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Abstract Number: 842

Risk of Serious Infection in Patients with Rheumatoid Arthritis Treated with Biologic Vs. Non-Biologic Dmards

Gulsen Ozen1, Sofia Pedro2, Bryant R. England3, Bella Mehta4, Frederick Wolfe2 and Kaleb Michaud1, 1Rheumatology, University of Nebraska Medical Center, Omaha, NE, 2National Data Bank for Rheumatic Diseases, Wichita, KS, 3Division of Rheumatology & Immunology, Department of Internal Medicine, Nebraska-Western IA VA Health Care System & University of Nebraska Medical Center, Omaha, NE, 4Rheumatology, Hospital for Special Surgery/Weill Cornell Medical College, New York, NY

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Biologic drugs, Epidemiologic methods, infection and rheumatoid arthritis (RA)

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Session Information

Date: Sunday, November 5, 2017

Session Title: Epidemiology and Public Health I: Lung, Bone, and Infection Outcomes

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: Serious infections (SIs) are a major concern in RA patients, significantly contributing to increased mortality. We examined the SI risk associated with bDMARDs compared to csDMARDs in a US-wide observational RA cohort.

Methods: RA patients initiating bDMARDs or csDMARDs from 2001 through 2016 in the National Data Bank for Rheumatic Diseases (NDB) were assessed for SIs (infection + intravenous antibiotics, hospitalization or death). DMARDs were categorized into 3 groups: (1) csDMARDs-reference (bDMARD naive) (2) TNF inhibitors (TNFi) (3) Non-TNFi biologics (abatacept, rituximab, tocilizumab, and anakinra). Each patient contributed to the last DMARD reached. Followup continued until the first SI, DMARD discontinuation, death, or end of study period. SIs were attributed to the corresponding DMARD group when the treatment was ongoing or discontinued ≤3 months before SI. Propensity scores (PS) reflecting the probability of receiving a specific DMARD were calculated using multinomial logistic regression models with characteristics at treatment initiation. PS was added to the Cox models as a continuous variable along with time-varying confounders (age, disease duration, comorbidities, HAQ, pain and patient global scores, weighted cumulative exposure [WCE] of glucocorticoids [GC], prior sDMARDs and bDMARDs counts) of which changes over time might alter the SI risk.

Results: 694 (5.9%) first SIs were identified in 11,623 RA patients during a 27,552 patient-years of follow-up. TNFi and non-TNFi biologics-initiators had significantly higher disease activity, disability, and comorbidity scores than csDMARDs initiators. Crude incidence rate (95% CI) in TNFi group was non-significantly higher than csDMARD and non-TNFi biologic initiators (Figure). The PS-only adjusted model showed a non-significant SI risk increase with TNFi (HR 1.11[0.91-1.34], P= 0.309) and non-TNFi biologics (HR 1.26 [0.95-1.68], P= 0.102) whereas further adjustment for time-varying confounders revealed significantly increased risk of SI with both TNFi (HR 1.33 [1.05-1.68], P= 0.019) and non-TNFi (HR 1.48 [1.02-2.16], P= 0.041) compared to csDMARDs. Other factors associated with SI are presented in Table.

Conclusion: TNFi and non-TNFi biologics were associated with an increased SI risk in RA compared to csDMARDs. In addition to DMARDs, older age, comorbidity burden, pulmonary disease, higher disability, disease activity, and cumulative GC exposure were predictive of SI. Assessment and modification of these factors should be completed before and during bDMARD treatment to minimize SI risk.

 


Table. Risk of serious infections in rheumatoid arthritis by treatment: results from the Cox proportional hazard models with propensity scores* and time–varying confounders

 

Adjusted HR (95% CI)

P value

Age, years

 

 

<50

Reference

–

50-64

1.39 (1.03-1.89)

0.034

≥65

2.31 (1.70-3.12)

<0.001

Annual income > $45,000

0.70 (0.57-0.84)

0.001

Rheumatic disease comorbidity index

1.20 (1.13-1.26)

<0.001

Selected comorbidities

 

 

Diabetes

1.15 (0.94-1.41)

0.174

Pulmonary disease

1.46 (1.21-1.77)

<0.001

Disease duration, years

1.00 (0.99-1.01)

0.852

HAQ disability

1.27 (1.10-1.47)

0.001

Pain scale

1.04 (1.00-1.08)

0.050

Patient global scale

1.06 (1.02-1.11)

0.008

WCE-prednisone

1.33 (1.22-1.45)

<0.001

Count of prior csDMARDs

1.11 (1.05-1.17)

<0.001

Count of prior bDMARDs

0.90 (0.80-1.02)

0.095

DMARD groups

 

 

csDMARDs

Reference

–

TNFi

1.33 (1.05-1.68)

0.019

Non-TNFi biologics

1.48 (1.02-2.16)

0.041

* Propensity score was estimated based on the following characteristics at the time of treatment initiation: age, gender, ethnicity, insurance, annual income, RA disease duration, smoking status, rheumatic diseases comorbidity index, HAQ, pain and patient global scores, GC use, prior csDMARDs and bDMARDs counts, prior serious infection, and calendar year.

 

WCE=Weighted cumulative exposure of glucocorticoid as prednisone equivalent doses: The weights assigned to past doses were estimated using a flexible cubic spline-based method.

 


Disclosure: G. Ozen, None; S. Pedro, None; B. R. England, None; B. Mehta, None; F. Wolfe, None; K. Michaud, None.

To cite this abstract in AMA style:

Ozen G, Pedro S, England BR, Mehta B, Wolfe F, Michaud K. Risk of Serious Infection in Patients with Rheumatoid Arthritis Treated with Biologic Vs. Non-Biologic Dmards [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/risk-of-serious-infection-in-patients-with-rheumatoid-arthritis-treated-with-biologic-vs-non-biologic-dmards/. Accessed April 1, 2023.
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