Session Information
Session Type: ACR Late-breaking Abstract Session
Session Time: 9:00AM-11:00AM
Background/Purpose:
The safety of treatment with biological DMARDs (bDMARDs) has been carefully studied for the past 15 years, however, it is still largely unknown whether this treatment is safe in arthritis patients with a history of cancer. We studied the risk of a second malignant neoplasm (SMN) and mortality in rheumatoid arthritis (RA) patients with a history of a primary cancer diagnosis and treated with bDMARDs.
Methods:
In total, 1678 RA patients registered in the DANBIO Register during 2000-2011, had a primary cancer according to the Danish Cancer Registry. Hazard Ratios (HR) for SMN and death were calculated.
Results:
There were 190 RA patients who had received bDMARDs before their primary cancer diagnosis only, 220 only after, 92 both before and after, while 1176 arthritis patients with cancer had never received bDMARDs. Among 502 patients ever treated with bDMARDs, the HR (cancer site adjusted) for developing a SMN was 1.11 (95% Confidence interval (CI) 0.74-1.67) compared with never treated, Table 1. The HR for death among patients treated with bDMARDs before the primary cancer diagnosis only, was 1.53 (95% CI 1.13-2.09). After further adjustment for extent of the primary cancer, the HR for death was 1.20 (95% CI 0.88-1.63) among patients treated with bDMARDs before the primary cancer diagnosis only, 1.36 (95% CI 0.78-2.39) among patients treated only after the cancer and 1.22 (95% CI 0.70-2.13) among patients treated both before and after the cancer.
Conclusion:
RA patients with a history of cancer and treated with bDMARDs had no increased risk of a SMN compared with never treated. No clear conclusion can be drawn regarding mortality in bDMARD-treated patients.
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Table 1. Risk of a second malignant neoplasm (SMN) in rheumatoid arthritis patients according to biological DMARD treatment |
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Treatment |
SMN, N |
Person-years |
HR1 (95% CI) |
|
NeverbDMARDs (N=1176) |
70 |
2461 |
1 (ref.) |
|
Ever bDMARDs (N=502) |
38 |
1225 |
1.11 (0.74-1.67) |
|
bDMARDs only before first cancer |
11 |
272 |
1.06 (0.52-2.14) |
|
bDMARDs after first cancer |
27 |
953 |
1.13 (0.71-1.80) |
|
bDMARDs only after first cancer |
21 |
760 |
1.15 (0.68-1.95) |
|
bDMARDs both before and after first cancer |
6 |
193 |
1.09 (0.46-2.57) |
|
TNF-I after |
21 |
723 |
1.21 (0.73-2.03) |
|
Rituximab after |
7 |
235 |
1.05 (0.47-2.34) |
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Abbreviations: DMARD, Disease modifying anti-rheumatic drug; HR, Hazard Ratio; TNF-I, tumour necrosis factor-alpha inhibitor. 1 Adjusted for age, gender, calendar time and cancer site |
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Table 2 Observed number of deaths (Obs) and overall mortality in rheumatoid arthritis patients with cancer according to biological DMARD treatment |
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All N=1678 |
Extent of disease recorded N= 1326 |
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Treatment |
Deaths Obs |
Person-years |
Adjusted1 HR (95% CI) |
Deaths Obs |
Person- years |
Adjusted1 HR (95% CI) |
Further adjusted2 HR (95% CI) |
|
NeverbDMARDs |
207 |
2461 |
1 (ref.) |
150 |
2022 |
1 (ref.) |
1 (ref.) |
|
Ever bDMARDs |
135 |
1225 |
1.25 (0.99-1.57) |
110 |
982 |
1.35 (1.04-1.76) |
1.23 (0.94-1.60) |
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bDMARDs only before first cancer |
93 |
272 |
1.50 (1.15-1.97) |
75 |
214 |
1.53 (1.13-2.09) |
1.20 (0.88-1.63) |
|
bDMARDs after first cancer |
42 |
953 |
0.92 (0.64-1.31) |
35 |
767 |
1.08 (0.73-1.61) |
1.29 (0.86-1.94) |
|
bDMARDs only after first cancer |
23 |
760 |
1.01 (0.62-1.65) |
20 |
640 |
1.19 (0.69-2.04) |
1.36 (0.78-2.39) |
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bDMARDs both before and after first cancer |
19 |
193 |
0.85 (0.52-1.38) |
15 |
128 |
0.99 (0.57-1.73) |
1.22 (0.70-2.13) |
|
TNF-I after |
35 |
723 |
0.96 (0.66-1.41) |
29 |
568 |
1.13 (0.73-1.74) |
1.42 (0.91-2.20) |
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Rituximab after |
9 |
235 |
0.86 (0.43-1.72) |
8 |
205 |
1.13 (0.54-2.40) |
1.11 (0.53-2.35) |
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Abbreviations: DMARD, Disease modifying anti-rheumatic drug; HR, Hazard Ratio; TNF-I, tumour necrosis factor-alpha inhibitor. 1 Adjusted for age, gender, calendar time, cancer site 2 Further adjusted for extent of disease |
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Disclosure: L. Dreyer, MSD, UCB and Janssen Pharmaceutical, 8; R. Cordtz, None; I. M. J. Hansen, Roche Pharmaceuticals, 2; L. E. Kristensen, Pfizer, AbbVie, Amgen, UCB, Celgene, BMS, Biogen, Forward Pharma, MSD, Novartis, Eli Lilly, and Janssen pharmaceuticals, 8; M. Lund Hetland, AbbVie, BMS, MSD, Pfizer, Orion, Novartis, Biogen, Eli Lilly, Celltrion, 2; L. Mellemkjær, None.
To cite this abstract in AMA style:
Dreyer L, Cordtz R, Hansen IMJ, Kristensen LE, Lund Hetland M, Mellemkjær L. Risk of Second Malignant Neoplasm and Mortality in Rheumatoid Arthritis Patients Treated with Biological Dmards: A Danish Population-Based Cohort Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/risk-of-second-malignant-neoplasm-and-mortality-in-rheumatoid-arthritis-patients-treated-with-biological-dmards-a-danish-population-based-cohort-study/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/risk-of-second-malignant-neoplasm-and-mortality-in-rheumatoid-arthritis-patients-treated-with-biological-dmards-a-danish-population-based-cohort-study/