Background/Purpose: It is largely unknown whether it is safe to treat arthritis patients with a previous malignancy with biologics. Only a few studies have address the question of whether therapy with biologics influences the malignancy rate and mortality in patients with prior cancer and the results are conflicting. We aimed to study 1) the overall mortality and 2) the incidence of second cancers in arthritis patients treated with or without biologics after a primary cancer diagnosis.

Methods:  A total of 23,233 arthritis patients (RA:15,286, PSA:3196, MB:2189, other:2562) registered in the nationwide DANBIO database between January 2000 and Dec 2011 were included and linked to the Central Population Register (information on dates of death or emigration) and the Danish Cancer Registry (identification of all cancer cases). Follow-up for death and second cancer started at the date for diagnosis of the primary cancer or at entry in DANBIO whatever came latest. Information on recurrence of cancers was not available. Hazard Ratio (HR) for death and second cancer among arthritis patients ever receiving biologics compared with patients never receiving biologics were calculated using Cox proportional hazard models, adjusted for age, sex and calendar time.

Results:  A total of 2972 patients with a primary cancer were identified. Of these, 262 had been treated with biologics before the primary cancer diagnosis, 501 after and 244 both before and after, while 1965 cancer cases never had received biologics. The first biological treatment given after the primary cancer diagnosis among 745 patients were: adalimumab(25%), etanercept(23%), infliximab(29%), rituximab(16%) and other(7%). Among the 2972 cancer patients, HR for death in patients ever treated with biologics compared to never treated was slightly increased: 1.26(95%CI: 1.04-1.53). The same was observed among the non-cancer patients HR 1.38(95%CI 1.16-1.64) (data not shown). An increased risk for overall mortality including (HR 1.49) and excluding (HR 1.50) non-melanona skin cancer were observed in patients treated with biologics only before first cancer diagnosis. An increased risk of developing a second cancer was observed in arthritis patients treated with biologics both before and after primary cancer diagnosis, when non-melanoma skin cancers were excluded from the calculations (HR= 5.29), table.

Conclusion: Arthritis patients treated with biologics had a slightly increased mortality (≈30%) compared to patients never treated with biologics, and this increase was independent of whether they got cancer or not. Treatment with biologics after a primary cancer was associated with an increased risk for a second cancer.

 

Risk of death and second cancer in arthritis patients treated with biologics (bio) after a primary cancer.
Type of first cancer	Outcome	Bio treatment	Events	Person-years	HR (95% CI)
All types	Death
		Never bio	300	4155	1 (ref)
		Bio only after first cancer	59	1765	0.96 (0.70-1.32)
		Bio only before first cancer	111	457	1.49 (1.16-1.91)
		Bio both before and after first cancer	32	614	0.83 (0.56-1.21)
All types excluding non-melanoma skin cancer1	Death
		Never bio	257	2924	1 (ref)
		Bio only after first cancer	41	1024	1.07 (0.73-1.56)
		Bio only before first cancer	118	365	1.50 (1.18-1.93)
		Bio both before and after first cancer	27	236	0.95 (0.63-1.44)
All types	All types of second cancer
		Never bio	51	3793	1 (ref)
		Bio only after first cancer	22	1610	1.30 (0.76-2.25)
		Bio only before first cancer	9	454	1.19 (0.55-2.60)
		Bio both before and after first cancer	12	598	1.52 (0.79-2.94)
All types excluding non-melanoma skin cancer1	All types excluding non-melanoma skin cancer
		Never bio	47	2584	1 (ref)
		Bio only after first cancer	13	885	1.66 (0.82-3.36)
		Bio only before first cancer	8	338	0.47 (0.21-1.04)
		Bio both before and after first cancer	19	240	5.29 (2.98-9.40)
1Arthritis patients with non-melanoma skin cancer before entry in DANBIO but diagnosed with another cancer type after entry were included in the analysis.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/impact-of-biological-treatment-on-overall-mortality-and-on-incidence-of-second-cancers-in-arthritis-patients-a-follow-up-study-from-the-danish-danbio-registry/