmanJonathan L, MoreauPhilippe, OriolAlbert, PlesnerTorben, BenboubkerLotfi, HellemansPeter, MastersonTara, ClemensPamela L, LuoMan, LiuKevin, San-MiguelJesus

MM treatment
Subcutaneous administration
Infusion reactions
Thrombocytopenia

This study investigates the safety and pharmacokinetics of subcutaneously administered daratumumab in combination with rHuPH20 in patients with relapsed or refractory multiple myeloma (MM). The subcutaneous administration was well-tolerated, with PK concentrations and responses consistent with IV daratumumab.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Results of an early access treatment protocol of daratumumab in United States patients with relapsed or refractory multiple myeloma.

Author: ChariAjai, LonialSagar, MarkTomer M, KrishnanAmrita Y, Stockerl-GoldsteinKeith E, UsmaniSaad Z, LondheAnil, EtheredgeDelores, FlemingSarah, LiuBaolian, UkropecJon, LinThomas S, JagannathSundar, NookaAjay K

Consistent with previous studies
Safe
Infusion reactions

Daratumumab was well-tolerated and showed a consistent safety profile in heavily pretreated patients with relapsed or refractory multiple myeloma (MM). The most common adverse events were thrombocytopenia, anemia, and infusion reactions. Montelukast premedication may help to reduce the rate of infusion reactions.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Managing Infusion Reactions to New Monoclonal Antibodies in Multiple Myeloma: Daratumumab and Elotuzumab.

Author: NookaAjay K, GleasonCharise, SargeantMarva Ollivierre, WalkerMichelle, WatsonMelanie, PanjicElyse Hall, LonialSagar

Myeloma treatment
Reduced infusion time
Infusion-related reactions

This article reviews the use of monoclonal antibodies, elotuzumab and daratumumab, for treating multiple myeloma. It discusses the incidence of infusion-related reactions and their management, highlighting the importance of pre- and post-infusion medication strategies to reduce these adverse events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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