Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Comparative research has gained attention in the field of Rheumatology. Evaluations of baseline characteristics in patients receiving similar treatments are critical in the conduct of comparative observational research to assess medication safety and effectiveness in rheumatoid arthritis (RA). Appropriate methods used in comparative research are critical. Making certain assumptions regarding the underlying distribution of baseline characteristics and the targeted population is important. Most patients receive TNF inhibitors (TNFi) as a first biologic for the treatment of RA; however, increasing numbers are starting with a non TNFi (NTNFi) biologic as an initial biologic treatment. The purpose of this analysis is to compare baseline characteristics of RA patients receiving abatacept (ABA) and other NTNFi with those taking TNFi as their first biologic.
Methods: RA patients in the National Data Bank for Rheumatic Diseases (NDB) provide treatment and other characteristics (demographics, comorbidities, and clinical status) through self-reported biannual questionnaires. Data during the period of 2005 through 2013 were used as this timeframe includes data when the first NTNFi biologics were marketed. We also limited analyses to patients who completed a questionnaire within 6-months prior to initiating their first biologic. P-values were based on ANOVA test for continuous and Chi2 tests for categorical measures.
Results: A total of 2,125 RA patients (1,916 TNFi; 129 NTNFi; 80 ABA) initiated their first biologic therapy after 2005. ABA patients were significantly older and have a higher proportion of diabetes and cancer when compared to TNFi (see Table). ABA patients reported significantly higher pain, fatigue, and activity scores than TNFi initiators. When compared to the NTNFi patients, ABA patients are older and reported slightly higher baseline pain. The NTNFi patients are more likely to have diabetes and hypertension.
|
ABA (N=80) |
TNFi (N=1,916) |
NTNFi (N=129) |
|
|
Age (yrs)* BMI (kg/m2) Disease Duration (yrs) |
64.6 (12.5) 29.2 (6.2) 13.3 (13.5) |
58.5 (12.7) 28.9 (7.1) 14.2 (10.9) |
60.8 (13.4) 29.1 (6.7) 14.3 (11.1) |
|
Ever Smoked (%) |
51.3 |
52.3 |
56.6 |
|
Comorbidity Index (0-9)* |
2.2 (1.8) |
1.6 (1.5) |
2.1 (1.7) |
|
Cancer (%)* |
32.5 |
19.2 |
31.8 |
|
Hypertension (%)* Diabetes (%)* Hospitalized Infection (%) Congestive Heart Disease (%) |
33.8 13.8 0.0 0.0 |
35.2 10.5 1.5 0.6 |
47.3 17.1 2.3 0.0 |
|
Prednisone (%) |
38.8 |
32.7 |
37.2 |
|
MTX (%)* Other DMARD (%) HAQ (0-3)* Pain VAS (0-10)* Fatigue VAS (0-10)* Patient Activity Scale (0-10)* |
65.0 22.5 1.2 (0.7) 5.1 (3.0) 5.4 (3.3) 4.2 (2.2) |
67.5 15.2 1.0 (0.7) 4.2 (2.8) 4.6 (3.1) 3.1 (0.7) |
45.7 24.8 1.2 (0.7) 4.4 (2.9) 5.3 (3.1) 3.4 (0.7) |
*P value < 0.05
Conclusion: RA patients who receive a NTNFi as their first biologic differ from those initiating TNFi. Proper application of statistical methods and careful examination of baseline characteristics including co-morbid chronic conditions, prior/concomitant medications and biologic use is critical when performing comparative effectiveness analyses. Line of therapy should also be considered in future comparative research analyses.
Disclosure:
K. Michaud,
None;
K. Gandhi,
Bristol-Myers Squibb,
3;
T. Simon,
Bristol-Myers Squibb,
3;
S. Pedro,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/are-patients-with-rheumatoid-arthritis-initiating-a-tnf-biologic-comparable-to-patients-initiating-a-non-tnf/