Incidence Rates of Adverse Events with Death As an Outcome during Abatacept Treatment in RA: Results from an Integrated Data Analysis from 16 Clinical Trials

D Fleming¹, TA Simon¹, A Torbeyns², U Meier-Kriesche¹ and A Johnsen¹, ¹Bristol-Myers Squibb, Princeton, NJ, ²Bristol-Myers Squibb, Braine l’Alleud, Belgium

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Abatacept, death, drug safety and safety

Session Information

Date: Monday, November 6, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster II: Prognostic Factors, Imaging and Miscellaneous Reports

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Patients with RA have a 1.5–2-fold increased risk of mortality compared with the general population. The association between mortality rates and different RA treatments has been investigated: increased (glucocorticoids),¹ decreased (MTX),² and no impact of treatment on mortality (TNF inhibitors)³ have been reported. To date, the impact of treatment with the selective T-cell co-stimulation modulator abatacept on mortality across clinical trials have not been comprehensively reported. Methods: The risk of mortality in adult patients with RA treated with abatacept was investigated using an integrated safety database, which included 16 short- and long-term clinical trials of both SC and IV abatacept (N=7044). Of the 16 trials in this analysis, 9 were double-blind (DB), placebo-controlled studies (n=4138; non-biologic DMARD was a background therapy for all patients). Incidence rates (IRs) (95% CI) per 100 person-years (p-y) of deaths were calculated as the number of patients experiencing an event with death as the outcome divided by the total number of p-y of exposure. The p-y of exposure was censored at the time of onset of the first event with an outcome of death, discontinuation, or end of study. Results: Most patients were women; mean duration of RA was 8 years and <10% had a history of a prior biologic therapy (Table 1). During the DB, controlled period, IRs for overall deaths were 0.5 and 1.0 in the abatacept and placebo groups, respectively, with overlapping 95% CIs (Table 2). The most frequent causes of death were in the cardiovascular and infection System Organ Classes. In the cumulative population on abatacept, the most frequent causes of death were pneumonia (IR [95% CI]: 0.09 [0.05, 0.14]) and cardiac arrest (0.05 [0.03, 0.09]). IRs were similar with overlapping 95% CIs within each age group, with the highest IR in patients aged >65 years (1.73 [1.3, 2.3]), as expected. These rates are within the ranges reported in the literature.

Conclusion: The data from this ongoing assessment of abatacept safety are consistent with the current known benefit–risk profile of abatacept. In the DB phases, the overall IRs of death (95% CI) were 0.5 (0.3, 0.9) on abatacept and 1.0 (0.5, 1.6) on plabebo. In the cumulative abatacept population, IR was 0.7 (0.5, 0.8), similar to both the DB population and published literature.

1. Sihvonen S, et al. J Rheumatol 2006;33:1740–6.

2. Choi HK, et al. Lancet 2002;359:1173–7.

3. Jacobsson LT, et al. Ann Rheum Dis 2007;66:670–5.

Disclosure: D. Fleming, Bristol-Myers Squibb, 3; T. Simon, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1, 9; A. Torbeyns, Bristol-Myers Squibb, 3; U. Meier-Kriesche, Bristol-Myers Squibb, 3; A. Johnsen, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3.

To cite this abstract in AMA style:

Fleming D, Simon T, Torbeyns A, Meier-Kriesche U, Johnsen A. Incidence Rates of Adverse Events with Death As an Outcome during Abatacept Treatment in RA: Results from an Integrated Data Analysis from 16 Clinical Trials [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/incidence-rates-of-adverse-events-with-death-as-an-outcome-during-abatacept-treatment-in-ra-results-from-an-integrated-data-analysis-from-16-clinical-trials/. Accessed .

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