Occurrence of Serious Infection in Patients with Rheumatoid Arthritis Treated with Biologics and Denosumab Observed in a Clinical Setting

Lau, Arthur; Wong-Pack, Matthew; Rodjanapiches, Rod; Ioannidis, George; Wade, Sally; Spangler, Leslie; Balasubramanian, Akhila; Pannacciulli, Nicola; Lin, Celia J F; Roy-Gayos, Patrick; Bensen, W.; Bensen, Robert; Adachi, Jonathan D.

doi:10.3899/jrheum.161270

Cited by 25 publications

(19 citation statements)

References 18 publications

(22 reference statements)

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“…41 In a chart review of 308 patients with rheumatoid arthritis in two Canadian rheumatology practices, there was a low risk of serious and opportunistic infections in patients with rheumatoid arthritis and in patients treated with denosumab plus another biologic. 42 Taken as a whole, recognizing the limitations of these studies, there is no convincing evidence for increased infection risk by combining denosumab and another biologic. Large prospective randomized trials are needed to settle the issue with certainty.…”

Section: Infection Risk Combining Denosumab With Another Biologic Agentmentioning

confidence: 99%

New and emerging concepts in the use of denosumab for the treatment of osteoporosis

Lewiecki

2018

Therapeutic Advances in Musculoskeletal

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Denosumab is a fully human monoclonal antibody to receptor activator of nuclear factor kappa-B ligand (RANKL), a cytokine expressed by cells of the osteoblast lineage that is a key regulator of osteoclastic bone resorption. By binding and neutralizing RANKL, denosumab inhibits osteoclast differentiation, activity, and survival. Clinical trials in postmenopausal women with osteoporosis have shown that it reduces the risk of vertebral fractures, nonvertebral fractures, and hip fractures, with a generally favorable safety profile. With a dose of 60 mg subcutaneously every 6 months, it is approved for: treatment of postmenopausal women and men with osteoporosis, and for women and men with glucocorticoid-induced osteoporosis who are at high risk for fracture; treatment to increase bone mass in men at high risk for fracture receiving androgen-deprivation therapy for nonmetastatic prostate cancer; and treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Atypical femur fractures and osteonecrosis of the jaw have been reported in patients treated with denosumab. Discontinuation of denosumab is followed by rapidly rising bone turnover markers, decreasing bone density, and vertebral fracture risk that returns to baseline, with a possible increase in the risk of multiple vertebral fractures. Further study is needed to clarify this potential risk. After stopping long-term denosumab, patients should be switched to another antiresorptive agent to maintain the benefit achieved with denosumab.

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Section: Infection Risk Combining Denosumab With Another Biologic Agentmentioning

confidence: 99%

New and emerging concepts in the use of denosumab for the treatment of osteoporosis

Lewiecki

2018

Therapeutic Advances in Musculoskeletal

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“…Studies of denosumab in postmenopausal osteoporosis indicate an increased risk of skin and soft tissue infections . However, no infection safety signals have been found in studies of denosumab in patients receiving concurrent immunomodulatory treatment for rheumatoid arthritis and among patients receiving concomitant chemotherapy for solid‐organ tumors …”

Section: Pharmacologic Osteoporosis Treatmentmentioning

confidence: 99%

Osteoporosis Management in the Era of COVID-19

Tsourdi

Clarke

et al. 2020

Journal of Bone and Mineral Research

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Osteoporosis is a chronic condition that reflects reduced bone strength and an associated increased risk for fracture. As a chronic condition, osteoporosis generally requires sustained medical intervention(s) to limit the risks for additional bone loss, compromise of skeletal integrity, and fracture occurrence. Further complicating this issue is the fact that the abrupt cessation of some therapies can be associated with an increased risk for harm. It is in this context that the COVID-19 pandemic has brought unprecedented disruption to the provision of health care globally, including near universal requirements for social distancing. In this Perspective, we provide evidence, where available, regarding the general care of patients with osteoporosis in the COVID-19 era and provide clinical recommendations based primarily on expert opinion when data are absent. Particular emphasis is placed on the transition from parenteral osteoporosis therapies. It is hoped that these recommendations can be used to safely guide care for patients with osteoporosis until a return to routine clinical care standards is available.

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“…However, analysis have not confirmed that this risk extends to the combination of biologic used for RA and denosumab. There is a low absolute risk of serious infection while on denosumab [32] and a recent small retrospective study reported a low risk of serious infection and opportunistic infection in patients receiving both a RA biologic and denosumab [33]. In RA patients treated with a biologic, the risk of serious infection with denosumab appears no higher than being on zoledronic acid [34].…”

Section: Concomitant Therapymentioning

confidence: 99%

Prediction of infection risk in rheumatoid arthritis patients treated with biologics: are we any closer to risk stratification?

Jani

Barton

Hyrich

2019

Current Opinion in Rheumatology

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Purpose of review There are currently several available biologics for rheumatoid arthritis (RA) with similar efficacy in most trials. A major consideration therefore in choosing a biologic, continues to be safety concerns such as infection. Considerable advances have been made in the understanding of biologic safety on a population level; however, how close are we to stratifying risk for individual patients? This review discusses evidence published in the last year, with reference to key previous literature. Recent findings Comparative safety of biologics has been studied in observational cohorts, with a possible increased risk of serious infection in tocilizumab-treated patients compared with etanercept. Rheumatoid arthritis patients on biologics are often on concomitant medications such as steroids and opioids, and the advances in relation to infection are summarized. Pharmacological biomarkers and optimizing existing risk prediction scores may allow better future risk stratification. Summary Improved quantification of personalized benefit:harms would allow better-informed decisions, reduction of infection-associated morbidity as well as direct/indirect costs associated with biologics. Although advances have been made to better understand and predict risk, future studies are likely to require a range of novel data sources and methodologies for the goal of precision medicine to be truly realized.

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Occurrence of Serious Infection in Patients with Rheumatoid Arthritis Treated with Biologics and Denosumab Observed in a Clinical Setting

Cited by 25 publications

References 18 publications

New and emerging concepts in the use of denosumab for the treatment of osteoporosis

New and emerging concepts in the use of denosumab for the treatment of osteoporosis

Osteoporosis Management in the Era of COVID-19

Prediction of infection risk in rheumatoid arthritis patients treated with biologics: are we any closer to risk stratification?

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