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The risk of cancer in patients with rheumatoid arthritis taking tumor necrosis factor antagonists: a nationwide cohort study.

Wu CY, Chen DY, Shen JL, Ho HJ, Chen CC, Kuo KN, Liu HN, Chang YT, Chen YJ - Arthritis Res. Ther. (2014)

Bottom Line: We compared 4426 new users of TNF-α antagonists and 17704 users of nbDMARDs with similar baseline covariate characteristics.On modified Cox proportional hazards analysis, the risk of cancer was significantly reduced in subjects in biologics cohort (adjusted HR 0.63, 95% CI 0.49 to 0.80, P < .001), after adjusting for age, gender, disease duration, major co-morbidities, and prior use of DMARDs and corticosteroids.However, there was an increased risk for hematologic cancers in biologics cohort, yet without statistical significance.

View Article: PubMed Central - PubMed

ABSTRACT

Introduction: The association between cancer and use of biologic therapy among rheumatoid arthritis (RA) patients remains controversial. We aimed to compare the relative risk of cancer development between RA patients taking tumor necrosis factor α (TNFα) antagonists and those taking nonbiologic disease-modifying anti-rheumatic drugs (nbDMARDs).

Methods: We conducted a nationwide cohort study between 1997 and 2011 using the Taiwan National Health Insurance Research Database. The risk of newly diagnosed cancer was compared between patients starting TNF-α antagonists (biologics cohort) and matched subjects taking nbDMARDs only (nbDMARDs cohort). Cumulative incidences and hazard ratios (HR) were calculated after adjusting for competing mortality. Standardized incidence ratio (SIR) was calculated for cancer risk. Multivariate analyses were performed using Cox proportional hazards model.

Results: We compared 4426 new users of TNF-α antagonists and 17704 users of nbDMARDs with similar baseline covariate characteristics. The incidence rates of cancer among biologics and nbDMARDs cohorts were 5.35 (95% confidence interval (CI) 4.23 to 6.46) and 7.41 (95% CI 6.75 to 8.07) per 1000 person-years, respectively. On modified Cox proportional hazards analysis, the risk of cancer was significantly reduced in subjects in biologics cohort (adjusted HR 0.63, 95% CI 0.49 to 0.80, P < .001), after adjusting for age, gender, disease duration, major co-morbidities, and prior use of DMARDs and corticosteroids. However, there was an increased risk for hematologic cancers in biologics cohort, yet without statistical significance. The effect of biologics was consistent across all multivariate stratified analyses and the association between biologics use and cancer risk was independent of dosage of concomitant nbDMARDs.

Conclusion: These findings suggested that RA patients taking TNF-α antagonist are associated with a lower risk of cancer, but not for hematologic cancers, than RA patients taking nbDMARDs alone.

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Related in: MedlinePlus

Flow chart of study subject selection. RA, rheumatoid arthritis; RCIPD, Registry for Catastrophic Illness Patient Database; NHIRD, Taiwan National Health Insurance Research Database; DMARD, disease-modifying anti-rheumatic drug.
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Fig1: Flow chart of study subject selection. RA, rheumatoid arthritis; RCIPD, Registry for Catastrophic Illness Patient Database; NHIRD, Taiwan National Health Insurance Research Database; DMARD, disease-modifying anti-rheumatic drug.

Mentions: We identified 47,531 potentially eligible RA patients from the RCIPD. A total of 2,763 patients who never received DMARDs were excluded. Among the remaining 44,768 subjects, 6,871 patients with a history of biologics use including TNFα antagonists and rituximab were eligible for inclusion in the biologics group and the remaining 37,897 patients who had never used biologics were eligible to be included in the nbDMARDs group. We excluded 2,445 patients in the eligible biologics group who received biologics or traditional DMARDs for less than 3 months; or were followed up for less than 6 months, after starting biologics treatments. Next, we matched four subjects in the eligible nbDMARDs cohort with each subject in the biologics cohort, based on the matching criteria listed in Methods. Finally, the biologics group and the nbDMARDs group consisted of 4,426 and 17,704 patients, respectively, as shown in Figure 1.Figure 1


The risk of cancer in patients with rheumatoid arthritis taking tumor necrosis factor antagonists: a nationwide cohort study.

Wu CY, Chen DY, Shen JL, Ho HJ, Chen CC, Kuo KN, Liu HN, Chang YT, Chen YJ - Arthritis Res. Ther. (2014)

Flow chart of study subject selection. RA, rheumatoid arthritis; RCIPD, Registry for Catastrophic Illness Patient Database; NHIRD, Taiwan National Health Insurance Research Database; DMARD, disease-modifying anti-rheumatic drug.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4201718&req=5

Fig1: Flow chart of study subject selection. RA, rheumatoid arthritis; RCIPD, Registry for Catastrophic Illness Patient Database; NHIRD, Taiwan National Health Insurance Research Database; DMARD, disease-modifying anti-rheumatic drug.
Mentions: We identified 47,531 potentially eligible RA patients from the RCIPD. A total of 2,763 patients who never received DMARDs were excluded. Among the remaining 44,768 subjects, 6,871 patients with a history of biologics use including TNFα antagonists and rituximab were eligible for inclusion in the biologics group and the remaining 37,897 patients who had never used biologics were eligible to be included in the nbDMARDs group. We excluded 2,445 patients in the eligible biologics group who received biologics or traditional DMARDs for less than 3 months; or were followed up for less than 6 months, after starting biologics treatments. Next, we matched four subjects in the eligible nbDMARDs cohort with each subject in the biologics cohort, based on the matching criteria listed in Methods. Finally, the biologics group and the nbDMARDs group consisted of 4,426 and 17,704 patients, respectively, as shown in Figure 1.Figure 1

Bottom Line: We compared 4426 new users of TNF-α antagonists and 17704 users of nbDMARDs with similar baseline covariate characteristics.On modified Cox proportional hazards analysis, the risk of cancer was significantly reduced in subjects in biologics cohort (adjusted HR 0.63, 95% CI 0.49 to 0.80, P < .001), after adjusting for age, gender, disease duration, major co-morbidities, and prior use of DMARDs and corticosteroids.However, there was an increased risk for hematologic cancers in biologics cohort, yet without statistical significance.

View Article: PubMed Central - PubMed

ABSTRACT

Introduction: The association between cancer and use of biologic therapy among rheumatoid arthritis (RA) patients remains controversial. We aimed to compare the relative risk of cancer development between RA patients taking tumor necrosis factor α (TNFα) antagonists and those taking nonbiologic disease-modifying anti-rheumatic drugs (nbDMARDs).

Methods: We conducted a nationwide cohort study between 1997 and 2011 using the Taiwan National Health Insurance Research Database. The risk of newly diagnosed cancer was compared between patients starting TNF-α antagonists (biologics cohort) and matched subjects taking nbDMARDs only (nbDMARDs cohort). Cumulative incidences and hazard ratios (HR) were calculated after adjusting for competing mortality. Standardized incidence ratio (SIR) was calculated for cancer risk. Multivariate analyses were performed using Cox proportional hazards model.

Results: We compared 4426 new users of TNF-α antagonists and 17704 users of nbDMARDs with similar baseline covariate characteristics. The incidence rates of cancer among biologics and nbDMARDs cohorts were 5.35 (95% confidence interval (CI) 4.23 to 6.46) and 7.41 (95% CI 6.75 to 8.07) per 1000 person-years, respectively. On modified Cox proportional hazards analysis, the risk of cancer was significantly reduced in subjects in biologics cohort (adjusted HR 0.63, 95% CI 0.49 to 0.80, P < .001), after adjusting for age, gender, disease duration, major co-morbidities, and prior use of DMARDs and corticosteroids. However, there was an increased risk for hematologic cancers in biologics cohort, yet without statistical significance. The effect of biologics was consistent across all multivariate stratified analyses and the association between biologics use and cancer risk was independent of dosage of concomitant nbDMARDs.

Conclusion: These findings suggested that RA patients taking TNF-α antagonist are associated with a lower risk of cancer, but not for hematologic cancers, than RA patients taking nbDMARDs alone.

Show MeSH
Related in: MedlinePlus