A recent study was conducted to determine whether the concurrent use of denosumab with a biologic disease-modifying antirheumatic drug (bDMARD), such as adalimuab, etanercept, or infliximab, increases the risk of infection.
Rheumatoid arthritis (RA) is associated with a number of comorbidities, including osteoporosis. The known risk of bone loss in patients with RA lead physicians to prescribe additional therapies, such as oral bisphosphonates or denosumab, for osteoporosis. A recent study, published in The Journal of Rheumatology, was conducted to determine whether the concurrent use denosumab with a biologic disease-modifying antirheumatic drug (bDMARD), such as adalimumab, etanercept, or infliximab, increases the risk of infection.
Denosumab is a fully human monoclonal antibody that binds to the receptor activator of nuclear factor-xB ligand (RANKL) and blocks the interaction of RANKL with its receptor on the surface of osteoclasts and osteoclast precursors. This leads to a reduction in osteoclast number and activity, a decrease in bone resorption, an increase in bone mass, and a reduction in vertebral and nonvertebral fracture risk.
RANKL is expressed in activated T and B lymphocytes and in lymph nodes; therefore, there is a hypothetical possibility that denosumab may increase the risk of infections due to the inhibition of the RANK pathway. Previous studies have suggested that exposure to multiple biologic agents, each carrying an independent elevated risk of infection, may be associated with an even higher risk of infection.
The study’s participants were chosen from patients from 2 academic rheumatology practices in Canada between July 1, 2010 and July 31, 2014. The medical records from these rheumatology practices during the designated time period included about 3000 patients taking bDMARD therapy. Eligible patients for the study fit into the following criteria: 18 years or older with an RA diagnosis, received 1 or more injection or infusion, or filled a prescription for a bDMARD for RA during the study period.
Patients in the concurrent therapy group (n = 102) were required to have a moderate to high risk of fracture and to have received 1 or more injection of denosumab while taking a bDMARD.
Conversely, patients in the bDMARD-only group (n = 206) never received denosumab during the study period. The patients in the concurrent group were matched 1:2 to patients receiving solely a bDMARD.
There were 3 serious infection events reported in the concurrent group, and 4 serious infection events and 1 opportunistic infection event reported in the bDMARD-only group. The most commonly reported type of infection was pneumonia. The rates of serious or opportunistic infections were 1.22 per 100 patient-years (95% confidence interval [CI]; range, —0.25 to 3.56) in the concurrent group and 0.98 per 100 patient-years (95% CI; range, 0.32 to 2.29) in the bDMARD-only group, with a rate difference of 0.24.
The study showed that the occurrence of serious infections was low in patients with RA treated concurrently with a bDMARD and denosumab, and in patients treated with a bDMARD alone. This data should encourage patients that their drug regimen is unlikely to cause infections or other illnesses.
Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD
May 18th 2024A real-world study in Spain on inflammatory bowel disease (IBD) patients found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars
May 15th 2024At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.