Lack of adverse effect of anti‐tumor necrosis factor‐α biologics in treatment of rheumatoid arthritis: 5 years follow‐up

Dewedar, Ahmed; Shalaby, Medhat; Al-Homaid, Sulaiman; Mahfouz, Ahmed; Shams, Osama A.; Fathy, Ahmed

doi:10.1111/j.1756-185x.2012.01715.x

Cited by 18 publications

(11 citation statements)

References 31 publications

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“…Our findings are consistent with several published studies examining risks associated with different anti‐TNFs . One study that combined data from 4 major US databases reported that among patients with RA and other inflammatory diseases, the HZ risk was similar among different anti‐TNFs .…”

Section: Introductionsupporting

confidence: 92%

“…One study that combined data from 4 major US databases reported that among patients with RA and other inflammatory diseases, the HZ risk was similar among different anti‐TNFs . Similarly, using a cohort with 5 years of followup, another study showed that infliximab, adalimumab, and etanercept had comparable HZ risks and did not significantly increase HZ risk in comparison with nonbiologic disease‐modifying antirheumatic drugs (DMARDs) . In contrast, data from the German biologics register RABBIT suggested that adalimumab and infliximab may be associated with increased risk of HZ infection compared to etanercept .…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Risks of Herpes Zoster in Patients With Rheumatoid Arthritis According to Biologic Disease‐Modifying Therapy

Yun

Xie

Delzell

et al. 2015

Arthritis Care & Research

104

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Objective To evaluate whether the risks of herpes zoster (HZ) differed by biologic agents with different mechanisms of action (MOAs) in older rheumatoid arthritis (RA) patients. Methods Using Medicare data from 2006–2011, among RA patients with prior biologic agent use and no history of cancer or other autoimmune diseases, this retrospective cohort study identified new treatment episodes of abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, and tocilizumab. Followup started on initiation of the new biologic agent and ended at any of the following: first incidence of HZ, a 30‐day gap in current exposure, death, a diagnosis of other autoimmune disease or cancer, loss of insurance coverage, or December 31, 2011. We calculated the proportion of RA patients vaccinated for HZ in each calendar year prior to biologic agent initiation and HZ incidence rate for each biologic agent. We compared HZ risks among therapies using Cox regression adjusted for potential confounders. Results Of 29,129 new biologic treatment episodes, 28.7% used abatacept, 15.9% adalimumab, 14.8% rituximab, 12.4% infliximab, 12.2% etanercept, 6.1% tocilizumab, 5.8% certolizumab, and 4.4% golimumab. The proportion of RA patients vaccinated for HZ prior to biologic agent initiation ranged from 0.4% in 2007 to 4.1% in 2011. We identified 423 HZ diagnoses with the highest HZ incidence rate for certolizumab (2.45 per 100 person‐years) and the lowest for golimumab (1.61 per 100 person‐years). Neither the crude incidence rate nor the adjusted hazard ratio differed significantly among biologic agents. Glucocorticoid use had a significant association with HZ. Conclusion Among older patients with RA, the HZ risk was similar across biologic agents, including those with different MOAs.

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Section: Introductionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Risks of Herpes Zoster in Patients With Rheumatoid Arthritis According to Biologic Disease‐Modifying Therapy

Yun

Xie

Delzell

et al. 2015

Arthritis Care & Research

104

View full text Add to dashboard Cite

show abstract

“…Recently, some reports have described LD in patients receiving TNF-α inhibitors [22][23][24] and the relative risk for LD in patients treated with TNF-α inhibitor was between 16.5 and 21 compared to that for the overall population [22]. Although our patients received methotrexate and some reports described that the incidence of serious infections in patients with TNF-alpha inhibitor was not significantly higher than those with disease modifying anti-rheumatic drugs (DMARDs) [35,36], two in vivo studies have reinforced the notion of an increasing risk for LD among patients receiving TNF-α inhibitors. First, the administration of a TNF-α-neutralizing antibody to mice in vivo inhibited TNF-α activity and resulted in enhanced L. pneumophila growth in the mouse lung [37].…”

Section: Discussionmentioning

confidence: 84%

Detection of Legionella pneumophila serogroup 1 in blood cultures from a patient treated with tumor necrosis factor-alpha inhibitor

Kaku

Yanagihara

Morinaga

et al. 2013

Journal of Infection and Chemotherapy

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A 65-year-old man was admitted to our hospital with a fever of 39.3°C, cough, sputum and pharyngeal discomfort that had persisted for three days. Rheumatoid arthritis had been treated with methotrexate and adalimumab for two years and pancreatic metastasis of gastric cancer had been treated with S-1 (tegafur, gimeracil, and oteracil potassium) for two months. Regardless of the underlying pathologies, his general condition was good and he had worked as an electrician until two days before admission. However, his appetite had suddenly decreased from the day before admission, and high fever and hypoxia were also evident upon admission. A chest X-ray and computed tomography scan revealed left pleural effusion and consolidation in both lungs. The pneumonia severity index score was 165 and risk class was V. Accordingly, we started to treat the pneumonia with a combination of levofloxacin and meropenem. Thereafter, we received positive urinary antigen test (UAT) findings for Legionella pneumophila. Despite the application of appropriate antibiotics, vasopressors and oxygenation, the hypotension and hypoxia progressed and the patient died eight hours after admission. Even after his death, blood cultures had been continued to consider the possibility of bacterial co-infection. Although no bacteria were detected from blood cultures, Gimenez staining 3 revealed pink bacteria in blood culture fluids. Subsequent blood fluid culture in selective medium revealed L. pneumophila serogroup 1.

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“…Because there are no adequately powered head‐to‐head randomized clinical trials with hospitalized infection as the outcome, results of studies using registries and administrative databases to evaluate the risk of hospitalized infection among RA patients treated with various biologic medications are inconsistent . For example, one study using the Dutch Rheumatoid Arthritis Monitoring registry showed that the risk of serious infection in RA patients treated with etanercept was lower than that in patients treated with adalimumab or infliximab .…”

Section: Discussionmentioning

confidence: 99%

Comparative Risk of Hospitalized Infection Associated With Biologic Agents in Rheumatoid Arthritis Patients Enrolled in Medicare

Yun

Xie

Delzell

et al. 2015

Arthritis & Rheumatology

152

115

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Objective The risks of hospitalized infection associated with biologic agents used to treat rheumatoid arthritis (RA) are unclear. The aim of this study was to determine whether the associated risk of hospitalized infections differed between specific biologic agents used to treat RA. Methods In a retrospective cohort study using Medicare data from 2006–2011 for all enrolled patients with RA, new episodes of treatment with etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept, rituximab, and tocilizumab were identified. Patients were required to have received another biologic agent previously and to have been continuously enrolled in Medicare medical and pharmacy plans during the baseline period and throughout followup. Followup started on the date of initiation of treatment with the new biologic agent (after previous treatment with a different biologic agent) and ended on the date of the earliest hospitalized infection, at 12 months, after an exposure gap of >30 days, or at the time of death or loss of Medicare coverage. Cox regression analysis was used to calculate the adjusted hazard ratio (HR) for hospitalized infection, adjusting for an infection risk score and other confounders. Results Of 31,801 new biologic treatment episodes in patients who had previously received another biologic agent, 12.0% were with etanercept, 15.2% with adalimumab, 5.9% with certolizumab, 4.4% with golimumab, 12.4% with infliximab, 28.9% with abatacept, 14.8% with rituximab, and 6.3% with tocilizumab. During followup, we identified 2,530 hospitalized infections; incidence rates ranged from 13.1 per 100 person‐years (abatacept) to 18.7 per 100 person‐years (rituximab). After adjustment, etanercept (HR 1.24, 95% confidence interval [95% CI] 1.07–1.45), infliximab (HR 1.39, 95% CI 1.21–1.60), and rituximab (HR 1.36, 95% CI 1.21–1.53) had significantly higher HRs for hospitalized infection compared with abatacept. Conclusion In RA patients with prior exposure to a biologic agent, exposure to etanercept, infliximab, or rituximab was associated with a greater 1‐year risk of hospitalized infection compared with the risk associated with exposure to abatacept.

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Lack of adverse effect of anti‐tumor necrosis factor‐α biologics in treatment of rheumatoid arthritis: 5 years follow‐up

Abstract: Our results indicate that the use of TNFi therapy appeared to be as safe as traditional DMARDs in treatment of rheumatoid arthritis patients and long-term follow-up with careful examination is essential to pick up any abnormal ADEs.

Cited by 18 publications

References 31 publications

Risks of Herpes Zoster in Patients With Rheumatoid Arthritis According to Biologic Disease‐Modifying Therapy

Risks of Herpes Zoster in Patients With Rheumatoid Arthritis According to Biologic Disease‐Modifying Therapy

Detection of Legionella pneumophila serogroup 1 in blood cultures from a patient treated with tumor necrosis factor-alpha inhibitor

Comparative Risk of Hospitalized Infection Associated With Biologic Agents in Rheumatoid Arthritis Patients Enrolled in Medicare

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