Literature Scan
Denosumab Versus Zoledronic Acid for Reducing Time to Skeletal Events in Multiple Myeloma
Approximately 90 percent of patients diagnosed with multiple myeloma ( MM ) present with bone lesions and are typically treated with zoledronic acid ( ZA ), a potentially nephrotoxic agent . In results from a phase III trial published in The Lancet Oncology , the monoclonal antibody denosumab was noninferior to ZA in delaying the time between MM diagnosis and first skeletal-related event , and had similar rates of adverse events ( AEs ).
Denosumab , which targets the RANK ligand ( a mediator of bone resorption ) is not renally cleared , explained the authors , led by Noopur Raje , MD , of Harvard Medical School in Boston . “ I certainly believe these data will impact clinical care , specifically in patients with renal impairment ,” Dr . Raje told ASH Clinical News . “ The progression-free survival ( PFS ) data for denosumab appear to favor denosumab use and , moreover , denosumab seems to be more convenient to use than other therapies .”
The authors compared the safety and efficacy of ZA and denosumab in 1,718 patients ( median age = 63 years ; range = 29-91 years ) with symptomatic , newly diagnosed MM in the randomized , double-blind trial . Participants also were considered at high risk for skeletal-related events , had an Eastern Cooperative
“ The PFS data for denosumab appear to favor denosumab use and , moreover , [ it ] seems to be more convenient to use than other therapies .”
30 ASH Clinical News
— NOOPUR RAJE , MD
Oncology Group performance status score of 0-2 , and presented with at least one lytic bone lesion . Patients were excluded if they had a baseline creatinine clearance < 30 mL / min .
ADYNOVATE ® is FDA approved for patients of all ages with Hemophilia A
Patients were randomized to either :
• subcutaneous denosumab 120 mg plus intravenous placebo every four weeks ( n = 859 )
PROVEN PROPHYLAXIS + SIMPLE ,* TWICE-WEEKLY
DOSING SCHEDULE = moments
• intravenous ZA 4 mg plus subcutaneous placebo every four weeks ( n = 859 )
Participants also received anti-MM therapy
Y OSING SCHEDULE =
THEIR WAY
* ADYNOVATE allows patients to infuse on the same 2 days every week .
ADYNOVATE [ Antihemophilic Factor ( Recombinant ), PEGylated ] Important Information
Indications
ADYNOVATE , Antihemophilic Factor ( Recombinant ), PEGylated , is a human antihemophilic factor indicated in children and adults with hemophilia A ( congenital factor VIII deficiency ) for :
• On-demand treatment and control of bleeding episodes
• Perioperative management
• Routine prophylaxis to reduce the frequency of bleeding episodes
Limitation of Use ADYNOVATE is not indicated for the treatment of von Willebrand disease .
DETAILED IMPORTANT RISK INFORMATION
CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE , to the parent molecule ( ADVATE [ Antihemophilic Factor ( Recombinant )]), mouse or hamster protein , or excipients of ADYNOVATE ( e . g . Tris , mannitol , trehalose , glutathione , and / or polysorbate 80 ).
WARNINGS & PRECAUTIONS Hypersensitivity Reactions
Hypersensitivity reactions are possible with ADYNOVATE . Allergic-type hypersensitivity reactions , including anaphylaxis , have been reported with other recombinant antihemophilic factor VIII products , including the parent molecule , ADVATE . Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema , chest tightness , dyspnea , wheezing , urticaria , and pruritus . Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur .